JPH067450A - Medical tube - Google Patents

Abstract

PURPOSE:To continuously mold a tube main body by burying a reinforcing member over the whole length in a tube main body on the outer periphery of a main lumen, providing an expansion body around the outer periphery of the tip section of the tube main body, and providing an inflation lumen communicated with the inside of the expansion body at one end. CONSTITUTION:A main lumen 3 is formed along the longitudinal direction of a flexible tube main body 2 on a bronchial tube 1, and an inflation lumen 5 is provided in parallel with it. A extendable/shrinkable cuff 6 communicated with the inflation lumen 5 via a side hole 11 is provided to surround the outer periphery of the tube main body 2 near the tip 22 of the tube main body 2. A spiral reinforcing member 4 made of resin is buried over the whole length of the tube main body 2 in the tube main body 2. The tube main body 2 having an excellent kink preventing function can be continuously molded by the cutting of a lengthy object, and the labor and cost for production can be reduced.

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 an expandable body, and more particularly to an endotracheal tube used for general anesthesia during surgery, artificial respiration control after surgery, and long-term respiration control.

[0002]

2. Description of the Related Art Conventionally, a medical tube having an expandable / contractible expandable body such as an endotracheal tube has been used.

As shown in FIG. 5, an endotracheal tube 40
Is inserted into the trachea 43 of the patient 42, and air is supplied using a syringe or the like to the check valve 4 at the rear of the pilot balloon 44.
By press-fitting through 1, the cuff 45 at the distal end is expanded and fixed in the trachea 43 so as to seal the trachea, and through the connector 46 and the flexible tube 47 attached to the proximal end thereof, anesthesia not shown. Used by connecting to a ventilator or artificial respirator.

Such an endotracheal tube causes a bend (kink) when the patient 42 is inserted into the trachea 43,
There is a problem that the main lumen formed in the tube or the inflation lumen for sending air for inflating the cuff may be blocked. In particular, when performing surgery related to the brain or otolaryngology, the patient is often placed in a special posture such as lying down, and thus, the 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. 60-15339). .

However, such a medical tube has the following drawbacks.

[1] In order to form the tip of the tube into a predetermined shape (end processing) and to allow the connector to be attached to the base end of the tube, both ends of the tube are
It is necessary to form a portion having no metal wire. The method is performed, for example, by preparing a separate member such as a short tube in which the metal wire is not buried, and joining it, or when winding the metal wire around the inner tube that becomes the core in the tube manufacturing process. , Partially avoid winding the wire. However, in these methods, a great deal of labor is required for the production, and since the tubes have to be produced one by one, the productivity is low and the cost is high.

[2] When the tube is used, the base end of the tube may be cut in order to adjust the length of the tube according to the case. However, as described in [1] above, the base of the tube may be cut. Since there is a portion at the end that does not have the metal wire of the length necessary for mounting the connector, the length of the tube cannot be adjusted by cutting the base end, or even if it can be cut, Significantly limited in length.

[3] In the case of an endotracheal tube, in consideration of its usage state, the tube is molded so as to be curved when no external force is applied (natural state), but a tube in which a metal wire is embedded Since the shape of the tube in its natural state depends on the elasticity of the metal wire, it is difficult to make such a bend, especially when the tube is made of a highly flexible material such as silicone.

[4] The tube itself is usually composed of a soft resin such as soft polyvinyl chloride or silicone rubber or an elastomer, but the adhesion between these and the embedded metal wire is poor, and the metal wire is peeled off. I have something to do.

[5] Should the outer surface of the tube be damaged by a tooth or the like, the embedded metal wire may be exposed and the human tissue may be damaged.

[0012]

DISCLOSURE OF THE INVENTION An object of the present invention is to make it possible to continuously mold the tube body in a tube having a kink preventing function, which can reduce the labor and cost of manufacturing and is optimal. The object is to provide a medical tube which can easily obtain various shapes and dimensions and which has higher safety.

[0013]

The above object is achieved by the present invention described in (1) and (2) below. Further, the following (3) to (6) are preferable.

(1) A tube body having flexibility,
A main lumen formed along the longitudinal direction of the tube body, a resin reinforcing member embedded in the tube body on the outer periphery of the main body along the entire length of the tube body, and a tip of the tube body. Medical device having an expandable / contractible expander provided around the outer peripheral surface of the tube main body near the portion, and an inflation lumen provided at the tube main body and having one end communicating with the inside of the expandable body tube.

(2) a tube body having flexibility,
A main lumen formed along the longitudinal direction of the tube body, a resin reinforcing member embedded in the tube body on the outer periphery of the main body along the entire length of the tube body, and a tip of the tube body. In the vicinity of the portion, an expandable / contractible expansion body provided so as to surround the outer peripheral surface of the tube body, and an inflation lumen provided in the tube body and having one end communicating with the inside of the expansion body, The maximum thickness of the reinforcing member in the thickness direction is 1.
A medical tube having a bending rigidity of 0 mm or less and a bending rigidity of 150 gf or more.

(3) The medical device according to (1) or (2) above, wherein the reinforcing member is hollow, and the lumen of the reinforcing member communicates with the inside of the expansion body to function as the inflation lumen. tube.

(4) The medical tube according to the above (1) or (2), wherein the reinforcing member has a spiral shape.

(5) The medical tube according to the above (1) or (2), wherein the reinforcing member is connected by a plurality of ring connecting members.

(6) The cross-sectional shape of the reinforcing member is a flat shape in the longitudinal direction of the tube body.
The medical tube according to any one of (5).

(7) The medical tube according to the above (2), wherein the reinforcing member is a monofilament formed by drawing.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION The medical tube of the present invention will be described below in detail with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a perspective view showing a constitutional example in which the medical tube of the present invention is applied to an endotracheal tube, FIG.
[Fig. 2] is an enlarged vertical sectional view of the endotracheal tube shown in Fig. 1.

As shown in these figures, an endotracheal tube 1 is provided with a flexible tube body 2, a main lumen 3 formed along the longitudinal direction thereof, and a main lumen 3 in parallel therewith. , The inflation lumen 5 extended to at least the vicinity of the tip of the tube body 2, and the tube body 2 near the tip of the tube body 2.
Is provided so as to surround the outer peripheral surface of the inflation lumen 5, and one end of the inflation lumen 5 communicates with the inside, which is an expandable / contractible expandable body, and the inflation tube 5 communicates with the other end of the inflation lumen 5. Cuff 6
Has a pilot balloon 9 for confirming whether or not the balloon is expanded.

The tube body 2 is made of a material to be described later, and has a main lumen 3 penetrating from a base end 21 to a tip 22 for introducing anesthetic gas, oxygen gas and the like.

The tip 22 of the tube main body 2 is processed to have a tip, and as shown in FIG. 2, is formed into a smooth bevel shape for easy insertion into the body.
A connector 12 for connecting to the breathing circuit is attached to the base end 21 of the tube body 2.

The constituent material of the tube body 2 may be any material as long as it fulfills the function of the endotracheal tube as a tube body, for example, soft polyvinyl chloride, ethylene-vinyl acetate copolymer, polyurethane, Examples include soft resins and elastomers such as silicone rubber, polyamide elastomer, and soft fluororesin.

The tube wall forming the tube body 2 has the structure shown in FIG.
As shown in, an inflation lumen 5 thinner than the main lumen 3 is provided along the longitudinal direction of the tube body 2. This inflation lumen 5
A lumen for feeding a gas for cuff expansion into the cuff 6, which will be described later, and the inside of the cuff 6 via a side hole (communication hole) 11 formed on the outer surface of the tube wall of the tube body 2 in the cuff 6. It communicates with the space. 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 flexibility for inflation 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 communicates with the tube 8.

The inflation tube 8 and the inflation lumen 5 are connected by, for example, inserting a preheated mandrel into the inflation lumen 5,
Simultaneously with the removal of the mandrel, the inflation tube 8 is inserted into the inflation lumen 5 and fixed by using a solvent or an adhesive.

In the vicinity of the tip of the tube body 2, the cuff 6 which can be expanded and contracted so as to surround the outer peripheral surface thereof in an annular shape.
Is provided.

The cuff 6 is covered with a film formed in a tubular shape in advance on the outer circumference of the tube body 2 so as to cover the side hole 11, and both ends of the cuff 6 are adhered to the outer circumference of the tube body 2 with an adhesive or a solvent. It is attached in an airtight manner by adhering or fusing with heat, high frequency, or the like.

At the rear end portion of the inflation tube 8, a pilot balloon 9 which can be expanded and contracted for recognizing the degree of expansion and contraction of the cuff 6 is provided.
It is installed to communicate with the inside.

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 provided. is set up. 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 stored in the pilot balloon 9,
The cuff 6 is inflated (expanded) by being fed into the cuff 6 through the inflation tube 8 and the inflation lumen 5 and the side hole 11.

The same material as the tube body 2 can be used as the constituent material of the inflation tube 8.

The constituent material of the film of the pilot balloon 9 is, for example, soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone or the like, or a material selected from these materials. The thing which mixed arbitrarily is mentioned.

In the endotracheal tube 1 of the present invention, the spiral reinforcing member 4 made of a material described later is embedded in the tube body 2 on the outer periphery of the main lumen 3 over the entire length of the tube body 2. Has been done. This increases the strength of the tube body 2 against bending (kinks),
Blockage of the main lumen 3 and the inflation lumen 5 due to kinks is prevented.

The constituent material of the reinforcing member 4 may be any resin as long as it is a resin having a rigidity enough to obtain a sufficient reinforcing effect, for example, polyethylene terephthalate (PET), polybutylene terephthalate (PBT).
Polyester such as, polyethylene, polyolefin such as polypropylene, rigid polyvinyl chloride, polyamide, polystyrene, thermoplastic polyurethane, polycarbonate, ABS resin, acrylic resin, polymethylmethacrylate (PMMA), polyacetal (PA), polyarylate, poly Oxymethylene (POM), high-strength polyvinyl alcohol, fluororesin, polyvinylidene fluoride (PVdF), ethylene-vinyl acetate saponified product (E
VOH), polysulfone, polyether sulfone, polyether ketone, polyphenylene oxide, polyphenylene sulfide, liquid crystal polyarylate, liquid crystal polyester carbonate, liquid crystal polyazomethine, liquid crystal polymer simple substance such as liquid crystal polyesteramide, or polymer alloy containing them. . Among these,
In particular, polyethylene terephthalate, polybutylene terephthalate, polypropylene, hard polyvinyl chloride, polyacetal, polyarylate, polyvinylidene fluoride, and polyamide are preferable because they are nontoxic, easy to mold, and inexpensive.

The preferred constituent material of the reinforcing member 4 may be selected in relation to the constituent material of the tube body 2 itself. That is, in consideration of the tip processing described later, it is preferable that the constituent material of the reinforcing member 4 is compatible or adhesive with the constituent material of the tube body 2 itself. Specific examples of such combinations of constituent materials are shown in Table 1 below.

[0039]

[Table 1] As described above, when the combination of compatible or adhesive materials is used, the peeling of the reinforcing member 4 is more reliably prevented, and particularly in the vicinity of the tip 22 formed by the tip processing, the tube body is 2 and the reinforcing member 4 are compatible with each other and are integrated.

In the constituent material of the reinforcing member 4, for example, various additives such as a hardening agent and a softening agent for adjusting strength (rigidity, hardness), a binder, a stabilizer, a coloring agent and the like. Additives can be added.

It is also possible to mix a filler made of an X-ray opaque material in the constituent material of the reinforcing member 4 so that the tube body 2 has a contrast property. Examples of the X-ray opaque material include bismuth oxide, bismuth subcarbonate, barium carbonate, tungsten, gold and platinum.

The preferred hardness of the reinforcing member 4 is related to the cross-sectional shape and various dimensions of the reinforcing member 4 which will be described later, but the Shore D in the durometer hardness test method (JIS K 7215) is preferably 70 or more, It is preferably 75 or more, more preferably 80 or more. The suitable hardness of the reinforcing member 4 can be expressed by "bending rigidity" in addition to the durometer hardness test method (JIS K 7215). The bending rigidity used in the present invention may be 150 gf or more, and more preferably 200 gf or more. Here, the bending strength is the maximum load when a straight reinforcing member is sandwiched between autographs (Shimadzu AGS-100A) with a chuck distance of 40 mm and pushed 10 mm at a speed of 100 mm / min. is there. Among the materials mentioned above, polyethylene terephthalate (PET), liquid crystal polymer, nylon, polyolefin, polyoxymethylene (POM), polysulfone, and monomers thereof are used as materials for achieving the desired bending rigidity. Alternatively, a mixture of two or more is preferable.

The cross-sectional shape of the reinforcing member 4 is not limited to the circular shape shown in the figure, 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, or an eyebrow shape. Further, if the tube body 2 has a flat shape in the longitudinal direction of the tube body 2 (hereinafter referred to as a flat shape) such as an elliptical shape, a semicircular shape, a semielliptical shape, a rectangular shape, or an eyebrow shape, the thickness of the tube wall of the tube body 2 Can be made thinner, which is preferable.

When the reinforcing member 4 has a circular (or elliptical) cross section, its diameter (average diameter) is 0.5 to 1.0.
It is preferably about mm, particularly about 0.5 to 0.8 mm.

The forming pitch of the reinforcing member 4 is 1.0 to 1
It is preferably about 5.0 mm, particularly about 1.5 to 5.0 mm. If the forming pitch exceeds 15.0 mm, the reinforcing effect becomes insufficient depending on the material used, and it is difficult to form the forming pitch below 1.0 mm.

As a method of manufacturing such a tube main body 2, for example, a reinforcing member 4 is spirally wound around the outer surface of an inner tube serving as a core, and a liquid resin is attached onto the reinforcing member 4 by coating or dipping. Then, it is cured to form an outer coating layer (tube). In addition,
After winding the reinforcing member 4 around the outer surface of the inner tube,
It is also possible to cover this with an outer tube and bond or fuse both tubes.

Further, the inflation lumen 5 is formed by using a thin core material when forming the outer tube, and thereafter, a necessary portion such as the vicinity of the tip 22 is closed by heating or filling with a filling material.

Each of the tube bodies 2 may be manufactured separately, but a long continuous tube body is preferably manufactured continuously, and the tube body is cut into a predetermined length to obtain a plurality of tubes. It is preferable to obtain the tube body 2 of. As a result, productivity can be significantly improved and cost can be significantly reduced.

From this manufacturing method, the tube body 2
Not only in the middle of the process, but also in the vicinity of the cut portion of the tube body 2, that is, at the base end 21 and the tip end 22, the reinforcing member 4 is embedded.

It should be noted that the tube body can be cut easily because the buried reinforcing member 4 is made of resin instead of the conventional metal, and the cut end face has good properties. Becomes In the case of the endotracheal tube, the base end 21 side of the tube body 2 may be cut and removed by a predetermined length at the time of use to adjust the tube body 2 to a length according to the case. It can be easily cut, and there is no restriction on the cutting length.

The tip 22 of the tube body 2 is subjected to tip processing by molding under heat, but since the reinforcing member 4 is made of the resin as described above, the tip is processed at the time of tip processing. The reinforcing member 4 embedded in the vicinity of 22 is also thermally deformed or melted together with the constituent material of the tube body 2 itself, and in some cases fused with the constituent material of the tube body 2 itself to be molded into a desired mold shape. Note that, in FIG. 2, the reinforcing member 4 is shown in its original shape in the vicinity of the distal end 22, but in reality, the reinforcing member 4 is deformed, melted, or fused with the constituent material of the tube body 2 itself by processing the distal end. It may be in a state.

Further, at the base end 21 of the tube body 2, the connector 12 is fitted in the main lumen 3, but since the reinforcing member 4 is made of the resin as described above, it is easily deformed by heating. However, since the inner diameter of the main lumen 3 is enlarged, the connector 12 can be fitted easily and reliably.

Even when the tube body 2 is bent, the reinforcing member 4 is easily deformed by heating, so that the tube body 2 can be easily formed into a desired curved shape regardless of the constituent material. be able to.

FIG. 3 is an enlarged vertical sectional view showing another structural example of the endotracheal tube of the present invention. In the endotracheal tube 1'shown in the figure, the shape of the reinforcing member is different from the above. That is, in the tube main body 30, a spiral reinforcing member (the constituent material is the same as above) 31 is embedded along the entire length of the tube main body 30, and the reinforcing member 31 is hollow and has an inner cavity. 32 has the same function as the inflation lumen 5. That is, the reinforcing member 31
The inner cavity 32 of the tube communicates with the inside of the cuff 6 through at least one side hole 33, and also with the inflation tube 8 through the same cutout portion 7 formed on the outer surface of the tube wall of the tube body 30. It is in communication.

In such a configuration, as shown in FIG.
Since it is not necessary to separately provide the inflation lumen 5, the manufacturing process can be simplified, and the thickness t of the tube wall of the tube body 30 can be made thinner, resulting in a smaller outer diameter of the tube body 30. As a result, the resistance at the time of airway insertion is reduced and the burden on the patient is reduced. Further, in the case of the configuration shown in FIG. 2, since the inflation lumen 5 is formed in the soft tube body 2 itself, the tube body 2 may be closed due to extreme bending, twisting, compression, etc. Since the tube 1'is formed in the hard reinforcing member 4, it does not close even in such a case.

The cross-sectional shape of such a reinforcing member 31 is
A flat shape represented by an ellipse as shown in FIG. 3 is preferable. By making the cross-sectional shape of the reinforcing member 31 flat, it is possible to further reduce the thickness t of the tube wall of the tube body 30 while obtaining a sufficient reinforcing effect.

The cross-sectional shape of the inner cavity 32 is not particularly limited, but it is preferable that it is a flat shape, and in particular, the reinforcing member 31.
More preferably, the flat shape corresponds to the flat cross-sectional shape of. Thereby, the air permeability of the inner cavity 32 can be improved without increasing the thickness of the reinforcing member 31.

[0058] Incidentally, the cross-sectional area of the lumen 32, taking into account the permeability (air resistance increase suppression), 0.6 mm ² or more, preferably in particular 0.9 mm ² or more.

In the present invention, the reinforcing member is not limited to the spiral member. FIG. 4 is a perspective view showing another configuration example of the reinforcing member. The reinforcing member 35 shown in the figure is formed by arranging a plurality of rings 36 preferably at equal intervals and connecting them by a connecting rod 37. This reinforcing member 35
Is preferably manufactured by integral molding.

The constituent material of the reinforcing member 35, the cross-sectional shape, the formation pitch of the ring 36, and the like are the same as those of the reinforcing members 4 and 31.

Further, similarly to the above, the reinforcing member 35 may be hollow and its inner cavity may be used as an inflation lumen. In this case, it is preferable that the connecting rod 37 is mainly hollow. With such a configuration, the flow path for air supply is shorter than that of the reinforcing member 31, and the air supply resistance (pressure) is reduced, which is preferable.

In the tube body in which the reinforcing member 35 is embedded as described above, in the case where a bend is added, a connecting rod 37 is used.
It is preferable that the side with the curve be the inside of the curve.

There may be two or more connecting rods 37.

The endotracheal tube has been described above as the medical tube of the present invention, but the present invention is not limited to this, and any medical tube having an expanded body such as a balloon catheter may be used.

[0065]

EXAMPLES Next, specific examples of the present invention will be described.

Example 1 A stainless steel core rod having a diameter of 8 mm was wound around a polyethylene terephthalate linear reinforcing member (JIS K 72) having a winding diameter of 8.6 mm, a pitch of 2.0 mm and a wire diameter of 0.7 mm.
15 Shore D: 80) is spirally wound, and a soft polyvinyl chloride paste resin solution (100 parts by weight of the paste resin is added with 7 parts of DOP which is a plasticizer).
It was dipped in 0 part by weight of epoxidized soybean oil as a stabilizer (containing 5 parts by weight) and then cured at 120 ° C. for 10 minutes.

Next, a wire with a diameter of 0.5 mm was placed on the surface of the hardened soft polyvinyl chloride, which was dipped in the soft polyvinyl chloride paste resin solution several times, and then 1
It was cured at 70 ° C. for 30 minutes.

The wire was pulled out to form an inflation lumen, and the stainless steel core rod was removed to form a tube body having the structure shown in FIG. The tube body has an outer diameter of 12.0 mm and an inner diameter of 8.0 mm (wall thickness 2.
0 mm) and the total length was 400 mm, and the reinforcing member was buried over the entire length.

After cutting the tip of the tube main body obliquely with respect to the axial direction, this portion was inserted into a mold heated to 200 ° C. and the tip was processed by heat molding. The reinforcing member near the tip was melted together with polyvinyl chloride, which is a constituent material of the tube body, and the tip edge portion had a rounded shape (R shape). In addition, due to this tip processing, the inner lumen on the tip side of the inflation lumen was closed.

A filling material is filled on the proximal end side of the inflation lumen to close it, a communication hole with a cuff is provided near the distal end portion of the inflation lumen obtained by this, and an attachment hole for an inflation tube (at the proximal end portion). A notch) was produced. An inflation tube made of soft polyvinyl chloride having a check valve at the base end and a pilot balloon made of polyvinyl chloride was inserted in the middle of the mounting hole, and airtightly fixed by an adhesive.

On the other hand, the base end of the tube body was heated and softened, and the connector was fitted.

Further, a polyvinyl chloride cuff (film thickness 0.2 mm) was prepared by heat and pressure molding in a mold, and the 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 an endotracheal tube of the present invention.

(Example 2) In the same manner as in Example 1, a long tube body having an outer diameter of 11.5 mm, an inner diameter of 8.0 mm and a total length of about 1 m was manufactured, and this was cut with a cutter to obtain the total length. Two 400 mm tube bodies were obtained. In the same manner as in Example 1, tip processing, inflation lumen processing, inflation tube attachment, connector and cuff attachment were performed on each tube body to obtain an endotracheal tube of the present invention.

(Embodiment 3) A polyethylene terephthalate linear reinforcing member having a cross section of an elliptical shape with a major axis of 3.0 mm and a minor axis of 1.0 mm, and having an elliptical lumen with a cross-sectional area of 0.9 mm ^2. (Shore D: 80 stipulated in JIS K7215) was prepared, and this reinforcing member was spirally wound around a stainless steel core rod having a diameter of 8 mm with a winding diameter of 8.6 mm and a pitch of 2.0 mm. It was dipped several times in the same soft polyvinyl chloride paste resin solution as in the above, and then cured at 170 ° C for 30 minutes.

The stainless steel core rod was removed to obtain a tube body having the structure shown in FIG. The tube body has an outer diameter of 12.0 mm and an inner diameter of 8.0 mm (wall thickness 2.
0 mm) and the total length was 400 mm, and the reinforcing member was buried over the entire length.

After cutting the tip of the tube main body obliquely with respect to the axial direction, this portion was inserted into a mold heated to 200 ° C. and the tip was processed by heat molding. The reinforcing member near the tip was melted together with polyvinyl chloride, which is a constituent material of the tube body, and the tip edge portion had a rounded shape. By this tip processing, the inner cavity on the tip side of the reinforcing member was closed.

The inner cavity of the reinforcing member on the proximal end side is filled with a filling material so as to be closed, and a communication hole with a cuff is provided near the distal end portion, and an attachment hole (cutout portion) for an inflation tube is provided at the proximal end portion. Was produced. An inflation tube made of soft polyvinyl chloride having a check valve at the base end and a pilot balloon made of polyvinyl chloride was inserted in the middle of the mounting hole, and airtightly fixed by an adhesive.

On the other hand, the base end of the tube body was heated and softened, and the connector was fitted.

Further, a polyvinyl chloride cuff (film thickness: 0.2 mm) was produced on 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 an endotracheal tube of the present invention.

(Example 4) In the same manner as in Example 3, a long tube body having an outer diameter of 11.5 mm, an inner diameter of 8.0 mm and a total length of about 1 m was manufactured, and this was cut with a cutter to obtain the total length. Two 400 mm tube bodies were obtained. The tip processing, the attachment of the inflation tube, the attachment of the connector and the cuff were performed on each tube body in the same manner as in Example 3 to obtain the endotracheal tube of the present invention.

(Example 5) An endotracheal tube was produced in the same manner as in Example 2 except that hard polyvinyl chloride was used as the constituent material of the reinforcing member.

(Example 6) An endotracheal tube was produced in the same manner as in Example 4 except that hard polyvinyl chloride was used as the constituent material of the reinforcing member.

The endotracheal tubes of Examples 1 to 6 were bent at 180 ° and compressed in the radial direction of the tubes. In both cases, the main lumen and the inflation lumen (the lumen of the reinforcing member) were used. ) No occlusion occurred at all.

Further, particularly in Examples 2, 4, 5 and 6, the tube body can be easily cut,
The cut surface was also flat and good.

Further, particularly in Examples 5 and 6,
Since the material of the tube body itself and the material of the reinforcing member are excellent in compatibility, the material of the tube body and the material of the reinforcing member are integrated at the tip of the tube body to have an appropriate rounded shape.

Example 7 A polyethylene terephthalate linear reinforcing member (bending rigidity 250 gf) having a winding diameter of 8.6 mm, a pitch of 2.0 mm and a wire diameter of 0.7 mm was spirally wound on a stainless steel core rod having a diameter of 8 mm. Wrap it and paste it into a soft polyvinyl chloride paste resin solution (paste resin 100
70 parts by weight of DOP, which is a plasticizer, and 5 parts by weight of epoxidized soybean oil, which is a stabilizer, are soaked in 5 parts by weight),
Then, it was cured at 120 ° C. for 10 minutes.

Then, a wire having a diameter of 0.5 mm was placed on the surface of the hardened soft polyvinyl chloride, which was dipped in the soft polyvinyl chloride paste resin solution several times, and then 1
It was cured at 70 ° C. for 30 minutes.

The wire was pulled out to form an inflation lumen, and the stainless steel core rod was removed to form a tube body having the structure shown in FIG. The tube body has an outer diameter of 12.0 mm and an inner diameter of 8.0 mm (wall thickness 2.
0 mm) and the total length was 400 mm, and the reinforcing member was buried over the entire length.

After cutting the tip of the tube body obliquely with respect to the axial direction, this portion was inserted into a mold heated to 200 ° C. and the tip was processed by heat molding. The reinforcing member near the tip was melted together with polyvinyl chloride, which is a constituent material of the tube body, and the tip edge portion had a rounded shape (R shape). In addition, due to this tip processing, the inner lumen on the tip side of the inflation lumen was closed.

The base end side of the inflation lumen is filled with a filler to close it, and a communication hole with the cuff is provided near the tip end of the inflation lumen obtained by this, and an attachment hole for the inflation tube (at the base end) ( A notch) was produced. An inflation tube made of soft polyvinyl chloride having a check valve at the base end and a pilot balloon made of polyvinyl chloride was inserted in the middle of the mounting hole, and airtightly fixed by an adhesive.

On the other hand, the base end of the tube body was heated and softened, and the connector was fitted.

Further, a polyvinyl chloride cuff (film thickness: 0.2 mm) was produced on 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 an endotracheal tube of the present invention.

Example 8 An endotracheal tube was prepared in the same manner as in Example 7 except that the reinforcing member was aromatic nylon (Mitsubishi Gas Chemical MX nylon: bending rigidity 200 gf).

Comparative Example 1 An endotracheal tube was prepared in the same manner as in Example 7 except that nylon 6 (flexural rigidity 70 gf) was used as the reinforcing member.

When a bend of 180 ° was applied to the above Examples 7 and 8, the main lumen was not blocked at all in Examples 7 and 8, but the main lumen was blocked in Comparative Example 1 and air was blocked. Continuity was extremely difficult.

[0096]

As described above, according to the medical tube of the present invention, it exhibits an excellent function of preventing bending (kink) against bending, twisting, compression, etc., and prevents the main lumen and the inflation lumen from being blocked. .

In manufacturing the tube body,
Since the long tube body can be cut and divided to obtain the tube body, continuous production is possible, productivity is improved, and production labor and cost can be significantly reduced.

Furthermore, for example, when using a medical tube, it is possible to easily cut the proximal end portion in order to adjust the length of the tube according to the case, and the cutting length can be freely selected. be able to.

Further, since the embedded reinforcing member is made of resin, it is possible to favorably perform the heat forming process such as the tip processing even in the region where the reinforcing member is embedded, and the tube is easily formed. You can also add a bend.

Further, since the buried reinforcing member is made of resin, the reinforcing member is peeled off from the tube body or protruded onto the outer surface of the tube body, especially at the distal end and the proximal end, like the conventional metal reinforcing member. It is extremely safe.

When the reinforcing member is hollow and the inner cavity of the reinforcing member is used as an inflation lumen, the manufacturing process can be simplified and the tube wall of the tube body can be thinned to reduce the outer diameter of the tube body. Can be made smaller, and the blocking of the inflation lumen can be prevented more reliably.

In particular, the bending strength of the reinforcing member is 150 g.
By setting it to be f or more, the kink resistance becomes more reliable and it can be used with confidence.

[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 an enlarged vertical sectional view showing another configuration example of the endotracheal tube.

FIG. 4 is a perspective view showing another configuration example of a reinforcing member.

FIG. 5 is a schematic view showing a usage state of an endotracheal tube.

[Explanation of symbols]

 1, 1'Endotracheal tube 2 Tube body 21 Base end 22 Tip 3 Main lumen 4 Reinforcement member 5 Inflation lumen 6 Cuff 7 Cutout 8 Inflation tube 9 Pilot balloon 10 Check valve 11 Side hole 12 Connector 30 Tube body 31 Reinforcement Member 32 Lumen 33 Side hole 35 Reinforcing member 36 Ring 37 Connecting rod 40 Endotracheal tube 41 Check valve 42 Patient 43 Trachea 44 Pilot balloon 45 Cuff 46 Connector 47 Serpentine tube

Claims (1)

[Claims] 1. A flexible tube main body, a main lumen formed along the longitudinal direction of the tube main body, and a tube main body at the outer periphery of the main lumen, embedded along the entire length of the tube main body. A reinforcing member made of resin, an expandable / contractible expander provided near the distal end of the tube body so as to surround the outer peripheral surface of the tube body, and provided on the tube body, and one end of the expandable body is provided. A medical tube having an inflation lumen communicating with the inside of the expansion body.