JP3055533B2 - Inner layer PTFE composite catheter tube and method of manufacturing the same - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to an inner layer PTFE composite catheter tube and a method for producing the same.

[0002]

2. Description of the Related Art Catheters are widely used as medical devices for directly examining the trachea, stomach, intestine and the like. More recently,
Catheters are also being used as therapeutic devices without surgery.

[0003] The catheter here comprises a catheter tube and an operation section. The outer periphery of the catheter tube or the intermediate layer is provided with a spirally wound braided layer or a braided braided layer of a metal wire or a non-metallic striatum in order to improve operability.

[0004] In such a catheter tube used as a medical examination and treatment device, a drug and a small treatment device come and go in the tube. For this reason, in a catheter tube used as a treatment device, it is required that the inner diameter of the tube be as large as possible and that the inner layer be as lubricious as possible.

Conventionally, a catheter tube having a good lubricating property in the inner layer is made of a fluororesin having a good lubricating property, for example, a polytetrafluoroethylene resin (hereinafter referred to as PTFE) in the inner layer, and the outer layer has good mechanical properties and end processing properties. A composite plastic catheter tube made of excellent polyamide resin, polyamide elastomer, polyurethane resin, polyurethane elastomer, or the like is used.

In a composite plastic catheter tube in which the inner layer is made of PTFE and the outer layer is made of polyamide resin, polyamide elastomer, polyurethane resin, polyurethane elastomer or the like, the outer diameter is required to be small, which is a characteristic requirement of catheter tubes. There is a demand that the inner diameter be made as wide as possible from the viewpoint of the penetration of the micro-therapeutic instrument inserted through the tube. Therefore, the inner layer PTF
The E layer is made very thin.

[0007]

However, if the inner layer is P
The composite plastic catheter tube in which TFE and the outer layer are made of a polyamide resin or a polyurethane resin has the following difficulties.

(1) A PTFE layer having an extremely thin PTFE layer
Difficulty PTFE super hard on blanking manufacturing, high softening point, is remarkably poor extrusion moldability since it is a resin of high melt viscosity, it is impossible to continuous tube extruded by the results extruder. For this reason, the operation of extruding an extremely thin PTFE tube is performed intermittently by a ram extrusion method. However, in the intermittent extrusion of the ram extrusion method, it is extremely difficult to extrude to an extremely thin thickness, and since it is an intermittent extrusion operation, only a short one can be made, or even if a long one is made, there is a drawback that there is a lot. There is. And P
When a thin metal wire blade or the like is provided together as a reinforcing layer of the TFE tube, there is a concern that the metal wire blade may be broken by a high extrusion pressure of PTFE.

(2) Adhesion Failure PTFE to the Blade Layer PTFE is essentially non-adherent and non-tacky and has a low coefficient of friction.

[0010] Therefore, the blade disposed on the PTFE tube having an extremely thin thickness is easy to slip, and as a result, when the outer layer is extruded and coated on the PTFE tube on which the blade is disposed, the position of the blade is disturbed or the outer layer is easily coated. There was a problem that it was peeled off.

Conventionally, the following measures have been taken against such disturbance of the blade.

This method increases the blade tension during blade operation, and
Embed it on the PTFE tube surface.

[0013] The adhesive treatment to the blade this method, an adhesive is applied onto the blade surface during blade operation, thereby bonding the blade and PTFE tube surface.

However, these improvements have the following disadvantages.

Enhancing the tension of the blade If the tension of the blade is increased by this method, the workability is degraded and the disconnection of the blade frequently occurs.

Further, as a result of embedding the blade on the ultra-thin walled PTFE tube, unevenness of the PTFE tube may occur, or a cut of the PTFE tube may occur.
In severe cases, the PTFE tube pieces may peel off.

The adhesive treatment to the blade in this way, the results of applying an adhesive onto the surface of the blade, there is difficulty working steps increases, and aging of the safety issues and the adhesive on the human body of applied adhesive There are difficulties such as deterioration.

The present invention has been made in view of such a point, and an object of the present invention is to solve the above-mentioned drawbacks of the prior art. An object of the present invention is to provide an inner-layer PTFE composite catheter tube having a wide inside diameter, excellent lubricity, a small outside diameter, and excellent operability, and a method for producing the same, which can be brought into close contact with each other.

[0019]

The gist of the present invention lies in the following three points.

(1) An inner layer PTFE composite catheter tube in which a blade layer is provided on an inner layer of a PTFE resin tube layer and an outer layer resin layer is coated on the blade layer, the inner layer of polytetrafluoroethylene
Metal wire or non-metal wire
A spiral layer having a spirally wound blade layer.
A polytetrafluoroethylene resin dispersion is applied on the scroll.
Made of cloth, baked, sintered
In the gap between the titanium resin tube layer and the blade layer,
Concentrated polytetrafluoroethylene resin dispersion
An inner-layer PTFE composite catheter tube characterized by being covered with a spiral wound .

(2) A PTFE resin tube is prepared by applying, baking and sintering a PTFE resin dispersion on a mandrel rod, and then providing a blade layer on the PTFE resin tube, and then attaching the blade layer. applying the PTFE resin dispersion on a PTFE resin tube, baking, sintering, manufacturing method of the inner layer PTFE composite catheter tube, characterized in that pull out the end into the mandrel bar.

(3) A PTFE resin tube is prepared by applying, baking and sintering a PTFE resin dispersion on a mandrel rod, and then forming a PTE resin tube on the PTFE resin tube.
TFE resin dispersion coating, baking, providing a blade layer formed by sintering, and heat-sealed with the PTFE resin tube and PTFE resin layer and thereafter the blade layer, pull pull the end the mandrel rod A method for producing an inner layer PTFE composite catheter tube, characterized in that:

That is, the first feature of the inner layer PTFE composite catheter tube and the method of manufacturing the same according to the present invention is as follows.
An object of the present invention is to produce a very thin PTFE resin tube by applying, baking and sintering a resin dispersion. The second feature is that a blade layer is provided on an ultra-thin PTFE resin tube, and then the PTFE resin dispersion is applied again, baked, and sintered to form the blade layer into a PT layer.
That is, it is embedded in the FE resin tube.
In other words, when the PTFE resin dispersion is applied again, the PT
The PTFE resin dispersion concentrates in the gap between the FE resin tube and the blade layer due to capillary action, and as a result, the blade layer is selectively covered with the PTFE resin. As a result, the blade layer is efficiently placed in the PTFE resin tube. It is buried.

Further, as a result of the blade layer being efficiently embedded in the PTFE resin tube, a convex portion of the blade layer is generated on the outer peripheral side of the PTFE resin tube. And the convex part of this blade layer becomes a physical anchor of the outer layer coating layer, and the inner layer, the blade layer and the outer layer are firmly bonded to each other. As a result, the inner diameter is wide and the lubricating property is excellent, and the outer diameter is thin. An inner layer PTFE composite catheter tube with excellent operability can be obtained.

[0025]

Next, an embodiment of the inner layer PTFE composite catheter tube of the present invention and a method for producing the same will be described.

In the present invention, the mandrel rod includes a metal wire, an alloy wire, and a plated metal wire. Examples of the metal wire include a copper wire, an aluminum wire, a silver wire, and a gold wire. In consideration of the low cost and safety to the human body, a silver plated copper wire or the like is appropriate as the mandrel bar.

The PTFE resin dispersion may be either an aqueous dispersion or a solvent dispersion, but is preferably an aqueous dispersion from the viewpoint of fire prevention and working environment.

The particle size and concentration of the PTFE resin particles are determined appropriately. Also, the dispersion liquid has a dispersion stabilizer, a viscosity modifier,
A surfactant, a colorant, a pH adjuster and the like can be appropriately compounded. The surfactant desirably leaks a hydrophilic group such as an oxyethylene group.

The blade layer is provided as a layer for imparting rotational torque transmission, pressure resistance, elasticity, flexibility and the like of the catheter tube. The outer diameter of this blade is φ30
There are stainless steel wires of up to 70 mm.

FIG. 2 is a flowchart showing a method for manufacturing the inner layer PTFE composite catheter tube of the present invention.

As can be seen from FIG. 2, the inner layer PT of the present invention
The manufacturing method of the FE composite catheter tube is as follows.

1. 1. Application, baking and sintering of PTFE resin dispersion on metal wire 2. Formation of blade layer on PTFE resin tube Processing of blade layer 3-1. Application, baking, and sintering of PTFE resin dispersion to blade layer 3-2. 3. Applying and baking a PTFE resin dispersion to a PTFE resin tube to form a sintered metal wire blade layer, and then heat-sealing the two PTFE layer layers together. Outer layer coating 5. Pull out the metal wire and take out the inner layer PTFE composite catheter tube

[0033]

Next, examples of the inner layer PTFE composite catheter tube of the present invention and a method for producing the same will be described together with comparative examples.

(Example 1) Outer diameter φ to be a mandrel rod
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.85 mm silver-plated copper wire, P
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, an outer diameter φ is placed on the PTFE tube.
A blade layer was provided by spirally winding a collective wire consisting of eight 0.04 mm stainless wires.

Next, an aqueous dispersion of PTFE is repeatedly applied twice on the PTFE tube provided with the blade layer.
By baking and sintering, the blade layer embedded P
A TFE tube was made. Here, half of the collective wire composed of eight stainless wires was filled with the aqueous dispersion of PTFE twice by repeated application and baking.

FIG. 1 is an explanatory view of the PTFE tube having the blade layer embedded therein, thus obtained.

In FIG. 1, 1 is a silver-plated copper wire and 2 is a PT
The FE tube 3 is a blade layer.

Next, the PTFE tube embedded with the blade layer thus obtained was extruded and coated with a polyamide elastomer to a thickness of 200 μm by an extruder, whereby an inner layer PTFE having an outer diameter of 1.50 mm was obtained.
A composite catheter tube was obtained.

Finally, the inner layer PTFE of Example 1 was cut off by cutting off the inner layer PTFE composite catheter tube at both ends and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Example 2) Outer diameter φ to be a mandrel bar
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.55 mm silver-plated copper wire,
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, a stainless wire 8 having an outer diameter of 0.04 mm
By applying, baking and sintering an aqueous dispersion of PTFE on the collecting line made of books, the PTFE thickness is 10 μm.
PTFE-coated stainless steel wire assembly wire was prepared.

Next, the above-obtained PTFE-coated stainless steel wire assembly wire was spirally wound on the PTFE tube obtained above to provide a blade layer.

Next, the PTFE-coated stainless steel wire-assembled wire spiral wound PTFE tube obtained above was passed through an electric furnace at 450 ° C. to form a PTFE-coated stainless steel wire-assembled wire spirally wound PTFE tube, and a PTFE tube. With PTFE.

Next, on the PTFE-coated stainless steel wire assembly wire spirally wound PTFE tube thus obtained,
By extruding and coating the polyamide elastomer to a thickness of 200 μm with an extruder, the outer diameter is φ1.2.
A 0 mm inner layer PTFE composite catheter tube was obtained.

Finally, the inner layer PTFE of Example 2 was cut off by cutting off the inner layer PTFE composite catheter tube at both ends and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Example 3) Outer diameter φ to be a mandrel bar
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.55 mm silver-plated copper wire,
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, an outer diameter φ is placed on the PTFE tube.
A blade layer was provided by spirally winding a collective wire composed of eight 0.03 mm stainless wires.

Next, an aqueous dispersion of PTFE was repeatedly applied twice on the PTFE tube provided with the blade layer.
By baking and sintering, the blade layer embedded P
A TFE tube was made. Here, a half of the collective wire composed of eight stainless wires was filled with the aqueous dispersion of PTFE twice by repeatedly applying, baking and sintering.

Next, a polyamide elastomer was extruded to a thickness of 150 μm by an extruder on the thus obtained PTFE tube with a blade layer embedded therein, thereby forming an inner layer PTFE having an outer diameter of 1.00 mm.
A composite catheter tube was obtained.

Finally, the inner layer PTFE of Example 3 was cut off by cutting off the inner layer PTFE composite catheter tube at both ends, and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Comparative Example 1) Outer diameter φ to be a mandrel bar
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.85 mm silver-plated copper wire, P
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, an outer diameter φ is placed on the PTFE tube.
A blade layer was provided by spirally winding a collective wire consisting of eight 0.04 mm stainless wires.

Next, the PTFE tube with the blade layer thus obtained was extruded and coated with a polyamide elastomer to a thickness of 200 μm by an extruder, so that an inner layer PTFE composite catheter having an outer diameter of 1.50 mm was obtained. A tube was obtained.

Finally, the inner layer PTFE of Comparative Example 1 was cut off by cutting off the inner layer PTFE composite catheter tube at both ends and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Comparative Example 2) Outer diameter φ to be a mandrel bar
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.55 mm silver-plated copper wire,
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, a stainless steel wire 8 having an outer diameter of 0.04 mm 8
An aqueous dispersion of PTFE is applied and baked on a collection line composed of books to form a PTFE having a thickness of 10 μm.
An FE-coated stainless steel wire assembly wire was prepared.

Next, the above-obtained PTFE-coated stainless wire assembly wire was spirally wound on the PTFE tube obtained above to provide a blade layer.

Next, a polyamide elastomer was extruded onto the spirally wound PTFE tube obtained in this manner so as to have a thickness of 200 μm by an extruder, thereby forming an inner layer having an outer diameter of φ1.2 mm. PT
An FE composite catheter tube was obtained.

Finally, the inner layer PTFE of Comparative Example 2 was obtained by cutting off the inner layer PTFE composite catheter tube at both ends and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Comparative Example 3) Outer diameter φ to be a mandrel bar
By repeatedly applying, baking and sintering an aqueous dispersion of PTFE three times on a 0.55 mm silver-plated copper wire,
A PTFE tube having a TFE wall thickness of 30 μm was prepared.

Next, an outer diameter φ is placed on the PTFE tube.
A blade layer was provided by spirally winding a collective wire composed of eight 0.03 mm stainless wires.

Next, the PTFE tube with the blade layer obtained in this manner was extruded and coated with a polyamide elastomer to a thickness of 150 μm by an extruder, thereby forming an inner layer PTFE composite catheter having an outer diameter of 1.00 mm. A tube was obtained.

Finally, the inner layer PTFE of Comparative Example 3 was obtained by cutting off the inner layer PTFE composite catheter tube at both ends and then pulling out the silver-plated copper wire of the mandrel rod.
A composite catheter tube was obtained.

(Characteristic Test Method) Next, a characteristic test was performed on the inner-layer PTFE composite catheter tubes of Examples 1 to 3 and Comparative Examples 1 to 3 thus obtained.

A. Ultra-thin wall moldability: A sample having an extremely thin PTFE composite catheter tube was indicated by a circle, and a tube having no thin-walled PTFE composite catheter was indicated by a cross.

B. When the orderly outer layer of the blade layer was extruded and coated, the blade layer having no disturbance was indicated by ○, and the disordered blade layer was indicated by x.

[0068] c. Adhesion between inner layer and outer layer The inner layer PTFE composite catheter tubes of Examples 1 to 3 and Comparative Examples 1 to 3 were subjected to 90-degree bending resistance 20 times, and then the adhesion between the inner layer and the outer layer was examined. The results were indicated by ○ when there was no abnormality in the adhesion between the inner layer and the outer layer, and indicated by x when the inner layer and the outer layer were separated.

(Characteristic test results) Table 1 shows the characteristic test results.

[0070]

[Table 1]

As can be seen from Table 1, the inner layer PTFE composite catheter tubes of Examples 1 to 3 and Comparative Examples 1 to 3 are all manufactured by the coating and baking method, so that the ultrathin wall moldability is excellent. .

However, the inner layer PTFE composite catheter tubes of Comparative Examples 1 to 3 all had problems in that the blade layer was disturbed and the inner layer and the outer layer were separated.

On the other hand, the inner layer PT of Examples 1 to 3
In each of the FE compound catheter tubes, there is no disturbance of the blade layer, and the inner layer and the outer layer are completely bonded,
As a result, the reliability can be significantly improved.

[0074]

According to the inner layer PTFE composite catheter tube and the method of manufacturing the same according to the present invention, an ultra-thin PTFE tube can be easily formed at the time of manufacturing, the blades can be in close contact with each other, and the product obtained by manufacturing has an inner diameter. Is wide and excellent in lubricity, and has a small outer diameter, and is excellent in operability, and is industrially useful.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram of an intermediate product in an inner-layer PTFE composite catheter tube and a method of manufacturing the same according to the present invention.

FIG. 2 is a flowchart showing a method for manufacturing the inner layer PTFE composite catheter tube of the present invention.

[Explanation of symbols]

 1 silver-plated copper wire 2 PTFE tube 3 blade layer

──────────────────────────────────────────────────続 き Continued on front page (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 25/00

Claims (4)

(57) [Claims] An inner layer PTF in which a blade layer is provided on an inner layer of a polytetrafluoroethylene resin tube layer, and an outer layer resin layer is coated on the blade layer.
In the E composite catheter tube, the inner layer of polytetra
Metal wire or non-wire on the fluoroethylene resin tube layer
Spiral rolls in which a blade layer made of metal wire is spirally wound
Having a polytetrafluoroethylene tree on the spiral wound
The fat dispersion is applied, baked and sintered
Gap between lafluoroethylene resin tube layer and blade layer
Dispersion of the sintered polytetrafluoroethylene resin
An inner-layer PTFE composite catheter tube characterized in that the liquid concentrates and covers the spiral wound . 2. An inner layer polytetrafluoroethylene resin tube having a thickness of 100 μm or less obtained by applying a polytetrafluoroethylene resin dispersion on a mandrel rod, baking and sintering. The inner layer PTFE composite catheter tube according to claim 1, wherein 3. A polytetrafluoroethylene resin dispersion is applied to a mandrel rod, baked, and sintered to form a polytetrafluoroethylene resin tube, and then a blade layer is provided on the polytetrafluoroethylene resin tube. Then, a polytetrafluoroethylene resin dispersion is applied onto the polytetrafluoroethylene resin tube with the blade layer, baked, sintered, and finally, the mandrel bar is pulled out.
A method for producing an E-composite catheter tube. 4. A polytetrafluoroethylene resin tube is prepared by coating, baking and sintering a polytetrafluoroethylene resin dispersion on a mandrel rod, and then a polytetrafluoroethylene resin tube is formed on the polytetrafluoroethylene resin tube. A resin dispersion is applied, baked, and sintered to provide a blade layer. Thereafter, the polytetrafluoroethylene resin layer of the blade layer and the polytetrafluoroethylene resin tube are thermally fused, and finally, the mandrel is formed. Inner layer PT characterized by pulling out a rod
A method for manufacturing an FE composite catheter tube.