JP2000051365A - Composite catheter tube with ptfe inner laser and its manufacture - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an inner layer PTFE(polytetrafluoroethylene resin) composite catheter tube with PTFE inner layer and a manufacturing method therefor. SOLUTION: In a composite catheter tube with PTFE inner layer formed by covering an inner layer PTEF resin tube layer 1 with an outer covering layer directly or through a blade layer, the PTFE resin tube is a solid particle mixed PTFE resin overcoat pure PTEF tube. A method of manufacturing a tube includes the steps of applying PTFE resin dispersed liquid to a mandrel bar, baking and sintering the same, applying a solid particle mixed PTFE resin dispersed liquid, baking and sintering the same to form a solid particle mixed PTFE resin overcoat pure PTFE tube, covering the upper layer thereof with an outer covering layer by extruding directly or through a blade layer, and finally pulling out the mandrel bar to take out the PTFE composite catheter tube with PTFE inner layer.

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. Further, in recent years, with the advancement of medical technology, catheters have been used as treatment devices without surgery in order to reduce physical pain of patients, shorten treatment and healing time, and the like.

[0003] Here, the catheter is composed of a catheter tube and an operation section. The outer periphery or the intermediate layer of the catheter tube is provided with a spirally wound blade layer or a braided blade layer of a metal wire or a non-metallic filament in order to improve operability, flexibility, mechanical properties, and the like as necessary. It is supposed to be.

[0004] In a catheter tube used as a medical examination and treatment device, a medicine and a small treatment device come and go in the tube. Therefore, in a catheter tube used as a medical 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 an 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, etc., the outer diameter is required to be small, which is a unique requirement of the catheter tube. 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, the composite plastic catheter tube in which the inner layer is made of PTFE and the outer layer is made of polyamide resin or polyurethane resin has the following drawbacks.

(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 a very 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 wall 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 are numerous steps. There are disadvantages. In addition, when a thin metal wire blade or the like is provided as a reinforcing layer of the PTFE tube, there is a concern that the thin metal wire 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. For this reason, very thin PTF
When a blade layer of a thin metal wire or the like is provided on the E tube, there is a problem that the thin metal slides on the PTFE tube and the blade layer is easily disturbed. When the outer coating layer is extruded and coated on the blade layer, there is a problem that the turbulence of the blade layer further progresses due to the pushing force of the outer coating layer, and in the worst case, the blade layer is separated on the surface.

Conventionally, the following measures have been taken against such disturbances of the blade. This method increases the blade tension during blade work,
Embed it on the PTFE tube surface.

[0011] 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 blade tension If the method is used to increase the blade tension, the workability is degraded and the disconnection of the blade frequently occurs.

Further, as a result of embedding the blade on the ultra-thin 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.

[0015] Adhesive treatment of the blade When the adhesive is applied onto the blade surface by this method, there is a problem that the number of work steps is increased, there is a problem of safety of the applied adhesive to the human body, and aged deterioration of the adhesive. There are disadvantages.

SUMMARY OF THE INVENTION 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 disadvantages of the prior art. Layers can be prevented from being disordered, and the product obtained by manufacturing has a wide inner diameter, excellent lubricity, and a thin outer diameter, and further has excellent adhesion between the PTFE tube, the blade layer, and the outer coating layer, Another object of the present invention is to provide an inner layer PTFE composite catheter tube having excellent operability and a method for producing the same.

[0017]

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

(1) An inner layer PTFE composite catheter tube in which an outer coating layer is coated directly or via a blade layer on an inner layer PTFE resin tube layer, wherein the PTFE resin tube is a solid particle-containing PTF.
An inner layer PTFE composite catheter tube, which is an E-resin overcoated pure PTFE tube.

(2) Pure PTFE is obtained by applying, baking and sintering a PTFE resin dispersion on a mandrel rod.
After forming the resin tube, the solid particle-containing PTFE resin dispersion is applied to the pure PTFE resin tube, baked, and sintered to form a solid particle-containing PTFE resin overcoated pure PTFE tube, and then the solid particles are formed. The inner layer PTFE is characterized in that the inner layer PTFE is obtained by extruding the outer coating layer directly or after providing the blade layer on the compounded PTFE resin overcoated pure PTFE tube, and finally by pulling out the mandrel rod to remove the inner layer PTFE composite catheter tube. A method for manufacturing a composite catheter tube.

[0020]

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. The alloy wire includes a copper alloy wire containing silver, a copper alloy wire containing chromium, a copper alloy wire containing zinc, and a copper alloy wire containing tin. Examples of the plated metal wire include a silver-plated copper wire and a chrome-plated copper wire. Among these, silver-plated copper wires are excellent in cost and safety to human body.

Further, these mandrel rods may be single wires, stranded wires, collectively plated stranded wires, or the like. The single wire has excellent smoothness.

In the present invention, the PTFE resin dispersion may be either an aqueous dispersion or a solvent dispersion. PTFE
The aqueous resin dispersion has excellent fire prevention properties and work environment safety.

In the PTFE resin dispersion, the particle size and concentration of the PTFE resin particles are appropriately determined.

Further, if necessary, a dispersion stabilizer, a viscosity modifier, a surfactant, a colorant, a pH
A regulator and the like can be appropriately compounded. As the surfactant, those having a hydrophilic group such as an oxyethylene group are desirable.

In the present invention, even if the blade layer is provided,
It is not necessary to provide it. In the catheter tube provided with this blade layer, the transmission of torque, pressure resistance, elasticity,
Flexibility and the like can be further improved. As a material of such a blade layer, an outer diameter is small, for example, an outer diameter φ3.
There is a stainless wire of 0 to 70 mm or the like.

In the present invention, the solid particles to be mixed with the PTFE resin dispersion may be those having a high melting point that can withstand the temperature at which the PTFE resin dispersion coating wire is baked, and may be either inorganic substance powder or organic substance powder. .

Here, examples of the inorganic substance powder include silicon dioxide, calcium carbonate, magnesium carbonate, magnesium oxide, tetrasilicon fluoride, alumina, titanium dioxide, glass powder, potassium titanate and the like.

As organic substance powder, PFA powder, ETF
E powder, PTFE powder, FEP powder, PCTFE powder,
PVdF powder and the like.

These inorganic and organic powders may be surface-modified with a suitable surface treating agent. As such a surface-treated product, there is a product in which a silanol group (—SiOH) on the surface of silicon dioxide is modified into a methyl group (—CH ₃ ).

Further, the particle diameter of these solid particles is PT
When the particle diameter of the PTFE resin particles in the FE resin dispersion is 0.0
5 to 20 times, preferably 0.2 to 5 times is good. This is because if there is a large difference between the two particle diameters, the fine particles will be adsorbed on the large particle surface, and as a result, the film forming property at the time of baking will be impaired.

In the present invention, the compounding amount of the solid particles is PT
3 to 15 with respect to the PTFE resin particles in the FE resin dispersion.
% By weight is preferred. If the content is 3% by weight or less, there is no effect, and if the content is 15% by weight or more, the film-forming property and mechanical properties deteriorate.

[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.

In these examples and comparative examples, in order to clearly show the effect, the inner layer PTF having no blade layer was used.
The E composite catheter tube was tested.

(Example 1) Outer diameter φ to be a mandrel rod
On a 0.85 mm silver-plated copper wire, apply 2 PTFE aqueous dispersions.
By repeating application, baking and sintering twice, PT
A pure PTFE tube having an FE thickness of 20 μm was prepared.

Next, on the obtained pure PTFE tube,
An aqueous PTFE dispersion containing 5% by weight of silica (manufactured by Fuji Silysia; Sylysia # 350) in a resin content ratio is applied, baked and sintered to form a silica-containing PTFE layer of 1%.
0μm thick silica-containing PTFE overcoat pure PT
FE tubes were made.

Next, the obtained silica-containing PTFE overcoated pure PTFE tube was extruded and coated with an extruder so that the polyamide elastomer layer had a thickness of 200 μm and an outer diameter of φ1.50 mm.

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.

FIG. 1 shows a step view of the inner layer PTFE composite catheter tube of Example 1 thus obtained.

In FIG. 1, 1 is a pure PTFE tube,
2 is a PTFE layer containing silica, and 3 is a polyamide elastomer layer.

(Example 2) Outer diameter φ to be a mandrel bar
On a 0.55 mm silver-plated copper wire, add 1 aqueous PTFE dispersion
A pure PTFE tube having a PTFE wall thickness of 10 μm was prepared by repeated application, baking, and sintering.

Next, on the obtained pure PTFE tube,
An aqueous PTFE dispersion containing 5% by weight of silica (manufactured by Fuji Silysia; Sylysia # 350) in a resin content ratio is applied, baked and sintered to form a silica-containing PTFE layer of 1%.
0μm thick silica-containing PTFE overcoat pure PT
FE tubes were made.

Next, the resulting silica-containing PTFE overcoated pure PTFE tube was extruded and coated with an extruder so that the polyamide elastomer layer had a thickness of 200 μm and an outer diameter of φ1.00 mm.

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.

(Comparative Example 1) Outer diameter φ to be a mandrel bar
On a 0.85 mm silver-plated copper wire, apply 3 aqueous PTFE dispersions.
By repeating application, baking and sintering twice, PT
A pure PTFE tube having an FE thickness of 30 μm was prepared.

Next, an inner layer PTFE composite catheter tube was obtained by extruding the pure PTFE tube with an extruder so that the polyamide elastomer layer had a thickness of 200 μm and an outer diameter of φ1.50 mm.

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
On a 0.55 mm silver-plated copper wire, apply 2 aqueous PTFE dispersions.
By repeating application, baking and sintering twice, PT
A pure PTFE tube having an FE thickness of 20 μm was prepared.

Next, on the obtained pure PTFE tube,
By extruding and coating the polyamide elastomer layer with an extruder so that the polyamide elastomer layer has a diameter of 200 μm and an outer diameter of φ1.2 mm, an inner layer PTFE 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.

(Properties Test Method) Next, the inner layer PTFE composite catheter tubes of Examples 1 and 2 and Comparative Examples 1 and 2 thus obtained were subjected to a tube adhesion test.

The tube adhesion test was conducted in Example 1,
The intermediate products before the silver-plated copper wires of the mandrel rods of Comparative Example 2 and Comparative Examples 1 and 2 were drawn out were each 10 cm in length.

Next, the coating layer was peeled off about 5 cm at the end of the intermediate product before the silver-plated copper wire of these mandrel bars was pulled out.

Next, the inner layer PTFE composite catheter tube intermediate product 4 from which the coating layer 7 at the end of 5 cm was peeled off,
As shown in FIG. In FIG. 2, 4 is an intermediate product of the inner layer PTFE composite catheter tube, 5 is a mandrel bar, 6 is a nail jig, and 7 is a coating layer.

Next, the silver-plated copper wire of the mandrel bar 5 was pulled downward, and the pulling load was determined.

As a result, the obtained pull-out load was converted to the adhesion force (k
g).

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

[0058]

FIG.

As can be seen from Table 1, the inner layer P of Comparative Example 1
The TFE composite catheter tube has an adhesion of 0.35 kg
And small.

The inner layer PTFE composite catheter tube of Comparative Example 2 has the smallest adhesion of 0.22 kg.

On the other hand, the inner layer PTFE of Example 1
The composite catheter tube showed excellent results with an adhesion of 1.85 kg <, and the inner layer PTFE composite catheter tube of Example 2 showed an adhesion of 1.35 kg <. As a result, the inner layer and the outer layer are completely adhered, and as a result, the reliability can be significantly improved.

Although not illustrated, the inner layer P of the present invention is not shown.
The TFE composite catheter tube can be easily formed into an ultra-thin PTFE tube when manufactured, and the product obtained by the manufacture has a large inner diameter and excellent lubricity,
Moreover, the outer diameter is small and the operability is excellent.

[0063]

According to the inner layer PTFE composite catheter tube of the present invention and the method for producing the same, an extremely thin PTFE tube can be easily formed at the time of production, and the product obtained by the production has a wide inner diameter and lubricity. Is excellent,
In addition, the outer diameter is small, and the inner layer and the outer layer are completely bonded, which is industrially useful.

[Brief description of the drawings]

FIG. 1 shows a step view of an inner layer PTFE composite catheter tube of Example 1 of the present invention.

FIG. 2 is an explanatory front view showing a tube adhesion test method.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Pure PTFE tube 2 Silica-containing PTFE layer 3 Polyamide elastomer layer 4 Inner layer PTFE composite catheter tube intermediate product 5 Mandrel bar 6 Nail jig 7 Coating layer

Continuation of the front page F term (reference) 4C081 AC08 BB05 BC01 CA132 CA211 CA231 CF112 CF132 CF142 CF152 DA03 DA15 DC03 DC04 DC05 DC06 EA02 EA04 4F100 AA00B AA00H AA08B AA08H AA17B AA17H AA19B AA19A AAAAAAAAAAABAAAAAH18 BA03 BA07 BA10A BA10C BA13 CA23B DA11 DE01B DE01H EH172 EH462 GB66 JK06 JK16 JK17

Claims (4)

[Claims] 1. An inner-layer PTFE composite catheter tube comprising an outer coating layer coated directly or via a blade layer on an inner-layer polytetrafluoroethylene resin tube layer, wherein the polytetrafluoroethylene resin tube has solid particles. An inner layer PTFE composite catheter tube which is a blended polytetrafluoroethylene resin overcoated pure PTFE tube. 2. An inorganic substance powder wherein the solid particles have a thermal softening point not lower than the sintering temperature of the polytetrafluoroethylene resin.
The inner layer PTFE composite catheter tube according to claim 1, wherein the inner layer is an organic substance. 3. The method according to claim 1, wherein the inorganic substance powder is one selected from the group consisting of silicon dioxide, calcium carbonate, magnesium carbonate, magnesium oxide, alumina, titanium dioxide, glass powder, and potassium titanate. 3. The inner layer PTFE composite catheter tube according to 2. 4. A pure polytetrafluoroethylene resin tube is prepared by coating, baking and sintering a polytetrafluoroethylene resin dispersion on a mandrel rod, and then a solid is placed on the pure polytetrafluoroethylene resin tube. The particle-containing polytetrafluoroethylene resin dispersion is applied, baked, and sintered to form a solid particle-containing polytetrafluoroethylene resin overcoat pure polytetrafluoroethylene tube, and then the solid particle-containing polytetrafluoroethylene resin Overcoat Pure polytetrafluoroethylene Directly or by providing a blade layer on the tube and extruding and coating the outer coating layer,
Finally, pull out the mandrel bar to remove the inner layer PT.
A method for producing an inner layer PTFE composite catheter tube, comprising removing the FE composite catheter tube.