JPH08299431A - Urethra catheter - Google Patents

Abstract

PURPOSE: To provide a urethra catheter with improved peeling strength between a baloon and a shaft tube while flexibility and restoring properties are kept. CONSTITUTION: A urethra catheter 10 wherein either one of a shaft tube 11 and a baloon 12 is formed of the first compsn. contg. a styrene-ethylene-butylene- styrene block copolymer and an ethylene-propylene random copolymer and another one is formed of the second compsn. contg. a styrene-ethylene-butylene- styrene block copolymer and an olefin resin, is provided.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a urethral catheter used for continuous urination by inserting and leaving the bladder through the urethra.

[0002]

2. Description of the Related Art In a urethral catheter that is inserted and left in the urethra or the like for the purpose of urination, after inserting a shaft tube into the urethra, fluid is injected into the balloon from the fluid injection / exhaust port, and the balloon is inserted into the bladder. It is used for the purpose of indwelling the urethral catheter by inflating it and collecting urine from the urethral opening.

As a material for such a urethral catheter,
Japanese Patent Laid-Open No. 53-69488 discloses Kraton G-16.
A balloon formed from a composition in which a thermoplastic elastomer having a trade name of 50,1652 is mixed with a plasticizing oil such as paraffin oil, a stiffening agent and a non-degrading agent such as polypropylene, and the balloon and the shaft have Kraton G.
-7055 is described as a Foley catheter or urethral catheter. Kraton G-16
50 and 1652 are trade names of styrene-ethylene-butylene-styrene block copolymer (SEBS),
Kraton G-2705 is a trade name of SEBS containing naphtha oil and a non-degrading agent. In addition, Japanese Patent Publication No. 2-3718
Japanese Patent Publication No. 5 describes that a cuff formed from a composition obtained by mixing SEBS with silicone oil and polypropylene, and that it can be used for a Foley catheter (urethral catheter).

Furthermore, a prior application relating to the urethral catheter of the present applicant (Japanese Patent Laid-Open Nos. 2-232067 and 3-2809).
68, JP-A-3-280970, and JP-A-5-18466.
4, JP-A-6-335033) describes a urethral catheter made of SEBS under the trade name Lavalon (Mitsubishi Petrochemical Co., Ltd.). The lavalons used in these are all SEBS blended with polypropylene.

The balance of hardness, permanent elongation, peel strength, etc. is important for the balloon and shaft tube. Peel strength is particularly important because it can lead to balloon rupture and leakage within the bladder. A composition obtained by adding polypropylene or high-density polyethylene to SEBS has good hardness and permanent elongation, which are indicators of flexibility and resilience, but the minimum required value for the peel strength between the balloon and the shaft tube. Met. Therefore, it has been desired to increase the peel strength.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a urethral catheter in which the peeling strength between the balloon and the shaft tube is further improved while maintaining flexibility and restorability.

[0007]

[Means for Solving the Problems] As a result of repeated research to solve the above problems, SEBS is blended with an ethylene-propylene random copolymer to provide good flexibility and good restorability, and to achieve a remarkable peel strength. The present invention has been found to be improved, and the inventions (1) to (9) described below have been completed.

(1) A shaft tube having a main lumen and a sub-lumen and having a urine introduction port communicating with the main lumen at its tip and a sub-lumen opening provided on the outer periphery of the tip of the shaft tube. A urethra provided with a balloon to be capped, a urine outlet communicating with the main lumen at the proximal end of the shaft tube, and a fluid injecting / exhausting port communicating with the sublumen for injecting or discharging a balloon inflation fluid. In the catheter, one of the shaft tube and the balloon is formed from a first composition containing a styrene-ethylene-butylene-styrene block copolymer and an ethylene-propylene random copolymer, and the other is Second containing a styrene-ethylene-butylene-styrene block copolymer and an olefin resin A urethral catheter formed from the composition of claim 1.

(2) The urethral catheter according to (1), wherein the peel strength between the shaft tube and the balloon is 1.0 kg / cm or more.

(3) The shaft tube is formed from the first composition, and the ethylene in the composition is
The urethral catheter according to (1) or (2), wherein the propylene random copolymer is 10 to 20% by weight.

(4) The urethral catheter according to (1) or (2), wherein the shaft tube is formed from the second composition, and the olefin resin in the composition is 10 to 20% by weight. .

(5) The balloon is formed from the first composition, and the ethylene-propylene random copolymer in the composition is 5 to 15% by weight (1),
The urethral catheter according to (2) or (4).

(6) The balloon according to any one of (1) to (3), wherein the balloon is formed from the second composition, and the olefin resin in the composition is 5 to 15% by weight. Urethral catheter.

(7) The urethral catheter according to any one of (1) to (6), wherein the olefin resin is the ethylene-propylene random copolymer and / or polypropylene.

(8) The shaft tube is formed from the first composition, the ethylene-propylene random copolymer in the composition is less than 20% by weight, and the composition further comprises polyethylene and / or (1), (2), (6) or (7), wherein the total amount of the ethylene-propylene random copolymer and the polyethylene and / or polypropylene is 10 to 20% by weight. Urethral catheter.

(9) The shaft tube is formed of the first composition, the balloon is formed of the second composition, and the olefin resin contained in the second composition. Is polypropylene (1),
The urethral catheter according to any one of (2), (3), (6), (7) or (8).

The random copolymer referred to in the present invention is a copolymer in which a plurality of different monomers are randomly arranged in a polymer chain, and the block copolymer is a plurality of copolymers. It is a copolymer composed of linear polymers having different homopolymers as partial constituents.

FIG. 1 is a front view of the urethral catheter of the present invention. FIG. 2 is a partial cross-sectional view of the urethral catheter of the present invention. FIG. 3 is a partially enlarged sectional view showing a balloon portion of the urethral catheter of the present invention. FIG. 4 is a cross-sectional view of the shaft tube of the urethral catheter of the present invention taken along the line AA ′ of FIG. The urethral catheter 10 is composed of a shaft tube 11, a balloon 12 and a base 13. The shaft tube 11 is provided with a main lumen 14 and a sub-lumen 15, and a urine outlet 16 communicating with the main lumen 14 is provided on the side portion of the distal end portion.

As shown in FIG. 3, the balloon 12 is formed at the outer peripheral portion of the tip of the shaft tube 11 and the shaft tube 11.
The sub-lumen 15 is provided around the opening 17 and is crowned. Further, the shaft tube 11 is provided with an X-ray contrast line 21 in its longitudinal direction.

The base portion 13 is provided on the base end side of the shaft tube 11 and communicates with the main lumen 14.
8 and a valve 19 (liquid injection / discharge port) communicating with the sub-lumen 15 for injecting or discharging the balloon inflation liquid. The valve 19 is fitted to the end of the base 13 and is fixed by the caulking member 20.

The urethral catheter 10 is used by connecting a urine drainage tube leading to a urine storage bag to the urine drainage port 18, and the urine guided from the urine drainage port 16 of the shaft tube 11 can be drained through the main lumen 14 and the urine drainage port 18. To do. In addition,
The balloon 12 is inflated by supplying a balloon inflation fluid such as sterilized water injected from a syringe inserted in the valve 19 through the sublumen 15.

Either one of the shaft tube 11 and the balloon 12 of the urethral catheter of the present invention is a styrene-ethylene-butylene-styrene block copolymer (S
EBS) and ethylene-propylene random copolymer (random PP) are formed from a first composition, and the other is formed from a second composition containing SEBS and an olefin resin.

The peel strength between the shaft tube and the balloon is preferably 1.0 Kg / cm or more, more preferably 1.1 Kg / cm or more. Peel strength is 1.0
If it is Kg / cm or more, there is no risk of balloon rupture or leak, which is preferable.

SEBS used in the present invention is hydrogenated to a triblock type copolymer (SBS) having a structure of polystyrene-polybutadiene (block copolymer of 1,2-bond and 1,4-bond) -polystyrene. It is a block copolymer obtained by. It is preferred that the total of polystyrene parts (S parts) at both ends occupy 10 to 60% by weight in SEBS, and more preferably 20 to 40.
It is preferable to make up the weight percentage. The ethylene butylene copolymer part (EB part) has a butylene part ratio of 20 to 90.
Those which occupy weight% are preferable, and more preferably 30
It is preferable to occupy 80% by weight. In addition, SEBS
Those having a molecular weight of 5,000 to 1,000,000 are preferable,
More preferably, it is preferably 10,000 to 8,000,000. The amount of SEBS is 20 to 60% by weight of the composition.
Is preferable, and more preferably 30 to 50% by weight.

As the olefin resin blended in the second composition, ethylene, propylene, butene-1, pentene-1, hexene-1, 4-methylpentene-1 and the like α-olefins are isolated by a conventional method. Or in the form of copolymerization,
A resin obtained by polymerization can be used. For example, at least one resin selected from the group consisting of polyethylene, polypropylene and random PP can be used, preferably polypropylene, random PP and a combination of polypropylene and random PP, with polypropylene being particularly preferred.

Further, the shaft tube is SEBS.
And a random composition containing random PP,
When the balloon is formed from the second composition containing SEBS and polypropylene, the peel strength is particularly high, which is more preferable.

The amount of the random PP blended in the first composition and the amount of the olefin resin blended in the second composition are each 1 when formed in the shaft tube.
0 to 20% by weight is preferable, and 13 to 17 is more preferable.
When it is formed into a balloon, it is preferably 5 to 15% by weight, and more preferably 8 to 12% by weight. In the shaft tube, when the blending amount of the random PP and the olefin resin is less than 10% by weight, the peel strength of the balloon becomes 0.9 Kg / cm or less, and the peel strength is satisfied to the minimum necessary level, but it is not sufficiently satisfactory. Absent. Further, in the balloon, when the blending amount of the random PP and the olefin resin is less than 5% by weight, the peeling strength of the balloon becomes 0.9 Kg / cm or less, and the peeling strength is satisfied to the minimum necessary level, but it is sufficiently satisfactory. However, if the blending amount exceeds 15% by weight, the balloon becomes hard, which is not preferable.

The first composition contains SEBS and random P
In addition to P, a resin may be further mixed. As other resins to be further blended, α-olefins such as ethylene, propylene, butene-1, pentene-1, hexene-1, 4-methylpentene-1 are polymerized by a conventional method in the form of a homopolymer or a copolymer. The resulting resin can be used. It is preferably polyethylene, polypropylene or a combination of polyethylene and polypropylene, more preferably a combination of polyethylene and polypropylene.
When the shaft tube is formed from the first composition, the blending amount of the random PP is preferably less than 20% by weight of the composition, more preferably 3 to 17% by weight, and the total amount of the random PP and the other resin is 10 to 20% by weight is preferable, and 13 to 17% by weight is more preferable. If the total amount of the random PP and the other resin is less than 10% by weight, the peel strength of the balloon becomes 0.9 Kg / cm or less, and the peel strength is satisfied to the minimum necessary level, but it is not sufficiently satisfactory.

In addition to SEBS and random PP, a plasticizer can be added to the first composition and the second composition up to 60% by weight of the composition, and preferably 25 to 50% by weight, more preferably 40-50% by weight
Is. Paraffin oil or the like can be used as the plasticizer. When the plasticizer is blended in an amount of more than 60% by weight of the composition, the properties of SEBS are deteriorated and it is not suitable for the material of the urethral catheter, which is not preferable.

Further, if necessary, a lubricant such as silicone oil or oleic acid amide, an antioxidant such as dibutylhydroxytoluene, a filler such as talc and the like can be added.

Each of the above-mentioned compositions can be pelletized by putting a predetermined amount of each compounding component into a mixing device and stirring and mixing, and melt-kneading the mixture with an extruder or the like. Next, a balloon and a shaft tube can be manufactured from the pellet by extrusion molding or the like. The method for producing the urethral catheter of the present invention is a known method (for example, Japanese Patent Laid-Open No. 2-2
32067, etc.) can be used.

FIG. 5 is a diagram showing a method for measuring the peel strength between the shaft tube 11 and the balloon 23 in the present invention. First, as shown in (A), the urethral catheter 1
0 is cut at the BB 'and CC' lines. Next, as shown in (B), one side of the shaft tube 11 and the balloon 23 is cut along the line DD ′. Then, as shown in (C), the shaft tube and the balloon are expanded, and the fusion-bonded portion 22 is peeled off or the balloon 23 is ruptured between the entire width of the end portion 25 of the shaft tube 11 and the entire width of the end portion 24 of the balloon 23. Until 180 °, pull in the direction of 180 °. The peel strength (Kg / cm) is a value obtained by dividing the tensile strength (Kg) when the fusion-bonded portion 22 is peeled or the balloon 23 is broken without peeling by the outer peripheral length (cm) of the shaft tube 11. Is. When the balloon 23 is broken without peeling the fusion-bonded portion 22, the peel-off strength of the fusion-bonded portion 22 is higher than the strength of the material of the balloon 23.

[0033]

EXAMPLE A partial preparation of the urethral catheter of the present invention,
The peel strength was examined. Further, the hardness and the permanent elongation were measured to examine the suitability of the material for the balloon or the shaft tube.

Materials and Methods Examples 1 to 12, Comparative Examples 1 and 2 Compositions: The compositions of the shaft tube and balloon tube of Examples 1 to 12 and Comparative Examples 1 and 2 are shown in Tables 1 to 1.
Code No. Trademark name shown in 3 Lavalon (Mitsubishi Chemical Corporation)
Was used. Each of the code numbers of Lavalon is SEB.
S and paraffin oil are included only in the contents of the present invention described above, but the contents of the synthetic resins shown in Tables 1 to 3 are different. MFR
Is a flow tester (Shimadzu Corporation, CFT-500)
Using C), the values are measured under the conditions of a temperature of 190 ° C., a load of 40 kg, a die length of 10 mm and an inner diameter of 1 mm.

[Table 1]

[Table 2]

[Table 3] Molding: using pellets of the above SEBS composition,
Shaft tube (diameter 5.33m at 170-210 ℃)
m) and a tube for balloon (length 70 mm, inner diameter 5.3 mm, wall thickness 0.55 mm) were extruded. In addition, for hardness measurement, a prescribed sheet was extruded under the same conditions.

Peel strength: 5 mm of the tip of the balloon tube on the tip of the shaft tube obtained above
Was heat-sealed in a coronal shape by the method described in JP-A-3-280968. Next, regarding these (Examples 1 to 12)
(20 for each, 10 for Comparative Examples 1 and 2), and as shown in FIG. 5 (B), one side of the shaft tube 11 and the balloon tube 24 is cut along the line DD ′, and shown in (C). So that after deployment, the end portion 2 of the balloon tube 23
4 and the end 25 of the shaft tube 11 are chucked,
It was pulled at a pulling speed of 50 mm / min until peeling or breaking. Tensile strength is measured by a tensile tester (trade name: Autograph, Shimadzu Corporation, model number: AGS-100
It was measured using A). Then, the tensile strength (Kg) when the fusion-bonded portion 22 is peeled off or the balloon tube 23 is broken is determined by the length (c) of the outer circumference of the shaft tube 11.
The value divided by m) was taken as the peel strength (Kg / cm). Further, the peeled state was evaluated by the following three scales. A: The balloon tube was broken without peeling the fused surface, B: The fused surface was peeled about half and the balloon tube was broken, and C: The fused surface was completely peeled.

Hardness: The rubber hardness JIS-A was measured according to JIS standard K6301 “Test method for hardness of vulcanized rubber”.

Permanent elongation: 300 shaft tube
% Elongation, held for 10 minutes, then released, and after 60 minutes, the total length was measured. Permanent elongation (%) is the value obtained by subtracting the original length from the length after releasing the elongation, divided by the original length, and then 10
It is a value multiplied by zero.

[Measurement Results] Shaft tubes, balloon tubes and sheets were molded and fused by Examples 1 to 12 and Comparative Examples 1 and 2.
All were in good condition, and no foreign matter, foaming, etc. were observed, and a highly uniform product was obtained.

As shown in Table 1, the shaft tubes mixed with random PP (Examples 1 to 5) have a high peel strength of 1.0 Kg / cm or more from the balloon tube mixed with polypropylene and have a fusion-bonded surface. It was good without peeling. On the other hand, shaft tubes containing polypropylene or block PP (Comparative Examples 1 and 2)
The peel strength was as low as 0.9 kg / cm or less, and about half or all of the fused surface was peeled off.

As shown in Table 2, the balloon tube containing the random PP is a shaft tube containing polypropylene or random PP (Examples 6 to 6).
The peel strength with 9) was as high as 1.0 Kg / cm or more, and the fused surface was good without peeling.

As shown in Table 3, the shaft tube mixed with random PP or the like contains polypropylene in an amount of 5 to 1
A balloon tube containing 0% by weight (Examples 10 to 1)
The peel strength with 2) was as high as 1.0 Kg / cm or more, and the fusion-bonded surface was good without peeling.

For hardness and permanent elongation, Example 1
~ 4, 8 (Example 8 is the same material as 4) and Comparative Example 1,
It was confirmed that all of the values were suitable for the urethral catheter (see Table 1). The compositions of Examples 5 to 7 and 9 to 11 (Example 12 is the same as that of 4) are similar to the compositions of Examples 1 to 4, and it can be inferred that the values are about the same from these measured values. , Did not measure.

[Conclusion] In the urethral catheter of the present invention, one of the balloon and the shaft tube is formed from a composition containing SEBS and random PP, and the other is SEBS.
When formed from a composition containing an olefin resin and a olefin resin, the peel strength is as high as 1.0 Kg / cm or more, and the fused surface is not peeled off, so there is no risk of balloon rupture or leakage. Further, it was revealed that these hardness and permanent elongation are values suitable for a urethral catheter, and are flexible and have good restoring properties.

[0044]

In the catheter for urethra of the present invention, one of the shaft tube and the balloon contains a styrene-ethylene-butylene-styrene block copolymer and an ethylene-propylene random copolymer. Formed of a styrene-ethylene-butylene-styrene block copolymer, and the other is formed of a second composition containing an olefin-based resin, so that the flexibility and restitution are good and the material of the urethral catheter is good. Suitable as Further, since the peeling strength between the balloon and the shaft tube is high and the fused surface is not peeled off, there is no risk of the balloon rupturing or leaking.

In particular, when the peel strength between the shaft tube and the balloon is 1.0 Kg / cm or more,
Since the fused surface is not peeled off, there is no risk of balloon rupture or leak.

When the shaft tube is formed from the first composition and the ethylene-propylene random copolymer in the composition is 10 to 20% by weight, the peel strength is higher and the balloon burst. There is no risk of leaks.

When the shaft tube is formed from the second composition and the olefin resin in the composition is 10 to 20% by weight, the peel strength is higher and there is a risk of balloon rupture or leak. There is no

When the balloon is formed from the first composition and the ethylene-propylene random copolymer in the composition is 5 to 15% by weight, the peel strength is higher, and the balloon is ruptured or broken. There is no risk of leaks.

The balloon is formed from the second composition, and the olefin resin in the composition is 5 to 15
When it is wt%, the peel strength is higher and there is no risk of balloon rupture or leak.

When the olefin resin is an ethylene-propylene random copolymer and / or polypropylene, the peel strength is particularly high, and there is no risk of balloon rupture or leak.

The shaft tube is formed from the first composition, the ethylene-propylene random copolymer in the composition is less than 20% by weight, and the composition further comprises polyethylene and / or polypropylene. , The total amount of the ethylene-propylene random copolymer and the polyethylene and / or polypropylene is 10
When it is up to 20% by weight, the peel strength is higher and there is no risk of balloon rupture or leak.

The shaft tube is formed of the first composition, the balloon is formed of the second composition, and the olefin resin contained in the second composition is polypropylene. In this case, the peel strength is particularly high, and there is no risk of balloon rupture or leak.

[Brief description of drawings]

FIG. 1 is a front view of a urethral catheter of the present invention.

FIG. 2 is a partial cross-sectional view of the urethral catheter of the present invention.

FIG. 3 is a partial enlarged cross-sectional view showing a balloon portion of the urethral catheter of the present invention.

FIG. 4 is a sectional view of the shaft tube of the urethral catheter of the present invention taken along the line 1A-A ′ of FIG.

FIG. 5 is a diagram showing a method for measuring the peel strength between the balloon (balloon tube) of the urethral catheter and the shaft tube.

[Brief description of reference numerals]

 10 Urethral Catheter 11 Shaft Tube 12 Balloon 13 Base 14 Main Lumen 15 Subrumen 16 Urinating Port 17 Opening 18 Urination 19 Valve 20 Caulking Member 21 X-ray Contrast Line 22 Fusion Part 23 Balloon (Balloon Tube) 24 Balloon ( End of balloon tube 25 End of shaft tube

Front page continuation (72) Inventor Yutaka Ito 150 Maimaigi-cho, Fujinomiya-shi, Shizuoka Terumo Corporation

Claims (9)

[Claims] 1. A shaft tube having a main lumen and a sub-lumen, and having a urine introduction port communicating with the main lumen at a distal end portion thereof, and a sub-lumen opening provided at an outer peripheral portion of the distal end of the shaft tube, covering the crown. Urethral catheter provided with a balloon to be attached, a urine outlet communicating with the main lumen at the proximal end of the shaft tube, and a fluid injecting / exhausting port communicating with the sub-lumen for injecting or discharging a balloon inflation fluid In either one of the shaft tube and the balloon, styrene-
An ethylene-butylene-styrene block copolymer and an ethylene-propylene random copolymer formed from a first composition, the other is a styrene-ethylene-butylene-styrene block copolymer, and an olefin resin. A urethral catheter formed from a second composition comprising: 2. The urethral catheter according to claim 1, wherein the peel strength between the shaft tube and the balloon is 1.0 kg / cm or more. 3. The shaft tube is formed from the first composition, and the ethylene-propylene random copolymer in the composition is 10 to 20% by weight. The urethral catheter according to 2. 4. The shaft tube is formed from the second composition, and the olefin-based resin in the composition is 10 to 20% by weight. Urethral catheter. 5. The balloon is formed from the first composition, and the ethylene-propylene random copolymer in the composition is 5 to 15% by weight. Or the urethral catheter according to any one of 4 above. 6. The balloon is formed from the second composition, and the olefin resin in the composition is 5 to 1
The urethral catheter according to claim 1, wherein the urethral catheter is 5% by weight. 7. The urethral catheter according to claim 1, wherein the olefin resin is the ethylene-propylene random copolymer and / or polypropylene. 8. The shaft tube is formed from the first composition, wherein the ethylene-propylene random copolymer in the composition is less than 20 wt% and the composition further comprises polyethylene and / or polypropylene. And the total amount of the ethylene-propylene random copolymer and the polyethylene and / or polypropylene is 1
0 to 20% by weight,
The urethral catheter according to any one of 6 and 7. 9. The shaft tube is formed from the first composition, the balloon is formed from the second composition, and the olefin resin contained in the second composition is , Polypropylene, The urethral catheter according to any one of claims 1, 2, 3, 6, 7 or 8.