JPH03280968A - Manufacture of balloon catheter - Google Patents

Abstract

PURPOSE:To stabilize a surface condition and shape in a fusion part so as to ensure a firm fusion condition by contracting a heat-shrinkable tube around the periphery of a balloon tube and fusing its both end parts to a catheter. CONSTITUTION:In the case of coating a shaft tube 12 with a balloon tube 20, a peripheral part of the balloon tube 20 for coating the shaft tube 12 is coated with a heat-shrinkage tube 30 in a floating-inserted condition by first coating a tip end peripheral part of the shaft tube 12 with the balloon tube 20. Next, the heat-shrinkable tube 30 is contracted by giving hot air to its both end parts. Both end parts of the balloon tube 20 are respectively fused to the peripheral parts of the shaft tube 12 by heating both the end parts of the balloon tube 20, which are restrited to the parts of the shaft tube 12 by the contracted heat- shrinkable tube 30. And then, the heat-shrinkable tube 30 is removed from the surface of the balloon tube 20.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a method for manufacturing a catheter having a balloon at its tip, particularly a balloon catheter that is inserted and left in the bladder through the urethra and used for continuous urination.

[Prior Art] Generally, a balloon catheter has a main lumen, at least one sublumen provided within the thickness of the catheter wall forming the main lumen, and a balloon communicating with the sublumen. . Further, among these, a balloon catheter inserted and placed in the urethra etc. has a base portion and a shaft tube, and the base portion has a proximal opening and a fluid injection/discharge portion for controlling the balloon equipped with a valve. The shaft tube (catheter) has a distal opening provided at the distal end, a balloon communication port provided at the outer periphery of the distal end, and a shaft tube (catheter) that is attached around the balloon communication port at the outer periphery of the distal end. and a main lumen extending from the proximal opening of the base to the distal opening of the shaft tube, and extending from the balloon control fluid injection/discharge portion of the base to the balloon communication port of the shaft tube (further, The shaft tube is constructed with a sub-lumen (located within the wall thickness of the shaft tube).

That is, in the case of a catheter that is inserted and left in the urethra etc. (hereinafter referred to as urethral catheter), the shaft tube is inserted into the urethra, and the fluid is injected from the balloon control fluid injection/discharge section through the sublumen and the balloon communication port. After the balloon is inflated with balloon inflation fluid and placed in the bladder, urine can be collected from the distal opening that serves as the urine drainage port and the proximal opening that serves as the urine collection port via the main lumen. do.

However, in the conventional manufacturing method of a balloon catheter such as a urinary catheter, the step of attaching the balloon tube to the shaft tube involves attaching the balloon tube 2 to the outer periphery of the distal end of the shaft tube 1, as shown in FIG. 6(A). With the core metal 3 passed through the main lumen of the shaft tube 1, the heating mold 4 is brought into contact with both ends of the balloon tube 2 and the shaft tube 1 and the core metal 3 are rotated. Rotate the balloon tube 2,
Both ends of the balloon tube 2 are fused to the shaft tube 1.

[Problem to be solved by the invention] However, the prior art has the following problems (1) to (3).

■Since the outer surfaces of both ends of the balloon tube 2 are in contact with the heating mold 4, surface roughness occurs on the outer surface of this fused portion due to friction (see Figure 6 (B)). Roughness is inappropriate for a urinary catheter that must be inserted without damaging the patient's urethral mucosa.

■Since the outer surfaces of both ends of the balloon tube 2 are in direct contact with the heating mold 4, when the balloon tube 2 comes into contact with the heating mold 4 at a position shifted from the standard contact position, the edges of the heating mold 4 This causes the outer surface of the fused portion of the balloon tube 2 to become depressed, and the shape of this fused portion is not stabilized (see FIG. 6(C)). It is inappropriate for a urethral catheter to be inserted without damaging a patient's urethral mucosa if the shape of the fused portion is unstable due to unevenness or the like.

■Both ends of the balloon tube 2 are placed on the heating mold 4 and fused to the shaft tube 1 while rotating.
No pressure is applied to actively press both ends of the balloon tube 2 to the outer circumference of the shaft tube 1. However, the contact force acting between both ends of the balloon tube 2 and the outer periphery of the shaft tube 1 during the fusion step is also not constant in the circumferential direction. For this reason, shaft tube 1
The fusion force of the balloon tube 2 to the balloon tube 2 is not stable in the circumferential direction thereof, and it is difficult to ensure a strong fusion state without any risk of peeling.

Incidentally, such surface roughness and unevenness of the fused portion of the balloon tube 2 not only hinders the ease of insertion of the urethral catheter, but also induces and promotes the adhesion of urine components etc. due to long-term (period) indwelling. Adhesion of urine components, which may also be absorbed, increases the difficulty of removing the catheter. Further, a decrease in the fusing strength of the balloon tube may lead to leakage of balloon inflation fluid. Furthermore, if the fusion force is not stable in the circumferential direction of the balloon, a portion of the balloon may peel off during insertion of the catheter, reducing work efficiency and increasing pain to the patient.

An object of the present invention is to stabilize the surface condition and shape of the fused portion and to ensure a strong fused state when a balloon tube is fused to a shaft tube.

[Means for Solving the Problems] The present invention as set forth in claim 1 has a main lumen and at least one sublumen provided within the catheter wall thickness forming the main lumen, and communicating with the sublumen. In a method for manufacturing a balloon catheter having a balloon, a portion of the catheter communicating with the sub-lumen is covered with a balloon tube, an outer periphery of the balloon tube is covered with a heat-shrinkable tube, and then the heat-shrinkable tube is shrunk. Further, both ends of the balloon tube are fused to the catheter.

The present invention according to claim 2 has a base portion and a shaft tube, the base portion has a proximal opening and a balloon control fluid injection/discharge portion, and the shaft tube has a distal side provided on a distal side. The shaft tube has an opening, a balloon communication port provided on the outer periphery of the distal end, and a balloon attached around the balloon communication port on the outer periphery of the distal end. In a method for manufacturing a balloon catheter comprising a main lumen extending to an opening and a sub-lumen extending from a fluid injection/discharge portion for controlling the balloon at the base to a balloon communication port of the shaft tube, the outer periphery of the distal side of the shaft tube After covering the outer circumference of the balloon tube with a heat shrink tube, the heat shrink tube was shrunk, and both ends of the balloon were fused to the shaft tube. It is something.

The present invention according to claim 3 provides that the contraction of the heat-shrinkable tube and the fusion of the balloon tube to the shaft tube are performed by applying hot air to at least both ends of the heat-shrinkable tube. After the tube is deflated, both ends of the balloon tube are brought into contact with a heating mold to fuse both ends of the balloon tube to the shaft tube.

[Function] According to the present invention as set forth in claim 1, there are the following functions and effects.

(2) When fusing both ends of the balloon to the shaft tube, the outer periphery of the balloon tube is covered with a heat-shrinkable tube in a contracted state. For this reason, when the outer surfaces of both ends of the balloon tube are heated for fusion, the outer surface of the balloon tube does not come into direct contact with the heating mold, and the outer surface of the fused portion is roughened due to friction. Therefore, for example, a urinary catheter can be inserted without damaging the patient's urethral mucosa or the like.

■Similar to ■ above, when heating both ends of the balloon tube for fusion, the outer surface of the balloon tube does not come into direct contact with the heating mold, and the balloon tube does not touch the heating mold. Even if contact is made at a position shifted from the standard contact position, the heated edge will not indent the outer surface of the fused portion of the balloon tube, and the tapered shape of this fused portion will remain stable. Therefore, for example, a urinary catheter can be inserted without damaging the patient's urethral mucosa or the like.

(2) Both ends of the balloon tube are fused to the outer periphery of the shaft tube under equal pressure in the circumferential direction of the shaft tube by the contraction force of the heat-shrinkable tube. Therefore, the fusion force of the balloon tube to the shaft tube is reliable and stable in the circumferential direction thereof, and a strong fusion state without any risk of separation can be ensured.

According to the present invention as set forth in claim 2, there is the following effect (2).

(2) After the balloon tube is secured around the shaft tube by contraction of the heat-shrinkable tube, both ends thereof are brought into contact with a heating mold. Therefore, the balloon tube can be reliably fused to the shaft tube at a predetermined position without deviation.

[Example] Fig. 1 is a schematic diagram showing an example of the balloon fusion process according to the present invention, Fig. 2 is an external view showing a urinary catheter, Fig. 3 is a cross-sectional view of the main part of Fig. 2, and Fig. 4 is a schematic diagram showing an example of the balloon fusion process according to the present invention. FIG. 5 is a sectional view showing the balloon portion of FIG. 2, and FIG. 5 is a sectional view showing the shaft tube portion of FIG. 2.

As shown in FIGS. 2 to 5, the urinary catheter 10 includes a base portion 11 having a large outer diameter and a shaft tube 12 having a small outer diameter.

The base 11 includes a base main body 11A and a base branch 11B branched from the base main body 11A.
1A is provided with a proximal opening 13, and a proximal branch portion 11B is provided with a balloon control fluid injection/discharge portion 14. The balloon control fluid injection/discharge section 14 is a valve 1 that injects or discharges the balloon inflation fluid into the opening and prevents its backflow.
5. The valve 15 is fixed by caulking rubber 16. Note that a heat shrinkable tube may be used as the caulking rubber 16.

The shaft tube 12 has a distal opening 17 provided on the side of the distal end, a balloon communication port 18 provided on the outer periphery of the distal end, and a balloon communication port 18 on the outer periphery of the distal end.
A balloon 19 is provided around the balloon.

The urinary catheter 10 includes a main lumen 21 extending from the proximal opening 13 of the base 11 to the distal opening 17 of the shaft tube 12 and from the balloon control fluid injection/discharge section 14 of the base 11 to the shaft tube 12. It is configured to include a sub-lumen 22 extending to the balloon communication port 18 of the balloon.

The urinary catheter 10 is used by connecting a urinary tube leading to a urine storage bag to a proximal opening 13 (urinary opening), and directs urine from the distal opening 17 (urinary opening) of the shaft tube 12 into the main lumen 21. , allowing urination through the proximal opening 13. At this time, the balloon 19 is connected to the valve 15.
A balloon inflation fluid such as sterile water is injected from a syringe inserted into the sub-lumen 22, and the catheter 10 is inflated, allowing the catheter 10 to be indwelled from the bladder to the urethra.

In addition, the urinary catheter 10 has the shaft tube 12,
It is provided with an X-ray contrast line 25 along its longitudinal direction.

Therefore, the urinary catheter 10 uses the following materials (A) to 19 for the base portion 11, shaft tube 12, and balloon 19.
Thermoplastic elastomers defined in group (D) can be selected and used.

(A) Polystyrene thermoplastic elastomer, e.g. 5E
BS (styrene-ethylene-butylene-styrene)
5BS (styrene-butadiene-styrene) 5I
S (Styrene-Isoprene-Styrene) In the practice of the present invention, a suitable 5EBS is RABALON (trade name) manufactured by Mitsubishi Yuka.

(B) Polyolefin thermoplastic elastomer such as E
Partially crosslinked polyolefin thermoplastic elastomer such as PBM-polyethylene, butyl rubber-polypropylene (C) Polyurethane thermoplastic elastomer For example, polyurethane-polyester, polyurethane-polyol (DJ Vinyl matured thermoplastic elastomer, ethylene-vinyl acetate thermoplastic elastomer, etc.)
Polyvinyl chloride thermoplastic elastomer In carrying out the present invention, the materials for the base 11, shaft tube 12, and balloon 19 are not limited to the above-mentioned thermoplastic elastomer, but latex rubber or silicone rubber may also be used. .

Hereinafter, a method for attaching the balloon tube 20 to the shaft tube 12 in the urinary catheter 10 will be explained (see FIG. 1).

(1) Cover the outer periphery of the shaft tube 12 on the distal end side with the seven belloon tube 20 (see FIG. 1(A)).

(2) A heat-shrinkable tube 3o is loosely inserted around the outer periphery of the balloon tube 20 that has been covered with the shaft tube 12 in (1) above (see FIG. 1(A)).

The heat shrink tube 30 has a larger diameter and is longer than the balloon tube 20.

The heat-shrinkable tube 30 is a tube made by heating an extruded plastic tube to an appropriate temperature and inflating it under a force of 1 to orient the molecules in the circumferential direction. When the heat-shrinkable tube 30 is reheated, the internal stress caused by the molecular orientation is relaxed and the tube shrinks to its original size. In carrying out the present invention, a silicone heat-shrinkable tube 30 is suitable.

(3) Apply hot air to both ends of the heat-shrinkable tube 30 in (2) above to shrink the heat-shrinkable tube 30 (see Fig. 1).
See B).

Note that the hot air may be applied to the heat-shrinkable tube 30 over the entire heat-shrinkable tube 30, or may be applied to both ends of the heat-shrinkable tube 30.

(4) For balloons that are held captive on the outer periphery of the shaft tube 12 with the heat-shrinkable tube 30 shrunk in (3) above with the core bar 31 inserted into the main lumen 21 of the shaft tube 12 Both ends of the tube 2o are brought into contact with the concave surface of a heated mold 32 made of brass, for example. Then, by rotating the core bar 31, the balloon tube 20 and the heat shrinkable tube 30 are heated while being rotated on the concave surface of the mold 32, and the balloon tube 20
Both ends of the shaft tube 12 are fused to the outer periphery of the shaft tube 12 (see FIG. 1(C)).

Note that the concave surface of the mold 32 is coated with Teflon.

Then, the mold 32 is heated to about 240° C. using a heater.

(5) Remove the heat shrink tube 30 from the outer periphery of the balloon tube 20.

Note that the heat-shrinkable tube 30 does not melt to the balloon tube 20 during the heating process in (4) above,
) A material is selected that facilitates the removal work, such as the aforementioned silicone.

Further, it is preferable that the heat-shrinkable tube 30 is provided with tear guide grooves in the longitudinal direction of its outer surface in advance so as to facilitate the removal operation in step (5).

Hereinafter, the operation of the above embodiment will be explained.

(2) When both ends of the balloon tube 20 are fused to the shaft tube 12, the outer periphery of the balloon tube 20 is covered with a heat-shrinkable tube 30 in a contracted state. Therefore, when heating the outer surfaces of both ends of the balloon tube 20 for fusion, the outer surface of the balloon tube 20 does not come into direct contact with the heating mold 32, and there is no friction on the outer surface of the fused portion. No surface roughness will occur.

Therefore, according to this urinary catheter 1o, it can be inserted into the urethra smoothly.

■Similar to (■) above, when heating both ends of the balloon tube 20 for fusion, the outer surface of the balloon tube 20 does not come into direct contact with the heating mold 32, and the balloon tube 20 Even if the heating mold 32 contacts the heating mold 32 at a position shifted from the standard contact position, the edge of the heating mold 32 will not indent the outer surface of the fused portion of the balloon tube 20, and the shape of this fused portion will remain stable. be. Therefore, according to this urinary catheter 10, it can be inserted into the urethra in smooth contact with the catheter.

(2) Both ends of the balloon tube 2o are fused to the outer periphery of the shaft tube 12 under equal pressure in the circumferential direction of the shaft tube 12 by the contraction force of the heat-shrinkable tube 30.

Therefore, the fusion force of the balloon tube 20 to the shaft tube 12 is reliable and stable in the circumferential direction thereof, and a strong fusion state without any possibility of separation can be ensured.

(2) After the balloon tube 20 is secured and held around the shaft tube 12 by contraction of the heat-shrinkable tube 30, both ends thereof are brought into contact with the heating mold 32. Therefore, the balloon tube 2o can be reliably fused to the shaft tube 12 at a predetermined attachment position without any deviation.

In the above embodiment, the process of applying hot air for shrinking the heat shrinkable tube 30 and the process of applying hot air to the balloon tube 20 are explained.
The process for heating is separated from the process for heating. However, in carrying out the present invention, the step of shrinking the heat-shrinkable tube and the step of heating the balloon tube can be combined into a single step. This can be realized, for example, by clamping each half-split heating mold around the contraction tube, balloon tube, and shaft tube.

Although the manufacturing method of the balloon catheter of the present invention has been explained using a urinary catheter as an example, the balloon catheter manufactured by the manufacturing method of the present invention is not limited to a urethral catheter, and can be used as an expansion material for PTCA. Needless to say, it can be used as appropriate for a catheter equipped with a balloon, such as a cuff inside a tensioned catheter.

[Effects of the Invention] As described above, according to the present invention, when a balloon tube is fused to a shaft tube, the surface condition of the fused portion,
It is possible to stabilize the shape and ensure a strong fused state.

[Brief explanation of drawings]

Fig. 1 is a schematic diagram showing an example of the balloon fusion process according to the present invention, Fig. 2 is an external view showing a urinary catheter, Fig. 3 is a cross-sectional view of the main part of Fig. FIG. 5 is a sectional view showing the balloon portion, FIG. 5 is a sectional view showing the shaft tube portion of FIG. 2, and FIG. 6 is a schematic diagram showing a conventional example. DESCRIPTION OF SYMBOLS 10... Urinary catheter, 11... Base, 2... Shaft tube, 3... Proximal end opening, 4... Fluid injection/discharge part for balloon control, 7... Distal side opening , 8...Balloon communication port, 9...Balloon, 0...Balloon tube, 1...Main lumen, 2...Sub lumen, 0...Heat shrink tube, 2...・Heating type.

Claims (3)

[Claims] (1) A method for manufacturing a balloon catheter having a main lumen and at least one sublumen provided within the catheter wall thickness forming the main lumen, and a balloon communicating with the sublumen. After covering the communicating portion with a balloon tube and covering the outer periphery of the balloon tube with a heat shrink tube, the heat shrink tube is shrunk, and both ends of the balloon tube are fused to the catheter. A method for manufacturing a balloon catheter characterized by the following. (2) It has a base and a shaft tube, the base has a base opening and a balloon control fluid injection/discharge part, and the shaft tube has a distal opening provided on the distal side and an outer periphery on the distal side. A main lumen extending from the proximal opening of the base to the distal opening of the shaft tube. In the method for manufacturing a balloon catheter, the balloon catheter is provided with a sub-lumen extending from a fluid injection/discharge portion for controlling the balloon at the base to a balloon communication port portion of the shaft tube, in which the balloon tube is coated on the outer periphery of the distal side of the shaft tube. A method for manufacturing a balloon catheter, comprising: covering the outer periphery of the balloon tube with a heat-shrinkable tube, then shrinking the heat-shrinkable tube, and further fusing both ends of the balloon to the shaft tube. (3) Shrinking the heat shrink tube and fusing the balloon tube to the shaft tube after applying hot air to at least both ends of the heat shrink tube to shrink the heat shrink tube; 3. The method for manufacturing a balloon catheter according to claim 1, wherein both ends of the balloon tube are brought into contact with a heating mold to fuse both ends of the balloon tube to the shaft tube.