JPH0349586B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (I) Background of the Invention <Technical Field> The present invention relates to a method of manufacturing a balloon catheter and an apparatus used in the method of manufacturing the same.

<Prior art and its problems> Balloon catheters are used as indwelling urinary catheters, cardiac catheters, intratracheal catheters, and the like.

Conventionally, various methods have been considered for manufacturing this type of balloon catheter. In particular, the manufacturing method disclosed in Japanese Patent Publication No. 52-43032 by the present applicant does not require the work of punching holes in the sub-channels, has high production efficiency, and has a high production efficiency. It is possible to manufacture a balloon catheter in which the inner layer of latex rubber forming the urinary tract is difficult to peel off. However, in the invention described in Japanese Patent Publication No. 52-43032, a thin rod-shaped mold for forming a sub-passage, which is a rod-shaped mold with a latex rubber inner layer coated with a coagulant for latex rubber, is slightly set back from the rod-shaped mold. Then, while rotating the mold, a gap-forming material for forming a balloon portion is attached to the rod-shaped mold from above. However, with this method, if the gap-forming substance drips from the wall of the spray container onto the latex rubber inner layer formed in the rod-shaped mold, the gap-forming substance may not be completely atomized due to changes in the spray machine, etc., and become quite large particles. may adhere to the latex rubber inner layer formed in the rod-shaped mold. Even if a rod-shaped mold with such a large amount of gap-forming substance attached is next immersed in a latex rubber tank, the latex rubber may not partially adhere and a balloon part cannot be formed, and even if it does adhere, a sufficient amount may not be able to form. In some cases, the latex rubber did not adhere and only weak balloon parts were formed. Furthermore, the adhesion boundary line of the gap-forming substance adhering to the latex rubber inner layer could not be made clear, and could be tilted, so that the formed balloon part could not inflate uniformly in the radial direction. Furthermore, Tokko Akira
The spray device disclosed in No. 52-43032 is also intended to be implemented in the manufacturing method disclosed in the above-mentioned publication, and even when that device is used, there are cases in which problems similar to those described above may occur.

() Object of the Invention Therefore, an object of the present invention is to provide a method for manufacturing a balloon catheter that can efficiently manufacture a balloon catheter that inflates uniformly in the radial direction and has a balloon portion with sufficient strength. Furthermore, a second invention of the present application provides a spray device that is directly used in carrying out the above-described method for manufacturing a balloon catheter.

To achieve the above object, there is provided a method for manufacturing a balloon catheter having a conduit passage, at least one sub-passage within the catheter wall forming the conduit passage, and a balloon portion communicating with the sub-passage, comprising: a latex rubber inner layer; A slender rod-shaped mold for forming an auxiliary passageway, to which a latex rubber coagulant is adhered, is placed parallel to the rod-shaped mold for forming a conduction path and at its tip. is arranged slightly backward from the tip of the rod-shaped mold for forming a conduit passage, and then the rod-shaped mold for forming a conduit passage and the narrow rod-shaped mold for forming a sub-passage are rotated together to form the sub-passage. During the balloon part formation period, the forming substance is atomized and sprayed from the lower side of the rod-shaped mold for forming a conductive path at the tip of the thin rod-shaped mold for forming and a position near the same. A balloon for attaching a forming substance and then forming a latex rubber outer layer on the rod-shaped mold for forming a conduit passage and the thin rod-shaped mold for forming an auxiliary passage, and then removing the rod-shaped mold and the thin rod-shaped mold for forming the sub-channel. This is a method for manufacturing a catheter.

Preferably, the barrier-forming material is a mixture of a volatile silicone solution and an alcohol solution of a divalent or trivalent metal salt.

Further, the device that achieves the above object includes at least one part in the conduit and the catheter wall forming the conduit.
A spray device used in a method for manufacturing a balloon catheter having two sub-passages and a balloon portion communicating with the sub-passages, the spray device comprising: a rod-shaped mold for forming a conduit; a rotation mechanism that integrally rotates a rod-shaped mold and a thin rod-shaped mold for forming a secondary passageway arranged in parallel; and forming the conductive path at a tip of the narrow rod-shaped mold for forming a secondary passageway and a position near the tip thereof. a wind tunnel that extends vertically and has an insertion opening for a rod-shaped mold for forming a conduit passage for accommodating a rod-shaped mold for use in the wind tunnel; This is a spray device for manufacturing a balloon catheter, which has a suction mechanism attached above to suck up the mist-forming substance sprayed from the spray machine. Preferably, the sprayer is detachably attached to the wind tunnel. Furthermore, it is preferable that the rotation mechanism is capable of connecting and rotating the plurality of rod-shaped molds for forming conductive paths. moreover,
The rotation mechanism is capable of connecting and rotating the plurality of rod-shaped molds for forming conduction paths, and is capable of rotating the plurality of rod-shaped molds for forming conduction paths in the same direction and at the same speed. It is preferable that the

() Specific Description of the Invention The present invention will be described in detail below based on illustrated embodiments.

A method for manufacturing a balloon catheter according to the present invention is a method for manufacturing a balloon catheter having a conduit, at least one sub-passage within the catheter wall forming the conduit, and a balloon portion communicating with the sub-passage. , a rod-shaped mold 1 for forming a conduction path, in which a latex rubber coagulant is adhered to the latex rubber inner layer and the latex rubber inner layer 2, and a thin rod-shaped mold 3 for forming a sub-channel, to which a latex rubber coagulant 4 is adhered, are combined into a rod-shaped mold for forming a conduction path. 1, and its tip is slightly set back from the tip of the rod-shaped mold 1 for forming a conduit passage, and then the rod-shaped mold 1 for forming a conduit passage and the narrow rod-shaped mold 3 for forming a sub-passage are integrated. At the same time, while rotating the thin rod-shaped mold 3 for forming the auxiliary passage, the material 6 for forming the balloon portion is atomized and sprayed from the lower side of the rod-shaped mold 1 for forming the conduit passage at the tip and the vicinity thereof. While suctioning from the upper side
After the forming substance 6 is attached and the latex rubber outer layer 7 is formed on the rod-shaped mold 1 for forming the conduit passage and the thin rod-shaped mold 3 for forming the sub-channel, the rod-shaped mold 1 and the thin rod-shaped mold 3 are removed. It is something.

1 to 5 show the method according to the present invention in the order of steps. As shown in Figure 1,
First, a rod-shaped mold 1 for forming a conduction path for a drainage liquid or a chemical solution is coated with a coagulant for latex rubber and immersed in a latex rubber bath, thereby forming a latex rubber inner layer on the circumferential surface of the rod-shaped mold 1. 2. The latex rubber used in the present invention is liquid and includes natural latex rubber, synthetic rubber such as styrene-butadiene rubber, acrylonitrile-butadiene rubber,
Various latex rubbers such as regenerated rubber and isoprene rubber can be used. Further, to this latex rubber, powdered sulfur, colloidal sulfur, etc. are added as a vulcanizing agent, diethyldithiocarbamate, etc. are added as a vulcanization accelerator, and milk casein, etc. are added as a thickening agent. Furthermore, surfactants, emulsifiers, etc. may be added as necessary. Suitable coagulants for latex rubber include lower alcohol solutions of divalent or trivalent metal salts such as barium chloride, calcium chloride, barium nitrate, aluminum sulfate, and calcium nitrate.

After the latex rubber inner layer 2 is formed on the rod-shaped mold 1 for forming a conductive path, a latex rubber coagulant 5 is further applied. Then, a latex rubber coagulant 4 is applied to a narrow rod-shaped die 3 for forming a sub-passage for inflating or deflating the balloon. The coagulant for latex rubber 4 used here can also be the coagulant for latex rubber described above, but in order to facilitate the removal of the thin rod-shaped mold 3 after molding the balloon catheter,
A solution prepared by appropriately mixing a volatile solution of silicone with a lower alcohol solution of a divalent or trivalent metal salt is suitable.

Then, as shown in FIG. 2, the thin rod-shaped mold 3 coated with the latex rubber coagulant 4 is arranged along the longitudinal direction of the rod-shaped mold 1 coated with the latex rubber inner layer 2 and the latex rubber coagulant 5. Set up In order to prevent the thin rod-shaped mold 3 from being easily displaced, it is preferable that the rod-shaped mold 1 is provided with a thin rod-shaped mold fixture 22. The thin rod-shaped mold is placed at a position where its tip is retreated from the tip of the rod-shaped mold 1 by a predetermined distance. The tip of this thin rod-shaped mold 3 and its vicinity become the balloon forming portion. Next, in order to form the balloon part, as shown in FIG. 3, a gap-forming substance 5 is applied to a predetermined width of the rod-shaped mold 1 at the tip of the thin rod-shaped mold 3 and a position near it. During this time, make sure that the later-described latex rubber outer layer 7 does not adhere to the latex rubber inner layer 2 on the area where the forming substance 5 has been applied.

As the gap-forming substance 5, a volatile solution of silicone and a lower alcohol solution of a divalent or trivalent metal salt are preferably used, and these are used as a mixed solution or individually in sequence. As volatile solvents for silicone, known ones such as tetrahydrofuran and acetone can be used, usually in a ratio of 100 parts by volume per 7 to 20 parts by volume of silicone. Divalent or trivalent metal salts are used as coagulants for rubber latex, and specifically, calcium chloride, barium chloride, calcium nitrate, barium nitrate, aluminum sulfate, calcium nitrate, etc. are suitable.

As the lower alcohol, one having 4 or less carbon atoms is preferable from the viewpoint of compatibility with the polyvalent metal salt. Usually, the polyvalent metal salt is used as a 5-10% solution using the lower alcohol as a solvent. Further, the volume ratio of the alcoholic solution of the polyvalent metal salt to the volatile solution of silicone is preferably 3:1 to 4:1. If the amount of the alcohol solution of the polyvalent metal salt is so large as to exceed 3:1, no gap will be formed between the latex rubber outer layer 7 and the latex rubber inner layer 2 to be deposited next, so that the balloon portion may not be formed. It is from. Also, if the amount of volatile silicone solution exceeds 4:1,
This is because even if the rod-shaped mold 1 is then immersed in a latex rubber bath to form the latex rubber outer layer, the latex rubber liquid may not adhere to the portion to which the forming material has been deposited. When the gap-forming substance 5 is applied to the rod-shaped mold 1 and the thin rod-shaped mold 3 as shown in FIG. 4, it must be applied so that the outline of the applied end is clearly defined in a straight line. Furthermore, the amount of coating must be uniform on the coated surface. Therefore, the rod-shaped mold 1 and the thin rod-shaped mold 3 are rotated together, and during rotation, the gap-forming substance 5 is sprayed from below the rod-shaped mold 1 onto the tip of the thin rod-shaped mold and its vicinity. At the same time, it is suctioned from above. This can prevent the gap-forming substance from dripping, or the gap-forming substance will fall due to its own weight due to its large size.
It does not reach the rod-shaped mold 1 and has a relatively uniform diameter, so that uniform coating can be performed on the coating surface. Furthermore, the contour of the application edge becomes straight and clear. After applying the gap-forming substance, the whole is immersed in the latex rubber bath again, taken out, and dried.
As shown in the figure, the balloon portion is also formed at the same time as the latex rubber outer layer 7 is formed. The thickness of the latex rubber inner layer and outer layer to be formed is adjusted by the number of repetitions of dipping. Then, the rod-shaped mold 1 and the thin rod-shaped mold 3 are removed from the latex rubber formed product, and the manufacturing of the balloon catheter is completed through processes such as vulcanization and chlorination as required.

Next, as an apparatus directly used for carrying out the above invention, a gap-forming substance 5 is sprayed in the form of a mist from below while rotating the rod-shaped mold 1.
The spray device of the present invention, which is a spray device for coating the rod-shaped mold 1, will be explained using a preferred embodiment.

FIG. 6 is a schematic sectional view showing one embodiment of the spray device of the present invention.

The spray device of this embodiment has a rotation mechanism that integrally rotates a rod-shaped mold 1 for forming a conduit passage and a thin rod-shaped mold 3 for forming an auxiliary passage, which is arranged parallel to the rod-shaped mold 1 for forming a conduit passage. 21, and a vertically extending wind tunnel 8a having a passage opening 24 for accommodating the rod-shaped mold 1 for forming a conduction passage at the tip of the thin rod-shaped mold 3 for forming a sub-passage and a position near the tip. 8b
and the mist-like chamber installed below the wind tunnel 8b.
It has a sprayer 20 that sprays the forming substance, and a suction mechanism 11 that is installed above the wind tunnel 8a and sucks the atomized forming substance 5 sprayed from the sprayer 20. First, rod-shaped mold 1
In order to rotate the rod-shaped mold 3 integrally with the rod-shaped mold 3, it is necessary to provide a thin rod-shaped mold fixture 22 that grips the thin rod-shaped mold 3 and fixes it to the rod-shaped mold 1, as shown in FIG. preferable. Next, the mechanism for rotating the rod-shaped mold 1 may be directly connected to a conventionally known rotating means, such as a motor, but if a gear is used as the rotating shaft of the motor, or a belt is used, a single unit may be used. A plurality of rod-shaped molds 1 can be rotated simultaneously by a motor. As a specific example, as shown in FIG. 7, a gear a is fixed to the rotating shaft of a motor, and a rod-shaped mold 1 is attached to the center of the gear to interlock with the gear a.
It has a gear b having a chuck 23 for detachably gripping it, and a gear c, which is the same as the gear a, is provided in conjunction with the gear b. By providing the required number of combinations of gears b and c, and by connecting the rod-shaped mold 1 to the chuck 23 of each gear b, a plurality of rod-shaped molds 1 can be operated at the same speed with one motor. This is preferable because it becomes a rotating mechanism that rotates at the same time. The reason why they are rotated in the same direction is to prevent the airflow of the atomized material of the gap-forming material from becoming uneven between adjacent rod-shaped molds, which would otherwise result in uneven application. The purpose of rotating at the same speed is to make the amount of gap-forming substance applied uniform.

Next, the spray device of the present invention shown in FIG. 6 has an opening at its upper end and lower end, and is provided with wind tunnels 8a and 8b which are detachably attached to the suction mechanism 11 and the spray machine 20, respectively. The wind tunnels 8a, 8b have rod-shaped mold insertion openings 24 through which the rod-shaped mold 1 can be inserted with a gap. Although the wind tunnels 8a and 8b may be formed integrally, they are composed of two parts: a spray machine side wind tunnel 8b attached to the spray machine and a suction machine side wind tunnel 8a attached to the suction machine, and the gap between them is formed into a rod shape. It is preferable to use the mold insertion opening 24 because attachment and detachment work is easy. The widths of the wind tunnels 8a and 8b vary depending on the number of rod-shaped molds inserted at the same time, and the thickness of the wind tunnels also changes depending on the thickness of the balloon catheter to be manufactured. That is, in the case of a thick balloon catheter, since the width of the balloon portion is also increased, it is necessary to increase the area on which the gap-forming substance 5 is adhered. Therefore, the wind tunnel is
In order to manufacture balloon catheters of different types using one spray machine, it is preferable that the size can be changed, that is, that it can be attached and detached. Next, the spray machine 20, which is airtightly connected to the lower end of the wind tunnel 8b, has a gap-forming substance spray nozzle 16 provided in the spray chamber 17, a gap-forming substance storage tank 15 communicating with this nozzle, and a high-pressure A high-pressure air supply device 13 is provided for feeding air and spraying the gap-forming material from the spray nozzle. Furthermore, if the high-pressure air supply machine alone cannot spray sufficiently, it is preferable to provide a conveyance air supply machine 19 that supplies conveyance air from below the spray chamber. At the upper end of the wind tunnel 8a, there is a suction passage 25 connected in an airtight manner to suction the gap-forming material that has been sprayed by a sprayer and passed through the wind tunnel, and a trap 10 and a suction machine 9 communicating with this passage. A mechanism 11 is provided.

() Specific effects of the invention The effects of the balloon catheter manufacturing method of the present invention are as described above. Next, the operation of the spray device of the present invention will be explained.

A latex rubber inner layer 2 and a latex rubber coagulating liquid 5 are coated on a rod-shaped mold 1, and a latex rubber coagulant is coated on a thin rod-shaped mold 3, which are placed side by side on the rod-shaped mold using a thin rod-shaped mold fixture 22. do. Then, the rod-shaped mold 1 is attached to each chuck 23 provided on an appropriate several rotation mechanism 21. Next, the tip of the rod-shaped mold 1, which is the front and rear ends of the thin rod-shaped mold 3, is installed so that it is located in the rod-shaped mold insertion opening 24 of the wind tunnels 8a, 8b.
Then, the motor 12 is operated to rotate the rod-shaped mold 1 and the thin rod-shaped mold 3 integrally. and,
The high-pressure air supply device 13 of the spray machine is activated to spray the gap-forming material from the spray nozzle 16. If necessary, the conveying air supply machine is also activated at the same time to feed the gap-forming material into the wind tunnel.

Then, in conjunction with the operation of the spray machine, the suction machine 9 is operated to suck the gap-forming material sent from below through the wind tunnel 8b through the wind tunnel 8a. After a predetermined amount of gap-forming material is applied to the balloon forming portion of the rod-shaped mold 1 covered with the latex rubber inner layer 2, the operation of the spray device is stopped. Then, the rod-shaped mold with the gap-forming substance adhered to the latex rubber inner layer and the vicinity of the tip of the thin rod-shaped mold is pulled out from the insertion opening of the wind tunnel, immersed in a latex rubber bath using a dipping machine (not shown), etc., and dried. to form a latex rubber outer layer.

() Specific Effects of the Invention The method for manufacturing a balloon catheter of the present invention provides that the conductive path has at least one sub-path within the catheter wall forming the conduit, and has a balloon portion communicating with the sub-path. In the method for manufacturing a balloon catheter, a thin rod-shaped mold for forming a sub-channel having a latex rubber coagulant adhered thereto is attached to a rod-shaped mold for forming a conduit having a latex rubber inner layer and a latex rubber coagulant adhered on the latex rubber inner layer to form the conduit. After disposing parallel to the rod-shaped mold for forming a conduit passage and with its tip slightly set back from the tip of the rod-shaped mold for forming a conduit passage, the rod-shaped mold for forming a conduit passage and the narrow rod-shaped mold for forming a sub-channel While integrally rotating the auxiliary channel forming thin rod shaped mold, the material for forming the balloon part is atomized and sprayed from the lower side of the conduit passage forming rod shaped mold at the tip and its vicinity. At the same time, a latex rubber outer layer is formed on the rod-shaped mold for forming the conduit passage and the narrow rod-shaped mold for forming the auxiliary passage, and then the material is applied to the rod-shaped mold by suctioning from the upper side. Since the slender rod-shaped mold is removed, a gap-forming substance with small diameter particles floating in the air adheres to the surface of the latex rubber inner layer, the tip of the slender mold, and its vicinity, and the large-diameter Since the particles fall due to their own weight, their adhesion can be prevented, resulting in a uniform amount of adhesion.Also, since the gap-forming substances can be prevented from dripping, the latex rubber liquid to be formed next will not adhere to the surface of the latex rubber inner layer. Therefore, it is possible to easily and efficiently manufacture a balloon catheter having a balloon portion having sufficient strength and uniform thickness without forming a balloon portion having a small amount of adhesion and weak strength. Furthermore, since the gap-forming substance is sprayed and sucked from above, the boundary of the surface to which the gap-forming substance is attached can be clearly defined and in a straight line with respect to the rod-shaped mold, allowing the balloon to expand uniformly in the radial direction. A balloon catheter having a section can be easily manufactured.

Further, the spray device of the present invention is used in a method for manufacturing a balloon catheter, which has a conduit passage, at least one sub-passage within a catheter wall forming the conduit passage, and a balloon portion communicating with the sub-passage. A spray device, the spray device comprising:
a rotation mechanism that integrally rotates a rod-shaped mold for forming a conduit passage and a thin rod-shaped mold for forming an auxiliary passage disposed in parallel with the rod-shaped mold for forming a conduit passage; A vertically extending wind tunnel having a passageway-forming rod-shaped mold insertion opening for accommodating the conduction-path-forming rod-shaped mold at the tip of the mold and a position near the mold, and a mist-type space installed below the wind tunnel. The device is equipped with a spray machine that sprays the gap-forming substance, and a suction mechanism that is installed above the wind tunnel and sucks the mist sprayed from the spray machine, so that the gap-forming substance is not sprayed. Even if large particles of pore-forming material are generated due to dripping down the inner wall of the room or due to malfunction of the spray machine,
Since it sprays from the bottom to the top, it prevents it from falling due to its own weight and adhering to the rod-shaped mold, and it also allows small-diameter objects that float in the air to adhere, so the formation material adheres uniformly. is possible. Furthermore, if the wind tunnel is made removable, the application width of the gap-forming substance can be changed by replacing the wind tunnel, making it easier to manufacture balloon catheters of different diameters.

Furthermore, the rotation mechanism is capable of connecting and rotating a plurality of rod-shaped molds at the same time, and
If a plurality of rod-shaped molds are rotated in the same direction and at the same speed, a uniform amount of the gap-forming material can be deposited on the plurality of rod-shaped molds simultaneously and in a uniform amount.

[Brief explanation of drawings]

1 to 5 are cross-sectional views of main parts showing the method for manufacturing a balloon catheter of the present invention in order of steps, and FIG.
The figure is a sectional view of a spray device used to carry out the method of the invention. FIG. 7 is a perspective view of the rotation mechanism of the spray device of the present invention. In the figure, 1... Rod-shaped mold, 2... Latex inner layer, 3... Thin rod-shaped die, 4... Coagulant for latex rubber, 5... Coagulant for latex rubber, 6...
Gap forming substance, 7... Latex rubber outer layer, 8
a, 8b... Wind tunnel, 9... Suction machine, 10... Trap, 11... Suction mechanism, 12... Motor, 1
3... High pressure air supply machine, 14... Gap forming material, 15... Storage tank, 16... Spray nozzle, 17... Spray chamber, 18... Hose, 19
...Transportation air supply machine, 20...Spray machine,
21... Rotation mechanism, 22... Thin rod-shaped mold fixture,
23...chuck, 24...rod-shaped mold insertion opening,
25...Air passage, a, b, c...gear.

Claims (1)

Claims: 1. A method for manufacturing a balloon catheter having a conduit, at least one sub-passage in a catheter wall forming the conduit, and a balloon portion communicating with the sub-passage, comprising: a latex rubber inner layer; A thin rod-shaped mold for forming a sub-channel, to which a latex rubber coagulant is attached, is placed parallel to the rod-shaped mold for forming a conduction path, and the tip thereof After arranging the rod-shaped mold for forming a conductive path slightly backward from the tip thereof, the rod-shaped mold for forming a conductive path and the thin rod-shaped mold for forming a sub-path are rotated together to form the sub-path. During the formation of the balloon part from the lower side of the rod-shaped mold for forming the conductive path at the tip of the thin rod-shaped mold for use in the process and in the vicinity thereof, the forming substance is atomized and sprayed, and at the same time, it is sucked from the upper side. After adhering a forming substance and then forming a latex rubber outer layer on the rod-shaped mold for forming the conduit passage and the narrow rod-shaped mold for forming the sub-channel, the rod-shaped mold and the thin rod-shaped mold are removed. A method for manufacturing a featured balloon catheter. 2. The method for manufacturing a balloon catheter according to claim 1, wherein the gap-forming substance is a mixture of a volatile silicone solution and an alcohol solution of a divalent or trivalent metal salt. 3. A spray device used in a method for manufacturing a balloon catheter having a conduit passage, at least one sub-passage within a catheter wall forming the conduit passage, and a balloon portion communicating with the sub-passage, the spray device comprising: The apparatus includes a rotation mechanism that integrally rotates a rod-shaped mold for forming a conduit passage and a thin rod-shaped mold for forming an auxiliary passage disposed in parallel with the rod-shaped mold for forming the auxiliary passage. A wind tunnel extending vertically and having a passageway-forming rod-shaped mold insertion opening for accommodating the conduction-path-forming rod-shaped mold at the tip of the thin rod-shaped mold and a position near the same, and a mist installed below the wind tunnel. A balloon catheter comprising: a spray machine that sprays a mist-forming substance; and a suction mechanism that is attached above the wind tunnel and sucks the mist-forming substance sprayed from the spray machine. Manufacturing spray equipment. 4. Claim 3, wherein the spray machine is detachably attached to the wind tunnel.
Spray equipment as described in Section. 5. The spray device according to claim 3 or 4, wherein the rotation mechanism is capable of connecting and rotating the plurality of rod-shaped molds for forming conductive passages. 6. The rotation mechanism is capable of connecting and rotating the plurality of rod-shaped molds for forming conduction passages, and rotates the plurality of rod-shaped molds for forming conduction passages in the same direction and at the same speed. 6. The spray device according to claim 5, which is capable of