JP6880314B2 - Catheter balloon manufacturing jig and balloon manufacturing method using this - Google Patents

Description

The present invention relates to a jig for manufacturing a balloon for a catheter and a method for manufacturing a balloon using the jig.

In general, catheter balloons are used as medical devices for areas that are useful for draining swelling of patient lesions or that require friction, and serve to treat patients by moving or rotating them back and forth around the lesions using catheters. To do.

As a conventional technique for manufacturing such a catheter balloon, the method for manufacturing a catheter balloon disclosed in Patent Document 1 first prepares an elastic PTU material and dries it at 50 to 55 ° C. for 20 days. Aged in a vessel and cut to a length suitable for each application so that it can be used as a first and second tube and an expandable member (balloon). After that, the index ring is positioned in the second tube, and the material cut according to the use of the expandable member is welded and connected to the first and second tubes, and the first and second tubes are connected. It is connected to a manifold having various ports. Then, it is placed in the upper and lower molding frames (molds), and air is injected into the port to mold an expandable member according to the size and pattern. After that, drying and aging are carried out in a dryer at 50 to 55 ° C. for 5 hours, a pressure test is performed on the expandable member, and after washing, drying and aging are carried out in a dryer at 50 to 55 ° C. for 48 hours.

However, in the conventional method for manufacturing a balloon for a catheter, in order to manufacture an expandable material, the material cut according to the use of the expandable member must be connected to the first and second tubes one by one by welding. There is a problem that workability is reduced because it must be used.

Further, since the structure is such that the expandable member is molded by the upper and lower molded frames, even if it is necessary to slightly change the taper angles on both sides of the expandable member, the entire upper and lower molded frames are replaced. If this is not done, the changes cannot be reflected, so there is a problem that the cost of changing the taper angle is excessive. Further, since a separate contact mechanism for the upper and lower molding frames is required, not only the equipment cost increases, but also the yield decreases due to the addition of the step of contacting the upper and lower molding frames. is there.

US Registered Patent Gazette US8,382,931

A technical object of the present invention is to provide a manufacturing jig for a balloon for a catheter, which does not require welding of a material and can easily change the taper angle of the balloon, and a method for manufacturing a balloon using the jig.

In order to achieve the above object, the manufacturing jig for a balloon for a catheter according to an embodiment of the present invention is a jig for manufacturing a balloon for a catheter for manufacturing a balloon for a catheter using a tube material, and is described above. A cylinder-shaped center jig member having a center molding portion in the middle portion for molding the central portion of the balloon, and a center jig member that can be pulled in and out in the length direction through one end open portion of the center jig member. The length direction is passed through a first side jig member that forms a first tapered portion between one end of the balloon and the center of the balloon so as to be tapered, and an open portion at the other end of the center jig member. A second side jig member is provided so as to be retractable and retractable, and a second tapered portion is formed between the other end of the balloon and the central portion of the balloon so as to be tapered.

A plurality of dimples can be formed in the center molded portion.

The center jig member extends from one end of the center forming portion to the opening portion of the one end, and guides the insertion / withdrawal of the first side jig member. A second pull-in / pull-out guide portion that extends from the other end to the open end portion and guides the pull-in / pull-out of the second side jig member can be further included.

The center molded portion has an inner diameter relatively smaller than that of the first and second pull-in / pull-out guide portions, and can have a shape having a step with the first and second pull-in / pull-out guide portions.

The first side jig member is formed long in the length direction at the center of the first pull-in / pull-out body and the first pull-in / pull-out body along the first pull-in / pull-out guide portion. A first tube insertion path into which the tube material is inserted and a first taper molding portion that expands in a cone form from the end of the first tube insertion passage and connects to one end of the center molding portion can be included. The second side jig member is formed long in the length direction at the center of the second pull-in / pull-out body and the second pull-in / pull-out body along the second pull-in / pull-out guide portion. It can include a second tube insertion path into which the tube material is inserted, and a second taper molded portion that expands from the end of the second tube insertion path in the form of a cone and connects to the other end of the center molded portion.

The jig for manufacturing a balloon for a catheter according to an embodiment of the present invention described above is provided at the exposed end of the first pull-in / pull-out body and has a first through hole that is connected to and communicates with the first tube insertion path. A 1 deadline member and a second deadline member provided at the exposed end of the second lead-in / pull-out body and having a second through hole connected to the second tube insertion path can be further included.

The second through hole can have an inner diameter smaller than that of the first through hole, and the rear end of the second tube insertion path has a reduced pipe so as to have the same inner diameter as the second through hole. It can be connected to and communicated with the second through hole.

Each of the first and second deadline members can be made of a polyetheretherketone material (PEEK; polyetheretherketone).

On the other hand, the method for manufacturing a balloon using the manufacturing jig for a balloon for a catheter according to the present invention is a method for manufacturing a balloon using another jig for manufacturing a balloon for a catheter according to the above-described embodiment of the present invention. The stage of pulling the first and second side jig members into the first and second lead-in / pull-out guide portions of the center jig member, respectively, and the tube material being inserted into the first tube insertion path and the center forming portion. And the step of sequentially inserting the tube material into the second tube insertion path, and closing the rear end of the tube material so that the tube material is formed into the balloon by the first and second taper molding portions and the center molding portion. , The step of applying an expansion pressure to the tip of the tube material, and if the balloon is formed, the first and second side jig members are pulled out from the first and second pull-in / pull-out guide portions, and then the balloon. Including the stage of extracting.

The method for manufacturing a balloon using the catheter balloon manufacturing jig according to another embodiment of the present invention described above can further include a step of cutting both ends of the balloon after the step of pulling out the balloon.

As described above, the jig for manufacturing a balloon for a catheter and the method for manufacturing a balloon using the jig according to the embodiment of the present invention can have the following effects.

According to the embodiment of the present invention, a long tube material can be formed into a balloon without welding, and only the first and second side jig members are left as they are with the center jig member as it is. By changing to, the first and second tapered portions of the balloon can be diversified.

Further, according to the embodiment of the present invention, since a plurality of dimples are formed in the center molded portion, a plurality of embossed protrusions can be provided in the center portion of the balloon formed through the dimples, and the balloon is connected to the catheter. When used, it can cause even greater friction around the patient's lesions, such as being more helpful in draining the patient's lesions.

Further, the effect of the present invention is not limited to this, and includes other effects that can be derived from the configuration of the present invention.

It is a partial incision perspective view which roughly showed the manufacturing jig of the balloon for a catheter by one Example of this invention. FIG. 5 is a cross-sectional view schematically showing a jig for manufacturing a balloon for a catheter of FIG. It is a drawing which shows roughly the state which the 1st and 2nd side jig members are pulled in and out to a center jig member. It is a partial incision drawing which shows the state which the 1st and 2nd deadline members are further provided in the manufacturing jig of the balloon for a catheter of FIG. It is a drawing which shows schematic the balloon manufactured by the manufacturing jig of the balloon for catheter of FIG. It is a flowchart which showed the manufacturing method of the balloon using the manufacturing jig of the balloon for a catheter by another Example of this invention.

Hereinafter, examples of the present invention will be described in detail with reference to the accompanying drawings so that a person having ordinary knowledge in the technical field to which the present invention belongs can easily carry out the examples. However, the present invention can be embodied in a variety of different forms and is not limited to the examples described herein.

FIG. 1 is a partially incised perspective view schematically showing a jig for manufacturing a catheter balloon according to an embodiment of the present invention, and FIG. 2 is a schematic view of the jig for manufacturing a catheter balloon of FIG. It is a cross-sectional view shown, and FIG. 3 is a drawing schematically showing a state in which the first and second side jig members are pulled in and out of the center jig member. FIG. 4 is a partial incision drawing schematically showing a state in which the first and second deadline members are further provided on the catheter balloon manufacturing jig of FIG. 1, and FIG. 5 is a partial incision drawing for the catheter of FIG. It is a drawing which showed schematicly the balloon manufactured by the balloon manufacturing jig.

As shown in FIGS. 1 to 5, the manufacturing jig 100 for a catheter balloon according to an embodiment of the present invention is for manufacturing a catheter balloon for manufacturing a catheter balloon 200 using a long tube material 10. The tool includes a center jig member 110, a first side jig member 120, and a second side jig member 130. Hereinafter, each component will be described in detail with reference to FIGS. 1 to 5.

The center jig member 110 is a component that not only forms the central portion 210 of the balloon 200, but also guides the pull-in / pull-out of the first and second side jig members 120 and 130 along the length direction thereof. .. As shown in FIGS. 1 to 3, such a center jig member 110 can have a cylinder shape in which both ends thereof penetrate, and in order to form the central portion 210 of the balloon 200 in the intermediate portion inside the center jig member 110. A center forming portion 111 can be provided.

Further, as shown in FIGS. 1 to 3, a plurality of dimples 111a can be formed in the center forming portion 111. Therefore, the central portion 210 of the balloon 200 manufactured by the above-described catheter balloon manufacturing jig 100 of the present invention by the plurality of dimples 111a has a plurality of embossed protrusions 211 as shown in FIG. When the balloon 200 is used in conjunction with a catheter, it can provide even greater friction around the patient's lesion, such as being more helpful in draining the patient's lesion.

Specifically, as shown in FIGS. 1 to 3, the center jig member 110 has first and second lead-in / pull-out guides for pull-in / pull-out of the first and second side jig members 120 and 130, respectively. Drawer guides 112 and 113 can be further included. The first pull-in / pull-out guide portion 112 extends from one end of the center forming portion 111 to the one-end open portion 110a of the center jig member 110, and can guide the pull-in / pull-out of the first side jig member 120. 2. The pull-in / pull-out guide portion 113 can extend from the other end of the center forming portion 111 to the other end open portion 110b of the center jig member 110 to guide the pull-in / pull-out of the second side jig member 130.

Further, the center forming portion 111 has an inner diameter relatively smaller than that of the first and second pull-in / pull-out guide portions 112 and 113, and has a shape having a step with the first and second pull-in / pull-out guide portions 112 and 113. Can have. Therefore, a sufficiently plurality of dimples 111a can be formed in the center forming portion 111 having a relatively large thickness (that is, having a large thickness), and the first and second side jig members 120 and 130 are drawn into the center forming portion 111. In this case, the first and second side jig members 120 and 130 can be brought into close contact with both ends of the center forming portion 111 through such a stepped shape. The size and number of the plurality of dimples 111a can be changed depending on the individual balloons.

The first side jig member 120 has a first tapered portion (FIG. 5) so that the center portion (210 in FIG. 5) and one end portion (221 in FIG. 5) of the balloon (200 in FIG. 5) are tapered. It is a component for molding 231) of 5. As shown in FIG. 3, such a first side jig member 120 is provided so as to be able to be pulled in and out in the length direction through the one end opening portion 110a and the first pull-in / pull-out guide portion 112 of the center jig member 110. Can be done.

For example, the first side jig member 120 can include a first lead-in / pull-out body 121, a first tube insertion path 122, and a first taper forming portion 123, as shown in FIGS. 1 to 3. The first pull-in / pull-out body 121 can be pulled in / pulled out along the first pull-in / pull-out guide portion 112 while being in close contact with the first pull-in / pull-out guide portion 112, and the first tube insertion path 122 is the center of the first pull-in / pull-out body 121. The tube material [material for molding the balloon 200] 10 is formed long in the length direction thereof, and the first taper molding portion 123 is inserted from the end of the first tube insertion path 122. The tube can be expanded in the form of a cone and connected to one end of the center forming portion 111. Therefore, the first tapered portion 231 can be formed between the central portion 210 and the one end portion 221 of the balloon 200 through the first tapered forming portion 123.

The second side jig member 130 has a second tapered portion (22 in FIG. 5) between the central portion (210 in FIG. 5) and the other end (222 in FIG. 5) of the balloon (200 in FIG. 5). It is a component for molding 232) of FIG. As shown in FIG. 3, such a second side jig member 130 can be pulled in and out in the length direction through the other end opening portion 110b and the second pull-in / pull-out guide portion 113 of the center jig member 110. Can be equipped.

For example, as shown in FIGS. 1 to 3, the second side jig member 130 can include a second lead-in / pull-out body 131, a second tube insertion path 132, and a second taper molding portion 133. The second pull-in / pull-out body 131 can be pulled in / pulled out while being in close contact with the second pull-in / pull-out guide portion 113, and the second tube insertion path 132 is the center of the second pull-in / pull-out body 131. The tube material 10 can be inserted into the second tapered forming portion 133, in which the tube expands in a cone form from the end of the second tube insertion path 132 to form a center forming portion. It can be connected to the other end of 111. Therefore, the second tapered portion 232 can be formed between the central portion 210 and the other end portion 222 of the balloon 200 through the second tapered portion 133.

Along with this, the catheter balloon manufacturing jig 100 according to the above-described embodiment of the present invention may further include the first and second deadline members 140 and 150, as shown in FIG.

The first deadline member 140 is provided at the exposed end of the first lead-in / pull-out body 121, and can have a first through hole 141 that is connected to and communicates with the first tube insertion path 122, and the second deadline member 150 is It can have a second through hole 151 that is provided at the exposed end of the second lead-in / pull-out body 131 and communicates with the second tube insertion path 132. In particular, the second through hole 151 can have an inner diameter smaller than that of the first through hole 141, and the rear end of the second tube insertion path 132 has the same inner diameter as the second through hole 151. It can be reduced and connected to the second through hole 151.

Further, each of the first and second deadline members 140 and 150 is made of a polyetheretherketone material (PEEK; polyetheretherketone) so that the first and second side jig members 120 and 130 can be prevented from becoming hot. Can consist of.

Hereinafter, a method for manufacturing a balloon using a catheter balloon manufacturing jig according to another embodiment of the present invention will be described with reference to FIGS. 1, 2, 3, and 6.

FIG. 6 is a flowchart showing a method for manufacturing a balloon using a jig for manufacturing a balloon for a catheter according to another embodiment of the present invention.

The method for manufacturing a balloon using the catheter balloon manufacturing jig according to another embodiment of the present invention is the method for manufacturing a balloon using the other catheter balloon manufacturing jig 100 according to the above-described embodiment of the present invention. First, as shown in FIG. 3, the first and second side jig members 120 and 130 are pulled into the first and second pull-in / pull-out guide portions 112 and 113 of the center jig member 110, respectively (S110). ). Then, as shown in FIG. 1, the first side jig member 120 is pulled into the first pull-in / pull-out guide portion 112 and comes into close contact with one end of the center forming portion 111, and the second side jig member 120 is brought into close contact with the center forming portion 111. The member 130 is pulled into the second pull-in / pull-out guide portion 113 and comes into close contact with the other end of the center forming portion 111.

Then, the tube material 10 is sequentially inserted into the first tube insertion path 122, the center forming portion 111, and the second tube insertion path 132 (see FIG. 2) (S120).

After that, as shown in FIG. 2, the rear end of the tube material 10 is closed with a nipper (see the vertical arrow in FIG. 2) or the like, and an expansion pressure is applied to the tip of the tube material 10 (S130). Then, the tube material 10 is formed into a balloon that fits the shape through the first and second taper forming portions 123, 133 and the center forming portion 111 while expanding.

When the balloon 200 is formed in this way, the first and second side jig members 120 and 130 are pulled out from the first and second lead-in / pull-out guide portions 112 and 123 of the center jig member 110 (see FIG. 3). , The balloon 200 is pulled out from the center jig member 110 while being pulled in the length direction thereof (S140). At this time, the embossed protrusion 211 formed on the central portion 210 of the balloon 200 can be easily removed from the dimple 111a of the center forming portion 111 only by pulling the balloon 200 by the elasticity of the balloon 200 itself.

At the same time, in the method for manufacturing a balloon using the jig for manufacturing a balloon for a catheter according to another embodiment of the present invention described above, when the process of removing the balloon 200 (S140) is completed, both ends of the balloon 200 are 221 and 222. It is possible to further include the process of cutting using a cutter or the like with a set length that can be used.

As described above, the catheter balloon manufacturing jig 100 according to the embodiment of the present invention and the balloon manufacturing method using the jig 100 can have the following effects.

According to the embodiment of the present invention, the balloon 200 can be formed without welding the long tube material 10, and the first and second side jig members 120, with the center jig member 110 as it is, By replacing only 130 with another, the first and second tapered portions 231 and 232 of the balloon 200 can be diversified.

Further, according to the embodiment of the present invention, since a plurality of dimples 111a are formed in the center forming portion 111, a plurality of embossed protrusions 211 can be provided in the central portion 210 of the balloon 200 formed through the dimples 111a, and the patient. It can cause even greater friction around the patient's lesion, such as being more helpful in removing the swelling of the lesion.

Although the preferred embodiment of the present invention has been described in detail above, the scope of rights of the present invention is not limited to this, and those skilled in the art using the basic concept of the present invention defined in the following claims. Various modifications and improvements also belong to the scope of the present invention.

The present invention can be used to manufacture catheter balloons.

Claims (6)

A jig for manufacturing catheter balloons for manufacturing catheter balloons using tube materials.
A cylinder-shaped center jig member having a center molding portion in the middle portion for molding the center portion of the balloon,
The center jig member is provided so as to be retractable and retractable in the length direction through one end open portion, and a first tapered portion is formed between the one end portion of the balloon and the center portion of the balloon so as to be tapered. 1st side jig member to be
A second tapered portion is provided so as to be retractable and retractable in the length direction through the other end opening portion of the center jig member so that the other end of the balloon and the central portion of the balloon are tapered. 2nd side jig member to mold
Only including,
The center jig member is
A first pull-in / pull-out guide portion that extends from one end of the center molding portion to the one-end open portion and guides the pull-in / pull-out of the first side jig member.
A second pull-in / pull-out guide portion that extends from the other end of the center molded portion to the other end open portion and guides the pull-in / pull-out of the second side jig member.
Including
The first side jig member is
The first pull-in / pull-out body and the first pull-in / pull-out body along the first pull-in / pull-out guide section.
A first tube insertion path formed long in the length direction at the center of the first lead-in / pull-out body and into which the tube material is inserted, and a first tube insertion path.
Including
The second side jig member is
The second pull-in / pull-out fuselage that pulls in / pulls out along the second pull-in / pull-out guide section,
A second tube insertion path formed long in the length direction at the center of the second lead-in / pull-out body and into which the tube material is inserted.
Including
The manufacturing jig for the balloon for catheter is
A first deadline member provided at the exposed end of the first lead-in / pull-out body and having a first through hole that is connected to and communicates with the first tube insertion path.
A second deadline member provided at the exposed end of the second lead-in / pull-out body and having a second through hole that is connected to and communicates with the second tube insertion path.
Including
The second through hole has an inner diameter smaller than that of the first through hole.
A jig for manufacturing a balloon for a catheter, in which the rear end of the second tube insertion path is connected to the second through hole by reducing the tube so as to have the same inner diameter as the second through hole. The jig for manufacturing a balloon for a catheter according to claim 1, wherein a plurality of dimples are formed in the center molding portion. The center mold portion, according to claim 1 having the first and has a relatively smaller inner diameter than the second pulling-in and pulled out of the guide portion, the first and second pulling-in and pulled out of the guide portion and a stepped shape Jig for manufacturing balloons for catheters. The first side jig member is
A first taper molded portion in which a tube extends from the end of the first tube insertion path in the form of a cone and is connected to one end of the center molded portion.
Further comprising a,
The second side jig member is
A second taper molded portion in which the tube extends from the end of the second tube insertion path in the form of a cone and is connected to the other end of the center molded portion.
The jig for manufacturing a balloon for a catheter according to claim 1 , further comprising. A method for manufacturing a balloon using the catheter balloon manufacturing jig according to any one of claims 1 to 4.
The stage of pulling the first and second side jig members into the first and second pull-in / pull-out guide portions of the center jig member, respectively, and
A step of sequentially inserting the tube material into the first tube insertion path, the center molding portion, and the second tube insertion path.
A step of closing the rear end of the tube material so that the tube material is molded into the balloon by the first and second taper molding portions and the center molding portion, and applying an expansion pressure to the tip of the tube material.
Once the balloon is formed, the first and second side jig members are pulled out from the first and second pull-in / pull-out guide portions, and then the balloon is pulled out.
How to make balloons, including. The method for manufacturing the balloon is
The method for manufacturing a balloon according to claim 5 , further comprising a step of cutting both ends of the balloon after the step of pulling out the balloon.

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