KR20170040713A - Baloon catheter and method for producing the baloon catheter - Google Patents

Baloon catheter and method for producing the baloon catheter Download PDF

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Publication number
KR20170040713A
KR20170040713A KR1020150140043A KR20150140043A KR20170040713A KR 20170040713 A KR20170040713 A KR 20170040713A KR 1020150140043 A KR1020150140043 A KR 1020150140043A KR 20150140043 A KR20150140043 A KR 20150140043A KR 20170040713 A KR20170040713 A KR 20170040713A
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South Korea
Prior art keywords
layer
resin layer
braided
resin
tube
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KR1020150140043A
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Korean (ko)
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KR101833881B1 (en
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하성용
고형철
조민재
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(주)에어레인
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0014—Connecting a tube to a hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Abstract

Disclosed are a balloon catheter and a production method thereof. The balloon catheter according to an embodiment of the present invention comprises: a hub; a shaft having one end connected to the hub; and a balloon extended and connected to the other end of the shaft, wherein the shaft comprises: a braid layer braided in mesh-shape; and an outer layer tube which is disposed on an outer surface of the braid layer, and has a plurality of sections in which hardness increases from the balloon to the hub, and where at least one section is formed in a multi-layered structure.

Description

TECHNICAL FIELD [0001] The present invention relates to a balloon catheter and a method of manufacturing the balloon catheter.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter and a method of manufacturing the same, and more particularly, to a balloon catheter improved in ease of press-fitting and trackability and a method of manufacturing the same.

Coronary artery disease or ischemic heart disease is a condition in which the fat component is deposited on the coronary arterial wall and the accompanying inflammatory reaction leads to a narrowing of the lumen of the coronary artery and a narrowing of the coronary artery It is caused by insufficient blood supply to the heart muscle (myocardium) due to lumen size.

Chest pain, dyspnea, and other symptoms may occur depending on the extent of myocardial infarction. These coronary artery diseases are clinical symptoms such as angina, acute myocardial infarction and sudden death.

In order to open the coronary artery occlusion site, it is necessary to dilate the blood vessel or insert a stent. In this case, the balloon catheter for percutaneous transluminal coronary angioplasty (PTCA) is used to physically expand the blood vessel.

PTCA was performed in 1977 by Andreas Gruenzig for the first time using a balloon catheter to perform vasodilation through balloon dilatation in atherosclerotic lesions, and then about 30,000 procedures were performed in the United States in 1983sus.

In Korea, PTCA was successfully performed for the first time in 1983, and in 2002, 26,169 cases of percutaneous coronary intervention using PTCA balloon catheter including balloon dilatation and stent insertion were performed.

The number of patients with domestic cardiovascular disease increased steadily from about 31,000 in 2006 to 46,000 in 2010, and the number of stent implants is also increasing.

On the other hand, a balloon catheter includes a hub, a balloon extending in the blood vessel, and a shaft having one end connected to the hub and the other end connected to the balloon.

These balloon catheters are inserted into sinusoidal blood vessels and then advance along the vessel until the distal end of the shaft reaches the desired position.

A force is applied to the distal end portion of the shaft when the shaft is advanced. However, the conventional balloon catheter has a problem that it is extremely difficult to properly manipulate the distal end portion of the shaft with the blood vessel deeply inserted.

In other words, the balloon catheter should have a good press-in capability, that is, the ability to transmit the force applied to the shaft from the hub side to the distal end of the shaft, while minimizing or preventing the twisting of the shaft, Should be.

However, the conventional balloon catheter is manufactured by bonding the shaft to the inner liner by adhering the tubes of the multi-layer structure to each other, thereby causing fine jaws in the shaft, thereby deteriorating tracking easiness of guiding the shaft along the blood vessel.

Therefore, efforts are needed to develop a balloon catheter that is easy to press and easy to track.

Korean Patent Publication No. 10-2005-0016954 (published on February 21, 2005)

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a balloon catheter having a plurality of sections in which the hardness increases from a balloon to a hub in the manufacture of a shaft and at least one section is formed into a multi- And a method for producing the same.

According to an aspect of the present invention, A shaft having one end connected to the hub; And a balloon extending and connected to the other end of the shaft, wherein the shaft includes: a braided layer braided in a net shape; And an outer layer tube disposed on the outer surface of the braided layer and having a plurality of sections in which the hardness increases from the balloon toward the hub, and at least one section is formed in a multilayered structure.

The outer layer tube has a distal end adjacent to the balloon, a proximal end adjacent to the hub, and an intermediate portion positioned between the proximal end and the proximal end, and the hardness may be increased and the thickness may be increased from the proximal end to the proximal end.

Wherein the outer layer tube comprises: a first resin layer formed continuously from the distal end to the proximal end; A second resin layer disposed on the intermediate portion and stacked on the first resin layer; And a third resin layer disposed on the base end portion and stacked on the first resin layer, wherein the hardness is increased in the order of the first resin layer, the second resin layer, and the third resin layer, The first resin layer may be attached to the braided layer and the second resin layer or the third resin layer may be continuously laminated on the outer surface of the first resin layer.

The first to third resin layers may be formed of a polyamide-based polyether block amide (PEBAX) material whose hardness increases from the first resin layer to the third resin layer.

The shaft may further include an inner layer tube made of polytetrafluoroethylene (PTFE) having a thickness of 0.01 to 0.015 mm to which the braided layer is attached on the outer surface.

The braided layer may be formed by braiding a reinforcing steel having a diameter of 0.015 to 0.02 mm made of stainless steel containing nickel and chromium in a net shape having an inclination angle of 45 degrees or more with respect to the longitudinal direction of the shaft.

According to another aspect of the present invention, there is provided a method of manufacturing a liner, comprising: attaching a net-like braided layer to an inner liner; And extruding the outer layer tube continuously on the outer surface of the braided layer, wherein the outer layer tube has a plurality of sections in which the hardness increases from the balloon to the hub, and at least one section is formed in a multi-layer structure A method of manufacturing a balloon catheter can be provided.

Wherein the outer layer tube has an end portion adjacent to the balloon side, a proximal end portion adjacent to the hub side, and an intermediate portion positioned between the distal end portion and the proximal end portion, the step of extruding the outer layer tube comprises: The first resin layer is continuously extruded from the first resin layer to the base portion, and at the same time, the second resin layer is extruded on the outer surface of the first resin layer in the intermediate portion, The strata can be extruded.

Wherein the first to third resin layers are formed of a polyamide based polyether block amide (PEBAX) material, and the polyether block amide material having a hardness increasing from the first resin layer to the third resin layer .

Said inner liner comprising: a core wire; And an inner layer tube attached to the outer surface of the core wire with polytetrafluoroethylene (PTFE) having a thickness of 0.01 to 0.015 mm and having the braided layer adhered to an outer surface thereof, wherein the outer layer tube is continuously attached to the outer surface of the braided layer And then removing the core wire after extrusion molding.

The braided layer may be formed by braiding a reinforcing steel having a diameter of 0.015 to 0.02 mm made of stainless steel containing nickel and chromium in a net shape having an inclination angle of 45 degrees or more with reference to the longitudinal direction of the inner liner.

In an embodiment of the present invention, the shaft is divided into a plurality of sections and at least one section is formed into a multi-layer structure, so that the hardness increases as the shaft moves from the balloon to the hub, thereby improving the ease of press-in and trackability.

1 is a view of a balloon catheter in accordance with an embodiment of the present invention.
2 is a perspective view illustrating a structure of a shaft according to an embodiment of the present invention.
3 is a view showing a state in which a braided layer and a multi-layered tube are attached to an inner liner according to an embodiment of the present invention.
FIGS. 4A to 4C are cross-sectional views illustrating a distal end portion, a middle portion, and a base end portion of a shaft according to an embodiment of the present invention.
5 is a schematic structural view of an apparatus for manufacturing a balloon catheter according to another embodiment of the present invention.
6 is a cross-sectional view showing an extrusion nozzle according to another embodiment of the present invention.
7A to 7C are views showing a state in which first to third resin layers according to another embodiment of the present invention are attached.

In order to fully understand the present invention, operational advantages of the present invention, and objects achieved by the practice of the present invention, reference should be made to the accompanying drawings and the accompanying drawings which illustrate preferred embodiments of the present invention.

Hereinafter, the present invention will be described in detail with reference to the preferred embodiments of the present invention with reference to the accompanying drawings. Like reference symbols in the drawings denote like elements.

FIG. 1 is a perspective view of a balloon catheter according to an embodiment of the present invention. FIG. 2 is a perspective view illustrating a structure of a shaft according to an embodiment of the present invention. FIGS. 4A to 4C are cross-sectional views of a distal end portion, a middle portion, and a base end portion of a shaft according to an embodiment of the present invention. FIG.

Referring to FIG. 1, a balloon catheter 100 according to an embodiment of the present invention includes a hub 110, a balloon 150, and a shaft 130 connecting the hub 110 and the balloon 150 .

The hub 110 is a portion grasped by the practitioner at the time of the procedure, and a communicating tube (not shown), which is a hollow portion, is formed in the hub 110, and the communicating tube is communicated with the shaft.

The balloon 150 is connected to and communicates with the shaft 130, and is a member capable of being inflated into a balloon 150 by supplying liquid to the inside through the shaft 130. It is possible to expand the stenotic region of the blood vessel as the balloon 150 is inflated.

One end of the shaft 130 is connected to the hub 110 and the other end is connected to the balloon 150 to connect the hub 110 and the balloon 150 in a mutually communicable manner.

The shaft 130 is formed of a soluble material.

2, the shaft 130 includes an inner layer tube 131b, a braided layer 133 attached to the outer surface of the inner layer tube 131b, an outer layer tube 135 attached to the outer surface of the braided layer 133, . That is, the shaft 130 has a structure in which the inner layer tube 131b, the braided layer 133, and the outer layer tube 135 are sequentially laminated.

The inner layer tube 131b is formed of a polytetrafluoroethylene (PTFE) material and may have a thickness of 0.01 to 0.015 mm. The inner layer tube 131b is stretched to reduce the thickness. In FIG. 2, the inner layer tube 131b is attached to the outer surface of the core wire 131a made of copper. In the actual balloon catheter 100, the core wire 131a is removed from the inner layer tube 131b.

The braided layer 133 attached to the outer surface of the inner layer tube 131b is formed by braiding a reinforcing yarn 133a made of stainless steel (specifically, sus 304) containing nickel and chromium in a net shape.

2, the braided layer 133 is manufactured by braiding the reinforcing yarn 133a on the outer surface of the inner layer tube 131b in a state where the inner layer tube 131b is attached to the outer surface of the core wire 131a A braided layer 133 is formed.

In the present embodiment, the diameter of the reinforcing yarn 133a is 0.015 to 0.02 mm, and the braided layer 133 is formed such that a plurality of reinforcing yarns 133a are inclined at an angle of 45 degrees or more with respect to the longitudinal direction of the shaft 130, (&Amp;thetas;). This is to prevent the shaft 130 from being easily bent when the inclination angle? Of the bolster 133a is smaller than 45 degrees (deg.), Thereby reducing the ease of press-fitting and the ease of tracing.

In this embodiment, the braid pitch 133 of the braided layer 133 can be adjusted to 0.3 to 10 mm. For example, in the braid pitch 4, the spacing of the reinforcing members 133a adjacent to the four reinforcing members 133a at intervals of 4 mm is 0.5 mm. In this embodiment, the braided layer 133 is formed with a braiding pitch of 3 so that the spacing of the reinforcing yarns 133a is 0.375 mm.

The outer layer tube 135 is disposed and attached to the outer surface of the braided layer 133 and has a plurality of sections whose hardness increases from the balloon 150 toward the hub 110.

1, the outer layer tube 135 includes a distal end A adjacent to the balloon 150, a proximal end C adjacent to the hub 110, a distal end A, C). In addition, the outer layer tube 135 is formed so that the hardness increases from the distal end A to the proximal end C, and the thickness increases.

1, 3, and 4, the outer layer tube 135 includes a first resin layer 135a continuously formed from the distal end A to the proximal end C, a second resin layer 135b disposed at the middle portion B, A second resin layer 135b stacked on the resin layer 135a and a third resin layer 135c disposed on the base end portion C and stacked on the first resin layer 135a.

Here, the hardness is increased in the order of the first resin layer 135a, the second resin layer 135b, and the third resin layer 135c.

The outer layer tube 135 is formed such that the first resin layer 135a is attached to the braided layer 133 at the intermediate portion B and the second resin layer 135b is attached to the outer surface of the first resin layer 135a The first resin layer 135a is attached to the braided layer 133 at the base end portion C and the third resin layer 135c is attached to the outer surface of the first resin layer 135a.

4A shows a structure in which the braided layer 133 and the first resin layer 135a are sequentially laminated on the outer surface of the inner layer tube 131b at the end portion A in FIG. 1, and FIG. 4B is a cross- a braided layer 133 and a first resin layer 135a and a second resin layer 135b are successively laminated on the outer surface of the inner layer tube 131b at the intermediate portion B in the cross section of FIG. A structure in which a braided layer 133, a first resin layer 135a and a third resin layer 135c are sequentially laminated on the outer surface of the inner layer tube 131b at the base end portion C in cross section in Fig.

Here, the first to third resin layers 135a, 135b, and 135c may be formed of a polyamide-based polyether block amide (PEBAX) material. The first resin layer 135a is PEBAX 4033, the second resin layer 135b is PEBAX 6333, and the second resin layer 135b is PEBAX 6333. The first resin layer 135a and the second resin layer 135b are different in hardness from the first resin layer 135a to the third resin layer 135c. The third resin layer 135c may have a material of PEBAX 7233.

An apparatus for manufacturing a balloon catheter for manufacturing the balloon catheter will now be described.

FIG. 5 is a schematic structural view of an apparatus for manufacturing a balloon catheter according to another embodiment of the present invention, FIG. 6 is a sectional view showing an extrusion nozzle according to another embodiment of the present invention, and FIGS. Fig. 5 is a view showing a state in which first to third resin layers according to the embodiment are attached.

5, an apparatus 200 for manufacturing a balloon catheter according to the present invention includes an inner liner 131 for extruding and attaching an inner layer tube 131b to an outer surface of a core wire 131a, A braided layer attaching unit 230 for attaching a mesh braid layer 133 to the outer surface of the inner liner 131 and specifically to the outer surface of the inner layer tube 131b and a braided layer 133 And an outer layer tube extrusion molding unit 250 for continuously extruding and attaching the outer layer tube 135 to the outer surface of the outer tube.

The inner layer tube extrusion forming unit 210 serves to continuously extrude and attach the inner layer tube 131b to the outer surface of the copper core wire 131a.

As described above, the inner layer tube 131b is formed of a polytetrafluoroethylene (PTFE) material and may have a thickness of 0.01 to 0.015 mm.

The inner layer tube extrusion forming unit 210 includes an extruder M0 for extruding PTFE and a first die 211 for stacking the PTFE extruded from the extruder M0 on the outer surface of the core wire 131a.

The core wire 131a passed through the inner layer tube extrusion forming unit 210 constitutes an inner liner 131 in which an inner layer tube 131b made of PTFE is laminated on the outer surface.

Then, the inner liner 131 is transferred to the braided layer attaching unit.

The braided layer attaching unit 230 according to the present embodiment serves to attach a mesh braided layer 133 to the outer surface of the inner layer tube 131b of the inner liner 131. [

As described above, the braided layer 133 is formed by braiding a reinforcing yarn 133a made of stainless steel (specifically, sus 304) containing nickel and chromium in a net shape.

The braided layer 133 is formed by braiding the reinforcing yarn 133a on the outer surface of the inner layer tube 131b with the inner layer tube 131b attached to the outer surface of the core wire 131a .

In the present embodiment, the diameter of the reinforcing yarn 133a is 0.015 to 0.02 mm, and the braided layer 133 is formed such that a plurality of the reinforcing yarns 133a is 45 degrees or more with respect to the longitudinal direction of the inner liner 131 Is formed by braiding in a net shape having an inclination angle (?). This is to prevent the shaft 130 from being easily bent when the inclination angle? Of the bolster 133a is smaller than 45 degrees, which reduces the ease of press-fitting and the ease of tracing.

In this embodiment, the braid pitch 133 of the braided layer 133 can be adjusted to 0.3 to 10 mm. For example, in the braid pitch 4, the spacing of the reinforcing members 133a adjacent to the four reinforcing members 133a at intervals of 4 mm is 0.5 mm. In this embodiment, the braided layer 133 is formed with a braiding pitch of 3 so that the spacing of the reinforcing yarns 133a is 0.375 mm.

The inner liner 131 having the braided layer 133 attached to its outer surface is conveyed to the outer layer tube extrusion forming unit 250.

The outer layer tube extrusion molding unit 250 according to the present embodiment serves to extrude the outer layer tube 135 having different hardness along the longitudinal direction of the inner liner 131 continuously on the outer surface of the braided layer 133 .

As described above, the outer layer tube 135 continuously forms the first resin layer 135a from the distal end A to the proximal end C so that the hardness increases from the distal end A to the proximal end C, A second resin layer 135b is formed by laminating the first resin layer 135a on the first resin layer 135a and the third resin layer 135c on the first resin layer 135a do.

To this end, the outer layer tube extrusion molding unit 250 according to this embodiment comprises first to third extruders M1, M2, M3 for melting and extruding the first to third resins mutually different from each other, The first resin layer 135a is continuously attached to the outer surface of the braided layer 133 and the second resin layer 135a is selectively formed on the outer surface of the first resin layer 135a in communication with the third extruder M1, And an extrusion nozzle 251 for continuously laminating the third resin layer 135b or the third resin layer 135c.

The first to third extruders M1 to M3 melt and extrude the first to third resins formed of a polyamide-based polyether block amide (PEBAX) material.

Specifically, the first resin may have PEBAX 4033, the second resin may be PEBAX 6333, and the third resin may be PEBAX 7233.

6, the extrusion nozzle 251 includes a nozzle body 252, a first liner (not shown) formed at the center of the nozzle body 252 and having an inner liner 131 attached with a braided layer 133, And a second resin transferring hole 253 which is provided adjacent to the first liner transfer hole 253 in the nozzle body 252 and communicates with the first extruder M1 to extrude the first resin on the outer surface of the braided layer 133, A first resin feed path 254 for forming a first resin layer 135a and a second resin feed path 254 provided adjacent to the first resin feed path 254 in the nozzle body 252 and communicating with the second extruder M2, A second resin transfer path 255 for forming a first resin layer 135a and a second resin layer 135b by extruding a second resin on the outer surface of the layer 135a, The first resin layer 135a is formed adjacent to the second resin transfer path 255 and communicated with the third extruder M3 to extrude a third resin on the outer surface of the first resin layer 135a, The resin layer ( And a third resin transfer path 256 for forming the second resin transfer path 135c.

The first resin transfer passage 254, the second resin transfer passage 255 and the third resin transfer passage 256 are spaced from each other in the height direction about the first liner transfer hole 253 in the nozzle body 252 .

The end portion of the first resin transfer path 254 through which the first resin is discharged is bent downwardly in the downward direction adjacent to the first liner transfer hole 253.

The ends of the second resin transfer path 255 and the third resin transfer path 256 are located on the same plane and the ends of the first resin transfer path 254 are connected to the second resin transfer path 255 and the third resin transfer path 256, Is positioned inside the end position of the resin transfer path (256). This is because the first resin layer 135a is first formed on the inner liner 131 and the second resin layer 135b or the third resin layer 135c is formed on the outer surface of the first resin layer 135a.

An operation of extruding the outer layer tube 135 on the outer surface of the inner liner 131 by the extrusion nozzle 251 will be described below.

7A, when the inner liner 131 is fed through the first liner feed hole 253, the first resin is fed from the first extruder M1 to the extrusion nozzle 251, The first resin is attached to the outer surface of the braided layer 133 of the inner liner 131 along the first resin transfer path 254 and is molded to form the first resin layer 135a.

When the inner liner 131 reaches the position corresponding to the position of the intermediate portion B after the inner liner 131 is continuously conveyed through the first liner feed hole 253 as shown in Fig. 7B, And the second resin is additionally supplied to the extrusion nozzle 251 in step (M2). The first resin is attached to the outer surface of the braided layer 133 of the inner liner 131 along the first resin transfer path 254 and molded to form the first resin layer 135a And the second resin is attached to the outer surface of the first resin layer 135a along the second resin transfer path 255 and is molded to form the second resin layer 135b.

7C, when the inner liner 131 reaches the position corresponding to the position of the base end C after the inner liner 131 is continuously conveyed through the first liner feed hole 253, the second extruder M2 is stopped and the third resin is further supplied to the extrusion nozzle 251 in the third extruder M3. The first resin is attached to the outer surface of the braided layer 133 of the inner liner 131 along the first resin transfer path 254 and molded to form the first resin layer 135a At the same time, the third resin is attached to the outer surface of the first resin layer 135a along the third resin transfer path 256 and is molded to form the third resin layer 135c.

As described above, in this embodiment, the outer layer tube 135 constituting the shaft 130 constituting the balloon catheter 100 is successively extruded and molded so that the outer layer tube 135 is manufactured by adhering the former multiple layers to form a fine jaw This can solve the problem that tracking easiness of guiding the shaft 130 along the blood vessel is lowered.

The first resin layer 135a and the second resin layer 135b or the second resin layer 135b and the third resin layer 135c are formed on the inner liner 131 through the extrusion nozzle 251 according to the present embodiment. The outer layer tube extrusion molding unit 250 according to the present embodiment is configured such that the outer surface of the outer layer tube 135 coupled to the front of the extrusion nozzle 251 and stacked on the inner liner 131 is tapered And a second die 257 for causing the raised section to have a round shape.

The second die 257 according to the present embodiment is bonded to the front of the extrusion nozzle 251 to form the first resin layer 135a and the second resin layer 135b or the first resin layer 135a And a second liner feed hole 258 through which the inner liner 131 with the third resin layer 135c attached thereto is passed.

The diameter of the second liner feed hole 258 is adjustable, and the outer surface of the outer layer tube 135 is tapered. Specifically, the diameter of the second liner feed hole 258 can be adjusted so that the thickness of the outer layer tube 135 becomes thicker from the distal end A to the base end C.

The braided layer 133 and the outer layer tube 135 are sequentially laminated on the inner liner 131 and then the core wire 131a constituting the inner liner 131 is removed to remove the core wire 131a of the shaft 133 of the balloon catheter 100, (130).

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Accordingly, such modifications or variations are intended to fall within the scope of the appended claims.

100: catheter 110: hub
130: shaft 131: inner liner
131a: core wire 131b: inner layer tube
133: braided layer 135: outer layer tube
135a: first resin layer 135b: second resin layer
135c: third resin layer 150: balloon
200: Manufacturing apparatus 210: Inner layer tube extrusion forming unit
230: braided layer attaching unit 250: outer layer tube extrusion forming unit
251: extrusion nozzle 252: nozzle body
253: first liner feed hole 254: first resin feed path
255: second resin transfer path 256: third resin transfer path
257: second die 258: second liner feed hole

Claims (11)

Herb;
A shaft having one end connected to the hub; And
And a balloon extending and connected to the other end of the shaft,
The shaft includes:
A braided layer braided in a net shape; And
And an outer layer tube disposed on the outer surface of the braided layer and having a plurality of sections with increasing hardness from the balloon toward the hub, wherein at least one section is formed in a multi-layered structure. The method according to claim 1,
Wherein the outer layer tube comprises:
A proximal end portion adjacent to the hub side and an intermediate portion positioned between the distal end portion and the proximal end portion,
Wherein the hardness increases from the distal end to the proximal end and the thickness increases. 3. The method of claim 2,
Wherein the outer layer tube comprises:
A first resin layer continuously formed from the distal end to the proximal end;
A second resin layer disposed on the intermediate portion and stacked on the first resin layer; And
And a third resin layer disposed on the base end portion and stacked on the first resin layer,
Wherein the hardness of the first resin layer, the second resin layer and the third resin layer is increased in the order of the first resin layer, the second resin layer, and the third resin layer, wherein the first resin layer is attached to the braided layer, Wherein the second resin layer or the third resin layer is continuously laminated. The method of claim 3,
Wherein the first to third resin layers are formed of a polyamide-based polyether block amide (PEBAX) material whose hardness increases from the first resin layer to the third resin layer. The method according to claim 1,
The shaft includes:
Further comprising an inner layer tube made of polytetrafluoroethylene (PTFE) having a thickness of 0.01 to 0.015 mm to which the braided layer is attached on the outer surface. 6. The method of claim 5,
Wherein the braided layer comprises:
A balloon catheter comprising a reinforcing bar made of stainless steel containing nickel and chromium and having a diameter of 0.015 to 0.02 mm and having a tilt angle of 45 degrees or more with respect to the longitudinal direction of the shaft and braided in a net shape. Attaching a net-like braided layer to the inner liner; And
And extruding the outer layer tube continuously on the outer surface of the braided layer,
Wherein the outer layer tube has a plurality of sections with increasing hardness from the balloon to the hub, and at least one section is formed in a multi-layered structure. 8. The method of claim 7,
Wherein the outer layer tube comprises:
A proximal end portion adjacent to the hub side and an intermediate portion positioned between the distal end portion and the proximal end portion,
The step of extruding the outer layer tube comprises:
Extruding a first resin layer continuously from the distal end portion to the proximal end portion on the outer surface of the braided layer and extruding a second resin layer on the outer surface of the first resin layer in the intermediate portion, And the third resin layer is extruded on the outer surface of the resin layer. 9. The method of claim 8,
The first to third resin layers are formed of a polyamide-based polyether block amide (PEBAX)
Wherein the hardness of the first resin layer is increased from the first resin layer toward the third resin layer. 8. The method of claim 7,
The inner liner
Core wire; And
And an inner layer tube attached to the outer surface of the core wire with polytetrafluoroethylene (PTFE) having a thickness of 0.01 to 0.015 mm and having the braided layer adhered to an outer surface thereof,
Further comprising the step of continuously extruding the outer layer tube on the outer surface of the braided layer and then removing the core wire. 11. The method of claim 10,
Wherein the braided layer comprises:
A method for manufacturing a balloon catheter, comprising the steps of braiding a reinforcing bar having a diameter of 0.015 to 0.02 mm made of stainless steel containing nickel and chromium in a net shape at an inclination angle of 45 degrees or more with respect to the longitudinal direction of the inner liner.
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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050016954A (en) 2002-07-03 2005-02-21 오르버스 메디칼 테크놀로지즈 인코포레이티드 Ballon catheter

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Publication number Priority date Publication date Assignee Title
JP2007319594A (en) * 2006-06-05 2007-12-13 Kaneka Corp Medical catheter tube

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050016954A (en) 2002-07-03 2005-02-21 오르버스 메디칼 테크놀로지즈 인코포레이티드 Ballon catheter

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