Manufacturing method of rapid exchange type balloon dilatation catheter and catheter

Abstract

The invention discloses a rapid exchange type balloon dilatation catheter manufacturing method and a catheter, and the manufacturing method comprises the following steps: positioning an inner tube with a guide wire channel in a far outer tube; a first channel is formed between at least part of the outer side wall of the inner pipe and at least part of the inner side wall far away from the outer pipe; aligning the proximal end of the inner tube with the proximal end of the distal outer tube in the axial direction of the distal outer tube; a near tube with a second channel is provided, the far end of the near tube is fixedly connected with the near end of part of the far outer tube and the near end of part of the inner tube, so that the second channel is communicated with the first channel, and an inlet of the guide wire channel is exposed outwards from the near end of part of the far outer tube. According to the balloon dilatation catheter, the outer tube is divided into the far outer tube and the near tube, during manufacturing, the inner tube is accurately positioned firstly and then connected with the outer tube, the length of the inner tube can be controlled more conveniently during positioning, the formed inner tube is prevented from protruding out of the outer tube, and damage to blood vessels in the using process of the balloon dilatation catheter is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medical catheters, in particular to a manufacturing method of a rapid exchange balloon dilatation catheter and the catheter. Background Art

[0002] Rapid exchange balloon dilatation catheters are currently widely used in PCI. Rapid exchange balloon dilatation catheters do not require extending the guidewire when replacing the balloon dilatation catheter. Their design features greatly facilitate the operator's operation and save time.

[0003] The prior art rapid exchange balloon dilatation catheter generally has an inner tube inserted inside an outer tube, and a side hole is opened at about 25cm-30cm from the proximal end of the outer tube. The inlet of the inner tube is exposed outward from the side hole to form a rapid exchange port, and the guide wire is inserted into the inner tube. The side walls of the inner tube and the outer tube are generally fixed together by welding. After welding, the excess inner tube exposed outward needs to be cut off. However, since the boundary after welding is not obvious, it is difficult to overlap the boundary of the inner tube with the outer tube when cutting, resulting in a little excess inner tube protruding outward, thereby causing certain risks during the operation. Summary of the invention

[0004] The purpose of the present invention is to provide a rapid exchange balloon dilatation catheter to solve the deficiencies in the prior art, effectively avoid the inner tube from protruding out of the outer tube after molding, and reduce the damage to the blood vessel caused by the balloon dilatation catheter during use.

[0005] The rapid exchange balloon dilatation catheter provided by the present invention comprises the following steps:

[0006] Compared with the prior art, the rapid exchange balloon dilatation catheter disclosed in the present invention divides the outer tube into two parts, a distal outer tube and a proximal tube. During the manufacturing process, the distal outer tube and the inner tube are first positioned, and then the proximal tube is connected with the distal outer tube and the inner tube after the inner tube is positioned. In the manufacturing method disclosed in the present invention, the inner tube is first accurately positioned and then connected with the outer tube. During the positioning process, the length of the inner tube can be more conveniently controlled, thereby preventing the formed inner tube from protruding out of the outer tube, thereby reducing the damage to the blood vessel caused by the balloon dilatation catheter during use. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 It is a schematic structural diagram of a rapid exchange balloon dilatation catheter disclosed in an embodiment of the present invention;

[0008] Figure 2 It is a schematic diagram of the structure of the rapid exchange balloon dilatation catheter disclosed in an embodiment of the present invention after the inner tube is positioned distally to the outer tube;

[0009] Figure 3It is a structural schematic diagram of the proximal end of the inner tube of the rapid exchange balloon dilatation catheter disclosed in an embodiment of the present invention being aligned with the proximal end of the distal outer tube after cutting;

[0010] Figure 4 It is a schematic structural diagram of the rapid exchange balloon dilatation catheter disclosed in an embodiment of the present invention after being positioned by the inner tube core shaft and the proximal tube core shaft;

[0011] Figure 5 yes Figure 4 Sectional view in the AA direction;

[0012] Figure 6 It is a structural schematic diagram of the rapid exchange balloon dilatation catheter disclosed in an embodiment of the present invention, in which the inner tube core shaft and the proximal tube core shaft are removed after welding is completed;

[0013] Explanation of the reference numerals: 1-distal outer tube, 10-first channel, 2-inner tube, 20-guidewire channel, 3-proximal tube, 30-second channel, 31-tube body, 32-transition portion, 4-balloon, 40-balloon cavity, 41-proximal weld foot, 42-distal weld foot, 5-catheter base, 6-connecting tube. DETAILED DESCRIPTION

[0014] The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, but should not be construed as limiting the present invention.

[0015] It should be understood that, unless otherwise clearly specified and limited, in the description of the present invention, the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, it should be noted that, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense, for example, the connection can be a direct connection or an indirect connection through an intermediate medium, and can be a fixed connection or a movable connection or a detachable connection or an integral connection. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0016] It should be noted that in the present invention, the terms "distal end" and "proximal end" should be understood as viewed from the direction of the instrument operator, the proximal end is the end close to the instrument operator, and the distal end is the end relatively far from the instrument operator. The instrument operator can be a syringe or a pneumatic conveyor, etc.

[0017] The present invention discloses a method for manufacturing a rapid exchange balloon dilatation catheter, comprising the following steps:

[0018] S1: Positioning an inner tube 2 having a guide wire channel 20 in a distal outer tube 1, wherein a first channel 10 is formed between at least a portion of the outer side wall of the inner tube 2 and at least a portion of the inner side wall of the distal outer tube 1; aligning the proximal end of the inner tube 2 with the proximal end of the distal outer tube 1 in the axial direction of the distal outer tube 1;

[0019] S2: Provide a proximal tube 3 with a second channel 30, and fix the distal end of the proximal tube 3 to the proximal end of a portion of the distal outer tube 1 and to the proximal end of a portion of the inner tube 2, so that the second channel 30 is connected to the first channel 10 and the inlet of the guide wire channel 20 is exposed outward from the proximal end of a portion of the distal outer tube 1.

[0020] like Figure 1-3 As shown, in this embodiment, the guidewire channel 20 of the inner tube 2 is used to pass a guidewire. After the proximal tube 3 is connected to the distal outer tube 1 and the inner tube 2, the first channel 10 is connected to the second channel 30, and the inlet of the guidewire channel 20 is exposed from the proximal end of the distal outer tube 1 to serve as a rapid exchange port. The first channel 10 and the second channel 30 after being connected are connected to the balloon 4 of the rapid exchange balloon dilatation catheter, and the first channel 10 and the second channel 30 can serve as flow channels for the fluid required when the balloon 4 is expanded.

[0021] The prior art rapid exchange balloon dilatation catheter generally has an inner tube inserted inside an outer tube, and a side hole is opened at about 25cm-30cm from the proximal end of the outer tube. The inlet of the inner tube is located at the side hole and forms a rapid exchange port. The inner tube is inserted through the rapid exchange port, and after the inner tube and the outer tube are welded, the inner tube extending outside the rapid exchange port is cut off. The prior art structure makes it difficult to cut the inner tube flat, making the position of the rapid exchange port relatively rough, and part of the inner tube will protrude relatively from the outer wall of the outer tube. When the rapid exchange balloon dilatation catheter moves in the blood vessel, the inner tube protruding outward is likely to cause puncture of the blood vessel wall, thereby increasing the risk of surgery.

[0022] The rapid exchange balloon dilatation catheter disclosed in the present invention divides the outer tube into two parts, the distal outer tube 1 and the proximal tube 3. During the manufacturing process, the distal outer tube 1 and the inner tube 2 are first positioned, and after the inner tube 2 is positioned, the proximal tube 3 is connected to the distal outer tube 1 and the inner tube 2. In the manufacturing method disclosed in the present invention, the inner tube 2 is first accurately positioned and then connected to the outer tube. During the positioning process, the length of the inner tube 2 can be more conveniently controlled, so that the inner tube 2 after molding can be prevented from protruding out of the outer tube, thereby reducing the damage to the blood vessel caused by the balloon dilatation catheter during use.

[0023] In order to make the inner tube 2 have better adaptability, the inner tube 2 is generally designed to be lengthy so that the inner tube 2 can cover outer tubes of different lengths on the market. Therefore, in this embodiment, after the inner tube 2 is positioned in the distal outer tube 1, part of the inner tube 2 needs to be cut off so that the proximal end of the inner tube 2 is aligned with the proximal end of the distal outer tube 1 in the axial direction of the distal outer tube 1.

[0024] In this embodiment, “aligning the proximal end of the inner tube 2 with the proximal end of the distal outer tube 1 in the axial direction of the distal outer tube 1” specifically includes:

[0025] S11: Positioning the distal end of the inner tube 2 and / or the distal outer tube; Figure 2 As shown;

[0026] S12: cutting off at least a portion of the inner tube 2 and / or the distal end of the distal outer tube along the radial direction of the distal outer tube, so that the proximal end of the inner tube 2 is aligned with the proximal end of the distal outer tube 1 in the axial direction of the distal outer tube 1, such as Figure 3 shown.

[0027] Cutting the proximal end of the inner tube 2 to align with the proximal end of the distal outer tube 1 can more conveniently achieve the connection with the proximal tube 3 in the subsequent steps.

[0028] In a specific embodiment, the cut-off portion may be a portion of the inner tube 2, and the cut-off portion of the inner tube 2 is the portion of the inner tube 2 that protrudes out of the proximal end of the distal outer tube 1 along the axial direction of the distal outer tube 1; in other embodiments, the cut-off portion may be a portion of the distal outer tube 1, and the cut-off portion of the distal outer tube 1 is the portion that protrudes out of the proximal end of the inner tube 2 in the axial direction; in other embodiments, the cut-off portion may also include both the inner tube 2 and the distal outer tube 1.

[0029] That is, in the specific embodiment, the inner tube 2 can be cut to align the proximal end of the inner tube 2 with the proximal end of the distal outer tube 1, or the distal outer tube 1 can be cut to align the proximal end of the inner tube 2 with the proximal end of the distal outer tube 1. Of course, the distal outer tube 1 and the inner tube 2 can also be cut at the same time to achieve alignment of the two.

[0030] In the above embodiments, the distal end of the inner tube 2 is first positioned, and then the cutting amount is determined by comparison to achieve alignment between the proximal end of the inner tube 2 and the proximal end of the distal outer tube 1. In other embodiments, the length of the inner tube 2 can be first determined by measurement according to the length of the distal outer tube 1, and the inner tube 2 is positioned after it is cut. After positioning, it can be appropriately trimmed according to actual conditions.

[0031] In a specific embodiment, the rapid exchange balloon dilatation catheter also has an expansion component, which is a balloon 4 in this embodiment. The balloon 4 has a balloon cavity 40, which is in communication with the first channel 10. The first channel 10 provides fluid for the balloon cavity 40 to expand the balloon cavity 40, and the balloon 4 has a proximal weld leg 41 and a distal weld leg 42. The proximal weld leg 41 is fixed to the distal end of the outer tube 1, and the distal weld leg 42 is correspondingly fixed to the distal end of the inner tube 2. In this embodiment, the balloon 4 can be used to realize the positioning of the distal end of the inner tube 2. Of course, in other embodiments, the inner tube 2 can also be positioned by other methods.

[0032] Specifically, in this embodiment, “S11: positioning the distal end of the inner tube 2” specifically includes:

[0033] S111: providing a balloon 4, wherein the balloon 4 has a proximal welding foot 41 and a distal welding foot 42;

[0034] S112: The proximal welding leg 41 is fixedly connected to the distal end of the distal outer tube 1;

[0035] S113: The inner tube 2 is inserted into the distal outer tube 1, and the distal welding leg 42 is fixedly connected to the distal end of the inner tube 2.

[0036] In the above embodiment, the balloon 4 is directly connected and fixed to the inner tube 2 through the distal welding foot 42. In other embodiments, the distal welding foot 42 of the balloon 4 can also be connected and fixed to the inner tube 2 through other connecting tubes or connecting parts. The balloon 4 can expand and contract elastically. When the inner cavity of the balloon cavity 40 of the balloon 4 is filled with fluid, the shape and volume of the balloon 4 change accordingly and expand. The specific material of the balloon 4 can be a silicone balloon, a latex balloon or a TPU balloon.

[0037] In this embodiment, the step S2: “connecting the distal end of the proximal tube 3 with the proximal end of part of the distal outer tube 1 and with the proximal end of part of the inner tube 2” specifically includes the following steps:

[0038] S21: positioning the distal end of the proximal tube 3 to the edge of the inlet of the first channel 10;

[0039] S22: fixedly connecting a portion of the distal end of the proximal tube 3 to a portion of the proximal end of the distal outer tube 1, wherein the portion fixedly connected to the distal end of the proximal tube 3 is the distal end of at least a portion of the distal outer tube 1 that forms the first channel, that is, the portion of the distal outer tube 1 fixedly connected to the distal end of the proximal tube 3 is located at the edge of the entrance of the first channel 10;

[0040] S23: fixedly connecting a portion of the distal end of the proximal tube 3 with a portion of the proximal end of the inner tube 2 , wherein the portion fixedly connected to the proximal tube 3 is the edge of the inner tube 2 located at the entrance of the first channel 10 .

[0041] In this embodiment, the near tube 3 and the distal outer tube 1 may be fixedly connected by welding, and the near tube 3 and the inner tube 2 may also be fixedly connected by welding.

[0042] The far outer tube 1, the near tube 3 and the inner tube 2 described in the present invention are all thermoplastic polymer materials. The specific material can be a block polyetheramide resin (pebax) material. It should be noted that the materials of the far outer tube 1, the near tube 3 and the inner tube 2 can be the same or different. The far outer tube 1, the near tube 3 and the inner tube 2 melt after being heated, and can be transformed from a stable glass state to a viscous flow state, so that the far outer tube 1, the near tube 3 and the inner tube 2 are fused and connected to each other at the docking position and fixed together after cooling.

[0043] In this embodiment, the distal end of the proximal tube 3 is welded to a part of the proximal end of the distal outer tube 1, and the distal end of the proximal tube 3 is welded to a part of the proximal end of the inner tube 2. The proximal tube 3 and the distal outer tube 1 are melted at the joint position by laser welding and connected and fixed together when they are cooled and solidified after melting, and the proximal tube 3 and the inner tube 2 are melted at the joint position and connected and fixed together when they are cooled and solidified after melting.

[0044] It should be noted that, since the distal end of the near tube 3 is connected to part of the inner tube 2 and part of the far outer tube 1 by welding, the cross-sectional shape of the distal end of the near tube 3 can be set to be mismatched with the shape of the inlet of the first channel 10, that is, the distal end of the near tube 3 may not completely cover the inlet of the first channel 10, and after the near tube 3 is positioned, part of the first channel 10 is not covered by the near tube 3 and is directly exposed to the outside. Because the product of the near tube 3, the inner tube 2 and the far outer tube 1 after being heated and melted will flow, the part of the first channel 10 that cannot be covered by the near tube 3 can be sealed during the flow process, so that only the first channel 10 and the second channel 30 are connected.

[0045] It is understandable that after being positioned, the near tube 3 can be overlapped or butted with the far outer tube 1 and / or the inner tube 2 so that the three melt after being heated. In order to facilitate the combination, part of the near tube 3 can be inserted into the first channel 10 after being positioned. In another embodiment, part of the near tube 3 is overlapped on the outer side wall of the far outer tube 1.

[0046] The proximal tube 3, the distal outer tube 1 and the inner tube 2 are heated by a welding process, and specifically resistance welding, ultrasonic welding, radio frequency induction welding or laser welding can be used, preferably laser welding. Laser welding is the preferred process in balloon catheter welding due to its advantages of accurate energy input, fast welding speed, high quality and small welding deformation. Of course, other heating methods in the prior art can also be used in other embodiments.

[0047] In S21, “positioning the distal end of the proximal tube to the edge of the inlet of the first channel” specifically includes the following steps:

[0048] S211: Figure 4-5 As shown, an inner tube core shaft 100 is arranged in the inner tube 2, and a near tube core shaft 200 is arranged in the near tube 3, wherein a portion of the near tube core shaft 200 extends along the axial direction of the near tube 3 and is arranged outside the distal end of the near tube 3;

[0049] S212: Figure 4-5 As shown, the proximal tube core shaft 200 extending outside the distal end of the proximal tube 3 is at least partially positioned in the first channel 10 , and the distal end of the proximal tube 3 is positioned to the edge of the entrance of the first channel 10 .

[0050] It should be noted that the inner tube core shaft 100 and the near tube core shaft 200 need to be removed after welding. Figure 6 As shown, after the inner tube core shaft 100 and the near tube core shaft 200 are moved out, the second channel 30 of the near tube 3 is connected to the first channel 10 .

[0051] The inner tube core shaft 100 and the proximal tube core shaft 200 can both be made of stainless steel, and the maximum outer diameter of the inner tube core shaft 100 is the same as the distal inner diameter of the inner tube 2 to ensure that the shape of the inner tube 2 does not change during the subsequent welding and heating process, while ensuring that the inner tube channel 20 of the inner tube 2 is unobstructed.

[0052] The maximum outer diameter of the proximal tube core shaft 200 is the same as the inner diameter of the proximal tube 3 to ensure that the second channel 30 of the proximal tube 3 is unobstructed.

[0053] The proximal tube core shaft 200 fits with the inner wall of the proximal tube 3 after positioning is completed. The proximal tube core shaft 200 has a flat surface and a cylindrical surface arranged opposite to each other. The cylindrical surface of the proximal tube core shaft 200 fits with the inner wall of the proximal tube 3, and the flat surface of the proximal tube core shaft 200 is inclined toward the inner tube 2.

[0054] Part of the inner tube core shaft 100 also extends outside the guide wire channel 20 , and the inner tube core shaft 100 extending outside the guide wire channel 20 has an inner tube core shaft flat surface that matches the flat surface of the proximal tube core shaft 200 .

[0055] In order to facilitate the extraction of the inner tube core shaft 100 and the proximal tube core shaft 200 , the inner tube core shaft 100 and the proximal tube core shaft 200 are coated with a core shaft coating, and the core shaft coating is a polytetrafluoroethylene coating and / or a polyparaxylene coating.

[0056] Another embodiment of the present invention further discloses a rapid exchange balloon manufactured by the method for manufacturing the rapid exchange balloon dilatation catheter, comprising:

[0057] A distal tube assembly, comprising a distal outer tube 1 and an inner tube 2 disposed in the distal outer tube 1, wherein the inner tube 2 has a guide wire channel 20, and a first channel 10 is formed between at least a portion of the outer side wall of the inner tube 2 and at least a portion of the inner side wall of the distal outer tube 1;

[0058] The proximal tube 3 has a second channel 30, the distal end of which is connected to the proximal end of part of the distal outer tube 1 and the proximal end of part of the inner tube 2 so that the second channel 30 is connected to the first channel 10, and the inlet of the guidewire channel 20 is exposed outward from the proximal end of the distal outer tube 1.

[0059] The proximal end of the inner tube 2 is aligned with the proximal end of the distal outer tube 1 .

[0060] In this embodiment, the end of the inner tube 2 is aligned with the proximal end of the distal outer tube 1 before welding, thereby preventing the inner tube 2 from extending outward excessively. The outward extension of the inner tube 2 not only easily forms rough burrs, thereby damaging the blood vessel wall during the use of the balloon dilatation catheter, but also increases the outer diameter of the balloon dilatation catheter, thereby affecting the use of the balloon dilatation catheter.

[0061] The opening direction of the inlet of the inner tube 2 is in the same direction as the axial direction of the distal outer tube 1 .

[0062] The proximal tube 3 comprises a tube body portion 31 and a transition portion 32, the radial cross-sectional circumference of the tube body portion 31 is consistent with the radial cross-sectional circumference of the distal outer tube 1, the distal end of the transition portion 32 is fixedly connected to at least a portion of the distal tube assembly, and the proximal end of the transition portion 32 is fixedly connected to the tube body portion 31; the radial cross-sectional circumference of the transition portion 32 gradually increases away from the distal tube assembly.

[0063] It should be noted that the radial cross-sectional circumference of the tube body portion 31 is the length of the outer circumference of the cross-sectional area perpendicular to the axial direction of the tube body portion 31 .

[0064] In this embodiment, the radial cross-sections of the tube body 31 and the distal outer tube 1 are both circular, the outer diameter of the tube body 31 is consistent with the outer diameter of the distal outer tube 1 , and the transition portion 32 is connected between the distal outer tube 1 and the tube body 31 .

[0065] In one embodiment, the transition portion 32 is wedge-shaped as a whole. The above-mentioned setting of the transition portion 32 actually forms a wedge-shaped avoidance space at the exit position of the guidewire channel 20, which can avoid the outward exposure of the guidewire channel 20, thereby better facilitating the insertion of the guidewire.

[0066] like Figure 1-5 In the radial direction of the proximal tube 3, the transition portion 32 which is wedge-shaped as a whole has a top wall and a bottom wall which are arranged opposite to each other, and the bottom wall is inclined, and the inclination angle of the bottom wall is approximately 1-2°. Figure 1 The schematic diagram is a rough structural diagram. For the sake of convenience, the bottom wall inclination angle is enlarged for illustration. However, the bottom wall inclination angle of the actual product is Figure 2 and Figure 3 Shown is relatively flat.

[0067] In this embodiment, the maximum outer diameter of the cross section of the distal outer tube 1 is consistent with the maximum outer diameter of the cross section of the tube body 31, so that the outer diameter of the distal outer tube 1 can be prevented from being too large, thereby affecting the use of the balloon dilatation catheter. The tube body 31 is coaxially arranged with the distal outer tube 1. The transition portion 32 is arranged to achieve a smooth transition between the distal outer tube 1 and the proximal tube 3, and this connection method is conducive to the stability of the catheter during transportation.

[0068] The rapid exchange balloon dilatation catheter also includes a catheter base 5, a core wire and a connecting tube 6 connecting the catheter base 5 and the proximal tube 3;

[0069] The core wire has a fixed end fixed to the inner wall of the connecting tube 6 and a free end arranged opposite to the fixed end; the free end of the core wire passes through the second channel 30 and extends to be arranged in the first channel 10; the near tube 3 and the far outer tube 1 are both flexible pipes, and the connecting tube 6 is a rigid pipe.

[0070] The core wire is also a metal piece, specifically, a nickel-titanium wire or a stainless steel wire. The core wire is used to support the lumen of the proximal tube 3 .

[0071] It should be noted that the structure of the catheter base 5 and the connection structure between the catheter base 5 and the proximal tube 3 can all be based on the existing technology, and will not be described in detail. The connecting tube 6 is a hypotube.

[0072] Since the guide wire is passed through the proximal end of the distal outer tube 1, the guide wire is a rigid part that can support and guide the distal outer tube 1, but the proximal tube 3 between the distal outer tube 1 and the connecting tube 6 has greater flexibility, and is prone to bending and deformation during the process of passing through the balloon dilatation catheter, which is inconvenient for the use of the balloon dilatation catheter. In order to avoid the above problems, a core wire is set, one end of the core wire is fixed on the rigid connecting tube 6, and the other end passes through the second channel 30 and finally extends into the first channel 10. As a rigid part, the core wire can provide certain support for the flexible distal outer tube 1 to prevent the distal outer tube 1 from bending during the process of passing into the body.

[0073] The above describes in detail the structure, features and effects of the present invention based on the embodiments shown in the drawings. The above is only a preferred embodiment of the present invention, but the present invention is not limited to the scope of implementation shown in the drawings. Any changes made according to the concept of the present invention, or modifications to equivalent embodiments with equivalent changes, which still do not exceed the spirit covered by the description and drawings, should be within the protection scope of the present invention.

Claims

1. A method for manufacturing a rapid exchange balloon dilatation catheter, characterized in that: The steps include: Positioning an inner tube having a guidewire channel in the distal outer tube; forming a first channel between at least a portion of the outer side wall of the inner tube and at least a portion of the inner side wall of the distal outer tube; Aligning the proximal end of the inner tube with the proximal end of the distal outer tube along the axial direction of the distal outer tube; A proximal tube with a second channel is provided, and the distal end of the proximal tube is fixedly connected to the proximal end of part of the distal outer tube and to the proximal end of part of the inner tube, so that the second channel is connected to the first channel, and the inlet of the guidewire channel is exposed outward from the proximal end of part of the distal outer tube.

2. The method for manufacturing a rapid exchange balloon dilatation catheter according to claim 1, characterized in that: "Aligning the proximal end of the inner tube with the proximal end of the distal outer tube along the axial direction of the distal outer tube;" specifically includes: positioning the distal end of the inner tube and / or the distal outer tube; At least a portion of the inner tube and / or the distal end of the distal outer tube is cut off along the radial direction of the distal outer tube, so that the proximal end of the inner tube is aligned with the proximal end of the distal outer tube in the axial direction of the distal outer tube.

3. The method for manufacturing a rapid exchange balloon dilatation catheter according to claim 2, characterized in that: "Location of the distal end of the inner tube and / or the distal outer tube" specifically includes: Providing an expansion component, the expansion component having a proximal welding leg and a distal welding leg; The proximal welding leg is fixedly connected to the distal end of the distal outer tube; The inner tube is inserted into the distal outer tube, and the distal end welding foot is fixedly connected to the distal end of the inner tube.

4. The method for manufacturing a rapid exchange balloon dilatation catheter according to claim 1, characterized in that: “Connecting the distal end of the proximal tube to the proximal end of part of the distal outer tube and to the proximal end of part of the inner tube” specifically comprises the following steps: positioning the distal end of the proximal tube at an edge of the inlet of the first channel; Fixedly connecting the distal end of part of the proximal tube to the proximal end of part of the distal outer tube, wherein the part fixedly connected to the distal end of the proximal tube is the distal end of at least part of the distal outer tube forming the first channel; The distal end of a portion of the proximal tube is fixedly connected to the proximal end of a portion of the inner tube, wherein the portion fixedly connected to the proximal tube is the edge of the inner tube located at the inlet of the first channel.

5. The method for manufacturing a rapid exchange balloon dilatation catheter according to claim 4, characterized in that: “Locate the distal end of the proximal tube to the edge of the inlet of the first channel” specifically comprises the following steps: An inner tube core shaft is arranged in the inner tube, and a near tube core shaft is arranged in the near tube, wherein at least a portion of the near tube core shaft extends along the axial direction of the near tube and is arranged outside the distal end of the near tube; The proximal tube core shaft extending outside the distal end of the proximal tube is at least partially positioned into the first channel, and the distal end of the proximal tube is positioned to the edge of the inlet of the first channel.

6. A rapid exchange balloon dilatation catheter manufactured by the method for manufacturing a rapid exchange balloon dilatation catheter according to any one of claims 1 to 5, characterized in that: include: A distal tube assembly, comprising a distal outer tube and an inner tube disposed in the distal outer tube, the inner tube having a guide wire channel, and a first channel formed between at least a portion of an outer side wall of the inner tube and at least a portion of an inner side wall of the distal outer tube; The proximal tube has a second channel, the distal end of the proximal tube is connected to the proximal end of part of the distal outer tube and the proximal end of part of the inner tube so that the second channel is connected to the first channel, and the inlet of the guidewire channel is exposed outward from the proximal end of the distal outer tube.

7. The rapid exchange balloon dilatation catheter according to claim 6, characterized in that: The proximal end of the inner tube is aligned with the proximal end of the distal outer tube.

8. The rapid exchange balloon dilatation catheter according to claim 6, characterized in that: The opening direction of the inner tube inlet is in the same direction as the axial direction of the far outer tube.

9. The rapid exchange balloon dilatation catheter according to claim 6, characterized in that: The proximal tube comprises a tube body and a transition portion, the radial cross-sectional circumference of the tube body is consistent with the radial cross-sectional circumference of the distal outer tube, the distal end of the transition portion is fixedly connected to at least a portion of the distal tube assembly, and the proximal end of the transition portion is fixedly connected to the tube body; the radial cross-sectional circumference of the transition portion gradually increases away from the distal tube assembly.

10. The rapid exchange balloon dilatation catheter according to claim 6, characterized in that: The rapid exchange balloon dilatation catheter also comprises a catheter base, a core wire and a connecting tube connecting the catheter base and the proximal tube; The core wire has a fixed end fixed to the inner wall of the connecting tube and a free end arranged opposite to the fixed end; the free end of the core wire passes through the second channel and extends to be arranged in the first channel; the near tube and the far outer tube are both flexible pipes, and the connecting tube is a rigid pipe.

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