Bend tip balloon catheter and manufacturing process thereof

Abstract

The invention discloses an elbow tip balloon catheter and a manufacturing process thereof, and relates to the field of medical instruments, the elbow tip balloon catheter comprises a balloon main body and a built-in tube arranged in the balloon main body, a rear outer tube is integrally formed at one end of the balloon main body, and the other end of the built-in tube penetrates through the other end of the balloon main body and extends outwards to naturally form a guide part; an inner cavity is formed in the built-in pipe, a medium channel is formed in one end of the inner cavity, an actuating cavity is formed in the other end of the inner cavity, and a medium filled in the actuating cavity is adjusted through the medium channel so that the internal space of the actuating cavity can be changed, and therefore the guiding part can be bent towards the side away from or close to the actuating cavity. The bending angle of the guide part is randomly adjusted by the actuating cavity, and the bending direction is controlled by the rotation of the hypotube, so that the effect of quickly passing through the multi-point tortuous part of the blood vessel is achieved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a curved-tip balloon catheter and its manufacturing process. Background Technology

[0002] When used in coronary interventional procedures, balloon catheters serve as the core device for dilating narrowed blood vessels and implanting stents. The catheter is continuously guided along the artery to the coronary lesion site, and then a medium is injected into the balloon through the catheter tip, causing the balloon to inflate and support the narrowed portion of the artery caused by the lesion. Subsequently, a stent is installed, allowing blood to effectively pass through the narrowed segment.

[0003] However, during the insertion of balloon catheters into blood vessels, the tortuous and winding nature of the vessels makes it difficult for the catheter tip to adapt to the tortuous direction and extend during its journey. This results in difficult insertion and a high risk of damaging the vessel wall. Furthermore, the angle and extent of tortuosity within the blood vessel vary, making it impossible to pre-set the angle of the balloon catheter tip according to a predetermined plan. Existing solutions typically use a flexible material for the tip, allowing it to enter the tortuous blood vessel by rotating the catheter while slowly and repeatedly pushing and pulling when encountering a tortuous section, thus extending inward. However, the effect is uncontrollable, the implementation is difficult, it requires a high level of experience from the surgeon, and it also makes the entire insertion process time-consuming. Therefore, a curved-tip balloon catheter and its manufacturing process are provided. Summary of the Invention

[0004] The purpose of this invention is to provide a curved tip balloon catheter and its manufacturing process to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a curved-tip balloon catheter, comprising a balloon body and an internal tube disposed within the balloon body, wherein a radiopaque ring is disposed on the balloon body, and a rear external tube is integrally formed at one end of the balloon body, through which a medium is injected into the balloon body to change the internal inflation state of the balloon body; the internal tube extends axially along the rear external tube and penetrates the other end of the balloon body and extends outward to form a guide portion, the outer wall of the guide portion being sealed to the balloon body, so that... The guide portion can move synchronously with the balloon body. The internal tube is provided with an inner chamber. One end of the inner chamber extends along the axis of the internal tube to the rear end of the external tube and passes through the outer end of the internal tube to form a medium channel. The other end of the inner chamber extends into the guide portion to form an actuation cavity. The actuation cavity is located at a non-axial position of the guide portion. The medium filling medium inside the actuation cavity is adjusted through the medium channel to change the internal space of the actuation cavity, thereby causing the guide portion to bend away from or closer to the actuation cavity.

[0006] Preferably, the inner wall of the actuation cavity is provided with an expansion joint, and multiple sets of expansion joints are continuously arranged along the axial direction of the guide portion, so that when the internal space of the actuation cavity changes, the guide portion is guided in the bending direction through the expansion joint, and at the same time, it is used to release the deformation stress generated by the bending of the inner wall of the guide portion.

[0007] Preferably, the actuation cavity includes an expansion cavity, which is disposed on the side of the guide portion away from its bending direction. The two sides of the inner wall of the expansion cavity are in contact with each other when unfilled. As the internal filling medium increases, the thinner side of the outer wall of the expansion cavity expands outward and bulges into an outer arc shape, so that the guide portion continuously bends along the outer arc tangential direction.

[0008] Preferably, the expansion cavity has a crescent-shaped cross-section, so that when the guide portion bends, the inner wall of the expansion cavity and the side closest to the bending direction can bend continuously, thereby avoiding the formation of internal compressive stress on both sides of the crescent-shaped expansion cavity.

[0009] Preferably, the expansion joint is located on the inner wall of the expansion cavity near the bending direction of the guide portion, and the expansion joint is closed in its natural state, gradually opening as the bending amplitude of the guide portion increases.

[0010] Preferably, the actuation cavity includes a collapse cavity, which is disposed in the guide portion near its bending direction. The interior of the collapse cavity is in an open state in its natural state. As the internal filling medium decreases, the thinner side of the outer wall of the collapse cavity contracts inward and fits against the other side of the inner wall of the collapse cavity, so that the outer wall of the guide portion and the side near the collapse cavity continuously concave inward, thereby pulling the other side of the outer wall of the guide portion to bend towards the concave side.

[0011] Preferably, the collapsed cavity is elliptical, so that when the collapsed cavity collapses, as the two walls come closer together, the two sides where the two walls meet can naturally bend, thereby reducing the generated torsional stress.

[0012] Preferably, the expansion joint is located on the side of the inner wall of the collapsed cavity away from the bending direction of the guide portion, and the expansion joint is open in its natural state, gradually closing as the bending amplitude of the guide portion increases.

[0013] Preferably, the end of the guide portion is provided with a hemispherical guide head, and the hemispherical guide head is smoothly connected to the guide portion;

[0014] The outer diameter of the built-in tube is smaller than the inner diameter of the rear external tube, so that a feeding channel that is connected to the main body of the balloon is naturally formed between the two.

[0015] The diameter of the medium channel is much smaller than the outer diameter of the built-in tube, which makes the built-in tube thick-walled so that the built-in tube will not expand when the medium flows through the medium channel. At the same time, the built-in tube has stronger bending resistance, thereby providing bending resistance support for the rear outer tube.

[0016] Preferably, a sodium hypochlorite tube is fixedly installed on the outer wall of the rear section of the rear outer tube, a conduit seat is installed at the end of the rear outer tube, a rubber sleeve is installed between one end of the conduit seat and the outer wall of the rear outer tube, a first sealing joint is integrally formed at the other end of the conduit seat, and a second sealing joint is integrally formed at the end of the inner tube.

[0017] A manufacturing process for a curved-tip balloon catheter includes the following steps:

[0018] S1. The built-in tube is formed by continuous extrusion using a dual-cavity extrusion die. The front end selects different chamber cores according to the differences in the actuation chamber, thereby forming a preset guide section.

[0019] S2. After the guide part is formed, the cavity core shrinks and resets. At this time, continuous air blowing and pressure stabilization are carried out through the original position of the cavity core so that the media channel is naturally formed in the rear section of the built-in tube.

[0020] S3. When the rear section of the internal tube is formed, a co-extrusion process is used to integrally form the balloon body on the outer wall of the internal tube, and the balloon body is expanded outward by the negative pressure of the external mold.

[0021] S4. The rear outer tube is continuously co-extruded and finally integrally formed with the inner tube.

[0022] S5. The rubber sleeve, conduit seat, first sealing joint and second sealing joint are sequentially installed at the end of the rear outer tube and the end of the inner tube by a pasting process.

[0023] The technical effects and advantages of this invention are as follows:

[0024] 1. This curved-tip balloon catheter allows for simultaneous rotation of the entire post-implantation tubing by holding the hypotube, causing the guide section to rotate synchronously. This ensures that the side of the guide section to bend faces the tortuous direction. At this point, a dedicated media input / output pump is connected through the second sealing connector. The pump is connected to the actuation chamber through the media channel. The pump changes the filling state inside the actuation chamber, causing the guide section to bend in the tortuous direction. Simultaneously, the internal expansion joint allows the thicker side of the actuation chamber wall to release deformation stress, preventing deformation resistance. This allows the hemispherical guide head to smoothly enter the tortuous end. Once past the tortuous position, the pump immediately restores the filling state inside the actuation chamber. Thus, during the entire catheter insertion process, the bending angle of the guide section can be adjusted arbitrarily using the actuation chamber, and the bending direction can be controlled by rotating the hypotube, thereby achieving the effect of quickly passing through multiple tortuous parts of the blood vessel.

[0025] 2. The actuation cavity of the elbow-tip balloon catheter is an expansion cavity located on the side opposite to the bending direction of the guide section. During use, a medium is pumped into the expansion cavity through the pump body, causing the expansion cavity to fill. At this time, the thinner side wall of the expansion cavity bulges outward, thereby changing the shape of the entire outer wall of the guide section. The guide section will then bend along the side opposite to the expansion of the expansion cavity, and the bending angle of the guide section can be adjusted by controlling the filling degree of the expansion cavity. During this process, the expansion joint is located on the side with the thicker side wall of the expansion cavity, and this side will bend synchronously in the direction of expansion and bulging. The expansion joint allows the side wall at this location to adapt to the curvature change and eliminate the internal stress generated by deformation, thereby enabling the entire guide section to bend.

[0026] 3. The actuation cavity of the elbow-tip balloon catheter is a collapsed cavity located in the guide section near the bending direction. In its natural state, the collapsed cavity is a tangible chamber filled with media. When the guide section needs to be bent, the media inside is extracted by the pump, causing the collapsed cavity to begin to collapse. At this time, the thinner sidewall of the collapsed cavity contracts inward, thereby causing the outer wall of the guide section on that side to contract and form a traction force, pulling the opposite side to bend in that direction. At this time, the expansion joint is located on the thicker side of the inner wall of the collapsed cavity. The expansion joint is also a tangible cavity in its natural state. During collapse, the expansion joint gradually closes as the guide section bends, thereby absorbing the internal compressive stress on the thicker side of the guide section during bending, so that the guide section can bend in a preset direction. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the overall structure of the balloon catheter with the elbow tip of the present invention;

[0028] Figure 2 This is a schematic diagram of the outer surface of the balloon body of the present invention;

[0029] Figure 3 This is a schematic diagram of the structure of the expansion cavity in the unfilled state of the present invention;

[0030] Figure 4 This is a schematic diagram of the expansion cavity filling state of the present invention;

[0031] Figure 5 This is a schematic diagram of the end face structure of the expansion cavity of the present invention;

[0032] Figure 6 This is a schematic diagram of the structure of the collapsed cavity in its uncollapsed state according to the present invention;

[0033] Figure 7 This is a schematic diagram of the collapsed cavity structure of the present invention in its collapsed state.

[0034] Figure 8 This is a schematic diagram of the end face of the collapsed cavity in the uncollapsed state of the present invention;

[0035] Figure 9 This is a schematic diagram of the end face of the collapsed cavity in the present invention.

[0036] In the diagram: 1. Balloon body; 2. Internal tube; 3. Guide section; 4. Rear external tube; 5. Hypotube; 6. Rubber sleeve; 7. Catheter seat; 8. First sealing joint; 9. Second sealing joint; 10. Imaging ring; 11. Media channel; 12. Actuation chamber; 121. Expansion cavity; 122. Collapse cavity; 123. Expansion joint; 13. Hemispherical guide head. Detailed Implementation

[0037] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] This invention provides, for example Figures 1 to 9 The illustrated elbow-tipped balloon catheter includes a balloon body 1 and an internal tube 2 disposed within the balloon body 1. A contrast-enhancing ring 10 is provided on the balloon body 1. A rear external tube 4 is integrally formed at one end of the balloon body 1, through which a medium is introduced into the balloon body 1 to change its internal inflation state. One end of the internal tube 2 extends axially along the rear external tube 4 and penetrates the distal sidewall of the rear external tube 4. The other end of the internal tube 2 penetrates the other end of the balloon body 1 and extends outward to naturally form a guide portion 3. The outer wall of the guide portion 3 is sealed to the balloon body 1. The connection allows the guide section 3 to move synchronously with the balloon body 1. An inner chamber is provided in the inner tube 2. One end of the inner chamber extends along the axis of the inner tube 2 to the rear end of the outer tube 4 and passes through the outer end of the inner tube 2 to form a medium channel 11. The other end of the inner chamber extends into the guide section 3 to form an actuation cavity 12. The actuation cavity 12 is located at a non-axial position of the guide section 3. The medium filling medium inside the actuation cavity 12 is adjusted through the medium channel 11 to change the internal space of the actuation cavity 12, thereby causing the guide section 3 to bend away from or closer to the actuation cavity 12.

[0039] The inner wall of the actuation cavity 12 is provided with an expansion joint 123. Multiple sets of expansion joints 123 are continuously arranged along the axial direction of the guide part 3 so that when the internal space of the actuation cavity 12 changes, the guide part 3 is guided in the bending direction through the expansion joint 123, and at the same time, it is used to release the deformation stress generated by the bending of the inner wall of the guide part 3.

[0040] The end of the guide portion 3 is provided with a hemispherical guide head 13, the diameter of which is the same as the diameter of the guide portion 3, so that the two are smoothly connected.

[0041] The outer diameter of the internal tube 2 is smaller than the inner diameter of the rear external tube 4, so that a feeding channel that is connected to the balloon body 1 is naturally formed between the two.

[0042] The diameter of the medium channel 11 is much smaller than the outer diameter of the inner tube 2, which makes the inner tube 2 thick-walled so that the inner tube 2 will not expand when the medium flows through the medium channel 11. At the same time, the inner tube 2 has stronger bending resistance, thus providing bending resistance to the rear outer tube 4.

[0043] A sodium hypochlorite tube 5 is fixedly installed on the outer wall of the rear section of the rear external tube 4. A conduit seat 7 is installed at the end of the rear external tube 4. A rubber sleeve 6 is installed between one end of the conduit seat 7 and the outer wall of the rear external tube 4. A first sealing joint 8 is integrally formed at the other end of the conduit seat 7. A second sealing joint 9 is integrally formed at the end of the internal tube 2.

[0044] Working principle: When in use, the device is inserted into the blood vessel with the hemispherical guide head 13 as the end, and moves inward along the blood vessel. When encountering a tortuous part of the blood vessel, the entire rear external tube 4 is rotated by holding the hypotube 5, causing the guide part 3 to rotate synchronously. This makes the side of the guide part 3 to be bent face the tortuous direction. At this time, a dedicated medium input / output pump is connected through the second sealing connector 9. The pump is connected to the actuation chamber 12 through the medium channel 11. The pump changes the filling state inside the actuation chamber 12, so that the guide part 3 bends in the tortuous direction. At the same time, the internal expansion joint 123 allows the thicker side of the inner wall of the actuation chamber 12 to bend. The expansion joint 123 is used to release deformation stress and avoid deformation resistance, so that the hemispherical guide head 13 can smoothly enter the tortuous end. At this time, the rear external tube 4 is moved by holding the hypotube 5, so that the entire device passes through the tortuous position through the hemispherical guide head 13. After passing through the tortuous position, the pump body immediately restores the filling state inside the actuator cavity 12, so that the guide part 3 is straight and continues to move forward. In this way, the bending angle of the guide part 3 can be adjusted at will by using the actuator cavity 12 during the entire tube insertion process, and the bending direction can be controlled by rotating the hypotube 5, so as to achieve the effect of quickly passing through the tortuous parts of the blood vessel.

[0045] Once the balloon body 1 reaches the preset position, the medium is pumped in through the pump body connected to the first sealing connector 8, causing the balloon body 1 to expand and open the blood vessel at the preset position, so as to facilitate subsequent stent implantation.

[0046] Example 1: This example provides the following... Figures 3 to 5 An arrangement scheme for the actuation cavity 12,

[0047] The actuation cavity 12 includes an expansion cavity 121, which is disposed in the guide portion 3 on the side away from its bending direction. The two sides of the inner wall of the expansion cavity 121 are in contact with each other when not filled. As the internal filling medium increases, the thinner side of the outer wall of the expansion cavity 121 expands outward and bulges into an outer arc shape, so that the guide portion 3 continuously bends along the outer arc tangential direction.

[0048] The expansion cavity 121 has a crescent-shaped cross section so that when the guide part 3 bends, the inner wall of the expansion cavity 121 and the side closer to the bending direction can bend continuously, thereby avoiding the formation of internal compressive stress on both sides of the crescent-shaped expansion cavity 121.

[0049] The expansion joint 123 is located on the inner wall of the expansion cavity 121 on the side near the bending direction of the guide part 3. The expansion joint 123 is closed in its natural state, and gradually expands as the bending amplitude of the guide part 3 increases.

[0050] Working principle: In this embodiment, the actuation cavity 12 is an expansion cavity 121 located on the side opposite to the bending direction of the guide portion 3. During use, a medium is pumped into the expansion cavity 121 by a pump body, causing the expansion cavity 121 to fill. At this time, the thinner side wall of the expansion cavity 121 bulges outward, thereby changing the shape of the outer wall of the entire guide portion 3. The guide portion 3 will then bend along the side opposite to the expansion of the expansion cavity 121. The bending angle of the guide portion 3 is adjusted by controlling the filling degree of the expansion cavity 121. During this process, the expansion joint 123 is located on the thicker side wall of the expansion cavity 121, and this side will bend synchronously in the direction of expansion and bulging. The expansion joint 123 enables the side wall at this location to adapt to the curvature change and eliminate the internal stress generated by deformation, thereby enabling the entire guide portion 3 to bend.

[0051] Example 2: This example provides the following... Figures 6 to 9 Another arrangement of the actuation cavity 12 shown is as follows;

[0052] The actuating cavity 12 includes a collapse cavity 122, which is disposed in the guide portion 3 on the side near its bending direction. The interior of the collapse cavity 122 is in an open state in its natural state. As the internal filling medium decreases, the thinner side of the outer wall of the collapse cavity 122 contracts inward and fits against the other side of the inner wall of the collapse cavity 122, so that the outer wall of the guide portion 3 and the side near the collapse cavity 122 continuously indents inward, thereby pulling the other side of the outer wall of the guide portion 3 to bend towards the concave side.

[0053] The collapsed cavity 122 is elliptical so that when the collapsed cavity 122 collapses, as the two walls come together, the two sides where the two walls meet can naturally bend, thereby reducing the generated torsional stress.

[0054] The expansion joint 123 is located on the side of the inner wall of the collapsed cavity 122 away from the bending direction of the guide part 3, and the expansion joint 123 is open in its natural state. The expansion joint 123 gradually closes as the bending amplitude of the guide part 3 increases.

[0055] Working principle: In this scheme, the actuation cavity 12 is a collapsed cavity 122 located in the guide part 3 near the bending direction. The collapsed cavity 122 is a tangible cavity in its natural state, filled with a medium. When the guide part 3 needs to be bent, the medium inside is extracted by the pump, causing the collapsed cavity 122 to begin to collapse. At this time, the thinner sidewall of the collapsed cavity 122 contracts inward, thereby causing the outer wall of the guide part 3 on that side to contract and form a traction force, pulling the opposite side to bend in that direction. At this time, the expansion joint 123 is located on the thicker side of the inner wall of the collapsed cavity 122. The expansion joint 123 is also a tangible cavity in its natural state. During collapse, the expansion joint 123 gradually closes as the guide part 3 bends, thereby absorbing the internal compressive stress on the thicker side of the guide part 3 during bending, so that the guide part 3 can bend smoothly in the preset direction.

[0056] Example 3, see attached document Figure 1 To be continued Figure 9 Based on Embodiment 1 and Embodiment 2, a manufacturing process for a bent-tip balloon catheter is proposed, including the following steps:

[0057] S1. The built-in tube 2 is formed by continuous extrusion using a dual-cavity extrusion die. The front end is selected with different chamber cores according to the differences in the actuation chamber 12, thereby forming the preset guide part 3.

[0058] S2. After the guide part 3 is formed, the cavity core shrinks and resets. At this time, continuous air blowing and pressure stabilization are carried out through the original position of the cavity core so that the rear section of the built-in tube 2 naturally forms the medium channel 11.

[0059] S3. When the rear section of the internal tube 2 is formed, a co-extrusion process is used to integrally form the balloon body 1 on the outer wall of the internal tube 2, and the balloon body 1 is expanded outward by the negative pressure of the external mold.

[0060] S4 and the rear outer tube 4 are continuously co-extruded and finally integrally formed with the inner tube 2.

[0061] S5. Install the rubber sleeve 6, conduit seat 7, first sealing joint 8 and second sealing joint 9 sequentially at the end of the rear outer tube 4 and the end of the inner tube 2 by adhesive bonding process.

[0062] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A balloon catheter with a bent tip, characterized in that, The system includes a balloon body (1) and an internal tube (2) disposed within the balloon body (1). A radiopaque ring (10) is provided on the balloon body (1). A rear external tube (4) is integrally formed at one end of the balloon body (1). A medium is injected into the balloon body (1) through the rear external tube (4) to change the inflation state of the balloon body (1). The internal tube (2) extends axially along the rear external tube (4) and penetrates the distal end of the balloon body (1), extending outward to form a guide portion (3). The outer wall of the guide portion (3) is sealed to the balloon body (1) so that the guide portion (3) can connect with the balloon body (1). The inner chamber is provided in the inner tube (2) and one end of the inner chamber extends along the axis of the inner tube (2) to the rear end of the outer tube (4) and passes through the outer end of the inner tube (2) to form a medium channel (11). The other end of the inner chamber extends to the guide part (3) to form an actuation cavity (12). The actuation cavity (12) is located at the non-axial position of the guide part (3). The medium channel (11) is used to adjust the filling medium inside the actuation cavity (12) so that the internal space of the actuation cavity (12) changes, thereby causing the guide part (3) to bend away from or close to the actuation cavity (12).

2. The bent-tip balloon catheter according to claim 3, characterized in that, The inner wall of the actuation cavity (12) is provided with an expansion joint (123). Multiple sets of expansion joints (123) are continuously arranged along the axial direction of the guide part (3) so that when the internal space of the actuation cavity (12) changes, the guide part (3) is guided to bend through the expansion joint (123), and at the same time, it is used to release the deformation stress generated by bending of the inner wall of the guide part (3).

3. A curved-tip balloon catheter according to claim 2, characterized in that, The actuation cavity (12) includes an expansion cavity (121), which is located on the side of the guide portion (3) away from its bending direction. The two sides of the inner wall of the expansion cavity (121) are in contact with each other in the unfilled state. As the internal filling medium increases, the thinner side of the outer wall of the expansion cavity (121) expands outward and bulges into an outer arc shape, so that the guide portion (3) continuously bends along the outer arc tangential direction.

4. A curved-tip balloon catheter according to claim 3, characterized in that, The expansion cavity (121) has a crescent-shaped cross section, so that when the guide (3) bends, the inner wall of the expansion cavity (121) and the side near the bending direction can bend continuously, thereby avoiding the formation of internal compressive stress on both sides of the crescent-shaped expansion cavity (121).

5. A curved-tip balloon catheter according to claim 4, characterized in that, The expansion joint (123) is located on the inner wall of the expansion cavity (121) on the side near the bending direction of the guide (3), and the expansion joint (123) is closed in its natural state. The expansion joint (123) gradually opens as the bending amplitude of the guide (3) increases.

6. A bent-tip balloon catheter according to claim 2, characterized in that, The actuation cavity (12) includes a collapse cavity (122), which is disposed in the guide (3) on one side near its bending direction. The interior of the collapse cavity (122) is in an open state in its natural state. As the internal filling medium decreases, the thinner side of the outer wall of the collapse cavity (122) contracts inward and fits against the other side of the inner wall of the collapse cavity (122), so that the outer wall of the guide (3) and the side near the collapse cavity (122) continuously indents inward, thereby pulling the other side of the outer wall of the guide (3) to bend towards the concave side.

7. A curved-tip balloon catheter according to claim 6, characterized in that, The collapsed cavity (122) is elliptical so that when the collapsed cavity (122) collapses, as the two walls come together, the two sides where the two walls meet can naturally bend, thereby reducing the generated torsional stress.

8. A curved-tip balloon catheter according to claim 7, characterized in that, The expansion joint (123) is located on the side of the inner wall of the collapsed cavity (122) away from the bending direction of the guide (3), and the expansion joint (123) is open in its natural state. The expansion joint (123) gradually closes as the bending amplitude of the guide (3) increases.

9. A curved-tip balloon catheter according to claim 1, characterized in that, The end of the guide portion (3) is provided with a hemispherical guide head (13), and the hemispherical guide head (13) is smoothly connected to the guide portion (3); The outer diameter of the built-in tube (2) is smaller than the inner diameter of the rear external tube (4) so ​​that a feeding channel that is connected to the balloon body (1) is naturally formed between the two. The diameter of the medium channel (11) is much smaller than the outer diameter of the built-in tube (2), so that the built-in tube (2) is thick-walled, so that the built-in tube (2) will not expand when the medium flows through the medium channel (11), and at the same time, the built-in tube (2) has stronger bending resistance, thereby providing bending resistance to the rear outer tube (4).

10. A curved-tip balloon catheter according to claim 9, characterized in that, The rear outer wall of the rear external tube (4) is fixedly provided with a hyaluronic acid tube (5), and a conduit seat (7) is installed at the end of the rear external tube (4). A rubber sleeve (6) is installed between one end of the conduit seat (7) and the outer wall of the rear external tube (4). A first sealing joint (8) is integrally formed at the other end of the conduit seat (7), and a second sealing joint (9) is integrally formed at the end of the internal tube (2).

11. A manufacturing process for a curved-tip balloon catheter, used to manufacture the curved-tip balloon catheter according to any one of claims 1-10, characterized in that, Includes the following steps: S1. The built-in tube (2) is continuously extruded using a dual-cavity extrusion die. The front end is selected according to the difference of the actuation cavity (12) to form a pre-set guide part (3). S2. After the guide part (3) is formed, the cavity core shrinks and resets. At this time, continuous air blowing and pressure stabilization are carried out through the original position of the cavity core so that the rear section of the built-in tube (2) naturally forms a medium channel (11). S3. When the rear section of the built-in tube (2) is formed, a co-extrusion process is used to integrally form the balloon body (1) on the outer wall of the built-in tube (2), and the balloon body (1) is expanded outward by the negative pressure of the outer mold. S4. The rear outer tube (4) is continuously co-extruded and finally integrally formed with the inner tube (2). 12.S5. The rubber sleeve (6), the conduit seat (7), the first sealing joint (8) and the second sealing joint (9) are sequentially installed at the end of the rear outer tube (4) and the end of the inner tube (2) by the pasting process.

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