Balloon catheter

Abstract

The application relates to a balloon catheter, which comprises a balloon assembly and a limiting assembly. The balloon assembly comprises a main body section, a proximal connecting section and a distal connecting section. The proximal connecting section is connected to the proximal end of the main body section, and the distal connecting section is connected to the distal end of the main body section. The diameter of the main body section gradually decreases from the proximal end to the distal end when the balloon assembly is in an inflated state. The limiting assembly is wrapped outside the balloon assembly and has a plurality of mesh holes. The limiting assembly is used to apply a radial compression force to the balloon assembly when the balloon assembly is in the inflated state, so that the main body section bulges outward to form a protruding part at positions corresponding to the plurality of mesh holes. In the axial direction of the balloon assembly, the diameter of the position corresponding to the protruding part closer to the distal connecting section is smaller than the diameter of the position corresponding to the protruding part farther away from the distal connecting section. The balloon catheter can reduce the probability of the occurrence of a tear and a dissection at the distal end of a diseased blood vessel.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon catheter. BACKGROUND

[0002] Lower extremity arterial stenosis or occlusion is a common manifestation of lower extremity arteriosclerosis obliterans. The core of the treatment for lower extremity arteriosclerosis obliterans is to restore blood flow to improve distal blood supply. Traditional treatments include surgical bypass surgery and endovascular intervention, while balloon dilation technology, as the basis of endovascular intervention, has undergone iterative upgrades from ordinary balloons to special function balloons, and has gradually become the mainstream solution. Lower extremity arteriosclerosis often presents as long segment lesions, and the diseased vessels are conical, which brings many difficulties to balloon dilation. Standard balloons have consistent diameters and are difficult to fit conical vessels. Selecting a balloon that fits the proximal end may lead to overexpansion of the distal end and increase the risk of perforation; selecting a balloon that fits the distal end may result in insufficient expansion of the proximal end and poor efficacy. When the balloon is expanded in the distal small vessels, the shear force generated by the unfolding of the balloon wings is unevenly distributed, which may result in residual stenosis or significant elastic recoil, affecting long-term patency. Endothelial tears and vessel ruptures often occur at the distal end, and blood flow reconstruction is not ideal after long lesion expansion, which can easily form a dissection or thrombus. SUMMARY

[0003] Therefore, a balloon catheter is provided to solve the problem of dissection at the distal end of the diseased vessel.

[0004] The present application provides a balloon catheter, comprising:

[0005] A balloon assembly comprising a main body segment, a proximal connecting segment and a distal connecting segment, the proximal connecting segment being connected to the proximal end of the main body segment, and the distal connecting segment being connected to the distal end of the main body segment, the diameter of the main body segment gradually decreasing from the proximal end to the distal end when the balloon assembly is in an inflated state;

[0006] A limiting assembly wrapped on the outside of the balloon assembly, the limiting assembly having a plurality of mesh holes, the limiting assembly being used to exert a radial compression force on the balloon assembly when the balloon assembly is in an inflated state, so that the main body segment bulges outward to form protrusions at positions corresponding to the plurality of mesh holes, and the diameter at the position corresponding to the protrusion closer to the distal connecting segment is smaller than the diameter at the position corresponding to the protrusion farther from the distal connecting segment along the axial direction of the balloon assembly.

[0007] In one embodiment, the number of protrusions formed circumferentially at the proximal end of the balloon catheter is greater than or equal to the number of protrusions formed circumferentially at the distal end when the balloon assembly is in an inflated state;

[0008] Or, the surface area of the protrusion formed in the circumferential direction of the proximal end of the balloon catheter is greater than or equal to the surface area of the protrusion formed in the circumferential direction of the distal end when the balloon assembly is in the inflated state.

[0009] Or, the protrusion formed in the circumferential direction of the proximal end of the balloon catheter has a protrusion height from the corresponding mesh hole that is greater than or equal to the protrusion height from the corresponding mesh hole of the protrusion formed in the circumferential direction of the distal end when the balloon assembly is in the inflated state.

[0010] In one of the embodiments, the material of the limiting assembly is a shape memory metal material.

[0011] And / or, the limiting assembly has a compressed state and an expanded state, and is capable of switching from the compressed state to the expanded state when the balloon assembly is inflated, and switching from the expanded state to the compressed state when the balloon assembly is deflated.

[0012] In one of the embodiments, the limiting assembly has an expanded position, and in the expanded position, the portion of the limiting assembly corresponding to the main body section has the same taper as the main body section of the balloon assembly, and the limiting assembly remains in the expanded position when the balloon assembly is expanded.

[0013] In one of the embodiments, the proximal end of the limiting assembly is connected to the proximal connecting section, the distal end of the limiting assembly is connected to the distal connecting section, the limiting assembly includes a telescopic section, the telescopic section covers the entire main body section, and the telescopic section can expand and form a plurality of mesh holes when the main body section expands in diameter when the balloon assembly is expanded.

[0014] In one of the embodiments, the telescopic section includes a plurality of first connecting wires and a plurality of second connecting wires, the plurality of first connecting wires are arranged at intervals in the circumferential direction of the balloon assembly, the plurality of second connecting wires are arranged around the circumferential side of the balloon assembly, and the plurality of first connecting wires and the plurality of second connecting wires intersect with each other to form a plurality of mesh holes.

[0015] In one of the embodiments, the first connecting wire includes a first section and a second section, the first section is arranged in the axial direction of the telescopic section, the second section is connected to the distal end of the first section, and the second section is arranged in a spiral around the central axis of the telescopic section, wherein the length of the second section in the axial direction of the telescopic section is greater than or equal to 1 / 2 of the axial length of the telescopic section.

[0016] In one of the embodiments, the diameter of the first connecting wire gradually decreases from the proximal end to the distal end, and the diameter of the proximal end of the first connecting wire is 0.5mm to 6mm, and the diameter of the distal end of the first connecting wire is 0.2mm to 4mm.

[0017] In one embodiment, along the axial direction of the telescopic segment, the diameter of the second connecting wire closer to the distal end is smaller than the diameter of the second connecting wire farther from the distal end.

[0018] In one embodiment, the diameter of the second connecting wire closest to the distal end of the telescopic section is 0.2 mm to 4 mm, and the diameter of the second connecting wire furthest from the distal end of the telescopic section is 0.5 mm to 6 mm.

[0019] In one embodiment, at the location corresponding to the same mesh opening, the diameter of the first connecting wire is less than or equal to the diameter of the second connecting wire.

[0020] In one embodiment, the balloon catheter further includes a catheter assembly, with both ends of the balloon assembly and both ends of the restraint assembly connected to the catheter assembly, the catheter assembly being used to inflate and deflate the balloon assembly.

[0021] In one embodiment, the proximal connecting segment includes a first cone and a first connecting portion, the first cone being connected between the main body segment and the first connecting portion; the limiting component includes a first support segment and a first fixing segment, the first support segment being connected between the first fixing segment and the telescopic segment; the first support segment is conical and corresponds to the first cone; the first fixing segment is sleeved on the outside of the first connecting portion and fixes the first connecting portion to the catheter assembly.

[0022] And / or, the distal connection segment includes a second cone and a second connection, the second cone being connected between the main body segment and the second connection, the limiting component includes a second support segment and a second fixing segment, the second support segment being connected between the second fixing segment and the telescopic segment, the second support segment being conical and corresponding to the second cone, the second fixing segment being sleeved on the outside of the second connection and fixing the second connection to the catheter assembly.

[0023] The aforementioned balloon catheter includes a balloon assembly and a restraining assembly. The restraining assembly covers the outside of the balloon assembly. Because the restraining assembly has multiple mesh openings, when the balloon assembly is inflated, the restraining assembly applies a radial gripping force to the balloon assembly, causing a portion of the balloon assembly's structure to bulge from the mesh openings and form a protrusion. Since the diameter of the protrusion closer to the distal connecting segment along the axial direction of the balloon assembly is smaller than the diameter of the protrusion farther from the distal connecting segment, the balloon catheter expands more in the proximal region with a larger diameter and less in the distal region with a smaller diameter when implanted into the diseased blood vessel, thereby reducing the probability of tearing and dissection at the distal end of the diseased blood vessel. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the balloon assembly of a balloon catheter in an inflated state according to one embodiment.

[0025] Figure 2 This is a schematic diagram of the combined structure of the balloon assembly and the restraint assembly in a balloon catheter according to one embodiment, when the balloon assembly is inflated.

[0026] Figure 3 This is a schematic diagram of the combined structure of the balloon assembly and the restraint assembly in a balloon catheter according to another embodiment, when the balloon assembly is inflated.

[0027] Figure 4 This is a schematic diagram of the combined structure of the balloon assembly and the restraint assembly in a balloon catheter in another embodiment, when the balloon assembly is inflated.

[0028] Figure 5 This is a schematic diagram of the structure of a balloon catheter according to one embodiment.

[0029] Explanation of icon numbers:

[0030] 10. Balloon assembly; 10a. Protrusion; 11. Main body segment; 12. Proximal connecting segment; 121. First cone; 122. First connecting portion; 13. Distal connecting segment; 131. Second cone; 132. Second connecting portion; 20. Restriction assembly; 20a. Mesh; 21. Telescopic segment; 211. First connecting wire; 2111. First segment; 2112. Second segment; 212. Second connecting wire; 22. First support segment; 23. First fixation segment; 24. Second support segment; 25. Second fixation segment; 30. Catheter assembly. Detailed Implementation

[0031] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0032] It should be noted that when a component is described as "fixed to" or "set on" another component, it can be directly on the other component or there may be an intervening component. When a component is described as "connected to" another component, it can be directly connected to the other component or there may be an intervening component.

[0033] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end away from the operator (such as the doctor) during the procedure, while "proximal" refers to the end closer to the operator. Axial direction refers to the direction in which the central axis of the medical device extends; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0034] Combination Figure 1 As shown, Figure 1 The structure of the balloon assembly 10 in its inflated state is shown. The balloon catheter includes the balloon assembly 10. Embodiments of this application provide a balloon catheter in which the balloon assembly 10 includes a main body segment 11, a proximal connecting segment 12, and a distal connecting segment 13. The proximal connecting segment 12 is connected to the proximal end of the main body segment 11, and the distal connecting segment 13 is connected to the distal end of the main body segment 11. When the balloon assembly 10 is inflated, the diameter of the main body segment 11 gradually decreases from the proximal end to the distal end, thus the main body segment 11 is generally conical to facilitate support for the vessel wall of a diseased blood vessel with a conical shape.

[0035] The inventors discovered that although the diameter of the main body segment 11 gradually decreases from proximal to distal, allowing the balloon assembly 10 to better fit cone-shaped lesions and conform more closely to vascular anatomy, reducing over- or under-dilation and lowering the risk of distal perforation and dissection, for vessels with long lesions, the diameter difference between the distal and proximal ends of the main body segment 11 can easily cause excessive dilation of the distal end of the vessel, leading to tearing and dissection.

[0036] Combination Figure 2 As shown, Figure 2The balloon catheter illustrating an embodiment of this application further includes a restraining component 20. The restraining component 20 covers the outer side of the balloon assembly 10. The restraining component 20 has a plurality of mesh openings 20a, which are used to apply a radial gripping force to the balloon assembly 10 when it is inflated, causing the main body segment 11 to bulge outwards at positions corresponding to the mesh openings 20a to form protrusions 10a. Along the axial direction of the balloon assembly 10, the diameter of the protrusion 10a closer to the distal connecting segment 13 is smaller than the diameter of the protrusion 10a farther from the distal connecting segment 13.

[0037] It should be noted that the balloon catheter is inserted into the diseased blood vessel while the balloon assembly 10 is in a contracted state. After the diseased blood vessel is inserted, the balloon assembly 10 is inflated by inflating it. Since the balloon assembly 10 is covered by the restricting component 20, after the balloon assembly 10 inflates to a certain extent, the part of the balloon assembly 10 restricted by the restricting component 20 (i.e., the part of the balloon assembly 10 that abuts against the structure forming the mesh 20a in the restricting component 20) will stop inflating, while the part not restricted by the restricting component 20 (i.e., the part of the balloon assembly 10 corresponding to the mesh 20a) will bulge outward from the corresponding mesh 20a position as it is inflated, forming a protrusion.

[0038] When these protrusions support the blood vessel wall, the protrusions 10a at different axial positions of the main body segment 11 exert different compressive forces on the plates on the blood vessel wall, resulting in different degrees of expansion of the blood vessel at different axial positions. Since the diameter of the protrusion 10a closer to the distal connecting segment 13 is smaller than the diameter of the protrusion 10a farther from the distal connecting segment 13, the protrusions in the distal region exert less expansion on the blood vessel, and the protrusions in the proximal region exert less expansion on the blood vessel, which helps to reduce the probability of tearing and dissection at the distal end of the blood vessel.

[0039] It should be noted that the size of the mesh 20a corresponding to the limiting component 20 can be set to be different, or the gripping force applied to different axial positions of the main body segment 11 corresponding to the limiting component 20 can be different, so that protrusions 10a of different sizes are formed at different axial positions of the main body segment 11, so as to apply different squeezing forces to the plaque on the blood vessel wall.

[0040] For example, in some embodiments, when the balloon assembly 10 is inflated, the number of protrusions 10a formed in the proximal circumferential direction of the balloon catheter is greater than or equal to the number of protrusions 10a formed in the distal circumferential direction. As another example, when the balloon assembly 10 is inflated, the surface area of ​​the protrusions 10a formed in the proximal circumferential direction of the balloon catheter is greater than or equal to the surface area of ​​the protrusions 10a formed in the distal circumferential direction. In other embodiments, when the balloon assembly 10 is inflated, the bulge height of the protrusions 10a formed in the proximal circumferential direction of the balloon catheter from the corresponding mesh 20a is greater than or equal to the bulge height of the protrusions 10a formed in the distal circumferential direction from the corresponding mesh 20a.

[0041] In some embodiments, the restraining component 20 is made of a shape-memory metal material, so that the restraining component 20 can maintain its memorized shape to facilitate a consistent gripping effect when the balloon assembly 10 is gripped. Shape-memory metal materials include, but are not limited to, nickel-titanium alloys, copper-based alloys (such as Cu-Zn-Al or Cu-Al-Ni), or iron-based alloys (such as Fe-Mn-Si).

[0042] In some embodiments, the restraining component 20 has a gripping state and an expanded state, and can switch from the gripping state to the expanded state when the balloon assembly 10 is inflated, and from the expanded state to the gripping state when the balloon assembly 10 is depressurized. Thus, when the balloon assembly 10 is in the depressurized state, the restraining component 20 is in the gripping state, resulting in both the balloon assembly 10 and the restraining component 20 having a relatively small diameter. At this time, after the restraining component 20 covers the balloon assembly 10, it can be easily inserted into a delivery sheath for delivery to the appropriate location on the diseased blood vessel for release. It should be noted that after the balloon assembly 10 and the restraining component 20 are released together into the diseased blood vessel, the balloon assembly 10 can be inflated, causing the balloon assembly 10 to expand radially and simultaneously driving the restraining component 20 to expand, thereby switching the restraining component 20 from the gripping state to the expanded state. Therefore, in this embodiment, by configuring the restraining component 20 to expand and contract with the inflation and deflation of the balloon assembly 10, the ease of implantation and subsequent support of the blood vessel wall can be improved.

[0043] It should be noted that the limiting component 20 has an expanded position, and in the expanded position, the portion of the limiting component 20 corresponding to the main body segment 11 has the same taper as the main body segment 11 of the balloon assembly 10. When the balloon assembly 10 expands, the limiting component 20 remains in the expanded position, so that when the balloon assembly 10 continues to inflate, the limiting component 20 no longer expands. Furthermore, the limiting component 20 maintains the same taper as the main body segment 11 of the balloon assembly 10, so that the limiting component 20 applies a uniform gripping effect to the balloon assembly 10, facilitating the stable outward bulging of the balloon assembly 10 at the corresponding locations of the multiple mesh openings 20a, thereby improving the stability of the protrusions 10a and providing support at the corresponding locations on the blood vessel wall.

[0044] Continue to combine Figure 2 As shown, the proximal end of the limiting component 20 is connected to the proximal connecting segment 12. The distal end of the limiting component 20 is connected to the distal connecting segment 13. The limiting component 20 includes a telescopic segment 21 that covers the entire main body segment 11. When the balloon assembly 10 expands, the telescopic segment 21 can unfold along with the diameter expansion of the main body segment 11 to form multiple mesh openings 20a. In this embodiment, the limiting component 20 forms mesh openings 20a by providing the telescopic segment 21, which not only allows the limiting component 20 to be easily held in a compressed state with the depressurized balloon assembly 10 for easy delivery, but also facilitates the expansion of the diameter of the main body segment 11 during the inflation of the balloon assembly 10, which will drive the telescopic segment 21 to unfold and form multiple mesh openings 20a, so that the balloon assembly 10 eventually bulges outward at the positions corresponding to the multiple mesh openings 20a to form protrusions 10a.

[0045] In some embodiments, the telescopic section 21 includes multiple first connecting wires 211 and multiple second connecting wires 212. The multiple first connecting wires 211 are spaced apart circumferentially around the balloon assembly 10, and the multiple second connecting wires 212 are arranged around the periphery of the balloon assembly 10, with the multiple first connecting wires 211 and the multiple second connecting wires 212 intersecting each other to form multiple mesh openings 20a. In this embodiment, since the mesh openings 20a are formed by the intersecting arrangement of the first connecting wires 211 and the second connecting wires 212, the mesh openings 20a formed are stable, facilitating the obtaining of a stable protrusion 10a.

[0046] It should be noted that in some embodiments, the number of first connecting wires 211 can be 4 to 7, for example, 4, 5, 6, or 7. The number of second connecting wires 212 can be 5 to 8, for example, 5, 6, 7, or 8. The number of first connecting wires 211 and second connecting wires 212 is not limited here. Specifically, it can be set according to the required protrusion 10a and the size of the protrusion 10a.

[0047] likeFigure 2 As shown, the first connecting wire 211 can extend from the proximal end to the distal end of the telescopic segment 21. That is, each first connecting wire 211 on the telescopic segment 21 extends from the proximal end to the distal end of the telescopic segment 21. With this structure, the overall tensile strength of the first connecting wire 211 is good, which is beneficial for dividing the balloon assembly 10 into multiple uniform parts in the circumferential direction around the main body segment 11 by multiple first connecting wires 211, thereby making the number of protrusions 10a at different positions in the axial direction of the balloon assembly 10 consistent. For example, the telescopic segment 21 includes 5 first connecting wires 211, and all 5 first connecting wires 211 extend from the proximal end to the distal end of the telescopic segment 21, so that at different positions in the axial direction of the corresponding balloon assembly 10, there will be 5 protrusions 10a separated by 5 first connecting wires 211.

[0048] Combination Figure 3 As shown, the first connecting wire 211 may not extend from the proximal end to the distal end of the telescopic segment 21. In some embodiments, the number of first connecting wires 211 between any two adjacent second connecting wires 212 is different. Thus, at different axial positions of the corresponding telescopic segment 21, the number of mesh openings 20a formed by the first connecting wires 211 and the second connecting wires 212 is different, and correspondingly, the number of protrusions 10a formed by the balloon assembly 10 corresponding to the mesh openings 20a is different. For example, in some embodiments, the number of first connecting wires 211 located at the proximal end of the telescopic segment 21 is 8. The 8 first connecting wires 211 divide the mesh openings 20a between 2 adjacent second connecting wires 212, thereby forming 8 protrusions on the balloon assembly 10 at the proximal position of the mesh openings 20a corresponding to the telescopic segment 21. For example, if there are 5 first connecting wires 211 at the far end of the telescopic section 21, then the 5 first connecting wires 211 divide 5 meshes 20a between 2 adjacent second connecting wires 212, so that the meshes 20a at the far end of the balloon assembly 10 at the corresponding telescopic section 21 protrude outward to form 5 protrusions.

[0049] Combination Figure 4 As shown, in some embodiments, the first connecting wire 211 includes a first segment 2111 and a second segment 2112. The first segment 2111 is arranged along the axial direction of the telescopic segment 21, and the second segment 2112 is connected to the distal end of the first segment 2111. The second segment 2112 is spirally wound around the central axis of the telescopic segment 21, wherein the length of the second segment 2112 in the axial direction of the corresponding telescopic segment 21 is greater than or equal to 1 / 2 of the axial length of the telescopic segment 21.

[0050] It should be noted that because the second segment 2112 is spirally coiled, the mesh 20a corresponding to the second segment 2112 is approximately rhomboid in shape when the balloon assembly 10 is inflated. This makes the distal end of the balloon catheter more flexible and easier to pass through stenotic lesions, thus minimizing damage to the blood vessels at the stenosis site. Since the first segment 2111 near the proximal end of the telescopic segment 21 extends approximately along the central axis of the telescopic segment 21, the mesh 20a corresponding to the first segment 2111 is approximately square-shaped when the balloon is inflated. This arrangement provides stronger support along the axial direction of the telescopic segment 21, thereby enhancing the axial pushability of the proximal position of the balloon catheter and preventing balloon stacking.

[0051] In some embodiments, the diameter of the first connecting wire 211 gradually decreases from proximal to distal, with the diameter at the proximal end of the first connecting wire 211 being 0.5 mm to 6 mm and the diameter at the distal end being 0.2 mm to 4 mm. Thus, the finer the diameter of the first connecting wire 211, the better its flexibility; correspondingly, the thicker the diameter of the first connecting wire 211, the better its axial support performance. Therefore, in this embodiment, setting the diameter of the first connecting wire 211 to decrease from the proximal end to the distal end of the assembly allows the distal end of the restricting component 20 to have good flexibility, facilitating passage through stenotic lesions and minimizing damage to the blood vessels at the stenosis site. Simultaneously, it allows the proximal end of the restricting component 20 to have sufficient support, enhancing the axial pushability of the proximal position of the balloon catheter to prevent balloon stacking.

[0052] In some embodiments, along the axial direction of the telescopic segment 21, the diameter of the second connecting wire 212 closer to the distal end is smaller than the diameter of the second connecting wire 212 farther from the distal end. Since the second connecting wire 212 is arranged around the periphery of the balloon assembly 10, the thinner the second connecting wire 212, the easier it is to contract at the corresponding position, and correspondingly, the smaller the radial outward expansion force. Consequently, with this structural arrangement in this embodiment, the distal end of the telescopic segment 21 is easily compressed and deformed radially; in other words, the expansion force of the distal end of the telescopic segment 21 on the blood vessel wall is small, thus reducing the likelihood of tearing the distal end of the blood vessel and causing dissection. Correspondingly, the proximal end of the telescopic segment 21 is not easily compressed and deformed radially; in other words, the expansion force of the proximal end of the telescopic segment 21 on the blood vessel wall is large, which helps to increase the support force of the protrusion 10a at the corresponding position on the proximal end of the blood vessel wall.

[0053] In some embodiments, the diameter of the second connecting wire 212 closest to the distal end of the telescopic segment 21 is 0.2 mm to 4 mm, for example, 0.2 mm, 0.3 mm, 0.9 mm, 1.3 mm, 2.5 mm, 3.3 mm, or 4 mm. The diameter of the second connecting wire 212 furthest from the distal end of the telescopic segment 21 is 0.5 mm to 6 mm, for example, 0.5 mm, 1.3 mm, 2.9 mm, 3.3 mm, 4.5 mm, 5.3 mm, or 6 mm. In this embodiment, by reasonably setting the diameters of the second connecting wires 212 at the distal and proximal ends of the telescopic segment 21, the distal end of the telescopic segment 21 is made easier to contract, thereby reducing the expansion force on the blood vessel wall, and the proximal end of the telescopic segment 21 can maintain a sufficiently large expansion force, thereby improving the stability of the protrusion 10a near the proximal end.

[0054] It should be noted that the diameters of the first connecting wire 211 and the second connecting wire 212 can be the same or different, and this is not limited here. For example, in some embodiments, at the position corresponding to the same mesh 20a, the diameter of the first connecting wire 211 is less than or equal to the diameter of the second connecting wire 212, thereby making the limiting component 20 have good flexibility in the axial direction to facilitate passing through narrow places; at the same time, the limiting component 20 has stable support in the radial direction to facilitate maintaining the stability of the protrusion 10a.

[0055] Combination Figure 5 As shown, in some embodiments, the balloon catheter further includes a catheter assembly 30, with both ends of the balloon assembly 10 and both ends of the restraining component 20 connected to the catheter assembly 30. The catheter assembly 30 is used to inflate and deflate the balloon assembly 10. In this embodiment, the catheter assembly 30 is used to inflate and deflate the balloon assembly 10 to meet the usage requirements of the balloon catheter. For example, before the balloon catheter is implanted into a blood vessel, the balloon assembly 10 can be kept in a contracted state. After the balloon assembly 10 is released to a suitable position in the blood vessel using a delivery structure such as a delivery sheath, the balloon assembly 10 is inflated through the catheter assembly 30, causing the balloon assembly 10 to bulge outward at multiple mesh openings 20a corresponding to the restraining component 20, forming protrusions 10a. These protrusions 10a apply appropriate pressure to the blood spots on the blood vessel wall, which is beneficial to the stability of the balloon assembly 10 in the blood vessel and reduces the probability of tearing and dissection at the distal end of the blood vessel.

[0056] In some embodiments, the proximal connecting segment 12 includes a first conical portion 121 and a first connecting portion 122. The first conical portion 121 is connected between the main body segment 11 and the first connecting portion 122. The limiting component 20 includes a first supporting segment 22 and a first fixing segment 23. The first supporting segment 22 is connected between the first fixing segment 23 and the telescopic segment 21. The first supporting segment 22 is conical and corresponds to the first conical portion 121. The first fixing segment 23 is sleeved on the outside of the first connecting portion 122 and fixes the first connecting portion 122 to the catheter assembly 30.

[0057] In some embodiments, the distal connection segment 13 includes a second cone portion 131 and a second connection portion 132. The second cone portion 131 is connected between the main body segment 11 and the second connection portion 132. The limiting component 20 includes a second support segment 24 and a second fixing segment 25. The second support segment 24 is connected between the second fixing segment 25 and the telescopic segment 21. The second support segment 24 is cone-shaped and corresponds to the second cone portion 131. The second fixing segment 25 is sleeved on the outside of the second connection portion 132 and fixes the second connection portion 132 to the catheter assembly 30.

[0058] In some embodiments, the catheter assembly 30 includes an outer tube, an inner tube, and connectors. The outer tube may be a three-layer composite structure. In some embodiments, the middle layer of the outer tube is made of circular braided stainless steel with a variable-density braiding pattern that gradually decreases in density from distal to proximal, with a PPI ranging from 70 to 35. The outer tube's rigidity increases from distal to proximal. This results in a more flexible distal end of the outer tube, facilitating passage over tortuous lesions, while the greater rigidity of the proximal end facilitates insertion.

[0059] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0060] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of this patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the inventive concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A balloon catheter, characterized in that, include: The balloon assembly (10) includes a main body segment (11), a proximal connecting segment (12) and a distal connecting segment (13), wherein the proximal connecting segment (12) is connected to the proximal end of the main body segment (11) and the distal connecting segment (13) is connected to the distal end of the main body segment (11). When the balloon assembly (10) is inflated, the diameter of the main body segment (11) gradually decreases from the proximal end to the distal end. A restraining component (20) covers the outside of the balloon assembly (10). The restraining component (20) has a plurality of mesh openings (20a). The restraining component (20) is used to apply a radial gripping force to the balloon assembly (10) when the balloon assembly (10) is inflated, so that the main body segment (11) protrudes outward at the positions corresponding to the plurality of mesh openings (20a) to form protrusions (10a). Along the axial direction of the balloon assembly (10), the protrusions (10a) closer to the distal connecting segment (13) are... The diameter of the position corresponding to 0a) is smaller than the diameter of the position corresponding to the protrusion (10a) which is farther away from the distal connecting segment (13); the proximal end of the limiting component (20) is connected to the proximal connecting segment (12), the distal end of the limiting component (20) is connected to the distal connecting segment (13), the limiting component (20) includes a telescopic segment (21), the telescopic segment (21) covers the entire main body segment (11), and when the balloon assembly (10) expands, the telescopic segment (21) can move with the main body segment (11). 11) The diameter expands and unfolds to form multiple mesh openings (20a). The telescopic section (21) includes multiple first connecting wires (211) and multiple second connecting wires (212). The multiple first connecting wires (211) are arranged at intervals in the circumferential direction of the balloon assembly (10), and the multiple second connecting wires (212) are arranged around the periphery of the balloon assembly (10). The multiple first connecting wires (211) and the multiple second connecting wires (212) intersect each other to form multiple mesh openings (20a). The first connecting wire (211) includes a first segment (2111) and a second segment (2112). The first segment (2111) is arranged along the axial direction of the telescopic segment (21). The second segment (2112) is connected to the distal end of the first segment (2111). The second segment (2112) is spirally coiled around the central axis of the telescopic segment (21). The length of the second segment (2112) in the axial direction corresponding to the telescopic segment (21) is greater than or equal to 1 / 2 of the axial length of the telescopic segment (21).

2. The balloon catheter according to claim 1, characterized in that, When the balloon assembly (10) is inflated, the number of protrusions (10a) formed in the proximal circumferential direction of the balloon catheter is greater than or equal to the number of protrusions (10a) formed in the distal circumferential direction. Alternatively, when the balloon assembly (10) is inflated, the surface area of ​​the protrusion (10a) formed in the proximal circumferential direction of the balloon catheter is greater than or equal to the surface area of ​​the protrusion (10a) formed in the distal circumferential direction. Alternatively, when the balloon assembly (10) is inflated, the height of the protrusion (10a) formed in the proximal circumferential direction of the balloon catheter from the corresponding mesh (20a) is greater than or equal to the height of the protrusion (10a) formed in the distal circumferential direction from the corresponding mesh (20a).

3. The balloon catheter according to claim 1 or 2, characterized in that, The material of the limiting component (20) is a shape memory metal material; And / or, the limiting component (20) has a gripping state and an expanded state, and is capable of switching from the gripping state to the expanded state when the balloon assembly (10) is inflated, and from the expanded state to the gripping state when the balloon assembly (10) is depressurized.

4. The balloon catheter according to claim 1 or 2, characterized in that, The limiting component (20) has an expanded position, and in the expanded position, the portion of the limiting component (20) corresponding to the main body segment (11) has the same taper as the main body segment (11) of the balloon assembly (10), and the limiting component (20) remains in the expanded position when the balloon assembly (10) expands.

5. The balloon catheter according to claim 1, characterized in that, The diameter of the first connecting wire (211) gradually decreases from the proximal end to the distal end, and the diameter of the first connecting wire (211) at the proximal end is 0.5 mm to 6 mm, and the diameter of the first connecting wire (211) at the distal end is 0.2 mm to 4 mm.

6. The balloon catheter according to claim 1, characterized in that, Along the axial direction of the telescopic section (21), the diameter of the second connecting wire (212) closer to the distal end is smaller than the diameter of the second connecting wire (212) farther from the distal end.

7. The balloon catheter according to claim 6, characterized in that, The diameter of the second connecting wire (212) closest to the far end of the telescopic section (21) is 0.2 mm to 4 mm, and the diameter of the second connecting wire (212) farthest from the far end of the telescopic section (21) is 0.5 mm to 6 mm.

8. The balloon catheter according to claim 1, characterized in that, At the position corresponding to the same mesh (20a), the diameter of the first connecting wire (211) is less than or equal to the diameter of the second connecting wire (212).

9. The balloon catheter according to claim 1, characterized in that, The balloon catheter also includes a catheter assembly (30), both ends of the balloon assembly (10) and both ends of the restraint assembly (20) are connected to the catheter assembly (30), and the catheter assembly (30) is used to inflate and deflate the balloon assembly (10).

10. The balloon catheter according to claim 9, characterized in that, The proximal connecting segment (12) includes a first conical portion (121) and a first connecting portion (122). The first conical portion (121) is connected between the main body segment (11) and the first connecting portion (122). The limiting component (20) includes a first supporting segment (22) and a first fixing segment (23). The first supporting segment (22) is connected between the first fixing segment (23) and the telescopic segment (21). The first supporting segment (22) is conical and corresponds to the first conical portion (121). The first fixing segment (23) is sleeved on the outside of the first connecting portion (122) and fixes the first connecting portion (122) to the catheter assembly (30).

11. The balloon catheter according to claim 9 or 10, characterized in that, The distal connection segment (13) includes a second cone (131) and a second connection (132). The second cone (131) is connected between the main body segment (11) and the second connection (132). The limiting component (20) includes a second support segment (24) and a second fixing segment (25). The second support segment (24) is connected between the second fixing segment (25) and the telescopic segment (21). The second support segment (24) is cone-shaped and corresponds to the second cone (131). The second fixing segment (25) is sleeved on the outside of the second connection (132) and fixes the second connection (132) to the catheter assembly (30).

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