Balloon dilation catheter

Abstract

A balloon dilation catheter, comprising a catheter body (1), a first balloon (21), a second balloon (22) and a buffer structure (3). The catheter body (1) is provided with a guide wire channel (111), a first inflation channel (121) and a second inflation channel (131), which are arranged in parallel to each other, the guide wire channel (111) being configured to allow for passage of a guide wire that can guide the distal end of the catheter body (1) to move, the first inflation channel (121) being configured to inflate the first balloon (21) with fluid, and the second inflation channel (131) being configured to inflate the second balloon (22) with fluid. It is not necessary for the catheter to replace balloons of different models and different characteristics for multiple dilations, and it is also not necessary for the catheter to use a single balloon for dilation at different locations, thereby saving on the operation time and creating favorable conditions for a success of operation. The buffer structure (3) is arranged on a bending section and covers a first communication joint (101), and is configured to smooth the variation in stiffness of the proximal end of the bending section, the first communication joint (101), and the distal end of the bending section, so as to prevent the bending section from kinking.

Description

balloon dilation catheter

[0001] This application claims priority to Chinese Patent Application No. 202411479445.2, filed on October 22, 2024, entitled "Balloon Dilatation Catheter", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical device technology, specifically to balloon dilation catheters. Background Technology

[0003] Autogenous arteriovenous fistulas (AVFs) are surgically created by connecting nearby arteries and superficial veins subcutaneously, forming an artificial direct channel between the arteries and veins within the body. After a period of use, AVFs may develop complications such as calcification, stenosis, occlusion, thrombosis, infection, bleeding, aneurysmal dilatation, steal syndrome, and swollen hand. The most common complication is vascular stenosis. In clinical practice, vascular stenosis is the most common complication of AVFs and a major cause of thrombosis and eventual loss of function, thus posing a significant challenge to vascular access for hemodialysis patients. Currently, the most common solutions for stenosis are surgical intervention or percutaneous angioplasty, also known as balloon angioplasty.

[0004] Stenosis typically occurs near the arteriovenous anastomosis or puncture site. Due to the inherent structure of autogenous fistulas, both the artery and vein require dilation (and sometimes both need simultaneous dilation). Because of the differences in diameter and characteristics between arteries and veins, different types and characteristics of conventional balloons are usually used for dilation during surgery. This is expensive and time-consuming. Using a single balloon for dilation at different locations can easily lead to insufficient dilation, over-dilation damaging the vessel, and surgical failure. Most commercially available balloons are better suited to the characteristics of veins, such as high pressure and non-compliance. Their balloons and catheters require high-strength materials, making it difficult for the balloon catheter to pass through the angle at the arteriovenous anastomosis. In particular, the sudden change in hardness at the weld between the balloon and catheter makes the weld prone to kinking when the balloon passes through the angle, causing difficulty in balloon inflation. Furthermore, forcing the balloon through the angle can cause significant pain for the patient. Summary of the Invention

[0005] In view of this, this application provides a balloon dilation catheter to solve the problem of poor dilation effect of conventional single balloons and the fact that conventional balloon catheters cannot smoothly pass through the angle at the arteriovenous anastomosis due to their own structure, which makes the catheter very prone to kinking.

[0006] This application provides a balloon dilation catheter, comprising:

[0007] The tube body has guide wire channels, a first filling channel and a second filling channel arranged in parallel with each other;

[0008] A first balloon and a second balloon are spaced apart at the distal end of the tube body. The tube body has a bend between the first balloon and the second balloon. The first balloon is connected to the first inflation channel and forms a first connecting node on the bend. The second balloon is connected to the second inflation channel.

[0009] A buffer structure is provided on the curve segment and covers the first connecting node to balance the stiffness changes at the near end of the curve segment, the first connecting node, and the far end of the curve segment.

[0010] Optionally, the buffer structure includes a flexible sleeve disposed on the bend section, with one end extending distally from the first connecting node and the other end extending proximally from the first connecting node.

[0011] Optionally, the hardness of the bending section is greater than the hardness of the flexible sleeve, and the extension length of the flexible sleeve from the first connecting node to the distal end is greater than the extension length of the flexible sleeve from the first connecting node to the proximal end; the flexible sleeve is attached to the bending section.

[0012] Optionally, the buffer structure includes a hyaluronic acid tube structure or a spiral tube structure disposed in the first filling channel, one end of the hyaluronic acid tube structure or the spiral tube structure extending distally from the first connecting node, and the other end extending proximally from the first connecting node; the distal end of the hyaluronic acid tube structure or the spiral tube structure is fixedly connected to the tube body.

[0013] Optionally, the distal end of the hyaluronic acid tube structure or the spiral tube structure is positioned close to the inner side of the first filling channel.

[0014] Optionally, the buffer structure includes a plurality of reinforcing ribs disposed in the first filling channel. The plurality of reinforcing ribs are evenly disposed along the circumference of the first filling channel, with one end extending from the first connecting node to the distal end and the other end extending from the first connecting node to the proximal end; the distal end of the reinforcing rib is fixedly connected to the tube body.

[0015] Optionally, the reinforcing rib is elongated, with its inner surface being a first plane and its outer surface having a continuous serrated groove structure from the proximal end to the distal end.

[0016] Optionally, the buffer structure includes a plurality of support members disposed within the first filling channel. The plurality of support members are uniformly disposed along the circumference of the first filling channel. Each support member includes a second plane facing the first connecting node and an arcuate surface facing away from the first connecting node. The second plane is fixedly connected to the outer side of the first filling channel.

[0017] Optionally, the tube body includes an inner tube, a first inflation tube, and a second inflation tube sequentially sleeved from the inside out. The inner tube extends from the proximal end to the distal end of the tube body and has the guidewire channel. The first inflation tube extends from the proximal end to the distal end of the tube body to connect with the first inlet tube of the first balloon, forming the first communication node. The first inflation tube and the inner tube form the first inflation channel. The second inflation tube extends from the proximal end to the distal end of the tube body to connect with the second inlet tube of the second balloon. The second inflation tube and the first inflation tube form the second inflation channel. Alternatively, the tube body includes an inner tube and a first sealing edge and a second sealing edge disposed on the outer side of the inner tube. The first sealing edge and the second sealing edge are evenly divided by the same circumference. The first sealing edge extends from the proximal end to the distal end to connect with the first inlet tube of the first balloon, forming the first communication node. The second sealing edge extends from the proximal end to the distal end to connect with the inlet tube of the second balloon. The first sealing edge and the second sealing edge respectively form independent first inflation channels and second inflation channels with the outer wall of the inner tube.

[0018] Optionally, a first catheter seat is provided at the proximal end of the tube body. The first catheter seat is provided with a first guidewire cavity communicating with the guidewire channel, a first filling cavity communicating with the first filling channel, and a second filling cavity communicating with the second filling channel.

[0019] Optionally, the proximal end of the tube body is provided with a second catheter seat and a third catheter seat. The second catheter seat is provided with a third filling cavity communicating with the first filling channel and a fourth filling cavity communicating with the second filling channel. The third catheter seat is provided with a second guidewire cavity communicating with the guidewire channel.

[0020] Optionally, the proximal end of the tube body is provided with a fourth catheter seat and a fifth catheter seat. The fourth catheter seat is provided with a fifth filling cavity communicating with the first filling channel and a third guidewire cavity communicating with the guidewire channel. The fifth catheter seat is provided with a sixth filling cavity communicating with the second filling channel. Beneficial effects:

[0021] This application provides a balloon dilation catheter, comprising: a tube body, a first balloon, a second balloon, and a buffer structure.

[0022] The tube has a guidewire channel, a first filling channel and a second filling channel arranged in parallel with each other. The guidewire channel is used to allow the guidewire to pass through and guide the distal end of the tube to move. The first filling channel is used to inflate the first balloon with liquid and the second filling channel is used to inflate the second balloon with liquid.

[0023] The first and second balloons are spaced apart at the distal end of the tube body. The tube body has a bend between the first and second balloons. The first balloon is connected to the first filling channel and forms a first connecting node on the bend. The second balloon is connected to the second filling channel. The first balloon is used to support the arterial blood vessels, and the second balloon is used to support the venous blood vessels. The bend can bend at the arteriovenous anastomosis. There is a certain distance between the first and second balloons and the bend of the internal fistula. During subsequent balloon dilation, the bend of the internal fistula will not be straightened by either balloon, thus avoiding aggravating the patient's pain. Compared with the prior art, this application can fully dilate the arterial and venous blood vessels according to the structure of the arteries and veins by using the first and second balloons spaced apart on the same tube body. It is not necessary to replace balloons of different models and characteristics for dilation, nor is it necessary to use a single balloon for dilation at different locations, saving surgical time and creating favorable conditions for surgical success.

[0024] A buffer structure is installed on the bend section and covers the first connecting node to balance the hardness changes at the proximal end of the bend section, the first connecting node, and the distal end of the bend section. The first connecting node is the welding point connecting the first balloon and the catheter. The first connecting node has a relatively high hardness, and the hardness increases sharply from the proximal end to the distal end of the bend section at the first connecting node. The distal end of the bend section plays a major role in driving the bending. Conventional balloon catheters cannot effectively navigate bends. The buffer structure of this application can greatly reduce the hardness difference between the proximal and distal ends of the bend section and the first connecting node, reducing the impact of the first connecting node on the bending ability of the bend section. This allows the distal end of the bend section to smoothly drive the first connecting node to bend, thereby driving the proximal end of the bend section to bend, preventing the bend section from buckling, and ensuring that the subsequent first inflation channel can effectively inflate the first balloon with liquid. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0026] Figure 1 is a schematic diagram of the structure of the balloon dilation catheter according to Embodiment 1 of this application;

[0027] Figure 2 is a schematic diagram of the cross-sectional structure at A1-A1 in Figure 1;

[0028] Figure 3 is a reference diagram showing the usage status of the balloon dilation catheter in Figure 1;

[0029] Figure 4 is an enlarged view of point A in Figure 1;

[0030] Figure 5 is a schematic diagram of the cross-sectional structure at A2-A2 in Figure 1;

[0031] Figure 6 is a schematic diagram of the cross-sectional structure at A3-A3 in Figure 1;

[0032] Figure 7 is a schematic diagram of the buffer structure in Embodiment 2 of this application;

[0033] Figure 8 is a schematic diagram of the buffer structure in Embodiment 3 of this application;

[0034] Figure 9 is a schematic diagram of the buffer structure in Embodiment 4 of this application;

[0035] Figure 10 is a cross-sectional structural diagram of the tube at section A1-A1 in Embodiment 5 of this application;

[0036] Figure 11 is a schematic cross-sectional view of the tube at A2-A2 in Embodiment 5 of this application;

[0037] Figure 12 is a schematic diagram of the buffer structure in Embodiment 5 of this application;

[0038] Figure 13 is a schematic diagram of the catheter seat structure in Embodiment 6 of this application;

[0039] Figure 14 is a schematic diagram of the catheter seat structure in Embodiment 7 of this application.

[0040] Explanation of reference numerals in the attached drawings: 1. Tube body; 101. First connecting node; 102. Second connecting node; 103. End; 11. Inner tube; 111. Guide wire channel; 12. First filling tube; 121. First filling channel; 13. Second filling tube; 131. Second filling channel; 14. First sealing edge; 15. Second sealing edge; 21. First balloon; 211. First inlet tube; 22. Second balloon; 221. Second inlet tube; 31. Flexible sleeve; 32. Spring tube; 33. Reinforcing rib; 34. Support; 41. First catheter seat; 411. 412. First guidewire lumen; 413. First filling lumen; 414. Second filling lumen; 415. First stress relief section; 42. Second catheter seat; 421. Third filling lumen; 422. Fourth filling lumen; 423. Second stress relief section; 43. Third catheter seat; 431. Second guidewire lumen; 432. Third stress relief section; 44. Fourth catheter seat; 441. Fifth filling lumen; 442. Third guidewire lumen; 443. Fourth stress relief section; 45. Fifth catheter seat; 451. Sixth filling lumen; 452. Fifth stress relief section. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0042] Example 1

[0043] As shown in Figures 1 and 2, this embodiment provides a balloon dilation catheter, including: a tube body 1, a first balloon 21, a second balloon 22, and a buffer structure 3.

[0044] The tube body 1 has a guidewire channel 111, a first filling channel 121 and a second filling channel 131 arranged in parallel with each other. The guidewire channel 111 is used to allow the guidewire to pass through, and the guidewire can guide the distal end of the tube body 1 to move so as to guide the first balloon 21 and the second balloon 22 to the corresponding positions. The first filling channel 121 is used to inflate the first balloon 21 with liquid, and the second filling channel 131 is used to inflate the second balloon 22 with liquid.

[0045] The first balloon 21 and the second balloon 22 are spaced apart at the distal end of the tube body 1. The tube body 1 has a bend between the first balloon 21 and the second balloon 22. The first balloon 21 communicates with the first inflation channel 121 and forms a first connecting node 101 on the bend. The second balloon 22 communicates with the second inflation channel 131 and forms a second connecting node 102 on the tube body 1. The first balloon 21 is used to support arterial vessels, and the second balloon 22 is used to support venous vessels. The bend can bend at the arteriovenous anastomosis. There is a certain distance between the bend of the internal fistula and the balloon. During the subsequent balloon dilation process, the bend of the internal fistula will not be straightened by any balloon, thus avoiding aggravating the patient's pain. Compared with the prior art, this embodiment can fully dilate arterial and venous vessels according to the structure of arteries and veins by using the first balloon 21 and the second balloon 22 set at intervals on the same tube 1. There is no need to replace balloons of different models and characteristics for dilation, nor is it necessary to use a single balloon for dilation at different locations, which saves surgical time and creates favorable conditions for surgical success.

[0046] The buffer structure 3 is disposed on the bend section and covers the first connecting node 101 to balance the hardness changes of the proximal end of the bend section, the first connecting node 101, and the distal end of the bend section. The first connecting node 101 is the welding point connecting the first balloon 21 and the tube body 1. The first connecting node 101 has a relatively high hardness, and the hardness increases sharply from the proximal end to the distal end of the bend section at the first connecting node 101. The distal end of the bend section plays a major role in driving the bending. Conventional balloon catheters cannot effectively bend at the angle between the artery and vein. The buffer structure 3 in this embodiment can greatly reduce the hardness difference between the proximal and distal ends of the bend section and the first connecting node 101, reducing the influence of the first connecting node 101 on the bending ability of the bend section. This allows the distal end of the bend section to smoothly drive the first connecting node 101 to bend, thereby driving the proximal end of the bend section to bend, avoiding the bend section from buckling, and ensuring that the subsequent first filling channel 121 can effectively inflate the first balloon 21 with liquid.

[0047] The balloon dilation catheter of this embodiment can dilate arterial and venous vessels respectively through the first balloon 21 and the second balloon 22, and can also ensure that the bending section can bend smoothly through the buffer structure 3 to avoid kinking, thus ensuring the effectiveness of subsequent fluid inflation of the first balloon 21, shortening the operation time, and creating favorable conditions for the success of the operation.

[0048] In this embodiment, "proximal" and "distal" are not structural limitations of any component, but rather directional terms defined based on the distance between the medical device component and the operator. The end closer to the operator is defined as "proximal," and the end farther from the operator is defined as "distal." "Proximal" and "distal" will be used in the following text.

[0049] To more clearly illustrate the support method of the first balloon 21 and the second balloon 22 in this embodiment, as well as the bending method of the bend section, a usage reference diagram is provided as shown in Figure 3. In this diagram, the marked J indicates the vein, the marked D indicates the artery, and the marked W indicates the bend at the arteriovenous anastomosis. Under the guidance of the guidewire, the distal end of the tube 1 drives the first balloon 21 into the artery D, and the second balloon 22 stays at the corresponding position of the vein J. This avoids any component of the first balloon 21, the second balloon 22, or the bend section from straightening the bend W, thus reducing the impact of the dilation surgery on the artery and vein. During the process of the first balloon 21 entering the arterial vessel D, the buffer structure 3 can balance the stiffness of the first connecting node 101 and the proximal and distal ends of the bend, so that the distal end of the bend can smoothly drive the first connecting node and the proximal end of the bend to bend. The bending angle of the bend can be an acute angle to avoid the bend from folding, ensuring that the subsequent first filling channel 121 can fill the first balloon 21 with liquid, so that the arterial vessel D can be effectively expanded.

[0050] As shown in Figures 1, 2, and 4, in this embodiment, the tube body 1 includes an inner tube 11, a first inflation tube 12, and a second inflation tube 13, which are sequentially sleeved from the inside out. The inner tube 11 extends from the proximal end to the distal end of the tube body 1 and has a guidewire channel 111. The first inflation tube 12 extends from the proximal end to the distal end of the tube body 1 and connects to the first inlet tube 211 of the first balloon 21. The first inlet tube 211 is the balloon tube foot of the first balloon 21. The first inlet tube 211 and the first inflation tube 12 are connected... A first connecting node 101 is formed, and a first inflation channel 121 is formed between the first inflation tube 12 and the inner tube 11. The second inflation tube 13 extends from the proximal end of the tube body 1 to the distal end and connects with the second inlet tube 221 of the second balloon 22. The second inlet tube 221 is the balloon tube foot of the second balloon 22. The second inlet tube 221 and the second inflation tube 13 are connected to form a second connecting node 102, and a second inflation channel 131 is formed between the second inflation tube 13 and the first inflation tube 12. This arrangement makes the structure of the tube body 1 more compact and easier to operate.

[0051] Because the first filling tube 12 and the first inlet tube 211 of the first balloon 21 are connected by welding, the first connecting node 101 formed is too hard, which makes it impossible for the bending section to bend smoothly and easily causes the "fish mouth effect".

[0052] To address the aforementioned issues, the buffer structure 3 includes a flexible sleeve 31. The flexible sleeve 31 is positioned on the bending section, with one end extending distally from the first connecting node 101 and the other end extending proximally from the first connecting node 101. The flexible sleeve 31 can cover the first connecting node 101. The flexible sleeve 31 can be fitted onto the outer wall of the bending section for external support or inserted into the bending section for internal support. In other words, the flexible sleeve 31 covers the first inlet pipe 211, the first filling pipe 12, and the welding point between the first inlet pipe 211 and the second filling pipe 12. This arrangement allows the flexible sleeve 31 to structurally reinforce the first inlet pipe 211 and the first filling pipe 12, thereby reducing the hardness difference between the first inlet pipe 211 and the first filling pipe 12 and the first connecting node 101, balancing the hardness distribution of the bending section, and enabling the bending section to bend smoothly, greatly preventing kinking.

[0053] Since the first filling tube 12 is located between the inner tube 11 and the second filling tube 13, the first filling tube 12 itself needs to have a certain strength to overcome the liquid pressure in the first filling channel 121 and the second filling channel 131. Therefore, the mechanical strength of the first filling tube 12 is generally stronger than that of the first inlet tube 211, resulting in different hardnesses at the near end and far end of the bending section and at the first connecting node 101. Theoretically, the hardness of the first connecting node 101 > the hardness of the near end of the bending section > the hardness of the far end of the bending section, which further affects the bending performance of the bending section.

[0054] To address the aforementioned issues, as shown in Figure 4, the extension length of the flexible sleeve 31 from the first connecting node 101 to the distal end is greater than the extension length of the flexible sleeve 31 from the first connecting node 101 to the proximal end. For example, with the first connecting node 101 as the boundary, the ratio of the length dimension of the flexible sleeve 31 at the distal end to the length dimension at the proximal end is 3:2. This allows for more structural reinforcement at the distal end of the bending section where the hardness is relatively low, greatly balancing the hardness of the first connecting node 101, the hardness of the proximal end of the bending section, and the hardness of the distal end of the bending section, ensuring that no kinking occurs at any point in the bending section.

[0055] The hardness of the bending section is greater than that of the flexible sleeve 31. This is because the flexible sleeve 31 covers part of the first inlet pipe 211. If the hardness of the flexible sleeve 31 is greater than that of the first inlet pipe 211, it will cause the first inlet pipe 211 to be bent at the far end of the flexible sleeve 31. The flexible sleeve 31 can reinforce the first inlet pipe 211. Therefore, the hardness of the flexible sleeve 31 is at least less than or equal to the hardness of the first inlet pipe 211.

[0056] The flexible sheath 31 is fitted onto the bend section because, during the process of the first balloon 21 entering the artery, the distal end of the bend section plays a major guiding role, and the distal end of the bend section bends preferentially. This arrangement facilitates the gradual bending of the proximal end by the distal end of the flexible sheath 31. The inner wall of the flexible sheath 31 can be completely fitted and fixed with the outer wall of the first inlet tube 211, the outer wall of the first connecting node 101, and the outer wall of the first filling tube 12. Alternatively, the outer wall of the flexible sheath 31 can be completely fitted and fixed with the inner wall of the first inlet tube 211, the inner wall of the first connecting node 101, and the inner wall of the first filling tube 12, so as to ensure the flexibility of the flexible sheath 31, the first inlet tube 211, and the first filling tube 12 during bending.

[0057] In this embodiment, the flexible sleeve 31 can be made of flexible materials such as Pebax (polyether amide block copolymer) or TPU (thermoplastic polyurethane). The length of the flexible sleeve 31 is greater than or equal to 5 mm, and the thickness of the sidewall ranges from 0.01 mm to 0.1 mm.

[0058] As shown in Figure 1, in this embodiment, a first catheter seat 41 is provided at the proximal end of the tube body 1. The first catheter seat 41 is provided with a first guidewire cavity 411 communicating with the guidewire channel 111, a first filling cavity 412 communicating with the first filling channel 121, and a second filling cavity 413 communicating with the second filling channel 131. A first stress relief part 414 is provided at the proximal end of the first catheter seat 41.

[0059] The first guidewire cavity 411 is disposed in the axial direction of the first catheter seat 41. The first guidewire cavity 411 has a proximal opening located on the first catheter seat 41 and communicating with the guidewire channel 111, and a distal opening away from the first catheter seat 41. The guidewire can be inserted into the guidewire channel 111 through the proximal opening and the distal opening of the first guidewire cavity 411.

[0060] The first filling cavity 412 is located on one side of the first catheter seat 41 in the radial direction. It has a distal opening located within the first catheter seat 41 and communicating with the first filling channel 121, and a proximal opening away from the first catheter seat 41. The proximal opening of the first filling cavity 412 can be connected to an external filling tubing. The second filling cavity 413 is located on the other side of the first catheter seat 41 in the radial direction. It has a distal opening located within the first catheter seat 41 and communicating with the second filling channel 131, and a proximal opening away from the first catheter seat 41. The proximal opening of the second filling cavity 413 can be connected to an external filling tubing. The first filling cavity 412 and the second filling cavity 413 are located on opposite sides of the first catheter seat 41 to facilitate independent liquid filling. The first guidewire cavity 411, the first filling cavity 412, and the second filling cavity 413 are independent of each other and are all located on the first catheter seat 41, which is beneficial for operators.

[0061] Specifically, as shown in Figure 2, the inner tube 11, the first filling tube 12, and the second filling tube 13 form the sleeve structure described above. The proximal end of the inner tube 11 extends in the first catheter seat 41 to connect with the distal opening of the first guidewire lumen 411. The proximal end of the first filling tube 12 extends in the first catheter seat 41 to communicate with the first filling cavity 412. The proximal end of the second filling tube 13 extends in the first catheter seat 41 to communicate with the second filling cavity 413. For example, the first filling tube 12 extends to a position close to the first filling cavity 412. Adhesive is applied to the proximal sidewall of the first filling tube 12 and to the proximal sidewall of the inner tube 11. The distal opening of the first filling cavity 412 is located between the two, forming a [structure / structure] between the proximal end of the first filling tube 12 and the proximal end of the inner tube 11. A first sealed chamber is connected to the first filling channel 121 and the first filling cavity 412, allowing liquid in the first filling cavity 412 to enter the first filling channel 121 through the first sealed chamber; a second filling tube 13 extends to a position close to the second filling cavity 413, with adhesive at the proximal end of the second filling tube 13 and the proximal opening of the second filling cavity 413 located between the proximal end of the second filling tube 13 and the proximal end of the first filling tube 12, forming a second sealed chamber connected to the second filling channel 131 and the second filling cavity 413 between the proximal ends of the second filling tube 13 and the first filling tube 12, allowing liquid in the second filling cavity 413 to enter the second filling channel 131 through the second sealed chamber.

[0062] As shown in Figure 1, in this embodiment, the distal end of the inner tube 11 is provided with an end head 103, and the end head 103 may be provided with a spiral outer wall to facilitate the smooth movement of the end head 103.

[0063] Furthermore, arteries and veins differ in size and the nature of their stenosis differs, thus requiring balloons of different sizes and characteristics for dilation treatment. Venous stenosis is usually due to intimal hyperplasia, which is highly elastic and thickens after repeated treatments, making it even more difficult to dilate and reshape. Therefore, a high-pressure balloon is needed to tear apart the tough intimal hyperplasia. Arteries, on the other hand, are usually composed of calcified plaques. If high pressure is used forcibly to dilate them, it can easily cause intimal dissection or rupture.

[0064] As shown in the table below, the size of the second balloon 22 in this embodiment can be larger than the size of the first balloon 21. For example, the length of the first balloon 21 can be 20 mm and the diameter ranges from 2 mm to 4 mm to adapt to the structure of arterial blood vessels. The length of the second balloon 22 can be 40 mm and the diameter ranges from 4 mm to 7 mm to adapt to the structure of venous blood vessels. The expansion capacity of the second balloon 22 can be stronger than that of the first balloon 21. For example, the nominal pressure of the first balloon 21 can be 6 ATM and the nominal pressure of the second balloon 22 can be 14 ATM, thereby achieving adaptive expansion of arterial and venous blood vessels through the first balloon 21 and the second balloon 22 on the same catheter.

[0065] Figure 2 shows a cross-sectional view of section A1-A1 in Figure 1. The inner tube 11, the first filling tube 12, and the second filling tube 13 are fitted together. The guidewire channel 111 allows the guidewire to pass through. The first filling channel 121 is used to inflate the first balloon 21 with liquid, and the second filling channel 131 is used to inflate the second balloon 22 with liquid. The first filling channel 121 and the second filling channel 131 are independent of each other, which facilitates independent control of the first balloon 21 and the second balloon 22 to dilate the arterial vessel D and the venous vessel J, respectively, thereby meeting the different dilation requirements of the arterial and venous vessels. For the arterial vessel, the first balloon 21 can be inflated with a lower pressure to protect the arterial vessel from over-dilation. For the venous vessel, the second balloon 22 can be inflated with a higher pressure to ensure that the venous vessel is fully dilated.

[0066] Figure 5 shows a cross-sectional view of section A2-A2 in Figure 1, and Figure 6 shows a cross-sectional view of section A3-A3 in Figure 1.

[0067] As shown in Figure 1, in this embodiment, both the distal and proximal ends of the first balloon 21 are provided with imaging points 132. Similarly, both the distal and proximal ends of the second balloon 22 are also provided with imaging points 132, so that the operator can observe the position of the first balloon 21 and the second balloon 22 through an external imaging device.

[0068] Example 2

[0069] The composition and connection method of the tube body 1, the first balloon 21, the second balloon 22 and the first catheter hub 41 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the buffer structure 3 in this embodiment is different from the buffer structure in Embodiment 1. The buffer structure 3 in this embodiment will be described in detail below with reference to Figure 7.

[0070] As shown in Figure 7, in one embodiment of this invention, the buffer structure 3 includes a hyaluronic acid tube structure or a spiral tube structure disposed in the first filling channel. One end of the hyaluronic acid tube structure or the spiral tube structure extends distally from the first connecting node 101, and the other end extends proximally from the first connecting node 101. That is, the hyaluronic acid tube structure or the spiral tube structure covers the first inlet tube 211, the first filling tube 12, and the welding point located between the first inlet tube 211 and the first filling tube 12. This arrangement can provide internal support for the first inlet tube 211 and the first filling tube 12 through the hyaluronic acid tube structure or the spiral tube structure. When the bending section is bent, the hyaluronic acid tube structure or the spiral tube structure can increase the support force on the inner tube 11 and transfer the stress of the bending of the inner tube 11 to the first inlet tube 211 and the first filling tube 12, so that the first inlet tube 211 and the first filling tube 12 can bend with the inner tube 11, reducing the fish mouth effect caused by the difference in hardness and size.

[0071] The distal end of the hysterosaccharipheral tube structure or the spiral tube structure is fixedly connected to the tube body 1. This is because during the process of the first balloon 21 entering the arterial blood vessel, the distal end of the bend section plays a major guiding role, and the distal end of the bend section bends preferentially. This arrangement can facilitate the distal end of the hysterosaccharipheral tube structure or the spiral tube structure to gradually drive the proximal end to bend. The distal end of the hysterosaccharipheral tube structure or the spiral tube structure is fixedly connected to the inner tube 11. Other parts can be attached to the outer wall of the inner tube 11 but not fixed, so as to ensure the smoothness of the bending of the flexible sleeve 31, the first inlet tube 211 and the first filling tube 12. Alternatively, the three can be attached and fixed, depending on the actual situation.

[0072] In this embodiment, the distal end of the hyaluronic acid tube structure or the spiral tube structure is located close to the inner side of the first filling channel 121. Other parts of the hyaluronic acid tube structure or the spiral tube structure can fit into the inner tube 11. Alternatively, the distal end of the hyaluronic acid tube structure or the spiral tube structure is constricted, allowing other parts of the hyaluronic acid tube structure or the spiral tube structure to fit into the first inlet tube 211, the first connecting node 101, and the first filling tube 12. Compared to the flexible sleeve 31 in Embodiment 1, which provides structural reinforcement to the inner / outer support of the first inlet tube 211, the first connecting node 101, and the first filling tube 12, the hyaluronic acid tube structure or the spiral tube structure in this embodiment uses an internal support method to adaptively transfer the stress when the inner tube 11 bends to the first inlet tube 211, the first connecting node 101, and the first filling tube 12, thereby causing the first inlet tube 211, the first connecting node 101, and the first filling tube 12 to bend sequentially.

[0073] For example, as shown in Figure 7, the spiral tube structure can be a spring tube 32. The far end of the spring tube 32 is located close to the inner side of the first filling channel 121. The space between the outer wall of the spring tube 32 and the first inlet tube 211, the first connecting node 101 and the first filling tube 12 allows liquid to enter the first balloon 21, so that the bending section has both good bending performance and stability in filling the first balloon 21.

[0074] The sodium hypotube structure or spiral tube structure can be made of metal or non-metal materials with a certain strength, such as nickel-titanium, stainless steel, tungsten steel, PET (polyethylene terephthalate), PEEK (polyether ether ketone), polyimide, etc. The thickness of the sidewall of the sodium hypotube structure can range from 0.001 to 0.003 inches, and the sidewall can have a spiral engraved pattern. When the spiral tube structure is a spring tube 32, it can be made by winding round wire or flat wire. The diameter of the round wire can range from 0.001 to 0.003 inches, and the thickness of the flat wire can range from 0.0005 to 0.003 inches.

[0075] Example 3

[0076] The composition and connection method of the tube body 1, the first balloon 21, the second balloon 22 and the first catheter hub 41 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the buffer structure 3 in this embodiment is different from the buffer structure in Embodiment 1. The buffer structure 3 in this embodiment will be described in detail below with reference to Figure 8.

[0077] As shown in Figure 8, in this embodiment, the buffer structure includes a plurality of reinforcing ribs 33 disposed in the first filling channel 121. The plurality of reinforcing ribs 33 are uniformly disposed around the first filling channel 121, with one end extending from the first connecting node 101 to the distal end and the other end extending from the first connecting node 101 to the proximal end. That is, the plurality of reinforcing ribs 33 are uniformly disposed around the inner tube 11 and cover the first inlet tube 211, the first filling tube 12 and the welding point located between the first inlet tube 211 and the second filling tube 12. This arrangement can provide internal support for the first inlet tube 211 and the first filling tube 12 through the plurality of reinforcing ribs 33. When the bending section bends, the reinforcing ribs 33 can increase the support force on the inner tube 11 and transfer the stress of the bending of the inner tube 11 to the first inlet tube 211 and the first filling tube 12, so that the first inlet tube 211 and the first filling tube 12 can bend with the inner tube 11, reducing the fish mouth effect caused by the difference in hardness and size.

[0078] The distal end of the reinforcing rib 33 is fixedly connected to the tube body 1. This is because during the process of the first balloon 21 entering the arterial blood vessel, the distal end of the bend section has the main guiding and driving effect, and the distal end of the bend section bends preferentially. This arrangement can facilitate the distal end of the reinforcing rib 33 to gradually drive the proximal end to bend. The distal end of the reinforcing rib 33 can be attached to and fixed to the inner tube 11, while the other parts can be attached to but not fixed to the outer wall of the inner tube 11. This ensures that the reinforcing rib 33 can adaptively transfer the bending stress of the inner tube 11 to the first inlet tube 211 and the first filling tube 12, so as to ensure the flexibility of the flexible sleeve 31, the first inlet tube 211 and the first filling tube 12. It can also be attached and fixed, depending on the actual situation.

[0079] The reinforcing rib 33 is positioned close to the inner side of the first filling channel 121, thus fitting more closely to the outer wall of the inner tube 11. Compared to the flexible sleeve 31 in Embodiment 1, which provides structural reinforcement for the external support of the first inlet tube 211, the first connecting node 101, and the first filling tube 12, the reinforcing rib 33 in this embodiment uses internal support to strengthen the structural strength of the inner tube 11. This causes the inner tube 11 to bend the reinforcing rib 33, which in turn causes the first inlet tube 211, the first connecting node 101, and the first filling tube 12 to bend sequentially. The gaps between the multiple reinforcing ribs 33, as well as the gaps between the reinforcing rib 33 itself and the first inlet tube 211 and the first filling tube 12, allow liquid to smoothly enter the first balloon 21.

[0080] As shown in Figure 8, in this embodiment, the reinforcing rib 33 is elongated, and the inner surface of the reinforcing rib 33 is a first plane, which facilitates its fit with the outer wall of the inner tube 11. The outer surface has a continuous serrated groove structure from the proximal end to the distal end, which facilitates the bending of the reinforcing rib 33.

[0081] In this embodiment, at least three reinforcing ribs 33 are provided. For example, three, four, five or even more can be uniformly arranged along the circumference of the outer wall of the inner tube 11, depending on the actual situation. At least three reinforcing ribs 33 are uniformly arranged around the inner tube 11, which is beneficial for the bending section to bend smoothly in all directions. The reinforcing ribs 33 can be made of metal or non-metal materials. The thickness of the reinforcing ribs 33 in the radial direction of the bending section can be in the range of 0.001 to 0.003 inches.

[0082] Example 4

[0083] The composition and connection method of the tube body 1, the first balloon 21, the second balloon 22 and the first catheter hub 41 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the buffer structure 3 in this embodiment is different from the buffer structure in Embodiment 1. The buffer structure 3 in this embodiment will be described in detail below with reference to Figure 9.

[0084] As shown in Figure 9, in this embodiment, the buffer structure includes multiple support members 34 disposed within the first filling channel 121. The multiple support members 34 are uniformly disposed circumferentially along the first filling channel 121. Each support member 34 includes a second plane facing the first connecting node 101 and an arc-shaped surface facing away from the first connecting node 101. The second plane is fixedly connected to the outer side of the first filling channel 121. One end of the second plane extends to be fitted and fixed to the inner wall of the first inlet pipe 211, and the other end extends to be fitted and fixed to the inner wall of the first filling pipe 12. This can balance the hardness difference between the first connecting node 101 and the near and far ends of the bending section. When the inner pipe 11 bends, it can drive the first inlet pipe 211, the first connecting node 101, and the first filling pipe 12 to bend smoothly. At the same time, the arc-shaped surface of the support member 34 can also prevent the inner pipe 11 from directly folding.

[0085] In this embodiment, at least three support members 34 are provided. For example, three, four, five or even more can be uniformly provided along the circumference of the outer wall of the inner tube 11. The support members 34 can be made of metal or non-metal materials, and the structural thickness ranges from 0.001 to 0.003 inches.

[0086] Example 5

[0087] The composition and connection method of the first balloon 21, the second balloon 22 and the buffer structure 3 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the tube body 1 in this embodiment is different from the tube body 1 in Embodiment 1. The tube body 1 in this embodiment will be described in detail below with reference to Figures 10 to 12.

[0088] Figure 10 shows a cross-sectional view of section A1-A1 in this embodiment, and Figure 11 shows a cross-sectional view of section A2-A2 in this embodiment.

[0089] In this embodiment, the tube body 1 includes an inner tube 11, and a first sealing edge 14 and a second sealing edge 15 disposed on the outer side of the inner tube 11. The first sealing edge 14 and the second sealing edge 15 are evenly divided by the same circumference. The first sealing edge 14 extends from the proximal end to the distal end to connect with the first inlet tube 211 of the first balloon 21, forming a first connecting node 101. The second sealing edge 15 extends from the proximal end to the distal end to connect with the second inlet tube 221 of the second balloon 22. The first sealing edge 14 and the second sealing edge 15 respectively form an independent first filling channel 121 and a second filling channel 131 with the outer wall of the inner tube. In use, liquid can still be injected into the first balloon 21 and the second balloon 22 through the first filling channel 121 and the second filling channel 131, respectively.

[0090] As shown in Figure 12, correspondingly, there is a first sealing edge 14 on one side of the inner tube 11, the first inlet tube 211 is welded to the first sealing edge 14, and the other side of the inner tube 11 is welded to the first inlet tube 211 to seal the gap between the first inlet tube 211 of the first balloon 21 and the tube body 1.

[0091] Furthermore, the buffer structure 3 in this embodiment can be any one of Embodiment 1, Embodiment 2, Embodiment 3 and Embodiment 4. Those skilled in the art can deduce how it can be applied to the tube body 1 structure in this embodiment by referring to the above description, and it can achieve the same technical effect. It will not be repeated here.

[0092] Example 6

[0093] The composition and connection method of the tube body 1, the first balloon 21, the second balloon 22 and the buffer structure 3 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the catheter seat structure in this embodiment is different from the first catheter seat 41 in Embodiment 1. The catheter seat structure of this embodiment will be described in detail below with reference to Figure 13.

[0094] As shown in Figure 13, in this embodiment, a second catheter seat 42 and a third catheter seat 43 are provided at the proximal end of the tube body 1. The second catheter seat 42 is provided with a third filling cavity 421 communicating with the first filling channel 121 and a fourth filling cavity 422 communicating with the second filling channel 131. The second catheter seat 42 is provided with a second stress relief part 423. The third catheter seat 43 is provided with a second guidewire cavity 431 communicating with the guidewire channel 111 and a third stress relief part 432. The way the first filling tube 12 and the second filling tube 13 are connected to the second catheter seat 42 and the way they communicate with the third filling cavity 421 and the fourth filling cavity 422 can be referred to Embodiment 1, and will not be repeated here.

[0095] Example 7

[0096] The composition and connection method of the tube body 1, the first balloon 21, the second balloon 22 and the buffer structure 3 in this embodiment are exactly the same as the corresponding structure in Embodiment 1. The difference is that the catheter seat structure in this embodiment is different from the first catheter seat 41 in Embodiment 1. The catheter seat structure of this embodiment will be described in detail below with reference to Figure 14.

[0097] As shown in Figure 14, in this embodiment, a fourth catheter seat 44 and a fifth catheter seat 45 are provided at the proximal end of the tube body 1. The fourth catheter seat 44 is provided with a fifth filling cavity 441 communicating with the first filling channel 121 and a third guidewire cavity 442 communicating with the guidewire channel 111. The fourth catheter seat 44 is provided with a fourth stress relief part 443. The fifth catheter seat 45 is provided with a sixth filling cavity 451 communicating with the second filling channel 131 and a fifth stress relief part 452. The connection method between the first filling tube 12 and the inner tube 11 and the fourth catheter seat 44, as well as the communication method between them and the third guidewire cavity 442 and the fifth filling cavity 441, can be referred to in Embodiment 1. The connection method between the second filling tube 13 and the fifth catheter seat 45, as well as the communication method between them and the sixth filling cavity 451, can also be referred to in Embodiment 1, and will not be repeated here.

[0098] Although embodiments of this application have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of this application, and all such modifications and variations fall within the scope defined by the appended claims.

Claims

1. A balloon dilation catheter, characterized in that, include: The tube body (1) has guide wire channels (111), a first filling channel (121) and a second filling channel (131) arranged in parallel with each other; A first balloon (21) and a second balloon (22) are spaced apart at the distal end of the tube body (1). The tube body (1) has a bend between the first balloon (21) and the second balloon (22). The first balloon (21) is connected to the first inflation channel (121) and forms a first connecting node (101) on the bend. The second balloon (22) is connected to the second inflation channel (131). A buffer structure is provided on the bend section and covers the first connecting node (101) to balance the stiffness changes at the near end of the bend section, the first connecting node (101) and the far end of the bend section.

2. The balloon dilation catheter according to claim 1, characterized in that, The buffer structure includes a flexible sleeve (31) disposed on the bend section, with one end extending from the first connecting node (101) to the distal end and the other end extending from the first connecting node (101) to the proximal end.

3. The balloon dilation catheter according to claim 2, characterized in that, The hardness of the bending section is greater than that of the flexible sleeve (31), and the extension length of the flexible sleeve (31) from the first connecting node (101) to the distal end is greater than the extension length of the flexible sleeve (31) from the first connecting node (101) to the proximal end; the flexible sleeve (31) is attached to the bending section.

4. The balloon dilation catheter according to claim 1, characterized in that, The buffer structure includes a hysteresis tube structure or a spiral tube structure disposed in the first filling channel (121). One end of the hysteresis tube structure or the spiral tube structure extends from the first connecting node (101) to the distal end, and the other end extends from the first connecting node (101) to the proximal end. The distal end of the hysteresis tube structure or the spiral tube structure is fixedly connected to the tube body (1).

5. The balloon dilation catheter according to claim 4, characterized in that, The distal end of the hysteresis tube structure or spiral tube structure is located close to the inner side of the first filling channel (121).

6. The balloon dilation catheter according to claim 1, characterized in that, The buffer structure includes a plurality of reinforcing ribs (33) disposed in the first filling channel (121). The plurality of reinforcing ribs (33) are evenly disposed circumferentially along the first filling channel (121), with one end extending from the first connecting node (101) to the distal end and the other end extending from the first connecting node (101) to the proximal end; the distal end of the reinforcing rib (33) is fixedly connected to the tube body (1).

7. The balloon dilation catheter according to claim 6, characterized in that, The reinforcing rib (33) is long and narrow, with its inner surface being a first plane and its outer surface having a continuous serrated groove structure from the proximal end to the distal end.

8. The balloon dilation catheter according to claim 1, characterized in that, The buffer structure includes a plurality of support members (34) disposed in the first filling channel (121). The plurality of support members (34) are evenly disposed along the circumference of the first filling channel (121). Each support member (34) includes a second plane facing the first connecting node (101) and an arc-shaped surface facing away from the first connecting node (101). The second plane is fixedly connected to the outside of the first filling channel (121).

9. The balloon dilation catheter according to any one of claims 1 to 8, characterized in that, The tube body (1) includes an inner tube (11), a first inflation tube (12), and a second inflation tube (13) sequentially sleeved from the inside out. The inner tube (11) extends from the proximal end to the distal end of the tube body (1) and has the guidewire channel (111). The first inflation tube (12) extends from the proximal end to the distal end of the tube body (1) and connects with the first inlet tube (211) of the first balloon (21) to form the first connecting node (101). The first inflation channel (121) is formed between the first inflation tube (12) and the inner tube (11). The second inflation tube (13) extends from the proximal end to the distal end of the tube body (1) and connects with the second inlet tube of the second balloon (22). The second inflation channel (131) is formed between the second inflation tube (13) and the first inflation tube (12); or, The tube body (1) includes an inner tube (11) and a first sealing edge (14) and a second sealing edge (15) disposed on the outside of the inner tube (11). The first sealing edge (14) and the second sealing edge (15) are evenly divided into the same circumference. The first sealing edge (14) extends from the proximal end to the distal end to connect with the first inlet tube (211) of the first balloon (21) to form the first connecting node (101). The second sealing edge (15) extends from the proximal end to the distal end to connect with the inlet tube of the second balloon (22). The first sealing edge (14) and the second sealing edge (15) respectively form an independent first filling channel (121) and a second filling channel (131) with the outer wall of the inner tube (11).

10. The balloon dilation catheter according to any one of claims 1 to 8, characterized in that, The proximal end of the tube body (1) is provided with a first catheter seat (41), and the first catheter seat (41) is provided with a first guidewire cavity (411) communicating with the guidewire channel (111), a first filling cavity (412) communicating with the first filling channel (121), and a second filling cavity (413) communicating with the second filling channel (131).

11. The balloon dilation catheter according to any one of claims 1 to 8, characterized in that, The proximal end of the tube body (1) is provided with a second catheter seat (42) and a third catheter seat (43). The second catheter seat (42) is provided with a third filling cavity (421) communicating with the first filling channel (121) and a fourth filling cavity (422) communicating with the second filling channel (131). The third catheter seat (43) is provided with a second guidewire cavity (431) communicating with the guidewire channel (111).

12. The balloon dilation catheter according to any one of claims 1 to 8, characterized in that, The proximal end of the tube body (1) is provided with a fourth catheter seat (44) and a fifth catheter seat (45). The fourth catheter seat (44) is provided with a fifth filling cavity (441) communicating with the first filling channel (121) and a third guidewire cavity (442) communicating with the guidewire channel (111). The fifth catheter seat (45) is provided with a sixth filling cavity (451) communicating with the second filling channel (131).

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