A balloon assembly, a vertebral balloon catheter, and a method for manufacturing the balloon assembly.

Abstract

This application provides a balloon assembly and a vertebral balloon catheter. The vertebral balloon catheter includes a balloon assembly comprising an outer balloon, an inner balloon, and a radiopaque ring. The inner balloon is axially inserted through the outer balloon, with its outer sidewall conforming to the inner sidewall of the outer balloon. The radiopaque ring abuts between the outer and inner balloons. A method for manufacturing the balloon assembly includes the following steps: S10: preparing a first flexible tube and stretching it to form an outer balloon; S20: preparing a second flexible tube and stretching it to form an inner balloon; S30: placing the radiopaque ring on either the outer or inner balloon; S40: conforming the outer sidewall of the inner balloon to the inner sidewall of the outer balloon, such that the radiopaque ring abuts between the outer and inner balloons; wherein the order of steps S10, S20, S30, and S40 is not limited. This application avoids contact between the radiopaque ring and external fluids, reducing the risk of the radiopaque ring detaching.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and more specifically, relates to a balloon assembly, a vertebral balloon catheter, and a method for manufacturing the balloon assembly. Background Technology

[0002] Vertebral balloon catheters are mainly used clinically in minimally invasive surgeries such as vertebroplasty and kyphosis correction. They are instruments used to create a channel, restore vertebral height, and form a cavity for bone cement injection. They can be used on vertebrae such as the thoracic and lumbar spine. During the procedure, after successful puncture and channel establishment, the balloon of the vertebral balloon catheter is inserted into the vertebra. Pressure is applied to inflate the balloon, repositioning the collapsed vertebra and creating a cavity. After inflation, the balloon is depressurized and withdrawn from the vertebra.

[0003] A vertebral balloon catheter typically includes a balloon, a contrast ring, an outer tube, an inner tube, a pressure connector, and a sheath. The proximal ends of the outer and inner tubes are connected to the pressure connectors, respectively. The outer tube is fitted over the inner tube. The proximal end of the balloon is welded to the distal end of the outer tube, and the distal end of the balloon is welded to the proximal end of the inner tube. The contrast ring is installed on the inner tube at the position corresponding to the balloon. During use, the contrast ring is prone to detachment, which can scratch the balloon, leading to balloon and contrast failure. Summary of the Invention

[0004] The purpose of this application is to provide a balloon assembly, a vertebral balloon catheter, and a method for manufacturing the balloon assembly, so as to solve the technical problems in the prior art where the imaging ring is easy to fall off, leading to imaging failure and balloon failure.

[0005] In a first aspect, to achieve the above objectives, the technical solution adopted in this application is: to provide a balloon assembly, including an outer balloon, an inner balloon, and a radiopaque ring; the inner balloon is axially disposed through the outer balloon, the outer sidewall of the inner balloon is attached to the inner sidewall of the outer balloon, and the radiopaque ring abuts between the outer balloon and the inner balloon.

[0006] In one possible design, the imaging ring is attached to the inner wall of the outer balloon.

[0007] In one possible design, the outer balloon includes a first intermediate segment and two first connecting segments at both ends, the two first connecting segments being respectively connected to opposite ends of the first intermediate segment, the inner diameter of the first connecting segments gradually decreasing from the first intermediate segment toward the direction away from the first intermediate segment; the imaging rings are distributed and affixed to the inner sidewalls of the opposite ends of the first intermediate segment.

[0008] The beneficial effects of the balloon assembly provided in this application are as follows: The balloon assembly provided in this application provides a double-layer balloon structure formed by an outer balloon and an inner balloon, with a radiopaque ring disposed between the outer and inner balloons. The outer and inner balloons are fitted together, thereby preventing the radiopaque ring from contacting other structures or external fluids and reducing the risk of radiopaque ring detachment. Simultaneously, placing the radiopaque ring between the outer and inner balloons further improves the installation reliability of the radiopaque ring between the outer and inner balloons, reducing the risk of radiopaque ring detachment and preventing damage to the outer or inner balloons if the radiopaque ring detaches. Furthermore, by embedding the radiopaque ring between the outer and inner balloons, this application simplifies the installation and positioning of the radiopaque ring, reduces the installation difficulty, and improves the installation accuracy of the radiopaque ring.

[0009] Secondly, this application also provides a method for manufacturing a balloon assembly, comprising the following steps:

[0010] S10: Prepare the first tubing and stretch the first tubing to form the outer balloon;

[0011] S20: Prepare the second tubing and stretch the second tubing to form the inner balloon;

[0012] S30: Place the imaging ring on the outer balloon or the inner balloon;

[0013] S40: The outer sidewall of the inner balloon is attached to the inner sidewall of the outer balloon, and the imaging ring is placed between the outer balloon and the inner balloon.

[0014] The order of steps S10, S20, S30 and S40 is not limited.

[0015] In one possible design, after stretching to form the outer balloon,

[0016] First, attach the imaging ring to the inner wall of the outer balloon;

[0017] Then the second tubing is inserted through the outer balloon.

[0018] Finally, the second tubing is stretched to form the inner balloon, and the outer wall of the inner balloon is made to fit against the inner wall of the outer balloon.

[0019] In one possible design, when assembling the developing ring, UV-curable adhesive is first applied to the inner wall of the outer balloon, then the developing ring is placed on the outer balloon at the position corresponding to the UV-curable adhesive, and finally the UV-curable adhesive on the outer balloon is cured.

[0020] In one possible design, during the stretching of the second hose;

[0021] First, the second flexible tube is axially inserted through the outer balloon.

[0022] Then, one end of the second tubing and one end of the outer balloon are sealed.

[0023] Finally, the outer balloon and the second tubing are heated together, gas is added to the other end of the second tubing to make the pressure inside the second tubing reach the first pressure value, and gas is added to the other end of the outer balloon to make the pressure inside the outer balloon reach the second pressure value, until the second tubing is stretched to a preset shape;

[0024] The first pressure value is 8-15 atmospheres, and the second pressure value is 1.2-1.8 atmospheres.

[0025] In one possible design, during the stretching of the second hose, the temperature of the outer balloon and the second hose gradually increases, the first pressure value gradually increases, and the second pressure value remains unchanged.

[0026] In one possible design, the outer balloon and the inner balloon are first formed separately, then the imaging ring is attached to the outer balloon or the inner balloon, and finally the inner balloon is sleeved and attached to the outer balloon.

[0027] The beneficial effects of the balloon assembly manufacturing method provided in this application are as follows: The balloon assembly manufacturing method provided in the embodiments of this application can manufacture a double-layer balloon and place the imaging ring between the double-layer balloon, which reduces the risk of the imaging ring falling off and avoids damage to the outer or inner balloon after the imaging ring falls off.

[0028] Thirdly, this application also provides a vertebral balloon catheter, including the aforementioned balloon assembly.

[0029] The beneficial effects of the vertebral balloon catheter provided in this application are as follows: the vertebral balloon catheter provided in this application embodiment, through the above-mentioned balloon component setting, makes the fabrication of the vertebral balloon catheter simpler and the imaging accuracy higher. Attached Figure Description

[0030] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1 A cross-sectional schematic diagram of the balloon assembly provided in an embodiment of this application;

[0032] Figure 2 for Figure 1 A schematic diagram of the structure of the middle and outer layers of the balloon;

[0033] Figure 3 This is a schematic diagram of the structure after the second flexible tube is inserted into the outer balloon, as provided in an embodiment of this application.

[0034] Figure 4 A cross-sectional schematic diagram of the vertebral balloon catheter provided in an embodiment of this application;

[0035] Figure 5 for Figure 4 A magnified view of part A in the diagram;

[0036] Figure 6 for Figure 4 A magnified view of part B in the diagram.

[0037] The following are the labeling elements in the figure:

[0038] 100. Pressurization connector; 200. Balloon assembly; 210. Outer balloon; 211. First intermediate section; 212. First connecting section; 220. Inner balloon; 221. Second intermediate section; 222. Second connecting section; 230. Imaging ring; 300. Inner tube; 400. Outer tube; 500. Connector; 510. First mounting hole; 600. Locking element; 700. Outer cylinder; 710. Cylindrical section; 720. Conical section; 730. First groove; 1000. Second flexible tube. Detailed Implementation

[0039] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0040] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0041] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0042] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0043] Please see Figure 1 The balloon assembly 200 provided in the embodiments of this application will now be described. The balloon assembly 200 is used to be inserted into a human vertebra, and expands after being pressurized to reposition a collapsed vertebra and form a cavity, and can be contracted and folded to be withdrawn from the human vertebra after expansion.

[0044] The balloon assembly 200 includes an outer balloon 210, an inner balloon 220, and a radiopaque ring 230. The inner balloon 220 is axially disposed through the outer balloon 210, and the outer sidewall of the inner balloon 220 is attached to the inner sidewall of the outer balloon 210. The radiopaque ring 230 abuts between the outer balloon 210 and the inner balloon 220.

[0045] The outer balloon 210 has an axially open structure at both ends, so the inner balloon 220 can be axially inserted into the outer balloon 210. The inner balloon 220 also has an axially open structure at both ends, so that the inner balloon 220 can be fitted over the inner tube 300 of the vertebral balloon catheter.

[0046] Both the outer balloon 210 and the inner balloon 220 are elastic. When fluid is injected into the inner balloon 220, the inner balloon 220 and the outer balloon 210 will expand synchronously. When the fluid in the inner balloon 220 is removed, the inner balloon 220 and the outer balloon 210 will contract synchronously.

[0047] The balloon assembly 200 in this application forms a double-layer balloon structure with an outer balloon 210 and an inner balloon 220. A radiopaque ring 230 is disposed between the outer balloon 210 and the inner balloon 220, and the outer balloon 210 and the inner balloon 220 are fitted together, thereby preventing the radiopaque ring 230 from coming into contact with other structures or external fluids and reducing the risk of the radiopaque ring 230 falling off. At the same time, the radiopaque ring 230 abuts against the outer balloon 210 and the inner balloon 220, further improving the installation reliability of the radiopaque ring 230 between the outer balloon 210 and the inner balloon 220, reducing the risk of the radiopaque ring 230 falling off, and preventing damage to the outer balloon 210 or the inner balloon 220 if the radiopaque ring 230 falls off. Furthermore, by embedding the developing ring 230 between the outer balloon 210 and the inner balloon 220, this application simplifies the installation and positioning of the developing ring 230, reduces the installation difficulty of the developing ring 230, and improves the installation accuracy of the developing ring 230.

[0048] In one embodiment, see Figure 1 The imaging ring 230 is adhered to the inner wall of the outer balloon 210. In this embodiment, the imaging ring 230 is adhered to the outer balloon 210 by adhesive bonding, which improves the installation reliability of the imaging ring 230 between the outer balloon 210 and the inner balloon 220 and reduces the risk of the imaging ring 230 falling off.

[0049] Optionally, the radiopaque ring 230 can be adhered to the outer balloon 210 using UV-curable adhesive. It is understood that in other embodiments of this application, the radiopaque ring 230 can also be adhered to the outer balloon 210 using other adhesives. Furthermore, an axial step can be formed on the inner wall of the outer balloon 210 to limit the radiopaque ring 230.

[0050] In the embodiments of this application, since the inner balloon 220 is stretched and formed after the imaging ring 230 is installed (described in detail later), the imaging ring 230 needs to be adhered to the inner wall of the outer balloon 210 first, and then the inner balloon 220 is formed in the outer balloon 210. In other embodiments of this application, when both the outer balloon 210 and the inner balloon 220 are stretched before assembly, the imaging ring 230 can also be adhered to the outer wall of the inner balloon 220; this is not the only possible embodiment.

[0051] In one embodiment, see Figure 1 and Figure 2The outer balloon 210 includes a first intermediate section 211 and two first connecting sections 212 at both ends. The two first connecting sections 212 are respectively connected to the opposite ends of the first intermediate section 211. The inner diameter of the first connecting section 212 gradually decreases from the first intermediate section 211 away from the first intermediate section 211. Imaging rings 230 are distributed on the inner sidewalls of the opposite ends of the first intermediate section 211. The two first connecting sections 212 are used to connect the outer balloon 210 to external structures.

[0052] Similarly, the inner balloon 220 includes a second intermediate segment 221 and two second connecting segments 222 at both ends. The two second connecting segments 222 are respectively connected to opposite ends of the second intermediate segment 221, and the inner diameter of the second connecting segments 222 gradually decreases from the second intermediate segment 221 in the direction away from the second intermediate segment 221. After assembly, the first intermediate segment 211 is fitted with the second intermediate segment 221, and the two first connecting segments 212 are fitted with the two second connecting segments 222 respectively.

[0053] Please see Figure 4 and Figure 5 When the balloon assembly 200 is assembled into the vertebral balloon catheter, the balloon assembly 200 is fitted over the inner tube 300, with the second connecting section 222 spaced apart from the inner tube 300. The distal second connecting section 222 is welded to the inner tube 300, and the proximal second connecting section 222 is welded to the outer tube 400. The second intermediate section 221, the two second connecting sections 222, and the inner tube 300 together form a cavity for containing fluid. When fluid is filled into the cavity, the first intermediate section 211 and the second intermediate section 221 expand outward.

[0054] In addition, in this embodiment, two imaging rings 230 are respectively located at opposite ends of the first intermediate section 211. Since steps are formed between the first intermediate section 211 and the two first connecting sections 212, it is beneficial to limit the installation of the imaging rings 230. At the same time, the two imaging rings 230 can be used to position the two ends of the balloon assembly 200 respectively, resulting in higher positioning accuracy.

[0055] This application also provides a method for manufacturing the above-mentioned balloon assembly 200, which specifically includes the following steps:

[0056] S10: Prepare the first tubing and stretch the first tubing to form the outer balloon 210;

[0057] S20: Prepare the second tubing 1000 and stretch the second tubing 1000 to form the inner balloon 220;

[0058] S30: Place the imaging ring 230 on the outer balloon 210 or the inner balloon 220;

[0059] S40: The outer wall of the inner balloon 220 is attached to the inner wall of the outer balloon 210, and the imaging ring 230 is abutted between the outer balloon 210 and the inner balloon 220.

[0060] The order of steps S10, S20, S30 and S40 is not limited. For example, the balloon assembly 200 can be formed by performing S10, S30, S20 and S40 in sequence, or the balloon assembly 200 can be formed by performing S10, S20, S30 and S40 in sequence.

[0061] In one embodiment, the balloon assembly 200 is formed by sequentially performing steps S10, S30, S20, and S40. For details, please refer to [link to relevant documentation]. Figure 3 After stretching to form the outer balloon 210, the imaging ring 230 is first attached to the inner wall of the outer balloon 210. Then, the second flexible tube 1000 is inserted through the outer balloon 210. Finally, the second flexible tube 1000 is stretched to form the inner balloon 220, and the outer wall of the inner balloon 220 is attached to the inner wall of the outer balloon 210. In this embodiment, the outer balloon 210 is directly used as the base for stretching the inner balloon 220, so that the inner balloon 220 is directly attached to the inner wall of the outer balloon 210 after stretching, and the imaging ring 230 abuts between the outer balloon 210 and the inner balloon 220, eliminating the need for further assembly of the inner balloon 220. This not only reduces the assembly difficulty of the inner balloon 220 but also improves the tightness of the fit between the inner balloon 220 and the outer balloon 210.

[0062] In one embodiment, during the stretching of the outer balloon 210, a first flexible tube is first placed in a balloon forming mold. Then, one end of the first flexible tube is sealed, and the temperature inside the balloon mold is gradually increased while high-pressure gas is gradually introduced from the other end of the first flexible tube. The gas pressure increases with the temperature until the balloon is stretched to the desired shape. Finally, the temperature of the balloon mold is reduced by a water-cooling system outside the mold, and the outer balloon 210 is formed after cooling.

[0063] The high-pressure gas is a compressed inert gas. The high-pressure inert gas squeezes the first flexible tube, thereby gradually stretching the first flexible tube into a specific shape of the outer balloon 210, so that the outer balloon 210 has a certain degree of elasticity and can expand and contract.

[0064] Optionally, the material of the first hose can be polyurethane hose, polyvinyl chloride, polyethylene, and polyethylene terephthalate, etc.

[0065] In one embodiment, see Figure 1When assembling the developing ring 230, first apply UV-curable adhesive to the inner wall of the outer balloon 210, then place the developing ring 230 into the position corresponding to the UV-curable adhesive on the outer balloon 210, and finally cure the UV-curable adhesive on the outer balloon 210.

[0066] Please refer to Figure 3 Before cutting both ends of the outer balloon 210, the imaging ring 230 is located deep inside the outer balloon 210, and the inner diameter of the outer balloon 210 is small. Therefore, UV-curable adhesive can be applied to the inner wall of the outer balloon 210 through a pinhole.

[0067] In addition, the developing ring 230 is generally formed by winding a rectangular tantalum metal foil. Specifically, the tantalum metal foil can be wound into a ring-shaped developing ring 230 using a special clamp, and the developing ring 230 is inserted from the port of the outer spherical capsule 210 and placed at the position coated with ultraviolet curing adhesive.

[0068] Finally, the outer balloon 210 and the developing ring 230 are placed together under ultraviolet light to cure the ultraviolet curing adhesive, thereby making the developing ring 230 firmly attached to the inner wall of the outer balloon 210.

[0069] In one embodiment, see Figure 3 When stretching the second hose 1000, the second hose 1000 is first axially inserted through the outer balloon 210; then one end of the second hose 1000 and one end of the outer balloon 210 are sealed; next, the balloon forming mold is heated so that the outer balloon 210 and the second hose 1000 are heated together, and gas is added to the other end of the second hose 1000 so that the pressure inside the second hose 1000 reaches the first pressure value, and gas is added to the other end of the outer balloon 210 so that the pressure inside the outer balloon 210 reaches the second pressure value, until the second hose 1000 is stretched to the preset shape.

[0070] The first pressure value is 8-15 atmospheres, and the second pressure value is 1.2-1.8 atmospheres, with the first pressure value being greater than the second pressure value. Specifically, the first pressure value can be 8, 9, 10, 11, 12, 13, 14, or 15 atmospheres, and the second pressure value can be 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, or 1.8 atmospheres.

[0071] In this embodiment, when stretching the second flexible tube 1000, high pressure is applied not only to the second flexible tube 1000 but also low pressure is applied to the outer balloon 210. This allows the second flexible tube 1000 to be stretched on both its inner and outer sides, and it also stretches slightly during the stretching process. Simultaneously, because the pressure on the inner side of the second flexible tube 1000 is much greater than the pressure on its outer side, the second flexible tube 1000 can be stretched towards the outer balloon 210 and adhere to it. This ensures that the entire balloon assembly 200 fits tightly and expands and contracts synchronously. It also ensures that the imaging ring 230 fits tightly between the outer balloon 210 and the inner balloon 220, preventing detachment and achieving high installation accuracy.

[0072] In one embodiment, during the stretching process of the second hose 1000, the temperature of the outer balloon 210 and the second hose 1000 gradually increases, the first pressure value gradually increases, and the second pressure value remains unchanged. That is, as the temperature rises, the first pressure value inside the second hose 1000 gradually increases, so that the second hose 1000 is gradually stretched to a preset shape and the thickness is thin enough.

[0073] Specifically, once the second hose 1000 is assembled and both one end of the second hose 1000 and one end of the outer balloon 210 are sealed, the stretching of the second hose 1000 includes the following four steps:

[0074] First, heat the balloon forming mold to 66 degrees and hold for 70 seconds. At the same time, gas is introduced into the other end of the second hose 1000 so that the internal air pressure of the second hose 1000 reaches 8 atmospheres. Then, gas is added to the other end of the outer balloon 210 so that the air pressure in the outer balloon 210 reaches 1.5 atmospheres.

[0075] The second step is to continue heating the balloon forming mold to 100 degrees and hold it for 25 seconds, and continue to input gas into the second hose 1000 so that the internal air pressure of the second hose 1000 reaches 12 atmospheres, while keeping the air pressure inside the outer balloon 210 unchanged.

[0076] The third step is to continue heating the balloon forming mold to 140 degrees and hold it for 15 seconds, and continue to input gas into the second hose 1000 so that the internal air pressure of the second hose 1000 reaches 15 atmospheres, while keeping the air pressure inside the outer balloon 210 unchanged.

[0077] The fourth step is to keep the internal air pressure of the second hose 1000 and the outer balloon 210 constant, and cool the balloon molding mold to below 25 degrees Celsius to form the inner balloon 220.

[0078] The process involves three steps: first, stretching the second hose 1000 to a preset shape; second, stretching the second hose 1000 to a thinner shape; third, shaping the stretched inner balloon 220; and finally, cooling.

[0079] Optionally, the material of the second hose 1000 can be polyurethane hose, polyvinyl chloride, polyethylene, and polyethylene terephthalate, etc.

[0080] In addition, in this embodiment, in order to ensure that the outer balloon 210 and the inner balloon 220 can be completely fused, an adhesive can be used to bond the inner balloon 220 and the outer balloon 210 after the inner balloon 220 is stretched.

[0081] Please see Figure 1 After the outer balloon 210 and the inner balloon 220 are stretched, the outer balloon 210 can be cut at the outer ends of the two first connecting sections 212, and the inner balloon 220 can be cut at the outer ends of the two second connecting sections 222, so as to facilitate the subsequent installation of the balloon assembly 200.

[0082] In another embodiment of this application, the manufacturing of the balloon assembly 200 can also be performed sequentially according to steps S10, S20, S30, and S40. Specifically, the outer balloon 210 and the inner balloon 220 are first formed through steps S10 and S20, respectively, wherein the stretching method of the outer balloon 210 and the inner balloon 220 is the same as that of the outer balloon 210 in the previous embodiment. Next, the imaging ring 230 is attached to the inner sidewall of the outer balloon 210 or to the outer sidewall of the inner balloon 220 using UV-curable adhesive; finally, the inner balloon 220 and the outer balloon 210 are interlocked and pressed together, thereby ensuring that the inner balloon 220 and the outer balloon 210 are tightly fitted together, and also ensuring that the imaging ring 230 is securely installed.

[0083] Specifically, the inner balloon 220 can be pressurized together with the outer balloon 210 by inflating the inner balloon 220 with gas. Furthermore, to ensure complete fusion between the outer balloon 210 and the inner balloon 220, an adhesive can be used to bond the inner balloon 220 and the outer balloon 210 together after the inner balloon 220 has been stretched.

[0084] On the other hand, please see Figure 4This application also provides a vertebral balloon catheter, including a pressure connector 100, an inner tube 300, an outer tube 400, and a balloon assembly 200. The outer tube 400 is sleeved outside the inner tube 300, and the outer tube 400 and inner tube 300 are radially spaced apart. The proximal ends of the outer tube 400 and the inner tube 300 are respectively connected to the pressure connector 100. The distal end of the balloon assembly 200 is fixedly connected to the distal end of the inner tube 300, and the proximal end of the balloon assembly 200 is fixedly connected to the distal end of the outer tube 400. The pressure connector 100 is used to communicate with an external air source. The external air source introduces gas through the pressure connector 100 into the gap between the outer tube 400 and the inner tube 300, and the gas flows into the inner cavity of the balloon assembly 200 to inflate the balloon assembly 200.

[0085] Specifically, the second connecting segment 222 at the distal end of the inner balloon 220 is connected to the inner tube 300, and the second intermediate segment 221 of the inner balloon 220 is spaced apart from the inner tube 300. Gas can flow from the gap between the inner balloon 220 and the inner tube 300 into the inner cavity of the inner balloon 220, thereby squeezing and expanding the inner balloon 220 and the outer balloon 210 outward.

[0086] Optionally, the distal end of the balloon assembly 200 is welded to the inner tube 300, and the proximal end of the balloon assembly 200 is welded to the outer tube 400.

[0087] Optionally, the proximal end of the inner tube 300 is glued to the pressure fitting 100. The proximal end of the outer tube 400 is glued to the pressure fitting 100.

[0088] Optionally, the inner tube 300 is made of metal, which has better structural and support strength than plastic, thus providing better support for the outer tube 400 and the balloon assembly 200. This eliminates the need for support wires and support seats for installing support wires inside the inner tube 300, thereby simplifying the structure of the vertebral balloon catheter, reducing assembly difficulty, and saving structural costs while ensuring the support strength of the inner tube 300.

[0089] Optionally, the outer tube 400 is supported by a rigid plastic material, which gives the outer tube 400 a certain structural strength and prevents deformation.

[0090] In one embodiment, see Figure 4 and Figure 5The vertebral balloon catheter also includes an outer tube 700, a connector 500, and a locking element 600. The outer tube 700 is sleeved over the outer tube 400 and at least part of the balloon assembly 200; the position of the outer tube 700 along its axial direction is adjustable to adjust the exposed length of the balloon assembly 200; the connector 500 is fixedly sleeved with the pressure fitting 100, and the proximal end of the outer tube 700 is slidably connected to the connector 500; the locking element 600 can lock the outer tube 700 and the connector 500 after the position of the outer tube 700 is adjusted.

[0091] Please see Figure 5 The outer tube 700 includes a cylindrical section 710 and a conical section 720. The cylindrical section 710 is sleeved outside the outer tube 400. The proximal end of the cylindrical section 710 is connected to the connector 500. The conical section 720 is connected to the distal end of the cylindrical section 710. The inner diameter of the conical section 720 gradually decreases from the cylindrical section 710 toward the direction away from the cylindrical section 710. The end of the conical section 720 away from the cylindrical section 710 can provide pressure and limit the balloon assembly 200 around one circumference.

[0092] Specifically, the conical segment 720 is fitted over the balloon assembly 200. The minimum inner diameter of the conical segment 720 is larger than the outer diameter of the balloon assembly 200 after folding, and the maximum inner diameter of the conical segment 720 is smaller than the outer diameter of the balloon assembly 200 after inflation. When the balloon assembly 200 inflates, the end of the conical segment 720 opposite to the cylindrical segment 710 can abut against the outer circumference of the balloon assembly 200 to prevent the portion of the balloon assembly 200 located inside the conical segment 720 from inflating.

[0093] In one embodiment, see Figure 6 The connector 500 has a first mounting hole 510, and the outer cylinder 700 has a first sliding groove 730, which extends along the axial direction of the outer cylinder 700. The locking member 600 can pass through the first sliding groove 730 and the first mounting hole 510 to lock the outer cylinder 700 onto the connector 500.

[0094] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A method for manufacturing a balloon assembly, characterized in that, Includes the following steps: S10: Prepare the first tubing and stretch the first tubing to form the outer balloon; S20: Prepare the second tubing and stretch the second tubing to form the inner balloon; S30: Place the imaging ring on the outer balloon; S40: The outer sidewall of the inner balloon is attached to the inner sidewall of the outer balloon, and the imaging ring is placed between the outer balloon and the inner balloon. Both the outer and inner balloons are elastic. When fluid is injected into the inner balloon, the inner and outer balloons will expand synchronously. When the fluid is removed from the inner balloon, the inner and outer balloons will contract synchronously. The outer balloon includes a first intermediate segment and two first connecting segments at both ends. The two first connecting segments at both ends are respectively connected to the opposite ends of the first intermediate segment. The inner diameter of the first connecting segments gradually decreases from the first intermediate segment toward the direction away from the first intermediate segment. The imaging rings are respectively attached to the inner sidewalls of the opposite ends of the first intermediate segment. Specifically, after stretching to form the outer balloon, First, attach the imaging ring to the inner wall of the outer balloon; Then the second tubing is inserted through the outer balloon. Finally, the second tubing is stretched to form the inner balloon, and the outer wall of the inner balloon is made to fit against the inner wall of the outer balloon.

2. The method for manufacturing the balloon assembly as described in claim 1, characterized in that, When assembling the developing ring, first apply UV-curable adhesive to the inner wall of the outer balloon, then place the developing ring on the outer balloon at the position corresponding to the UV-curable adhesive, and finally cure the UV-curable adhesive on the outer balloon.

3. The method for manufacturing the balloon assembly as described in claim 1, characterized in that, During the second hose stretching; First, the second flexible tube is axially inserted through the outer balloon. Then, one end of the second tubing and one end of the outer balloon are sealed. Finally, the outer balloon and the second tubing are heated together, gas is added to the other end of the second tubing to make the pressure inside the second tubing reach the first pressure value, and gas is added to the other end of the outer balloon to make the pressure inside the outer balloon reach the second pressure value, until the second tubing is stretched to a preset shape; The first pressure value is 8-15 atmospheres, and the second pressure value is 1.2-1.8 atmospheres.

4. The method for manufacturing the balloon assembly as described in claim 3, characterized in that, During the stretching of the second hose, the temperature of the outer balloon and the second hose gradually increases, the first pressure value gradually increases, and the second pressure value remains unchanged.

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