Non-compliant balloon dilatation catheter

Abstract

This invention discloses a non-compliant balloon dilation catheter, relating to the field of textile manufacturing technology. It includes a balloon assembly, a catheter assembly, and a connecting assembly. The catheter assembly is connected to the balloon assembly, and the connecting assembly penetrates the interior of both the balloon and catheter assemblies. The balloon assembly comprises an inner liner, a middle layer, and an outer layer, forming a three-layer composite structure to improve the fatigue resistance of the balloon assembly. A first nitinol mesh is installed between the inner liner and the middle layer to alleviate stress concentration during high-pressure dilation of the balloon assembly. A detection module is installed between the middle layer and the outer layer. The three-layer composite structure incorporates a micro-pressure sensor embedded on the outer surface of the balloon. Through the synergistic effect of nanocomposite and microstructure, it significantly improves fatigue resistance while maintaining non-compliance, overcomes the limitations of traditional single-point pressure monitoring, and can identify the risk of asymmetric dilation of calcified lesions, reducing the incidence of vascular perforation.

Description

Technical Field

[0001] This invention relates to the field of textile production technology, specifically to a non-compliant balloon dilation catheter. Background Technology

[0002] Non-compliant balloon dilatation catheters are high-strength and rigid medical devices that use the dilating force generated by inflating a balloon to dilate narrowed or blocked blood vessels or channels to restore their normal patency. During the procedure, the doctor inserts the catheter into the patient's artery or vein and, guided by X-rays or other imaging techniques, delivers the balloon to the narrowed or blocked site. Then, by injecting pressurized fluid or gas into the balloon, it inflates, using the balloon's dilution force to compress the narrowed plaque or vessel wall, thereby widening the vessel's diameter and restoring normal blood flow. After dilation is complete, the balloon is deflated, and the catheter is removed from the patient's body.

[0003] However, existing non-compliant balloon dilation catheters have the following shortcomings:

[0004] Currently, the mainstream materials for balloon dilation catheters are polyethylene terephthalate (PET) and nylon 12. Although these materials can achieve low deformation rates, they have significant limitations. First, the high material stiffness can easily cause stress concentration in the blood vessel wall, increasing the risk of vascular injury. Second, the materials have poor fatigue resistance, affecting the lifespan of the device and clinical safety. In addition, existing monitoring technologies can only obtain the internal pressure data of the balloon through the pressure sensor in the catheter lumen, and cannot sense the actual contact pressure between the outer surface of the balloon and the blood vessel wall in real time. This monitoring blind spot can easily lead to vascular perforation due to local pressure loss at the calcified lesion site, resulting in poor safety.

[0005] Therefore, we propose a non-compliant balloon dilation catheter to address the problems mentioned above. Summary of the Invention

[0006] The purpose of this invention is to provide a non-compliant balloon dilation catheter that employs a three-layer composite structure and embeds a micro pressure sensor on the outer surface of the balloon. Through the synergistic effect of nanocomposite and microstructure, it significantly improves anti-fatigue performance while maintaining non-compliance, and overcomes the limitations of traditional single-point pressure monitoring. It can identify the risk of asymmetric dilation of calcified lesions, assist in judging the integrity of balloon-vascular wall adhesion, and reduce the incidence of vascular perforation, thereby solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a non-compliant balloon dilation catheter, comprising: a balloon assembly, a catheter assembly, and a connecting assembly, wherein the catheter assembly is connected to the balloon assembly, and the connecting assembly penetrates the interior of the balloon assembly and the catheter assembly;

[0008] The balloon assembly includes:

[0009] The inner liner, the middle layer, and the outer layer form a three-layer composite structure to improve the fatigue resistance of the balloon assembly.

[0010] The first Nitinol grid, which is installed between the inner liner and the intermediate layer, is used to alleviate stress concentration during high-pressure expansion of the balloon assembly;

[0011] The detection module, installed between the middle layer and the outer layer, is used to monitor the local pressure distribution on the surface of the balloon.

[0012] The support module, located at the proximal end of the outer layer, is used to achieve stable expansion of the balloon with zero displacement.

[0013] The detection module includes a set of miniature pressure sensors and miniature optical fibers. The miniature optical fibers are embedded in a spiral shape on the outer surface of the middle layer. All the miniature pressure sensors are electrically connected through the miniature optical fibers. A drug storage tank is provided on the outer surface of the outer layer.

[0014] Preferably, the catheter assembly includes an inner tube, a middle tube, and an outer tube, which form a three-layer composite structure to improve the fatigue resistance of the catheter assembly. A second nitinol mesh is installed between the inner tube and the middle tube.

[0015] Preferably, the connecting component includes a connector, the output end of which is connected to a guide tube, and the output end of the connector is provided with a liquid inlet. Both the connector and the guide tube have interconnected liquid inlet channels, and the liquid inlet channels are connected to the liquid inlet. The top of the connector is provided with a light guide end and an observation end. Both the connector and the guide tube have interconnected light guide channels and interconnected observation channels, and the light guide channels and observation channels are connected to the light guide end and the observation end, respectively. Optical fibers are inserted into the light guide channels and the observation channels, respectively.

[0016] Preferably, a detection end is provided on one side of the outer wall of the connector, and a detection channel is provided inside the connector, and the detection channel is connected to the detection end.

[0017] Preferably, a heating end is provided on the other side of the outer wall of the connector, and a heating channel is provided inside the connector, and the heating channel is connected to the heating end.

[0018] Preferably, the support module includes a heat-conducting plate, a shape memory anchoring claw is provided on one side of the outer wall of the heat-conducting plate, and neodymium iron boron magnets are arranged in a ring array at the far end of the middle layer.

[0019] Preferably, the inner liner, the middle layer, and the outer layer are interconnected with the inner tube, the middle tube, and the outer tube, and the first Nitinol grid is connected to the second Nitinol grid.

[0020] Preferably, the guide tube passes through the inner liner and one end of the outer wall of the inner tube, and a guide head is sleeved on one end of the outer wall of the guide tube, and one side of the outer wall of the guide head is connected to the inner liner, the intermediate layer and the outer layer.

[0021] Preferably, the bottom of the guide tube has a liquid outlet, and the outer wall of the guide tube is provided with two radiopaque marks, and the liquid outlet and the two radiopaque marks are both located inside the inner liner.

[0022] Preferably, the micro optical fiber passes between the intermediate tube and the outer tube, is inserted into the detection channel, and is electrically connected to the detection end; the guide wire of the heat-conducting plate passes between the intermediate tube and the outer tube, is inserted into the heating channel, and is electrically connected to the heating end.

[0023] Compared with the prior art, the beneficial effects of the present invention are:

[0024] In this invention, a three-layer composite balloon assembly significantly improves the balloon's fatigue resistance. The outer layer uses a heparin-modified polyurethane-based self-lubricating hydrogel coating. This coating, with its unique hydrophilic properties, greatly reduces resistance during catheter advancement, making catheter delivery within the blood vessel smoother. Simultaneously, the heparin modification effectively inhibits thrombus formation, reducing the risk of postoperative thrombosis-related complications from the source. The middle layer uses high-density polyethylene, which possesses excellent rigidity and stability, providing robust structural support for the balloon. The inner layer utilizes 3D electrospinning technology to directionally align silicon carbide nanowires, constructing a radial tensile-resistant network structure. This structure endows the balloon with high non-compliance, ensuring precise targeting of the lesion site during expansion, maintaining a stable expansion shape, and avoiding damage to surrounding normal tissues due to over-expansion. This provides a basis for further improvement. The reliability of the balloon assembly is ensured by embedding a nitinol mesh between the inner and middle layers of the balloon. Nitinol material has excellent shape memory properties and superelasticity, which can effectively alleviate stress concentration caused by high-pressure balloon expansion, prevent local rupture or damage due to excessive stress, extend the life of the balloon, and improve the safety of surgical procedures. In addition, the matching detection module is equipped with a micro-sensor array. This array breaks through the limitations of traditional single-point pressure monitoring and can comprehensively monitor the local pressure distribution on the balloon surface. When dealing with calcified lesions, it can accurately identify the risk of asymmetric expansion, helping doctors to predict surgical risks in advance and formulate more reasonable surgical plans. At the same time, this monitoring system can also help doctors judge the integrity of the balloon's adhesion to the blood vessel wall, ensuring that the balloon can adhere tightly to the blood vessel wall after expansion, reducing the probability of complications such as vascular dissection, and providing a strong guarantee for the successful implementation of the surgery.

[0025] 2. In this invention, by using a support module in conjunction with neodymium iron boron magnets, the precision and stability of catheter manipulation are further improved. The support module integrates a miniature neodymium iron boron magnet array. These magnets possess high magnetic energy levels and good biocompatibility, and can generate precise magnetic coupling with an external magnetic field generator under X-ray fluoroscopy. During the procedure, the surgeon manipulates the external magnetic field generator, using magnetic navigation principles to guide the catheter in three-dimensional space, enabling the balloon to quickly and accurately reach the lesion site. This significantly shortens the surgical positioning time and reduces the risk of vascular damage caused by repeated adjustments. Once the catheter reaches the target position, the shape memory anchoring claws inside the balloon... Instant activation: The anchoring claw, made of nickel-titanium alloy, is temperature-triggered by a micro-resistance heating device inside the balloon (with a precisely set phase transition temperature of 40℃). The anchoring claw rapidly expands and embeds itself into the blood vessel wall at a safe depth of <100μm, forming a multi-point mechanical anchoring structure. This design effectively overcomes the "watermelon seed effect" (i.e., axial slippage) caused by uneven force during high-pressure balloon expansion in traditional balloons. Especially for complex lesions such as severe calcification and angulation, it can achieve stable expansion with zero displacement, ensuring that the balloon expansion force is applied evenly and precisely to the lesion area, avoiding under-expansion or over-expansion caused by balloon slippage, and significantly improving the surgical treatment effect and safety.

[0026] 3. In this invention, a multifunctional connecting component is set up. Its mounting head adopts a standardized threaded interface design. With the threaded interlocking structure, it can achieve quick and stable connection and disassembly of various pipelines, significantly improving the assembly efficiency of surgical instruments and reducing surgical preparation time. The component integrates a dual optical path system of optical fiber and observation optical fiber. The optical fiber end is connected to a specially cooled lamp head. This cooled lamp adopts low-heat, high-brightness LED light source technology. When the light is transmitted through the optical fiber, it can illuminate the inside of the blood vessel with uniform and soft brightness, avoiding damage to blood vessel tissue caused by heat generation of traditional light sources. The observation end is equipped with a high-resolution miniature camera. The camera is connected to an external high-definition display device through a dedicated data interface. Utilizing the image transmission performance of the observation optical fiber, the real-time image inside the blood vessel is transmitted to the external display device, providing the surgeon with clear and intuitive images of the inside of the blood vessel. This allows the surgeon to observe the morphology, location, and relationship with surrounding tissues of the lesion site in real time and accurately, thereby formulating a more precise surgical strategy and greatly improving the accuracy and safety of the surgical operation. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the main structure of a non-compliant balloon dilation catheter according to the present invention;

[0028] Figure 2 This is a cross-sectional schematic diagram of a non-compliant balloon dilation catheter according to the present invention;

[0029] Figure 3This is a cross-sectional schematic diagram of the balloon assembly in a non-compliant balloon dilation catheter according to the present invention;

[0030] Figure 4 This is a schematic diagram of the balloon assembly portion of a non-compliant balloon dilation catheter according to the present invention;

[0031] Figure 5 This is an enlarged structural schematic diagram of a non-compliant balloon dilation catheter according to the present invention;

[0032] Figure 6 This is an enlarged structural schematic diagram of a non-compliant balloon dilation catheter according to the present invention (Figure B).

[0033] Figure 7 This is a schematic diagram of the detection module in a non-compliant balloon dilation catheter according to the present invention;

[0034] Figure 8 This is a schematic diagram of the catheter assembly portion of a non-compliant balloon dilation catheter according to the present invention;

[0035] Figure 9 This is a schematic diagram of the connecting assembly in a non-compliant balloon dilation catheter according to the present invention;

[0036] Figure 10 This is an enlarged structural schematic diagram of a non-compliant balloon dilation catheter according to the present invention (Figure C).

[0037] Figure 11 This is a schematic diagram of the side-thrown connecting component in a non-compliant balloon dilation catheter according to the present invention;

[0038] Figure 12 This is a schematic diagram of the side-thrown connecting component in a non-compliant balloon dilation catheter according to the present invention.

[0039] In the diagram: 100, balloon assembly; 101, inner liner; 102, intermediate layer; 103, outer layer; 104, first Nitino mesh; 105, detection module; 1051, miniature pressure sensor; 1052, miniature optical fiber; 106, support module; 1061, heat-conducting plate; 1062, shape memory anchoring claw; 107, neodymium iron boron magnet; 108, drug reservoir; 200, catheter assembly; 201, inner tube; 202, intermediate tube; 203, outer tube; 204. Second Nitinol mesh; 300, Connecting assembly; 301, Connector; 302, Guide tube; 303, Liquid inlet end; 304, Liquid inlet channel; 305, Light guide end; 306, Light guide channel; 307, Light guide fiber; 308, Observation end; 309, Observation channel; 310, Observation fiber; 311, Detection end; 312, Detection channel; 313, Heating end; 314, Heating channel; 315, Liquid outlet; 316, Non-transmissive marking; 317, Guide head. Detailed Implementation

[0040] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] Example 1, as Figure 1 and Figure 2 As shown: A non-compliant balloon dilation catheter includes a balloon assembly 100, a catheter assembly 200 and a connecting assembly 300, wherein the catheter assembly 200 is connected to the balloon assembly 100 and the connecting assembly 300 passes through the interior of the balloon assembly 100 and the catheter assembly 200.

[0042] like Figure 4 and Figure 5 As shown: The balloon assembly 100 includes:

[0043] The inner liner 101, the middle layer 102, and the outer layer 103 form a three-layer composite structure to improve the fatigue resistance of the balloon assembly 100.

[0044] like Figure 3 As shown: The first Nitino mesh 104 is installed between the inner liner 101 and the intermediate layer 102 to alleviate stress concentration during high-pressure expansion of the balloon assembly 100;

[0045] like Figure 6 and Figure 7 As shown: Detection module 105, which is installed between the middle layer 102 and the outer layer 103, is used to monitor the local pressure distribution on the surface of the balloon;

[0046] The detection module 105 includes a set of miniature pressure sensors 1051 and miniature optical fibers 1052. The miniature optical fibers 1052 are embedded in a spiral shape on the outer surface of the intermediate layer 102. The set of miniature pressure sensors 1051 are all electrically connected through the miniature optical fibers 1052. A drug storage tank 108 is provided on the outer surface of the outer layer 103.

[0047] In this embodiment, the outer layer 103 is made of polyurethane-based self-lubricating hydrogel coating material. Utilizing the hydrophilicity of the hydrogel, a water film lubrication layer is formed when it comes into contact with the inner wall of the blood vessel, significantly reducing friction during the pushing process and allowing the balloon to reach the lesion site more smoothly. At the same time, heparin, as an anticoagulant, can inhibit the activation of coagulation factors in the blood, effectively preventing thrombus formation on the balloon surface. The middle layer 102 is made of high-density polyethylene material. With its high rigidity and structural stability, it provides a basic support frame for the balloon, resisting external pressure and maintaining the balloon shape. The inner liner 101 uses 3D electrospinning technology to orient silicon carbide nanowires to form a radial tensile-resistant network structure. When the balloon is inflated, this network structure restricts excessive radial deformation of the balloon, ensuring that the balloon maintains non-compliance and allowing the expansion force to be concentrated on the lesion site for precise expansion. The three-layer structure works together to improve the fatigue resistance of the balloon assembly 100 and extend its service life from three aspects: lubrication, support, and shape control.

[0048] Nickel-Titanium has shape memory effect and superelasticity. During the high-pressure expansion of the balloon assembly 100, when the balloon is subjected to the reaction force of the blood vessel wall, stress concentration will occur, especially at the curved parts of the balloon or the irregular contact points at the lesion site. The first nickel-Titanium mesh 104 is installed between the inner bladder 101 and the intermediate layer 102. With its own superelasticity, it can absorb and disperse these concentrated stresses through elastic deformation, and distribute the stress evenly to the overall structure of the balloon. This avoids excessive local stress that may cause the balloon to rupture or material damage, thereby ensuring the structural integrity and safety of the balloon during repeated high-pressure expansion.

[0049] The 1051 miniature pressure sensor is a ZXPA invasive pressure sensor independently developed and manufactured by Zhixin Sensing for use in minimally invasive medical fields. Measuring only 650μm × 220μm × 75μm, the miniature pressure sensors 1051 are arrayed on the balloon surface, enabling real-time acquisition of local pressure data at the contact point between the balloon and the blood vessel wall. Each miniature pressure sensor 1051 converts the pressure signal into an electrical signal, which is transmitted through a spiral-shaped micro-optical fiber 1052 tightly embedded in the outer surface of the intermediate layer 102. The micro-optical fiber 1052 not only has advantages such as low signal transmission loss and strong anti-electromagnetic interference capability, but its spiral layout can also adapt to the morphological changes of the balloon during expansion and contraction, ensuring the stability of signal transmission. The pressure data transmitted to the external control device is analyzed and processed by a dedicated algorithm to identify whether the pressure distribution on the balloon surface is uniform, determine the risk of asymmetric expansion due to calcification lesions, and simultaneously assist in assessing the integrity of the balloon's adhesion to the blood vessel wall, providing crucial information for doctors to adjust surgical strategies.

[0050] The drug reservoir 108 on the outer surface of the outer layer 103 can be pre-loaded with the necessary medications, such as antithrombotic drugs and vasodilators, before surgery. After the balloon reaches the lesion site and completes dilation, a certain pressure is applied to the balloon through the drug delivery channel of the connecting component 300, causing a slight deformation on the surface of the balloon and squeezing the drug reservoir 108 to release the stored medication to the lesion site on the blood vessel wall. This localized and precise drug delivery method can increase the concentration of the drug at the lesion site, enhance the therapeutic effect, and at the same time reduce the amount of drug used in the systemic blood circulation, thus reducing drug side effects.

[0051] Example 2, as Figure 6 As shown, the support module 106 is installed at the proximal end of the outer layer 103 to achieve stable expansion of the balloon with zero displacement.

[0052] like Figure 1 , Figure 2 as well as Figure 8 As shown: The conduit assembly 200 includes an inner tube 201, an intermediate tube 202, and an outer tube 203. The inner tube 201, intermediate tube 202, and outer tube 203 form a three-layer composite structure to improve the fatigue resistance of the conduit assembly 200. A second Nitinol mesh 204 is installed between the inner tube 201 and the intermediate tube 202. The inner liner 101, the intermediate layer 102, and the outer layer 103 are interconnected with the inner tube 201, the intermediate tube 202, and the outer tube 203, respectively. The first Nitinol mesh 104 is connected to the second Nitinol mesh 204. The guide tube 302 passes through one end of the outer wall of the inner liner 101 and the inner tube 201, and a guide head 317 is sleeved on one end of the outer wall of the guide tube 302. One side of the outer wall of the guide head 317 is connected to the inner liner 101, the intermediate layer 102, and the outer tube 103.

[0053] like Figure 6 As shown: The support module 106 includes a heat-conducting plate 1061, a shape memory anchoring claw 1062 is provided on one side of the outer wall of the heat-conducting plate 1061, and neodymium iron boron magnets 107 are arranged in a ring array at the far end of the intermediate layer 102.

[0054] In this embodiment, the neodymium iron boron magnets 107 distributed in a ring array at the distal end of the intermediate layer 102 generate a gradient magnetic field under X-ray fluoroscopy guidance. By precisely controlling the magnetic field strength and direction, three-dimensional spatial navigation of the balloon assembly 100 is achieved. When the balloon approaches the lesion site, the distal neodymium iron boron magnets 107 first generate magnetic coupling with the external magnetic field, providing initial positioning guidance. As the balloon gets closer to the target, the magnets in the support module 106 play a dominant role, achieving millimeter-level precise positioning.

[0055] Once the balloon reaches the target position, the heat generated by the micro-resistance heating wire within the connecting component 300 is rapidly and evenly transferred to the shape memory anchoring claw 1062 via the heat-conducting plate 1061. The shape memory anchoring claw 1062 is made of nickel-titanium alloy, and its phase transition temperature is precisely controlled at 40℃. When the temperature reaches the phase transition point, the anchoring claw rapidly transforms from its initial contracted state to a preset deployed shape, embedding itself into the blood vessel wall at a safe depth of <100μm. The tip of each anchoring claw adopts a special serrated design, ensuring embedding stability while avoiding excessive damage to the blood vessel wall. After deployment, the anchoring claw forms a 360° annular support structure, which can withstand expansion pressures of up to 8 atm without displacement, effectively solving the problem of axial sliding of traditional balloons under high pressure.

[0056] Example 3, as Figures 9-12 As shown, the connection assembly 300 includes a connector 301, the output end of which is connected to a guide tube 302, and the output end of the connector 301 is provided with a liquid inlet 303. Both the connector 301 and the guide tube 302 have interconnected liquid inlet channels 304, which are connected to the liquid inlet 303. The top of the connector 301 is respectively provided with a light guide end 305 and an observation end 308. Both the connector 301 and the guide tube 302 have interconnected light guide channels 306 and interconnected observation channels 309. 306 and observation channel 309 are respectively connected to light guide end 305 and observation end 308. Light guide fiber 307 and observation fiber 310 are respectively inserted into the light guide channel 306 and observation channel 309. A detection end 311 is provided on one side of the outer wall of connector 301. A detection channel 312 is opened inside connector 301 and is connected to detection end 311. A heating end 313 is provided on the other side of the outer wall of connector 301. A heating channel 314 is opened inside connector 301 and is connected to heating end 313.

[0057] like Figure 11 As shown: The bottom of the guide tube 302 is provided with a liquid outlet 315, and the outer wall of the guide tube 302 is provided with two non-transparent markings 316, and the liquid outlet 315 and the two non-transparent markings 316 are both located inside the inner liner 101.

[0058] The micro optical fiber 1052 passes between the intermediate tube 202 and the outer tube 203 and is inserted into the detection channel 312 and electrically connected to the detection end 311. The guide wire of the heat-conducting plate 1061 passes between the intermediate tube 202 and the outer tube 203 and is inserted into the heating channel 314 and electrically connected to the heating end 313.

[0059] In this embodiment, the inlet end 303 is used to connect to an external pressure device. During the operation, the operator injects the contrast agent through the inlet end 303. The liquid is transmitted through the inlet channel 304, which is interconnected with the connector 301 and the guide tube 302, and finally discharged from the outlet 315 at the bottom of the guide tube 302. The outlet 315 is precisely set inside the inner liner 101, which can directly deliver the liquid to the vicinity of the balloon. On the one hand, when the contrast agent is injected, the morphology of blood vessels and the position of the balloon can be clearly displayed under X-ray or other imaging equipment to assist the doctor in positioning. On the other hand, injecting saline or other liquids can provide a medium for balloon inflation and ensure that the balloon expansion process is smooth.

[0060] The light guide end 305 is connected to an external cold lamp light source device. The light emitted by the light source enters the light guide channel 306 and is transmitted by the light guide fiber 307 inserted therein. The light guide fiber 307 has high light transmittance characteristics and can transmit light to the front end of the balloon, uniformly illuminating the inside of the blood vessel and providing sufficient illumination for observation. The observation end 308 is connected to a miniature camera. The observation fiber 310 transmits the optical image inside the blood vessel from the front end of the balloon through the observation channel 309 to the observation end 308. The transmitted image signal is converted and displayed on an external display screen. Doctors can observe the lesion inside the blood vessel and the adhesion between the balloon and the blood vessel wall in real time and clearly through the display screen, so as to perform surgical operations more accurately, such as adjusting the position of the balloon and judging the degree of dilation.

[0061] The heating end 313 is connected to an external power supply and temperature control device. When the balloon reaches the lesion location and the shape memory anchoring claw 1062 needs to be activated, the operator sets the heating parameters through the external device. The current enters the heat-conducting wire located in the heating channel 314 through the heating end 313, and then is conducted to the heat-conducting plate 1061. The heat-conducting plate 1061 evenly transfers the heat to the shape memory anchoring claw 1062. When the temperature reaches the 40°C trigger temperature, the shape memory anchoring claw 1062 undergoes a phase change, unfolds from the contracted state and embeds into the blood vessel wall, realizing the stable expansion of the balloon with zero displacement.

[0062] The two radiopaque markers 316 on the outer wall of the guide tube 302 are made of a high atomic number alloy material and have strong imaging properties under X-ray or other imaging equipment. During the operation, the doctor can accurately determine the specific location of the guide tube 302 and balloon assembly 100 in the blood vessel by observing the position of the radiopaque markers 316 in the image. This provides a precise spatial positioning reference for the operation, avoids the surgical risks caused by misjudgment of position, and ensures that the balloon accurately reaches the lesion site for dilation treatment.

[0063] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A non-compliant balloon dilation catheter, characterized in that, include: The balloon assembly (100), the catheter assembly (200), and the connecting assembly (300) are connected to the balloon assembly (100), and the connecting assembly (300) passes through the interior of the balloon assembly (100) and the catheter assembly (200). The balloon assembly (100) includes: The inner liner (101), the middle layer (102), and the outer layer (103) form a three-layer composite structure to improve the fatigue resistance of the balloon assembly (100); The first Nitinol mesh (104) is installed between the inner liner (101) and the intermediate layer (102) to alleviate stress concentration during high-pressure expansion of the balloon assembly (100); The detection module (105) is installed between the intermediate layer (102) and the outer layer (103) to monitor the local pressure distribution on the surface of the balloon. The support module (106) is installed at the proximal end of the outer layer (103) to achieve stable expansion of the balloon with zero displacement; The detection module (105) includes a set of miniature pressure sensors (1051) and miniature optical fibers (1052). The miniature optical fibers (1052) are embedded in the outer surface of the intermediate layer (102) in a spiral shape. All of the miniature pressure sensors (1051) are electrically connected through the miniature optical fibers (1052). The outer surface of the outer layer (103) is provided with a drug storage tank (108). The connection component (300) includes a connector (301); A heating end (313) is provided on the other side of the outer wall of the connector (301), and a heating channel (314) is provided inside the connector (301), and the heating channel (314) is connected to the heating end (313); The support module (106) includes a heat-conducting plate (1061), and a shape memory anchoring claw (1062) is provided on one side of the outer wall of the heat-conducting plate (1061). The distal end of the intermediate layer (102) is arranged with neodymium iron boron magnets (107). The micro optical fiber (1052) passes between the intermediate tube (202) and the outer tube (203), and is inserted into the detection channel (312) and electrically connected to the detection end (311). The guide wire of the heat-conducting plate (1061) passes between the intermediate tube (202) and the outer tube (203), and is inserted into the heating channel (314) and electrically connected to the heating end (313).

2. The non-compliant balloon dilation catheter according to claim 1, characterized in that: The catheter assembly (200) includes an inner tube (201), an intermediate tube (202) and an outer tube (203). The inner tube (201), the intermediate tube (202) and the outer tube (203) form a three-layer composite structure to improve the fatigue resistance of the catheter assembly (200). A second Nitinol mesh (204) is installed between the inner tube (201) and the intermediate tube (202).

3. The non-compliant balloon dilation catheter according to claim 1, characterized in that: The output end of the connector (301) is connected to the guide tube (302), and the output end of the connector (301) is provided with a liquid inlet end (303). The connector (301) and the guide tube (302) are both provided with interconnected liquid inlet channels (304), and the liquid inlet channels (304) are connected to the liquid inlet end (303). The top of the connector (301) is provided with a light guide end (305) and an observation end (308). The connector (301) and the guide tube (302) are both provided with interconnected light guide channels (306) and interconnected observation channels (309). The light guide channels (306) and the observation channels (309) are connected to the light guide end (305) and the observation end (308) respectively. The light guide channels (306) and the observation channels (309) are respectively inserted with light guide optical fibers (307) and observation optical fibers (310).

4. The non-compliant balloon dilation catheter according to claim 1, characterized in that: A detection end (311) is provided on one side of the outer wall of the connector (301), and a detection channel (312) is provided inside the connector (301), and the detection channel (312) is connected to the detection end (311).

5. A non-compliant balloon dilation catheter according to claim 2, characterized in that: The inner liner (101), the middle layer (102) and the outer layer (103) are respectively connected to the inner tube (201), the middle tube (202) and the outer tube (203), and the first Nitinol mesh (104) is connected to the second Nitinol mesh (204).

6. A non-compliant balloon dilation catheter according to claim 3, characterized in that: The guide tube (302) passes through the inner liner (101) and one end of the outer wall of the inner tube (201), and a guide head (317) is sleeved on one end of the outer wall of the guide tube (302), and one side of the outer wall of the guide head (317) is connected to the inner liner (101), the intermediate layer (102) and the outer layer (103).

7. A non-compliant balloon dilation catheter according to claim 3, characterized in that: The bottom of the guide tube (302) is provided with a liquid outlet (315), and the outer wall of the guide tube (302) is provided with two non-transparent markings (316), and the liquid outlet (315) and the two non-transparent markings (316) are both located inside the inner liner (101).

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