Non-compliant balloon dilatation catheter

Abstract

The invention discloses a non-compliance balloon dilatation catheter, and relates to the technical field of textile production, the non-compliance balloon dilatation catheter comprises a balloon assembly, a catheter assembly and a connecting assembly, the catheter assembly is communicated with the balloon assembly, the connecting assembly penetrates through the interiors of the balloon assembly and the catheter assembly, the balloon assembly comprises an inner container, a middle layer and an outer layer, the inner container, the middle layer and the outer layer form a three-layer composite structure and are used for improving the anti-fatigue performance of the balloon assembly, the first nitinol grid is arranged between the inner container and the middle layer and is used for relieving stress concentration during high-pressure expansion of the balloon assembly, and the detection module is arranged between the middle layer and the outer layer and is of the three-layer composite structure. A micro pressure sensor is embedded in the outer surface of the balloon, through the synergistic effect of nano-composition and a microstructure, the anti-fatigue performance is remarkably improved while the non-compliance is kept, the limitation of traditional single-point pressure monitoring is broken through, the asymmetric dilation risk of calcification lesions can be recognized, and the occurrence rate of vascular perforation is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of textile production, in particular to a non-compliant balloon dilatation catheter. Background Art

[0002] A non-compliant balloon dilatation catheter is a medical device with high strength and rigidity. It uses the expansion force generated by the inflated balloon to expand narrowed or blocked blood vessels or pipes to restore their normal patency. During the operation, the doctor inserts the catheter into the patient's artery or vein and, guided by X-ray or other imaging technology, delivers the balloon to the narrowed or occluded area. The balloon is then inflated by injecting pressurized liquid or gas. The balloon's expansion force compresses the narrowed plaque or blood vessel wall, thereby widening the inner diameter of the blood vessel and restoring normal blood flow. After the expansion is completed, the balloon is deflated and the catheter is removed from the patient.

[0003] However, existing non-compliant balloon dilatation catheters have the following shortcomings: Currently, the mainstream materials for balloon dilatation catheters are polyethylene terephthalate (PET) and nylon 12. Although these materials can achieve low deformation rates, they have significant limitations. First, the higher material stiffness can easily cause stress concentration in the blood vessel wall, increasing the risk of vascular damage. Second, the material's fatigue resistance is poor, affecting the service life and clinical safety of the device. In addition, existing monitoring technology can only obtain internal balloon pressure data through the catheter's intraluminal pressure sensor, and cannot perceive the actual contact pressure between the balloon's outer surface and the blood vessel wall in real time. This monitoring blind spot can easily lead to vascular perforation due to local pressure loss in calcified lesions, resulting in poor safety.

[0004] Therefore, we propose a non-compliant balloon dilatation catheter to solve the above problems. Summary of the Invention

[0005] The purpose of the present invention is to provide a non-compliant balloon dilatation catheter that adopts a three-layer composite structure and embeds a micro pressure sensor on the outer surface of the balloon. Through the synergistic effect of nano-composite and microstructure, the fatigue resistance is significantly improved while maintaining non-compliance, and breaks through the limitations of traditional single-point pressure monitoring. It can identify the risk of asymmetric expansion of calcified lesions, assist in judging the integrity of the balloon and the blood vessel wall, and reduce the incidence of vascular perforation, so as to solve the problems raised by the above-mentioned background technology.

[0006] To achieve the above-mentioned object, the present invention provides the following technical solution: a non-compliant balloon dilatation 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 passes through the interior of the balloon assembly and the catheter assembly; The balloon assembly includes: 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; A first nitinol grid is disposed between the inner liner and the intermediate layer to alleviate stress concentration during high-pressure expansion of the balloon assembly; A detection module is disposed between the middle layer and the outer layer and is used to monitor the local pressure distribution on the balloon surface; A support module is installed at the proximal end of the outer layer and is used to achieve zero-displacement stable expansion of the balloon; The detection module includes a group of micro pressure sensors and micro optical fibers. The micro optical fibers are spirally embedded in the outer surface of the middle layer. The group of micro pressure sensors are electrically connected through the micro optical fibers. A drug storage tank is provided on the outer surface of the outer layer.

[0007] Preferably, the catheter assembly includes an inner tube, an intermediate tube and an outer tube, which form a three-layer composite structure to improve the fatigue resistance of the catheter assembly. A second nitinol grid is installed between the inner tube and the intermediate tube.

[0008] Preferably, the connecting component includes a connector, the output end of the connector is connected to a guide tube, and the output end of the connector is provided with a liquid inlet end, the interiors of the connector and the guide tube are provided with mutually connected liquid inlet channels, and the liquid inlet channels are connected to the liquid inlet end, the top of the connector is respectively provided with a light guide end and an observation end, the interiors of the connector and the guide tube are provided with mutually connected light guide channels and mutually connected observation channels, the light guide channel and the observation channel are respectively connected to the light guide end and the observation end, and the interiors of the light guide channel and the observation channel are respectively provided with a light guide optical fiber and an observation optical fiber.

[0009] Preferably, a detection end is provided on one side of the outer wall of the connector, a detection channel is provided inside the connector, and the detection channel is communicated with the detection end.

[0010] Preferably, a heating end is provided on the other side of the outer wall of the connecting head, a heating channel is provided inside the connecting head, and the heating channel is connected to the heating end.

[0011] Preferably, the support module includes a heat conducting plate, one side of the outer wall of the heat conducting plate is provided with a shape memory anchoring claw, and the distal annular array of the middle layer has a neodymium iron boron magnet.

[0012] Preferably, the inner liner, the middle layer and the outer layer are respectively connected to the inner tube, the middle tube and the outer tube, and the first nitinol grid is connected to the second nitinol grid.

[0013] 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 middle layer and the outer layer.

[0014] Preferably, a liquid outlet is provided at the bottom of the guide tube, two radiopaque markers are provided on the outer wall of the guide tube, and the liquid outlet and the two radiopaque markers are both located inside the inner liner.

[0015] Preferably, the micro optical fiber passes between the middle tube and the outer tube, is inserted in the detection channel, and is electrically connected to the detection end. The guide wire of the heat conducting plate passes between the middle tube and the outer tube, is inserted in the heating channel, and is electrically connected to the heating end.

[0016] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, a three-layer composite balloon component is provided to significantly improve the fatigue resistance of the balloon. The outer layer adopts a heparin-modified polyurethane-based self-lubricating hydrogel coating. The coating can greatly reduce the resistance during the catheter pushing process due to its unique hydrophilic properties, making the catheter delivery in the blood vessel smoother. At the same time, the modification of heparin effectively inhibits the formation of thrombus, reducing the risk of postoperative thrombosis-related complications from the source. The middle layer is made of high-density polyethylene material, which has good rigidity and stability, providing a solid structural support for the balloon. The inner layer uses 3D electrospinning technology to orient the silicon carbide nanowires to construct a radial tensile-resistant network structure. This structure gives the balloon a high degree of non-compliance, ensuring that the balloon can accurately act on the lesion site during the expansion process, maintain a stable expansion shape, and avoid damage to the surrounding normal tissues due to excessive expansion, in order to further improve To improve the reliability of the balloon assembly, a nitinol grid is embedded between the inner layer and the middle layer of the balloon. The nitinol material has excellent shape memory properties and superelasticity, which can effectively alleviate the stress concentration phenomenon caused by the balloon during high-pressure expansion, prevent the balloon from being ruptured or damaged due to excessive stress, extend the service life of the balloon, and improve the safety of surgical operations. In addition, the matching detection module is equipped with a micro-sensor array, which breaks through the limitations of traditional single-point pressure monitoring and can comprehensively monitor the local pressure distribution on the balloon surface. When facing calcified lesions, it can accurately identify the risk of asymmetric expansion, help doctors predict surgical risks in advance, and formulate more reasonable surgical plans. At the same time, the monitoring system can also assist doctors in judging the integrity of the balloon and the blood vessel wall, ensuring that the balloon can fit closely with the blood vessel wall after expansion, reducing the probability of complications such as vascular dissection, and providing strong guarantees for the successful implementation of the operation.

[0017] 2. In the present invention, by setting up a support module and cooperating with the NdFeB magnet, the accuracy and stability of the catheter operation are further improved. The support module integrates a micro NdFeB magnet array. The magnet has a high magnetic energy level and good biocompatibility. It can produce precise magnetic coupling with the external magnetic field generator under the X-ray fluoroscopy environment. During the operation, the doctor controls the external magnetic field generator and uses the magnetic navigation principle to guide the catheter in three dimensions, so that the balloon can reach the lesion site quickly and accurately, greatly shortening the surgical positioning time and reducing the risk of vascular damage caused by repeated adjustments. When the catheter reaches the target position, the shape memory anchoring claw built into the balloon It starts immediately. The anchoring claw is made of nickel-titanium alloy and is temperature-triggered by the micro-resistance heating device inside the balloon (the phase change temperature is precisely set at 40°C). The anchoring claw quickly unfolds and embeds into the blood vessel wall at a safe depth of less than 100μm, forming a multi-point mechanical anchoring structure. This design effectively overcomes the "watermelon seed effect" (i.e. axial sliding phenomenon) caused by uneven force during high-pressure expansion of traditional balloons. It is especially effective for complex lesions such as severe calcification and angulation. It can achieve zero-displacement stable expansion, ensure that the balloon expansion force acts evenly and precisely on the lesion area, avoid insufficient or excessive expansion due to balloon sliding, and significantly improve the effect and safety of surgical treatment.

[0018] 3. In the present invention, a multifunctional connection component is provided, and its mounting head adopts a standardized threaded interface design. With the threaded engagement structure, it can realize the rapid and stable connection and disassembly of various pipelines, significantly improving the assembly efficiency of surgical instruments and reducing the surgical preparation time. The component integrates a dual optical path system of light guide fiber and observation fiber. The light guide end is connected to a special cold light head. The cold light adopts low-heat, high-brightness LED light source technology. When the light is transmitted through the light guide fiber, it can illuminate the interior of the blood vessel with uniform and soft brightness, avoiding damage to the vascular tissue caused by heat generated by traditional light sources. The observation end is equipped with a high-resolution micro camera, which is connected to an external high-definition display device through a dedicated data interface. The image transmission performance of the observation fiber is used to transmit the real-time picture inside the blood vessel to the external display device, providing the surgeon with clear and intuitive internal images of the blood vessels, enabling the surgeon to observe the morphology, position and relationship with surrounding tissues of the lesion in real time and accurately, thereby formulating more precise surgical strategies and greatly improving the accuracy and safety of surgical operations. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the main structure of a non-compliant balloon dilatation catheter of the present invention; Figure 2 This is a schematic structural diagram of a cross-section of a non-compliant balloon dilatation catheter of the present invention; Figure 3 This is a schematic structural diagram of a cross-section of a balloon assembly in a non-compliant balloon dilatation catheter of the present invention; Figure 4 This is a schematic structural diagram of a balloon assembly in a non-compliant balloon dilatation catheter of the present invention; Figure 5 This is an enlarged structural diagram of Figure A of a non-compliant balloon dilatation catheter of the present invention; Figure 6 This is an enlarged structural diagram of Figure B of a non-compliant balloon dilatation catheter of the present invention; Figure 7 This is a schematic structural diagram of a detection module in a non-compliant balloon dilatation catheter of the present invention; Figure 8 This is a schematic structural diagram of a catheter assembly portion in a non-compliant balloon dilatation catheter of the present invention; Figure 9 This is a schematic structural diagram of a connection assembly in a non-compliant balloon dilatation catheter of the present invention; Figure 10 This is an enlarged structural diagram of Figure C of a non-compliant balloon dilatation catheter of the present invention; Figure 11 This is a schematic structural diagram of a side-thrown connection assembly in a non-compliant balloon dilatation catheter of the present invention; Figure 12 This is a schematic structural diagram of a side-thrown connection assembly in a non-compliant balloon dilatation catheter of the present invention.

[0020] In the figure: 100, balloon assembly; 101, liner; 102, middle layer; 103, outer layer; 104, first nitinol grid; 105, detection module; 1051, micro pressure sensor; 1052, micro optical fiber; 106, support module; 1061, heat conduction plate; 1062, shape memory anchor claw; 107, neodymium iron boron magnet; 108, drug storage tank; 200, catheter assembly; 201, inner tube; 202, middle tube; 203, outer tube; 204, Second nitinol grid; 300, connecting assembly; 301, connecting head; 302, guide tube; 303, liquid inlet end; 304, liquid inlet channel; 305, light-guiding end; 306, light-guiding channel; 307, light-guiding optical fiber; 308, observation end; 309, observation channel; 310, observation optical fiber; 311, detection end; 312, detection channel; 313, heating end; 314, heating channel; 315, liquid outlet; 316, radiopaque marker; 317, guide head. DETAILED DESCRIPTION

[0021] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the implementation regulations described are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0022] Example 1, as Figure 1 and Figure 2 As shown: A non-compliant balloon dilatation 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; like Figure 4 and Figure 5 As shown: 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; like Figure 3 As shown: a first nitinol grid 104, which is disposed between the inner liner 101 and the intermediate layer 102, and is used to relieve stress concentration during high-pressure expansion of the balloon assembly 100; like Figure 6 and Figure 7 As shown: a detection module 105, which is disposed between the middle layer 102 and the outer layer 103 and is used to monitor the local pressure distribution on the balloon surface; The detection module 105 includes a group of micro pressure sensors 1051 and micro optical fibers 1052. The micro optical fibers 1052 are spirally embedded in the outer surface of the middle layer 102. The group of micro pressure sensors 1051 are electrically connected through the micro optical fibers 1052. A drug storage tank 108 is provided on the outer surface of the outer layer 103.

[0023] In this embodiment, the outer layer 103 is made of a polyurethane-based self-lubricating hydrogel coating material. Leveraging the hydrophilicity of the hydrogel, it forms a water film lubrication layer when in contact with the inner wall of the blood vessel, significantly reducing friction during delivery and enabling the balloon to reach the lesion more smoothly. Heparin, an anticoagulant, inhibits the activation of coagulation factors in the blood, effectively preventing thrombus formation on the balloon surface. The middle layer 102 is composed of high-density polyethylene. Its high rigidity and structural stability provide a basic support framework for the balloon, resisting external pressure and maintaining its shape. The inner liner 101 utilizes 3D electrospinning technology to orientate silicon carbide nanowires to form a radially tensile-resistant network structure. When the balloon is inflated, this network structure limits excessive radial deformation, ensuring that the balloon remains non-compliant and concentrating the expansion force on the lesion, achieving precise expansion. The three-layer structure works together to improve the fatigue resistance of the balloon assembly 100 from the perspectives of lubrication, support, and morphological control, thereby extending its service life.

[0024] Nitinol has shape memory effect and superelastic properties. During the high-pressure expansion process 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 part of the balloon or the irregular contact point at the lesion. The first nitinol grid 104 is arranged between the inner liner 101 and the middle layer 102. It can absorb and disperse these concentrated stresses through elastic deformation by virtue of its own superelasticity, and evenly distribute the stress to the overall structure of the balloon, avoiding local excessive stress leading to balloon rupture or material damage, thereby ensuring the structural integrity and safety of the balloon during repeated high-pressure expansion.

[0025] The micro pressure sensor 1051 is a ZXPA invasive pressure sensor independently developed and produced by Zhixin Sensing for use in the field of minimally invasive medical treatment. It measures only 650μm×220μm×75μm. The micro pressure sensors 1051 are distributed in an array on the surface of the balloon and can collect local pressure data of the contact between the balloon and the blood vessel wall in real time. Each micro pressure sensor 1051 converts the pressure signal into an electrical signal and transmits it through the spiral micro optical fiber 1052 tightly embedded in the outer surface of the intermediate layer 102. The micro optical fiber 1052 not only has the advantages of low signal transmission loss and strong anti-electromagnetic interference ability, 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 and whether there is a risk of asymmetric expansion caused by calcification. At the same time, it assists in evaluating the wall integrity of the balloon and the blood vessel wall, providing a key basis for doctors to adjust surgical strategies.

[0026] The drug storage tank 108 provided on the outer surface of the outer layer 103 can be pre-loaded with drugs required for treatment, such as anti-thrombotic drugs, vasodilators, etc. before surgery. When the balloon reaches the lesion site and completes expansion, a certain pressure is applied to the balloon through the drug delivery channel of the connecting component 300, causing a slight deformation of the balloon surface, squeezing the drug storage tank 108, and releasing the stored drugs into the lesion site of the blood vessel wall. This local and precise drug delivery method can increase the concentration of the drug at the lesion site and enhance the therapeutic effect, while reducing the amount of the drug in the systemic blood circulation and reducing the side effects of the drug.

[0027] Example 2, as Figure 6 As shown, the support module 106 is arranged at the proximal end of the outer layer 103 and is used to achieve zero-displacement stable expansion of the balloon.

[0028] like Figure 1 、 Figure 2 as well as Figure 8 As shown: 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 for improving the fatigue resistance of the catheter assembly 200. A second nitinol grid 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 respectively connected to the inner tube 201, the intermediate tube 202 and the outer tube 203. The first nitinol grid 104 is connected to the second nitinol grid 204. 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 provided 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.

[0029] 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 a NdFeB magnet 107 is provided in a distal annular array of the intermediate layer 102 .

[0030] In this embodiment, the NdFeB magnets 107 distributed in a circular array at the distal end of the intermediate layer 102 generate a gradient magnetic field under the guidance of X-ray fluoroscopy, and the external magnetic field generator achieves three-dimensional spatial navigation of the balloon assembly 100 by precisely controlling the magnetic field strength and direction. When the balloon approaches the lesion site, the NdFeB magnets 107 at the distal end first generate magnetic coupling with the external magnetic field to provide preliminary positioning guidance. As the balloon approaches the target further, the magnets in the support module 106 play a leading role, achieving millimeter-level precise positioning.

[0031] When the balloon reaches the target position, the heat generated by the micro-resistance heating wire in the connecting component 300 is quickly and evenly transferred to the shape memory anchoring claw 1062 through 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°C. When the temperature reaches the phase transition point, the anchoring claw quickly changes from the initial contracted state to the preset expanded state, and is embedded in the blood vessel wall at a safe depth of less than 100μm. The tip of each anchoring claw adopts a special serrated design to ensure the embedding stability while avoiding excessive damage to the blood vessel wall. The deployed anchoring claw forms a 360° annular support structure that can withstand an expansion pressure of up to 8atm without displacement, effectively solving the problem of axial sliding of traditional balloons under high pressure.

[0032] Example 3, as Figures 9-12 As shown, the connection assembly 300 includes a connector 301, the output end of the connector 301 is connected to a guide tube 302, and the output end of the connector 301 is provided with a liquid inlet end 303, the interiors of the connector 301 and the guide tube 302 are provided with mutually connected liquid inlet channels 304, and the liquid inlet channel 304 is 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, respectively, the interiors of the connector 301 and the guide tube 302 are provided with mutually connected light guide channels 306 and mutually connected observation channels 309, the light guide channels 306 and the observation channel 309 are connected to the light guiding end 305 and the observation end 308 respectively, and the light guiding optical fiber 307 and the observation optical fiber 310 are respectively inserted into the light guiding channel 306 and the observation channel 309. A detection end 311 is provided on one side of the outer wall of the connector 301, and a detection channel 312 is opened inside the connector 301, and the detection channel 312 is connected to the detection end 311. A heating end 313 is provided on the other side of the outer wall of the connector 301, and a heating channel 314 is opened inside the connector 301, and the heating channel 314 is connected to the heating end 313.

[0033] like Figure 11 As shown, a liquid outlet 315 is provided at the bottom of the guide tube 302 , and two radiopaque markers 316 are provided on the outer wall of the guide tube 302 . The liquid outlet 315 and the two radiopaque markers 316 are both located inside the inner liner 101 .

[0034] The micro optical fiber 1052 passes between the middle tube 202 and the outer tube 203, is inserted into the detection channel 312, and is electrically connected to the detection end 311. The guide wire of the heat conducting plate 1061 passes between the middle tube 202 and the outer tube 203, is inserted into the heating channel 314, and is electrically connected to the heating end 313.

[0035] In this embodiment, the liquid inlet end 303 is used to connect to an external pressure device. During the operation, the operator injects the contrast agent through the liquid inlet end 303. The liquid is transmitted through the liquid inlet channel 304 interconnected with the connector 301 and the guide tube 302, and finally discharged from the liquid outlet 315 at the bottom of the guide tube 302. The liquid outlet 315 is precisely set inside the inner liner 101 and can directly transport the liquid to the vicinity of the balloon. On the one hand, when the contrast agent is injected, the blood vessel morphology and balloon position can be clearly displayed under X-ray or other imaging equipment to assist the doctor in positioning. On the other hand, the injection of liquids such as physiological saline can provide a medium for balloon inflation, ensuring a smooth balloon expansion process.

[0036] The light-guiding end 305 is connected to an external cold light source device. The light emitted by the light source enters the light-guiding channel 306 and is transmitted by the light-guiding optical fiber 307 inserted therein. The light-guiding optical fiber 307 has a high light transmittance characteristic and can transmit light to the front end of the balloon, evenly illuminating the interior of the blood vessel and providing sufficient lighting for observation. The observation end 308 is connected to a miniature camera, and the observation optical 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 the external display screen. The doctor can observe the internal lesions of the blood vessels, the fit between the balloon and the blood vessel wall, etc. 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 expansion.

[0037] The heating end 313 is connected to an external power supply and temperature control equipment. When the balloon reaches the lesion location and needs to activate the shape memory anchoring claw 1062, 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 is then conducted to the heat-conducting plate 1061. The heat-conducting plate 1061 transfers the heat evenly to the shape memory anchoring claw 1062. When the temperature reaches the trigger temperature of 40°C, the shape memory anchoring claw 1062 undergoes a phase change, expands from a contracted state and embeds into the blood vessel wall, achieving zero-displacement stable expansion of the balloon.

[0038] The two radiopaque markers 316 set on the outer wall of the guide tube 302 are made of high atomic number alloy material and have extremely strong visualization properties under X-rays or other imaging equipment. During the operation, the doctor can accurately determine the specific positions of the guide tube 302 and the balloon assembly 100 in the blood vessel by observing the position of the radiopaque marker 316 in the image, providing accurate spatial positioning reference for the surgical operation, avoiding surgical risks caused by misjudgment of position, and ensuring that the balloon accurately reaches the lesion site for expansion treatment.

[0039] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is apparent to those skilled in the art that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A non-compliant balloon dilatation catheter, characterized in that: include: 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); The balloon assembly (100) comprises: An inner liner (101), an intermediate layer (102), and an outer layer (103), wherein the inner liner (101), the intermediate layer (102), and the outer layer (103) form a three-layer composite structure for improving the fatigue resistance of the balloon assembly (100); A first nitinol grid (104) is disposed between the inner liner (101) and the intermediate layer (102) and is used to alleviate stress concentration during high-pressure expansion of the balloon assembly (100); A detection module (105) is disposed between the intermediate layer (102) and the outer layer (103) and is used to monitor the local pressure distribution on the balloon surface; A support module (106) is arranged at the proximal end of the outer layer (103) and is used to achieve zero-displacement stable expansion of the balloon; The detection module (105) includes a group of micro pressure sensors (1051) and micro optical fibers (1052), wherein the micro optical fibers (1052) are spirally embedded in the outer surface of the middle layer (102), and the group of micro pressure sensors (1051) are electrically connected via the micro optical fibers (1052). The outer surface of the outer layer (103) is provided with a drug storage tank (108).

2. The non-compliant balloon dilatation catheter according to claim 1, characterized in that: The catheter assembly (200) comprises an inner tube (201), an intermediate tube (202) and an outer tube (203), wherein the inner tube (201), the intermediate tube (202) and the outer tube (203) form a three-layer composite structure for improving the fatigue resistance of the catheter assembly (200), and a second nitinol grid (204) is arranged between the inner tube (201) and the intermediate tube (202).

3. The non-compliant balloon dilatation catheter according to claim 1, characterized in that: The connecting assembly (300) includes a connector (301), the output end of the connector (301) is connected to a guide tube (302), and the output end of the connector (301) is provided with a liquid inlet end (303), the interiors of the connector (301) and the guide tube (302) are both provided with mutually connected liquid inlet channels (304), and the liquid inlet channel (304) is connected to the liquid inlet end (303), and the top of the connector (301) is provided with a light guide end (305 ) and an observation end (308), the interiors of the connector (301) and the guide tube (302) are both provided with mutually communicating light guide channels (306) and mutually communicating observation channels (309), the light guide channels (306) and the observation channels (309) are respectively connected to the light guide end (305) and the observation end (308), and the interiors of the light guide channels (306) and the observation channels (309) are respectively provided with light guide optical fibers (307) and observation optical fibers (310).

4. The non-compliant balloon dilatation catheter according to claim 3, characterized in that: A detection end (311) is provided on one side of the outer wall of the connector (301), a detection channel (312) is provided inside the connector (301), and the detection channel (312) is communicated with the detection end (311).

5. The non-compliant balloon dilatation catheter according to claim 3, characterized in that: A heating end (313) is provided on the other side of the outer wall of the connecting head (301), a heating channel (314) is provided inside the connecting head (301), and the heating channel (314) is communicated with the heating end (313).

6. The non-compliant balloon dilatation catheter according to claim 1, characterized in that: The support module (106) comprises a heat conducting plate (1061), a shape memory anchoring claw (1062) is provided on one side of an outer wall of the heat conducting plate (1061), and a distal annular array of the intermediate layer (102) comprises a neodymium iron boron magnet (107).

7. The non-compliant balloon dilatation 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 grid (104) is connected to the second nitinol grid (204).

8. The non-compliant balloon dilatation 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 middle layer (102) and the outer layer (103).

9. The non-compliant balloon dilatation catheter according to claim 3, characterized in that: A liquid outlet (315) is provided at the bottom of the guide tube (302), and two radiopaque markers (316) are provided on the outer wall of the guide tube (302), and the liquid outlet (315) and the two radiopaque markers (316) are both located inside the inner liner (101).

10. The non-compliant balloon dilatation catheter according to claim 6, characterized in that: The micro optical fiber (1052) passes between the intermediate tube (202) and the outer tube (203), is inserted into the detection channel (312), and is 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), is inserted into the heating channel (314), and is electrically connected to the heating end (313).

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