A coaxial dual-lumen balloon dilation catheter

Abstract

The present application relates to the technical field of medical devices, in particular to a coaxial double-lumen balloon dilatation catheter, comprising a Y-shaped catheter seat, an inner tube, an outer tube and a balloon, the Y-shaped catheter seat is divided into a stent guide inlet and a balloon inflation port, the left end of the Y-shaped catheter seat is sealingly connected with the inner tube and the outer tube, the inner tube is connected with the stent guide inlet for instrument delivery, the gap between the outer tube and the inner tube is connected with the balloon inflation port for internal delivery of liquid or gas, the material of the outer tube is single-layer PEBAX, and the surface of the outer tube is coated with a hydrophilic coating, one end of the balloon is fixedly installed at the left end of the outer tube, the other end of the balloon is fixedly installed on the outer layer of the inner tube, the balloon inflation port delivers liquid or gas to the balloon through the outer tube to make the balloon expand, the expanded balloon squeezes the narrow blood vessels while enabling normal blood flow from the balloon.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a coaxial dual-lumen balloon dilation catheter. Background Technology

[0002] In recent years, with the continuous rise in the incidence of mixed ischemic and hemorrhagic stroke, clinicians are increasingly facing complex cerebrovascular lesions with simultaneous ischemic and hemorrhagic pathological changes, significantly increasing the difficulty of treatment. Currently, there is a lack of integrated, dedicated instruments for such mixed lesions: while balloon dilation catheters used for ischemic stroke can dilate narrowed vessels, their small lumen diameter and insufficient lubrication make them unsuitable for delivering coils or stents required for hemorrhagic stroke treatment; while microcatheters used for hemorrhagic stroke treatment can effectively deliver coils and stents, they lack angioplasty capabilities. Due to the limited functionality of existing instruments, surgeons often need to frequently change instruments when dealing with multiple coexisting lesions. Furthermore, the tortuous pathways and thin walls of intracranial vessels mean that multiple instrument exchanges not only significantly prolong surgical time but also increase the risk of vascular intimal injury, spasm, and even perforation.

[0003] Furthermore, this type of surgery faces a series of technical and clinical challenges: a high rate of restenosis, affecting long-term efficacy; the risk of compression of surrounding perfusion vessels during balloon inflation, leading to distal blood flow interruption; limited balloon inflation time, restricting the operative window for angioplasty; insufficient directional dilation control, making precise anatomical shaping difficult; fluid reflux may increase vessel wall stress, inducing secondary injury; and poor instrument accessibility in severely stenotic or tortuous segments, easily leading to operative failure or increased complications. These problems collectively exacerbate the complexity and uncertainty of the surgery, seriously affecting treatment outcomes and patient safety.

[0004] In view of the above, in order to overcome the above technical problems, the present invention designs a coaxial double-lumen balloon dilation catheter, which solves the above technical problems. Summary of the Invention

[0005] The technical objective of this invention is to design a coaxial dual-lumen balloon dilation catheter that allows the balloon to effectively dilate narrowed blood vessels after inflation while simultaneously allowing blood to flow through the inside of the balloon. This balances the therapeutic effect during angioplasty with the maintenance of blood flow during the procedure, significantly reducing the risk of ischemia. Furthermore, the catheter's coaxial dual-lumen structure ensures clearly defined and non-interfering channel functions, enabling both simultaneous balloon inflation and instrument delivery, as well as independent and safe procedures, significantly improving the reliability and operational controllability of the catheter structure.

[0006] To achieve the above-mentioned technical objectives, the present invention provides the following technical solution: This invention provides a coaxial dual-lumen balloon dilation catheter, including a Y-shaped catheter hub, an inner tube, an outer tube, and a balloon. The Y-shaped catheter hub is divided into a stent inlet and a balloon inflation port. The left end of the Y-shaped catheter hub is sealed and connected to the inner tube and the outer tube, and the inner tube is connected to the stent inlet for instrument delivery. The gap between the outer tube and the inner tube, connected to the balloon inflation port, is used to deliver liquid or gas into the inner tube. The outer tube is made of a single layer of PEBAX and its surface is coated with a hydrophilic coating. One end of the balloon is fixedly installed at the left end of the outer tube, and the other end of the balloon is fixedly installed on the outer layer of the inner tube. The balloon inflation port delivers liquid or gas into the balloon through the outer tube, causing the balloon to inflate. The inflated balloon compresses the narrowed blood vessel while allowing blood to flow normally through the balloon.

[0007] The Y-shaped catheter hub integrates the balloon inflation port and stent delivery port, achieving dual functions of balloon dilation and stent / instrument delivery through a single device. This simplifies the surgical procedure, reduces intraoperative instrument changes, and improves surgical efficiency. The outer tube uses a single layer of PEBAX material combined with a hydrophilic coating, significantly reducing frictional resistance when the catheter passes through narrowed vessel segments, enhancing catheter delivery and smoothness, while also improving biocompatibility and reducing irritation to the vessel wall. After inflation, the balloon effectively dilates the narrowed vessel. Its unique design allows blood to flow through the inside of the balloon while applying radial pressure, balancing the therapeutic effect during angioplasty with maintaining blood flow during the procedure and reducing the risk of ischemia. The coaxial dual-lumen design (inner tube and the gap between the inner and outer tubes) ensures clear division of functions and prevents interference, allowing balloon inflation and instrument delivery to be performed simultaneously or independently and safely, improving the reliability and controllability of the catheter structure. This catheter combines dilation, instrument delivery, and blood flow maintenance functions, making it particularly suitable for interventional treatment of stenosis in coronary and peripheral blood vessels, and meeting the needs of various complex surgical scenarios.

[0008] Preferably, the inner tube is located at the left end of the inlet of the support, and the inner tube is designed as a three-layer composite structure of an inner layer, a middle layer and an outer layer. The inner layer of the inner tube is a PTFE film, the middle layer of the inner tube is a metal reinforcing layer formed by a braided and spring-wound composite structure, and the outer layer of the inner tube is composed of a polymer layer and a multi-segment material with varying hardness.

[0009] The innermost layer of the inner tube is a PTFE membrane, which has an extremely low coefficient of friction. This significantly reduces the resistance of the stent or other instruments during transport, ensuring smooth and stable passage of the instruments and greatly improving transport efficiency and success rate.

[0010] The middle layer employs a metal reinforcement structure combining braided mesh and coiled springs. This design endows the inner tube with extremely high resistance to compression, bending, and kinking, effectively maintaining lumen patency even in tortuous blood vessels.

[0011] The outer layer is designed with a multi-segmented polymer material with gradually varying hardness, allowing for a smooth transition in hardness from proximal to distal end of the catheter. This structure greatly enhances the overall flexibility of the catheter, enabling it to easily navigate complex anatomical pathways, reducing the risk of damage to the vessel wall, while ensuring sufficient pushing force at the proximal end.

[0012] The three-layer structure works synergistically: the inner layer ensures lubrication, the middle layer provides support and flexural strength, and the outer layer optimizes flexibility and delivery force. This composite structure achieves optimal performance balance by ensuring high strength and flexural strength without sacrificing catheter flexibility.

[0013] Preferably, the left end of the inner tube extends 3cm beyond the balloon, which provides sufficient operating space for medical personnel to finely adjust the catheter position and select the entry angle within the blood vessel. This greatly improves the accuracy of balloon positioning and ease of operation in complex vascular anatomy. The inner tube is equipped with three ray-detectable markers, one of which is located at the leftmost end of the inner tube, and the other two are located on the inner tube inside the balloon.

[0014] Three radiographically detectable markers on the inner tube provide enhanced imaging. One marker, located at the far left of the catheter, clearly indicates the catheter tip's position; the other two markers are precisely positioned inside the balloon, clearly outlining the working section of the balloon under X-ray. During the procedure, the relative position of the balloon to the stenotic site can be accurately determined in real time based on the positions of these three markers, enabling precise dilation. Furthermore, the length of the stenotic lesion can be directly measured on the imaging, providing better reference for subsequent procedures.

[0015] Preferably, the two ends of the balloon are connected to the inner and outer tubes using laser-sealed seamless welding. This laser-sealed welding technique creates a smooth, seamless seam, ensuring reliable sealing at the connection point and preventing leakage under inflation pressure. It also significantly reduces frictional resistance between the catheter and the vessel wall during insertion, enhancing the ability to pass through stenotic lesions. The balloon is a double-layered composite structure made of nylon and PEBAX. This combination of the high strength of nylon and the flexibility of PEBAX gives the balloon excellent tear resistance and burst pressure resistance, while maintaining good flexibility to better conform to the anatomical shape of the blood vessel, achieving safe and effective expansion. The balloon's internal array contains transverse blood flow channels. This innovative design allows the balloon to maintain blood flow throughout the entire process of inflating and dilating the narrowed lesion, providing continuous blood perfusion to distal tissues. This effectively reduces the risk of myocardial or downstream tissue ischemia that may occur during traditional balloon dilation, making it particularly suitable for high-risk lesion surgeries.

[0016] The balloon has excellent folding and recoil characteristics and a very small folding diameter. It is easier to pass through tortuous blood vessels and calcified lesions, and it can quickly and evenly retract after inflation, facilitating smooth withdrawal.

[0017] Preferably, the tubing inside the balloon has outward-facing inlets on both sides, and a delivery tube is connected to each inlet. The other end of the delivery tube is connected to a unidirectional ball for allowing blood to flow in one direction. The unidirectional ball is hollow and connected to the delivery tube.

[0018] Through a unique design of the delivery tube and unidirectional balloon, the device achieves the function of actively guiding blood flow. When the balloon inflates, liquid or gas can flow in from the inlet on the side of the tube, enter the unidirectional balloon through the delivery tube, and cause the unidirectional balloon to expand while cooperating with the sealing ring to form a reliable unidirectional flow, effectively supplying blood to the blood vessels and greatly reducing the risk of ischemia caused by vascular occlusion in traditional balloon dilation.

[0019] Two hollow one-way spheres allow blood to flow in one direction under the influence of liquid or gas. This not only allows blood to flow in the forward direction, but also effectively prevents blood backflow, thus preventing complications such as thrombosis that may be caused by blood eddies or backflow.

[0020] Preferably, the pipe has two sealing rings installed inside, one sealing ring to the left of the one-way ball on the right and another sealing ring to the right of the one-way ball on the left, and support rings are installed in an array inside the pipe.

[0021] Sealing rings are placed at different positions on the two one-way balls, forming a reliable sealing unit. This design effectively prevents blood backflow during the flow process, ensuring reliable one-way blood flow.

[0022] An array of support rings is installed inside the tube, forming a robust internal framework. This structure significantly enhances the overall radial support of the tube, effectively resisting the enormous external compressive force generated during balloon inflation, preventing the tube from collapsing, and ensuring a stable and unobstructed channel for blood flow throughout the entire procedure.

[0023] This design significantly reduces surgical risks through dual safeguards. On the one hand, maintaining patency of the lumen prevents ischemia in distal organs; on the other hand, unidirectional blood flow prevents the possibility of blood backflow.

[0024] Preferably, three ball rings are fixedly installed around the periphery of the pipe. The inner diameter of the ball rings is the same as the outer diameter of the pipe. There is a ball ring to the left of the right inlet, a ball ring to the left of the left inlet, and a ball ring in the middle of the pipe.

[0025] The inner diameter of the balloon ring is exactly the same as the outer diameter of the tubing. When the balloon is inflated, the balloon ring expands synchronously and uniformly, providing radial support from the outside of the tubing. Together with the internal support ring, they resist external pressure, effectively preventing the tubing from collapsing or deforming during high-pressure balloon expansion, and ensuring that the blood flow channel remains fully open at all times.

[0026] The spherical ring located near the blood inlet has an expanded ring-shaped structure that effectively guides blood flow, helping to smoothly guide blood into the inlet on the side of the tube, thereby improving the efficiency of unidirectional blood flow.

[0027] The distribution of the ball rings is equivalent to adding multiple anchoring and support points to the outside of the catheter. This not only enhances the longitudinal stability of the entire catheter in the blood vessel, preventing it from shifting under the impact of blood flow, but also allows the pressure to be evenly distributed outside the catheter, improving the stability of the catheter.

[0028] Preferably, the ball ring is hollow inside, and a spreading hole is provided on the side of the ball ring near the inner tube. The spreading hole is oriented towards the direction of conveying liquid or gas. An arc cylinder is installed inside the ball ring at the spreading hole. One end of the arc cylinder is closed, and the other end of the arc cylinder is connected to the inside of the ball ring.

[0029] By orienting the expansion hole towards the fluid delivery direction and incorporating an internal arc-shaped cylinder structure, directional and controllable filling of the ball ring is achieved. Fluid can efficiently enter the ball ring along a preset path, ensuring uniform expansion in the designed direction, avoiding asymmetric deformation, and significantly improving the accuracy and controllability of the ball ring's expansion. The flow-guiding design of the arc-shaped cylinder reduces resistance and turbulence during fluid injection, allowing liquid or gas to fill the ball ring cavity more smoothly. This not only shortens the filling time but also improves the overall filling efficiency. As an internal flow guide and support component, the arc-shaped cylinder improves the pressure distribution inside the ball ring, preventing localized stress concentration. Simultaneously, its closed-end design guides the fluid to form annular flow within the ball ring, promoting uniform expansion into a complete circular shape, thereby providing more stable and reliable radial support for the pipeline.

[0030] Preferably, a pull wire is fixedly installed in an array around one side of the arc-shaped cylinder, forming a mesh, and the other end of the pull wire is connected to the outer wall of the inner tube.

[0031] By using an array of pull wires to form a mesh control structure, the expansion process of the spherical ring is actively guided, ensuring that the expansion hole always expands uniformly in the predetermined direction, avoiding asymmetrical deformation, and greatly improving the controllability and precision of the surgery. While guiding the fluid direction, the pull wire mesh can also work in conjunction with the arc-shaped cylinder to optimize the internal flow field distribution, reduce flow resistance, and allow liquid or gas to fill the spherical ring cavity more quickly, significantly improving the filling efficiency of the spherical ring.

[0032] The beneficial effects of this invention are as follows: 1. After inflation, the balloon effectively dilates narrowed blood vessels, while its unique structure allows blood to flow continuously through the balloon, thus maintaining intraoperative blood flow while achieving angioplasty and significantly reducing the risk of ischemia. Furthermore, the catheter employs a coaxial dual-lumen design, with each channel functioning independently and without interference. This allows for simultaneous balloon inflation and instrument delivery, or separate independent operations, significantly improving the reliability and controllability of the catheter structure.

[0033] 2. The three-layer structure complements each other and works together: the inner layer ensures lubrication, the middle layer provides support and flexural strength, and the outer layer optimizes flexibility and pushing force. While ensuring high strength and flexural strength, the flexibility of the conduit is not sacrificed, achieving the best balance of performance.

[0034] 3. Based on the location of the three ray-detecting markers, the relative relationship between the balloon and the stenotic part of the blood vessel can be accurately determined, enabling precise positioning and dilation. At the same time, the length of the stenotic lesion can be directly measured on the image, providing a better reference for subsequent surgery.

[0035] 4. The inner diameter of the balloon ring is exactly the same as the outer diameter of the tubing. When the balloon is inflated, the balloon ring expands synchronously and uniformly, providing radial support from the outside of the tubing. It works in conjunction with the internal support ring to resist external pressure, effectively preventing the tubing from collapsing or deforming during high-pressure balloon expansion, and ensuring that the blood flow channel is always fully open.

[0036] 5. By orificing the expansion hole towards the fluid delivery direction and incorporating a built-in arc-shaped cylinder structure, directional and controllable filling of the ball ring is achieved. The fluid can efficiently enter the interior of the ball ring along a preset path, ensuring uniform expansion in the designed direction, avoiding asymmetrical deformation, and significantly improving the accuracy and controllability of the ball ring's expansion. Attached Figure Description

[0037] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0038] The above and other aspects of the invention will now be described by way of example only, with reference to the accompanying drawings, in which: Figure 1 This is an overall schematic diagram of the invention; Figure 2 This is a cross-sectional view of the balloon of the present invention; Figure 3 This is a schematic diagram of the interior of the balloon of the present invention; Figure 4 This is a schematic diagram showing the positions of the inner and outer tubes of the present invention; Figure 5 This is a cross-sectional view of the inner and outer tubes of the present invention; Figure 6 This is a cross-sectional view of the pipeline of the present invention; Figure 7 This is a cross-sectional view of the ball ring and its back side of the present invention; Figure 8 This is an overall sectional view of the present invention.

[0039] In the diagram: 1. Y-shaped catheter hub; 11. Stent inlet; 12. Balloon inflation port; 2. Inner tube; 21. Inner layer; 22. Middle layer; 23. Outer layer; 24. X-ray detectable marker; 3. Outer tube; 4. Balloon; 41. Tube; 42. Inlet; 421. Delivery tube; 422. One-way ball; 43. Sealing ring; 44. Support ring; 45. Ball ring; 451. Expansion hole; 452. Arc cylinder; 453. Pull wire. Detailed Implementation

[0040] The technical solutions of the embodiments of the present invention will be described below with reference to the accompanying drawings. The embodiments described below 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] like Figure 1 , 2 As shown in Figures 3, 4, 5, 6, 7, and 8, the present invention provides a coaxial dual-lumen balloon dilation catheter 4, including a Y-shaped catheter hub 1, an inner tube 2, an outer tube 3, and a balloon 4. The Y-shaped catheter hub 1 is divided into a stent inlet 11 and a balloon inflation port 12. The left end of the Y-shaped catheter hub 1 is sealed and connected to the inner tube 2 and the outer tube 3, and the inner tube 2 is connected to the stent inlet 11 for instrument delivery. The gap between the outer tube 3 and the inner tube 2, which is connected to the balloon inflation port 12, is used for... The inner tube 3 is made of a single layer of PEBAX material and has a hydrophilic coating on its surface. One end of the balloon 4 is fixedly installed at the left end of the outer tube 3, and the other end of the balloon 4 is fixedly installed on the outer layer 23 of the inner tube 2. The balloon inflation port 12 delivers liquid or gas to the balloon 4 through the outer tube 3 to inflate the balloon 4. The inflated balloon 4 compresses the narrow blood vessel while allowing blood to flow normally from the balloon 4.

[0042] The Y-shaped catheter hub 1 integrates the balloon inflation port 12 and the stent delivery port 11, achieving the dual functions of balloon 4 expansion and stent delivery through a single device. This simplifies the surgical procedure, reduces the number of instrument changes during the operation, and thus improves surgical efficiency. The outer catheter 3 is made of a single layer of PEBAX material combined with a hydrophilic coating, which significantly reduces the frictional resistance of the catheter when passing through narrowed blood vessel segments, enhances pushability and passability, and improves biocompatibility, reducing irritation to the vascular wall. After balloon 4 is inflated, it can effectively dilate narrowed blood vessels. Its unique design allows blood to flow through the inside of balloon 4 while applying radial compression force, balancing the therapeutic effect and blood flow maintenance during angioplasty, and helping to reduce the risk of ischemia. The catheter adopts a coaxial dual-lumen structure with clearly defined and non-interfering channels, ensuring that balloon 4 inflation and instrument delivery can be performed simultaneously or independently and safely, improving the reliability and operational controllability of the catheter structure. This catheter combines functions such as dilation, instrument delivery, and blood flow maintenance, making it particularly suitable for interventional treatment of stenosis lesions in coronary arteries and peripheral blood vessels, and meeting the needs of various complex surgical scenarios.

[0043] like Figure 1 , 2As shown in Figures 3, 4, and 5, the inner tube 2 is located at the left end of the stent inlet 11. The inner tube 2 is designed as a three-layer composite structure consisting of an inner layer 21, a middle layer 22, and an outer layer 23. The inner layer 21 of the inner tube 2 is a PTFE film, which has an extremely low coefficient of friction, significantly reducing resistance during stent or other device delivery, ensuring smooth and stable passage of the device, and greatly improving delivery efficiency and success rate. The middle layer 22 of the inner tube 2 is a metal reinforcement layer formed by a braided and spring-loaded composite structure. This design gives the inner tube 2 extremely high resistance to compression, bending, and kinking, effectively maintaining lumen patency even in tortuous blood vessels. The outer layer 23 of the inner tube 2 is composed of a polymer layer and a multi-segment material with gradually changing hardness. The multi-segment material design of the outer layer 23 allows for a smooth transition in hardness from the proximal to the distal end of the catheter. This structure greatly enhances the overall flexibility of the catheter, allowing it to easily pass through complex anatomical pathways, reducing the risk of damage to the vessel wall, while ensuring sufficient pushing force at the proximal end.

[0044] The three-layer structure works synergistically: the inner layer 21 ensures lubrication, the middle layer provides support and flexural strength, and the outer layer 23 optimizes flexibility and pushing force. This composite structure achieves optimal performance balance by ensuring high strength and flexural strength without sacrificing the flexibility of the conduit.

[0045] like Figure 1 , 2 As shown in Figures 3 and 8, the left end of the inner tube 2 extends 3 cm out of the balloon 4, and the left end of the inner tube 2 extends 43 cm out of the balloon 4. This provides sufficient operating space for medical personnel to finely adjust the position of the catheter and select the entry angle within the blood vessel, greatly improving the accuracy of the balloon 4 in the complex vascular anatomy and the ease of operation. Three radiometric markers 24 are installed on the inner tube 2. One radiometric marker 24 is located at the leftmost end of the inner tube 2, and the other two radiometric markers 24 are located on the inner tube 2 inside the balloon 4.

[0046] Three radiographically detectable markers 24, positioned on the inner tube 2, provide imaging support. One marker, located at the far left end of the catheter, clearly indicates the tip position; the other two markers are precisely positioned inside the balloon 4, clearly outlining the working section of the balloon 4 under X-ray. During the procedure, the relative position of the balloon 4 to the stenotic site can be accurately determined in real time based on the positions of these three markers, enabling precise dilation and localization. Furthermore, the length of the stenotic lesion can be directly measured on the imaging, providing better reference for subsequent procedures.

[0047] like Figure 1 , 2As shown in Figures 3 and 8, the two ends of the balloon 4 are connected to the inner tube 2 and the outer tube 3 using laser-sealed seamless welding. This laser-sealed welding technique creates a smooth, seamless seam without sharp edges, ensuring reliable sealing at the connection point and preventing leakage under inflation pressure. It also significantly reduces the frictional resistance between the catheter and the vessel wall during insertion, enhancing its ability to pass through stenotic lesions. The balloon 4 is a double-layer composite structure made of nylon and PEBAX. This combination of the high strength of nylon and the flexibility of PEBAX gives the balloon excellent tear resistance and burst pressure resistance, while maintaining good flexibility to better conform to the anatomical shape of the blood vessel, achieving safe and effective expansion. The balloon 4 has an array of transverse tubes 41 for blood flow inside.

[0048] The balloon 4 has internal blood flow channels 41 running through both ends. This innovative design allows the balloon 4 to maintain blood flow during the inflation and dilation of the narrowed lesion, providing continuous perfusion to distal tissues. This effectively reduces the risk of myocardial or downstream tissue ischemia that may occur with traditional balloon 4 dilation, making it particularly suitable for high-risk lesion surgeries. Furthermore, the balloon 4 has excellent folding and recoil properties and a very small folding outer diameter, allowing it to more easily pass through tortuous vessels and calcified lesions, and to retract rapidly and evenly after dilation, facilitating smooth withdrawal.

[0049] like Figure 2 , 3 As shown in Figures 6 and 8, the tube 41 inside the balloon 4 has outward-facing inlets 42 on both sides. A delivery tube 421 is connected to the inlet 42. The other end of the delivery tube 421 is connected to a one-way ball 422 for making blood flow in one direction. The one-way ball 422 is a hollow ball and is connected to the delivery tube 421.

[0050] Through the unique design of the delivery tube 421 and the one-way bulb 422, this device achieves the function of actively guiding blood flow. When the balloon 4 inflates, liquid or gas can flow in from the inlet 42 on the side of the tube 41, enter the one-way bulb 422 through the delivery tube 421, causing it to expand and fit tightly with the sealing ring 43, forming a reliable one-way flow mechanism, thereby effectively supplying blood to the blood vessels. This design significantly reduces the risk of ischemia caused by vascular occlusion during the expansion of a conventional balloon 4. The two hollow one-way bulbs 422 work synergistically under the drive of liquid or gas to achieve one-way blood delivery. This device not only allows blood to flow in the forward direction, but also effectively prevents blood backflow, avoiding complications such as thrombosis that may be caused by blood eddies or reflux.

[0051] like Figure 2 , 3As shown in Figures 6 and 8, two sealing rings 43 are installed inside the pipe 41. There is a sealing ring 43 to the left of the one-way ball 422 on the right, and another sealing ring 43 to the right of the one-way ball 422 on the left. Support rings 44 are installed in an array inside the pipe 41.

[0052] Sealing rings 43 are placed at different positions on the two unidirectional balloons 422 to form a reliable sealing unit. This design effectively prevents backflow during blood flow and ensures the reliability of unidirectional blood flow. Support rings 44 are arranged in an array inside the conduit 41 to form a robust internal skeleton structure, which significantly enhances the overall radial support of the conduit 41. This effectively resists the external compressive force generated when the balloon 4 is inflated, preventing the conduit 41 from being crushed, thus providing a stable and unobstructed channel for blood delivery throughout the entire surgical procedure.

[0053] This design significantly reduces surgical risks through a dual protection mechanism: on the one hand, maintaining patency of the lumen prevents ischemia in distal organs; on the other hand, the unidirectional blood flow design effectively prevents blood backflow and related complications.

[0054] like Figure 2 , 3 As shown in Figures 7 and 8, three ball rings 45 are fixedly installed on the periphery of the pipe 41. The inner diameter of the ball rings 45 is the same as the outer diameter of the pipe 41. There is a ball ring 45 on the left side of the inlet 42 on the right side, a ball ring 45 on the left side of the inlet 42 on the left side, and a ball ring 45 in the middle of the pipe 41.

[0055] The inner diameter of the ball ring 45 is exactly the same as the outer diameter of the conduit 41. When the balloon 4 is inflated, the ball ring 45 expands synchronously and uniformly, providing radial support from the outside of the conduit 41. Working in conjunction with the internal support ring 44, it resists external pressure, effectively preventing the conduit 41 from collapsing or deforming during the high-pressure expansion of the balloon 4, ensuring continuous unobstructed blood flow. The ball ring 45, located at the blood inlet, forms a ring-shaped structure after expansion, effectively guiding blood flow and facilitating smoother flow into the inlet on the side of the conduit 41, thereby improving unidirectional blood flow efficiency. The ball rings 45 are spaced apart along the outside of the conduit 41, effectively adding multiple anchoring and support points. This not only enhances the longitudinal stability of the catheter within the blood vessel, preventing displacement under blood flow impact, but also helps to evenly distribute external pressure, further improving the structural stability of the entire conduit 41 structure.

[0056] like Figure 2 , 3As shown in Figures 7 and 8, the inside of the ball ring 45 is hollow. The ball ring 45 has a support hole 451 on the side near the inner tube 2. The support hole 451 is oriented towards the direction of conveying liquid or gas. An arc cylinder 452 is installed inside the ball ring 45 at the support hole 451. One end of the arc cylinder 452 is closed, and the other end of the arc cylinder 452 is connected to the inside of the ball ring 45.

[0057] By orienting the expansion hole 451 towards the fluid delivery direction and incorporating the built-in arc-shaped cylinder 452 structure, directional and controllable filling of the ball ring 45 is achieved. Fluid can efficiently enter the interior of the ball ring 45 along a preset path, ensuring uniform expansion in the designed direction, avoiding asymmetric deformation, and significantly improving the accuracy and controllability of the ball ring 45's expansion. The flow-guiding design of the arc-shaped cylinder 452 reduces resistance and turbulence during fluid injection, allowing liquid or gas to fill the cavity of the ball ring 45 more smoothly. This not only shortens the filling time but also improves the overall filling efficiency. As an internal flow guide and support component, the arc-shaped cylinder 452 improves the pressure distribution inside the ball ring 45, avoiding localized stress concentration. Simultaneously, its closed-end design guides the fluid to form annular flow within the ball ring 45, promoting uniform expansion of the ball ring 45 into a complete annular shape, thereby providing more stable and reliable radial support for the pipe 41.

[0058] like Figure 3 , 7 As shown in Figure 8, a pull wire 453 is fixedly installed on the outer periphery of the arc cylinder 452 on one side of the expansion hole 451. The pull wire 453 is arranged in a mesh, and the other end of the pull wire 453 is connected to the outer wall of the inner tube 2.

[0059] The array of drawstrings 453 forms a mesh control structure that actively guides the expansion process of the spherical ring 45, ensuring that the opening 451 always expands uniformly in the predetermined direction, avoiding asymmetric deformation, and thus significantly improving the controllability and operational precision of the surgery. While guiding the fluid direction, the drawstring mesh 453 also works synergistically with the arc-shaped cylinder 452 to optimize the internal flow field distribution, reduce flow resistance, and allow liquid or gas to fill the cavity of the spherical ring 45 more quickly, greatly improving the filling efficiency of the spherical ring 45.

[0060] In operation, during surgery, medical personnel insert a coaxial catheter through a narrow blood vessel. When balloon 4 reaches the narrowed area of ​​the blood vessel, liquid or gas is delivered into it through the balloon inflation port 12 on the Y-shaped catheter hub 1. The delivered liquid or gas enters balloon 4 through the gap between the outer tube 3 and the inner tube 2, causing balloon 4 to inflate. As balloon 4 inflates, it moves the tubing 41 outwards, achieving a stretching effect on tubing 41.

[0061] The moving and stretching tube 41 causes the ball ring 45 to move along with it. The expansion hole 451 on the ball ring 45 faces the direction of liquid or gas entry, and the expansion hole 451 is controlled by the pull wire 453, allowing liquid or gas to flow naturally into the ball ring 45 as it expands. This more effectively guides the liquid or gas into the ball ring 45, causing it to expand into a ring shape. Since the inner diameter of the ball ring 45 is the same as the outer diameter of the tube 41, the ball ring 45, when inflated, assists the tube 41 in unfolding, preventing the balloon 4 from collapsing during expansion. Collapse of the tube 41 would prevent blood flow. Therefore, the ball ring 45 optimizes blood flow and reduces surgical risks.

[0062] In addition, the tube 41 is equipped with support rings 44 arranged in an array to form a robust internal framework. These rings can further resist the compressive force generated when the balloon 4 inflates, ensuring that the tube 41 remains round and open even when fully inflated to the rated pressure, which is conducive to blood flow.

[0063] When liquid or gas enters balloon 4 through delivery tube 421, some of the liquid or gas will flow into one-way balloon 422 through inlet 42. The unidirectional flow of blood is achieved through the combined action of one-way balloon 422 and sealing ring 43, preventing backflow and avoiding other serious complications caused by increased vascular pressure.

[0064] The foregoing description is merely illustrative of this disclosure, and modifications may be made to the invention in light of the above detailed description. The terminology used in the appended claims should not be construed as limiting the invention to the specific embodiments disclosed in the specification. Rather, the scope of the invention will be fully defined by the appended claims, which will be interpreted according to established principles of claim interpretation.

Claims

1. A coaxial double-lumen balloon dilatation catheter comprising a Y-shaped catheter hub (1), characterized in that It also includes an inner tube (2), an outer tube (3), and a balloon (4). The Y-shaped catheter hub (1) is divided into a stent inlet (11) and a balloon inflation port (12). The left end of the Y-shaped catheter hub (1) is sealed with the inner tube (2) and the outer tube (3). The inner tube (2) is connected to the stent inlet (11) for instrument delivery. The gap between the outer tube (3) and the inner tube (2) is connected to the balloon inflation port (12) for delivering liquid or gas into the body. The material of the outer tube (3) is... It is composed of a single layer of PEBAX, and the surface of the outer tube (3) is coated with a hydrophilic coating. One end of the balloon (4) is fixedly installed at the left end of the outer tube (3), and the other end of the balloon (4) is fixedly installed on the outer layer (23) of the inner tube (2). The balloon inflation port (12) delivers liquid or gas to the balloon (4) through the outer tube (3) to inflate the balloon (4). The inflated balloon (4) squeezes the narrow blood vessels while allowing blood to flow normally from the balloon (4). The inner tube (2) is located at the left end of the inlet (11) of the support, and the inner tube (2) is designed as a three-layer composite structure of inner layer (21), middle layer (22) and outer layer (23). The inner layer (21) of the inner tube (2) is a PTFE film. The middle layer (22) of the inner tube (2) is a metal reinforcing layer formed by a braided and spring-wound composite structure. The outer layer (23) of the inner tube (2) is composed of a polymer layer and a multi-segment hardness gradient material. The left end of the inner tube (2) extends 3 cm out of the balloon (4). Three ray-detectable markers (24) are installed on the inner tube (2). One of the ray-detectable markers (24) is located at the leftmost end of the inner tube (2), and the other two ray-detectable markers (24) are located on the inner tube (2) inside the balloon (4). The balloon (4) is connected to the inner tube (2) and the outer tube (3) by laser non-marking welding at both ends. The balloon (4) is a double-layer composite structure made of nylon and PEBAX. The balloon (4) has an array of tubes (41) for blood circulation running through its interior. The balloon (4) has outward-facing inlets (42) on the left and right sides of the tube (41) inside. A delivery tube (421) is connected to the inlet (42), and the other end of the delivery tube (421) is connected to a one-way ball (422) for making blood flow in one direction. The one-way ball (422) is a hollow ball and is connected to the delivery tube (421). The pipe (41) is equipped with two sealing rings (43). There is a sealing ring (43) on the right side of the one-way ball (422) on the right side, and another sealing ring (43) on the right side of the one-way ball (422) on the left side. The pipe (41) is equipped with a support ring (44) in an array. When the balloon (4) is inflated, liquid or gas can flow in from the inlet (42) on the side of the pipe (41), enter the one-way ball (422) through the delivery pipe (421), and cause the one-way ball (422) to expand and fit tightly with the sealing ring (43) to form a reliable one-way flow mechanism. Three ball rings (45) are fixedly installed on the periphery of the pipe (41). The inner diameter of the ball rings (45) is the same as the outer diameter of the pipe (41). There is a ball ring (45) on the left side of the inlet (42) on the right side, and a ball ring (45) is installed on the left side of the inlet (42) on the left side. A ball ring (45) is installed in the middle of the pipe (41). The inside of the ball ring (45) is hollow. A support hole (451) is provided on the side of the ball ring (45) near the inner tube (2). The support hole (451) faces the direction of liquid or gas entry. An arc cylinder (452) is installed inside the ball ring (45) at the support hole (451). One end of the arc cylinder (452) is closed, and the other end of the arc cylinder (452) is connected to the inside of the ball ring (45). A pull wire (453) is fixedly installed on the outer periphery of the arc cylinder (452) on one side of the opening hole (451). The pull wire (453) is arranged in a mesh, and the other end of the pull wire (453) is connected to the outer wall of the inner tube (2).

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