Power-assisted balloon plugging catheter

Abstract

The invention provides a power-assisted balloon plugging catheter, and belongs to the technical field of blood vessel embolism material injection systems.The power-assisted balloon plugging catheter comprises a three-way opening, an outer rod, an inner rod and a balloon, the three-way opening comprises three openings, and one opening is in through connection with the outer rod; the two openings far away from the outer rod are a guide wire port and a pressure pump port respectively; the near end of the outer rod is connected with the three-way opening in a penetrating mode, the far end of the outer rod is connected with the balloon, and the balloon is used for temporarily blocking blood flow after being filled and reducing local blood pressure so as to reduce scattering of embolism products to peripheral non-target blood vessels. The inner rod is arranged inside the outer rod, and the inner rod and the guide wire port are located on the same straight line; the invention provides a power-assisted balloon plugging catheter which can solve the problems that an existing plugging catheter is pushed to the far end by completely depending on the pushing force of a doctor for injecting an injector, so that the displacement distance of an embolism product to the far end is limited, embolism is not thorough enough, and plugging of the far end is incomplete.

Description

Technical Field

[0001] The present invention belongs to the technical field of vascular embolic material injection systems, and in particular, relates to an assisted balloon occlusion catheter. Background Art

[0002] At present, microcatheters used for the injection of vascular embolic products such as microspheres and liquid embolic agents can easily cause the microspheres or liquid embolic agents to drift to non-target vessels due to blood flow or blood pressure, leading to ischemia of other normal tissues and organs, causing harm or even death to the patient. In order to solve this problem, balloon occlusion catheters are used clinically, that is, a balloon is loaded at the front end of the catheter. Before injecting embolic products such as microspheres or liquid embolic agents, the balloon is filled. The filled balloon will temporarily block the blood flow and reduce local blood pressure, thereby reducing the drift of embolic products to surrounding non-target vessels and improving the accuracy and clinical effectiveness of embolization of target vessels.

[0003] However, although the balloon occlusion catheter has solved the risk of non-target vascular embolism to a certain extent, for the target blood vessels, the embolization product is completely dependent on the pushing force of the doctor's injection syringe to be pushed to the distal end. This pushing results in the embolization product moving to the distal end to a limited distance, which may lead to problems such as incomplete embolism and incomplete distal occlusion. Summary of the invention

[0004] In view of this, the present invention provides an assisted balloon occlusion catheter, which can solve the problem that the existing balloon occlusion catheter is completely pushed to the distal end by the pushing force of the doctor's injection syringe, resulting in a limited distance for the embolization product to move to the distal end, which may lead to incomplete embolism and incomplete distal occlusion.

[0005] The present invention is achieved in that: The present invention provides a balloon-assisted occlusion catheter, which comprises a three-way port, an outer rod, an inner rod and a balloon, wherein the three-way port comprises three openings, one of which is connected to the outer rod; two openings away from the outer rod are respectively a guide wire port and a pressure pump port; the proximal end of the outer rod is connected to the three-way port, and the distal end is connected to the balloon, and the balloon is used to temporarily block blood flow and reduce local blood pressure after being filled to reduce the embolization product from drifting to the surrounding non-target blood vessels; the inner rod is arranged inside the outer rod, and extends in a direction away from the outer rod, and is in the same straight line as the guide wire port, and is used to insert the guide wire; The outer rod corresponding to the balloon is provided with a mark, and the mark includes two marks, which are used to show the position of the balloon occlusion catheter; A flap is arranged at one end of the inner rod away from the three-way port, and the flap is used to be agitated under the drive of the balloon to promote blood flow at the flap position; the flap includes at least one flap.

[0006] The outer rod is made of polyamide (Pebax), with an effective length of 98.5-148.5 cm, an inner diameter of 0.72-0.82 mm, an outer diameter of 0.85-0.95 mm, and a hardness of 63D-55D. The inner rod is made of any one or a combination of polyether block amide, polyimide, polyurethane, and nylon materials, and has at least three hardness levels. The three lengths are 1 / 2, 1 / 3, and 1 / 6 of the total length respectively from the proximal end, and the Shore hardnesses are 72D-63D, 55D-45D, and 35D-25D respectively.

[0007] The balloon is made of polyurethane material with a hardness less than or equal to 40A. The inner layer of the balloon is provided with a linear low-density polyethylene (LLDPE) coating or a liner.

[0008] Three-way port: One opening of the three-way port is connected to the outer rod, so that the balloon can be connected to the rest of the catheter system through the outer rod. The other two openings are used for the guidewire port and the pressure pump port. The guidewire port is used to insert the guidewire to guide the catheter to the target position, and the pressure pump port is used to inject or discharge liquid into the balloon to adjust the balloon's filling state.

[0009] Outer rod: The outer rod extends from the proximal end of the three-way port to the distal end, where the balloon is connected. The outer rod provides support and stability in the catheter, allowing the balloon to be properly positioned and maintained in the target vessel. The markings on the outer rod show the current position of the balloon, helping the doctor to operate accurately.

[0010] Inner rod: The inner rod is set inside the outer rod and extends away from the outer rod, along the same line as the guidewire port. It is used to place the guidewire to guide the catheter to the target location. The presence of the inner rod allows the guidewire to be guided to the exact position through the outer rod, ensuring accurate positioning of the balloon.

[0011] Balloon: The balloon is connected by an outer rod and is used to temporarily block blood flow and reduce local blood pressure after being inflated. This helps reduce the drift of embolic products to non-target vessels, thereby improving the precision and safety of the procedure.

[0012] Flap: The flap is set at the end of the inner rod away from the three-way port. After repeated operations of balloon pressurization and inflation and decompression and contraction, the flap will be fanned by the blood flow, thereby promoting the blood flow at the flap position. This helps to improve hemodynamics and increase the directionality of the embolization product to the target vascular embolization position.

[0013] On the basis of the above technical solution, the booster balloon occlusion catheter of the present invention can also be improved as follows: Wherein, the guide wire port and the pressure pump port are arranged at an angle, and the angle is 30-60°; The length of the guide wire port is 1.1-1.5 times the length of the pressure pump port.

[0014] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: Angle setting: The angle between the guidewire port and the pressure pump port is 30-60°. This design helps to maintain a stable fluid dynamic state in the catheter and avoid pressure loss or difficulty in guidewire insertion due to excessive angles. This angle setting allows the guidewire to connect to the pressure pump more smoothly when entering the catheter, effectively improving the accuracy of the operation.

[0015] Port length ratio: The length of the guidewire port is 1.1-1.5 times the length of the pressure pump port. This ratio ensures that the guidewire has sufficient length in the catheter to support the action of the pressure pump. It also helps to improve the stability and sealing of the catheter and reduce the risk of leakage.

[0016] Further, the three-way port is connected to the outer rod by a connecting piece, and the structure of the connecting piece includes two parts, namely a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of the opening of one end of the three-way port close to the outer rod, and the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod, and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port and the outer rod; The outer diameter of the outer rod is the same as the inner diameter of the three-way port near the outer rod.

[0017] The beneficial effects of adopting the above-mentioned improved solution are as follows: Connector design: The connector includes a first fixing member and a second fixing member, which are integrally arranged. The inner diameter of the first fixing member is the same as the outer diameter of the opening of the end of the three-way port close to the outer rod, which can ensure the initial sealing of the connection. The inner diameter of the second fixing member gradually decreases along the direction of the outer rod, which can better adapt to the changes of the outer rod and achieve a tight seal to prevent leakage.

[0018] Outer diameter of outer rod: The outer diameter of the outer rod is the same as the inner diameter of the tee port near the outer rod. This design ensures that the connection between the tee port and the outer rod is precisely matched, which helps to avoid pressure leakage at the connection.

[0019] Further, a connecting channel is provided at the position where the balloon is connected to the outer rod, the connecting channel passes through the balloon and the outer rod, and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port, and the arc structure is specifically a section of a hyperbola, the focus of the hyperbola corresponding to the arc is located at one end of the balloon away from the bending direction of the spiral channel; the focus of the other side of the hyperbola is located at the end position of the other side of the balloon; the diameter of the connecting channel is ≤0.5mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port, the outer rod and the inner rod, the connecting channel and the balloon, and is used to apply pressure to the balloon position to fill it; A guidewire entry channel is formed between the guidewire port and the interior of the inner rod.

[0020] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: Spiral structure: The connecting channel is spiral, and the bending direction is facing away from the three-way port. This structure helps to evenly distribute the pressure of the balloon and reduce the pressure concentration phenomenon generated during the filling process. The arc structure (hyperbolic segment) of the spiral channel helps to maintain the stability and fluid dynamics performance of the connecting channel.

[0021] Channel diameter and helix angle: The diameter is ≤0.5mm and the helix angle is 45-60°. This design helps to accurately control the pressure distribution during balloon inflation and ensure the strength and durability of the channel.

[0022] Pressure channel: A pressure channel is formed between the pressure pump port, the outer rod and the inner rod, the connecting channel and the balloon to apply pressure to the balloon. The design of this channel ensures the filling efficiency of the balloon and the smooth progress of the occlusion process.

[0023] Furthermore, the inner rod is a multi-layer structure, which is used to support the guide wire entering the channel to avoid being flattened by the outer rod and the pressure pumped into the inner rod; The multilayer structure comprises an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04 mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from an end close to the mark to an end far away from the mark.

[0024] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: Support structure: The inner rod is a multi-layer structure, which is used to support the guide wire to enter the channel to prevent it from being crushed by pressure. The multi-layer structure includes an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is woven with stainless steel wire and tungsten wire, and its thickness and number of strands (0.02-0.04mm thickness, 9-10 strands) can effectively improve the strength and pressure resistance of the guide wire.

[0025] Furthermore, the connection position between the balloon and the outer rod is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is provided inside the balloon to monitor the pressure inside the balloon during operation.

[0026] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: Z-shaped structure welding: The connection position between the balloon and the outer rod is fixed and welded with a Z-shaped structure to ensure the sealing of the pressure channel. This welding method can enhance the stability of the connection and reduce the risk of leakage.

[0027] Pressure monitoring: A pressure sensor is installed inside the balloon to monitor the pressure inside the balloon during operation. This helps to grasp the balloon filling status in real time and ensure the safety and accuracy during the operation.

[0028] Furthermore, the outer rod includes a double structural layer, an inner metal supporting layer and an outer elastic layer, wherein the elastic layer is used to provide flexibility, and the metal supporting layer is used to enhance the supporting force of the outer rod.

[0029] The beneficial effects of adopting the above improved scheme are as follows: Structural layer: The outer rod includes a metal support layer and an elastic layer, the metal support layer enhances the support force of the outer rod, and the elastic layer provides the necessary flexibility. This double-layer design improves the comprehensive performance of the outer rod, making it both stable and flexible during operation.

[0030] Furthermore, there is one petal, and the petal is fixed on the outer rod in a crescent shape, with two ends thereof symmetrically arranged about the outer rod, and a concave side arranged at a position away from the balloon.

[0031] The beneficial effects of adopting the above-mentioned improved solution are as follows: Sealing: Due to the crescent-shaped design and symmetrical installation of the petal, the concave side can effectively form a wider sealing area, which helps prevent fluid leakage when the balloon is inflated. The design of the concave part can enhance the sealing effect, especially when the balloon is inflated and the pressure changes.

[0032] Fluid Flow: The crescent-shaped petal design allows fluid to flow naturally around the petals, while the concave side reduces resistance to fluid flow, providing a smoother filling process.

[0033] Stability: The symmetrical configuration of the crescent-shaped petals ensures uniform force on the petals during use, improving overall stability and durability.

[0034] Furthermore, there are two petals, and the two petals are symmetrically fixed on the outer rod.

[0035] The beneficial effects of adopting the above-mentioned improvement scheme are: enhanced sealing: the two symmetrical petal designs provide better sealing in structure, and the two petals cooperate with each other to more effectively close the channel between the guide wire port and the pressure pump port, thereby preventing fluid leakage.

[0036] Pressure balance: The symmetrical setting of the two petals can evenly distribute the pressure during the filling process, reduce the risk of excessive force on a single petal, and improve the overall stability and service life.

[0037] Fluid flow: The symmetrical petal configuration helps the smooth flow of fluid, reduces the unevenness of fluid flow, and ensures smooth balloon filling.

[0038] Furthermore, there are three petals, which are symmetrically arranged on the inner rod, and the angle between adjacent petals is 60°.

[0039] The beneficial effects of adopting the above improved solution are: comprehensive closure: three symmetrical petals can form a triangular closure structure, and the angle between adjacent petals is 60°, providing a more comprehensive closure effect. The petals configured in this way can more evenly close the entire channel when the balloon is filled to prevent fluid leakage.

[0040] Pressure distribution: Since the petals are distributed at an angle of 60°, this setting can achieve a more uniform pressure distribution, avoid the problem of excessive local pressure, and improve the stability and reliability of the closure.

[0041] Fluid flow: The configuration of the three petals allows the fluid to be better guided and controlled during the filling process, reduces interference with fluid flow, and ensures a smooth filling process. Compared with the prior art, the beneficial effects of the balloon occlusion catheter provided by the present invention are: Balloon function: After the balloon is inflated, it can effectively temporarily block blood flow and lower local blood pressure, thereby reducing the drift of embolic products to surrounding non-target blood vessels and achieving the purpose of effective occlusion.

[0042] Three-way port and catheter: The three-way port provides three key interfaces - the interface connected to the outer rod, the guidewire port and the pressure pump port. The angle setting (30-60°) and length ratio (1.1-1.5 times) between the guidewire port and the pressure pump port can optimize the catheter's operability and performance, and enhance precise control and blood flow management.

[0043] Inner rod and guidewire: The design of the inner rod and the guidewire port on the same line makes the insertion and operation of the guidewire more stable and accurate.

[0044] Flap function: The flap design (one, two or three flaps, shape and symmetrical configuration) helps improve blood flow dynamics and prevent unnecessary obstruction or disturbance of blood flow. In particular, the crescent-shaped flap design helps promote blood flow.

[0045] Connector design: The two-part structure of the connector (first fixing part and second fixing part) ensures a good seal between the tee port and the outer rod to prevent leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative labor.

[0047] Figure 1 A schematic diagram of the structure of a one-petal assisted balloon occlusion catheter; Figure 2 A schematic diagram of the structure of a two-petal assisted balloon occlusion catheter; Figure 3 It is a schematic diagram of the structure of a three-petal booster balloon occlusion catheter; In the accompanying drawings, the components represented by the reference numerals are listed as follows: 10. Three-way port; 11. Guidewire port; 12. Pressure pump port; 20. Outer rod; 21. Marker; 30. Inner rod; 40. Balloon; 50. Petal. DETAILED DESCRIPTION

[0048] In order to make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0049] like Figure 1As shown, it is a first embodiment of a balloon occlusion catheter provided by the present invention. In this embodiment, it includes a three-way port 10, an outer rod 20, an inner rod 30 and a balloon 40. The three-way port 10 includes three openings, one of which is connected to the outer rod 20; the two openings away from the outer rod 20 are respectively a guide wire port 11 and a pressure pump port 12; the proximal end of the outer rod 20 is connected to the three-way port 10, and the distal end is connected to the balloon 40. After being filled, the balloon 40 is used to temporarily block blood flow and reduce local blood pressure to reduce the embolization product from drifting to the surrounding non-target blood vessels; the inner rod 30 is arranged inside the outer rod 20, and extends in a direction away from the outer rod 20, and is in the same straight line with the guide wire port 11, and is used to insert the guide wire; The outer rod 20 corresponding to the balloon 40 is provided with a mark 21, and the mark 21 includes two marks, which are used to show the position of the balloon occlusion catheter; A flap 50 is provided at one end of the inner rod 30 away from the three-way port 10 , and the flap 50 is used to be fanned by the balloon 40 to promote blood flow at the position of the flap 50 .

[0050] Among them, in the above technical solution, the guide wire port 11 and the pressure pump port 12 are arranged at an angle, and the angle is 30-60°; The length of the guide wire port 11 is 1.1-1.5 times the length of the pressure pump port 12 .

[0051] Further, in the above technical solution, the three-way port 10 is connected to the outer rod 20 by a connecting piece, and the structure of the connecting piece includes two parts, namely, a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of the opening at one end of the three-way port 10 close to the outer rod 20, and the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod 20, and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port 10 and the outer rod 20; The outer diameter of the outer rod 20 is the same as the inner diameter of the three-way port 10 near the outer rod 20 .

[0052] Further, in the above technical solution, a connecting channel is provided at the position where the balloon 40 is connected to the outer rod 20, the connecting channel passes through the balloon 40 and the outer rod 20, and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port 10, and the arc structure is specifically a section of a hyperbola, and the focus corresponding to the hyperbola and the arc is located at one end of the balloon 40 away from the bending direction of the spiral channel; the focus on the other side of the hyperbola is located at the end position on the other side of the balloon 40; the diameter of the connecting channel is ≤0.5mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port 12, the outer rod 20 and the inner rod 30, the connecting channel and the balloon 40, for applying pressure to the balloon 40 to fill it; A guidewire entry channel is formed between the guidewire port 11 and the interior of the inner rod 30 .

[0053] When using, first prepare the catheter and all accessories, and ensure that the connectors, balloon, outer rod and inner rod are in good condition. Insert the guidewire into the catheter through the guidewire port, and ensure that the guidewire reaches the target position along the inner rod. Introduce the catheter into the target blood vessel and ensure that the balloon reaches the predetermined position. Inject liquid through the pressure pump port to fill the balloon to temporarily block the blood vessel. Observe the mark to confirm the correct position of the balloon. After the balloon is inflated, the flap will push the blood flow according to the designed shape and position to ensure smooth blood flow or form the desired hemodynamic effect. Adjust the filling volume as needed to maintain the appropriate blood flow blocking effect, and monitor the position and effect of the balloon in real time. After completing the operation, slowly empty the balloon, remove the catheter, and dispose of the catheter and all accessories.

[0054] Further, in the above technical solution, the inner rod 30 is a multi-layer structure, which is used to support the guide wire entering the channel to avoid being flattened by the pressure pumped into the outer rod 20 and the inner rod 30; The multi-layer structure includes an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from the end close to the mark 21 to the end far away from the mark 21 .

[0055] Furthermore, in the above technical solution, the connection position between the balloon 40 and the outer rod 20 is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is provided inside the balloon 40 for monitoring the pressure inside the balloon 40 during operation.

[0056] Furthermore, in the above technical solution, the outer rod 20 includes a double structural layer, an inner metal support layer and an outer elastic layer, the elastic layer is used to provide flexibility, and the metal support layer is used to enhance the supporting force of the outer rod 20.

[0057] Furthermore, in the above technical solution, there is one flap 50 , and the flap 50 fixed on the outer rod 20 is in a crescent shape, with its two ends symmetrically arranged about the outer rod 20 , and the concave side is arranged at a position away from the balloon 40 .

[0058] like Figure 2As shown, it is a second embodiment of a balloon occlusion catheter provided by the present invention. In this embodiment, it includes a three-way port 10, an outer rod 20, an inner rod 30 and a balloon 40. The three-way port 10 includes three openings, one of which is connected to the outer rod 20; the two openings away from the outer rod 20 are respectively a guide wire port 11 and a pressure pump port 12; the proximal end of the outer rod 20 is connected to the three-way port 10, and the distal end is connected to the balloon 40. After being filled, the balloon 40 is used to temporarily block blood flow and reduce local blood pressure to reduce the embolization product from drifting to the surrounding non-target blood vessels; the inner rod 30 is arranged inside the outer rod 20, and extends in a direction away from the outer rod 20, and is in the same straight line as the guide wire port 11, and is used to insert the guide wire; The outer rod 20 corresponding to the balloon 40 is provided with a mark 21, and the mark 21 includes two marks, which are used to show the position of the balloon occlusion catheter; A flap 50 is provided at one end of the inner rod 30 away from the three-way port 10 , and the flap 50 is used to be fanned by the balloon 40 to promote blood flow at the position of the flap 50 .

[0059] Among them, in the above technical solution, the guide wire port 11 and the pressure pump port 12 are arranged at an angle, and the angle is 30-60°; The length of the guide wire port 11 is 1.1-1.5 times the length of the pressure pump port 12 .

[0060] Further, in the above technical solution, the three-way port 10 is connected to the outer rod 20 by a connecting piece, and the structure of the connecting piece includes two parts, namely, a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of the opening at one end of the three-way port 10 close to the outer rod 20, and the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod 20, and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port 10 and the outer rod 20; The outer diameter of the outer rod 20 is the same as the inner diameter of the three-way port 10 near the outer rod 20 .

[0061] Further, in the above technical solution, a connecting channel is provided at the position where the balloon 40 is connected to the outer rod 20, the connecting channel passes through the balloon 40 and the outer rod 20, and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port 10, and the arc structure is specifically a section of a hyperbola, and the focus corresponding to the hyperbola and the arc is located at one end of the balloon 40 away from the bending direction of the spiral channel; the focus on the other side of the hyperbola is located at the end position on the other side of the balloon 40; the diameter of the connecting channel is ≤0.5mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port 12, the outer rod 20 and the inner rod 30, the connecting channel and the balloon 40, for applying pressure to the balloon 40 to fill it; A guidewire entry channel is formed between the guidewire port 11 and the interior of the inner rod 30 .

[0062] Further, in the above technical solution, the inner rod 30 is a multi-layer structure, which is used to support the guide wire entering the channel to avoid being flattened by the pressure pumped into the outer rod 20 and the inner rod 30; The multi-layer structure includes an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from the end close to the mark 21 to the end far away from the mark 21 .

[0063] Furthermore, in the above technical solution, the connection position between the balloon 40 and the outer rod 20 is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is provided inside the balloon 40 for monitoring the pressure inside the balloon 40 during operation.

[0064] Furthermore, in the above technical solution, the outer rod 20 includes a double structural layer, an inner metal support layer and an outer elastic layer, the elastic layer is used to provide flexibility, and the metal support layer is used to enhance the supporting force of the outer rod 20.

[0065] Furthermore, in the above technical solution, there are two petals 50 , and the two petals 50 are symmetrically fixed on the outer rod 20 .

[0066] like Figure 3 As shown, it is a third embodiment of a balloon occlusion catheter provided by the present invention. In this embodiment, it includes a three-way port 10, an outer rod 20, an inner rod 30 and a balloon 40. The three-way port 10 includes three openings, one of which is connected to the outer rod 20; the two openings away from the outer rod 20 are respectively a guide wire port 11 and a pressure pump port 12; the proximal end of the outer rod 20 is connected to the three-way port 10, and the distal end is connected to the balloon 40. After being filled, the balloon 40 is used to temporarily block blood flow and reduce local blood pressure to reduce the embolization product from drifting to the surrounding non-target blood vessels; the inner rod 30 is arranged inside the outer rod 20, and extends in a direction away from the outer rod 20, and is in the same straight line with the guide wire port 11, and is used to insert the guide wire; The outer rod 20 corresponding to the balloon 40 is provided with a mark 21, and the mark 21 includes two marks, which are used to show the position of the balloon occlusion catheter; A flap 50 is provided at one end of the inner rod 30 away from the three-way port 10 , and the flap 50 is used to be fanned by the balloon 40 to promote blood flow at the position of the flap 50 .

[0067] Among them, in the above technical solution, the guide wire port 11 and the pressure pump port 12 are arranged at an angle, and the angle is 30-60°; The length of the guide wire port 11 is 1.1-1.5 times the length of the pressure pump port 12 .

[0068] Further, in the above technical solution, the three-way port 10 is connected to the outer rod 20 by a connecting piece, and the structure of the connecting piece includes two parts, namely, a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of the opening at one end of the three-way port 10 close to the outer rod 20, and the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod 20, and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port 10 and the outer rod 20; The outer diameter of the outer rod 20 is the same as the inner diameter of the three-way port 10 near the outer rod 20 .

[0069] Further, in the above technical solution, a connecting channel is provided at the position where the balloon 40 is connected to the outer rod 20, the connecting channel passes through the balloon 40 and the outer rod 20, and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port 10, and the arc structure is specifically a section of a hyperbola, and the focus corresponding to the hyperbola and the arc is located at one end of the balloon 40 away from the bending direction of the spiral channel; the focus on the other side of the hyperbola is located at the end position on the other side of the balloon 40; the diameter of the connecting channel is ≤0.5mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port 12, the outer rod 20 and the inner rod 30, the connecting channel and the balloon 40, for applying pressure to the balloon 40 to fill it; A guidewire entry channel is formed between the guidewire port 11 and the interior of the inner rod 30 .

[0070] Further, in the above technical solution, the inner rod 30 is a multi-layer structure, which is used to support the guide wire entering the channel to avoid being flattened by the pressure pumped into the outer rod 20 and the inner rod 30; The multi-layer structure includes an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from the end close to the mark 21 to the end far away from the mark 21 .

[0071] Furthermore, in the above technical solution, the connection position between the balloon 40 and the outer rod 20 is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is provided inside the balloon 40 for monitoring the pressure inside the balloon 40 during operation.

[0072] Furthermore, in the above technical solution, the outer rod 20 includes a double structural layer, an inner metal support layer and an outer elastic layer, the elastic layer is used to provide flexibility, and the metal support layer is used to enhance the supporting force of the outer rod 20.

[0073] Furthermore, in the above technical solution, there are three petals 50 , which are symmetrically arranged on the inner rod 30 , and the angle between adjacent petals 50 is 60°.

[0074] A fourth embodiment of a balloon occlusion catheter provided by the present invention comprises a three-way port 10, an outer rod 20, an inner rod 30 and a balloon 40. The three-way port 10 comprises three openings, one of which is connected to the outer rod 20; two openings away from the outer rod 20 are respectively a guide wire port 11 and a pressure pump port 12; the proximal end of the outer rod 20 is connected to the three-way port 10, and the distal end is connected to the balloon 40, which is used to temporarily block blood flow and reduce local blood pressure after filling to reduce the embolization product from drifting to the surrounding non-target blood vessels; the inner rod 30 is arranged inside the outer rod 20, and extends in a direction away from the outer rod 20, and is in the same straight line as the guide wire port 11, and is used to insert the guide wire; The outer rod 20 corresponding to the balloon 40 is provided with a mark 21, and the mark 21 includes two marks, which are used to show the position of the balloon occlusion catheter; A flap 50 is provided at one end of the inner rod 30 away from the three-way port 10 , and the flap 50 is used to be fanned by the balloon 40 to promote blood flow at the position of the flap 50 .

[0075] Among them, in the above technical solution, the guide wire port 11 and the pressure pump port 12 are arranged at an angle, and the angle is 30-60°; The length of the guide wire port 11 is 1.1-1.5 times the length of the pressure pump port 12 .

[0076] Further, in the above technical solution, the three-way port 10 is connected to the outer rod 20 by a connecting piece, and the structure of the connecting piece includes two parts, namely, a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of the opening at one end of the three-way port 10 close to the outer rod 20, and the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod 20, and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port 10 and the outer rod 20; The outer diameter of the outer rod 20 is the same as the inner diameter of the three-way port 10 near the outer rod 20 .

[0077] Further, in the above technical solution, a connecting channel is provided at the position where the balloon 40 is connected to the outer rod 20, the connecting channel passes through the balloon 40 and the outer rod 20, and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port 10, and the arc structure is specifically a section of a hyperbola, and the focus corresponding to the hyperbola and the arc is located at one end of the balloon 40 away from the bending direction of the spiral channel; the focus on the other side of the hyperbola is located at the end position on the other side of the balloon 40; the diameter of the connecting channel is ≤0.5mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port 12, the outer rod 20 and the inner rod 30, the connecting channel and the balloon 40, for applying pressure to the balloon 40 to fill it; A guidewire entry channel is formed between the guidewire port 11 and the interior of the inner rod 30 .

[0078] Further, in the above technical solution, the inner rod 30 is a multi-layer structure, which is used to support the guide wire entering the channel to avoid being flattened by the pressure pumped into the outer rod 20 and the inner rod 30; The multi-layer structure includes an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from the end close to the mark 21 to the end far away from the mark 21 .

[0079] Furthermore, in the above technical solution, the connection position between the balloon 40 and the outer rod 20 is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is provided inside the balloon 40 for monitoring the pressure inside the balloon 40 during operation.

[0080] Furthermore, in the above technical solution, the outer rod 20 includes a double structural layer, an inner metal support layer and an outer elastic layer, the elastic layer is used to provide flexibility, and the metal support layer is used to enhance the supporting force of the outer rod 20.

[0081] Furthermore, there are four or more petals 50, and the multiple petals 50 are symmetrically arranged on the inner rod 30, and the angles between adjacent petals 50 are the same.

[0082] Specifically, the principle of the present invention is: when using, first prepare the catheter and all accessories, and ensure that the connector, balloon, outer rod and inner rod are in good condition. Insert the guidewire into the catheter through the guidewire port to ensure that the guidewire reaches the target position along the inner rod. Introduce the catheter into the target blood vessel to ensure that the balloon reaches the predetermined position. Inject liquid through the pressure pump port to fill the balloon to temporarily block the blood vessel. Observe the mark to confirm the correct position of the balloon. After the balloon is filled, the flap will push the blood flow according to the designed shape and position to ensure smooth blood flow or form the required hemodynamic effect. Adjust the filling amount as needed to maintain the appropriate blood flow blocking effect, and monitor the position and effect of the balloon in real time. After completing the operation, slowly empty the balloon, remove the catheter, and handle the catheter and all accessories. If necessary, filling and emptying the balloon needs to be repeated several times to achieve better promotion of blood flow and push the embolization product into the expected position of the target blood vessel to achieve better embolization effect.

Claims

1. A balloon-assisted occlusion catheter, characterized in that: The device comprises a three-way port (10), an outer rod (20), an inner rod (30) and a balloon (40); the three-way port (10) comprises three openings, one of which is connected to the outer rod (20); two openings away from the outer rod (20) are respectively a guide wire port (11) and a pressure pump port (12); the proximal end of the outer rod (20) is connected to the three-way port (10), and the distal end is connected to the balloon (40); after being filled, the balloon (40) is used to temporarily block blood flow and reduce local blood pressure to reduce the dispersion of embolic products to peripheral non-target blood vessels; the inner rod (30) is arranged inside the outer rod (20), extends in a direction away from the outer rod (20), and is in the same straight line as the guide wire port (11), and is used to insert a guide wire; The outer rod (20) corresponding to the balloon (40) is provided with a mark (21), and the mark (21) includes two marks, which are used to indicate the position of the balloon occlusion catheter; A flap (50) is provided at one end of the inner rod (30) away from the three-way port (10), and the flap (50) is used to be agitated under the drive of the balloon (40) to promote blood flow at the position of the flap (50); the flap (50) includes at least one.

2. The balloon-assisted occlusion catheter according to claim 1, characterized in that: The guide wire port (11) and the pressure pump port (12) are arranged at an angle, and the angle is 30-60°; The length of the guide wire port (11) is 1.1-1.5 times the length of the pressure pump port (12).

3. The balloon-assisted occlusion catheter according to claim 2, characterized in that: The three-way port (10) and the outer rod (20) are connected via a connecting piece, the structure of the connecting piece comprises two parts, namely a first fixing piece and a second fixing piece, the first fixing piece and the second fixing piece are integrally arranged, the inner diameter of the first fixing piece is the same as the outer diameter of an opening at one end of the three-way port (10) close to the outer rod (20), the inner diameter of the second fixing piece gradually decreases from the proximal end to the distal end of the outer rod (20), and the first fixing piece and the second fixing piece are used to seal the connection between the three-way port (10) and the outer rod (20); The outer diameter of the outer rod (20) is the same as the inner diameter of the three-way port (10) at a position close to the outer rod (20).

4. The balloon-assisted occlusion catheter according to claim 3, characterized in that: A connecting channel is provided at the position where the balloon (40) and the outer rod (20) are connected, the connecting channel passes through the balloon (40) and the outer rod (20), and the connecting channel is a spiral structure; the spiral structure is an arc structure, the bending direction of which is toward the direction away from the three-way port (10), and the arc structure is specifically a section of a hyperbola, the focus of the hyperbola corresponding to the arc is located at one end of the balloon (40) away from the bending direction of the spiral channel; the focus of the other side of the hyperbola is located at the end position of the other side of the balloon (40); the diameter of the connecting channel is ≤0.5 mm, and the spiral angle is 45-60°; A pressure channel is formed between the pressure pump port (12), the outer rod (20) and the inner rod (30), the connecting channel and the balloon (40), and is used to apply pressure to the balloon (40) to fill it; A guide wire entry channel is formed between the guide wire port (11) and the interior of the inner rod (30).

5. The balloon-assisted occlusion catheter according to claim 4, characterized in that: The inner rod (30) is a multi-layer structure, used to support the guide wire entry channel to avoid being flattened by the pressure pumped into the outer rod (20) and the inner rod (30); The multilayer structure comprises an inner lining layer, a metal braided layer and an outer layer, wherein the metal braided layer is braided with stainless steel wire and tungsten wire, the thickness of the cross section is between 0.02-0.04 mm, and the number of braided strands is 9-10; The thickness of the multi-layer structure gradually decreases from an end close to the mark (21) to an end far away from the mark (21).

6. The balloon-assisted occlusion catheter according to claim 5, characterized in that: The connection position between the balloon (40) and the outer rod (20) is fixed with a Z-shaped structure and then welded to ensure the sealing of the pressure channel; A pressure sensor is arranged inside the balloon (40) for monitoring the pressure inside the balloon (40) during operation.

7. The balloon-assisted occlusion catheter according to claim 6, characterized in that: The outer rod (20) comprises a double structural layer, an inner metal support layer and an outer elastic layer, wherein the elastic layer is used to provide flexibility, and the metal support layer is used to enhance the supporting force of the outer rod (20).

8. The balloon-assisted occlusion catheter according to claim 7, characterized in that: The flap (50) is one, and the flap (50) is fixed on the outer rod (20) in a crescent shape, with two ends symmetrically arranged about the outer rod (20), and the concave side is arranged at a position away from the balloon (40).

9. The balloon-assisted occlusion catheter according to claim 8, characterized in that: There are two petals (50), and the two petals (50) are symmetrically fixed on the outer rod (20).

10. The balloon-assisted occlusion catheter according to claim 9, characterized in that: There are three petals (50), and the three petals (50) are symmetrically arranged on the inner rod (30), and the angle between adjacent petals (50) is 60°.

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