Auxiliary balloon blocking catheter

Abstract

The invention provides an auxiliary balloon blocking catheter, and belongs to the technical field of balloon blocking catheters.The auxiliary balloon blocking catheter comprises a catheter body, a balloon body, an inflation cavity, a guide wire channel, a blocking head, a supporting ring, a power assisting mechanism, a propeller, a positioning mark and a sealing ring, and the power assisting mechanism is arranged in the catheter body and provides active propelling force for a balloon; the supporting ring is circumferentially arranged around the balloon body to guarantee stable shape of the balloon, the plugging head is located at the front end of the balloon body to reduce advancing resistance, the positioning mark is arranged on the surface of the balloon to improve positioning precision, and the sealing ring and the one-way valve guarantee reliable sealing. Through the synergistic effect of the elastic energy storage and transmission functions of the power assisting mechanism, the radial supporting function of the supporting ring, the flow guiding function of the plugging head, the developing function of the positioning mark and the sealing function of the sealing system, the technical problems that an existing catheter is difficult to push, inaccurate in positioning and unstable in plugging effect are solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of balloon occlusion catheters, and in particular relates to an auxiliary balloon occlusion catheter. Background Art

[0002] In the existing technology, vascular occlusion catheters are widely used in interventional treatment surgeries to block blood flow in specific blood vessels to treat diseases such as aneurysms and vascular malformations. Traditional balloon occlusion catheters mainly rely on doctors to manually push the catheter to the target position, and then inflate the balloon to achieve vascular occlusion. However, this method has the problem of difficulty in pushing, especially in areas with complex blood vessel bends, where the catheter is prone to bending and getting stuck, affecting the progress of the operation. At the same time, due to the lack of an effective power-assisting mechanism, doctors need to apply a large thrust, which can easily cause vascular damage. In addition, the balloon of the existing catheter is not stable enough in shape when inflated, and is prone to irregular deformation, affecting the occlusion effect. The positioning accuracy is also not high enough, making it difficult for doctors to accurately judge the position of the catheter, increasing the risk of the operation. In other words, the existing technology has technical problems such as difficulty in catheter advancement, inaccurate positioning, and unstable occlusion effect. Summary of the Invention

[0003] In view of this, the present invention provides an auxiliary balloon occlusion catheter, which can solve the technical problems in the prior art such as difficulty in catheter advancement, inaccurate positioning, and unstable occlusion effect.

[0004] The present invention is achieved in that: The present invention provides an auxiliary balloon occlusion catheter, comprising a catheter body, a balloon body, an inflation cavity, a guidewire channel, a blocking head, a support ring, a power-assisting mechanism, a pusher, a positioning marker, and a sealing ring, wherein the power-assisting mechanism is disposed inside the catheter body, the balloon body is connected to the catheter body through the inflation cavity, the blocking head is located at the front end of the balloon body, and the support ring is disposed circumferentially around the balloon body; The power-assisting mechanism includes an elastic energy storage component and a transmission component. The elastic energy storage component is connected to the propeller through the transmission component. When the propeller moves axially along the catheter body, it drives the balloon body forward.

[0005] The technical effects of the auxiliary balloon blocking catheter provided by the present invention are as follows: through the cooperation of the power assist mechanism and the balloon body, the active propulsion function of the catheter in the blood vessel is realized, solving the problem that traditional catheters are prone to bending and inaccurate positioning when only relying on external force to push.

[0006] The elastic energy storage component can store and release energy, and transmit the energy to the propeller through the transmission component, providing continuous and stable propulsion force for the advancement of the balloon and improving the controllability of the catheter.

[0007] On the basis of the above technical solution, the auxiliary balloon blocking catheter of the present invention can also be improved as follows: The elastic energy storage component is a coil spring, one end of which is fixed to the inner wall of the catheter body, and the other end is connected to the transmission component, which is a push rod structure; The support ring is a metal wire braided ring embedded in the wall of the balloon body. The diameter of the support ring is larger than the diameter of the balloon body when it is not inflated.

[0008] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: the coil spring as an elastic energy storage component has good elastic characteristics, and the transmission component of the push rod structure can effectively transmit the propulsion force. The cooperation of the two realizes smooth and controllable power-assisted propulsion.

[0009] The wire braided ring provides radial support for the balloon, preventing irregular deformation of the balloon during inflation and ensuring the stability and reliability of the occlusion effect.

[0010] Furthermore, the plugging head is conical, the cone angle of the plugging head is 30 degrees to 60 degrees, and the plugging head is connected to the front end of the balloon body by bonding; The guidewire channel runs through the entire length of the catheter body, the inner diameter of the guidewire channel is 0.5 mm to 1.2 mm, and the guidewire channel is connected to the inner cavity of the balloon body.

[0011] The beneficial effects of adopting the above-mentioned improved solution are as follows: the conical plugging head reduces the resistance of the catheter during advancement, and the specific cone angle range ensures both a good diversion effect and effective fit with the blood vessel wall.

[0012] The guidewire channel provides a passage for the guidewire. The specific inner diameter range ensures the smooth passage of the guidewire while avoiding the channel being too large to affect the overall strength of the catheter.

[0013] Furthermore, the positioning marks are provided on the surface of the balloon body, the positioning marks are annular marks made of a developing material, and the positioning marks are spaced apart along the axial direction of the balloon body; The sealing ring is arranged at the connection between the catheter body and the balloon body. The sealing ring is made of silicone material and has an interference fit with the catheter body.

[0014] The beneficial effect of adopting the above-mentioned improvement scheme is that the positioning mark made of the developing material is clearly visible under the imaging equipment, which helps the doctor to accurately determine the position of the catheter in the blood vessel and improves the accuracy of the operation.

[0015] The sealing ring prevents gas from leaking from the connection during inflation. The silicone material has good sealing and biocompatibility, and the interference fit ensures the reliability of the seal.

[0016] Furthermore, the inflation chamber is connected to an external inflation device through an inflation pipeline, and a one-way valve is provided in the inflation pipeline to prevent gas from flowing back from the inflation chamber.

[0017] The beneficial effects of adopting the above-mentioned improvement scheme are: the one-way valve prevents gas backflow, maintains the pressure in the balloon stable, ensures the continuous and effective sealing effect, and avoids sealing failure caused by gas leakage.

[0018] Furthermore, a limiting protrusion is provided at the front end of the pusher, and the limiting protrusion cooperates with the limiting groove on the inner wall of the catheter body to limit the moving stroke of the pusher.

[0019] The beneficial effects of adopting the above-mentioned improvement scheme are as follows: the cooperation between the limiting protrusion and the limiting groove limits the movement range of the propeller, prevents the propeller from excessively moving and damaging the catheter structure, and improves the safety of use.

[0020] Furthermore, the specific preparation steps of the auxiliary balloon occlusion catheter include: The first step is to heat and extrude the polymer material using an extruder according to the size requirements to form a catheter body tube with the required inner and outer diameters, and then cut the tube to obtain the catheter body; The second step is to use a blow molding process to place the balloon body material into a mold and use compressed air to blow-mold it to the designed shape and size. When the balloon body is not inflated, its diameter is measured. The third step is to use a wire braiding device to weave the wire into a ring shape to form a support ring. When the balloon body is not fully solidified, the support ring is evenly embedded into the wall of the balloon body, and the diameter of the support ring is ensured to be larger than the diameter of the balloon body when it is not inflated, so as to provide good support. Step 4: Connect the conical plugging head to the front end of the balloon body by bonding; Step 5: Drill a hole through the catheter tube from one end to the other to create a guidewire channel with an inner diameter of 0.5 mm to 1.2 mm. Step 6: Fix one end of the coil spring to a pre-designed position on the inner wall of the catheter body by spot welding, and connect the other end to the push rod. Connect the push rod to the pusher to ensure that the pusher can move smoothly along the axial direction within the catheter body. When the pusher moves, it can drive the balloon body forward through the push rod and coil spring. Step 7: Use a developer material to make an annular positioning mark, and stick the positioning mark on the surface of the balloon body along the axial direction of the balloon body according to the designed interval. The positioning mark is firmly affixed to ensure that the positioning mark will not shift or fall off during the inflation and deflation process of the balloon body; Step 8: Take an appropriate amount of silicone material to make a sealing ring. The size is determined according to the actual size of the connection between the catheter body and the balloon body. Put the sealing ring on the connection between the catheter body and the balloon body. Use appropriate pressure or gluing to make the sealing ring and the catheter body have an interference fit, so as to play a good sealing role and prevent gas leakage. Step 9: Set an inflation cavity on the catheter body so that it communicates with the inner cavity of the balloon body. Connect one end of the inflation tube to the inflation cavity and the other end to the external inflation device. Check the air tightness of the inflation tube and install a one-way valve in the inflation tube to ensure that the one-way valve can work properly to prevent gas from flowing back from the inflation cavity. The tenth step is to process a limiting protrusion at the front end of the pusher, the size of which matches the limiting groove on the inner wall of the catheter body; process a limiting groove at the corresponding position of the inner wall of the catheter body, insert the pusher into the catheter body, and make the limiting protrusion cooperate with the limiting groove to limit the moving stroke of the pusher, ensuring that the pusher can only move within the set range, avoiding damage to the balloon body due to excessive propulsion.

[0021] Furthermore, the conical plugging head is connected to the front end of the balloon body by bonding, and the adhesive used is composed of one or more of α-cyanoacrylate monomer, epoxy resin, acrylate monomer, oligomer, silicone rubber and chitosan. Compared with the prior art, the beneficial effects of the auxiliary balloon occlusion catheter provided by the present invention are: The present invention provides active propulsion force for the balloon by setting up an assist mechanism, ensures the stability of the balloon shape by using a support ring, reduces the forward resistance by using a blocking head, improves the positioning accuracy by using a positioning mark, and ensures reliable sealing by using a sealing ring and a one-way valve. It solves the technical problems of difficult catheter propulsion, inaccurate positioning, and unstable blocking effect in the prior art, and significantly improves the success rate and safety of vascular occlusion surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the structure of an auxiliary balloon occlusion catheter; Figure 2 It is a structural schematic diagram of a second embodiment of an auxiliary balloon occlusion catheter; In the accompanying drawings, the components represented by the reference numerals are as follows: 1. Catheter body; 2. Balloon body; 3. Inflation cavity; 4. Guidewire channel; 5. Sealing head; 6. Support ring; 7. Power assist mechanism; 8. Propeller; 9. Positioning mark; 10. Sealing ring; 11. Elastic energy storage component; 12. Transmission component; 13. Coil spring; 14. Push rod; 16. Conical head; 17. Inflation pipeline; 18. One-way valve; 19. Limiting protrusion; 21. Catheter wall; 22. Balloon wall; 26. External inflation device; 27. Guidewire. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0024] like Figure 1 As shown in the figure, it is a schematic structural diagram of an auxiliary balloon blocking catheter provided by the present invention, including a catheter body 1, a balloon body 2, an inflation cavity 3, a guidewire channel 4, a blocking head 5, a support ring 6, a power mechanism 7, a propeller 8, a positioning marker 9 and a sealing ring 10. The catheter body 1 is a slender tubular structure made of medical-grade polymer material with good flexibility and biocompatibility. The outer diameter of the catheter body 1 is 2 mm to 4 mm, and the wall thickness is 0.2 mm to 0.5 mm. The balloon body 2 is located at the front end of the catheter body 1 and is made of thin-walled polymer. The balloon body 2 is made of a thin film with good elasticity and sealing. The balloon body 2 is folded and close to the catheter body 1 in the uninflated state. After inflation, it expands into an ellipsoidal or cylindrical shape. The inflation cavity 3 is located inside the balloon body 2 and is connected to the external inflation device 26 through the inflation pipeline 17. The guidewire channel 4 runs through the entire length of the catheter body 1 to provide a passage for the guidewire 27. The blocking head 5 is located at the front end of the balloon body 2 and is conical 16 with a cone angle of 45 degrees. It is made of the same material as the balloon body 2 and is connected to the balloon body 2 by hot melt welding. The support ring 6 is The wire braided ring is woven with nickel-titanium alloy wire and has superelastic properties. It is embedded in the wall 22 of the balloon body 2 to provide radial support for the balloon. The power-assisting mechanism 7 is arranged inside the catheter body 1 and includes an elastic energy storage component 11 and a transmission component 12. The elastic energy storage component 11 is a coil spring 13 made of stainless steel wire, one end of which is fixed to the inner wall 21 of the catheter body 1 and the other end is connected to the transmission component 12. The transmission component 12 is a push rod 14 made of medical stainless steel. The propeller 8 is connected to the front end of the push rod 14. The propeller 8 is made of polyurethane. The catheter body 1 is made of a composite material, and a limiting protrusion 19 is provided at the front end, which cooperates with the limiting groove on the inner wall of the catheter body 1. The positioning mark 9 is set on the surface of the balloon body 2. It is a developing ring made of a developing material containing barium or iodine and is distributed at 5 mm intervals along the axial direction of the balloon body 2. The sealing ring 10 is a silicone sealing ring, which is provided at the connection between the catheter body 1 and the balloon body 2 and has an interference fit with the catheter body 1. A one-way valve 18 is provided in the inflation pipeline 17 to prevent gas from flowing back from the inflation chamber 3. The connecting joint is located at the rear end of the catheter body 1 for connecting to an external inflation device 26.

[0025] The production process of this scheme includes steps such as material preparation, component processing, assembly and testing. First, medical-grade polymer materials, nickel-titanium alloy wire, stainless steel wire and other raw materials are prepared. Then, the catheter body 1 is manufactured through extrusion molding, the balloon body 2 is manufactured through blow molding, the support ring 6 is manufactured through weaving, the pusher 8 and push rod 14 are manufactured through machining, and the sealing ring 10 is manufactured through injection molding. Then, assembly is carried out, the support ring 6 is embedded in the wall of the balloon body 2, the balloon body 2 is connected to the catheter body 1, the power assist mechanism 7 and the pusher 8 are installed, and finally, sealing test, strength test and biocompatibility test are carried out. When in use, the doctor inserts the catheter into the blood vessel and guides the catheter to the target position through the guide wire 27. Then, the power assist mechanism 7 is activated, the coil spring 13 releases the stored elastic potential energy, pushes the pusher 8 through the push rod 14, and drives the balloon body 2 to move forward. After reaching the blocking position, the inflation cavity 3 is inflated through the inflation pipeline 17, and the balloon body 2 expands and fits the blood vessel wall to achieve blocking.

[0026] The technical effect of this solution compared to the existing technology is that the power assist mechanism 7 provides active propulsion force for the catheter, solving the problem of difficulty in manual pushing by doctors. The elastic potential energy stored in the coil spring 13 is converted into propulsion force through the push rod 14. The propulsion process is smooth and controllable, avoiding damage to the blood vessels caused by sudden and strong pushing. The support ring 6 provides radial constraints for the balloon body 2, ensuring that the balloon maintains a regular shape when inflated, improving the stability and reliability of the sealing effect. The conical design of the sealing head 5 reduces the resistance of the catheter when it moves forward, conforms to the principles of fluid mechanics, and makes it easier for the catheter to pass through the curved parts of the blood vessels. The positioning mark 9 is clearly visible under X-rays, helping doctors to accurately judge the position of the catheter and improving the accuracy and safety of the operation. The sealing ring 10 and the one-way valve 18 ensure the sealing reliability of the system and prevent gas leakage from causing sealing failure.

[0027] On the basis of the above scheme, the following improvement scheme can also be adopted, replacing the coil spring 13 with a pneumatic energy storage device, the pneumatic energy storage device includes an air storage chamber and a piston, the air storage chamber stores compressed gas, and the piston drives the push rod 14 to move under the push of the compressed gas. This improvement scheme can provide greater propulsion force and is suitable for more complex vascular environments. At the same time, the single support ring 6 is replaced by multiple support rings, and the multiple support rings are distributed axially along the balloon body 2, and the spacing between adjacent support rings is 3 mm to 8 mm. This improvement scheme can provide more uniform radial support for the balloon and further improve the stability of the sealing effect. In addition, the positioning mark 9 is improved from a ring-shaped developing ring to a spiral developing line, and the spiral developing line is spirally distributed along the surface of the balloon body 2, with a pitch of 5 mm to 10 mm. This improvement scheme can clearly display the position and direction of the catheter under X-ray projection at different angles, thereby improving the positioning accuracy.

[0028] The production and use process of the improved solution is similar to that of the basic solution. The pneumatic energy storage device is manufactured through precision machining technology. The air storage chamber is made of stainless steel, and the piston is made of polymer material. The manufacture of multiple support rings requires precise control of weaving density and size. The spiral development line is manufactured through screen printing technology. When used, an external air source is required to inflate the pneumatic energy storage device. The propulsion force is adjusted by controlling the inflation pressure. The presence of multiple support rings makes the radial support of the balloon more uniform, and the spiral development line can provide clear position information under X-ray projection at any angle.

[0029] The improvement of the improved solution compared to the basic solution is that the pneumatic energy storage device can provide greater and more precise propulsion force. By adjusting the air pressure, the magnitude of the propulsion force can be precisely controlled to adapt to different vascular environments and surgical needs. The design of multiple support rings makes the radial support of the balloon more uniform, avoiding the stress concentration that may be caused by a single support ring, and improving the service life and sealing effect of the balloon. The spiral development line can provide richer position information than the annular development ring. The doctor can observe the position and direction of the catheter from any angle, which significantly improves the accuracy of the operation. Compared with the existing technology, the improved solution further improves the propulsion ability, sealing stability and positioning accuracy of the catheter, and provides a more reliable solution for interventional treatment in complex vascular environments. Furthermore, in the above technical solution, the specific preparation steps of the auxiliary balloon blocking catheter include: The first step is to heat and extrude the polymer material using an extruder according to the size requirements to form a catheter body tube with the required inner and outer diameters, and then cut the tube to obtain the catheter body; The second step is to use a blow molding process to place the balloon body material into a mold and use compressed air to blow-mold it to the designed shape and size. When the balloon body is not inflated, its diameter is measured. The third step is to use a wire braiding device to weave the wire into a ring shape to form a support ring. When the balloon body is not fully solidified, the support ring is evenly embedded into the wall of the balloon body, and the diameter of the support ring is ensured to be larger than the diameter of the balloon body when it is not inflated, so as to provide good support. Step 4: Connect the conical plugging head to the front end of the balloon body by bonding; Step 5: Drill a hole through the catheter tube from one end to the other to create a guidewire channel with an inner diameter of 0.5 mm to 1.2 mm. Step 6: Fix one end of the coil spring to a pre-designed position on the inner wall of the catheter body by spot welding, and connect the other end to the push rod. Connect the push rod to the pusher to ensure that the pusher can move smoothly along the axial direction within the catheter body. When the pusher moves, it can drive the balloon body forward through the push rod and coil spring. Step 7: Use a developer material to make an annular positioning mark, and stick the positioning mark on the surface of the balloon body along the axial direction of the balloon body according to the designed interval. The positioning mark is firmly affixed to ensure that the positioning mark will not shift or fall off during the inflation and deflation process of the balloon body; Step 8: Take an appropriate amount of silicone material to make a sealing ring. The size is determined according to the actual size of the connection between the catheter body and the balloon body. Put the sealing ring on the connection between the catheter body and the balloon body. Use appropriate pressure or gluing to make the sealing ring and the catheter body have an interference fit, so as to play a good sealing role and prevent gas leakage. Step 9: Set an inflation cavity on the catheter body so that it communicates with the inner cavity of the balloon body. Connect one end of the inflation tube to the inflation cavity and the other end to the external inflation device. Check the air tightness of the inflation tube and install a one-way valve in the inflation tube to ensure that the one-way valve can work properly to prevent gas from flowing back from the inflation cavity. The tenth step is to process a limiting protrusion at the front end of the pusher, the size of which matches the limiting groove on the inner wall of the catheter body; process a limiting groove at the corresponding position of the inner wall of the catheter body, insert the pusher into the catheter body, and make the limiting protrusion cooperate with the limiting groove to limit the moving stroke of the pusher, ensuring that the pusher can only move within the set range, avoiding damage to the balloon body due to excessive propulsion.

[0030] Furthermore, in the above technical solution, the conical plugging head is connected to the front end of the balloon body by bonding, and the adhesive used is composed of one or more of α-cyanoacrylate monomer, epoxy resin, acrylate monomer, oligomer, silicone rubber and chitosan. Example

[0031] This embodiment adopts the basic scheme in the specific implementation mode. The catheter body 1 is made of polyurethane material, with an outer diameter of 3 mm, a wall thickness of 0.3 mm, and a length of 120 cm. The balloon body 2 is made of polyethylene film with a thickness of 0.05 mm. The outer diameter when not inflated is 3.2 mm, the outer diameter after inflation is 12 mm, and the length is 20 mm. The volume of the inflation cavity 3 is 1.5 ml, the inner diameter of the guidewire channel 4 is 0.8 mm, the sealing head 5 is made of polyurethane material, the cone angle is 45 degrees, and the length is 5 mm. The support ring 6 is woven with nickel-titanium alloy wire with a diameter of 0.1 mm and a braiding density of 20 wires per square millimeter. The outer diameter of the ring is 11.8 mm, and the coil spring 13 is 0.2 mm in diameter. Meter of stainless steel wire, the spring outer diameter is 2 mm, the free length is 50 mm, the elastic coefficient is 0.5 Newtons per millimeter, the push rod 14 is made of medical stainless steel, with a diameter of 1.5 mm and a length of 30 mm, the thruster 8 is made of polyamide material, with an outer diameter of 2.8 mm and a length of 10 mm, the positioning mark 9 is made of a polymer material containing barium sulfate, the ring width is 1 mm, and the thickness is 0.1 mm. A total of 4 developing rings are set, distributed at intervals of 5 mm, the sealing ring 10 is made of medical silicone, with an inner diameter of 2.9 mm, an outer diameter of 3.5 mm, and a thickness of 0.3 mm. The one-way valve 18 adopts a silicone diaphragm structure with an opening pressure of 0.1 kPa, and the inner diameter of the inflation pipe 17 is 0.5 mm.

[0032] The manufacturing process of this embodiment includes the following steps: first, the catheter body 1 is manufactured by an extrusion molding process, the extrusion temperature is 180 degrees Celsius, and the pulling speed is 5 meters per minute; then, the balloon body 2 is manufactured by a blow molding process, the blow molding temperature is 160 degrees Celsius, and the blow molding pressure is 0.3 MPa; then, the support ring 6 is braided by a braiding machine, the braiding tension is 2 Newtons, and the braiding speed is 100 revolutions per minute; the push rod 14 is processed by a CNC machine tool, and the processing accuracy is plus or minus 0.01 mm; the propeller 8 is manufactured by an injection molding process, and the injection molding temperature is 160 degrees Celsius and the blow molding pressure is 0.3 MPa. The temperature is 220 degrees Celsius and the injection molding pressure is 80 MPa. During assembly, the support ring 6 is first embedded in the wall of the balloon body 2, and then the balloon body 2 and the catheter body 1 are connected by hot melt welding. The welding temperature is 200 degrees Celsius and the welding time is 3 seconds. Then the power assist mechanism 7 is installed, one end of the coil spring 13 is fixed in the positioning groove on the inner wall of the catheter body 1, and the other end is connected to the push rod 14. Finally, the sealing ring 10 and the one-way valve 18 are installed, and the overall sealing test is carried out. The test pressure is 1.5 kPa and the pressure holding time is 10 minutes. No leakage is qualified.

[0033] The use effect of this embodiment and its progress over the existing technology are reflected in the following aspects: the power assist mechanism 7 can provide a maximum propulsion force of 10 Newtons. Compared with the traditional manual pushing method, the propulsion force is more stable and controllable, avoiding vascular damage caused by excessive or uneven thrust. The support ring 6 provides 360-degree uniform radial support for the balloon, so that the balloon maintains a regular circular cross-section after inflation, and the sealing effect is improved by more than 30% compared with the traditional unsupported balloon. The conical design of the sealing head 5 reduces the forward resistance of the catheter by 40%, significantly improving the ability of the catheter to pass through curved blood vessels. The contrast of the positioning mark 9 under X-ray is 50% higher than that of traditional marks. Doctors can judge the position of the catheter more accurately, and the accuracy of surgery is significantly improved. The reliability test of the sealing system shows that there is no leakage at a pressure of 1.5 kPa for 24 hours, which far exceeds the sealing performance of traditional catheters. Overall, compared with the existing technology, this embodiment has significant improvements in propulsion ability, sealing stability, positioning accuracy and sealing reliability, providing a safer and more effective tool for vascular interventional treatment. Example

[0034] like Figure 2 As shown, this embodiment adopts the improved scheme in the specific implementation method. The air storage chamber of the pneumatic energy storage device is made of medical stainless steel with an inner diameter of 8 mm, a length of 40 mm, a wall thickness of 1 mm, and a working pressure of 1 MPa. The piston is made of polytetrafluoroethylene material with a diameter of 7.8 mm and a length of 15 mm. A rubber sealing ring is provided between the piston and the air storage chamber. A total of 3 support rings 6 are provided, which are respectively located at the front end, middle part and rear end of the balloon body 2. The spacing between adjacent support rings is 6 mm. Each support ring is made of nickel-titanium alloy wire with a diameter of 0.08 mm. The outer diameter of the balloon body 2 is 11.5 mm. The spiral developing line is made of a polymer material containing iodide, with a line width of 0.5 mm, a thickness of 0.08 mm, a pitch of 8 mm, and two turns of spiral distribution along the surface of the balloon body 2. The sizes and materials of other components are basically the same as those in Example 1. The outer diameter of the catheter body 1 is 3.2 mm, the wall thickness is 0.35 mm, the outer diameter of the balloon body 2 after inflation is 13 mm, the volume of the inflation cavity 3 is 1.8 ml, the length of the push rod 14 is 35 mm, and the sealing ring 10 is made of fluororubber material, which has better chemical corrosion resistance.

[0035] The manufacturing process of this embodiment adds a manufacturing process of a pneumatic energy storage device on the basis of embodiment 1. The air storage chamber is manufactured by precision turning with a machining accuracy of plus or minus 0.005 mm and a surface roughness of 0.8 microns. The piston is manufactured by injection molding with an injection temperature of 260 degrees Celsius and an injection pressure of 120 MPa. The sealing ring is manufactured by vulcanization molding with a vulcanization temperature of 180 degrees Celsius and a vulcanization time of 20 minutes. The manufacture of multiple support rings requires strict control of the braiding tension and braiding density to ensure the dimensional consistency of the three support rings, and the dimensional deviation is controlled within plus or minus 0.1 mm. The spiral developing line is manufactured by screen printing process. Manufacturing, printing accuracy is plus or minus 0.05 mm, after printing, it needs to be cured at 120 degrees Celsius for 30 minutes, the position of multiple support rings needs to be accurately positioned during assembly, and special fixtures are used to ensure the accurate axial spacing of the support rings. The printing of spiral development lines requires the use of special templates to ensure the continuity and position accuracy of the spiral lines. The final product needs to undergo propulsion force testing, sealing testing and development effect testing. The propulsion force test requires that 20 Newtons of propulsion can be provided under 1 MPa air pressure, and the sealing test requires that the pressure be maintained at 2 kPa for 24 hours without leakage. The development effect test requires that the spiral lines are clearly visible under standard X-ray conditions.

[0036] The effectiveness and technological advancements of this embodiment are primarily reflected in the following aspects: The pneumatic energy storage device can provide greater propulsion force than a coil spring, with a maximum propulsion force of up to 20 Newtons, twice that of Example 1. By adjusting the inflation pressure, the propulsion force can be precisely controlled to meet the needs of different vascular environments. The multiple support rings provide more uniform radial support for the balloon, avoiding stress concentration. This increases the balloon's service life by over 50% compared to a single support ring solution, and significantly improves the stability of the occlusion effect. The spiral development line provides richer position information than the annular development ring, allowing physicians to observe the spatial position and orientation of the catheter from any angle. Positioning accuracy is 25% higher than that of Example 1, offering significant advantages in complex three-dimensional vascular environments. Improvements to the sealing system further enhance overall sealing performance, maintaining no leakage for 48 hours at 2 kPa, and exceeding the reliability of conventional products. Compared to existing technologies, this embodiment achieves higher levels of propulsion capacity, support uniformity, positioning accuracy, and system reliability. It is particularly suitable for precision interventional procedures in complex vascular environments, providing physicians with a more powerful surgical tool and significantly improving surgical success rates and patient safety.

[0037] Specifically, the principle of the present invention is as follows: the elastic energy storage component in the power-assisting mechanism stores externally applied energy. When propulsion is required, the stored elastic potential energy is converted into kinetic energy of the propeller through the transmission component, and the propeller drives the balloon forward. The support ring provides radial constraints for the balloon, so that the balloon maintains a regular circular cross-section when inflated, forming an effective seal with the blood vessel wall. The conical design of the sealing head conforms to the principles of fluid mechanics, reducing blood flow resistance and catheter forward resistance. The development characteristics of the positioning mark utilize the different absorption characteristics of X-rays for materials of different densities. The interference fit of the sealing ring utilizes the elastic deformation characteristics of the material to form a seal. The one-way valve utilizes the pressure difference principle to achieve one-way flow of gas. The entire system achieves efficient, safe and controllable blood vessel occlusion function through the synergistic effect of mechanical, fluid and material properties.

[0038] The above description is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with this technical field can easily think of changes or replacements within the technical scope disclosed by the present invention, which should be covered by the scope of protection of the present invention.

Claims

1. An auxiliary balloon occlusion catheter, comprising a catheter body, a balloon body, an inflation cavity, a guidewire channel, a blocking head, a support ring, a power assist mechanism, a propeller, a positioning marker and a sealing ring, characterized in that: The assist mechanism is arranged inside the catheter body, the balloon body is connected to the catheter body through the inflation cavity, the blocking head is located at the front end of the balloon body, and the support ring is arranged circumferentially around the balloon body; The power-assisting mechanism includes an elastic energy storage component and a transmission component. The elastic energy storage component is connected to the propeller through the transmission component. When the propeller moves axially along the catheter body, it drives the balloon body forward.

2. The auxiliary balloon occlusion catheter according to claim 1, characterized in that: The elastic energy storage component is a coil spring, one end of which is fixed to the inner wall of the catheter body, and the other end is connected to the transmission component, which is a push rod structure; The support ring is a metal wire braided ring embedded in the wall of the balloon body. The diameter of the support ring is larger than the diameter of the balloon body when it is not inflated.

3. The auxiliary balloon occlusion catheter according to claim 2, characterized in that: The plugging head is conical, with a cone angle of 30 to 60 degrees, and is connected to the front end of the balloon body by bonding; The guidewire channel runs through the entire length of the catheter body, the inner diameter of the guidewire channel is 0.5 mm to 1.2 mm, and the guidewire channel is connected to the inner cavity of the balloon body.

4. The auxiliary balloon occlusion catheter according to claim 3, characterized in that: The positioning marks are arranged on the surface of the balloon body, are annular marks made of a developing material, and are distributed at intervals along the axial direction of the balloon body; The sealing ring is arranged at the connection between the catheter body and the balloon body. The sealing ring is made of silicone material and has an interference fit with the catheter body.

5. The auxiliary balloon occlusion catheter according to claim 4, characterized in that: The inflation chamber is connected to an external inflation device through an inflation pipeline. A one-way valve is provided in the inflation pipeline to prevent gas from flowing back from the inflation chamber.

6. The auxiliary balloon occlusion catheter according to claim 5, characterized in that: A limiting protrusion is provided at the front end of the pusher, and the limiting protrusion cooperates with the limiting groove on the inner wall of the catheter body to limit the moving stroke of the pusher.

7. The auxiliary balloon occlusion catheter according to claim 6, characterized in that: The specific preparation steps of the auxiliary balloon occlusion catheter include: The first step is to heat and extrude the polymer material using an extruder according to the size requirements to form a catheter body tube with the required inner and outer diameters, and then cut the tube to obtain the catheter body; The second step is to use a blow molding process to place the balloon body material into a mold and use compressed air to blow-mold it to the designed shape and size. When the balloon body is not inflated, its diameter is measured. The third step is to use a wire braiding device to weave the wire into a ring shape to form a support ring. When the balloon body is not fully solidified, the support ring is evenly embedded into the wall of the balloon body, and the diameter of the support ring is ensured to be larger than the diameter of the balloon body when it is not inflated, so as to provide good support. Step 4: Connect the conical plugging head to the front end of the balloon body by bonding; Step 5: Drill a hole through the catheter tube from one end to the other to create a guidewire channel with an inner diameter of 0.5 mm to 1.2 mm. Step 6: Fix one end of the coil spring to a pre-designed position on the inner wall of the catheter body by spot welding, and connect the other end to the push rod. Connect the push rod to the pusher to ensure that the pusher can move smoothly along the axial direction within the catheter body. When the pusher moves, it can drive the balloon body forward through the push rod and coil spring. Step 7: Use a developer material to make an annular positioning mark, and stick the positioning mark on the surface of the balloon body along the axial direction of the balloon body according to the designed interval. The positioning mark is firmly affixed to ensure that the positioning mark will not shift or fall off during the inflation and deflation process of the balloon body; Step 8: Take an appropriate amount of silicone material to make a sealing ring. The size is determined according to the actual size of the connection between the catheter body and the balloon body. Put the sealing ring on the connection between the catheter body and the balloon body. Use appropriate pressure or gluing to make the sealing ring and the catheter body have an interference fit, so as to play a good sealing role and prevent gas leakage. Step 9: Set an inflation cavity on the catheter body so that it communicates with the inner cavity of the balloon body. Connect one end of the inflation tube to the inflation cavity and the other end to the external inflation device. Check the air tightness of the inflation tube and install a one-way valve in the inflation tube to ensure that the one-way valve can work properly to prevent gas from flowing back from the inflation cavity. The tenth step is to process a limiting protrusion at the front end of the pusher, the size of which matches the limiting groove on the inner wall of the catheter body; process a limiting groove at the corresponding position of the inner wall of the catheter body, insert the pusher into the catheter body, and make the limiting protrusion cooperate with the limiting groove to limit the moving stroke of the pusher, ensuring that the pusher can only move within the set range, avoiding damage to the balloon body due to excessive propulsion.

8. The auxiliary balloon occlusion catheter according to claim 7, characterized in that: The conical plugging head is connected to the front end of the balloon body by bonding, and the adhesive used is composed of one or more of α-cyanoacrylate monomer, epoxy resin, acrylate monomer, oligomer, silicone rubber and chitosan.

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