A high flexibility balloon sized high pressure balloon dilatation catheter

Abstract

The utility model discloses a high pressure balloon dilatation catheter of high flexibility balloon size adjustable, include: tubular body subassembly, the distal end of tubular body subassembly is installed with balloon subassembly, and the proximal end is installed with the control assembly for adjusting the control assembly of balloon size, through the overall structural design of tubular body subassembly, balloon subassembly, control assembly, control assembly pulls the adjustment pipe displacement, can change the space form between inside and outside balloon layer, break through the limitation of traditional fixed size balloon, can adapt to the blood vessel of different diameter or different expansion demand, improve the versatility of catheter, in addition, the reinforcing rib of nickel titanium alloy wire material is embedded in the wall of the communication main pipe and liquid inlet pipe, and the pipe body hardness is accurately matched according to the function demand of each component, realizes the gradient performance of "the tip is soft, the middle part is tough, and the proximal end is rigid", perfect adaptation double demand of in-vivo blood vessel advancing and high pressure expansion, balance the flexibility and high pressure resistance of catheter, ensure that the catheter is advanced in the curved blood vessel.

Description

Technical Field

[0001] This utility model relates to the field of high-pressure balloon dilation catheter technology, specifically a high-pressure balloon dilation catheter with adjustable balloon size and high flexibility. Background Technology

[0002] High-pressure balloon dilation catheters are core instruments in interventional vascular treatment. By expanding the balloon at the distal end of the catheter under high pressure, they can open up narrowed plaques or blocked areas in blood vessels and restore blood flow to the lumen.

[0003] Chinese patent publication number CN221513234U discloses a high-pressure resistant balloon dilation catheter, including a connecting inner tube, an expansion balloon fixedly connected to the outside of the connecting inner tube, a support ring fixedly connected to the outer wall of the connecting inner tube and located inside the expansion balloon, and a tension support assembly connected to one side of the support ring; the tension support assembly includes multiple silicone tension strips connected to one side of the support ring, a pressure-resistant reinforcing strip fixedly connected to the top of the silicone tension strip, a silicone connecting outer strip fixedly connected to the bottom of the pressure-resistant reinforcing strip and located on one side of the support ring, a silicone connecting inner strip provided at the bottom of the silicone connecting outer strip, a fixing support ring fixedly connected to the outer wall of the connecting inner tube and located on one side of the silicone connecting outer strip, and multiple silicone connecting support strips fixedly connected in a circular pattern at equal intervals on the outer wall of the fixing support ring.

[0004] The aforementioned patents can solve the corresponding technical problems, but they still have drawbacks in practical use:

[0005] The balloon in the aforementioned patent has a fixed size and limited adaptability. The length of the high-pressure balloon is a preset fixed value. Doctors need to estimate the size of the lesion through imaging examinations before surgery to select instruments. However, in actual surgery, the size of the lesion often has "prediction deviation". For example, the actual area of ​​the calcified plaque is larger than that shown on the image. If the balloon length is shorter than the lesion length, balloons of different lengths need to be changed multiple times, which prolongs the operation time, increases the consumption of instruments, and increases the risk of repeated vascular manipulation damage. In addition, the existing catheter body mostly uses a single polymer or conventional metal wire reinforced structure, which has high rigidity at the distal end. When passing through coronary artery branches, cerebral blood vessels, and other blood vessels with large curvature and small diameter, it is easy to encounter problems such as "sticking" or "vascular wall scraping". Not only is it difficult to accurately reach the lesion site, but it may also cause complications such as vascular intimal damage and dissection. Utility Model Content

[0006] The purpose of this invention is to provide a high-pressure balloon dilation catheter with adjustable balloon size and high flexibility, which solves the problems of fixed balloon size, limited adaptability, and low flexibility that easily damages blood vessels in the prior art.

[0007] To achieve the above objectives, the main technical solution adopted by this utility model includes: a high-pressure balloon dilation catheter with adjustable balloon size and high flexibility, comprising: a tube body assembly, wherein a balloon assembly is installed at the distal end of the tube body assembly, and a control assembly for adjusting the balloon size is installed at the proximal end; wherein the tube body assembly includes a main connecting tube, an inlet tube is fixedly connected to the proximal end of the main connecting tube, a guide tip tube is fixedly connected to the distal end, an air guide tube is fixedly connected to the inlet tube, and a traction channel is provided aligned between the main connecting tube and the inlet tube; the balloon assembly includes an inner balloon layer and an outer balloon layer, the inner balloon layer wraps around the outside of the main connecting tube, the outer balloon layer wraps around the outside of the inner balloon layer, and an adjustment tube is provided between the inner balloon layer and the outer balloon layer, and a receiving component is provided at the rear of the adjustment tube; the control assembly includes a traction component for pulling the adjustment tube to move, and the traction component is connected to the adjustment tube through the traction channel.

[0008] As a preferred technical solution, the main connecting pipe, the liquid inlet pipe, and the guide tip pipe are integrally formed;

[0009] The inner walls of the main connecting pipe and the inlet pipe are uniformly embedded with multiple reinforcing ribs along the circumference. The reinforcing ribs are made of nickel-titanium alloy wire and have a diameter of 0.04 to 0.06 mm.

[0010] As a preferred technical solution, the storage component is a storage tube, which is fixedly sleeved on the outside of the main connecting tube. The cavity between the inner bladder layer and the outer bladder layer is connected to one end of the storage tube, and the adjusting tube can be moved to the inside of the storage tube by the traction component.

[0011] The front ends of the inner capsule layer and the outer capsule layer are respectively sealed to the outer wall of the tail end of the guide tip tube, and the tail ends of the inner capsule layer and the outer capsule layer are respectively sealed to the outer wall of the front end of the receiving tube.

[0012] The inner lining layer encapsulates the main connecting tube, which has a through hole that communicates with the main connecting tube.

[0013] The distal port of the traction channel is connected to the interior of the receiving tube.

[0014] As a preferred technical solution, the control component further includes a mounting bracket fixedly installed on the liquid inlet pipe. Two bearings are fixedly installed at intervals on one side of the mounting bracket. A shaft is fixedly installed in the inner ring of the bearing. A driven gear is fixedly connected to one end of the lower shaft. A winding rod is fixedly connected to one end of the driven gear. A driving gear is fixedly connected to one end of the upper shaft. The driving gear meshes with the driven gear for transmission. A knob is fixedly connected to the other end of the upper shaft.

[0015] The traction component is a traction wire. The mounting bracket has a through hole aligned with the near port of the traction channel. One end of the traction wire is fixedly connected to the winding rod, and the other end extends sequentially from the through hole and the traction channel to the inside of the receiving tube and is fixedly connected to the tail end wall of the adjusting tube.

[0016] As a preferred technical solution, the inner capsule layer is made of nylon membrane material, and the outer capsule layer is made of polyurethane membrane material.

[0017] As a preferred technical solution, the traction wire is made of stainless steel.

[0018] As a preferred technical solution, the main connecting pipe is made of PEBAX D material, the inlet pipe is made of PEBAX D material, the guide tip pipe is made of PEBAX D material, and the inlet pipe has an integrally formed handle.

[0019] As a preferred technical solution, the number of traction wires is two, and the two traction wires are respectively fixedly connected to the upper pipe wall and the lower pipe wall of the regulating pipe.

[0020] As a preferred technical solution, a traction tube is fixedly installed inside the traction channel, and the traction wire passes through the inside of the traction tube, which is made of PTFE material.

[0021] As a preferred technical solution, when the regulating tube can be fully inserted into the interior of the receiving tube, the regulating tube does not contact the inner and outer capsule layers, and the balloon is at its maximum usable length.

[0022] This utility model has at least the following beneficial effects:

[0023] This invention provides a high-flexibility, adjustable-size high-pressure balloon dilation catheter. Through the overall structural design of the tube body assembly, balloon assembly, and control assembly, the control assembly pulls and adjusts the tube displacement, which can change the spatial morphology between the inner and outer balloon layers. This breaks through the limitations of traditional fixed-size balloons and can adapt to blood vessels of different diameters or different dilation needs, improving the versatility of the catheter. In addition, the connecting tube and the inlet tube are reinforced with nickel-titanium alloy wire, and the hardness of PEBAX material is precisely matched according to the functional requirements of each component, achieving a gradient performance of "flexible tip, tough middle, and rigid proximal end". This perfectly adapts to the dual needs of intravascular advancement and high-pressure dilation, balancing the catheter's flexibility and high-pressure resistance, and ensuring flexible advancement of the catheter in curved blood vessels.

[0024] The inner and outer bladder layers are sealed together with the guide tip tube and the receiving tube to form a closed bladder layer gap. The regulating tube can be stably displaced within the closed space. The through hole on the main tube enables communication between the inside of the tube body and the inside of the inner bladder layer, ensuring that the high-pressure liquid delivered by the inlet tube can accurately enter the inside of the inner bladder layer and push the inner bladder layer to expand outward. At the same time, the outer bladder layer, as the outer protective layer, can enhance the balloon's resistance to wear and puncture. The double bladder layer design improves the safety during high-pressure expansion and reduces the risk of bladder rupture.

[0025] By setting two traction wires to connect the upper and lower walls of the regulating tube respectively, a symmetrical traction force can be applied to the regulating tube when it is pulled, avoiding the unilateral force and skew of the regulating tube caused by a single traction wire, and ensuring that the regulating tube always moves along the central axis of the interstitial space during the displacement process. Attached Figure Description

[0026] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0027] Figure 1 This is a 3D physical image of the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0028] Figure 2 This is a three-dimensional structural schematic diagram of the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0029] Figure 3 This is a schematic diagram of the inlet tube structure of the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0030] Figure 4 This is a schematic diagram of the installation of reinforcing ribs in the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0031] Figure 5 This is a schematic diagram of the installation of the traction wire in the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0032] Figure 6 This is a schematic diagram showing the installation of the driven gear and the driving gear of the high-flexibility balloon dilation catheter with adjustable balloon size of this utility model.

[0033] Figure 7 This is a schematic diagram of a portion of the balloon expansion state of the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0034] Figure 8 This is a schematic diagram of the overall balloon expansion state of the high-flexibility, adjustable-size high-pressure balloon dilation catheter of this utility model.

[0035] Explanation of icon numbers:

[0036] 1. Pipe assembly; 101. Main connecting pipe; 102. Liquid inlet pipe; 1021. Air guide pipe; 103. Guide tip pipe; 1031. Reinforcing rib; 104. Traction channel; 105. Traction pipe; 106. Through hole; 107. Handle;

[0037] 2. Balloon assembly; 201. Inner capsule layer; 202. Outer capsule layer; 203. Adjustment tube; 204. Storage tube;

[0038] 3. Control components; 301. Mounting bracket; 302. Bearing; 303. Shaft; 304. Driven gear; 3041. Rewinding rod; 305. Driving gear; 306. Knob; 307. Traction wire; 308. Perforation. Detailed Implementation

[0039] The following will describe in detail the implementation of this application with reference to the accompanying drawings and embodiments, so that the implementation process of how this application uses technical means to solve technical problems and achieve technical effects can be fully understood and implemented accordingly.

[0040] Example

[0041] Please refer to Figures 1 to 8 As shown, this embodiment provides a high-flexibility, adjustable-size high-pressure balloon dilation catheter, comprising: a tube body assembly 1, a balloon assembly 2 mounted at the distal end of the tube body assembly 1, and a control assembly 3 for adjusting the balloon size mounted at the proximal end; wherein the tube body assembly 1 includes a main connecting tube 101, an inlet tube 102 fixedly connected to the proximal end of the main connecting tube 101, a guide tip tube 103 fixedly connected to the distal end, an air guide tube 1021 fixedly connected to the inlet tube 102, and a traction channel 104 aligned between the main connecting tube 101 and the inlet tube 102; the balloon assembly 2 includes an inner balloon layer 201 and an outer balloon layer 202, the inner balloon layer 201 wrapping around the outside of the main connecting tube 101, and the outer balloon layer 202 wrapping around the outside of the inner balloon layer 201, and the inner balloon layer 201 and the outer balloon layer 202 are connected in a manner that is not directly related to the balloon assembly 101. An adjustment tube 203 is provided between 202, and a storage component is provided behind the adjustment tube 203. The control component 3 includes a traction component for pulling the adjustment tube 203 to move. The traction component is connected to the adjustment tube 203 through the traction channel 104. Through the overall structural design of the tube body component 1, balloon component 2, and control component 3, the control component 3 pulls the adjustment tube 203 to move, which can change the spatial shape between the inner and outer balloon layers. This breaks through the limitations of traditional fixed-size balloons and can adapt to blood vessels of different diameters or different expansion needs, improving the versatility of the catheter. In addition, the integrated and connected design of the tube body component 1 avoids rigid protrusions caused by splicing multiple parts, laying a structural foundation for improving the overall flexibility of the catheter and reducing the risk of damage to the blood vessel wall when the catheter is advanced in the blood vessel.

[0042] The main connecting pipe 101, the inlet pipe 102, and the guide tip pipe 103 are integrally formed. Multiple reinforcing ribs 1031 are evenly embedded circumferentially inside the walls of the main connecting pipe 101 and the inlet pipe 102. These reinforcing ribs 1031 are made of nickel-titanium alloy wire, with a diameter of 0.04–0.06 mm. The integral forming of the main connecting pipe 101, the inlet pipe 102, and the guide tip pipe 103 eliminates gaps and weak points at component joints, preventing damage during high-pressure expansion. To prevent liquid leakage or catheter failure due to breakage at the joint, the structural strength and service life of the catheter are improved. In addition, a reinforcing rib 1031 made of nickel-titanium alloy wire is embedded in the wall of the connecting main tube 101 and the inlet tube 102. The diameter of the reinforcing rib 1031 is preferably 0.05mm. The reinforcing rib 1031 can enhance the tube wall's resistance to high pressure deformation, but it will not increase the rigidity of the tube body due to the reinforcing rib 1031 being too thick. This perfectly balances the flexibility and high pressure resistance of the catheter, ensuring that the catheter can be flexibly advanced in curved blood vessels.

[0043] The storage component is a storage tube 204, which is fixedly sleeved on the outside of the connecting main tube 101. The cavity between the inner bladder layer 201 and the outer bladder layer 202 is connected to one end of the storage tube 204. The adjusting tube 203 can be moved into the interior of the storage tube 204 by a traction component. The front ends of the inner bladder layer 201 and the outer bladder layer 202 are respectively sealed to the outer wall of the tail end of the guide tip tube 103, and the tail ends of the inner bladder layer 201 and the outer wall of the front end of the storage tube 204 are respectively sealed to the outer wall of the front end. A through hole 106 is opened on the connecting main tube 101 wrapped by the inner bladder layer 201, and the through hole 106 is connected to the connecting main tube 101. The distal end of the traction channel 104 is connected to the interior of the storage tube 204, and is connected to the guide tip tube 103 and the storage tube through the inner and outer bladder layers. The 204 sealing connection forms a closed bladder layer gap, allowing the regulating tube 203 to move stably within the closed space. The through hole 106 on the main tube 101 connects the inside of the tube body to the inside of the inner bladder layer 201, ensuring that the high-pressure liquid delivered by the inlet tube 102 can accurately enter the inside of the inner bladder layer 201, pushing the inner bladder layer 201 to expand outward. At the same time, the outer bladder layer 202 serves as an outer protective layer, enhancing the balloon's resistance to wear and puncture. The double bladder layer design improves safety during high-pressure expansion and reduces the risk of bladder rupture. The traction channel 104 connects to the inside of the receiving tube 204 through its distal port, allowing the traction component to extend directly to the tail of the regulating tube 203, avoiding traction jamming caused by bending of the traction path, ensuring smoother pulling of the regulating tube by the control component, and improving the response speed of size adjustment.

[0044] The control component 3 also includes a mounting bracket 301 fixedly mounted on the inlet pipe 102. Two bearings 302 are fixedly mounted at intervals on one side of the mounting bracket 301. A shaft 303 is fixedly mounted in the inner ring of the bearing 302. One end of the lower shaft 303 is fixedly connected to a driven gear 304, and one end of the driven gear 304 is fixedly connected to a winding rod 3041. One end of the upper shaft 303 is fixedly connected to a driving gear 305, which meshes with the driven gear 304. A knob 306 is fixedly connected to the other end of the upper shaft 303. The traction component is a traction wire 307. The mounting bracket 301 has a through hole 308 near the port of the traction channel 104. One end of the traction wire 307 is fixedly connected to the winding rod 3041, and the other end extends sequentially from the through hole 308 and the traction channel 104 to the inside of the receiving tube 204 and is fixedly connected to the tail end wall of the adjusting tube 203. The knob 306 is designed to be used for this purpose. The control assembly structure, consisting of a drive gear 305, a driven gear 304, and a winding rod 3041, allows medical personnel to rotate the winding rod 3041 via gear meshing by simply turning the knob 306. This enables the winding and unwinding of the traction wire 307. Compared to the traditional manual pulling method, gear transmission reduces the operating force, and the rotation angle of the knob 306 is linearly related to the winding amount of the winding rod 3041, facilitating precise control of the displacement of the adjusting tube 203 and improving operational convenience and adjustment accuracy. The mounting bracket 301 fixes the bearing 302 and the shaft 303, ensuring that the shaft 303 does not deviate during gear transmission, preventing the traction wire 307 from jamming or breaking due to transmission misalignment. The through hole 308 of the mounting bracket 301 aligns with the traction channel 104, providing a fixed guide path for the traction wire 307 and preventing the traction wire 307 from swinging around inside the tube, causing scratches on the tube wall or interference with other components, thus reducing the risk of failure during operation.

[0045] The inner capsule 201 is made of nylon membrane, and the outer capsule 202 is made of polyurethane membrane. The high strength of the nylon membrane and the high flexibility and wear resistance of the polyurethane membrane complement each other, which not only ensures the reliability of balloon expansion under high pressure, but also improves the adaptability and service life of the balloon in blood vessels. This solves the problem that traditional single-material capsules are either high pressure resistant but rigid, or flexible but weak in high pressure resistance.

[0046] Among them, the traction wire 307 is made of stainless steel. Due to the moderate rigidity of stainless steel, the traction wire 307 is not prone to excessive bending or entanglement when subjected to force in the tube, ensuring that the traction force can be quickly transmitted to the adjustment tube 203, improving the response speed of size adjustment, and avoiding adjustment delay caused by bending of the traction wire 307.

[0047] The main connecting pipe 101 is made of PEBAX 55D material, the inlet pipe 102 is made of PEBAX 70D material, and the guide tip pipe 103 is made of PEBAX 35D material. The inlet pipe 102 has an integrally formed handle 107. The hardness of the PEBAX material is precisely matched according to the functional requirements of each component. The guide tip pipe 103, made of PEBAX 35D, is highly flexible, allowing for easy maneuvering within curved blood vessels and reducing scratches on the vessel wall. The main connecting pipe 101, made of PEBAX 55D, balances flexibility with resistance to high-pressure deformation, ensuring a stable fluid delivery channel. The inlet pipe 102, made of PEBAX... The 70D catheter can withstand the pressure of liquid and gas delivery, preventing tube collapse and achieving a gradient performance of "flexible tip, tough middle, and rigid proximal end," perfectly adapting to the dual needs of intravascular advancement and high-pressure dilation. In addition, the inlet tube 102 has an integrated handle 107, which allows medical staff to hold the catheter stably, preventing slippage during advancement or adjustment and improving operational stability. Especially when finely adjusting the balloon size, the handle 107 can reduce the impact of hand tremors on adjustment accuracy.

[0048] There are two traction wires 307, and the two traction wires 307 are fixedly connected to the upper and lower pipe walls of the regulating tube 203 respectively. By setting two traction wires 307 to connect the upper and lower pipe walls of the regulating tube 203 respectively, a symmetrical traction force can be applied to the regulating tube when it is pulled, avoiding the unilateral force and skew of the regulating tube 203 caused by a single traction wire, and ensuring that the regulating tube 203 always moves along the central axis of the interstitial space during the displacement process.

[0049] The traction channel 104 is fixedly installed with a traction tube 105, and the traction wire 307 passes through the traction tube 105. The traction tube 105 is made of PTFE. By installing the PTFE traction tube 105 in the traction channel 104, PTFE has a low coefficient of friction and excellent wear resistance. The low coefficient of friction can reduce the frictional resistance between the traction wire 307 and the channel wall when it is extended and retracted, ensuring smooth traction. The wear resistance avoids scratches on the channel wall or wear of the traction wire 307 caused by repeated friction, thus extending the service life of both.

[0050] When the adjustment tube 203 can be fully inserted into the receptacle tube 204, the adjustment tube 203 does not contact the inner capsule layer 201 or the outer capsule layer 202, and the balloon is at its maximum length of use. This provides medical staff with a clear reference standard for size adjustment. Without the need for complicated measurements, the maximum expansion length of the balloon can be determined simply by confirming whether the adjustment tube 203 is fully receptive. This simplifies the operation process and avoids over- or under-expansion of blood vessels due to size misjudgment.

[0051] Working principle:

[0052] Intravascular catheter advancement: Medical staff hold the one-piece molded handle 107 on the inlet tube 102 and slowly push the catheter into the target blood vessel with the guide tip tube 103 as the front end. Due to the gradient flexibility design of the connecting tube 101 and the inlet tube 102, and the nickel-titanium alloy reinforcing rib 1031 embedded in the tube wall, the catheter can flexibly adapt to the curved blood vessel, while avoiding tube collapse or breakage during advancement and reducing scratching of the blood vessel wall.

[0053] Balloon assembly positioning confirmation: The position of the guide tip tube 103 is observed through medical imaging equipment to ensure that the balloon assembly accurately reaches the stenotic or dilated area of ​​the blood vessel. If the image shows that the current size of the balloon is not well matched with the blood vessel, the knob 306 is turned again to retract the traction wire 307. The adjustment tube 203 moves forward within the gap of the balloon layer to expand the expandable space of the inner and outer balloon layers. Since the two traction wires 307 are respectively connected to the upper and lower walls of the adjustment tube 203, the adjustment tube 203 is subjected to balanced force during the adjustment process, avoiding size deviation caused by offset.

[0054] High-pressure dilation operation: After confirming that the balloon size is suitable, high-pressure dilation fluid is injected into the connecting main pipe 101 through the inlet tube 102. The fluid enters the inner capsule 201 through the through hole 106 on the connecting main pipe 101, pushing the inner capsule 201 to expand outward. At the same time, the outer capsule 202 expands synchronously with the inner capsule 201, adhering to the blood vessel wall to dilate the narrowed area.

[0055] The foregoing description illustrates and describes several preferred embodiments of the present invention. However, as previously stated, it should be understood that the present invention is not limited to the forms disclosed herein and should not be construed as excluding other embodiments. It can be used in various other combinations, modifications, and environments, and can be altered within the scope of the inventive concept described herein through the foregoing teachings or techniques or knowledge in related fields. Any modifications and variations made by those skilled in the art that do not depart from the spirit and scope of the present invention should be within the protection scope of the appended claims.

Claims

1. A high-pressure balloon dilation catheter with adjustable balloon size and high flexibility, characterized in that, include: A tubular assembly (1), wherein a balloon assembly (2) is mounted at its distal end and a control assembly (3) for adjusting the balloon size is mounted at its proximal end; wherein The tube assembly (1) includes a main connecting pipe (101), with a liquid inlet pipe (102) fixedly connected to the proximal end of the main connecting pipe (101) and a guide tip pipe (103) fixedly connected to the distal end. A gas guide pipe (1021) is fixedly connected to the liquid inlet pipe (102), and a traction channel (104) is provided aligned between the main connecting pipe (101) and the liquid inlet pipe (102). The balloon assembly (2) includes an inner balloon layer (201) and an outer balloon layer (202). The inner balloon layer (201) wraps around the outside of the connecting tube (101), and the outer balloon layer (202) wraps around the outside of the inner balloon layer (201). An adjustment tube (203) is provided between the inner balloon layer (201) and the outer balloon layer (202), and a storage component is provided behind the adjustment tube (203). The control component (3) includes a traction member for pulling the regulating tube (203) to make a displacement, the traction member being connected to the regulating tube (203) through a traction channel (104).

2. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 1, characterized in that: The main connecting pipe (101), the liquid inlet pipe (102), and the guide tip pipe (103) are integrally formed structures; The inner walls of the connecting main pipe (101) and the liquid inlet pipe (102) are uniformly embedded with multiple reinforcing ribs (1031) along the circumference. The reinforcing ribs (1031) are made of nickel-titanium alloy wire and have a diameter of 0.04 to 0.06 mm.

3. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 2, characterized in that: The storage component is a storage tube (204), which is fixedly sleeved on the outside of the main connecting tube (101). The cavity between the inner bladder layer (201) and the outer bladder layer (202) is connected to one end of the storage tube (204). The adjusting tube (203) can be moved to the inside of the storage tube (204) by the traction component. The front ends of the inner capsule (201) and the outer capsule (202) are respectively sealed to the outer wall of the tail end of the guide tip tube (103), and the tail ends of the inner capsule (201) and the outer capsule (202) are respectively sealed to the outer wall of the front end of the receiving tube (204). The inner capsule layer (201) encloses the main connecting pipe (101) which has a through hole (106) and the through hole (106) communicates with the main connecting pipe (101). The distal port of the traction channel (104) is connected to the interior of the receiving tube (204).

4. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 3, characterized in that: The control component (3) further includes a mounting bracket (301) fixedly installed on the inlet pipe (102). Two bearings (302) are fixedly installed at intervals on one side of the mounting bracket (301). A shaft (303) is fixedly installed in the inner ring of the bearing (302). A driven gear (304) is fixedly connected to one end of the lower shaft (303). A winding rod (3041) is fixedly connected to one end of the driven gear (304). A driving gear (305) is fixedly connected to one end of the upper shaft (303). The driving gear (305) meshes with the driven gear (304) for transmission. A knob (306) is fixedly connected to the other end of the upper shaft (303). The traction component is a traction wire (307). The mounting bracket (301) is aligned with the near port of the traction channel (104) and has a through hole (308). One end of the traction wire (307) is fixedly connected to the winding rod (3041), and the other end extends sequentially from the through hole (308) and the traction channel (104) to the inside of the receiving tube (204) and is fixedly connected to the tail end wall of the adjusting tube (203).

5. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 1, characterized in that: The inner capsule layer (201) is made of nylon membrane, and the outer capsule layer (202) is made of polyurethane membrane.

6. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 4, characterized in that: The traction wire (307) is made of stainless steel.

7. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 1, characterized in that: The main connecting pipe (101) is made of PEBAX 55D material, the inlet pipe (102) is made of PEBAX 70D material, the guide tip pipe (103) is made of PEBAX 35D material, and the inlet pipe (102) has an integrally formed handle (107).

8. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 4, characterized in that: The number of the traction wires (307) is two, and the two traction wires (307) are fixedly connected to the upper and lower pipe walls of the regulating pipe (203) respectively.

9. The high-pressure balloon dilation catheter with adjustable balloon size according to claim 4, characterized in that: The traction channel (104) is fixedly installed with a traction tube (105), and the traction wire (307) passes through the traction tube (105). The traction tube (105) is made of PTFE material.

10. A high-flexibility, adjustable-size high-pressure balloon dilation catheter according to claim 3, characterized in that: When the regulating tube (203) can be fully inserted into the interior of the receiving tube (204), the regulating tube (203) does not contact the inner capsule layer (201) or the outer capsule layer (202), and the balloon is at its longest working length.

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