Pre-expansion guide wire

By designing a pre-expanded guidewire with a gradually thinning distal end and its supporting balloon structure, the problem of interventional instruments being difficult to pass through severe stenosis or occlusion of blood vessels is solved, and more effective interventional treatment and higher success rate are achieved.

CN120022518AInactive Publication Date: 2025-05-23DONGGUAN TIAN TIAN XIANG SHANG MEDICAL TECH
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Patent Information

Application Number
CN202510504287.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-22
Publication Date
2025-05-23
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

In the prior art, interventional devices are difficult to cross vascular lesions that are severely narrow, highly calcified or completely occluded, resulting in limited interventional treatment effects and subsequent balloons with larger outer diameters are difficult to reach the predetermined position.

Method used

A pre-expanded guide wire is designed, including a guide wire body and an expansion assembly. The distal end of the guide wire body is in a gradually thinning shape, equipped with a balloon structure and a balloon catheter. The balloon structure is pressurized or relieved through the catheter lumen to achieve the expansion and contraction of the balloon.

Benefits of technology

The guidewire can pass through complex and obstructive lesion areas safer and easier, achieving more effective interventional treatment, ensuring that subsequent treatment devices with larger outer diameters can reach the predetermined location smoothly, and reducing surgical complexity and patient risks.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of medical instruments, in particular to a pre-dilation guide wire which comprises a guide wire body, and the far end of the guide wire body is in a gradually-thinned shape. The expansion assembly comprises a balloon structure and a balloon catheter, the balloon catheter is arranged on the guide wire body in a sleeving mode, the far end of the balloon structure is connected to the guide wire body, and the near end of the balloon structure is connected to the far end of the balloon catheter; wherein the inner diameter of the balloon catheter is larger than the diameter of the guide wire body, and a catheter cavity used for pressurizing the balloon structure or releasing the pressure of the balloon structure is formed between the inner side of the balloon catheter and the guide wire body. The scheme is used for solving the problem that an interventional instrument in the prior art is difficult to pass through a seriously narrow, highly calcified or completely occluded vascular lesion site, and more effective interventional therapy is realized.
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Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a pre-expansion guide wire. Background Art

[0002] As a key medical device, guidewire plays an indispensable role in various interventional surgeries, especially in cardiovascular interventional treatment. The success of this type of surgery depends largely on whether the guidewire can be smoothly introduced into the blood vessel lumen and accurately reach the target location. Doctors usually first guide the guidewire into the blood vessel lumen, and then push the balloon along the guidewire path to the site of vascular lesions for pre-dilation operations to restore or improve blood flow. If necessary, devices such as stents or drug-coated balloons will be implanted along the same guidewire path to further consolidate the treatment effect.

[0003] However, although interventional therapy has become one of the main treatments for cardiovascular diseases, current technology still has limitations in the face of challenges such as total vascular occlusion (CTO), complex lesions and calcified lesions. Especially when dealing with severe stenosis, highly calcified lesions and completely occluded blood vessels, clinical practice often encounters the problem of guidewires having difficulty passing through the stenosis. Even if the guidewire barely passes through, the subsequent larger outer diameter balloon may not be able to reach the predetermined position for the same reason, thus hindering the continuation of the operation. This not only limits the effectiveness of interventional therapy, but also forces doctors to consider alternative solutions such as laser ablation, atherectomy and even more complex surgical operations to solve the problem, increasing the risk and cost of the operation. Summary of the invention

[0004] The present invention provides a pre-expansion guide wire, which is used to solve the problem in the prior art that interventional instruments are difficult to pass through severely narrowed, highly calcified or completely occluded vascular lesions, thereby achieving more effective interventional treatment.

[0005] The present invention provides a pre-expansion guidewire, comprising: a guidewire body, the distal end of which is in a gradually tapering shape; an expansion component, comprising a balloon structure and a balloon catheter, the balloon catheter is sleeved on the guidewire body, the distal end of the balloon structure is connected to the guidewire body, and the proximal end of the balloon structure is connected to the distal end of the balloon catheter; wherein the inner diameter of the balloon catheter is greater than the diameter of the guidewire body, and a catheter cavity for pressurizing or depressurizing the balloon structure is formed between the inner side of the balloon catheter and the guidewire body.

[0006] According to one embodiment of the present invention, the guide wire body includes a guide wire rod and a flexible spring; the flexible spring is connected to the distal end of the guide wire rod to serve as the terminal structure of the guide wire body.

[0007] According to one embodiment of the present invention, the guide wire rod is a solid structure.

[0008] According to one embodiment of the present invention, the distal end of the balloon structure is connected to the flexible spring, or to the distal end of the guide wire rod.

[0009] According to one embodiment of the present invention, the balloon structure and the balloon catheter, the guide wire rod and the flexible spring, and the balloon structure and the flexible spring are all connected by welding.

[0010] According to one embodiment of the present invention, the balloon catheter comprises a flexible tube portion and a metal tube portion disposed at the distal end of the balloon catheter, and the proximal end of the balloon structure is welded to the distal end of the metal tube portion.

[0011] According to one embodiment of the present invention, the balloon structure has a folded state and an unfolded state; in the folded state, the outer diameter of the balloon structure is smaller than the outer diameter of the balloon catheter; in the unfolded state, the outer diameter of the balloon structure is larger than the outer diameter of the balloon catheter.

[0012] According to one embodiment of the present invention, the proximal opening of the catheter cavity is connected to a pressure regulating device; the pressure regulating device can inject liquid and pressurize the balloon structure through the catheter cavity to convert the balloon structure from the folded state to the expanded state; the pressure regulating device can also extract the liquid in the balloon structure through the catheter cavity to relieve the pressure on the balloon structure, so that the balloon structure is converted from the expanded state to the folded state.

[0013] According to one embodiment of the present invention, it includes a development mark; the development mark is arranged on the guidewire body to display the position of the guidewire body under imaging equipment; and / or the development mark is arranged on the balloon structure to display the state of the balloon structure under imaging equipment.

[0014] According to one embodiment of the present invention, the outer surface of the balloon structure is provided with a drug coating, and the drug components of the drug coating include anti-proliferation drugs and / or anti-inflammatory drugs.

[0015] The pre-expansion guidewire provided by the present invention solves the problem that interventional instruments in the prior art are difficult to pass through severely narrowed, highly calcified or completely occluded vascular lesions by designing a guidewire body with a gradually tapered distal end and a matching balloon structure. The design of gradually tapering at the distal end of the guidewire body makes its tip softer and more flexible, and can pass through complex and obstructive lesions more safely and easily. At the same time, the balloon catheter sleeved on the guidewire body and the balloon structure connected thereto allow the doctor to perform a pre-expansion operation after the guidewire reaches the target position. When expansion is required, the balloon structure can be pressurized through the formed catheter cavity to expand the balloon to initially expand the stenosis segment and open up a channel for subsequent treatment instruments; and when expansion is not required or completed, the balloon structure can be depressurized to ensure that the entire device can be withdrawn smoothly. The present invention not only improves the success rate of the guidewire passing through difficult lesions, but also ensures that subsequent instruments such as balloons or stents with larger outer diameters can smoothly reach the predetermined position along the pre-expanded path, thereby achieving more effective interventional treatment and reducing surgical complexity and patient risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 It is one of the partial structural schematic diagrams of the pre-expansion guidewire provided by the present invention.

[0018] Figure 2 This is the second partial structural schematic diagram of the pre-expansion guidewire provided by the present invention.

[0019] Reference numerals: 10. Guidewire body; 11. Guidewire rod; 12. Flexible spring; 21. Balloon structure; 22. Balloon catheter; 23. Catheter cavity; 24. Metal tube. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] In the description of the embodiments of the present invention, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limitations on the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. It should also be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "set", "install", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0022] The pre-expansion guidewire of the present invention is intended to serve as a guide device and pre-expand the stenosis during interventional treatment. It is aimed at the clinical problem encountered during vascular interventional treatment, that is, although the guidewire can pass through the stenosis, the subsequent balloon cannot smoothly reach the target position, making it difficult to continue the operation. Since the pre-expansion guidewire of the present invention can immediately perform the expansion operation while successfully passing through the stenosis, it not only simplifies the surgical process and shortens the doctor's operation time, but also reduces the number of medical devices required. Therefore, it helps to reduce overall medical expenses and alleviate the economic burden on patients.

[0023] Combine the following Figure 1 , Figure 2 Specific embodiments of the pre-dilated guidewire of the present invention are described.

[0024] The present invention provides a pre-expansion guidewire, comprising: a guidewire body 10, the distal end of which is gradually tapered; an expansion assembly, comprising a balloon structure 21 and a balloon catheter 22, the balloon catheter 22 being sleeved on the guidewire body 10, the distal end of the balloon structure 21 being connected to the guidewire body 10, and the proximal end of the balloon structure 21 being connected to the distal end of the balloon catheter 22; wherein the inner diameter of the balloon catheter 22 is greater than the diameter of the guidewire body 10, and a catheter cavity 23 for pressurizing or depressurizing the balloon structure 21 is formed between the inner side of the balloon catheter 22 and the guidewire body 10. The pre-expansion guidewire can pre-expand the stenosis immediately after the guidewire reaches the target lesion position, thereby achieving more direct and effective interventional treatment preparation.

[0025] Specifically, when the guidewire body 10 successfully passes through the narrow or occluded blood vessel segment to reach the predetermined position, the doctor can inject liquid or gas through the catheter cavity 23 to pressurize the balloon structure 21, causing it to expand and exert pressure on the surrounding narrow blood vessel wall, thereby preliminarily expanding the lesion area and creating conditions for the subsequent introduction of larger outer diameter devices such as stents or drug-coated balloons. After the pre-expansion is completed, the pressure can be released through the catheter cavity 23 to retract the balloon structure 21 to ensure that the entire device can be safely withdrawn. This design allows the pre-expansion operation to be completed without removing the guidewire, which simplifies the surgical steps, improves efficiency, and reduces the trauma to the patient.

[0026] Furthermore, in order to optimize the operational performance and safety of the guidewire, the material of the guidewire body 10 can be selected from an alloy material with high torque transmission and good flexibility to ensure that the guidewire can flexibly advance in a tortuous vascular path without breaking or deviating from the direction. Secondly, the balloon structure 21 can adopt a low-profile design, that is, maintain a minimum diameter in an uninflated state, so that it is easier to pass through extremely narrow lesions. In addition, the surface of the balloon can be coated with a lubricant or other substance that helps to reduce friction, making it move more smoothly in the blood vessel. Finally, the balloon catheter 22 can be equipped with a pressure monitoring system for real-time monitoring and control of the pressure of balloon expansion to prevent excessive expansion from damaging the blood vessels.

[0027] When using the pre-expansion guidewire provided by the present invention, first follow the conventional interventional surgical process and introduce the guidewire body 10 into the patient's vascular system according to the doctor's professional judgment and operating skills. Since the distal end of the guidewire is designed to be gradually tapered, this gives its tip higher flexibility and penetration, allowing the guidewire to more safely and accurately pass through the narrow or completely occluded lesion area until it reaches the predetermined target location.

[0028] Once it is confirmed that the guidewire has successfully reached the lesion site, the stenosis segment can be pre-dilated. At this time, the doctor can inject an appropriate amount of liquid or gas into the catheter cavity 23 through the injection device connected to the balloon catheter 22 to pressurize the balloon structure 21. As the pressure increases, the balloon gradually expands and begins to apply uniform pressure to the surrounding stenotic blood vessel walls, thereby achieving a preliminary dilation effect, helping to expand the lesion area, improve blood flow, and create necessary space for stents or other therapeutic devices that may need to be implanted later.

[0029] After completing the pre-dilation operation, in order to ensure the safety of the entire system and prepare for the next surgical step, the pressure in the balloon can be released through the same catheter cavity 23, so that the balloon structure 21 can be restored to its low profile size in the uninflated state, ensuring that the guidewire and its auxiliary components can be smoothly withdrawn without causing additional damage.

[0030] In some cases, if further treatment of the lesion is required, such as placing a stent or a drug-coated balloon, the operation can be continued based on the pre-dilation guide wire. The pre-dilation guide wire of the present invention preferably may also be used in combination with a monitoring device, for example, a pressure sensor is arranged on the pressurizing side, so as to be able to understand the pressure change inside the balloon in real time, adjust the operation in time, and avoid the risk of blood vessel injury caused by over-dilation.

[0031] According to a pre-dilation guide wire of the present invention, the guide wire body 10 includes a guide wire rod 11 and a flexible spring 12. The flexible spring 12 is connected to the distal end of the guide wire rod 11 to serve as the end structure of the guide wire body 10. Specifically, the flexible spring 12 provides additional flexibility and plasticity, so that when the guide wire faces a complex blood vessel path, it can adjust its shape more flexibly, reduce the risk of damage to the blood vessel wall, and can also help the guide wire better adapt to the changes inside the blood vessel, ensuring that it can smoothly pass through the narrow or curved lesion area.

[0032] Furthermore, according to a pre-dilation guide wire of the present invention, the guide wire rod 11 is of a solid structure. Specifically, the solid structure enhances the overall rigidity and torque transmission performance of the guide wire, ensuring that the direction and position of the guide wire can be precisely controlled, and maintaining good maneuverability even in the case of fine operations, which helps to improve the success rate of the operation.

[0033] Furthermore, according to a pre-dilation guide wire of the present invention, the distal end of the balloon structure 21 is connected to the flexible spring 12 or the distal end of the guide wire rod 11. Specifically, directly connecting the balloon structure 21 to the outermost distal end of the flexible spring 12 or the guide wire rod 11 can maximize the flexibility and accessibility of the guide wire without increasing the overall length of the guide wire, allowing the balloon to be immediately deployed and work after reaching the target position, without the need for additional operations to adjust the position of the balloon, thereby improving the operation efficiency.

[0034] Furthermore, between the flexible springs 12 and between the balloon structure 21 and the flexible spring 12, they are all connected by welding. Specifically, the use of welding technology ensures the firm connection between the components, while avoiding the potential biocompatibility problems and long-term stability problems caused by the use of adhesives. The welding method provides a high-strength connection, maintains the smoothness of the surface of the guide wire, reduces the frictional damage to the blood vessel wall, and simplifies the assembly steps in the manufacturing process.

[0035] Preferably, the guide wire rod 11 of the pre-expansion guide wire is a solid structure, which can be made of nickel-titanium alloy (NiTi), stainless steel and other materials through grinding, drawing, casting and other processes. The distal end of the guide wire rod 11 is a variable diameter design, and the diameter gradually decreases from near to far. At the same time, a distal spring is set at the distal variable diameter part of the guide wire rod 11 to improve the flexibility of the distal end of the guide wire, making it easier to pass through curved blood vessels or enter bifurcated blood vessels. Through the selection of the above materials and process processing, the pre-expansion guide wire of the present invention can provide the necessary flexibility while ensuring strength to meet the needs of complex interventional surgery.

[0036] According to a pre-expansion guidewire of the present invention, the balloon catheter 22 includes a flexible tube portion and a metal tube portion 24 disposed at the distal end of the balloon catheter 22 to ensure smooth pressurization path, and the proximal end of the balloon structure 21 is preferably welded to the distal end of the metal tube portion 24. By combining the flexible tube portion with the metal tube portion 24, and welding the proximal end of the balloon structure 21 to the distal end of the metal tube portion 24, the pre-expansion guidewire of the present invention provides a stable and reliable pressurization path for balloon expansion while maintaining the overall flexibility of the catheter, thereby ensuring high efficiency and safety during interventional treatment.

[0037] The flexible tube is preferably made of a material with high flexibility and biocompatibility, such as polyurethane, polyethylene or other medical-grade elastomeric materials, to ensure that it can slide smoothly in tortuous blood vessels without causing damage. The design of the flexible tube not only provides the necessary flexibility to adapt to complex vascular pathways, but also ensures that the discomfort caused to the patient during the pushing process is minimized.

[0038] The metal tube 24 is located at the distal end of the balloon catheter 22 and is preferably made of high-strength metal materials such as stainless steel or nickel-titanium alloy. The main function of the metal tube 24 is to provide a solid supporting tubular structure to ensure that when the balloon structure 21 is pressurized through the catheter cavity 23, the pressure can be effectively transmitted to the balloon. In addition, the metal tube 24 enhances the support force of the distal end of the balloon catheter 22, so that the balloon maintains a stable shape during expansion and contraction, thereby improving the safety and accuracy of the operation.

[0039] According to a pre-expansion guidewire of the present invention, the balloon structure 21 has a folded state and an expanded state. In order to keep the expansion guidewire with the minimum outer diameter for crossing, in the folded state, the outer diameter of the balloon structure 21 is smaller than the outer diameter of the balloon catheter 22. In the expanded state, the outer diameter of the balloon structure 21 is larger than the outer diameter of the balloon catheter 22. Specifically, the balloon structure 21 is designed to be low-profile when not inflated, that is, its outer diameter is significantly reduced, ensuring that the entire pre-expansion guidewire can pass through the stenotic or occluded vascular lesion area with the minimum outer diameter. This low-profile design not only helps to reduce the pressure on the vascular wall, but also reduces the risk of surgery, making it easier for the guidewire to pass through complex vascular paths. When a pre-expansion operation is required, by injecting liquid or gas into the balloon structure 21, the balloon expands to its maximum design diameter, exceeding the outer diameter of the balloon catheter 22, thereby effectively applying pressure to the stenotic vascular segment to achieve initial expansion. After the expansion is completed, the medium in the balloon can be withdrawn to restore it to a folded state for safe withdrawal.

[0040] Further, according to a pre-expansion guidewire of the present invention, the proximal opening of the catheter cavity 23 is connected to a pressure regulating device. The pressure regulating device can inject liquid into the balloon structure 21 through the catheter cavity 23 to pressurize the balloon structure 21 from a folded state to an expanded state. The pressure regulating device can also extract the liquid in the balloon structure 21 through the catheter cavity 23 to relieve the pressure of the balloon structure 21, so that the balloon structure 21 is converted from an expanded state to a folded state. Specifically, the pressure regulating device preferably includes an injection valve for connecting an external syringe or other liquid / gas supply source. The amount of medium injected or extracted into the balloon can be accurately controlled by the pressure regulating device, thereby achieving fine adjustment of the degree of balloon expansion. During the operation, the pressure regulating device is first connected to the proximal opening of the catheter cavity 23, and then an appropriate amount of liquid or gas is injected into the balloon structure 21 using a device such as a syringe to expand the balloon and start to expand the blood vessel. When the expansion needs to be ended, the doctor can extract the medium in the balloon through the same pressure regulating device to restore the balloon to a folded state for subsequent operations or guidewire withdrawal.

[0041] A pre-expansion guidewire according to the present invention includes a development mark. The development mark is arranged on the guidewire body 10, and is used to display the position of the guidewire body 10 under the imaging device; and / or, the development mark is arranged on the balloon structure 21, and is used to display the state of the balloon structure 21 under the imaging device. Specifically, the development mark on the guidewire body 10 is usually made of high-density metals such as gold and platinum-iridium alloy, and can provide clear and visible marking points in imaging examinations such as X-ray fluoroscopy and CT scanning, helping doctors to accurately locate the position of the guidewire in the body and ensure that the guidewire reaches the target lesion site correctly. In addition, in order to monitor the expansion of the balloon structure 21 and its position relative to the blood vessel wall, a development mark can be set on the balloon surface or at both ends. It enables doctors to accurately judge whether the balloon has been fully expanded and its relationship with surrounding tissues under the guidance of images, so as to perform pre-expansion operations more safely and effectively.

[0042] Preferably, according to a pre-dilation guidewire of the present invention, the outer surface of the balloon structure 21 is provided with a drug coating, and the drug components of the drug coating include anti-proliferation drugs and / or anti-inflammatory drugs. The design of the drug coating is intended to combine the pre-dilation operation and directly deliver therapeutic drugs to the lesion site to prevent the occurrence of restenosis and reduce local inflammatory reactions, thereby significantly improving the effect of the drug and reducing the side effects that may be caused by systemic medication. Anti-proliferation drugs such as rapamycin or paclitaxel are used to inhibit the abnormal proliferation of smooth muscle cells and maintain the open state of the vascular cavity; while anti-inflammatory drugs such as corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs) are used to control local inflammatory reactions caused by surgical operations and promote healthy tissue repair. The drug coating is evenly covered on the outer surface of the balloon through micron- or nano-scale technology, and may be combined with a specific carrier material to ensure that the drug can be quickly and effectively released after reaching the target location. When the balloon expands and contacts the vascular wall, the drug will quickly penetrate into the surrounding tissue.

[0043] In addition, according to the characteristics of different patients' conditions and treatment needs, different drug combinations or concentration ratios can be selected to customize drug coatings to achieve personalized treatment plans, which not only improves the targeted treatment but also enhances the clinical effect.

[0044] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "mode", "specific mode", or "some modes" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or mode are included in at least one embodiment or mode of the embodiment of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or mode. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or modes in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or modes described in this specification and the features of the different embodiments or modes, without contradiction.

[0045] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A pre-expansion guidewire, characterized in that: include: A guidewire body (10), wherein the distal end of the guidewire body (10) is in a gradually tapering shape; An expansion component, comprising a balloon structure (21) and a balloon catheter (22), wherein the balloon catheter (22) is sleeved on the guidewire body (10), the distal end of the balloon structure (21) is connected to the guidewire body (10), and the proximal end of the balloon structure (21) is connected to the distal end of the balloon catheter (22); The inner diameter of the balloon catheter (22) is greater than the diameter of the guidewire body (10), and a catheter lumen (23) for pressurizing the balloon structure (21) or relieving pressure from the balloon structure (21) is formed between the inner side of the balloon catheter (22) and the guidewire body (10).

2. The pre-dilation guidewire according to claim 1, characterized in that: The guide wire body (10) comprises a guide wire rod (11) and a flexible spring (12); The flexible spring (12) is connected to the distal end of the guide wire rod (11) to serve as the terminal structure of the guide wire body (10).

3. The pre-dilation guidewire according to claim 2, characterized in that: The guide wire rod (11) is a solid structure.

4. The pre-dilation guidewire according to claim 2, characterized in that: The distal end of the balloon structure (21) is connected to the flexible spring (12), or is connected to the distal end of the guide wire rod (11).

5. The pre-dilation guidewire according to claim 4, characterized in that: The balloon structure (21) and the balloon catheter (22), the guide wire rod (11) and the flexible spring (12), and the balloon structure (21) and the flexible spring (12) are all connected by welding.

6. The pre-dilation guidewire according to any one of claims 1 to 5, characterized in that: The balloon catheter (22) comprises a flexible tube portion and a metal tube portion (24) arranged at the distal end of the balloon catheter (22), and the proximal end of the balloon structure (21) is welded to the distal end of the metal tube portion (24).

7. The pre-dilation guidewire according to any one of claims 1 to 5, characterized in that: The balloon structure (21) has a folded state and an unfolded state; In the folded state, the outer diameter of the balloon structure (21) is smaller than the outer diameter of the balloon catheter (22); In the expanded state, the outer diameter of the balloon structure (21) is greater than the outer diameter of the balloon catheter (22).

8. The pre-dilation guidewire according to claim 7, characterized in that: The proximal opening of the catheter cavity (23) is connected to a pressure regulating device; The pressure regulating device is capable of injecting liquid into the balloon structure (21) through the catheter cavity (23) to apply pressure, so that the balloon structure (21) is transformed from the folded state to the unfolded state; The pressure regulating device can also extract liquid from the balloon structure (21) through the catheter cavity (23) to relieve the pressure of the balloon structure (21), so as to convert the balloon structure (21) from the expanded state to the folded state.

9. The pre-dilation guidewire according to claim 7, characterized in that: Includes development markers; The imaging mark is arranged on the guide wire body (10) and is used to display the position of the guide wire body (10) under an imaging device; And / or, the development mark is arranged on the balloon structure (21) to display the state of the balloon structure (21) under imaging equipment.

10. The pre-dilation guidewire according to any one of claims 1 to 5, characterized in that: The outer surface of the balloon structure (21) is provided with a drug coating, and the drug components of the drug coating include anti-proliferation drugs and / or anti-inflammatory drugs.

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