Anchoring guide type microcatheter and method of operating the same

Abstract

This invention discloses an anchoring-guided microcatheter and its operation method. The anchoring-guided microcatheter comprises, from distal to proximal, a distal tip, a balloon anchoring body, an internal tube, a rear external tube, and a handle. The internal tube forms a continuous guidewire lumen, through which the guidewire enters from the proximal guidewire lumen interface and exits from the distal tip, providing guidewire support throughout the catheter's length. An independent injection chamber is formed between the rear external tube and the internal tube, allowing the balloon to inflate and retract, thereby achieving anchoring and fixation of the lesion area. The distal tip is a pre-formed fixed-angle structure with radiopaque properties, which, together with the radiopaque ring within the balloon, enables precise visual tracking of the distal end of the catheter and the anchoring position. This invention integrates anchoring, guidance, and radiopaque into a single unit, resulting in a simple and reliable structure that eliminates the need for complex active adjustment mechanisms. It can safely and efficiently pass through complex and tortuous vessels such as coronary arteries and peripheral CTO (chronic total occlusion), significantly improving the stability, positioning accuracy, and operational safety of interventional procedures.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and specifically relates to an anchoring-guided microcatheter and its operation method. Background Technology

[0002] Balloon catheters are core devices in coronary and peripheral vascular interventional therapy. Their core function is to precisely advance along the vascular pathway to the lesion site, expanding the narrowed segment of the vessel by filling the balloon with a medium, thus providing conditions for stent implantation, angioplasty, and other procedures. In interventional treatment of complex and tortuous vessels (such as the circumflex coronary artery and peripheral chronic total occlusion (CTO) lesions), the guiding ability, anchoring stability, and imaging localization capability of the distal catheter are key factors determining the success or failure of the procedure.

[0003] While conventional OTW balloon catheters offer a fully continuous guidewire lumen and excellent guidewire support, their distal ends are typically straight without a pre-formed bend. This results in severely inadequate guidance when navigating tortuous or angulated lesions, requiring repeated manipulation by the operator to pass through, leading to low operational efficiency and increasing the risk of vascular dissection and perforation. Furthermore, conventional OTW catheters only have contrast rings at both ends of the balloon, with the distal bend (or straight tip) lacking contrast, making it impossible to accurately position the catheter tip in real time. This is especially problematic in tortuous vessels, easily leading to "blind pushing" of the catheter tip and significantly increasing surgical risks.

[0004] Furthermore, existing balloon catheters with bend designs are mostly actively curved structures, which are not only complex and costly to manufacture, but also lack independent visualization of the bend, resulting in poor positioning accuracy. Conventional OTW catheters lack a pre-formed fixed bend design, resulting in insufficient permeability. They cannot simultaneously meet the four core clinical requirements of "strong support of the guidewire throughout the OTW", "efficient guidance of the fixed bend", "precise positioning with independent visualization of the bend", and "stable anchoring of the balloon during inflation", becoming a key bottleneck restricting the efficiency and safety of interventional treatment for complex and tortuous blood vessels. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing an anchoring-guided microcatheter and its operation method.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: an anchoring-guided microcatheter, wherein the anchoring-guided microcatheter comprises, from distal to proximal, a distal tip, a balloon anchoring body, a distal inner tube, a proximal inner tube, a contrast ring, an outer tube, and a handle;

[0007] The distal end is fixed to the distal end of the balloon anchoring body. The distal inner tube passes through the balloon anchoring body. The rear end of the balloon anchoring body is integrally formed with an outer tube. The proximal inner tube is located inside the outer tube. The rear end of the outer tube extends into the handle. The handle is provided with a guidewire cavity interface and an injection cavity interface.

[0008] The distal end, distal inner tube, and proximal inner tube form a continuous guidewire lumen. The guidewire passes through the guidewire lumen interface of the handle into the proximal and distal inner tubes and exits from the distal end. An independent injection chamber is formed between the outer tube and the proximal inner tube. The injection chamber is connected to the balloon anchoring body. The balloon anchoring body is filled or removed through the injection chamber interface of the handle to regulate its inflation state and achieve stable anchoring and support for the target vessel lesion.

[0009] The distal end is a pre-formed fixed-bend angle structure with X-ray imaging capabilities, used to precisely guide the catheter through tortuous parts of the blood vessel. A contrast ring is provided on the distal inner tube, and the two work together to achieve dual positioning.

[0010] Furthermore, the bending angle of the end bend is 20° to 45°, 80° to 100°, or 120° to 150°. It is pre-formed by thermoforming process. When no guide wire passes through or the soft section of the guide wire passes through the guide wire cavity, the bending angle remains the original pre-formed angle. When passing through the hard section of the guide wire, the bending angle can be reduced or expanded to 175° to 180° by the guide wire support.

[0011] Furthermore, the distal tip is made of Pebax material and contains radiopaque material. A radiopaque ring is provided on the distal inner tube of the balloon anchoring body. The number of radiopaque rings is 1 to 5, which are symmetrically distributed on the distal inner tube. The radiopaque ring is made of platinum-iridium alloy. The distal tip serves as a distal positioning marker, and the radiopaque ring serves as an anchoring position marker. The two work together to form a dual radiopaque positioning structure, realizing the visual tracking of the catheter tip and the anchoring area.

[0012] Furthermore, the developing material is tungsten powder, which accounts for 50% to 65% of the total mass of the end-tip material.

[0013] Furthermore, the angle between the centerline of the guidewire cavity at the end and the centerline of the end is between 5° and 20°. The guidewire cavity is biased towards the side of the bending angle, and several grooves perpendicular to the centerline are provided on the outer surface of the inner or outer side of the bending angle or the inner and outer sides.

[0014] Furthermore, the tip of the end is conical with a taper of 1.5° to 3°.

[0015] Furthermore, the distal inner tube comprises a three-layer structure: an inner layer of high-density polyethylene, a middle layer of linear low-density polyethylene, and an outer layer of nylon, with the thickness ratio of each layer being outer layer: middle layer: inner layer = 80%: 15%: 5%.

[0016] A method for operating the above-mentioned anchored guided microcatheter includes the following steps:

[0017] (1) Insert the balloon with the end of the balloon as the tip, and use the guide wire to anchor the main body to the preset position;

[0018] (2) Connect the filling syringe through the injection chamber interface of the handle and pump the medium into the injection chamber to anchor the balloon to the main body so as to facilitate subsequent stent implantation.

[0019] (3) After the operation is completed, the medium is extracted through the injection chamber to retract the balloon anchor body and the catheter is withdrawn along the guidewire.

[0020] Furthermore, in step (1), the distal end of the device presents the following state when passing through the guidewire:

[0021] When no guidewire passes through the end tip or when the soft segment of the guidewire passes through the guidewire lumen, the bending angle remains the original pre-shaped angle.

[0022] When the hard segment of the guidewire passes through the guidewire lumen at the tip, the bent portion of the tip is supported by the guidewire to a state of 175° to 180°.

[0023] After the hard segment of the guidewire retracts until the soft segment is fully inside the guidewire lumen at the tip, the tip will return to its initial bending angle.

[0024] Furthermore, in step (2), the pressure of pumping the medium into the injection chamber must not exceed 12 atm.

[0025] This invention provides the following technical solution: an anchoring-guided microcatheter, comprising a balloon anchoring body and an internal tube disposed within the balloon anchoring body. The balloon anchoring body has a contrast-enhancing ring, and one end of the balloon anchoring body is integrally formed with a rear external tube. An independent injection chamber is formed between the rear external tube and the internal tube. A medium is injected into or withdrawn from the balloon anchoring body through the injection chamber to regulate its inflation state, achieving stable anchoring and support for target vessel lesions. The internal tube extends axially along the rear external tube, penetrates the distal end of the balloon anchoring body, and extends outward to form a fixed-angle distal tip. The outer wall of the distal tip is sealed to the balloon anchoring body, allowing the distal tip to move synchronously with the balloon anchoring body. The interior of the internal tube is a fully continuous guidewire lumen. The guidewire enters from the proximal guidewire lumen inlet, extends along the entire length of the internal tube, and exits from the distal tip. The distal tip is a pre-formed fixed-angle structure during manufacturing and possesses X-ray... The radiographic imaging capability is used to precisely guide the catheter through tortuous parts of the blood vessel, and works with the radiographic ring to achieve dual positioning.

[0026] Preferably, the fixed bending angle of the distal end is 0° to 90°, and the distal end is pre-shaped by thermoforming process to stably adapt to the guide path with different blood vessel tortuosity.

[0027] Preferably, the distal end contains radiopaque material, and radiopaque rings are fitted at both ends of the balloon anchoring body; the distal end serves as a distal positioning marker, and the radiopaque rings serve as anchoring position markers. Together, they form a dual radiopaque positioning structure, enabling precise visual tracking of the catheter tip and the anchoring area.

[0028] Preferably, the injection chamber and the guidewire chamber are completely isolated and not connected to each other. The inflation state of the balloon anchor body can be independently adjusted by the injection medium in the injection chamber to achieve stable anchoring of the target blood vessel. The guidewire chamber is adapted to a 0.014" standard interventional guidewire, providing strong support for the catheter throughout the process and ensuring the reliability of the anchoring and guidance process.

[0029] The outer diameter of the built-in tube is smaller than the inner diameter of the rear external tube, so that an independent injection cavity that is connected to the balloon anchoring body is naturally formed between the two.

[0030] The interior of the built-in tube is a fully continuous guidewire lumen, with a diameter adapted to a 0.014" standard interventional guidewire. The full length of the guidewire lumen is consistent with the total length of the catheter, thus giving the built-in tube excellent bending resistance and providing bending resistance support for the rear-mounted external tube, while ensuring smooth guidewire passage throughout the entire process, meeting the operational requirements of the OTW structure.

[0031] An anchoring-guided microcatheter fabrication process includes the following steps:

[0032] S1. During the extrusion of the end tube, the imaging material is blended to achieve overall imaging; the proximal guidewire lumen tube is made of medical polymer material to ensure smooth guidewire sliding; the internal tube is formed to fully penetrate the guidewire lumen.

[0033] S2. The end head is pre-shaped through a thermoforming process to form a preset fixed angle. The bending angle is in three different ranges: 20°~45° or 80°~100° or 120°~150°, which completes the forming of the fixed angle of the bend and does not require intraoperative adjustment.

[0034] S3. The balloon anchoring body is fixed at both ends to the internal tube and the rear external tube respectively using welding technology; the balloon is formed by negative pressure using an external mold; imaging rings are assembled at both ends of the balloon to form a double imaging positioning structure;

[0035] S4. The rear external tube and the internal tube are continuously co-extruded, and an independent injection cavity that is connected to the balloon anchoring body is naturally formed between the rear external tube and the internal tube.

[0036] S5. The outer tube end and the inner tube end are sequentially installed with rubber sleeves and Y-shaped handles through an adhesive bonding process to complete the assembly of the catheter.

[0037] The technical effects and advantages of this invention are as follows:

[0038] 1. The anchoring-guided microcatheter of this application provides full-length guidewire support for the catheter through the fully permeable guidewire lumen formed by the built-in tube, significantly improving guidewire support. At the same time, the distal end of the catheter is a pre-formed fixed-angle tip during fabrication, eliminating the need for complex active bending actuation structures. It can utilize the natural guiding properties of the pre-bending angle, combined with the strong support of the full-length guidewire, to quickly and stably pass through multiple tortuous and angular parts of blood vessels, significantly reducing the difficulty of operation for the operator and greatly improving the efficiency of interventional surgery for complex lesions.

[0039] 2. The anchoring-guided microcatheter of this application incorporates a certain proportion of radiopaque material during extrusion of the distal end tube, resulting in uniform and stable X-ray imaging performance of the entire bend section. Combined with the radiopaque rings at both ends of the balloon anchoring body, a dual radiopaque positioning structure is formed, enabling real-time and precise tracking of the catheter tip position during the procedure. This completely avoids the "blind push" risk caused by traditional catheters relying solely on balloon radiopaque rings for positioning, significantly improving the safety and operational precision of interventional treatment for complex tortuous blood vessels.

[0040] 3. The guidewire lumen at the distal end has a certain angle between its axis and the axis of the distal end. The guidewire lumen is biased towards the side of the bending angle, and several grooves perpendicular to the axis are provided on the outer surface of the inner or outer side of the bending angle. This design makes it easier for the distal end to maintain the pre-processed bending angle. When the soft section of the guidewire passes through the distal end, it can more accurately maintain the guidewire exit direction. At the same time, when the hard section of the guidewire passes through the distal end, the bending angle can be changed more conveniently according to the curvature of the blood vessel, or the angle can be expanded to 175° to 180°.

[0041] 4. The end can be designed with a conical tip, which can make the outer diameter of the tip smaller, making it easier for the product to pass through narrow lesions. At the same time, a certain taper can make the product pass through narrow lesions more smoothly, eliminating the step-like shape caused by conventional diameter changes, thereby reducing the feeling of jamming when the product passes through the lesion.

[0042] 5. The anchoring-guided microcatheter of this application adopts a coaxial design of a rear-mounted external tube and an internal tube. The injection chamber and the guidewire chamber are completely isolated and do not communicate with each other. The injection chamber independently undertakes the balloon inflation / retraction function, ensuring the safety of balloon expansion and anchoring stability. The guidewire chamber is fully continuous and adaptable to a 0.014" standard interventional guidewire. The guidewire passes smoothly without the risk of media leakage. The structure is simple and the sealing reliability is high. Compared with traditional active bending catheters, it significantly reduces the risk of structural failure and intraoperative leakage.

[0043] 6. The anchoring-guided microcatheter of this application controls the inflation state of the balloon anchoring body through an independent injection chamber. After the balloon is inflated, it can closely adhere to the blood vessel wall to achieve stable mechanical anchoring of the target lesion site, providing continuous and reliable support for subsequent operations, avoiding catheter displacement, and further improving the stability and safety of surgical operations. Attached Figure Description

[0044] Figure 1 This is a schematic diagram of the overall anchoring and guiding microcatheter in the embodiment.

[0045] Figure 2 This is a partially enlarged schematic diagram of the balloon anchoring body and the distal end of the embodiment.

[0046] Figure 3 This is a schematic diagram of the cross-sectional structure of the conduit body in an embodiment.

[0047] Figure 4 This is a schematic diagram of the Y-type handle interface structure in the embodiment.

[0048] Figure 5 This is a partially enlarged schematic diagram of the end of the embodiment.

[0049] Reference numerals: 1. Balloon anchoring body; 2. Internal tube; 3. Terminal tip; 4. Rear external tube; 5. Rubber sleeve; 6. Y-shaped handle; 7. Injection chamber; 8. Guide wire chamber; 9. Imaging ring. Detailed Implementation

[0050] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0051] The present invention provides the following as shown in Figures 1 to 4. An anchoring-guided microcatheter, as shown, includes a balloon anchoring body 1 and an internal tube 2 disposed within the balloon anchoring body 1. The balloon anchoring body 1 has a contrast-enhancing ring 9, and a rear external tube 4 is integrally formed at one end of the balloon anchoring body 1. An independent injection chamber 7 is formed between the rear external tube 4 and the internal tube 2. Medium is injected into or removed from the balloon anchoring body 1 through the injection chamber 7 to regulate its inflation state, achieving stable anchoring and support for the target vessel lesion. The internal tube 2 extends axially along the rear external tube 4, penetrates the distal end of the balloon anchoring body 1, and extends outward to form a fixed-angle distal tip 3. The outer wall of the distal tip 3 is sealed to the balloon anchoring body 1, allowing the distal tip 3 to move synchronously with the balloon anchoring body 1. The interior of the internal tube 2 is a fully continuous guidewire lumen 8. The guidewire enters from the proximal guidewire lumen 8 entrance, extends along the entire length of the internal tube 2, and exits from the distal tip 3. The distal tip 3 is a pre-formed fixed-angle structure during manufacturing and possesses X-ray... The radiographic imaging properties are used to precisely guide the catheter through tortuous parts of the blood vessel, and work with the radiographic ring 9 to achieve dual positioning.

[0052] The fixed bending angle of the distal tip is in three different ranges: 20°~45° or 80°~100° or 120°~150°. The distal tip is pre-shaped by thermoforming process to stably adapt to the guidance path of different blood vessel tortuosity.

[0053] The end cap contains developing material, and developing rings are assembled at both ends of the balloon anchoring body. The end cap is made of Pebax 4533 material, and the developing material is tungsten powder. The mass ratio of Pebax 4533 to tungsten powder is 4:6.

[0054] The materials of the microcatheters are shown in Table 1:

[0055] Table 1

[0056]

[0057] The distal tip serves as a remote positioning marker, while the imaging ring serves as an anchoring position marker. Together, they form a dual imaging positioning structure, enabling precise visual tracking of the catheter tip and the anchoring area.

[0058] The injection chamber and guidewire chamber are completely isolated and not connected to each other. The inflation state of the balloon anchor body can be independently controlled by the injection medium in the injection chamber to achieve stable anchoring of the target vessel. The guidewire chamber is adapted to a 0.014" standard interventional guidewire, providing strong support for the catheter throughout the entire process and ensuring the reliability of the anchoring and guidance process.

[0059] The outer diameter of the internal tube is smaller than the inner diameter of the rear external tube, so that an independent injection chamber that is connected to the balloon anchoring body is naturally formed between the two.

[0060] The interior of the built-in tube is a fully continuous guidewire lumen, with a diameter adapted to a standard 0.014" interventional guidewire. The entire length of the guidewire lumen is consistent with the total length of the catheter, thus giving the built-in tube excellent bending resistance and providing bending resistance support for the rear-mounted external tube, while ensuring smooth guidewire passage throughout the entire process, meeting the operational requirements of the OTW structure.

[0061] Working principle: When in use, the device is inserted into a blood vessel with the end tip 3 as the tip and moves inward along the blood vessel. The inside of the catheter tube 2 is a guidewire lumen 8 that runs through the entire length. The guidewire is inserted from the guidewire lumen interface of the Y-shaped handle 6, extends along the entire length of the guidewire lumen 8 and exits from the end tip 3, providing full guidewire support for the catheter.

[0062] When the catheter is advanced to a tortuous or angulated section of the blood vessel, the pre-shaped, fixed-angle distal tip 3, with its natural guiding properties and the strong support of the guidewire, smoothly guides the distal tip 3 into the tortuous section. The advancement of the external catheter 4 then propels the entire device along the guidewire quickly and stably through the tortuous area. After passing through the tortuous section, the catheter continues to be advanced along the guidewire. Throughout the entire device insertion process, no additional adjustment of the bend angle is required; relying solely on the pre-shaped, fixed bend and the support of the guidewire, the device can efficiently and safely pass through multiple tortuous points in the blood vessel, significantly reducing the difficulty of the operator's operation.

[0063] Once the balloon anchoring body 1 reaches the preset lesion location, a filling syringe is connected to the injection chamber 7 of the Y-shaped handle 6, and contrast agent or other media are pumped into the injection chamber 7. The media enters the balloon anchoring body 1 through the injection chamber 7, causing the balloon to inflate and tightly adhere to the vessel wall, achieving stable mechanical anchoring at the lesion site. Simultaneously, it opens up the narrowed segment of the vessel, providing pathway and support for subsequent stent implantation, instrument advancement, and other procedures. After the procedure, the media is withdrawn through the injection chamber 7, causing the balloon anchoring body 1 to retract, and the catheter is withdrawn along the guidewire, completing the surgical procedure.

[0064] This embodiment provides, for example Figures 2 to 3 Fixed-angle end head and coaxial tube structure scheme:

[0065] The fixed-angle end tip 3 is a structure formed by the integral extension of the distal end of the built-in tube 2. During the extrusion molding of the tube, a certain proportion of radiopaque material is added to the raw material of the bend section to make the end tip 3 uniform and stable X-ray radiopaqueness. The radiopaque material is uniformly dispersed in the tube matrix, which maintains the flexibility and mechanical properties of the tube while ensuring the clarity of radiopaqueness. Together with the radiopaque rings 9 at both ends of the balloon anchoring body 1, a dual radiopaque positioning structure is formed, which can accurately track the position of the catheter tip in real time during the operation and avoid the risk of "blind push" caused by the traditional catheter relying solely on the radiopaque ring for positioning.

[0066] The fixed-angle end cap 3 is pre-formed using a thermoforming process, with three different bending angle ranges: 20°~45°, 80°~100°, or 120°~150°, ensuring the consistency and stability of the bend angle and adapting to vascular anatomy structures with different degrees of tortuosity. The thermoforming process, through precise temperature control and a molding mold, allows the bend to be formed and fixed at a single angle, eliminating the need for intraoperative adjustments. The structure is simple and highly reliable, significantly reducing the risk of structural failure compared to traditional active bending catheters.

[0067] The catheter body is integrally formed using an extrusion mold. The interior of the inner tube 2 forms a fully continuous guidewire lumen 8, and the outer tube 4 and the inner tube 2 form an independent injection lumen 7. The two lumens are completely isolated and do not communicate with each other. The guidewire lumen 8 is adapted to a 0.014" standard interventional guidewire, and its full length is consistent with the total length of the catheter, providing full guidewire support for the catheter. The injection lumen 7 is connected to the balloon anchoring body 1 and independently undertakes the balloon inflation function, ensuring the safety of balloon dilation.

[0068] Between the nominal pressure (NP) and the rated burst pressure (RBP), the diameter measurement of the balloon always deviated from the diameter indicated in Table 2 by less than ±10%.

[0069] Table 2

[0070]

[0071] Working principle: In this embodiment, the catheter is inserted into the blood vessel with the fixed-angle end 3 as the tip. When pushed along the blood vessel path, the catheter tip is guided by the pre-formed fixed-angle bend at the distal end, and with the strong support of the guidewire, the tip smoothly enters the tortuous part of the blood vessel. The entire device is quickly passed along the guidewire by pushing the external tube 4. During the entire tube insertion process, there is no need to adjust the bend angle. It can pass through the tortuous parts of the blood vessel stably and efficiently by relying only on the pre-formed fixed bend and the support of the guidewire.

[0072] Once the balloon anchor body 1 reaches the preset lesion location, a filling syringe connected to the injection chamber 7 (Luer connector) of the Y-shaped handle 6 is used to pump media into the injection chamber 7. The media enters the balloon anchor body 1 through the injection chamber 7, causing the balloon anchor body 1 to inflate and open the blood vessel at the preset location to facilitate subsequent stent implantation. After the operation is completed, the media is withdrawn through the injection chamber 7 to retract the balloon anchor body 1, and the catheter is withdrawn along the guidewire to complete the procedure.

[0073] See attached document Figure 1 To be continued Figure 4 A process for manufacturing a distal tip balloon catheter includes the following steps:

[0074] S1. During the extrusion of the end tube 3, the imaging material is blended to achieve overall imaging; the proximal guidewire lumen tube is made of medical polymer material to ensure smooth guidewire sliding; the internal tube 2 is formed to fully penetrate the guidewire lumen 8.

[0075] S2 and the end head 3 are pre-formed through a thermoforming process to form a preset fixed angle. The bending angle is in three different ranges: 20°~45° or 80°~100° or 120°~150°, thus completing the forming of the fixed angle of the bend without the need for intraoperative adjustment.

[0076] S3. The two ends of the balloon anchoring body 1 are fixed to the inner tube 2 and the rear outer tube 4 respectively by welding process; the balloon is formed by negative pressure using an outer mold; and imaging rings 9 are assembled at both ends of the balloon to form a double imaging positioning structure.

[0077] S4, the rear external tube 4 and the internal tube 2 are continuously co-extruded, and an independent injection cavity that is connected to the balloon anchoring body 1 is naturally formed between the rear external tube 4 and the internal tube 2.

[0078] S5, the end of the rear external tube 4 and the end of the internal tube 2 are sequentially installed with rubber sleeve 5 and Y-shaped handle 6 through an adhesive bonding process to complete the assembly of the catheter.

[0079] In another embodiment, such as Figure 5 As shown, starting from the head and tail ends, the guidewire cavity is biased towards the inner side of the bending angle. The inner cavity has a uniform wall thickness of 0.135 mm in all four directions for the first 1.5 mm from both ends. Moving towards the tail end, the outer wall thickness remains constant, while the inner wall thickness decreases to 0.1 mm, with an eccentricity of 0.035 mm. Several grooves perpendicular to the axis are also provided on the inner side of the bending angle.

[0080] In another embodiment, several grooves perpendicular to the axis are provided on the outer side of the bending angle, or several grooves perpendicular to the axis are provided on both the inner and outer surfaces.

[0081] In another embodiment, the outer diameter of the end head gradually decreases from 0.61 mm to 0.48 mm from 1.5 mm from the tail end to the head end in a smooth diameter variation manner, with a taper of approximately 0.0867 and a half-cone angle of approximately 2.48°.

[0082] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An anchored guided microcatheter, characterized in that: The anchoring-guided microcatheter, from distal to proximal, comprises a distal tip, a balloon anchoring body, a distal inner tube, a proximal inner tube, a contrast ring, an outer tube, and a handle. The distal end is fixed to the distal end of the balloon anchoring body. The distal inner tube passes through the balloon anchoring body. The rear end of the balloon anchoring body is integrally formed with an outer tube. The proximal inner tube is located inside the outer tube. The rear end of the outer tube extends into the handle. The handle is provided with a guidewire cavity interface and an injection cavity interface. The distal end, distal inner tube, and proximal inner tube form a continuous guidewire lumen. The guidewire passes through the guidewire lumen interface of the handle into the proximal and distal inner tubes and exits from the distal end. An independent injection chamber is formed between the outer tube and the proximal inner tube. The injection chamber is connected to the balloon anchoring body. The balloon anchoring body is filled or removed through the injection chamber interface of the handle to regulate its inflation state and achieve stable anchoring and support for the target vessel lesion. The distal end is a pre-formed fixed-bend angle structure with X-ray imaging capabilities, used to precisely guide the catheter through tortuous parts of the blood vessel. A contrast ring is provided on the distal inner tube, and the two work together to achieve dual positioning.

2. The anchoring-guided microcatheter according to claim 1, characterized in that: The bending angle of the end bend is between 20° and 45°, or 80° and 100°, or 120° and 150°. It is pre-formed by thermoforming. When no guide wire passes through or the soft section of the guide wire passes through the guide wire cavity, the bending angle remains at the original pre-formed angle. When the hard section of the guide wire passes through, the bending angle can be reduced or expanded to 175° and 180° by the guide wire support.

3. The anchoring-guided microcatheter according to claim 1, characterized in that: The distal tip is made of Pebax material and contains radiopaque material. A radiopaque ring is provided on the distal inner tube of the balloon anchoring body. The number of radiopaque rings is 1 to 5, which are symmetrically distributed on the distal inner tube. The radiopaque ring is made of platinum-iridium alloy. The distal tip serves as a distal positioning marker, and the radiopaque ring serves as an anchoring position marker. Together, they form a dual radiopaque positioning structure to achieve visual tracking of the catheter tip and the anchoring area.

4. The anchoring-guided microcatheter according to claim 3, characterized in that: The developing material is tungsten powder, which accounts for 50% to 65% of the total mass of the end-head material.

5. The anchoring-guided microcatheter according to claim 1, characterized in that: The angle between the centerline of the end guide wire cavity and the centerline of the end tip is 5° to 20°. The guide wire cavity is biased towards the side of the bending angle, and several grooves perpendicular to the centerline are provided on the outer surface of the inner or outer side of the bending angle or the inner and outer sides.

6. The anchoring-guided microcatheter according to claim 1, characterized in that: The top of the end cap is conical with a taper of 1.5° to 3°.

7. The anchoring-guided microcatheter according to claim 1, characterized in that: The distal inner tube comprises a three-layer structure: an inner layer of high-density polyethylene, a middle layer of linear low-density polyethylene, and an outer layer of nylon, with the thickness ratio of each layer being outer layer: middle layer: inner layer = 80%: 15%: 5%.

8. A method for operating an anchored guided microcatheter according to any one of claims 1 to 7, characterized in that... Includes the following steps: (1) Insert the balloon with the end of the balloon as the tip, and use the guide wire to anchor the main body to the preset position; (2) Connect the filling syringe through the injection chamber interface of the handle and pump the medium into the injection chamber to anchor the balloon to the main body so as to facilitate subsequent stent implantation. (3) After the operation is completed, the medium is extracted through the injection chamber to retract the balloon anchor body and the catheter is withdrawn along the guidewire.

9. The operating method according to claim 8, characterized in that: In step (1), the distal end of the device presents the following state when passing through the guidewire: When no guidewire passes through the end tip or when the soft segment of the guidewire passes through the guidewire lumen, the bending angle remains the original pre-shaped angle. When the hard segment of the guidewire passes through the guidewire lumen at the tip, the bent portion of the tip is supported by the guidewire to a state of 175° to 180°. After the hard segment of the guidewire retracts until the soft segment is fully inside the guidewire lumen at the tip, the tip will return to its initial bending angle.

10. The operating method according to claim 8, characterized in that: In step (2), the pressure of pumping the medium into the injection chamber shall not exceed 12 atm.

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