Quick integral exchange type balloon dilatation catheter

Abstract

The invention relates to the technical field of medical apparatus and instruments, in particular to a quick integral exchange type balloon dilatation catheter which comprises an integral exchange catheter and a balloon dilatation device, the integral exchange catheter comprises a catheter seat and a catheter body connected to the catheter seat, the catheter body and the catheter seat are communicated with a main channel, and the catheter body is provided with a balloon structure with an expanded state and a folded state; and the rapid exchange tube is arranged at the far end of the catheter main body, and a rapid exchange channel for the guide wire to pass through is formed in the rapid exchange tube on the outer side of the catheter main body. According to the scheme, the problems that an existing balloon dilatation catheter is single in function, and injection of drugs or contrast agents or rapid guide wire exchange and other functions cannot be achieved while dilatation is conducted are solved. The device integrates the functions of balloon dilatation, injection and guide wire exchange, and can greatly simplify the operation process and improve the treatment efficiency and safety when being used clinically.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a rapid integral exchange balloon dilatation catheter. Background Art

[0002] Minimally invasive vascular intervention is currently the mainstream treatment for vascular stenosis, with the core device being the dilatation balloon catheter. Prior art balloon catheters typically consist of a catheter body, an expandable portion, and positioning markers. Guided by a guidewire, they locate and dilate the lesion. In clinical practice, the catheter is pushed along the guidewire to the target location, with the aid of imaging markers to aid precise positioning.

[0003] Existing balloon catheters are primarily divided into two types based on the guidewire manipulation method: one requiring guidewire exchange throughout the entire catheter length, and the other utilizing a localized main channel design. While the former offers injection capabilities, its clinical application is declining due to the large space requirements and time required for manipulation. While the latter improves operational convenience, its structural limitations make it difficult to achieve instant injection during treatment.

[0004] With advancements in interventional therapy, the demand for balloon dilatation catheters in clinical practice has expanded beyond simple dilatation. Additional functions such as fluid delivery, drug infusion, or guidewire manipulation are often required during treatment. However, existing solutions have functional limitations and require the use of multiple auxiliary devices to complete complex treatment procedures, which not only increases surgical complexity but also prolongs treatment time. Summary of the Invention

[0005] The present invention provides a rapid integral exchange balloon dilatation catheter to address the defect that balloon catheters have a single function and cannot meet the growing demand for clinical interventional technology. It realizes a multifunctional operation integrating dilatation and injection functions, simplifies the surgical process and improves treatment efficiency and safety.

[0006] The present invention provides a rapid integral exchange balloon dilatation catheter, comprising: an integral exchange catheter, comprising a catheter seat and a catheter body connected to the catheter seat, the catheter body and the catheter seat being communicated with a main channel, the catheter body being provided with a balloon structure having an expanded state and a folded state; a rapid exchange tube, arranged at the distal end of the catheter body, the rapid exchange tube forming a rapid exchange channel on the outside of the catheter body for the passage of a guidewire.

[0007] According to one embodiment of the present invention, the catheter seat is provided with a balloon pressure-regulating channel isolated from the main channel; the catheter body includes: an outer tube, connected to the catheter seat; an inner tube, connected to the main channel of the catheter seat and located inside the outer tube, a balloon cavity connected to the balloon pressure-regulating channel is formed between the inner tube and the outer tube; the proximal end of the balloon structure is connected to the outer tube, and the distal end thereof is connected to the inner tube.

[0008] According to one embodiment of the present invention, it also includes a tip tube located at the distal end of the inner tube; the tip tube is connected to the inner tube and seals the distal end of the balloon cavity; the end of the tip tube is in the shape of a rounded cone, or the end of the tip tube is in the shape of a bevel, and the bevel angle is 45°±10°.

[0009] According to one embodiment of the present invention, the quick exchange tube is integrally formed with the tip tube; or, the quick exchange tube is a detachable accessory installed on the tip tube, and the quick exchange tube includes an assembly hole parallel to the quick exchange channel, and the quick exchange tube is sleeved on the tip tube through the assembly hole.

[0010] According to one embodiment of the present invention, a circumferential assembly groove is provided on the outer surface of the tip tube; the cross-sectional diameter of the circumferential assembly groove is adapted to the inner diameter of the assembly hole.

[0011] According to one embodiment of the present invention, the balloon structure includes a film structure made of an elastic memory material; in the folded state of the balloon structure, the film structure is folded on the surface of the inner tube under the elastic restoring action of the elastic memory material.

[0012] According to one embodiment of the present invention, in the expanded state, the film structure expands into a cylindrical shape under the action of a pressure medium; in the folded state, the film structure folds into a plurality of folds evenly distributed in the circumferential direction of the balloon structure, and the plurality of folds gather in the same direction in a spiral folding manner.

[0013] According to one embodiment of the present invention, the catheter seat is provided with a stress relief tube; the stress relief tube is wrapped around the connection position between the catheter seat and the outer tube.

[0014] According to one embodiment of the present invention, the surface of the inner tube and / or the outer tube is provided with a developing mark.

[0015] According to one embodiment of the present invention, the visualization mark of the inner tube is at least marked at a position corresponding to the balloon structure.

[0016] The present invention provides a rapid, integrated exchange balloon dilatation catheter. By optimizing the catheter's structural design, it innovatively integrates guidewire manipulation and fluid delivery while maintaining the advantages of rapid exchange functionality. The catheter utilizes an integrated catheter structure, comprising a catheter adapter connected to the main channel and a catheter body equipped with an expandable / foldable balloon. A separate rapid exchange channel is provided at the distal end. Specifically, the catheter adapter and the catheter body together form the complete main channel, while the balloon structure achieves pressure control through fluid connectivity within the main channel. The rapid exchange channel serves as a dedicated channel for the guidewire, ensuring convenient guidewire manipulation while also providing a feasible path for fluid delivery through structural optimization. This design allows physicians to quickly deliver instruments to the lesion site through the rapid exchange channel while simultaneously utilizing the main channel for contrast agent delivery or drug infusion, thereby achieving dual functions of dilatation and injection during a single intervention. Compared to existing technologies, this solution eliminates the need for replacing or adding additional instruments, significantly reducing surgical complexity, shortening treatment time, and minimizing the risk of vascular injury. This provides reliable technical support for the multifunctional treatment needs of complex interventional scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction is given below to 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 any creative work.

[0018] Figure 1 This is one of the structural schematic diagrams of the rapid integral exchange balloon dilatation catheter provided by the present invention.

[0019] Figure 2 This is the second structural schematic diagram of the rapid integral exchange balloon dilatation catheter provided by the present invention.

[0020] Figure 3 This is one of the schematic diagrams of the local use state of the rapid integral exchange balloon dilatation catheter provided by the present invention.

[0021] Figure 4 This is the second schematic diagram of the local use state of the rapid integral exchange balloon dilatation catheter provided by the present invention.

[0022] Figure 5 It is a partial schematic diagram showing the balloon structure of the rapid integral exchange balloon dilatation catheter provided by the present invention in a folded state.

[0023] Figure 6 It is a partial schematic diagram showing the balloon structure of the rapid integral exchange balloon dilatation catheter provided by the present invention in an expanded state.

[0024] Figure 7 It is a schematic cross-sectional structural diagram of a rapid exchange tube of a rapid integral exchange balloon dilatation catheter provided by the present invention.

[0025] Figure 8 It is a schematic cross-sectional view of the balloon structure of the rapid integral exchange balloon dilatation catheter provided by the present invention.

[0026] Reference numerals: 10. Catheter seat; 11. Main channel; 12. Balloon pressure regulating channel; 13. Stress relief tube; 20. Outer tube; 21. Balloon structure; 30. Inner tube; 31. Balloon cavity; 32. Development mark; 43. Tip tube; 44. Rapid exchange tube; 51. Rapid exchange channel; 52. Assembly hole; 53. Circumferential assembly groove; 54. Pleated part. DETAILED DESCRIPTION

[0027] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0028] 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 orientations or positional relationships based on the orientations 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, and do not indicate or imply 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 limiting 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.

[0029] Existing balloon catheters have a single function and cannot meet the growing demand for clinical interventional technology. For example, the same catheter can be used for angiography during catheter insertion or balloon dilation to reduce the risk of the device entering the wrong blood vessel; the same catheter can be used for drug treatment during or after balloon dilation; and the same catheter can be used to replace the guidewire in situ to simplify the surgical process and improve treatment efficiency and safety.

[0030] The present invention provides a rapid integral exchange balloon dilatation catheter, comprising: an integral exchange catheter, comprising a catheter seat 10 and a catheter body connected to the catheter seat 10, the catheter body being connected to the catheter seat 10 via a main channel 11, the catheter body being provided with a balloon structure 21 having an expanded state and a folded state; a rapid exchange tube 44, disposed at the distal end of the catheter body, the rapid exchange tube 44 forming a rapid exchange channel 51 on the outside of the catheter body for the passage of a guidewire. Specifically, the present invention innovatively designs a balloon dilatation catheter with multifunctional integrated capabilities by combining an integral exchange catheter with a rapid exchange function. The catheter comprises an integral exchange catheter, which is composed of a catheter seat 10 and a catheter body connected thereto, the catheter body being provided with a main channel 11 for the passage of a guidewire and the delivery of liquid, and an expandable and foldable balloon structure 21 being provided on the outside of the catheter body. The balloon structure 21 can switch states under external pressure control, thereby completing the dilation operation on the lesion site.

[0031] Furthermore, a rapid-exchange tube 44 is installed at the distal end of the catheter body. This tube 44 forms an independent rapid-exchange channel 51 on the outside of the catheter body, allowing for rapid insertion and removal of the guidewire, enabling in-situ replacement or rerouting of the guidewire, significantly improving operational convenience and surgical efficiency. More importantly, the design of the rapid-exchange channel 51 does not affect the functional integrity of the main channel 11, allowing the main channel 11 to be used simultaneously for additional procedures such as contrast agent injection and drug delivery.

[0032] The rapid, integrated exchange balloon dilatation catheter provided by the present invention not only retains the advantages of integrated exchange catheters in guidewire manipulation and fluid pathways, but also incorporates the operational convenience of rapid exchange catheters, integrating multiple functions such as balloon dilatation, guidewire replacement, angiography, and local drug therapy into a single catheter. This design effectively reduces the number of intraoperative instrument changes and intravascular operation time, lowering the risk of complications, meeting the growing clinical demand for multifunctional interventional therapies, and possessing significant clinical application value.

[0033] The following combination Figures 1-8 A specific embodiment of the rapid integral exchange balloon dilatation catheter of the present invention is described.

[0034] like Figure 1 、 Figure 2 、 Figure 3 、 Figure 4 、 Figure 5 and Figure 6 As shown, the present invention provides a rapid integral exchange balloon dilatation catheter, comprising a catheter hub 10, provided with a main channel 11 and a balloon pressure regulating channel 12 isolated from the main channel 11. The catheter body of the rapid integral exchange balloon dilatation catheter comprises an outer tube 20 and an inner tube 30, with the proximal end of the balloon structure 21 connected to the outer tube 20 and the distal end connected to the inner tube 30.

[0035] Specifically, the outer tube 20 is connected to the catheter adapter 10; the inner tube 30 is connected to the main channel 11 of the catheter adapter 10 and is located inside the outer tube 20. A balloon lumen 31 connected to the balloon pressure regulating channel 12 is formed between the inner tube 30 and the outer tube 20; a quick exchange tube 44 is provided at the distal end of the outer tube 20. The quick exchange tube 44 is provided with a quick exchange channel 51 that allows a guidewire to pass through. Through the above structural design, the balloon dilatation catheter not only has the operational stability of a traditional over-the-wire (OTW) catheter, but also introduces a quick exchange function, which allows the catheter to be replaced or adjusted in position without withdrawing the guidewire, significantly improving operational efficiency. The doctor can pressurize or release the balloon lumen 31 through the balloon pressure regulating channel 12, thereby controlling the expansion or retraction of the balloon structure 21 and achieving effective dilation of the stenotic part of the blood vessel.

[0036] This rapid, integrated exchange balloon dilatation catheter supports multiple operation modes, greatly enhancing its clinical applicability and flexibility. While performing balloon dilatation, the physician can inject contrast agents or medications through the main channel 11, enabling immediate observation and treatment of the lesion. By using the main channel 11 to carry a new guidewire to replace the old guidewire in the rapid exchange channel 51, the catheter can be replaced or repositioned without removing the guidewire, improving procedural efficiency and reducing patient risk. Furthermore, when navigating complex lesions, such as tortuosity and calcification, the rapid exchange channel 51 and the main channel 11 can be used simultaneously to insert guidewires, enhancing catheter pushability and stability. This dual-guidewire technology not only improves the catheter's ability to navigate complex lesions, but also ensures safe and precise operation. Therefore, whether it requires rapid device replacement, requires the traditional over-the-wire (OTW) approach requiring greater controllability and support, or requires dual-guidewire operation for complex lesions, this catheter provides an effective solution for a variety of interventional procedures, including coronary, peripheral, and cerebrovascular procedures. In particular, this rapid, integrated exchange balloon dilatation catheter allows for simultaneous balloon dilatation, utilizing main channel 11 as an injection channel to inject contrast agents or other therapeutic drugs into the targeted area. This allows for real-time assessment of treatment effectiveness and appropriate adjustments during dilatation. During this process, a guidewire placed in rapid exchange channel 51 can also assist in positioning, ensuring accurate injection placement and improving surgical safety and success rates.

[0037] Furthermore, the design of the rapid integral exchange balloon dilatation catheter can be optimized and adjusted according to different clinical needs, for example, by changing parameters such as the balloon material, size, or diameter of the balloon pressure regulating channel 12, to adapt to different types of vascular lesions, expand the scope of application, and improve the treatment effect. For example, the balloon structure 21 is preferably made of nylon, with a nominal diameter of preferably 2.5 mm and an effective length of preferably 12 mm; the overall effective length of the catheter is preferably 1400 ± 50 mm, and the outer diameter of the tube is preferably 0.87 ± 0.05 mm; the catheter seat 10 is preferably made of polycarbonate material. The inner diameter of the rapid exchange channel 51 is preferably 0.001-0.05 inches, allowing a guidewire from 0.001 to 0.050 inches to pass freely. The selection of the above parameters is intended to optimize the performance of the catheter in intravascular operations, ensuring that it can provide good controllability, safety, and clinical applicability while meeting multifunctional requirements.

[0038] In summary, the present invention introduces a rapid exchange structure and integrates multiple functions such as balloon expansion, liquid injection and guidewire-assisted positioning, thereby achieving efficient collaborative operation during interventional treatment, simplifying the surgical process, reducing the number of instrument changes, reducing the risk of complications, and significantly improving the overall efficiency and safety of interventional surgery.

[0039] According to a rapid integral exchange balloon dilatation catheter of the present invention, the catheter seat 10 is preferably provided with a stress relief tube 13; the stress relief tube 13 is wrapped around the connection position between the catheter seat 10 and the outer tube 20. The stress relief tube 13 is preferably made of PVC. The design of the stress relief tube 13 is intended to enhance the mechanical strength of the connection between the catheter seat 10 and the outer tube 20, and reduce the risk of damage caused by bending or kinking during operation. It is suitable for interventional surgical environments that require high flexibility and high strength, and can effectively protect the key connection parts of the catheter from external physical damage, ensuring stability and reliability during the operation. In addition, the stress relief tube 13 can also improve the overall control performance of the catheter, making navigation in complex vascular pathways smoother and more precise.

[0040] According to a rapid, integrally exchangeable balloon dilatation catheter of the present invention, the surface of the inner tube 30 and / or outer tube 20 is preferably provided with a developing marker 32 to provide a clear visual indication during vascular interventional procedures, ensuring that the physician can accurately locate the balloon relative to the lesion. The developing marker 32 preferably comprises an alloy of platinum (90%) and iridium (10%). This material combination not only has excellent radiopaque properties but also good biocompatibility and appropriate flexibility, allowing the marker to be clearly visible under X-ray or other imaging techniques without significantly affecting the catheter's operational flexibility. The developing marker 32 of the inner tube 30 is preferably at least marked at a position corresponding to the balloon structure 21. For example, developing markers 32 can be provided on the surface of the corresponding inner tube 30 at positions corresponding to the proximal and distal ends of the balloon structure 21, respectively, to assist the physician in determining the exact position of the balloon structure 21 through imaging. In practical applications, the developing marker 32 helps guide the accurate positioning and precise operation of the balloon, especially during complex interventional procedures. For example, when performing angioplasty, the doctor needs to accurately position the balloon at the site of stenosis or blockage and confirm whether the balloon is positioned correctly by using the visualization mark 32 .

[0041] Preferably, according to a rapid integral exchange balloon dilatation catheter of the present invention, the inner tube 30 may be composed of a three-layer structure. The inner layer of the inner tube 30 is made of high-density polyethylene material, which has good rigidity and chemical corrosion resistance, and can ensure the structural stability and durability of the inner tube of the catheter. The middle layer of the inner tube 30 is made of low-density polyethylene material, which increases the flexibility and sealing of the inner tube 30, making the catheter more flexible and less prone to leakage during operation, thereby improving the safety of use. The outer layer of the inner tube 30 is made of nylon material, which not only has excellent wear resistance and strength, but also can provide additional protection, making the inner tube 30 more resistant to external physical damage and wear.

[0042] The outer tube 20 is made of nylon and coated at its distal end with a hydrophilic coating to enhance insertion and reduce friction and damage to the vessel wall during insertion. This hydrophilic coating, which may include polyvinylpyrrolidone, forms a smooth hydration layer upon contact with water, significantly reducing friction between the catheter and the vessel wall, making it easier and safer for the catheter to navigate complex vascular pathways and reach its target location.

[0043] The rapid, integrally exchangeable balloon dilatation catheter according to the present invention also includes a tip tube 43, disposed at the distal end of the inner tube 30, to reduce the catheter's propulsive resistance within the blood vessel and improve its passage. The tip tube 43 communicates with the inner tube 30 and seals the distal end of the balloon lumen 31 formed between the outer tube 20 and the inner tube 30, preventing fluid leakage during pressurization and ensuring stable expansion and contraction of the balloon structure 21.

[0044] In addition, a rapid exchange tube 44 is positioned on one side of the tip tube, forming an independent rapid exchange channel 51 that allows a guidewire to pass through. This structure allows for greater clinical flexibility: physicians can use either the distal rapid exchange channel 51 or the main channel 11 independently, or both simultaneously (i.e., dual-guidewire mode) to enhance the catheter's pushability and stability. When a guidewire passes through the rapid exchange channel 51, the main channel 11 can be used as an injection channel, for example, for injecting contrast agents or other therapeutic drugs. When the guidewire passes through the main channel 11, the catheter assumes the traditional OTW (Over-The-Wire) mode, providing greater control precision and support. If two guidewires are placed in each channel, the catheter's controllability can be significantly improved, making it particularly suitable for treating complex lesions.

[0045] Furthermore, the rapid exchange tube 44 is preferably made of nylon and has a length of 1-100 mm. This ensures flexibility while providing sufficient structural strength, helping to reduce resistance when the catheter enters the blood vessel and maintain good operational stability. The design of the tip tube 43 also further optimizes the compliance and passability of the catheter tip, thereby effectively improving the safety and success rate of the procedure.

[0046] Furthermore, in a rapid, integrally exchangeable balloon dilatation catheter according to the present invention, the tip tube 43 preferably has a rounded conical shape. Specifically, this design helps reduce resistance encountered during catheter advancement within a blood vessel, enabling the catheter to more smoothly navigate complex vascular pathways. The rounded conical tip not only reduces potential damage to the vessel wall but also improves the catheter's flexibility and maneuverability, allowing physicians to more precisely navigate the catheter to the target location.

[0047] On the other hand, according to the rapid, integrally exchangeable balloon dilatation catheter of the present invention, the end of the tip tube 43 may also be beveled, with the bevel angle being 45°±10°. The bevel angle design optimizes the catheter's entry angle, making it easier to pass through curved or narrow blood vessels while maintaining sufficient flexibility and strength to avoid damaging the vascular endothelium.

[0048] Preferably Figure 5 、 Figure 6 and Figure 7 As shown, according to a rapid integral exchange balloon dilatation catheter of the present invention, the rapid exchange tube 44 can be integrally formed with the tip tube 43 , or preferably, the rapid exchange tube 44 is a detachable accessory mounted on the tip tube 43 .

[0049] In the case of a detachable accessory, the rapid exchange tube 44 preferably includes an assembly hole 52 parallel to the rapid exchange channel 51, through which the rapid exchange tube is sleeved onto the tip tube. Specifically, the rapid exchange tube is sleeved onto the tip tube through the assembly hole 52, and can achieve a secure connection without compromising the sealing of the balloon lumen, ensuring structural stability and no displacement during guidewire exchange and balloon operation. This detachable design also allows physicians to choose whether to enable the rapid exchange function based on the actual lesion condition or operating habits, thereby improving the personalized adaptability and clinical adaptability of the catheter system.

[0050] Furthermore, according to a rapid, integrally exchangeable balloon dilatation catheter of the present invention, a circumferential mounting groove 53 is provided on the outer surface of the tip tube; the cross-sectional diameter of the circumferential mounting groove 53 is adapted to the inner diameter of the mounting hole 52. Specifically, the circumferential mounting groove 53 provided on the outer surface of the tip tube forms a tight fit with the mounting hole 52 on the rapid exchange tube, achieving axial positioning and radial fixation through dimensional matching, preventing the rapid exchange tube from rotating or slipping during use. This assembly structure not only improves the reliability of the overall connection but also ensures that the catheter maintains a well-streamlined shape during intravascular advancement, reducing irritation and damage to the vessel wall, further enhancing the safety and passage performance of the catheter.

[0051] Preferably Figure 5 、 Figure 6 and Figure 8As shown, according to a rapid integral exchange balloon dilatation catheter of the present invention, the balloon structure includes a thin film structure made of an elastic memory material; in the folded state of the balloon structure, the thin film structure is folded on the surface of the inner tube under the elastic reset action of the elastic memory material. Specifically, the elastic memory material is preferably a polymer material with excellent resilience and fatigue resistance, such as polyurethane or nylon, which can quickly return to the initial folded shape after the balloon is depressurized, avoiding residual expansion deformation that affects subsequent operations. This self-retracting folding mechanism not only improves the retraction passability of the balloon, but also significantly reduces the friction damage caused to the blood vessel wall when the balloon moves in the blood vessel, thereby improving the safety and reusability of the operation.

[0052] Furthermore, according to a rapid integral exchange balloon dilatation catheter of the present invention, in the expanded state, the film structure expands into a cylindrical shape under the action of the pressure medium; in the folded state, the film structure folds into a plurality of pleated portions 54 evenly distributed in the circumferential direction of the balloon structure, and the plurality of pleated portions 54 are gathered in the same direction in a spiral folding manner. Specifically, this spiral folding method uses a pre-set crease process to make the balloon regularly fold along a single direction after depressurization, forming a compact and symmetrical shape, thereby effectively reducing the overall profile of the balloon and improving its ability to pass through narrow or curved blood vessels. At the same time, this regular folding method also helps the balloon to unfold evenly when pressurized again, reducing the risk of eccentric expansion and improving the consistency of the expansion effect and the reliability of treatment.

[0053] According to a preferred embodiment of the present invention, a rapid, integrated, and exchangeable balloon dilatation catheter is provided that combines versatility, efficiency, and safety, enhancing the effectiveness of interventional therapy and the patient experience. The catheter comprises a catheter hub 10 with a main channel 11 and a balloon pressure-regulating channel 12, preferably made of polycarbonate to ensure high strength. An inner tube 30 comprises a three-layer structure composed of high-density polyethylene (HDPE), low-density polyethylene (LDPE), and nylon, providing excellent rigidity, flexibility, and wear resistance. An outer tube 20 is made of nylon and coated with a hydrophilic coating containing polyvinyl pyrrolidone to reduce friction against the vessel wall. A balloon structure 21, preferably made of nylon, is located at the front end of the outer tube 20 and is equipped with a radiographic marker 32 to clearly indicate its position under X-rays. Furthermore, a stress relief tube 13 is included to enhance the mechanical strength and bending resistance of the connection.

[0054] Furthermore, the rapid, integrally exchangeable balloon dilatation catheter is designed with a tip tube 43 located at the front end of the outer tube 20. The shape can be a rounded cone or a bevel (bevel angle 45°±10°), effectively reducing propulsion resistance. The rapid exchange tube 44 is disposed between the distal end of the balloon and the tip tube 43, forming an independent rapid exchange channel 51 with a length of 1-100 mm. The proximal opening of the rapid exchange channel 51 is located at the distal end of the balloon, while the distal opening of the rapid exchange channel 51 is located on the side of the tip tube 43, facilitating operation and improving stability. In particular, the rapid exchange tube 44 is a detachable accessory mounted on the tip tube. It is sleeved on the tip tube through an assembly hole 52. The assembly hole 52 matches the circumferential assembly groove 53 provided on the outer surface of the tip tube to ensure axial positioning and radial fixation, preventing the rapid exchange tube from rotating or slipping during use.

[0055] The balloon structure 21 comprises a thin film made of an elastic memory material. When the balloon is folded, the film tightly folds against the surface of the inner tube due to the elastic restorative action of the elastic memory material, reducing frictional damage to the vessel wall during movement within the vessel. In the inflated state, the film expands into a cylindrical shape under the action of a pressure medium. In the folded state, the film folds into multiple pleats 54 evenly distributed around the circumference of the balloon. These pleats 54 spirally converge in the same direction, forming a compact and symmetrical shape, enhancing the balloon's ability to navigate narrow or tortuous vessels.

[0056] This invention not only integrates efficient vasodilation and fluid injection, but also significantly improves surgical safety and ease of use. It is applicable to a variety of clinical needs, bringing new solutions to the field of interventional therapy and improving patient outcomes and experience. For example, when contrast agents or other therapeutic drugs need to be injected, fluid can be delivered through the main channel of the inner tube, while a guidewire within the rapid exchange channel 51 is used for auxiliary positioning to ensure the accuracy of the injection position. This design allows physicians to flexibly select different operating modes to meet clinical needs in different pathological environments, improving surgical success rates and patient safety.

[0057] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "mode", "specific mode", or "some modes" 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 can be combined in any one or more embodiments or modes in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or modes and features of different embodiments or modes described in this specification without contradiction.

[0058] 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 various embodiments of the present invention.

Claims

1. A rapid integral exchange balloon dilatation catheter, characterized in that: include: An integral exchange catheter comprises a catheter seat and a catheter body connected to the catheter seat, wherein the catheter body and the catheter seat are connected via a main channel, and the catheter body is provided with a balloon structure having an expanded state and a folded state; A quick exchange tube is arranged at the distal end of the catheter body, and the quick exchange tube forms a quick exchange channel for the guide wire to pass through on the outside of the catheter body.

2. The rapid integral exchange balloon dilatation catheter according to claim 1, characterized in that: The catheter seat is provided with a balloon pressure regulating channel isolated from the main channel; The catheter body comprises: an outer tube connected to the catheter seat; an inner tube, connected to the main channel of the catheter seat and located inside the outer tube, wherein a balloon cavity connected to the balloon pressure regulating channel is formed between the inner tube and the outer tube; The proximal end of the balloon structure is connected to the outer tube, and the distal end thereof is connected to the inner tube.

3. The rapid integral exchange balloon dilatation catheter according to claim 2, characterized in that: Also included is a tip tube located at the distal end of the inner tube; The tip tube is connected to the inner tube and seals the distal end of the balloon lumen; The end of the tip tube is in the shape of a rounded cone, or the end of the tip tube is in the shape of a bevel, and the bevel angle is 45°±10°.

4. The rapid integral exchange balloon dilatation catheter according to claim 3, characterized in that: The quick exchange tube is integrally formed with the tip tube; Alternatively, the quick exchange tube is a detachable accessory mounted on the tip tube, and the quick exchange tube includes an assembly hole parallel to the quick exchange channel, and the quick exchange tube is sleeved on the tip tube through the assembly hole.

5. The rapid integral exchange balloon dilatation catheter according to claim 4, characterized in that: The outer surface of the tip tube is provided with a circumferential assembly groove; The cross-sectional diameter of the circumferential assembly groove is adapted to the inner diameter of the assembly hole.

6. The rapid integral exchange balloon dilatation catheter according to claim 2, characterized in that: The balloon structure includes a thin film structure made of elastic memory material; In the folded state of the balloon structure, the film structure is folded on the surface of the inner tube under the elastic restoring action of the elastic memory material.

7. The rapid integral exchange balloon dilatation catheter according to claim 6, characterized in that: In the expanded state, the film structure expands into a cylindrical shape under the action of the pressure medium; In the folded state, the film structure is folded into a plurality of folds evenly distributed in the circumferential direction of the balloon structure, and the plurality of folds are gathered in the same direction in a spiral folding manner.

8. The rapid integral exchange balloon dilatation catheter according to any one of claims 2 to 7, characterized in that: The catheter seat is provided with a stress relief tube; The stress relief tube is wrapped around the connection position between the catheter seat and the outer tube.

9. The rapid integral exchange balloon dilatation catheter according to any one of claims 2 to 7, characterized in that: The surface of the inner tube and / or the outer tube is provided with a developing mark.

10. The rapid integral exchange balloon dilatation catheter according to claim 9, characterized in that: The visualization mark of the inner tube is at least marked at a position corresponding to the balloon structure.

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