Three-stage expansion balloon with positioning function

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to a three-stage expansion balloon with a positioning function. In order to solve the problems that the relative position of a conveying sheathing canal and a positioning sheathing canal cannot be effectively locked after an existing three-stage expansion balloon is positioned, and a positioning balloon only can realize simple friction fixation, the following scheme is provided: the three-stage expansion balloon comprises an expansion balloon body, the conveying sheathing canal, the positioning sheathing canal and a positioning balloon body. The positioning balloon body has two stages of filling and fixing states, an inner concave circular groove is prefabricated in the inner side face of the positioning balloon body, the inner concave circular groove is kept in a groove shape when the positioning balloon body is filled to the first-stage pressure, and the inner concave circular groove is in an outward protruding state when the positioning balloon body is filled to the second-stage pressure. An annular groove is formed in the inner wall of the positioning sheathing canal, an annular membrane is connected to a notch of the annular groove in a sealed mode, and the annular membrane is attached to the outer wall of a canal body of the conveying sheathing canal in an outwards-protruding mode in the inflated state. By means of two-stage fixing of the positioning balloon and a locking mechanism of the annular diaphragm, collaborative integration of positioning, locking and expanding functions is achieved.

Description

Technical Field

[0001] This utility model relates to a three-stage dilatation balloon, specifically a three-stage dilatation balloon with positioning function, belonging to the field of medical device technology. Background Technology

[0002] Currently, in treating stenosis or obstruction of physiological cavities such as the respiratory, digestive, urinary, and vascular systems, dilatation balloons are generally used as adjunctive therapy before dilation. Currently available balloons include single-stage and three-stage dilatation balloons. Single-stage dilatation balloons maintain a relatively stable dilation diameter under pressure control. Compared to three-stage dilatation balloons, single-stage balloons require the use of multiple balloon catheters for dilation during interventional procedures, directly prolonging the procedure time and increasing the financial burden on patients. Three-stage dilatation balloons (progressive) use a pressure pump to achieve staged pressurization (e.g., low → medium → high pressure), avoiding the risk of tissue tearing caused by high-pressure dilation in a single procedure. Currently, to ensure effective dilation and prevent slippage during dilation, the length of dilatation balloons is generally longer than the stenosis area. When the stenosis is located in a tortuous or bifurcated tissue, the existing single-balloon structure suffers from poor compliance due to the excessive length of the balloon, potentially causing harm to the patient during dilation. In other words, the existing three-stage dilatation balloons still have several technical defects that need to be addressed during use.

[0003] In the prior art, for example, CN106039550A discloses an endovascular balloon catheter, which includes a flexible catheter and a balloon disposed at the distal end of the flexible catheter. The balloon may be composed of multiple parts. The endovascular balloon catheter is also provided with a fixing device such as a positioning ring for fixing the position of the inserted endovascular balloon catheter. The fixing device consists of two mating parts with a channel extending therefrom, into which the flexible catheter can be inserted. The parts are provided with springs or locking structures to prevent the inserted flexible catheter from sliding. While this technology provides positioning functionality, its positioning structure is an external attachment, making it complex and inconvenient to operate. More importantly, its locking structure is a mechanical spring or latch, concentrating the locking force at a localized point, which can easily damage the catheter wall and prevents continuous, fine-tuning of the position during surgery. Another example is CN113301941A, which discloses a system and method for controlled delivery of medical devices into a patient's body. This system is supported by a lockable balloon catheter equipped with a locking mechanism configured to lock onto delivery components such as guidewires within the body. The lockable balloon catheter can controllably switch between locking and unlocking modes by inflating or deflating the balloon. Although this technology proposes the concept of locking via balloon inflation, it locks the guidewire rather than the relative position between catheters. Furthermore, its balloon structure is a single balloon, lacking multi-level positioning and suction capabilities. In complex and tortuous physiological cavities, relying solely on a single balloon expansion for fixation is insufficient to resist traction forces from multiple directions, easily leading to displacement after positioning. In addition, existing three-stage dilatation balloons have the following technical defects: First, the positioning function is separated from the dilatation function, making it impossible to effectively lock the relative position of the delivery sheath and the positioning sheath after positioning. Even slight external force during the operation can cause the dilatation balloon to deviate from the lesion site. Second, the positioning balloon can only achieve simple mechanical friction fixation, which is poor in curved or bifurcated channels and is prone to slippage. Third, there is a risk of balloon rupture during high-pressure dilatation. Once ruptured, it will lead to contrast agent leakage and cause serious harm to the patient. Fourth, the existing balloon structure has poor compliance. When the stenosis is distributed in the curved or bifurcated channels of the tissue, the excessively long balloon will have poor compliance and cause additional harm to the patient. Utility Model Content

[0004] This invention addresses the problem that existing three-stage dilatation balloons cannot effectively lock the relative positions of the delivery sheath and the positioning sheath after positioning, and that the positioning balloon can only achieve simple mechanical friction fixation. Therefore, this invention provides a three-stage dilatation balloon with positioning function.

[0005] The present invention achieves the above objectives through the following technical solution: a three-stage dilatation balloon with positioning function, comprising a dilatation balloon body, a delivery sheath, a positioning sheath, and a positioning balloon body. One end of the delivery sheath is sealed to the dilatation balloon body. The positioning sheath is axially movably fitted onto the delivery sheath. The positioning balloon body is connected to the end of the positioning sheath facing the dilatation balloon body. The dilatation balloon body has a three-stage radial expansion elastic deformation state with pressure changes.

[0006] The positioning balloon has two levels of inflation and fixation. The inner side of the positioning balloon has a pre-made concave groove. When the positioning balloon is inflated to the first level of pressure, the concave groove maintains its groove shape. When the positioning balloon is inflated to the second level of pressure, the concave groove bulges outward.

[0007] The inner wall of the positioning sheath is provided with an annular groove, and an annular diaphragm is sealed at the opening of the annular groove. In the initial state, the annular diaphragm is in contact with the groove wall of the annular groove. When the annular diaphragm is in an inflated state in the groove of the annular groove, it is convex and tightly attached to the outer wall of the delivery sheath.

[0008] As a further embodiment of this utility model: the dilatation balloon includes an integrally formed middle section of the balloon, and a balloon diameter-changing section and a balloon docking section connected sequentially to both ends of the middle section of the balloon. The balloon docking section is sealed to the wall of the delivery sheath, and the balloon diameter-changing section is a smoothly transitioning conical structure.

[0009] As a further embodiment of this utility model: the delivery sheath is provided with a concave tube section, the positioning sheath is sleeved on the concave tube section of the delivery sheath, and the outer wall of the delivery sheath located inside the dilating balloon is connected with a contrast ring in an embedded manner, and the connection position of the contrast ring corresponds to the two ends of the middle section of the balloon.

[0010] As a further embodiment of this utility model: the delivery sheath has an independent expansion delivery cavity and a guide wire cavity. The expansion delivery cavity has a delivery hole on the end wall facing the expansion balloon body. The expansion delivery cavity is connected to the inner cavity of the expansion balloon body through the delivery hole. The rear end of the delivery sheath is fixedly connected to a tube tail connector. The expansion delivery cavity and the guide wire cavity are both connected to the tube tail connector. The guide wire cavity extends along the axial direction of the delivery sheath and passes through both ends of the delivery sheath.

[0011] As a further embodiment of this utility model: the tail connector is connected to a conveying connecting pipe and a guide wire connecting pipe. The conveying connecting pipe is connected to the expansion conveying cavity through the tail connector, and the guide wire connecting pipe is connected to the guide wire cavity through the tail connector.

[0012] As a further improvement of this utility model: the positioning sheath has an independent positioning delivery cavity and a locking delivery cavity inside. The positioning delivery cavity is connected to the inside of the positioning balloon body, and the locking delivery cavity is connected to the groove of the annular groove. The end of the positioning sheath away from the positioning balloon body is connected to a positioning connector that is movably sleeved on the body of the delivery sheath. A three-way regulating valve is embedded in the positioning connector, and the docking ends of the positioning connector, the positioning delivery cavity and the locking delivery cavity are respectively connected to the three passage interfaces of the three-way regulating valve.

[0013] As a further improvement of this utility model: several annular grooves are provided at equal intervals on the inner wall of the positioning sheath, and each of the annular grooves is independently connected to the locking and conveying cavity.

[0014] As a further improvement of this utility model, a reinforcing mesh is embedded in the position of the concave circular groove corresponding to the body of the positioning balloon.

[0015] As a further improvement of this utility model: the front end of the delivery sheath is sealed with a soft head, which has an arc-shaped structure.

[0016] The beneficial effects of this utility model are:

[0017] 1. This utility model comprises an inflatable balloon body, a delivery sheath, a positioning sheath, and a positioning balloon body. One end of the delivery sheath is sealed to the inflatable balloon body. The positioning sheath is axially movably fitted onto the delivery sheath. The positioning balloon body is connected to the end of the positioning sheath facing the inflatable balloon body. The inflatable balloon body exhibits a three-stage radial expansion elastic deformation state with pressure changes. The sealed connection between the delivery sheath and the inflatable balloon body ensures that the inflatable balloon body can stably receive the pressurizing medium from the delivery sheath when inflated, avoiding the risk of leakage at the connection. The positioning sheath and the delivery sheath... The sliding sleeve on the tube allows the positioning sheath to adjust the axial position of the positioning balloon relative to the dilating balloon, thus enabling intraoperative positioning of the dilating balloon according to the actual lesion location. The positioning balloon can be fixed before the dilating balloon, providing a stable anchor point for subsequent dilation operations. The three-stage radial dilation of the dilating balloon allows the surgeon to control the inflation pressure and gradually dilate the dilating balloon to different diameters, thereby achieving staged dilation of the stenotic lesion and effectively avoiding the risk of tissue tearing caused by high-pressure dilation in one procedure.

[0018] 2. The positioning balloon of this utility model has two-stage inflation and fixation states. The inner side of the positioning balloon has a pre-fabricated concave circular groove. When the positioning balloon is inflated to the first level of pressure, the concave circular groove maintains the groove shape. When the positioning balloon is inflated to the second level of pressure, the concave circular groove becomes outwardly convex. When the positioning balloon is inflated to the first level of pressure, the positioning balloon expands radially as a whole, and its outer wall contacts the human tissue to achieve initial fixation, providing a stable operating basis for the operator. When the positioning balloon is inflated to the second level of pressure, the concave circular groove changes from the groove shape to an outwardly convex ring structure. These protrusions make close contact with the tissue and compress the local tissue, realizing secondary fixation of the tissue. The initial fixation under the first level of pressure provides a buffer time for position confirmation, and the reinforcement under the second level of pressure enhances the stability of the positioning and effectively prevents the positioning balloon from slipping due to tissue tension or instrument operation during the subsequent three-stage expansion process.

[0019] 3. The positioning sheath of this invention has an annular groove on its inner wall. An annular diaphragm is sealed at the opening of the groove. In its initial state, the annular diaphragm fits against the groove wall. When inflated within the groove, the annular diaphragm bulges outward and adheres tightly to the outer wall of the delivery sheath. The annular groove provides space for the annular diaphragm. In its initial state, there is a small gap between the inner edge of the annular diaphragm and the outer wall of the delivery sheath, allowing the positioning sheath to slide freely relative to the delivery sheath. The operator can fine-tune the relative position of the dilation balloon and the lesion site as needed. When the annular diaphragm is inflated within the groove, it bulges outward due to pressure expansion, tightly gripping the outer wall of the delivery sheath and generating a large static friction force, thereby achieving axial locking between the positioning sheath and the delivery sheath. Simultaneously, because the locking force of the annular diaphragm acts on the entire circumference of the delivery sheath, it avoids local deformation or damage to the tube wall that may be caused by point locking. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of this utility model;

[0021] Figure 2 This is a schematic cross-sectional view of the connection part of the expansion balloon body of this utility model;

[0022] Figure 3 This is a schematic diagram of the cross-sectional structure of the conveying sheath of this utility model;

[0023] Figure 4 This is a schematic diagram of the connection structure between the positioning sheath and the positioning balloon body of this utility model;

[0024] Figure 5 This is a schematic diagram of the cross-sectional structure of the positioning sheath and positioning balloon of this utility model;

[0025] Figure 6 This utility model Figure 5 Schematic diagram of the structure at point A in the middle;

[0026] Figure 7 This utility model Figure 5 Schematic diagram of the structure at point B;

[0027] Figure 8 A schematic diagram of the cross-sectional structure of the concave circular groove portion of the positioning balloon body of this utility model;

[0028] Figure 9 This is a schematic diagram of the concave circular groove and outward convex structure of the positioning balloon body of this utility model.

[0029] In the diagram: 1. Dilatation balloon body; 11. Middle section of the balloon body; 12. Variable diameter section of the balloon body; 13. Connecting section of the balloon body; 2. Delivery sheath; 21. Concave tube section; 22. Imaging ring; 23. Delivery port; 24. Dilatation delivery cavity; 25. Guide wire cavity; 26. Tube tail connector; 27. Delivery connecting tube; 28. Guide wire connecting tube; 3. Positioning sheath; 31. Positioning connector; 32. Three-way regulating valve; 33. Positioning connecting tube; 34. Positioning delivery cavity; 35. Locking delivery cavity; 36. Annular groove; 4. Positioning balloon body; 41. Concave circular groove; 42. Reinforcing mesh; 5. Annular diaphragm; 6. Soft tip. Detailed Implementation

[0030] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0031] Example 1

[0032] like Figures 1 to 9As shown, a three-stage dilatation balloon with positioning function includes a dilatation balloon body 1, a delivery sheath 2, a positioning sheath 3, and a positioning balloon body 4. One end of the delivery sheath 2 is sealed to the dilatation balloon body 1. The positioning sheath 3 is axially movably fitted onto the delivery sheath 2. The positioning balloon body 4 is connected to the end of the positioning sheath 3 facing the dilatation balloon body 1. The dilatation balloon body 1 exhibits a three-stage radial expansion elastic deformation state with pressure changes. The sealed connection between the delivery sheath 2 and the dilatation balloon body 1 ensures that the dilatation balloon body 1 can stably receive the inflation medium from the delivery sheath 2 when inflated, avoiding the risk of leakage at the connection. The slidable sleeve on the positioning sheath 3 and the delivery sheath 2 allows the positioning sheath 3 to drive the positioning balloon body 4 to adjust its axial position relative to the dilation balloon body 1. This enables the dilation balloon body 1 to be positioned according to the actual lesion location during the operation. The positioning balloon body 4 can be fixed before the dilation balloon body 1, providing a stable anchor point for subsequent dilation operations. The three-stage radial dilation of the dilation balloon body 1 allows the surgeon to control the inflation pressure and gradually dilate the dilation balloon body 1 to different diameters, thereby achieving staged dilation of the stenotic lesion and effectively avoiding the risk of tissue tearing caused by one-time high-pressure dilation.

[0033] The positioning balloon 4 has two levels of inflation and fixation. The inner surface of the positioning balloon 4 has a pre-fabricated concave groove 41. When the positioning balloon 4 is inflated to the first level of pressure, the concave groove 41 maintains a groove shape. When the positioning balloon 4 is inflated to the second level of pressure, the concave groove 41 bulges outward. When the positioning balloon 4 is inflated to the first level of pressure, the positioning balloon 4 expands radially as a whole, and its outer wall contacts the human tissue to achieve initial fixation, providing a stable operating basis for the operator. When the positioning balloon 4 is inflated to the second level of pressure, the concave groove 41 changes from a groove shape to an outward bulging annular structure. These protrusions make close contact with the tissue and compress the local tissue, achieving secondary fixation of the tissue. The initial fixation under the first level of pressure provides a buffer time for position confirmation, and the reinforcement under the second level of pressure enhances the stability of the positioning and effectively prevents the positioning balloon 4 from slipping due to tissue tension or instrument operation during the subsequent three-level expansion process.

[0034] The inner wall of the positioning sheath 3 has an annular groove 36. An annular diaphragm 5 is sealed at the opening of the groove 36. In its initial state, the annular diaphragm 5 is in contact with the groove wall of the annular groove 36. When the annular diaphragm 5 is inflated within the groove of the annular groove 36, it bulges outward and adheres tightly to the outer wall of the delivery sheath 2. The annular groove 36 provides space for the annular diaphragm 5. In its initial state, there is a small gap between the inner edge of the annular diaphragm 5 and the outer wall of the delivery sheath 2, allowing the positioning sheath 3 to slide freely relative to the delivery sheath 2. The operator can fine-tune the expansion as needed. The relative position of the balloon body 1 and the lesion site; when the annular diaphragm 5 is inflated within the annular groove 36, it bulges outward due to the pressure expansion, tightly gripping the outer wall of the delivery sheath 2, generating a huge static friction force, thereby achieving axial locking between the positioning sheath 3 and the delivery sheath 2; simultaneously, because the locking force of the annular diaphragm 5 acts on the entire circumference of the delivery sheath 2, it avoids local deformation or damage to the tube wall that may be caused by point locking. It should be noted that the annular diaphragm 5 is made of medical-grade thermoplastic polyurethane (TPU) or medical-grade silicone rubber. This type of material has good elasticity, fatigue resistance and biocompatibility, and can expand uniformly in the radial direction during inflation, forming an annular gripping force tightly adhering to the outer wall of the delivery sheath 2, and can return to its initial shape after deflation.

[0035] Example 2

[0036] Improvements based on Example 1:

[0037] like Figure 1 As shown, the dilatation balloon 1 includes an integrally formed middle section 11, and a diameter-changing section 12 and a docking section 13 connected sequentially to both ends of the middle section 11. The docking section 13 is sealed to the wall of the delivery sheath 2, and the diameter-changing section 12 is a smoothly transitioning conical structure. The integrally formed middle section 11, diameter-changing section 12, and docking section 13 ensure the integrity and sealing of the dilatation balloon 1. The middle section 11 serves as the main working area of ​​the dilatation balloon 1, used to effectively dilate narrow areas. The diameter-changing section 12 adopts a smoothly transitioning conical structure, which effectively avoids stress concentration caused by abrupt changes in diameter. During repeated inflation and deflation of the balloon, it can evenly distribute the expansion pressure and extend the service life of the balloon.

[0038] like Figure 1 , Figure 2 and Figure 3As shown, the delivery sheath 2 has a concave section 21, and the positioning sheath 3 is sleeved on the concave section 21 of the delivery sheath 2. The delivery sheath 2 is located inside the balloon body 1 and has an embedded imaging ring 22 connected to its outer wall. The imaging ring 22 is connected to both ends of the middle section 11 of the balloon body. The concave section 21 on the delivery sheath 2 provides a mating area for the positioning sheath 3. When the annular diaphragm 5 is inflated, it grips the outer wall of the concave section 21 to achieve a locking effect. At the same time, the concave section 21 also limits the... The axial sliding range of the positioning sheath 3 relative to the delivery sheath 2 is limited to avoid excessive sliding of the positioning sheath 3, which could cause interference between the positioning balloon body 4 and the dilating balloon body 1. The setting of the imaging ring 22 allows the surgeon to clearly determine the start and end positions of the middle section 11 of the balloon body under X-ray imaging, thereby accurately aligning the working area of ​​the dilating balloon body 1 with the stenotic lesion. This ensures that the imaging mark directly indicates the effective working area of ​​the dilating balloon body 1, avoiding positioning errors caused by the deviation between the imaging mark and the working area of ​​the balloon.

[0039] Furthermore, the delivery sheath 2 has independent expansion delivery cavities 24 and guidewire cavities 25. The expansion delivery cavity 24 has a delivery hole 23 facing the end wall of the balloon body 1, and communicates with the inner cavity of the balloon body 1 through the delivery hole 23. A tube tail connector 26 is fixedly connected to the rear end of the delivery sheath 2. Both the expansion delivery cavity 24 and the guidewire cavity 25 are connected to the tube tail connector 26. The guidewire cavity 25 extends axially along the delivery sheath 2 and passes through both ends of the delivery sheath 2. The expansion delivery cavity 24 and the guidewire cavity 25 are independently configured, enabling efficient inflation of the balloon body 1 and effective guidancewire inflation. The guiding functions can be performed simultaneously without interference. The operator can inflate and evacuate the balloon body 1 while maintaining guidewire guidance. The delivery port 23 serves as the only connecting channel between the expansion delivery chamber 24 and the inner cavity of the expansion balloon body 1, allowing the inflation medium to accurately enter the expansion balloon body 1 and preventing media leakage. Secondly, the rear end of the delivery sheath 2 is fixedly connected to the tube tail connector 26. The expansion delivery chamber 24 and the guidewire chamber 25 are both connected to the tube tail connector 26, integrating the proximal interfaces of the two independent cavities into one tube tail connector 26, allowing the operator to complete inflation and guidewire operations with one hand.

[0040] Furthermore, the tail connector 26 is connected to a delivery connecting pipe 27 and a guide wire connecting pipe 28. The delivery connecting pipe 27 is connected to the expansion delivery chamber 24 through the tail connector 26, and the guide wire connecting pipe 28 is connected to the guide wire chamber 25 through the tail connector 26. The independent arrangement of the delivery connecting pipe 27 and the guide wire connecting pipe 28 completely separates the functions of the expansion delivery chamber 24 and the guide wire chamber 25. The operator can control the filling pressure and the guide wire position separately, avoiding the risk of misoperation. When it is necessary to change the filling medium or adjust the guide wire, the operator can operate the corresponding connecting pipe independently without affecting the normal operation of the other connecting pipe.

[0041] like Figure 1 , Figures 4 to 9 As shown, the positioning sheath 3 has two independent positioning delivery chambers 34 and locking delivery chambers 35. The positioning delivery chamber 34 is connected to the interior of the positioning balloon body 4, and the locking delivery chamber 35 is connected to the groove of the annular groove 36. A positioning connector 31, movably sleeved on the body of the delivery sheath 2, is connected to the end of the positioning sheath 3 away from the positioning balloon body 4. A three-way regulating valve 32 is embedded in the positioning connector 31, and the mating ends of the positioning connector 31, the positioning delivery chamber 34, and the locking delivery chamber 35 are respectively connected to the three passage interfaces of the three-way regulating valve 32. The positioning delivery chamber 34 and the locking delivery chamber 35 are independently configured, enabling the inflation function of the positioning balloon body 4 and the locking function of the annular diaphragm 5 to be achieved. The system can be independently controlled. The positioning delivery chamber 34 is used to control the inflation and deflation of the positioning balloon 4, achieving a two-stage inflation and fixation function. The locking delivery chamber 35 is used to control the inflation and deflation of the annular diaphragm 5, achieving locking and unlocking between the positioning sheath 3 and the delivery sheath 2. This allows the operator to flexibly perform preliminary fixation of the positioning balloon 4 according to the needs of the surgery, then make fine adjustments to its position, then lock the position through the locking delivery chamber 35, and finally perform secondary suction fixation of the positioning balloon 4. Secondly, the three-way regulating valve 32 enables the switching control between the inflation of the positioning balloon 4 and the locking of the annular diaphragm 5. The function switching can be completed simply by rotating the valve, improving the efficiency of the surgery.

[0042] Furthermore, several annular grooves 36 are evenly spaced on the inner wall of the positioning sheath 3, and each annular groove 36 is independently connected to the locking delivery cavity 35. When the locking delivery cavity 35 is pressurized, all annular diaphragms 5 expand synchronously and simultaneously grip the outer wall of the delivery sheath 2. The multi-point gripping locking method can share the locking force, making the locking force required at each locking point smaller, thereby reducing the risk of fatigue damage to the annular diaphragms 5. At the same time, the total friction force generated by multi-point gripping is much greater than that of single-point locking, making the axial fixation after locking more reliable and able to resist greater external impact, effectively preventing axial displacement caused by tissue tension or instrument operation during subsequent three-stage expansion.

[0043] Furthermore, a reinforcing mesh 42 is embedded in the body of the positioning balloon 4 at the position corresponding to the concave circular groove 41. When the positioning balloon 4 is inflated to the first level of pressure, the reinforcing mesh 42 provides structural support for the concave circular groove 41, ensuring that the concave circular groove 41 maintains a stable groove shape under lower pressure, avoiding unexpected deformation caused by local pressure fluctuations, and ensuring uniform and stable friction during initial fixation. Secondly, when the positioning balloon 4 is inflated to the second level of pressure, the reinforcing mesh 42 plays a role in guiding directional deformation. Due to the pre-set shape and elastic properties of the reinforcing mesh 42, when the internal pressure rises to a certain level, the concave circular groove 41 will bulge outward along the predetermined direction and shape under the guidance of the reinforcing mesh 42, forming a uniform and regular annular protrusion structure.

[0044] Furthermore, the front end of the delivery sheath 2 is sealed with a soft tip 6. The soft tip 6 has an arc-shaped structure. The soft tip 6 first contacts the inner wall of the cavity. Its soft material can effectively buffer the impact force generated during the push process, avoiding mechanical damage to the inner wall of the cavity, such as scratches, abrasions, or perforations, and other serious complications. Secondly, the arc-shaped structure of the front end of the soft tip 6 allows it to smoothly pass through the curved parts and narrow areas of the cavity during the push process, reducing the frictional resistance between the front end and the tissue, making it easier for the operator to use.

[0045] Working principle: First, the guidewire is introduced into the guidewire lumen 25 through the guidewire connecting tube 28 and the tube tail connector 26. The entire catheter is pushed to the vicinity of the target lesion area in the physiological cavity of the human body. At this time, both the dilation balloon 1 and the positioning balloon 4 are in an uninflated contracted state. The arc-shaped structure of the soft tip 6 ensures the safety and smoothness of the pushing process. The imaging ring 22 clearly shows the precise position of both ends of the middle section 11 of the balloon under X-ray, providing a reference for subsequent positioning.

[0046] Once the catheter reaches the target area, the operator switches to the positioning delivery chamber 34 via the three-way regulating valve 32, injecting the pressurizing medium into the positioning delivery chamber 34 through the positioning connector 31. The medium enters the positioning balloon body 4 along the positioning delivery chamber 34, at which point the positioning balloon body 4 begins to inflate. When the pressure reaches the first level of pressure, the positioning balloon body 4 expands radially to contact the tissue. The concave circular groove 41 on its outer wall maintains a stable groove shape under the support of the reinforcing mesh 42, achieving initial fixation with the tissue. At this time, the positioning balloon body 4 anchors the entire device near the target position.

[0047] After initial fixation, the operator can fine-tune the position of the delivery sheath 2 by axial sliding between the positioning sheath 3 and the delivery sheath 2 according to the indication of the imaging ring 22. This allows for precise adjustment of the relative position of the dilation balloon 1 and the stenotic lesion, ensuring that the middle section 11 of the balloon is accurately aligned with the lesion area. Once the position is confirmed to be correct, the operator switches to the locking delivery chamber 35 passage through the three-way regulating valve 32 and injects the pressurizing medium into the locking delivery chamber 35 through the positioning connector 31. The medium enters several equally spaced annular grooves 36 on the inner wall of the positioning sheath 3 along the locking delivery chamber 35. Under pressure, the annular diaphragm 5 in the annular grooves 36 expands radially and tightly hugs the concave tube section 21 on the outer wall of the delivery sheath 2, thereby locking the axial relative position of the positioning sheath 3 and the delivery sheath 2. At this time, the relative position of the dilation balloon 1 and the lesion area is precisely fixed.

[0048] After axial locking is completed, the operator continues to switch back to the positioning delivery chamber 34 through the three-way regulating valve 32, and injects the pressurizing medium into the positioning balloon 4 to the second level of pressure. The higher pressure causes the positioning balloon 4 to expand further. At this time, the reinforcing mesh 42 embedded in the concave circular groove 41 plays a directional deformation guiding role, so that the concave circular groove 41 bulges outward from the groove shape, forming a uniform bulging structure, and realizing the secondary fixation of the tissue.

[0049] Subsequently, the operator injects pressurizing medium into the expansion delivery chamber 24 through the delivery connection tube 27 and the tube tail connector 26. The medium flows along the expansion delivery chamber 24 and enters the inner cavity of the expansion balloon 1 through the delivery hole 23. The expansion balloon 1 begins to inflate and expand. Therefore, as the pressure increases step by step, the expansion balloon 1 achieves three-stage radial expansion, gradually expanding and treating the stenotic lesion.

[0050] After the dilatation balloon 1 completes three-stage dilation, the three-way regulating valve 32 is used to switch to the locking delivery chamber 35 to extract the pressurizing medium from the annular diaphragm 5. The annular diaphragm 5 returns to its initial state of being in contact with the wall of the annular groove 36, and the locking between the positioning sheath 3 and the delivery sheath 2 is released. Then, the three-way regulating valve 32 is used to switch to the positioning delivery chamber 34 to extract the pressurizing medium from the positioning balloon 4. The positioning balloon 4 contracts, releasing its fixation to the tissue. Finally, the dilatation delivery chamber 24 is used to extract the pressurizing medium from the dilatation balloon 1, and the dilatation balloon 1 contracts. After all the locking and fixation are released, the operator can safely remove the entire device from the patient's body.

[0051] It will be apparent to those skilled in the art that this invention is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or essential characteristics of this invention. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within this invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0052] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A three-stage dilatation balloon with positioning function, comprising a dilatation balloon body (1), a delivery sheath (2), a positioning sheath (3), and a positioning balloon body (4), characterized in that: One end of the delivery sheath (2) is sealed to the expansion balloon body (1), the positioning sheath (3) is axially movably fitted on the delivery sheath (2), the positioning balloon body (4) is connected to the end of the positioning sheath (3) facing the expansion balloon body (1), and the expansion balloon body (1) has a three-stage radial expansion elastic deformation state with pressure changes. The positioning balloon body (4) is provided with two-stage inflation and fixation states. The inner side of the positioning balloon body (4) is pre-fabricated with a concave circular groove (41). When the positioning balloon body (4) is inflated to the first level of pressure, the concave circular groove (41) maintains the groove shape. When the positioning balloon body (4) is inflated to the second level of pressure, the concave circular groove (41) is in an outward convex state. The inner wall of the positioning sheath (3) is provided with an annular groove (36), and an annular diaphragm (5) is sealed at the groove opening of the annular groove (36). In the initial state, the annular diaphragm (5) is in contact with the groove wall of the annular groove (36). When the annular diaphragm (5) is in an inflated state in the groove of the annular groove (36), it is convex and tightly attached to the outer wall of the delivery sheath (2).

2. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The expandable balloon (1) includes an integrally formed balloon middle section (11), and a balloon diameter-changing section (12) and a balloon docking section (13) connected sequentially to both ends of the balloon middle section (11). The balloon docking section (13) is sealed to the wall of the delivery sheath (2), and the balloon diameter-changing section (12) is a smoothly transitioned conical structure.

3. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The delivery sheath (2) is provided with a concave tube section (21), and the positioning sheath (3) is sleeved on the concave tube section (21) of the delivery sheath (2). The outer wall of the delivery sheath (2) located inside the dilatation balloon (1) is connected to a radiopaque ring (22), and the connection position of the radiopaque ring (22) corresponds to both ends of the middle section (11) of the balloon.

4. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The delivery sheath (2) has an independent expansion delivery cavity (24) and a guide wire cavity (25) on its body. The expansion delivery cavity (24) has a delivery hole (23) on the end wall facing the expansion balloon body (1). The expansion delivery cavity (24) is connected to the inner cavity of the expansion balloon body (1) through the delivery hole (23). The rear end of the delivery sheath (2) is fixedly connected to a tube tail connector (26). The expansion delivery cavity (24) and the guide wire cavity (25) are both connected to the tube tail connector (26). The guide wire cavity (25) extends along the axial direction of the delivery sheath (2) and passes through both ends of the delivery sheath (2).

5. The three-stage dilatation balloon with positioning function according to claim 4, characterized in that: The tail connector (26) is connected to a delivery connecting pipe (27) and a guide wire connecting pipe (28). The delivery connecting pipe (27) is connected to the expansion delivery cavity (24) through the tail connector (26), and the guide wire connecting pipe (28) is connected to the guide wire cavity (25) through the tail connector (26).

6. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The positioning sheath (3) has an independent positioning delivery cavity (34) and a locking delivery cavity (35) inside. The positioning delivery cavity (34) is connected to the inside of the positioning balloon body (4), and the locking delivery cavity (35) is connected to the groove of the annular groove (36). The end of the positioning sheath (3) away from the positioning balloon body (4) is connected to a positioning connector (31) that is movably sleeved on the body of the delivery sheath (2). The positioning connector (31) is embedded with a three-way regulating valve (32), and the docking ends of the positioning connector (31), the positioning delivery cavity (34) and the locking delivery cavity (35) are respectively connected to the three passage interfaces of the three-way regulating valve (32).

7. The three-stage dilatation balloon with positioning function according to claim 6, characterized in that: The annular grooves (36) are provided at equal intervals on the inner wall of the positioning sheath (3), and each of the annular grooves (36) is independently connected to the locking delivery cavity (35).

8. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The positioning balloon body (4) has a reinforcing mesh (42) embedded in the position corresponding to the concave circular groove (41).

9. The three-stage dilatation balloon with positioning function according to claim 1, characterized in that: The front end of the delivery sheath (2) is sealed with a soft head (6), which has an arc-shaped structure.

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