Thrombolysis balloon catheter for intracranial branch-penetrating blood vessel

Abstract

The invention relates to the technical field of medical instruments, and particularly provides a thrombolysis balloon catheter for an intracranial branch penetrating blood vessel. The catheter body comprises a three-way operation section and a quick exchange section which are oppositely arranged; the radiography balloon is arranged at one end, far away from the three-way operation section, of the quick exchange section; the thrombolysis sacculus and the radiography sacculus are arranged at an interval; the outer diameter of the expanded radiography balloon is larger than that of the expanded thrombolysis balloon; the thrombolysis balloon is arranged on the side surface, close to the three-way operation section, of the angiography balloon; the three-way operation seat is arranged on the three-way operation section, and the three-way operation seat is used for controlling the expansion volume of the thrombolysis balloon and the radiography balloon and far-end liquid medicine instillation; wherein a guide wire hole is formed between the three-way operation section and the rapid exchange section, a guide wire penetrates through the guide wire hole and penetrates out of one end of the rapid exchange section, the guide wire is used for sending the rapid exchange section to a designated position, and the risk that thrombolysis medicine is diluted by blood flow is reduced, so that the local medicine concentration is maintained, and the thrombolysis efficiency is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a thrombolytic balloon catheter for intracranial perforating blood vessels. Background Art

[0002] Perforating arteries are usually small arteries that branch out from the aorta and pass into the brain parenchyma. Their blockage can lead to perforating cerebral infarction and trigger ischemic lesions deep in the brain.

[0003] Currently, catheter-directed thrombolytic therapy for perforator thrombosis is commonly used. This involves injecting thrombolytic drugs directly into the vicinity of the thrombus via a catheter to achieve therapeutic effects. Existing devices primarily consist of a catheter body and a guidewire. The catheter body is a hollow medical tube with a nearly conical tip for entering the blood vessel. Immediately adjacent to the tip is the perfusion section, which releases the thrombolytic solution.

[0004] However, during the actual perfusion process, due to the influence of blood flow flushing, the perfused thrombolytic drugs flow to the end of the blood vessel, and the concentration is easily diluted rapidly, resulting in reduced local efficacy, thereby affecting the effect of thrombolytic therapy.

[0005] Therefore, the existing technology has defects and deficiencies and needs further improvement and development. Summary of the Invention

[0006] In view of the above-mentioned deficiencies in the prior art, the purpose of the present application is to provide a thrombolytic balloon catheter for intracranial perforating vessels, aiming to solve the problem that the concentration of thrombolytic drugs infused by the catheter-contact thrombolytic device in the prior art is easily diluted rapidly, thereby affecting the effect of thrombolytic treatment.

[0007] The technical solution adopted by the present application to solve the technical problem is as follows: a thrombolytic balloon catheter for intracranial perforating vessels, used for thrombolysis of perforating vessels, comprising: Finger guide wire; The catheter body comprises a three-way operation section and a quick exchange section that are arranged opposite to each other; A radiographic balloon, the radiographic balloon being arranged at one end of the rapid exchange section away from the three-way operation section; A thrombolytic balloon, the thrombolytic balloon and the angiographic balloon are spaced apart; the outer diameter of the angiographic balloon after expansion is larger than the outer diameter of the thrombolytic balloon after expansion; the thrombolytic balloon is arranged on the side of the angiographic balloon close to the three-way operation section; A three-way operating seat, which is arranged on the three-way operating section and is used to control the expansion volume of the thrombolytic balloon and the angiographic balloon and the distal drug solution drip; Among them, a guide wire hole is provided between the three-way operation section and the quick exchange section. The finger guide wire passes through the guide wire hole and passes through one end of the quick exchange section. The finger guide wire is used to send the quick exchange section to a designated position.

[0008] Optionally, a plurality of thrombolytic drug outlets are provided in the thrombolytic balloon, and each of the plurality of thrombolytic drug outlets is provided with a liquid outlet member, and the liquid outlet member slides up and down in the thrombolytic drug outlets.

[0009] Optionally, the liquid outlet part is provided with a sliding part and a closing part, the closing part is arranged above the sliding part, the closing part is provided with a liquid outlet end and a closing end, and the sliding part is provided with a liquid inlet end and a liquid storage end; the liquid outlet end and the sliding part are integrally formed.

[0010] Optionally, the closing portion is provided with a plurality of flexible opening and closing flaps, the inner and outer sides of the transverse cross-sections of the plurality of flexible opening and closing flaps are both arc-shaped, and the plurality of flexible opening and closing flaps gradually approach the axial direction of the liquid outlet part along the direction from the liquid outlet end to the closed end.

[0011] Optionally, the sliding portion is provided with an upper tapered opening and a lower tapered opening, and the upper tapered opening is communicated with the lower tapered opening.

[0012] Optionally, the sliding portion is further provided with a plurality of connecting holes, and the apertures of the plurality of connecting holes gradually decrease from the liquid inlet end toward the liquid storage end.

[0013] Optionally, the sliding portion is further provided with an upper positioning ring and a lower counterweight ring, the upper positioning ring is provided on a side close to the liquid storage end, and the lower counterweight ring is provided on a side close to the liquid inlet end; Wherein, the thrombolytic drug outlet is provided with a sliding ring groove adapted to the upper limit ring and the lower counterweight ring.

[0014] Optionally, the three-way operating seat includes a square handle, a high-pressure drip inlet, a contrast agent inlet and outlet, and a thrombolytic drug inlet and outlet; the high-pressure drip inlet is arranged on the left side of the square handle, the thrombolytic drug inlet and outlet is arranged on the right side of the square handle, and the thrombolytic drug inlet and outlet is arranged in the middle of the square handle.

[0015] Optionally, the catheter body is provided with a first interlayer cavity and a second interlayer cavity, the first interlayer cavity is used to connect the inlet and outlet of the thrombolytic drug with the thrombolytic balloon; the second interlayer cavity is used to connect the inlet and outlet of the contrast agent with the contrast balloon, and the through hole of the catheter body is connected to the high-pressure drip inlet.

[0016] Optionally, both ends of the angiographic balloon and the thrombolytic balloon along the axial direction are provided with radiopaque markers, and the radiopaque markers are used to identify the positions of the angiographic balloon and the thrombolytic balloon in the intracranial blood vessels.

[0017] Compared with the prior art, the present application provides a thrombolytic balloon catheter for intracranial perforating blood vessels, which realizes dual functional zoning by setting up a spaced double balloon structure of angiographic balloon and thrombolytic balloon. After expansion, the outer diameter of the angiographic balloon is larger than that of the thrombolytic balloon, which enables the angiographic balloon to effectively block the blood flow flushing path in the blood vessel and form a local closed space; the thrombolytic balloon is located on its proximal side and can release thrombolytic drugs at a specific point in the blocked area of the perforating blood vessel. The thrombolytic area is further physically isolated from the blood flow impact area, which significantly reduces the risk of the thrombolytic drug being diluted by the blood flow, thereby maintaining the local drug concentration and improving the thrombolytic efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic diagram of the three-dimensional structure of the thrombolytic balloon catheter for intracranial perforator vessels provided in the present application without the guide wire; Figure 2 This is a right side view of the thrombolytic balloon catheter for intracranial perforating vessels provided in the present application; Figure 3 This is a right side view of a thrombolytic balloon catheter and a fluid outlet for an intracranial perforator vessel provided in this application; Figure 4 This application provides Figure 3 The cross-sectional view along the Ⅰ-Ⅰ direction; Figure 5 This is a front view of the liquid outlet of the thrombolytic balloon catheter for intracranial perforating blood vessels provided in this application; Figure 6 This application provides Figure 5 Cross-sectional view along the II-II direction; Figure 7 This is a schematic diagram of the three-dimensional structure of the liquid outlet of the thrombolytic balloon catheter for intracranial perforating blood vessels provided in this application. Figure 8 This application provides Figure 4 Schematic diagram of the enlarged structure at point A in the middle.

[0019] Description of reference numerals: 10. Thrombolytic balloon catheter for intracranial perforators; 11. Guidewire; 12. Catheter body; 13. Angiographic balloon; 14. Thrombolytic balloon; 15. Three-way operating seat; 121. Three-way operating section; 122. Rapid exchange section; 123. Guidewire hole; 124. First interlayer cavity; 125. Second interlayer cavity; 141. Thrombolytic drug outlet; 142. Liquid outlet; 143. Sliding portion; 144. Closing portion; 151. Square handle; 152. High-pressure drip inlet; 153. Contrast agent inlet and outlet; 154. Thrombolytic drug inlet and outlet; 1431. Liquid inlet; 1432. Liquid storage end; 1433. Upper conical port; 1434. Lower conical port; 1435. Connecting hole; 1436. Upper limit ring; 1437. Lower counterweight ring; 1441. Liquid outlet; 1442. Closing end; 1443. Flexible opening and closing flap; 1411. Sliding ring groove; 16. Radiopaque marker. DETAILED DESCRIPTION

[0020] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0021] In the description of the present application, it should be understood 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 present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present application, unless otherwise specified, "multiple" means two or more.

[0022] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0023] Please refer to Figures 1 to 8 , Figures 1 to 8 The thrombolytic balloon catheter 10 for intracranial perforating vessels is shown in an expanded state. The thrombolytic balloon catheter 10 for intracranial perforating vessels primarily comprises a guidewire 11, a catheter body 12, an angiographic balloon 13, a thrombolytic balloon 14, and a three-way operating seat 15. The catheter body 12 includes a three-way operating section 121 and a rapid exchange section 122 disposed opposite each other, with a guidewire hole 123 defined between the two sections to facilitate insertion of the guidewire 11 through the guidewire hole 123 and exit from the distal end of the rapid exchange section 122, thereby enabling precise delivery of the thrombolytic balloon catheter 10 for intracranial perforating vessels along the guidewire 11. The angiographic balloon 13 is disposed at the distal end of the rapid exchange section 122, and a thrombolytic balloon 14 is disposed on its proximal side. The expanded outer diameter of the angiographic balloon 13 is larger than that of the thrombolytic balloon 14. A three-way operating seat 15 is mounted on the three-way operating section 121. This seat integrates a square handle 151, a left high-pressure drip inlet 152, a front contrast agent inlet 153, and a middle thrombolytic drug inlet 154, respectively connecting the through-hole of the catheter body 12, the second interlayer lumen 125, and the first interlayer lumen 124. Several thrombolytic drug outlets 141 are evenly spaced on the inner wall of the thrombolytic balloon 14. Each outlet is equipped with a liquid outlet 142, which is integrally formed with a lower sliding portion 143 and an upper closing portion 144. The sliding portion 143 is equipped with a lower tapered opening 1434 and an upper tapered opening 1433, as well as a connecting hole 1435 with a gradually decreasing diameter from the liquid inlet end 1431 to the liquid storage end 1432. An upper limit ring 1436 and a lower counterweight ring 1437 are mounted on the outer wall of the sliding portion 143, cooperating with the sliding ring groove 1411 within the thrombolytic drug outlet 141. Radiopaque markers 16 are provided at both ends of the angiographic balloon 13 and the thrombolytic balloon 14 along the axial direction to facilitate real-time positioning during surgery.

[0024] During the procedure, the operator first identifies and locates the occluded intracranial perforator artery under the dual guidance of existing cerebral vascular imaging (such as CTA or MRA) and digital subtraction angiography (DSA). A slender, flexible guidewire 11 is then advanced along the vascular pathway into the main vessel proximal to the target perforator artery. The guidewire tip is securely anchored at the branch point to ensure precise delivery of subsequent instruments.

[0025] After docking the distal opening of the thrombolytic balloon 14 catheter with the proximal end of the guidewire 11, the guidewire 11 is sequentially passed through the guidewire hole 123 and rapid exchange segment 122 of the catheter body 12, forming a rapid exchange system. After stabilizing the guidewire position, the operator advances the catheter body 12 along the guidewire toward the lesion until the rapid exchange segment 122 reaches the desired location. At this point, both the angiographic balloon 13 and the thrombolytic balloon 14 are flattened, clinging to the inner wall of the catheter body 12 and preventing blood flow interference.

[0026] The operator grasps the square handle 151 on the three-way operating base 15 and introduces normal saline through the left high-pressure drip inlet 152. The saline is then perfused through the catheter through the through-hole to the distal end. The saline continuously flows out of the opening, maintaining the patency of the microcirculation downstream of the perforating artery and clearing any residual thrombus debris within the lumen. After maintaining perfusion, the operator switches to the contrast agent inlet / outlet 153 and injects contrast agent into the second interlayer lumen 125, causing the angiographic balloon 13 to expand from its flattened state to a preset outer diameter (approximately 1.5-2.5 mm). This allows the balloon's sidewalls to cling to the inner wall of the main vessel, temporarily blocking blood flow and creating a bloodless environment. Simultaneously, radiopaque markers 16 at the axial ends of the angiographic and thrombolytic balloons 13 and 14 allow for real-time position correction under fluoroscopy.

[0027] After confirming proximal occlusion, the operator switches back to the thrombolytic drug inlet / outlet 154 and injects the thrombolytic solution through the first interlayer lumen 124, causing the thrombolytic balloon 14 to transition from a flattened state to a slightly inflated state, with an outer diameter slightly smaller than that of the angiographic balloon 13, precisely fitting the perforating artery opening. Under low pressure (≤3 atm), the thrombolytic solution pushes the liquid outlet members 142 within each thrombolytic drug outlet 141 to activate. The sliding portion 143 slides proximally along the sliding annular groove 1411 in the balloon wall, its travel limited by the upper limit ring 1436. The flexible flaps 1443 on the closing portion 144 open radially under the drug pressure, forming a uniform flow path. The drug solution enters from the inlet port 1431 through the lower tapered opening 1434, is buffered along the multi-stage, decreasing-diameter connecting holes 1435, and reaches the upper tapered opening 1433. It then gathers at the reservoir port 1432, ultimately seeping through the valve to directly infiltrate the thrombus, avoiding dilution caused by blood flow. The lower counterweight ring 1437 uses gravity to automatically stabilize the outlet member 142 in its axial position perpendicular to the vessel segment, ensuring continuous and controlled drug release.

[0028] Throughout the procedure, the operator can independently adjust the pressure in the first and second interlayer cavities 124 and 125 using valves on the three-way operating base 15, precisely controlling the expansion of the angiographic and thrombolytic balloons 13 and 14 to accommodate varying vascular anatomy. The ergonomic design of the square handle 151 provides clear mechanical feedback, facilitating single-handed channel switching and maintaining stable operation.

[0029] After thrombolysis is complete, the operator stops injecting the drug and reopens high-pressure drip inlet 152. The operator then flushes the first interlayer cavity 124 with saline, causing the sliding portion 143 to return to its original position under the action of gravity and its own elasticity. The flexible flap 1443 of the closing portion 144 automatically closes to prevent blood backflow. Subsequently, the angiographic balloon 13 and the thrombolytic balloon 14 are withdrawn through the contrast agent inlet 153 and the thrombolytic drug inlet 154, respectively, restoring their flattened positions. The catheter body 12 and guidewire are then quickly withdrawn along the guidewire 11 through the rapid exchange section 122. This eliminates the need for guidewire replacement, shortening the procedure and reducing the risk of vascular trauma.

[0030] Please refer to Figures 1 to 2 In some embodiments, the thrombolytic balloon catheter 10 for intracranial perforating blood vessels includes a finger guide wire 11, a catheter body 12, an angiographic balloon 13, a thrombolytic balloon 14 and a three-way operating seat 15; the finger guide wire 11 is used to pass through safe, narrow and curved blood vessels. Specifically, the user can flexibly select guide wires of different sizes and hardnesses according to actual conditions; the catheter body 12 includes a three-way operating section 121 and a rapid exchange section 122 that are relatively arranged; the angiographic balloon 13 is used to develop images in brain blood vessels, and the angiographic balloon 13 is arranged at one end of the rapid exchange section 122 away from the three-way operating section 121; the thrombolytic balloon 14 is used to release thrombolytic liquid, and the thrombolytic balloon 14 and the angiographic balloon The balloons 13 are spaced apart; the outer diameter of the angiographic balloon 13 after expansion is greater than the outer diameter of the thrombolytic balloon 14 after expansion; the thrombolytic balloon 14 is positioned on the side of the angiographic balloon 13 near the three-way operating section 121; the three-way operating seat 15 is positioned on the three-way operating section 121 and is used to control the expansion volume of the thrombolytic balloon 14 and the angiographic balloon 13 and distal drug infusion; a guidewire hole 123 is provided between the three-way operating section 121 and the rapid exchange section 122; the finger guidewire 11 passes through the guidewire hole 123 and exits from one end of the rapid exchange section 122; the finger guidewire 11 is used to deliver the rapid exchange section 122 to a designated position. Furthermore, by providing a spaced-apart dual balloon structure with the angiographic balloon 13 and the thrombolytic balloon 14, dual functional zoning is achieved. After expansion, the outer diameter of the angiographic balloon 13 is larger than that of the thrombolytic balloon 14, which enables the angiographic balloon 13 to effectively block the blood flow flushing path in the blood vessel, forming a local closed space; the thrombolytic balloon 14 is located on its proximal side and can release thrombolytic drugs at a fixed point in the blocked area of the perforator vessel. The thrombolytic area is further physically isolated from the blood flow impact area, significantly reducing the risk of thrombolytic drugs being diluted by the blood flow, thereby maintaining local drug concentration and improving thrombolysis efficiency. The coordinated design of the rapid exchange section 122 and the guidewire improves the placement rate of the catheter in the blocked perforator vessel, and the three-way operating seat 15 realizes the precise joint control of balloon pressure and drug infusion.

[0031] Please refer to Figures 2 to 3In some embodiments, a plurality of thrombolytic drug outlets 141 are provided in the thrombolytic balloon 14, and a plurality of the thrombolytic drug outlets 141 are provided with a liquid outlet 142, and the liquid outlet 142 slides up and down in the thrombolytic drug outlet 141. Furthermore, a thrombolytic drug outlet 141 with a sliding liquid outlet 142 is provided in the thrombolytic balloon 14. The up and down sliding mechanism of the liquid outlet 142 can automatically adjust the opening and closing degree of the outlet according to the change of the intracavitary pressure: when the drug infusion pressure increases, the liquid outlet 142 slides upward to expand the outlet area to increase the instantaneous drug release volume; when the external blood flow pressure fluctuates abnormally, the liquid outlet 142 resets to narrow the passage, forming a negative feedback regulation system. This dynamic adjustment function effectively balances the contradiction between the need for high-pressure pulse injection and the prevention of drug backflow and overflow, which not only ensures the effect of pulse thrombolysis, but also avoids the sudden drop in concentration caused by ineffective loss of drugs.

[0032] Please refer to Figures 4 to 7 In some embodiments, the liquid outlet part 142 is provided with a sliding portion 143 and a closing portion 144, the closing portion 144 is provided above the sliding portion 143, and the liquid outlet end 1441 is integrally formed with the sliding portion 143. Furthermore, a two-stage pressure trigger mechanism is formed by the integrated design of the closing portion 144 and the sliding portion 143. The sliding portion 143 is hydraulically driven to achieve axial displacement, and the valve structure of the closing portion 144 is deformed synchronously: under low perfusion pressure, the closed end 1442 remains in a closed state to prevent blood from flowing back into the blood vessels to dilute the drug; when the injection pressure reaches the threshold, the valve of the closed end 1442 expands outward to form a high-speed jet channel. This structure innovatively converts hydraulic pressure into a mechanical opening and closing action, realizing the function of a one-way valve, so that the drug is only released in a direction when actively injected, significantly improving the drug utilization rate.

[0033] Please refer to Figures 4 to 7 In some embodiments, the closing portion 144 is provided with a liquid outlet end 1441 and a closed end 1442, and the sliding portion 143 is provided with a liquid inlet end 1431 and a liquid storage end 1432; the closing portion 144 is provided with a plurality of flexible opening and closing flaps 1443, and the inner and outer sides of the transverse cross-sections of the plurality of flexible opening and closing flaps 1443 are both arc-shaped, and the plurality of flexible opening and closing flaps 1443 gradually approach the axial direction of the liquid outlet part 142 along the direction from the liquid outlet end 1441 to the closed end 1442. Furthermore, by adopting a tapered arc cross-section design for the flexible opening and closing flaps 1443, laminar flow guidance is achieved in fluid dynamics. When the valve is expanded, a tapered flow channel that is narrow in front and wide in the back is formed, so that the liquid medicine is accelerated axially and produces a targeted injection effect; when closed, the arc-shaped inner wall fits tightly to form a full-circumferential seal. This setting not only reduces flow resistance loss and improves injection efficiency, but its tapered structure can also store elastic potential energy through deformation under low-pressure conditions, automatically compensate for changes in opening and closing degree when pressure fluctuates, maintain a stable drug output rate, and suppress concentration changes.

[0034] Please refer to Figure 6 In some embodiments, the sliding portion 143 is provided with an upper conical opening 1433 and a lower conical opening 1434, and the upper conical opening 1433 is connected to the lower conical opening 1434. A Venturi effect acceleration channel is then formed through the connecting structure of the upper conical opening 1433 and the lower conical opening 1434. When the liquid medicine flows through the gradually converging lower conical opening 1434, the flow velocity increases and the dynamic pressure rises; after entering the gradually expanding upper conical opening 1433, part of the dynamic pressure is converted into static pressure, forming a local negative pressure zone to attract the surrounding liquid medicine for secondary acceleration. This two-stage speed-increasing structure greatly improves the penetration of the liquid medicine; at the same time, the gentle pressure gradient change in the tapered transition section reduces the generation of turbulence and reduces the ineffective consumption of thrombolytic drugs.

[0035] Please refer to Figure 6 In some embodiments, the sliding portion 143 is further provided with a plurality of connecting holes 1435, and the apertures of the plurality of connecting holes 1435 gradually decrease from the liquid inlet end 1431 toward the liquid storage end 1432. A diversion-type buffer structure is then formed through the plurality of connecting holes 1435. The structure in which the aperture decreases from the liquid inlet end 1431 to the liquid storage end 1432 causes the liquid medicine to be gradually decelerated and pressurized as it flows through: the large hole at the front end quickly passes a large amount of liquid medicine to achieve a pulse shock, and the small hole at the rear end continuously maintains the basic flow rate. This setting not only meets the needs of large-dose instantaneous shock in the early stage of thrombolysis, but also provides stable low-flow perfusion in the maintenance stage, so that the surface of the thrombus is always covered with an effective drug concentration layer, avoiding concentration fluctuations caused by repeated fluid infusion.

[0036] Please refer to Figure 5 In some embodiments, the sliding portion 143 is further provided with an upper limit ring 1436 and a lower counterweight ring 1437. The upper limit ring 1436 is positioned on the side proximal to the liquid storage end 1432, and the lower counterweight ring 1437 is positioned on the side proximal to the liquid inlet end 1431. The thrombolytic drug outlet 141 is provided with a sliding ring groove 1411 that mates with the upper limit ring 1436 and the lower counterweight ring 1437. This interference fit between the upper limit ring 1436 and the sliding ring groove 1411 creates a precise displacement limit, ensuring smooth movement of the liquid outlet 142 within a set stroke. The lower counterweight ring 1437 achieves gravity compensation by adjusting mass distribution, counteracting inertial offset caused by blood vessel oscillation. The synergistic effect of these two elements enables the liquid outlet 142 to maintain axial stability in complex blood flow environments, preventing intermittent drug release caused by catheter vibration and ensuring a smooth concentration curve.

[0037] Please refer to Figure 1In some embodiments, the three-way operating base 15 includes a square handle 151, a high-pressure drip inlet 152, a contrast agent inlet and outlet 153, and a thrombolytic drug inlet and outlet 154; the high-pressure drip inlet 152 is located on the left side of the square handle 151, the thrombolytic drug inlet and outlet 154 is located on the right side of the square handle 151, and the thrombolytic drug inlet and outlet 154 is located in the middle of the square handle 151. Furthermore, by integrating the high-pressure drip, contrast agent control, and thrombolytic drug input functions into the square handle 151, an ergonomic operating interface is formed. The independent channel setting of the high-pressure drip inlet 152 allows for simultaneous rapid injection while the balloon is inflated, avoiding ischemia of distal cerebral blood vessels.

[0038] Please refer to Figure 4 and Figure 8 In some embodiments, the catheter body 12 is provided with a first interlayer lumen 124 and a second interlayer lumen 125. The first interlayer lumen 124 is used to connect the thrombolytic drug inlet and outlet 154 with the thrombolytic balloon 14; the second interlayer lumen 125 is used to connect the contrast agent inlet and outlet 153 with the angiographic balloon 13. The through-hole of the catheter body 12 is connected to the high-pressure infusion inlet 152. The diversion between the first and second interlayer lumens 124, 125 achieves complete isolation of the functional channels. The contrast agent pathway and the thrombolytic drug pathway operate independently, eliminating drug dilution caused by crosstalk.

[0039] Please refer to Figure 8 In some embodiments, both ends of the angiographic balloon 13 and the thrombolytic balloon 14 along the axial direction are provided with radiopaque markers 16. Specifically, the commonly used materials of the radiopaque markers 16 include platinum or iridium-gold-tungsten alloy; the radiopaque markers 16 are used to identify the positions of the angiographic balloon 13 and the thrombolytic balloon 14 in the intracranial blood vessels. The high-density radiopaque markers 16 provided at both ends of the double balloons constitute a three-dimensional spatial positioning system. During the interventional operation, the axial torsion angle and radial expansion state of the balloon can be observed in real time to accurately determine whether the thrombolytic balloon 14 is completely aligned with the thrombus lesion. Combined with existing digital angiography technology, doctors can dynamically adjust the position of the catheter to ensure that the thrombolytic agent release area is highly consistent with the spatial distribution of the thrombus, reduce the range of ineffective perfusion, and maximize the therapeutic effect of the unit dose.

[0040] In some embodiments, the angiographic balloon 13 and the thrombolytic balloon 14 are made of a polymer such as soft polyvinyl chloride, polyurethane, or cross-linked polyethylene. The catheter body 12 is made of polyurethane on the exterior and nylon elastomer on the interior. The guide wire 11 can be made of stainless steel and is not part of the thrombolytic balloon catheter 10 for intracranial perforators. That is, the catheter 10 for intracranial perforators may not include the guide wire 11 when sold. The three-way operating base 15 can be made of polyvinyl chloride. The thrombolytic balloon catheter 10 for intracranial perforators is disposable and can be sterilized using ethylene oxide.

[0041] In some embodiments, the sizes of the angiographic balloon 13 and the thrombolytic balloon 14 can be flexibly selected according to actual conditions.

[0042] In some embodiments, the various structures of the intracranial perforator thrombolytic balloon catheter 10 work synergistically. The imaging balloon 13 and the thrombolytic balloon 14 are spaced apart and have a gradient outer diameter. Upon simultaneous inflation, they form a proximal-distal double-enclosed chamber, synergistically blocking blood flow. Combined with the radiopaque marker 16 for real-time positioning, the thrombolytic solution is completely enclosed between the two balloons. This structure effectively isolates the bloodstream from the thrombolytic solution, ensuring that the thrombolytic solution continues to act in a high-concentration, stable environment, significantly improving the efficiency of local thrombolysis. The first interlayer lumen 124 and the second interlayer lumen 125 connect the thrombolytic balloon 14 and the imaging balloon 13, respectively. Together with the contrast agent inlet 153, the high-pressure drip inlet 152, and the thrombolytic drug inlet 154 of the three-way operating base 15, the multiple fluid channels do not interfere with each other. High-pressure saline flushing, precise contrast agent inflation, and quantitative thrombolytic drug injection work synergistically to simultaneously achieve vascular patency, position confirmation, and local drug delivery, shortening surgical time and improving safety. The sliding portion 143 of the liquid outlet 142 is equipped with upper and lower tapered openings 1434, a connecting hole 1435, and a matching limit ring and counterweight ring. These cooperate with the sliding ring groove 1411 of the thrombolytic drug outlet 141, allowing the sliding portion 143 to move smoothly axially under the action of drug pressure and maintain its position under different blood vessel postures. The flexible opening and closing flaps 1443 on the closing portion 144 radially open under pressure and quickly close after the pressure disappears. This coordinated graded buffering and dynamic positioning achieves uniform and controllable drug liquid seepage throughout the closed chamber, avoiding overshoot or backflow, and effectively improving drug efficacy utilization. The square handle 151 of the three-way operating seat 15 provides an ergonomic operating feel. The high-pressure drip inlet 152 is rationally arranged with the various inlets and outlets, allowing the operator to switch multiple channels with one hand under video monitoring and to correct the balloon position in real time using the radiopaque marker 16. This structural synergy not only improves positioning accuracy and operational convenience, but also reduces the risk of misoperation, ensuring stability and reliability in clinical application.

[0043] In some embodiments, the catheter body 12 adopts a multi-section flexible structure, with a high-density braided layer at the proximal end that enhances pushing force, an elastic buffer layer set in the middle transition zone to adapt to the tortuous intracranial vascular path, and a highly flexible polymer material formed at the distal end, so that the catheter can conform to the natural curvature of the blood vessels during advancement, avoiding damage to the inner wall of the cerebral blood vessels. The surface of the thrombolytic balloon 14 and the angiographic balloon 13 is coated with a hydrophilic coating to reduce the resistance to passage, and the injected liquid is evenly released through micropores inside to achieve controlled sustained-release thrombolysis. The three-way operating seat 15 is provided with a standard Luer interface to facilitate connection with the syringe and pump body. The overall setting takes into account the compatibility and operational accuracy of the interventional path. During use, the thrombolytic balloon catheter 10 for the intracranial perforator vessel can be accurately positioned at the opening of the occluded perforator artery under the guidance of the contrast agent. The balloon blocks the blood flow under low-pressure filling state, and at the same time, thrombolytic drugs are locally injected through the inner cavity to achieve targeted dissolution of the thrombus in the occluded segment, effectively reducing the risk of distal embolism. After the large thrombus is dissolved, it becomes a small thrombus, greatly reducing the risk of large thrombus in the skull.

[0044] In summary, the present application provides a thrombolytic balloon catheter for intracranial perforator vessels, the thrombolytic balloon catheter for intracranial perforator vessels comprising: a finger guide wire; a catheter body, the catheter body comprising a three-way operating section and a rapid exchange section arranged relatively thereto; an angiographic balloon, the angiographic balloon being arranged at one end of the rapid exchange section away from the three-way operating section; a thrombolytic balloon, the thrombolytic balloon being spaced apart from the angiographic balloon; the outer diameter of the angiographic balloon after expansion being greater than the outer diameter of the thrombolytic balloon after expansion; the thrombolytic balloon being arranged on the side of the angiographic balloon close to the three-way operating section; a three-way operating seat, the three-way operating seat being arranged on the three-way operating section, the three-way operating seat being used to control the expansion volume of the thrombolytic balloon and the angiographic balloon and the distal drug drip; wherein a guide wire hole is provided between the three-way operating section and the rapid exchange section, the finger guide wire passing through the guide wire hole and passing through one end of the rapid exchange section, the finger guide wire being used to deliver the rapid exchange section to a designated position. Furthermore, by setting up a spaced dual balloon structure with angiographic and thrombolytic balloons, dual functional zoning is achieved. After expansion, the outer diameter of the angiographic balloon is larger than that of the thrombolytic balloon, which enables the angiographic balloon to effectively block the blood flow path within the blood vessel, forming a localized closed space; the thrombolytic balloon is located on its proximal side and can release thrombolytic drugs at a specific point in the blocked area of the perforating vessel. This further physically isolates the thrombolytic area from the blood flow impact area, significantly reducing the risk of thrombolytic drug dilution by the blood flow, thereby maintaining local drug concentration and improving thrombolysis efficiency.

[0045] It should be understood that the application of this application is not limited to the above examples. For ordinary technicians in this field, they can make improvements or changes based on the above description. All these improvements and changes should fall within the scope of protection of the claims attached to this application.

Claims

1. A thrombolytic balloon catheter for intracranial perforator vessels, used for thrombolysis of perforator vessels, characterized in that: The thrombolytic balloon catheter for intracranial perforating blood vessels comprises: Finger guide wire; The catheter body comprises a three-way operation section and a quick exchange section that are arranged opposite to each other; A radiographic balloon, the radiographic balloon being arranged at one end of the rapid exchange section away from the three-way operation section; A thrombolytic balloon, the thrombolytic balloon and the angiographic balloon are spaced apart; the outer diameter of the angiographic balloon after expansion is larger than the outer diameter of the thrombolytic balloon after expansion; the thrombolytic balloon is arranged on the side of the angiographic balloon close to the three-way operation section; A three-way operating seat, which is arranged on the three-way operating section and is used to control the expansion volume of the thrombolytic balloon and the angiographic balloon and the distal drug solution drip; Among them, a guide wire hole is provided between the three-way operation section and the rapid exchange section. The finger guide wire passes through the guide wire hole and passes out from one end of the rapid exchange section. The finger guide wire is used to send the rapid exchange section to a designated position.

2. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 1, characterized in that: A plurality of thrombolytic drug outlets are provided in the thrombolytic balloon, and each of the plurality of thrombolytic drug outlets is provided with a liquid outlet member, and the liquid outlet member slides up and down in the thrombolytic drug outlets.

3. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 2, characterized in that: The liquid outlet part is provided with a sliding part and a closing part, the closing part is arranged above the sliding part, the closing part is provided with a liquid outlet end and a closing end, and the sliding part is provided with a liquid inlet end and a liquid storage end; the liquid outlet end and the sliding part are integrally formed.

4. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 3, characterized in that: The closing portion is provided with a plurality of flexible opening and closing flaps, the inner and outer sides of the transverse cross-sections of the plurality of flexible opening and closing flaps are both arc-shaped, and the plurality of flexible opening and closing flaps gradually approach the axial direction of the liquid outlet part along the direction from the liquid outlet end to the closing end.

5. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 4, characterized in that: The sliding portion is provided with an upper tapered opening and a lower tapered opening, and the upper tapered opening is communicated with the lower tapered opening.

6. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 3, characterized in that: The sliding portion is further provided with a plurality of connecting holes, and the apertures of the plurality of connecting holes gradually decrease from the liquid inlet end toward the liquid storage end.

7. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 6, characterized in that: The sliding portion is further provided with an upper positioning ring and a lower counterweight ring, wherein the upper positioning ring is provided on a side close to the liquid storage end, and the lower counterweight ring is provided on a side close to the liquid inlet end; Wherein, the thrombolytic drug outlet is provided with a sliding ring groove adapted to the upper limit ring and the lower counterweight ring.

8. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 1, characterized in that: The three-way operating seat includes a square handle, a high-pressure drip inlet, a contrast agent inlet and outlet, and a thrombolytic drug inlet and outlet; the high-pressure drip inlet is arranged on the left side of the square handle, the thrombolytic drug inlet and outlet are arranged on the right side of the square handle, and the thrombolytic drug inlet and outlet are arranged in the middle of the square handle.

9. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 8, characterized in that: The catheter body is provided with a first interlayer cavity and a second interlayer cavity, the first interlayer cavity is used to connect the inlet and outlet of the thrombolytic drug with the thrombolytic balloon; the second interlayer cavity is used to connect the inlet and outlet of the contrast agent with the contrast balloon, and the through hole of the catheter body is connected to the high-pressure drip inlet.

10. The thrombolytic balloon catheter for intracranial perforating vessels according to claim 1, characterized in that: Both ends of the angiographic balloon and the thrombolytic balloon in the axial direction are provided with radiopaque markers, and the radiopaque markers are used to identify the positions of the angiographic balloon and the thrombolytic balloon in the intracranial blood vessels.

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