Non-liquid-filled balloon catheter with stroke control handle and method of operating same

Abstract

The application discloses a non-liquid-filled balloon guide tube with a stroke control handle and an operation method thereof. The balloon guide tube comprises a handle driving assembly, an inner tube and an outer tube. A tensioned braided stent is connected between the distal ends of the outer tube and the inner tube. The tensioned braided stent is coated with an elastic coating film. The two ends of the elastic coating film are respectively in sealing connection with the outer tube and the inner tube. The handle driving assembly drives the outer tube to move axially relative to the inner tube, so that the tensioned braided stent drives the elastic coating film to switch between an expansion state and a contraction state. The outer surface of the elastic coating film is coated with an anticoagulant drug coating. The tensioned braided stent comprises a uniform variation section located in the middle and gradient sections located at both ends of the uniform variation section. The balloon guide tube has the effects of eliminating the risk of liquid filling pressure relief delay and cavity blockage, improving the operation efficiency and safety, improving the supporting force and structural strength of the balloon guide tube, and reducing the probability of intraoperative complications.

Description

Technical Field

[0001] This invention relates to the field of balloon catheter technology, and in particular to a non-fluid-filled balloon catheter with a stroke control handle and its operation method. Background Technology

[0002] Stroke, commonly known as apoplexy, is a disease caused by damage to cerebral blood vessels due to various reasons, resulting in focal or overall brain tissue damage. Acute ischemic stroke accounts for more than 80% of all strokes, with more than 2 million new stroke patients in my country every year. The incidence rate is continuously rising and trending towards younger ages. For acute ischemic stroke caused by large vessel occlusion, mechanical thrombectomy has become the standard treatment. Its vascular recanalization rate and good prognosis rate are significantly better than drug therapy alone. The balloon guiding catheter is the core access device in mechanical thrombectomy. During the thrombectomy operation, the balloon is inflated to temporarily block proximal blood flow, preventing embolic fragments from escaping distally during the thrombectomy process. At the same time, it provides a stable delivery channel for instruments such as guidewires, microcatheters, thrombectomy stents, and aspiration catheters. Clinical studies have confirmed that using BGC-assisted thrombectomy can significantly improve the first-time recanalization rate and improve patient prognosis.

[0003] However, existing balloon guiding catheters have the following drawbacks: 1. After the balloon is inflated, the fluid needs to be manually aspirated to release the pressure and recover the balloon. However, the inflation channel of the current fluid-filled balloon guiding catheter is long and thin, resulting in a delay in decompression. In neurointerventional surgery, the small diameter of the blood vessels and the tortuous pathway make this delay more pronounced. More seriously, if the inflation channel is blocked by thrombus fragments or the syringe malfunctions, the balloon may not be able to decompress, causing the catheter to remain in the intracranial blood vessels for a long time, leading to serious complications such as vasospasm, dissection, or even rupture. At the same time, the doctor needs to repeatedly aspirate the syringe and calculate the volume of filling fluid during the operation, which is cumbersome.

[0004] 2. In the existing technology, balloons are basically made of homogeneous materials and are single-layer structures. Their support depends entirely on the continuous external hydraulic pressure. Their support and structural strength are weak. As a pressure vessel, the consequences of a balloon rupture in an intracranial blood vessel are extremely serious.

[0005] 3. The surface of the balloon in the existing technology does not have anticoagulant function and cannot effectively inhibit the formation of acute thrombus in the blockage area, which increases the risk of embolic complications during the operation. Summary of the Invention

[0006] The purpose of this invention is to provide a non-fluid-filled balloon guide tube with a travel control handle and its operation method, which has the effects of eliminating the risk of delayed inflation and depressurization and cavity blockage, improving surgical efficiency and safety, improving the support force and structural strength of the balloon guide tube, and reducing the probability of intraoperative complications.

[0007] The above-mentioned technical objective of the present invention is achieved through the following technical solution: a non-fluid-filled balloon guide tube with a stroke control handle, comprising a handle drive assembly, an inner tube, and an outer tube sleeved outside the inner tube. The end of the outer tube and the inner tube closer to the handle drive assembly is designated as the proximal end, and the end of the outer tube and the inner tube farther from the handle drive assembly is designated as the distal end. A tension braided support is connected between the distal end of the outer tube and the distal end of the inner tube. The tension braided support is covered with an elastic membrane. One end of the elastic membrane is sealed to the outer tube, and the other end of the elastic membrane is sealed to the inner tube. The handle drive assembly drives the outer tube to move axially relative to the inner tube, so that the tension braided support drives the elastic membrane to switch between an inflated state and a contracted state. The outer surface of the elastic membrane is coated with an anticoagulant drug coating. The tensioned braided bracket includes a uniform section in the middle and gradual sections at both ends of the uniform section. When the tensioned braided bracket is in an open state, the radial expansion outer diameter of the gradual section gradually decreases from the end near the uniform section to the direction away from the uniform section. The radial expansion outer diameter of the uniform section is greater than or equal to the maximum radial expansion outer diameter of the gradual section.

[0008] By adopting the above technical solution, this device utilizes a handle drive assembly to drive the outer tube to slide axially relative to the inner tube. When the outer tube moves towards extending from the handle drive assembly, the ends of the outer and inner tubes away from the handle drive assembly approach each other, causing the tensioned braided stent to be axially compressed and undergo radially outward expansion deformation. Simultaneously, this drives the elastic diaphragm to undergo radially outward elastic expansion, thereby occluding the blood vessel. When the outer tube moves towards retracting from the handle drive assembly, the ends of the outer and inner tubes away from the handle drive assembly move away from each other, causing the tensioned braided stent to axially stretch and undergo radially inward contraction deformation. Simultaneously, this drives the elastic diaphragm to undergo radially inward elastic contraction, facilitating the insertion or retrieval of the balloon guiding catheter. Furthermore, when the outer tube slides axially relative to the inner tube, the driving force is directly transmitted to the end of the tensioned braided stent, ensuring rapid response and stable deformation of the radial expansion or contraction of the tensioned braided stent, avoiding transmission lag or uneven radial expansion and contraction caused by connection position misalignment. The radial expansion outer diameter of the uniform expansion section is greater than... This expansion, or equal to the maximum radial expansion outer diameter of the transition section, allows the tensioned braided stent to form a smoother, rounded transition shape that conforms more closely to the inner wall of the blood vessel after expansion. This avoids mechanical stimulation or damage to the vessel wall caused by sharp edges or abrupt changes in the outer diameter of the tensioned braided stent tip, reducing the risk of vasospasm and dissection. It ensures that the expansion blockage area formed after the tensioned braided stent expands is precisely located in the surgical operation area distal to the balloon guiding catheter, which is beneficial for adapting to the proximal blood flow blockage requirements of intracranial vascular occlusion sites, improving the positioning accuracy and reliability of surgical operation. The anticoagulant coating can inhibit the adhesion and aggregation of platelets in the blood on the surface of the balloon guiding catheter and the tensioned expansion stent during the operation, reducing the risk of thrombosis, improving the anticoagulant effect in the blood flow blockage area, and reducing the probability of intraoperative secondary thrombosis and embolism complications. It has the effects of eliminating the risk of delayed filling and decompression and cavity blockage, improving surgical efficiency and safety, improving the support and structural strength of the balloon guiding catheter, and reducing the probability of intraoperative complications.

[0009] A further provision of the present invention is that the radial expansion diameter D of the tensioned braided support and the forward thrust X of the outer tube relative to the inner tube satisfy the following formula: D=-0.0064X 2 +0.4564X+1.9857; Where D is the diameter of the support, in millimeters (mm); X represents the forward thrust distance, 0 ≤ X ≤ 30, unit: millimeters (mm).

[0010] A further feature of the present invention is that the anticoagulant coating is selected from heparin coating or phosphocholine coating.

[0011] By adopting the above technical solutions, heparin coating or phosphocholine coating has excellent blood compatibility and stable anticoagulant properties, which can effectively inhibit platelet adhesion, aggregation and activation on the instrument surface, avoid the formation of acute thrombus in the blood flow blocking area, avoid the risk of secondary embolic complications during the operation, reduce the stimulation and inflammatory response of the instrument to the intracranial vascular endothelium, and reduce the occurrence of adverse conditions such as vasospasm and intimal damage. Combined with the mechanical blocking structure of the tension braided stent and elastic membrane of this device for blood flow, a dual safety guarantee of mechanical barrier and chemical anticoagulation is formed, which effectively improves the safety and stability of complex neurointerventional thrombectomy.

[0012] A further configuration of the present invention is as follows: the first end of the tension braided bracket is fixedly connected to the inner tube via a metal imaging ring, and the second end of the tension braided bracket is fixedly connected to the outer tube via another metal imaging ring.

[0013] By adopting the above technical solution, the metal imaging ring can improve the mechanical connection strength between the tensioned braided stent and the inner and outer tubes, ensuring the reliable transmission of driving force when the outer tube slides axially relative to the inner tube. This avoids the stent from falling off, shifting, or failing during repeated expansion and contraction. At the same time, the metal imaging ring connection structure has good sealing performance and high structural strength, which can improve the overall structural durability. Furthermore, the metal imaging ring can be clearly visualized with the help of medical imaging equipment, accurately locating the two ends of the tensioned braided stent and judging the expansion and contraction state of the tensioned braided stent in real time. This allows doctors to intuitively understand the placement position of the tensioned braided stent in the intracranial blood vessels.

[0014] A further configuration of the present invention is as follows: the handle drive assembly includes a handle body, a rotary drive component is rotatably disposed on the handle body, the rotary drive component includes a rotating wheel and an internally threaded sleeve coaxially fixed on the rotating wheel, the handle body is provided with a sliding cavity, a sliding post is slidably disposed in the sliding cavity, the sliding post is provided with an external thread, the sliding post is threadedly engaged with the internally threaded sleeve through the external thread, and the proximal end of the outer tube is fixedly connected to the sliding post; The handle body has guide grooves connected on both sides of the sliding cavity. The guide grooves on both sides extend along the axial direction of the handle body. Sliding blocks are fixed on both sides of the sliding column, and the sliding blocks are guided and engaged with the guide grooves.

[0015] By adopting the above technical solution, the guiding effect between the sliding block and the guide groove is used to prevent the sliding column from rotating circumferentially, ensuring the consistency of the sliding column's sliding direction along the handle body axis. When the rotating wheel is rotated, it will drive the inner threaded sleeve to rotate synchronously. By using the threaded transmission between the inner threaded sleeve and the sliding column, the sliding column is controlled to drive the outer tube to move axially relative to the inner tube, realizing the fine adjustment of the radial expansion and contraction of the tensioned braided stent. Moreover, the threaded transmission has a self-locking characteristic, which keeps the tensioned expansion stent stent stably in the open or contracted state, improving the controllability, stability and ease of use of the surgical operation.

[0016] A further feature of the present invention is that the handle body includes an upper shell and a lower shell that are fixedly connected. The upper shell and the lower shell are fastened together to form a rotating cavity that communicates with the sliding cavity. An internal threaded sleeve is rotatably disposed in the rotating cavity. The upper shell and the lower shell are respectively provided with rotating holes that communicate with the rotating cavity. The rotating wheel passes through the rotating holes on both sides and is at least partially exposed on the side walls of the handle body. The rotating wheel is provided with anti-slip ridges.

[0017] By adopting the above technical solution, the operator can adjust the outer tube axially by using the exposed wheels on both sides of the handle body, which improves the operator's ease of operation and efficiency. At the same time, the anti-slip ridges on the wheels help improve the operator's feel and the anti-slip properties of the wheels.

[0018] A further feature of the present invention is that: the sliding column is provided with an indicator line, the handle body is provided with a strip-shaped observation hole axially corresponding to the sliding column, the strip-shaped observation hole is connected to the sliding cavity, and the handle body is provided with a scale line on the side of the strip-shaped observation hole, the indicator line and the corresponding scale line are used to indicate the diameter of the tensioned braided bracket in the open state.

[0019] By adopting the above technical solution, the operator can intuitively and accurately read the movement distance of the outer tube relative to the inner tube during the operation, thereby quantitatively controlling the radial expansion diameter and contraction degree of the tensioned braided stent, realizing precise control of the vascular occlusion range and expansion force, avoiding excessive or insufficient expansion and contraction due to differences in operating experience, and improving the standardization and precision of the surgical operation.

[0020] A further feature of the present invention is that the tensioned braided support has at least one braided layer, each braided layer is formed into a tubular structure by multiple strands of metal fiber filaments, the number of metal fiber filaments in each braided layer is controlled between 2 and 128, the braiding density is controlled between 1 and 100, and the diameter of each metal fiber filament is controlled between 0.01 and 10 mm.

[0021] By adopting the above technical solution, relying on the structural strength of the metal fiber itself and the mechanical properties of the woven mesh, a stable radial support force is provided for the tensioned woven stent in the open state. At the same time, the metal fiber woven structure has good axial flexibility and radial deformation response. When the outer tube slides axially relative to the inner tube, it can quickly and uniformly achieve radial expansion and contraction. Moreover, the overall structural strength is high, avoiding local collapse or uneven deformation, and is suitable for the tortuous intracranial vascular environment.

[0022] A further feature of the present invention is that the elastic coating is made of thermoplastic polyurethane polymer material and is coated on the outer surface of the tensioned braided bracket by impregnation, spraying or heat shrinking process, and the thickness of the elastic coating is controlled between 0.1 and 2 mm.

[0023] By adopting the above technical solutions, thermoplastic polyurethane polymer materials possess excellent flexibility, sealing properties, and biocompatibility. Combined with the encapsulation process, the elastic membrane fits tightly against the outer wall of the tensioned braided stent, effectively blocking blood flow without easily damaging the inner wall of the blood vessel. The thickness of the elastic membrane is controlled between 0.1 and 2 mm. For interventional procedures with different inner diameters, balloon guide catheters of appropriate thickness are selected to ensure that the elastic membrane has sufficient structural strength, sealing properties, and flexibility.

[0024] Another technical objective of this invention is to provide a method for operating a non-fluid-filled balloon guide tube, comprising the following steps: S1. Instrument positioning adjustment: Control the handle drive assembly to keep the tensioned braided frame and the elastic membrane covering its outside in a fully contracted state, and deliver the distal end of the balloon guide tube to the preset working position. S2, Expansion Molding Positioning: The rotation drive component of the handle drive assembly drives the outer tube to make an axial extension sliding motion relative to the inner tube, applying axial compression force to the tension braided bracket. Under the action of axial compression, the tension braided bracket undergoes radial expansion deformation, which simultaneously drives the elastic membrane of the outer sealing connection to complete radial elastic expansion, so that the expanded elastic membrane forms a closed barrier structure with a preset outer diameter. S3. Workstation adaptation: Maintain the expansion and shaping state of the tensioned braided support and elastic membrane to provide a stable workstation for the supporting interventional instruments; S4. Shrinkage and Reset Adjustment: After completing the workstation adaptation, reverse the control handle to drive the component, drive the outer tube to make an axial retraction sliding motion relative to the inner tube, release the axial compression load on the tensioned braided bracket, so that the tensioned braided bracket can be axially stretched and reset and undergo radial shrinkage deformation, which drives the elastic film to elastically retract, so that the outer diameter of the overall structure shrinks to the preset storage size. S5. Instrument withdrawal and repositioning: Maintain the tensioned braided support and elastic membrane in their retracted state, remove the entire balloon guide tube from the working position, and complete the entire instrument operation procedure.

[0025] In summary, the present invention has the following beneficial effects: 1. A tensioned braided stent is used to connect the distal ends of the outer and inner tubes. The handle drive assembly propels the outer tube axially relative to the inner tube, allowing the tensioned braided stent to switch between expanded and contracted states. This eliminates the need for fluid inflatation to inflate and depressurize the balloon guide catheter, avoiding the depressurization delay caused by the narrow filling channel. It also eliminates the risk of vascular spasm, dissection, or even rupture caused by thrombus fragments blocking the filling channel or syringe malfunction preventing balloon depressurization. This eliminates the tedious operation of repeatedly aspirating and refilling the syringe and calculating the filling fluid volume during surgery. It improves the support and structural strength of the balloon guide catheter, effectively reducing the risk of balloon rupture in intracranial vessels, thereby enhancing the safety and ease of operation of mechanical thrombectomy. It effectively eliminates the risks of delayed inflation and depressurization, improves surgical efficiency and safety, and enhances the support and structural strength of the balloon guide catheter.

[0026] 2. An elastic diaphragm is wrapped around the tension-expanding stent, and an anticoagulant coating is applied to the elastic diaphragm. The anticoagulant coating inhibits the adhesion and aggregation of platelets in the blood on the surface of the balloon guiding catheter and the tension-expanding stent during the operation, reducing the risk of thrombosis, improving the anticoagulation effect in the blood flow blocking area, and reducing the probability of secondary thrombosis and embolism complications during the operation. Attached Figure Description

[0027] Figure 1 This is an overall structural diagram of the present invention, showing the tensioned braided support in a contracted state.

[0028] Figure 2 This is the present invention. Figure 1 Side view.

[0029] Figure 3 This is an overall structural diagram of the present invention, showing the tensioned braided support in an open state.

[0030] Figure 4 This is a partial cross-sectional view of the tensioned braided support frame of the present invention in the expanded state.

[0031] Figure 5 This is a partial exploded view of the present invention.

[0032] Figure 6 This is a cross-sectional view of the rotary drive component of the present invention.

[0033] In the diagram: 1. Handle body; 101. Upper shell; 102. Lower shell; 11. Rotary drive component; 111. Rotary wheel; 1111. Anti-slip ridge; 112. Internal threaded sleeve; 12. Sliding post; 121. External thread; 122. Sliding block; 123. Indicator line; 13. Sliding cavity; 14. Guide groove; 15. Rotating cavity; 16. Rotating hole; 17. Strip-shaped observation hole; 171. Scale line; 2. Inner tube; 3. Outer tube; 4. Tensioned braided bracket; 41. Uniform section; 42. Gradual section; 5. Elastic coating; 6. Metal imaging ring; 61. First metal imaging ring; 62. Second metal imaging ring; 7. Adhesive tube seat. Detailed Implementation

[0034] The invention will now be further described with reference to the accompanying drawings.

[0035] A non-fluid-filled balloon guiding catheter, such as Figures 1 to 4 As shown, the device includes a handle drive assembly, an inner tube 2, and an outer tube 3 sleeved around the inner tube 2. A tension braided support 4 is connected between the inner tube 2 and the outer tube 3. The handle drive assembly drives the outer tube 3 to move axially relative to the inner tube 2, allowing the tension braided support 4 to switch between an open and a contracted state. The tension braided support 4 is covered with an elastic membrane 5, one end of which is sealed to the outer tube 3, and the other end of which is sealed to the inner tube 2. The radial expansion diameter D of the tension braided support 4 and the forward thrust X of the outer tube 3 relative to the inner tube 2 satisfy the formula: D = -0.0064X. 2 +0.4564X+1.9857; where D is the diameter of the support, in millimeters (mm); X is the forward push distance, 0≤X≤30, in millimeters (mm).

[0036] like Figures 1 to 4As shown, the ends of the outer tube 3 and inner tube 2 closest to the handle drive assembly are designated as proximal ends, and the ends of the outer tube 3 and inner tube 2 furthest from the handle drive assembly are designated as distal ends. The tensioned braided stent 4 is connected between the distal ends of the outer tube 3 and the inner tube 2. When the outer tube 3 slides axially relative to the inner tube 2, the driving force is directly transmitted to the end of the tensioned braided stent 4, ensuring rapid response and stable deformation of the radial expansion or contraction of the tensioned braided stent 4. This avoids transmission lag or uneven radial expansion and contraction caused by misalignment of the connection position. Simultaneously, it ensures that the expansion blocking area formed after the tensioned braided stent 4 expands is precisely located in the surgical operation area distal to the balloon guiding catheter, better adapting to the proximal blood flow blocking requirements of intracranial vascular occlusion sites, and improving the positioning accuracy and blocking reliability of the surgical operation; tensioning The braided stent 4 includes a uniformly variable section 41 in the middle and gradually variable sections 42 at both ends of the uniformly variable section 41. When the tensioned braided stent 4 is in the expanded state, the radial expansion outer diameter of the gradually variable section 42 gradually decreases from the end near the uniformly variable section 41 to the end away from the uniformly variable section 41. This makes the tensioned braided stent 4 form a smoother arc transition shape that fits more closely to the inner wall of the blood vessel after expansion. This avoids the sharp corners or abrupt changes in the outer diameter of the tensioned braided stent 4 from causing mechanical stimulation or damage to the blood vessel wall, reducing the risk of vasospasm and dissection. At the same time, it improves the tightness and stability of blood flow obstruction. In the contracted state, it can also make the overall outline of the stent more regular and smooth, reducing the resistance when the catheter is delivered and withdrawn in tortuous intracranial blood vessels, and improving the access device passability and operation safety.

[0037] like Figures 1 to 5 As shown, the outer surface of the elastic membrane 5 is coated with an anticoagulant coating. This anticoagulant coating can inhibit the adhesion and aggregation of platelets in the blood on the surface of the balloon guiding catheter and the tensioning expansion stent during the operation, reducing the risk of thrombosis, improving the anticoagulant effect in the blood flow blocking area, reducing the probability of secondary thrombosis and embolism complications during the operation, and ensuring the biocompatibility between the vascular inner wall and the instrument contact surface, thereby improving the safety and reliability of neurointerventional surgery. In this embodiment, the anticoagulant coating is either a heparin coating or a phosphocholine coating. The first end of the tensioning braided stent 4 is fixedly connected to the inner tube 2 through a first metal imaging ring 61, and the second end of the tensioning braided stent 4 is fixedly connected to the inner tube 2 through a second metal imaging ring 61. The imaging ring 62 is fixedly connected to the outer tube 3. The metal imaging ring 6 can enhance the mechanical connection strength between the tensioned braided stent 4 and the inner tube 2 and outer tube 3, ensuring the reliable transmission of driving force when the outer tube 3 slides axially relative to the inner tube 2, and preventing the stent from falling off, shifting or failing during repeated expansion and contraction. At the same time, the metal imaging ring 6 has good sealing performance and high structural strength, which can improve the overall structural durability. Moreover, the metal imaging ring 6 can be clearly visualized with the help of medical imaging equipment, accurately positioning the two ends of the tensioned braided stent 4, and judging the expansion and contraction state of the tensioned braided stent 4 in real time, which is conducive to doctors intuitively understanding the placement position of the tensioned braided stent 4 in the intracranial blood vessels.

[0038] like Figures 1 to 6 As shown, the handle drive assembly includes a handle body 1, on which a rotary drive component 11 is rotatably mounted. The rotary drive component 11 includes a rotating wheel 111 and an internally threaded sleeve 112 coaxially fixed on the rotating wheel 111. A sliding post 12 is provided inside the handle body 1 to prevent rotation and slide. The sliding post 12 has an external thread 121, and the sliding post 12 is threadedly engaged with the internally threaded sleeve 112 through the external thread 121. The proximal end of the outer tube 3 is fixedly connected to the sliding post 12. Utilizing the anti-rotation effect between the sliding post 12 and the handle body 1, the rotating wheel 111 is rotated... The threaded drive controls the sliding column 12 to move the outer tube 3 axially relative to the inner tube 2, achieving precise adjustment of the radial expansion and contraction of the tensioned braided support 4. The threaded drive also has a self-locking characteristic, ensuring the tensioned expansion support remains stably in the open or contracted state, improving the controllability, stability, and ease of use of the surgical procedure. The handle body 1 has a sliding cavity 13, within which the sliding column 12 slides. Guide grooves 14 are connected on both sides of the sliding cavity 13, extending axially along the handle body 1. 2. Sliding blocks 122 are fixed on both sides, and the sliding blocks 122 cooperate with the guide groove 14 to form a stable axial guide for the sliding column 12, preventing the sliding column 12 from rotating circumferentially, ensuring the consistency of the sliding column 12's axial sliding direction along the handle body 1, avoiding circumferential deflection or jamming during rotation drive, and ensuring accurate and smooth axial movement of the outer tube 3 relative to the inner tube 2; the sliding column 12 is provided with an indicator line 123, and the handle body 1 is provided with a strip-shaped observation hole 17 corresponding to the axial direction of the sliding column 12, and the strip-shaped observation hole 17 is connected to the sliding cavity 13. Furthermore, the handle body 1 has a scale line 171 on the side of the strip-shaped observation hole 17. The indicator line 123 cooperates with the corresponding scale line 171 to indicate the diameter of the tensioned braided stent 4 in the expanded state. This allows the operator to intuitively and accurately read the movement distance of the outer tube 3 relative to the inner tube 2 during the operation, thereby quantifying and controlling the radial expansion diameter and contraction degree of the tensioned braided stent 4. This enables precise control of the vascular occlusion range and expansion force, avoiding excessive or insufficient expansion and contraction due to differences in operating experience, and improving the standardization and precision of the surgical operation.

[0039] like Figure 4As shown, the tensioned braided support 4 has at least one braided layer, each of which is a tubular structure formed by multiple strands of metal fibers. Relying on the structural strength of the metal fibers themselves and the mechanical properties of the woven mesh, it provides stable radial support for the tensioned braided support 4 in the open state. At the same time, the metal fiber braided structure has good axial flexibility and radial deformation response, and can quickly and uniformly achieve radial expansion and contraction when the outer tube 3 slides axially relative to the inner tube 2. Moreover, the overall structural strength is high, avoiding local collapse or uneven deformation. The elastic lining 5 is designed to adapt to the tortuous intracranial vascular environment. It is made of thermoplastic polyurethane polymer material and coated onto the outer surface of the tensioned braided stent 4 through impregnation, spraying, or heat-shrinking processes. The thickness of the elastic lining 5 is controlled between 0.1 and 2 mm. Thermoplastic polyurethane polymer material possesses excellent flexibility, sealing properties, and biocompatibility. Combined with the coating process, this ensures a tight fit between the elastic lining 5 and the outer wall of the tensioned braided stent 4, effectively blocking blood flow without easily damaging the vascular endothelium. The thickness of the elastic lining 5 is controlled between 0.1 and 2 mm. Between these, balloon guide catheters of appropriate thickness are selected for vascular interventional procedures with different inner diameters to ensure that the elastic membrane 5 has sufficient structural strength, sealing and flexibility; the braided layer is set to 1 to 100 layers, and in this embodiment, one or two layers are preferred. The metal fiber filaments are flexible metal fiber filaments. The number of braided strands of metal fiber filaments in each braided layer is controlled between 2 and 128, the braiding density is controlled between 1 and 100, and the diameter of each metal fiber filament is controlled between 0.01 and 10 mm.

[0040] like Figures 1 to 5 As shown, in this embodiment, the handle body 1 is fixedly connected by an upper shell 101 and a lower shell 102. The upper shell 101 and the lower shell 102 are connected by a snap-fit ​​structure, screws, or UV bonding. The upper shell 101 and the lower shell 102 are fastened together to form a rotating cavity 15, which is connected to the sliding cavity 13. The upper shell 101 and the lower shell 102 are respectively provided with rotating holes 16 that communicate with the rotating cavity 15. The rotating wheel 111 extends out of both sides of the handle body 1 through the rotating holes 16 on both sides. The user can rotate the rotating wheel 111 on either side of the handle body 1 for adjustment, making the operation more convenient. The inner tube 2 passes through the handle body 1 and is bonded and fixed to the handle body 1. The end of the inner tube 2 away from the tension braided bracket 4 is fixedly connected to a guide seat 7. The outer tube 3 is bonded and fixed to the end of the sliding column 12 away from the rotating drive component 11. The circumference of the rotating wheel 111 is provided with anti-slip ridges 1111 to improve the feel and anti-slip properties of rotating the rotating wheel 111.

[0041] The basic working principle of this invention is as follows: The device utilizes a handle drive assembly to drive the outer tube 3 to slide axially relative to the inner tube 2. When the outer tube 3 moves towards extending from the handle drive assembly, the ends of the outer tube 3 and inner tube 2 away from the handle drive assembly approach each other. The tension braided stent 4 is axially compressed and undergoes radially outward expansion deformation, simultaneously driving the elastic diaphragm 5 to undergo radially outward elastic expansion, thereby blocking the blood vessel. When the outer tube 3 moves towards retracting from the handle drive assembly, the ends of the outer tube 3 and inner tube 2 away from the handle drive assembly move away from each other. The tension braided stent 4 axially extends and undergoes radially inward contraction deformation, simultaneously driving the elastic diaphragm 5 to undergo radially inward elastic contraction, facilitating the insertion or retrieval of the balloon guide catheter. Furthermore, when the outer tube 3 slides axially relative to the inner tube 2, the driving force is directly transmitted to the end of the tension braided stent 4, ensuring rapid response and stable deformation of the radial expansion or contraction of the tension braided stent 4, avoiding transmission lag or uneven radial expansion and contraction caused by connection position misalignment; while the radial... The expansion outer diameter is greater than or equal to the maximum radial expansion outer diameter of the transition section 42, which makes the tensioned braided stent 4 form a smoother arc transition shape that fits more closely to the inner wall of the blood vessel after expansion. This avoids mechanical stimulation or damage to the blood vessel wall caused by the sharp corners or abrupt changes in the outer diameter of the tensioned braided stent 4, reduces the risk of vasospasm and dissection, and ensures that the expansion blocking area formed after the tensioned braided stent 4 is accurately located in the surgical operation area at the distal end of the balloon guiding catheter. This is beneficial for adapting to the proximal blood flow blocking requirements of intracranial vascular occlusion sites, improving the positioning accuracy and blocking reliability of surgical operations. The anticoagulant coating can inhibit the adhesion and aggregation of platelets in the blood on the surface of the balloon guiding catheter and the tensioned expansion stent during the operation, reduce the risk of thrombosis, improve the anticoagulant effect in the blood flow blocking area, and reduce the probability of intraoperative secondary thrombosis and embolism complications. It has the effects of eliminating the risk of delayed filling and decompression and cavity blockage, improving surgical efficiency and safety, improving the support and structural strength of the balloon guiding catheter, and reducing the probability of intraoperative complications.

[0042] Another technical objective of this invention is to provide a method for operating a non-fluid-filled balloon guide tube, comprising the following steps: S1. Instrument positioning adjustment: The control handle drives the assembly to keep the tensioned braided support 4 and the elastic membrane 5 covering its outside in a fully contracted state, and delivers the distal end of the balloon guide tube to the preset working position. S2, Expansion Molding Positioning: The rotation drive component 11 of the handle drive assembly drives the outer tube 3 to make an axial extension sliding motion relative to the inner tube 2, applying an axial compression force to the tension braided bracket 4. Under the action of axial compression, the tension braided bracket 4 undergoes radial expansion deformation, which simultaneously drives the elastic membrane 5 of the outer sealing connection to complete radial elastic expansion, so that the expanded elastic membrane 5 forms a closed barrier structure with a preset outer diameter. S3, Workstation Adaptation: Maintain the expanded and shaped state of the tensioned braided bracket 4 and the elastic membrane 5 to provide a stable workstation for the supporting interventional instruments; S4. Shrinkage and Reset Adjustment: After completing the workstation adaptation, reverse the control handle drive assembly to drive the outer tube 3 to make an axial retraction sliding motion relative to the inner tube 2, release the axial compression load on the tension braided bracket 4, so that the tension braided bracket 4 axially stretches and resets and undergoes radial shrinkage deformation, which drives the elastic film 5 to elastically retract synchronously, so that the outer diameter of the overall structure shrinks to the preset storage size. S5. Instrument withdrawal and reset: Keep the tensioned braided support 4 and elastic membrane 5 in a retracted and stored state, remove the entire balloon guide tube from the working position, and complete the entire instrument operation process.

[0043] The above description is only a preferred embodiment of the present invention. Therefore, all equivalent changes or modifications made to the structure, features and principles described in the claims of this patent application are included in the scope of this patent application.

Claims

1. A non-fluid-filled balloon guide tube with a stroke control handle, comprising a handle drive assembly, an inner tube (2), and an outer tube (3) sleeved outside the inner tube (2), characterized in that: The end of the outer tube (3) and the inner tube (2) closer to the handle drive assembly is designated as the proximal end, and the end of the outer tube (3) and the inner tube (2) further away from the handle drive assembly is designated as the distal end. A tension braided bracket (4) is connected between the distal end of the outer tube (3) and the distal end of the inner tube (2). The tension braided bracket (4) is covered with an elastic membrane (5). One end of the elastic membrane (5) is sealed to the outer tube (3), and the other end of the elastic membrane (5) is sealed to the inner tube (2). The handle drive assembly drives the outer tube (3) to move axially relative to the inner tube (2), so that the tension braided bracket (4) drives the elastic membrane (5) to switch between an expanded state and a contracted state. The outer surface of the elastic membrane (5) is coated with an anticoagulant drug coating; The tensioned braided bracket (4) includes a uniform section (41) located in the middle and a gradual section (42) located at both ends of the uniform section (41). When the tensioned braided bracket (4) is in the open state, the radial expansion outer diameter of the gradual section (42) gradually decreases from the end close to the uniform section (41) toward the direction away from the uniform section (41). The radial expansion outer diameter of the uniform section (41) is greater than or equal to the maximum radial expansion outer diameter of the gradual section (42).

2. The non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: The radial expansion diameter D of the tensioned braided support (4) and the forward thrust X of the outer tube (3) relative to the inner tube (2) satisfy the following formula: D=-0.0064X 2 +0.4564X+1.9857; Where D is the diameter of the support, in millimeters (mm); X represents the forward thrust distance, 0 ≤ X ≤ 30, unit: millimeters (mm).

3. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: For anticoagulant coatings, heparin coatings or phosphocholine coatings are selected.

4. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: The first end of the tension braided bracket (4) is fixedly connected to the inner tube (2) through a metal developing ring (6), and the second end of the tension braided bracket (4) is fixedly connected to the outer tube (3) through another metal developing ring (6).

5. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: The handle drive assembly includes a handle body (1), on which a rotary drive component (11) is rotatably provided. The rotary drive component (11) includes a rotating wheel (111) and an internally threaded sleeve (112) coaxially fixed on the rotating wheel (111). The handle body (1) is provided with a sliding cavity (13), in which a sliding column (12) is slidably provided. The sliding column (12) is provided with an external thread (121). The sliding column (12) is threadedly engaged with the internally threaded sleeve (112) through the external thread (121). The proximal end of the outer tube (3) is fixedly connected to the sliding column (12). The handle body (1) has guide grooves (14) connected to both sides of the sliding cavity (13). The guide grooves (14) on both sides extend along the axial direction of the handle body (1). Sliding blocks (122) are fixed on both sides of the sliding column (12), and the sliding blocks (122) are guided and cooperate with the guide grooves (14).

6. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 5, characterized in that: The handle body (1) includes an upper shell (101) and a lower shell (102) fixedly connected. The upper shell (101) and the lower shell (102) are fastened together to form a rotating cavity (15) that communicates with the sliding cavity (13). The internal threaded sleeve (112) is rotatably disposed in the rotating cavity (15). The upper shell (101) and the lower shell (102) are respectively provided with rotating holes (16) that communicate with the rotating cavity (15). The rotating wheel (111) passes through the rotating holes (16) on both sides and is at least partially exposed on the two side walls of the handle body (1). The rotating wheel (111) is provided with anti-slip ridges (1111).

7. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 5, characterized in that: The sliding column (12) is provided with an indicator line (123). The handle body (1) is provided with a strip-shaped observation hole (17) axially corresponding to the sliding column (12). The strip-shaped observation hole (17) is connected to the sliding cavity (13). The handle body (1) is provided with a scale line (171) on the side of the strip-shaped observation hole (17). The indicator line (123) and the corresponding scale line (171) cooperate to indicate the diameter of the tensioned braided bracket (4) in the open state.

8. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: The tensioned braided support (4) has at least one braided layer. Each braided layer is woven from multiple strands of metal fiber to form a tubular structure. The number of strands of metal fiber in each braided layer is controlled between 2 and 128, the braiding density is controlled between 1 and 100, and the diameter of each metal fiber is controlled between 0.01 and 10 mm.

9. A non-fluid-filled balloon guide tube with a stroke control handle according to claim 1, characterized in that: The elastic coating (5) is made of thermoplastic polyurethane polymer material and is coated on the outer surface of the tensioned braided bracket (4) by impregnation, spraying or heat shrinking process, and the thickness of the elastic coating (5) is controlled between 0.1 and 2 mm.

10. A method of operating the non-fluid-filled balloon guide tube according to any one of claims 1-9, characterized in that, Includes the following steps: S1. Instrument positioning adjustment: Control the handle drive assembly to keep the tension braided support (4) and the elastic membrane (5) covering its outside in a fully contracted storage state, and deliver the distal end of the balloon guide tube to the preset working position. S2, Expansion molding positioning: The rotation drive component (11) of the handle drive assembly drives the outer tube (3) to make an axial extension sliding motion relative to the inner tube (2), and applies axial compression force to the tension braided bracket (4). Under the action of axial compression, the tension braided bracket (4) undergoes radial expansion deformation, which simultaneously drives the elastic membrane (5) of the outer sealing connection to complete radial elastic expansion, so that the expanded elastic membrane (5) forms a closed barrier structure with a preset outer diameter. S3, Workstation Adaptation: Maintain the expansion and shaping state of the tensioned braided bracket (4) and the elastic membrane (5) to provide a stable workstation for the supporting interventional instruments; S4. Shrinkage and Reset Adjustment: After completing the workstation adaptation operation, reverse the control handle drive assembly to drive the outer tube (3) to make axial retraction sliding motion relative to the inner tube (2), release the axial compression load on the tension braided bracket (4), so that the tension braided bracket (4) axially stretches and resets and undergoes radial shrinkage deformation, which drives the elastic film (5) to elastically retract, so that the outer diameter of the overall structure shrinks to the preset storage size; S5. Instrument withdrawal and reset: Keep the tensioned braided support (4) and elastic membrane (5) in a retracted state, move the entire balloon guide tube out of the working position, and complete the entire instrument operation process.

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