Composite thrombolysis device for intracranial veins and operation method of composite thrombolysis device

Abstract

The invention relates to a composite thrombolysis device for intracranial veins and an operation method thereof, and relates to the technical field of medical instruments.The device comprises a thrombolysis catheter assembly which comprises a micro catheter and a blood vessel wall supporting assembly; the blood vessel wall supporting assembly comprises a cylindrical elastic support net arranged at the far end of the micro catheter in a sleeving mode, and the side, close to the near end of the micro catheter, of the cylindrical elastic support net is connected with the outer wall of the micro catheter through an elastic guiding part. The conveying catheter is arranged on the outer wall of the micro catheter in a sliding and sleeving mode so that the blood vessel wall supporting assembly can retract to or be disengaged from the conveying catheter. According to the application, blood vessels can be successfully supported, local blood flow smoothness is recovered, a stable and wide administration environment is provided for subsequent administration of thrombolytic drugs, permanent foreign body implantation to blood vessel walls can be avoided, and the risk of long-term complications is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a composite thrombolytic device for intracranial veins and an operation method thereof. BACKGROUND

[0002] In the clinical treatment of intracranial venous sinus thrombosis (CVST), the existing technology mainly relies on an intervention scheme of step-by-step operation: first, thrombus is removed by a catheter or a stent to remove part of the thrombus, and then a microcatheter is left to implement contact thrombolysis. However, clinical practice shows that when a large amount of thrombus is formed in the intracranial venous system, the blood vessel wall is continuously in a contracted state due to the compression of the thrombus, and it is difficult to restore the original expanded shape. This blood vessel contraction leads to blocked venous blood return, not only hindering the normal recovery of blood flow dynamics, but also continuously inducing new thrombus formation. At the same time, the blood vessel stenosis makes it difficult for the subsequent microcatheter to be stably inserted and effectively pump the thrombolytic drug (such as urokinase), and the drug thrombolysis efficiency is significantly reduced. SUMMARY

[0003] The present application provides a composite thrombolytic device for intracranial veins and an operation method thereof, which can solve the problem of poor drug administration effect caused by the difficulty of blood vessel recovery to the expanded state in the treatment of intracranial venous sinus thrombosis in the prior art.

[0004] In a first aspect, the present application provides a composite thrombolytic device for intracranial veins, comprising: a thrombolytic catheter assembly comprising a microcatheter and a blood vessel wall support assembly; the blood vessel wall support assembly comprises a cylindrical elastic stent mesh sleeved on the distal end of the microcatheter, and the side of the cylindrical elastic stent mesh close to the proximal end of the microcatheter is connected to the outer wall of the microcatheter through an elastic guide part; a delivery catheter which is slidably sleeved on the outer wall of the microcatheter to retract or withdraw the blood vessel wall support assembly into the delivery catheter.

[0005] In some embodiments, the elastic guide part comprises a plurality of guide wires arranged obliquely to form a circular truncated cone structure, one end of the guide wire being connected to the outer wall of the cylindrical elastic stent mesh and the other end being connected to the outer wall of the microcatheter.

[0006] In some embodiments, a delivery sheath tube is further included, the inner diameter of the delivery sheath tube being greater than the outer diameter of the microcatheter, the delivery sheath tube being slidably sleeved on the outer wall of the microcatheter to retract the blood vessel wall support assembly into the delivery sheath tube to send the blood vessel wall support assembly into the delivery catheter along the axial direction.

[0007] In some embodiments, the proximal end of the microcatheter is provided with a microcatheter operation handle; the proximal end of the delivery catheter is provided with a delivery catheter operation handle; The side wall of the delivery catheter operation handle is provided with a circular annular concave surface for abutting the delivery sheath tube.

[0008] In some embodiments, the microcatheter is a metal wire braided structure, the outer wall of which is coated with a flexible plastic, and the surface is coated with a hydrophilic coating.

[0009] In some embodiments, the delivery sheath is made of polyethylene resin, and a long strip-shaped opening is provided on the sheath in the axial direction.

[0010] In some embodiments, the distal end of the delivery catheter is a metal wire braided structure, the proximal end is made of polymer material, the outer wall of the delivery catheter is coated with a flexible plastic, and the surface is coated with a hydrophilic coating.

[0011] In some embodiments, a developing marker mechanism is provided at the connection between the outer wall of the microcatheter and the guide wire.

[0012] In some embodiments, the developing marker mechanism is a metal ring sleeved on the outer wall of the microcatheter.

[0013] In a second aspect, the embodiments of the present application also provide an operation method of a composite thrombolytic device for intracranial veins, which is implemented by using any of the composite thrombolytic devices for intracranial veins described above. The method comprises the following steps: sending the delivery catheter to the target thrombus position in the intracranial vein; sleeving the delivery sheath to the microcatheter wall, pushing the delivery sheath towards the distal end of the microcatheter, and making the blood vessel wall support assembly retract into the delivery sheath; extending the distal end of the microcatheter from the proximal end of the delivery catheter, pushing the microcatheter, and making the blood vessel wall support assembly sent from the delivery sheath into the distal end of the delivery catheter; retracting the delivery catheter, making the blood vessel wall support assembly out of the delivery catheter, expanding the cylindrical elastic stent net to support the blood vessel wall, and sending the thrombolytic liquid into the microcatheter; after the thrombolytic treatment is completed, pushing the delivery catheter to make the blood vessel wall support assembly retract into the delivery catheter, and simultaneously withdrawing the delivery catheter and the thrombolytic catheter assembly.

[0014] The technical scheme provided by the embodiments of the present application has the following beneficial effects: The embodiments of the present application provide a composite thrombolytic device for intracranial veins and an operation method thereof. The device of the present application comprises: a thrombolytic catheter assembly comprising a microcatheter and a blood vessel wall support assembly; the blood vessel wall support assembly comprises a cylindrical elastic stent net sleeved on the distal end of the microcatheter, and the side of the cylindrical elastic stent net close to the proximal end of the microcatheter is connected to the outer wall of the microcatheter through an elastic guide part; a delivery catheter which is slidably sleeved on the outer wall of the microcatheter to make the blood vessel wall support assembly retract into or out of the delivery catheter.

[0015] The device realizes instant support of the blood vessel wall at the lesion site and effective release of the drug through the thrombolytic catheter assembly design. The blood vessel wall support assembly includes a cylindrical elastic stent mesh sleeved on the distal end of the microcatheter. After being delivered to the target position (i.e., the position where the blood vessel lesion needs to be dosed) through the delivery catheter, the cylindrical elastic stent mesh can automatically expand when it is withdrawn from the delivery catheter. This expansion action can instantaneously expand the blood vessel wall that is cramped and contracted due to thrombus compression, and forcibly reconstruct a smooth flow channel for the return of venous blood. It can directly restore the local blood flow patency and provide a stable and open dosing environment for subsequent thrombolytic drug dosing.

[0016] After successfully supporting the drug delivery channel of the blood vessel, the opening at the distal end of the microcatheter is located in the supported blood vessel lesion area. At this time, the thrombolytic drug (such as urokinase) pumped through the microcatheter can directly and uniformly infiltrate and act on the surface of the residual thrombus without interference from the stenotic lumen, avoiding drug loss or uneven distribution caused by blood vessel stenosis, and significantly improving the thrombolytic efficiency and speed of the drug.

[0017] In addition, the device of the present application also embodies clinical applicability and safety. The blood vessel wall support assembly in the device is connected to the outer wall of the microcatheter through an elastic guide part. Specifically, the cylindrical elastic stent mesh is connected to the outer wall of the microcatheter through the elastic guide part. In the expanded state of the cylindrical elastic stent mesh, the outer periphery of the connection between the cylindrical elastic stent mesh and the elastic guide part is wider than the outer periphery of the connection between the elastic guide part and the outer wall of the microcatheter in the vertical direction, forming a frustum with a gradually increasing diameter in the direction from the proximal end to the distal end of the microcatheter. This allows the cylindrical elastic stent mesh to be captured again by the delivery catheter and safely retracted into the lumen of the delivery catheter after supporting, thereby facilitating the complete recovery of the entire device from the patient's body. This "temporary support and postoperative recovery" design concept avoids permanent foreign body implantation on the blood vessel wall, reduces the risk of long-term complications, and at the same time makes the entire device have both the minimally invasive nature of interventional therapy and the fundamental nature of surgical treatment, providing a new and efficient, safe and reliable operation device for vascular thrombolysis.

[0018] The present application proposes an innovative integrated solution to address the problems of persistent contraction of the blood vessel, difficulty in restoring blood flow, and subsequent dosing difficulties faced by the prior art in treating intracranial venous sinus thrombosis. The device integrates the functions of temporary blood vessel support shaping and local precise dosing, fundamentally optimizing the treatment process and improving the therapeutic effect. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly introduced. Obviously, the drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 A schematic view of a delivery catheter provided by the embodiments of the present application; Figure 2 A schematic view of a microcatheter and a blood vessel wall support assembly; Figure 3 A schematic view at the blood vessel wall support assembly; Figure 4 A schematic view of a delivery sheath; Figure 5 A process schematic view of an operation method provided by the present application; Figure 6 A process schematic view of an operation method provided by the present application; Figure 7 A process schematic view of an operation method provided by the present application; Figure 8 A process schematic view of an operation method provided by the present application; Figure 9 A process schematic view of an operation method provided by the present application; Figure 10 A process schematic view of an operation method provided by the present application; Figure 11 A process schematic view of an operation method provided by the present application; Figure 12 A process schematic view of an operation method provided by the present application; Figure 13 A process schematic view of an operation method provided by the present application; Figure 14 A process schematic view of an operation method provided by the present application; Figure 15 A process schematic view of an operation method provided by the present application.

[0021] In the drawings: 1, microcatheter; 2, microcatheter handle; 3, cylindrical elastic stent net; 4, delivery catheter; 5, delivery catheter handle; 6, delivery sheath; 7, liquid injection device; 31, elastic guide part; 32, developing mark mechanism; 61, long strip-shaped through port. DETAILED DESCRIPTION

[0022] In order for those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described in the following with reference to the accompanying drawings. Obviously, the described embodiments are only some of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the present application.

[0023] The present application provides a composite thrombolytic device for intracranial veins and its operation method, which can solve the problem of poor thrombolytic drug administration effect caused by difficult recovery and expansion of blood vessels in the treatment of intracranial venous sinus thrombosis in the prior art.

[0024] Referring to Figures 1 to 3 As shown in the first aspect, the present application provides a composite thrombolytic device for intracranial veins, comprising: The thrombolytic catheter assembly comprises a microcatheter 1 and a blood vessel wall support assembly; the blood vessel wall support assembly comprises a cylindrical elastic stent mesh 3 sleeved on the distal end of the microcatheter 1, and the side of the cylindrical elastic stent mesh 3 close to the proximal end of the microcatheter 1 is connected with the outer wall of the microcatheter 1 through an elastic guide part 31; The delivery catheter 4 is slidably sleeved on the outer wall of the microcatheter 1, so that the blood vessel wall support assembly is retracted or withdrawn from the delivery catheter 4.

[0025] The device realizes instant support of the blood vessel wall at the lesion site and effective release of the drug through the design of the thrombolytic catheter assembly. The blood vessel wall support assembly comprises a cylindrical elastic stent mesh 3 sleeved on the distal end of the microcatheter 1, which can automatically expand after being withdrawn with the withdrawal of the delivery catheter 4 at the target position (i.e. the position where the drug needs to be administered at the blood vessel lesion). This expansion action can instantly prop open the blood vessel wall which is cramped and contracted due to thrombus compression, and forcibly reconstruct a smooth flow channel for the venous blood return. It can directly restore the local blood flow patency and provide a stable and open drug administration environment for subsequent administration of thrombolytic drugs.

[0026] After successfully propping up the drug administration channel of the blood vessel, the distal end opening of the microcatheter 1 is located in the blood vessel lesion area which is propped open. At this time, the thrombolytic drug (such as urokinase) pumped through the microcatheter 1 can directly and uniformly infiltrate and act on the surface of the residual thrombus without interference from the narrow lumen, avoiding drug loss or uneven distribution caused by blood vessel stenosis, and significantly improving the thrombolysis efficiency and speed of the drug.

[0027] Furthermore, the device of this application also demonstrates clinical applicability and safety. The vascular wall support component in the device is connected to the outer wall of the microcatheter 1 via an elastic guide 31. Specifically, the cylindrical elastic stent mesh 3 is connected to the outer wall of the microcatheter 1 via the elastic guide 31. When the cylindrical elastic stent mesh 3 is in its supported state, because the outer periphery of the connection between the cylindrical elastic stent mesh 3 and the elastic guide 31 is wider in the vertical direction than the outer periphery of the connection between the elastic guide 31 and the outer wall of the microcatheter 1, a frustum with a gradually increasing diameter is formed from the proximal to the distal end of the microcatheter 1. This allows the cylindrical elastic stent mesh 3 to be captured again by the delivery catheter 4 and safely retracted into the lumen of the delivery catheter 4 after support is achieved, facilitating the complete retrieval of the entire device from the patient. This "temporary support, postoperative retrieval" design concept avoids permanent foreign body implantation into the vascular wall, reduces the risk of long-term complications, and simultaneously makes the entire device possess both the minimally invasive nature of interventional therapy and the fundamental nature of surgical treatment, providing a more efficient, safe, and reliable new operating device for thrombolysis.

[0028] This application addresses a series of problems encountered by existing technologies in treating intracranial venous sinus thrombosis, such as persistent vasoconstriction, difficulty in restoring blood flow, and challenges in subsequent drug administration, and proposes an innovative integrated solution. This device integrates two major functions: instantaneous vascular support and shaping, and precise local drug delivery, fundamentally optimizing the treatment process and improving efficacy.

[0029] In this application, the terms "distal" and "proximal" are industry terms. The distal end is the working end of the device, responsible for performing tasks at the deepest and most precise location within the body, i.e., the end of the device that is most deeply inserted into the patient's body. The proximal end is the control end of the device, located outside the patient's body, for the physician to operate on (such as pushing, rotating, or connecting external devices).

[0030] In practice, the tubular elastic stent mesh 3 is made of closed-loop nickel-titanium alloy guide wires, with an effective length of 10-20cm. Its diameter after full expansion is 4-8mm, and its overall diameter under compression is controlled within 2.2mm. The distal end of the stent mesh is located 1cm from the tail end of the microcatheter 1 after full expansion.

[0031] In some alternative embodiments, such as Figure 2 and Figure 3 The elastic guide section 31 includes multiple guidewires that are inclined and form a frustum-shaped structure. One end of the guidewire is connected to the outer wall of the cylindrical elastic support mesh 3, and the other end is connected to the outer wall of the microcatheter 1.

[0032] The design forms a circular table structure with gradually increasing outer diameter in the axial direction in the stent expanded state through the inclined arrangement of the guide wire, so that the outer periphery of the connection between the cylindrical elastic stent net 3 and the elastic guide part 31 is wider than the outer periphery of the connection between the elastic guide part 31 and the outer wall of the microcatheter 1 in the vertical direction, thereby providing a precise capture path for the delivery catheter 4 during the recovery stage. This structure effectively avoids the risk of jamming caused by sudden diameter change during stent recovery, ensures that the stent can be safely and completely retracted into the delivery catheter 4, and significantly improves the reliability and smoothness of device recovery.

[0033] In some optional embodiments, such as Figure 4 The delivery sheath tube 6 also includes a delivery sheath tube 6 with an inner diameter greater than the outer diameter of the microcatheter 1, which is slidably sleeved on the outer wall of the microcatheter 1, and is used to retract the blood vessel wall support assembly into the delivery sheath tube 6 to send the blood vessel wall support assembly into the delivery catheter 4 in the axial direction.

[0034] Since the inner diameter of the delivery sheath tube 6 is designed to be larger than the outer diameter of the microcatheter 1, an annular and sufficient operating space is formed between the two. The operator can first push the delivery sheath tube 6 forward, use the guiding effect of the edge of the delivery sheath tube 6 to force the elastic stent net in the expanded state with a certain radial support force to gradually compress radially, and smoothly slide into the cavity inside the delivery sheath tube 6.

[0035] Before the operation begins, the blood vessel wall support assembly with a larger radial size can be easily compressed and accommodated in the delivery sheath tube 6 with a larger inner diameter outside the body. Then, the delivery sheath tube 6 with the blood vessel wall support assembly preloaded as a whole is guided by itself to dock the components inside it to the proximal end opening of the delivery catheter 4. Finally, only the delivery catheter 4 needs to be fixed, the delivery sheath tube 6 is retracted in reverse, and the microcatheter 1 is pushed forward (into the delivery catheter 4) to transfer the blood vessel wall support assembly in the compressed state to the cavity of the delivery catheter 4 through relative movement without obstruction, and complete the preparation work.

[0036] By using the delivery sheath tube 6 as a medium, the cylindrical elastic stent net 3 in the expanded state is accommodated in the delivery sheath tube 6, and through the docking of the delivery sheath tube 6 and the delivery catheter 4, and the size cooperation between them and the microcatheter 1, an ideal transition channel and operating space are created, making the retraction and axial feeding of the blood vessel wall support assembly smooth, controllable and non-destructive to the equipment, fundamentally simplifying the operation process and improving the efficiency and safety of the operation.

[0037] In some optional embodiments, such as Figure 1 and Figure 2The proximal end of the microcatheter 1 is provided with a microcatheter handle 2, and the proximal end of the delivery catheter 4 is provided with a delivery catheter handle 5. The side wall of the delivery catheter handle 5 is provided with a circular annular concave surface for abutting the delivery sheath tube 6.

[0038] The proximal end of the delivery catheter 4 is provided with a delivery catheter handle 5, and the side wall of the delivery catheter handle 5 is provided with a circular annular concave surface for abutting the delivery sheath tube 6. The design of the handle provides a stable operating fulcrum for the operator. The microcatheter handle 2 is used for handle-type operation and is used to connect a Y valve and a liquid injection device 7 for perfusion of liquid medicine. The circular annular concave surface structure can accurately abut the delivery sheath tube 6, facilitating the use of the delivery sheath tube 6 to deliver the vascular wall support assembly into the delivery catheter 4. This design significantly improves the stability and convenience of operation. The delivery catheter handle 5 is provided with a standard luer connector, which is convenient for connecting a syringe or a pressure monitoring device to realize rapid perfusion or suction function.

[0039] In some optional embodiments, the microcatheter 1 is a metal guide wire woven structure, the outer wall of which is covered with flexible plastic, and the surface is coated with a hydrophilic coating. The metal guide wire woven structure gives the microcatheter 1 excellent axial support stiffness, ensuring resistance to blood vessel bending and pressure deformation during pushing. The flexible plastic coating effectively reduces the friction coefficient between the catheter and the blood vessel inner wall. The hydrophilic coating further optimizes the passability of the catheter, making it easier to slide in narrow blood vessels, significantly reducing the risk of vascular intima injury and intraoperative bleeding, while ensuring the stable placement of the microcatheter 1 after stent support, creating ideal conditions for precise release of thrombolytic drugs.

[0040] In some optional embodiments, the delivery sheath tube 6 is made of polyethylene resin material, and a long strip-shaped opening 61 is provided on the axial direction thereof. The polyethylene resin material has both flexibility and structural strength, and the long strip-shaped opening 61 is arranged to facilitate the insertion and withdrawal of the delivery sheath tube 6 from the side wall of the microcatheter 1. In practice, the length of the delivery sheath tube 6 can be 30 cm, and the inner diameter is 2.2 mm.

[0041] In some alternative embodiments, the distal end of the delivery catheter 4 is a metal wire braid structure, and the proximal end is a polymer material. The outer wall of the delivery catheter 4 is coated with a flexible plastic, and the surface is coated with a hydrophilic coating. In practice, the outer diameter of the delivery catheter 4 is 6-8F, the length is 100-130cm, and the inner diameter is 1.5-2.5mm. The distal end of the tube wall is composed of a metal wire braid, and the outer layer is coated with a flexible plastic. The proximal end of the tube body is made of a polymer material. The entire catheter surface is covered with a hydrophilic coating. The rear end has excellent support stiffness, and the front end exhibits excellent through compliance. The excellent support stiffness of the distal end of the delivery catheter 4 ensures that it can withstand high axial pressure during pushing to prevent the tube from collapsing or kinking. The excellent through compliance of the proximal end adapts to the complex anatomical structure of the intracranial vein, easily passes through narrow or curved parts, and reduces the risk of vascular injury. The polymer material is high-density polyethylene, which enhances durability and fatigue resistance. The hydrophilic coating not only reduces the friction coefficient to improve sliding performance, but also maintains lubrication in a physiological environment, reducing operation time. The balance between precise pushing of the distal end and comfortable operation of the proximal end significantly improves the adaptability of the device in narrow vessels such as intracranial venous sinuses.

[0042] In some alternative embodiments, as Figure 3 , a radiographic marker mechanism 32 is provided at the connection between the outer wall of the microcatheter 1 and the guide wire.

[0043] The radiographic marker mechanism 32 clearly indicates the connection position and deployment state of the stent and the microcatheter 1 through X-ray imaging, allowing the operator to monitor the precise positioning of the stent in the blood vessel in real time. The metal ring as the radiographic marker mechanism 32 has high radiographic rate and structural stability, and can clearly mark the key position of the guide wire connection. It avoids operation delay or mistakes caused by unclear imaging.

[0044] In a second aspect, the embodiments of the present application also provide an operation method for a composite thrombolytic device for intracranial veins, which is implemented by using any of the above composite thrombolytic devices for intracranial veins. The method comprises: Sending the delivery catheter 4 to the target thrombus position in the intracranial vein; Sleeving the delivery sheath 6 to the tube wall of the microcatheter 1 and pushing the delivery sheath 6 towards the distal end of the microcatheter 1 to make the blood vessel wall support assembly retract into the delivery sheath 6; Extending the distal end of the microcatheter 1 from the proximal end of the delivery catheter 4 and pushing the microcatheter 1 to make the blood vessel wall support assembly sent from the delivery sheath 6 to the distal end of the delivery catheter 4; Retracting the delivery catheter 4 to make the blood vessel wall support assembly out of the delivery catheter 4, and the cylindrical elastic stent mesh 3 is deployed to support the blood vessel wall, and the thrombolytic liquid is sent into the microcatheter 1; After the thrombolytic treatment is completed, the delivery catheter 4 is pushed so that the blood vessel wall support assembly is retracted into the delivery catheter 4, and the delivery catheter 4 and the thrombolytic catheter assembly are withdrawn at the same time.

[0045] The complete process is described as follows, as Figure 5 The delivery catheter 4 is sent to the intracranial target thrombus position; As Figure 6 The delivery sheath 6 is sleeved to the microcatheter 1 tube wall (by means of the long strip-shaped through opening 61 on the delivery sheath 6), and the delivery sheath 6 is pushed towards the distal end of the microcatheter 1, so that the blood vessel wall support assembly is retracted into the delivery sheath 6; As Figures 7 to 9 The distal end of the microcatheter 1 is extended from the proximal end of the delivery catheter 4 ( Figure 7 ), the microcatheter 1 is pushed ( Figure 8 ), and the blood vessel wall support assembly is sent into the delivery catheter 4 from the distal end of the delivery sheath 6 (as Figure 9 , at this time the delivery sheath 6 is withdrawn); As Figure 10 The microcatheter 1 and the blood vessel wall support assembly have been sent into the target position in the delivery catheter 4; As Figure 11 and Figure 12 The delivery catheter 4 is withdrawn ( Figure 11 ), so that the blood vessel wall support assembly is out of the delivery catheter 4, the cylindrical elastic stent mesh 3 is unfolded to support the blood vessel wall, and the thrombolytic liquid is sent into the microcatheter 1 ( Figure 12 The liquid is delivered by the liquid injection device 7, and the liquid will flow out of the distal end of the microcatheter 1 and reach the target position to achieve thrombolysis); As Figures 13 to 15 After the thrombolytic treatment is completed, the delivery catheter 4 is pushed ( Figure 13 ), so that the blood vessel wall support assembly is retracted into the delivery catheter 4 ( Figure 14 ), and the delivery catheter 4 and the thrombolytic catheter assembly are withdrawn at the same time ( Figure 15 ).

[0046] The arrows in the figure are schematic operation direction of the device, and the "X" in the figure is a schematic representation of withdrawing the device.

[0047] The operation method provided in the application converts the structural advantages of the device into significant clinical efficacy through a set of highly coordinated and sequential operation processes. The core technical effect of the method is that it realizes a complete and controllable minimally invasive treatment closed loop from "precise delivery", "temporary support and efficient thrombolysis" to "safe withdrawal".

[0048] Firstly, in the initial stage, the method uses the delivery sheath 6 as a key preloading tool to retract the blood vessel wall support assembly by pushing it forward, which completes the regular compression of the stent mesh in vitro or in vivo proximal, ensuring that it can be smoothly and damage-free introduced into the delivery catheter 4, laying a solid foundation for subsequent accurate delivery. Then, the microcatheter 1 and the support assembly at its distal end are pushed to the distal end of the delivery catheter 4, which fully utilizes the channel of the delivery catheter 4 that has been prearranged at the target thrombus position, realizes the delivery of the support assembly in the complex blood vessel path, and ensures the controllability and accuracy of the operation.

[0049] By retracting the delivery catheter 4, the cylindrical elastic stent mesh 3 is released and self-expands. This operation completes the mechanical support of the spasmatic and contracted blood vessel in an instant, forcibly reconstructs the blood flow channel, and creates an ideal fluid dynamics environment for subsequent thrombolysis. At this time, the thrombolytic drug solution pumped through the microcatheter 1 can fully infiltrate the thrombus in the open and stable lumen, significantly improving the contact area and action efficiency of the drug and the thrombus, and fundamentally solving the problem of poor drug delivery effect caused by blood vessel stenosis.

[0050] After the thrombolytic treatment is completed, the expanded stent mesh can be recaptured and retracted into its lumen by pushing the delivery catheter 4 again. This recyclable mechanism avoids the long-term risks that may be caused by the retention of permanent implants in the body, and realizes the function positioning similar to a temporary bridge. Finally, the delivery catheter 4 and the thrombolytic catheter assembly are withdrawn as a whole, which is simple and smooth, and completely ends the interventional treatment, minimizing the secondary damage to the blood vessel wall and the impact on the patient. The entire process is closely linked, with the dual advantages of efficient thrombolysis and safety.

[0051] In the description of the present application, it should be noted that the terms "upper", "lower" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. Unless otherwise expressly specified and limited, the terms "mounting", "connection", "connection" should be broadly understood, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, and it can be the communication between two elements inside. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0052] It should be noted that, in the present application, the relational terms such as "first" and "second", and the like, are used solely to distinguish one entity or action from another, without necessarily requiring or implying any actual relationship or order between such entities or actions. Moreover, the terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without more constraints, exclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0053] The foregoing is considered as illustrative only of the principles of the application. Numerous modifications and changes will readily occur to those skilled in the art, and the generic principles defined herein can be applied to other embodiments without departing from the spirit or scope of the application. Therefore, the application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A composite thrombolytic device for intracranial veins, characterized in that, include: The thrombolytic catheter assembly includes a microcatheter (1) and a vascular wall support assembly; the vascular wall support assembly includes a cylindrical elastic stent mesh (3) sleeved on the distal end of the microcatheter (1), and the cylindrical elastic stent mesh (3) is connected to the outer wall of the microcatheter (1) via an elastic guide part (31) on the side near the proximal end of the microcatheter (1). Delivery catheter (4) is slidably fitted onto the outer wall of the microcatheter (1) so that the vascular wall support assembly retracts into or disengages from the delivery catheter (4).

2. The composite thrombolytic device for intracranial veins as described in claim 1, characterized in that: The elastic guide part (31) includes multiple guide wires that are inclined and form a frustum-shaped structure. One end of the guide wire is connected to the outer wall of the cylindrical elastic support mesh (3), and the other end is connected to the outer wall of the microcatheter (1).

3. The composite thrombolytic device for intracranial veins as described in claim 1, characterized in that: It also includes a delivery sheath (6) with an inner diameter larger than the outer diameter of the microcatheter (1). The delivery sheath (6) is slidably fitted onto the outer wall of the microcatheter (1) to retract the vascular wall support assembly into the delivery sheath (6) so that the vascular wall support assembly can be axially inserted into the delivery catheter (4).

4. The composite thrombolytic device for intracranial veins as described in claim 3, characterized in that: The microcatheter (1) is provided with a microcatheter operating handle (2) at its proximal end; the delivery catheter (4) is provided with a delivery catheter operating handle (5) at its proximal end. The side wall of the delivery conduit operating handle (5) is provided with an annular concave surface for abutting the delivery sheath (6).

5. The composite thrombolytic device for intracranial veins as described in claim 1, characterized in that: The microcatheter (1) is a metal guide wire braided structure, with its outer wall covered with flexible plastic and its surface coated with a hydrophilic coating.

6. The composite thrombolytic device for intracranial veins as described in claim 3, characterized in that: The delivery sheath (6) is made of polyethylene resin and has an elongated opening (61) along its axial direction.

7. The composite thrombolytic device for intracranial veins as described in claim 1, characterized in that: The distal end of the delivery conduit (4) is a metal guide wire braided structure, and the proximal end is made of polymer material. The outer wall of the delivery conduit (4) is covered with flexible plastic and coated with a hydrophilic coating.

8. The composite thrombolytic device for intracranial veins as described in claim 2, characterized in that: A radiographic marking mechanism (32) is provided at the connection between the outer wall of the microcatheter (1) and the guidewire.

9. The composite thrombolytic device for intracranial veins as described in claim 8, characterized in that: The imaging and marking mechanism (32) is a metal ring fitted on the outer wall of the microcatheter (1).

10. A method for operating a composite thrombolytic device for intracranial veins, characterized in that, The method is carried out using the composite thrombolytic device for intracranial veins according to any one of claims 1-9, the method comprising: The delivery catheter (4) is advanced to the target thrombus location in the brain; The delivery sheath (6) is fitted onto the wall of the microcatheter (1), and the delivery sheath (6) is pushed toward the distal end of the microcatheter (1) so that the vascular wall support assembly retracts into the delivery sheath (6); The distal end of the microcatheter (1) is inserted from the proximal end of the delivery catheter (4), and the microcatheter (1) is pushed so that the vascular wall support assembly is inserted from the delivery sheath (6) to the distal end of the delivery catheter (4); The delivery catheter (4) is retracted, causing the vascular wall support component to disengage from the delivery catheter (4). The cylindrical elastic stent mesh (3) unfolds to support the vascular wall and deliver the thrombolytic drug into the microcatheter (1). After thrombolysis treatment is completed, push the delivery catheter (4) to retract the vascular wall support assembly into the delivery catheter (4), and then withdraw the delivery catheter (4) and the thrombolysis catheter assembly at the same time.

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