Recoverable covered aneurysm plugging stent

Abstract

The invention belongs to the technical field of aneurysm stents, and particularly relates to a recoverable covered aneurysm blocking stent which comprises a stent body, the stent body is of a cylindrical self-expanding metal net structure, the stent body is hollow and forms a center channel in the blood flow direction, the outer side of the middle of the stent body is sleeved with a covering film, and the covering film is arranged on the outer side of the stent body. The covering film is used for being attached to the inner wall of an artery blood vessel, and the stent is preassembled in a delivery device before being used. By means of the arrangement, the recoverable covered aneurysm blocking stent can rapidly block broken aneurysms in a sealing mode, reduces the risk of rebleeding, is good in biocompatibility, adapts to intracranial zigzag blood vessels and is suitable for intracranial broken aneurysms of various forms.

Description

Technical Field

[0001] This invention belongs to the field of aneurysm stent technology, and particularly relates to a retrievable covered aneurysm occlusion stent. Background Technology

[0002] Intracranial aneurysms are a common cerebrovascular disease. Once an aneurysm ruptures, it can cause subarachnoid hemorrhage, which has a high rate of disability and death. Current clinical treatment methods mainly include open craniotomy clipping and endovascular embolization (such as coil embolization), with endovascular treatment becoming the mainstream due to its minimally invasive nature.

[0003] However, the following problems still exist when treating ruptured aneurysms: 1. High risk of incomplete occlusion or rebleeding: Traditional coil embolization cannot physically isolate the tumor from the blood vessel lumen, and some blood flow can still enter the tumor, which can easily lead to rebleeding or recanalization.

[0004] 2. Limitations of stent-assisted techniques: For example, the use of stent-assisted embolization or flow diversion devices may result in insufficient blood flow diversion or non-retrievable stent implantation.

[0005] 3. Disadvantages of permanent implantation: If the patient's condition changes or complications occur, the existing stent cannot be moved or removed after deployment, making it difficult to make timely adjustments during the operation.

[0006] Therefore, there is an urgent need for a device that can seal ruptured tumors, maintain blood flow, and be controllable during surgery, in order to improve the safety and adaptability of treatment. Summary of the Invention

[0007] The purpose of this invention is to provide a retrievable covered aneurysm occlusion stent to solve the above-mentioned problems.

[0008] To achieve the above objectives, the present invention provides the following solution: A retrievable covered aneurysm occlusion stent includes: a stent, the stent being a cylindrical self-expanding metal mesh structure, the stent being hollow and forming a central channel along the blood flow direction, the stent having a covering membrane fitted to the outer side of the middle portion of the stent to conform to the inner wall of the artery, and the stent being pre-loaded into a delivery device before use.

[0009] Preferably, at least two imaging markers are fixedly connected to the support.

[0010] Preferably, the support is made of nickel-titanium alloy.

[0011] Preferably, the coating is a thermoplastic polyurethane film.

[0012] Preferably, the film is fixedly sleeved on the outer side of the middle part of the bracket by thermoplastic molding.

[0013] Preferably, the delivery device is a hollow conduit, which is sleeved on the outside of the support and the membrane.

[0014] Preferably, the proximal end of the bracket is detachably connected to a push rod.

[0015] Preferably, the distal end of the support is detachably connected to a guide wire.

[0016] Preferably, the diameter of the guidewire is 0.014'' or 0.010''.

[0017] Compared with the prior art, the present invention has the following advantages and technical effects: 1. Rapidly seals ruptured aneurysms, reducing the risk of rebleeding. TPU coatings can quickly expand within blood vessels and form a tight barrier, effectively isolating the ruptured aneurysm from blood flow and reducing the possibility of aneurysm rebleeding.

[0018] 2. Maintain blood flow pathways to prevent distal ischemia. 3. The hollow stent structure ensures the permeability of the main blood vessel, does not block downstream perfusion, and improves the safety of treatment.

[0019] 4. The stent is retrievable and its positioning can be adjusted intraoperatively. The retrievable structure allows for repeated deployment and fine-tuning of positioning during the operation, adapting to different tumors and lesion sites, and improving surgical control.

[0020] 5. The material has good biocompatibility. It uses medical-grade materials such as TPU, which are less likely to cause thrombosis or inflammatory reactions and have high safety.

[0021] 6. It has a wide range of applications and is suitable for intracranial ruptured aneurysms of various shapes and locations, especially for irregular or dissecting aneurysms.

[0022] By utilizing these devices, the present invention addresses the problems of incomplete occlusion or high risk of rebleeding in the prior art, the limitations of stent-assisted technology, and the difficulty in timely intraoperative adjustments due to permanent implantation. It provides a retrievable covered aneurysm occlusion stent that can quickly and completely seal ruptured aneurysms, reduce the risk of rebleeding, has good biocompatibility, adapts to tortuous intracranial vessels, and is suitable for various morphologies of ruptured intracranial aneurysms. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Figure 1This is a front view of the device; Figure 2 This is a frontal perspective view of the device; Figure 3 This is a 3D schematic diagram of the structure of this device; Figure 4 This is a schematic diagram of the device in use.

[0024] Among them, 1. support; 2. connector; 3. coating; 4. developing mark. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0027] Reference Figures 1 to 3 The present invention discloses a recyclable covered aneurysm occlusion stent, comprising: a stent 1, the stent 1 being a cylindrical self-expanding metal mesh structure, the stent 1 being hollow and forming a central channel along the blood flow direction, the stent 1 being covered with a membrane 3 on the outer side of the middle part, the membrane 3 being used to adhere to the inner wall of the artery, and the stent 1 being pre-installed in a delivery device before use.

[0028] This device, through the provided cylindrical self-expanding metal mesh structure of the stent 1, unfolds in the artery. The membrane 3 in the middle can unfold and fit well against the inner wall of the artery to effectively block the broken aneurysm. Compared with traditional coil embolization, which cannot physically isolate the aneurysm from the lumen of the blood vessel, allowing some blood flow to still enter the aneurysm and easily leading to the risk of rebleeding or recanalization, this device can effectively seal the aneurysm through the membrane 3. At the same time, its hollow structure does not affect blood flow and maintains distal blood transfusion.

[0029] In addition, this device, through its delivery mechanism, can reposition the stent 1 and the covering membrane 3 when changes in the patient's condition or complications are detected during surgery.

[0030] The design was further optimized so that at least two imaging markers 4 were fixedly connected to the support 1.

[0031] This device has at least two developing marks 4, but it is foreseeable that, as Figure 1-3As shown, this device typically has multiple developing marks 4 set as needed, so that the device can accurately determine the position during use.

[0032] Further optimization of the design resulted in bracket 1 being made of nickel-titanium alloy.

[0033] This device is made of nickel-titanium alloy, which has good flexibility and support, and is suitable for tortuous intracranial blood vessels.

[0034] The solution was further optimized by using a thermoplastic polyurethane film as the coating 3.

[0035] Thermoplastic polyurethane (TPU) film has a continuous and complete closed structure, which can adhere tightly to the inner wall of blood vessels after unfolding, effectively blocking the aneurysm from contacting the blood flow.

[0036] The solution was further optimized by fixing the film 3 to the outer side of the middle part of the bracket 1 through thermoplastic molding.

[0037] The thermoplastic molding method relies on the properties of the polyurethane film itself. This molding method can effectively adapt to the size of the bracket 1, and the bond is strong and not easy to fall off after molding, resulting in good performance.

[0038] The solution was further optimized by using a hollow conduit as the delivery device, which was fitted over the outside of the support 1 and the membrane 3.

[0039] Further optimization involves detachably connecting an advancement rod to the proximal end of stent 1 (here, "proximal end" refers to the end closest to the operator during the procedure). For example... Figure 1-3 As shown, the proximal end of the support 1 converges to form a fixing point, thereby fixing the fixing point to the push rod.

[0040] One end of the hollow catheter extends. When the device is installed, the hollow catheter is inserted together with the stent 1 and the diaphragm 3. When it is necessary to release the stent 1 and the diaphragm 3, the hollow catheter is pulled back by pushing the push rod to release the stent 1 and the diaphragm 3. Then, the stent 1 and the diaphragm 3 are unfolded and attached to the inner wall of the artery by the elasticity of the stent 1 itself and the pushing action of blood flow.

[0041] When it is necessary to move and recycle the support 1 and the membrane 3, the push rod is pulled back, and the hollow conduit is pushed forward, so that the support 1 and the membrane 3 retract back into the hollow conduit, thus achieving their recycling.

[0042] In a further optimized design, the distal end of stent 1 (here, distal end refers to the end furthest from the operator during the procedure) is detachably connected to a guidewire. The distal end of stent 1 is then brought together to form another fixation point, which is connected to the guidewire.

[0043] Further optimization of the design resulted in a guidewire diameter of 0.014'' or 0.010''.

[0044] The purpose of the guidewire is to pull the stent 1. Specifically, refer to... Figure 1-4 As shown: The aneurysm stent 1 of this device reaches the lesion site using vascular interventional techniques. The specific steps are as follows: 1. Puncture approach Doctors usually make a puncture in the femoral artery (groin) or the radial artery (wrist).

[0045] Insert an introducer sheath to provide a passage for subsequent operations.

[0046] 2. Guidewire and catheter navigation Under the guidance of X-ray fluoroscopy (DSA, digital subtraction angiography), the intracranial blood vessels are first accessed through a microguidewire (0.014'' or 0.010'').

[0047] The hollow catheter is then advanced along the guidewire to the proximal position of the target blood vessel, creating a stable pathway for the delivery of stent 1.

[0048] 3. Microcatheter positioning The doctor uses a guidewire to precisely deliver a hollow catheter to the lesion site in the blood vessel where the aneurysm is located.

[0049] Under fluoroscopy, the distal position of the microcatheter can be determined by using the marker band 4.

[0050] 4. Stent delivery The stent 1 is usually pre-installed in the delivery system and can be compressed in a hollow conduit.

[0051] The doctor uses a pusher to push the stent 1 to the aneurysm or the diseased blood vessel segment.

[0052] 5. Stent Release After confirming the accurate location under fluoroscopy, the hollow catheter is slowly withdrawn, allowing the stent 1 to gradually expand and adhere to the vessel wall, covering the aneurysm opening or altering hemodynamics.

[0053] 6. Confirmation and Withdrawal The location of stent 1 and changes in blood flow were confirmed by angiography.

[0054] Remove the hollow catheter and seal the puncture site.

[0055] This invention addresses the key challenges in treating ruptured intracranial aneurysms through a multi-dimensional synergistic effect. Its core efficacy revolves around a non-linear support system encompassing "occlusion, blood flow, controllability, and adaptability." The TPU continuous occlusive membrane is crucial for acute occlusion. After self-expansion, it seamlessly adheres to the vessel wall, directly and physically isolating the aneurysm from blood flow, terminating the impact of blood flow on the rupture site. This is more efficient than the "indirect flow restriction" of traditional coil embolization and can also adapt to wide-necked and dissecting aneurysms. This effect relies on the radial support force of the nickel-titanium alloy stent, ensuring the membrane remains in place long-term.

[0056] The hollow cavity design simultaneously avoids the risk of ischemia, while the superelasticity and flexibility of the nickel-titanium alloy prevent the stent from folding in the tortuous blood vessels within the brain, maintaining the main blood flow and achieving "sealing the tumor without blocking the blood vessel." Retrievability is a core breakthrough: the distal pull ring, combined with the "retraction push rod + forward microcatheter" operation, can compress the deployed stent back into the microcatheter, allowing for repositioning or removal during the procedure, solving the error tolerance problem of permanent stents. Imaging markers also assist in precise operation, conforming to existing interventional procedures.

[0057] In addition, the biocompatibility of nickel-titanium alloy with TPU reduces long-term complications such as thrombosis and inflammation, transforming short-term treatment effects into long-term safety benefits and improving overall treatment safety and adaptability.

[0058] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0059] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A retrievable covered aneurysm occlusion stent, characterized in that, include: The stent (1) is a cylindrical self-expanding metal mesh structure. The stent (1) is hollow and forms a central channel along the blood flow direction. A membrane (3) is fitted on the outer side of the middle part of the stent (1). The membrane (3) is used to adhere to the inner wall of the artery. The stent (1) is pre-installed in the delivery device before use.

2. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: At least two imaging markers (4) are fixedly connected to the bracket (1).

3. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: The support (1) is made of nickel-titanium alloy.

4. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: The coating (3) is a thermoplastic polyurethane film.

5. A retrievable covered aneurysm occlusion stent according to claim 4, characterized in that: The film (3) is fixedly sleeved on the outer side of the middle part of the bracket (1) by thermoplastic molding.

6. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: The delivery device is a hollow conduit, which is sleeved on the outside of the support (1) and the membrane (3).

7. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: The proximal end of the bracket (1) is detachably connected to a push rod.

8. The retrievable covered aneurysm occlusion stent according to claim 1, characterized in that: The distal end of the stent (1) is detachably connected to a guide wire.

9. A retrievable covered aneurysm occlusion stent according to claim 8, characterized in that: The diameter of the guidewire is 0.014'' or 0.010''.

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