Vascular thrombectomy device

Abstract

The present invention discloses a vascular thrombus removal device, comprising: a tip portion with a guide wire inserted therein; a first balloon capable of switching between an expanded and filled state and a contracted state under the action of an external force, the distal end of the first balloon being connected to the tip portion, and the proximal end of the first balloon being connected to the outside, to achieve filling as required; a thrombus removal stent and a catheter; when the thrombus removal stent is released, the thrombus removal stent is in an expanded state, the thrombus removal stent is located between the first balloon and the catheter, and when the first balloon is in an expanded and filled state, the diameter of the first balloon is greater than the maximum outer diameter of the thrombus removal stent. The thrombus removal stent comprises a thrombus crushing portion and a thrombus catching portion, the thrombus crushing portion being located at an end away from the first balloon and being used to crush the thrombus by cutting the thrombus, and the thrombus catching portion being located at an end close to the first balloon and being used to capture the crushed thrombus, and the thrombus removal stent can both crush and capture the thrombus. The vascular thrombus removal device can achieve the effects of blocking the distal end, cutting and crushing the thrombus, capturing the thrombus, and thrombus removal by catheter, and can achieve reliable thrombus removal.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a vascular thrombectomy device. Background Art

[0002] Venous thromboembolism (VTE) includes deep vein thrombosis (DVT) in the lower extremities and pulmonary embolism (PE). DVT is a common peripheral vascular disease, often caused by abnormal blood coagulation in the lower extremities, which blocks blood flow. Pulmonary embolism (PE) has become the third leading cause of death from cardiovascular disease.

[0003] Currently, the treatments for acute ischemic stroke primarily involve interventional thrombolysis and mechanical thrombectomy, each with its own advantages and disadvantages. In 2015, the Journal of Neurology published a series of multicenter, randomized, controlled clinical trials of endovascular treatment for acute ischemic stroke: the MR CLEAN, ESCAPE, SWIFT PRIME, EXTEND-IA, and REVASCAT studies. These studies all demonstrated the safety and effectiveness of thrombolysis within 6 hours of acute ischemic stroke onset as a bridge to mechanical thrombectomy. However, thrombectomy for venous thrombosis (VTE) has only gained attention in recent years due to its rapid onset and high mortality rate. DVT, however, is insidious, with subtle symptoms and difficult to detect. As diagnostic awareness in my country has increased, the hospitalization rate for VTE has increased from 3.2 per 100,000 in 2007 to 17.5 per 100,000 in 2016, making its treatment urgent.

[0004] Currently, mechanical thrombectomy devices come in a variety of configurations, including catheters, stents, and baskets. For example, Chinese patent publication number CN103417257B discloses an intracranial vascular thrombectomy catheter. Different configurations often offer varying advantages and characteristics. For example, aspiration catheters can rapidly aspirate thrombi and restore perfusion, but are difficult to treat with harder, complex thrombi. Stents are more effective at rechecking thrombi, but are prone to fragmentation during thrombectomy, leading to unexpected distal embolism. Therefore, in clinical thrombectomy, a balloon or protective umbrella is often used distally to capture unexpected fragments. For different thrombi, a combination of catheter thrombectomy and stent thrombectomy is often used.

[0005] The above treatments can achieve varying results based on the clinician's judgment. However, since they often involve combining different instruments, they place high demands on the surgeon, increase the potential for unexpected adverse events during the procedure, and impose a certain burden on the patient. In other words, in existing technologies, achieving optimal thrombectomy requires combining multiple instruments, which not only places high demands on the surgeon but also places a significant burden on the patient. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a vascular thrombectomy device to overcome the above-mentioned defects in the prior art, in order to obtain a better thrombectomy effect, a combination of multiple different instruments is required, which not only places high demands on the operator but also puts a greater burden on the patient.

[0007] The present invention solves the above technical problems through the following technical solutions:

[0008] A vascular thrombectomy device, comprising:

[0009] The tip of the device has a guide wire inserted inside;

[0010] a first balloon capable of switching between an expanded and filled state and a deflated state under the action of an external force, wherein the distal end of the first balloon is connected to the tip portion and the proximal end of the first balloon is connected to the outside to achieve inflation or decompression;

[0011] thrombectomy stents and catheters;

[0012] Wherein, when the thrombectomy stent is released, the thrombectomy stent is in an expanded state, the thrombectomy stent is located between the first balloon and the catheter, and when the first balloon is in the expanded and filled state, the diameter of the first balloon is greater than the maximum outer diameter of the thrombectomy stent;

[0013] The thrombus removal stent includes a thrombus crushing portion and a thrombus catching portion. The thrombus crushing portion is located at an end away from the first balloon and is used to crush the thrombus by cutting it. The thrombus catching portion is located at an end close to the first balloon and is used to catch the broken thrombus.

[0014] The catheter is a multi-lumen catheter, the distal end of which is connected to the thrombectomy stent, and the proximal end is connected to the outside for negative pressure suction or accessory delivery.

[0015] In this solution, the setting of the tip makes it easier for the vascular thrombectomy device to reach the lesion area. When the first balloon is in an expanded and filled state, it can block the distal end, which can prevent the thrombus from reaching the distal end, such as the brain. Prevent abnormal distal embolism during thrombus removal. The thrombus-crushing part of the thrombus removal stent can crush the thrombus, and the thrombus-catching part can capture the broken thrombus. By applying negative pressure to the catheter, the broken thrombus can be extracted, thereby achieving thrombus removal. The vascular thrombus removal device can achieve the effects of blocking the distal end, cutting the broken thrombus, catching the thrombus and removing the thrombus by catheter, and can achieve reliable thrombus removal without the need for the coordinated use of multiple instruments. It can reduce the requirements for the operator and the burden on the patient.

[0016] Preferably, the thrombus retrieval stent is a mesh structure, the thrombus crushing portion is a sparse structure, and the thrombus catching portion is a dense structure, so that the density of the mesh of the thrombus catching portion is higher than that of the mesh of the thrombus crushing portion;

[0017] Alternatively, the thrombus removal stent includes a stent body and a capturing membrane, the stent body is a mesh structure and includes the thrombus crushing part and the thrombus capturing part, the thrombus crushing part and the thrombus capturing part are both evacuation structures, the capturing membrane is sleeved on the outside of the thrombus capturing part, and the capturing membrane is provided with a plurality of capturing holes for filtering blood and capturing broken thrombi.

[0018] In this embodiment, when the thrombus-crushing portion is configured as a dispersed structure and the thrombus-catching portion is configured as a dense structure, the thrombus-crushing portion is configured as a dispersed structure, making it easier to cut and thus fragment the thrombus, while the thrombus-catching portion is configured as a dense structure, making it easier to capture the thrombus. When both the thrombus-crushing portion and the thrombus-catching portion are configured as dispersed structures, the thrombus-catching membrane can also be used to more reliably capture the thrombus.

[0019] Preferably, the capture membrane is coated with a first drug coating, wherein the first drug coating is composed of a drug for dissolving thrombus.

[0020] In this solution, the first drug coating can dissolve part of the thrombus, which can be more helpful in achieving reliable thrombus removal.

[0021] Preferably, the plug-breaking portion is connected to the catheter by welding or bonding.

[0022] Preferably, the thrombus removal stent is a self-expanding stent;

[0023] Alternatively, the thrombus retriever stent is a balloon-expandable stent, and a second balloon is provided inside the thrombus retriever stent for expanding the thrombus retriever stent when the thrombus retriever stent is released.

[0024] In this embodiment, when the thrombectomy stent is configured as a self-expanding stent, it automatically expands when the thrombectomy stent is released, resulting in a simple structure. When the thrombectomy stent is configured as a balloon-expandable stent, expansion of the thrombectomy stent can be achieved by expanding or filling a second balloon, such as by connecting it to an external device.

[0025] Preferably, the second balloon is a semi-compliant balloon or a non-compliant balloon.

[0026] Preferably, the first balloon is a compliant balloon;

[0027] And / or, the proximal end of the first balloon is adhesively connected to the tip portion.

[0028] In this solution, the first balloon is set as a compliant balloon. Under the action of external force, the first balloon can expand or fill to different degrees according to actual needs, and has better flexibility.

[0029] Preferably, the first balloon is coated with a lubricating coating;

[0030] Alternatively, the first balloon is coated with a second drug coating, wherein the second drug coating is made of a drug that helps endothelialization.

[0031] In this solution, the lubricating coating facilitates the first balloon to enter and exit the lesion area, making thrombus removal easier, while the second drug coating promotes endothelial cell growth.

[0032] Preferably, the lubricating coating is made of polytetrafluoroethylene, pyrrolidone or sodium hyaluronate;

[0033] The second drug coating is made of simvastatin, resveratrol or endothelial cell growth factor.

[0034] Preferably, the catheter is a single-layer uniform structure or a composite structure, and the composite structure includes an inner layer structure, an intermediate layer structure and an outer layer structure. The inner layer structure is fluoroplastic or elastomer, the intermediate layer structure is a braided structure, a spring wound or a sea wave tube cutting structure, and the outer layer structure is made of polyurethane or nylon.

[0035] The positive progress effect of the present invention is:

[0036] In this vascular thrombectomy device, the setting of the tip facilitates the vascular thrombectomy device to reach the lesion area. When the first balloon is in an expanded and filled state, it can block the distal end, which can prevent the thrombus from reaching the distal end, such as the brain. Prevent abnormal distal embolism during thrombus removal. The thrombus-crushing part of the thrombus removal stent can crush the thrombus, and the thrombus-catching part can capture the broken thrombus. By applying negative pressure to the catheter, the broken thrombus can be extracted, thereby achieving thrombus removal. This vascular thrombus removal device can achieve the effects of blocking the distal end, cutting the broken thrombus, catching the thrombus and removing the thrombus by catheter, and can achieve reliable thrombus removal without the need for the coordinated use of multiple instruments. It can reduce the requirements for the operator and the burden on the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Schematic diagram of the structure of the vascular thrombectomy device according to Example 1 of the present invention.

[0038] Figure 2 This is a partial structural diagram of the vascular thrombectomy device according to Example 1 of the present invention, showing the tip portion and the first balloon.

[0039] Figure 3 This is a schematic diagram of another portion of the structure of the vascular thrombectomy device according to Example 1 of the present invention, showing the tip portion and the first balloon at another angle.

[0040] Figure 4 This is another partial structural diagram of the vascular thrombectomy device according to Example 1 of the present invention, showing the thrombectomy stent.

[0041] Figure 5This is a partial structural diagram of the vascular thrombectomy device according to Example 2 of the present invention, showing the tip portion, the first balloon, the second balloon, and part of the thrombectomy stent.

[0042] Figure 6 This is a partial structural diagram of the vascular thrombectomy device according to Example 3 of the present invention, showing the tip portion, the first balloon, and part of the thrombectomy stent.

[0043] Figure 7 This is a partial structural diagram of the vascular thrombectomy device according to Example 4 of the present invention, showing the tip portion, the first balloon and part of the thrombectomy stent.

[0044] Figure 8 This is a partial structural diagram of the vascular thrombectomy device according to Example 5 of the present invention, showing a first balloon coated with a second drug layer.

[0045] Description of reference numerals:

[0046] 101 Tip

[0047] 201 First Balloon

[0048] 201-1 Second drug layer

[0049] 202 Second Balloon

[0050] 301 thrombectomy stent

[0051] 302 Broken Bolt

[0052] 303 bolt catching department

[0053] 304 capture film

[0054] 401 catheter DETAILED DESCRIPTION

[0055] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples.

[0056] Example 1

[0057] like Figure 1-4 As shown, this embodiment discloses a vascular thrombectomy device, which includes a tip portion 101, a first balloon 201, a thrombectomy stent 301, and a catheter 401. A guidewire is inserted into the tip portion 101; the first balloon 201 can switch between an expanded and deflated state under the action of an external force. The distal end of the first balloon 201 is connected to the tip portion 101, and the proximal end of the first balloon 201 is connected to the outside to achieve inflation or decompression as needed.

[0058] When the thrombus retriever stent 301 is released, the thrombus retriever stent 301 is in an expanded state and is located between the first balloon 201 and the catheter 401. When the first balloon 201 is in an expanded and filled state, the diameter of the first balloon 201 is greater than the maximum outer diameter of the thrombus retriever stent 301.

[0059] The thrombus removal stent 301 includes a thrombus crushing portion 302 and a thrombus catching portion 303. The thrombus crushing portion 302 is located at an end away from the first balloon 201 and is used to crush the thrombus by cutting the thrombus. The thrombus catching portion 303 is located at an end close to the first balloon 201 and is used to capture the broken thrombus.

[0060] The catheter 401 is a multi-lumen catheter, the distal end of which is connected to the thrombectomy stent 301 and the proximal end is connected to the outside for negative pressure suction or accessory delivery.

[0061] In this embodiment, the provision of the tip portion 101 facilitates the vascular thrombectomy device to reach the lesion area. When the first balloon 201 is in an expanded and filled state, it can block the distal end, preventing thrombi from reaching the distal end, such as the brain. This prevents abnormal distal embolism during thrombus removal. The thrombus-crushing portion 302 of the thrombus-removing stent 301 can crush thrombi, and the thrombus-catching portion 303 can capture the crushed thrombi. By applying negative pressure to the catheter 401, the crushed thrombi can be extracted, thereby achieving thrombus removal. This vascular thrombus removal device can achieve the effects of blocking the distal end, cutting and crushing thrombi, capturing thrombi, and thrombus removal by the catheter 401, enabling reliable thrombus removal without the need for the coordinated use of multiple instruments, thereby reducing both the requirements for the operator and the burden on the patient.

[0062] It should be noted that the first balloon 201 is usually filled by injecting physiological saline.

[0063] During thrombus removal, the vascular thrombus removal device is partially passed through the thrombus via a guidewire through existing interventional means, and the first balloon 201 is filled or expanded to block the blood vessel, thereby preventing abnormal distal embolism during thrombus removal. The thrombus removal stent 301 is released, and the thrombus is cut and captured. The catheter 401 is operated to aspirate the thrombus, thereby capturing and extracting the thrombus in the blood vessel, thereby reopening the blocked blood vessel and achieving a therapeutic effect.

[0064] The interior of the tip portion 101 is a hollow structure, which allows the guide wire to pass through smoothly and facilitates passing through the thrombus.

[0065] Furthermore, the thrombus removal stent 301 is an extension of the middle braided structure of the catheter 401 structure. The catheter 401 is a single-layer or multi-layer multi-lumen catheter 401, which is made of a single material or fluoroplastics, thermoplastics and metals such as stainless steel and nickel titanium. Negative pressure suction can be performed at the proximal end to remove the thrombus from the body.

[0066] It should be noted that catheter 401 can be a single-layer uniform structure or a composite structure, wherein the composite structure includes an inner layer structure, an intermediate layer structure, and an outer layer structure. The inner layer structure is made of fluoroplastic or elastomer; the intermediate layer structure is a braided structure, a coiled spring, or a hypotube cut structure, preferably made of conventional medical materials such as nickel-titanium and stainless steel; and the outer layer structure is made of polyurethane or nylon.

[0067] In this embodiment, the catheter 401 is a multi-lumen tube. This configuration simplifies the overall structure of the thrombectomy device, as one lumen can be used to communicate with the outside to inflate the first balloon 201 as needed, and a guidewire can be passed through one of the lumens to facilitate the delivery of related accessories (including but not limited to a guidewire).

[0068] Furthermore, the thrombus retriever stent 301 has a mesh structure, with the thrombus fragmentation unit 302 having a loose structure and the thrombus capture unit 303 having a dense structure. This ensures that the mesh density of the thrombus capture unit 303 is higher than that of the thrombus fragmentation unit 302. The looser arrangement of the thrombus fragmentation unit 302 facilitates clot cutting and thus facilitates clot fragmentation, while the denser arrangement of the thrombus capture unit 303 facilitates clot capture. When both the thrombus fragmentation unit 302 and the thrombus capture unit 303 have loose structures, the capture membrane 304 also enables reliable clot capture.

[0069] In this embodiment, the bolt-breaking portion 302 is bonded to the conduit 401. In other alternative embodiments, other connection methods may be used, such as welding.

[0070] In a preferred embodiment, the thrombus retrieval stent 301 is a self-expanding stent. When the thrombus retrieval stent 301 is set as a self-expanding stent, the thrombus retrieval stent 301 automatically expands when the thrombus retrieval stent 301 is released, resulting in a simple structure. For example, the thrombus retrieval stent 301 can be made of stainless steel.

[0071] In another preferred embodiment, the first balloon 201 is a compliant balloon. In addition, the proximal end of the first balloon 201 is bonded to the tip portion 101 .

[0072] The first balloon 201 is configured as a compliant balloon. Under the action of external force, the first balloon 201 can expand or fill to different degrees according to actual needs, and has better flexibility.

[0073] Example 2

[0074] like Figure 5 As shown, this embodiment provides another vascular thrombectomy device, which is basically the same as the vascular thrombectomy device in Example 1, and the difference lies in the thrombectomy bracket 301. In this embodiment, the same reference numerals as in Example 1 refer to the same elements.

[0075] Specifically, the thrombectomy stent 301 is a balloon-expandable stent. A second balloon 202 is disposed within the stent 301 for expanding the stent 301 when the stent 301 is released. The stent 301 is configured as a balloon-expandable stent. By expanding or filling the second balloon 202, the stent 301 can be expanded, if connected to an external device.

[0076] Furthermore, the second balloon 202 is a semi-compliant balloon or a non-compliant balloon.

[0077] A non-compliant balloon refers to a balloon whose expansion or filling degree is determined regardless of the environment it is in. A semi-compliant balloon refers to a balloon whose expansion or filling degree is between that of a non-compliant balloon and a compliant balloon.

[0078] Example 3

[0079] like Figure 6 As shown, this embodiment provides another vascular thrombectomy device, which is basically the same as the vascular thrombectomy device in Example 1, and the difference lies in the thrombectomy bracket 301. In this embodiment, the same reference numerals as in Example 1 refer to the same elements.

[0080] Specifically, the embolism removing device 301 has a braided structure for the embolism breaking portion 302 and a laser-cut structure for the embolism catching portion 303. In other alternative embodiments, the embolism removing device may also have a fully braided structure or a fully cut structure.

[0081] Example 4

[0082] like Figure 7 As shown, this embodiment provides another vascular thrombectomy device, which is basically the same as the vascular thrombectomy device in Example 1, and the difference lies in the thrombectomy bracket 301. In this embodiment, the same reference numerals as in Example 1 refer to the same elements.

[0083] Specifically, the thrombus removal stent 301 includes a stent body and a capturing membrane 304. The stent body is a mesh structure and includes a thrombus crushing part 302 and a thrombus capturing part 303. The thrombus crushing part 302 and the thrombus capturing part 303 are both evacuation structures. The capturing membrane 304 is sleeved on the outside of the thrombus capturing part 303. The capturing membrane 304 is provided with multiple capturing holes for filtering blood and capturing broken thrombi.

[0084] When both the bolt-breaking portion 302 and the bolt-catching portion 303 are configured as evacuation structures, bolts can be caught more reliably through the catching membrane 304 .

[0085] Furthermore, the capture membrane 304 is coated with a first drug coating, which is composed of a drug for dissolving thrombus.

[0086] Among them, the first drug coating can dissolve part of the thrombus, which can be more helpful in achieving reliable thrombus removal.

[0087] Example 5

[0088] like Figure 8 As shown, this embodiment provides another vascular thrombectomy device, which is basically the same as the vascular thrombectomy device in Example 1, and the difference mainly lies in the first balloon 201. Among them, the same reference numerals in this embodiment and Example 1 refer to the same elements.

[0089] Specifically, the first balloon 201 in this embodiment is coated with a second drug coating, which is made of a drug that helps endothelialization, such as simvastatin, resveratrol, or endothelial cell growth factor.

[0090] Wherein, most of the endothelial cells are dead at the location of the thrombus. When the first balloon 201 passes through the location, it will leave some of the second drug, so that the endothelial cells can grow rapidly under the action of the second drug, thereby facilitating endothelialization.

[0091] In other alternative embodiments, the second drug coating can be replaced with a lubricating coating, wherein the lubricating coating facilitates the first balloon 201 to enter and exit the lesion area and facilitates thrombus removal. The lubricating coating is made of polytetrafluoroethylene, pyrrolidone or sodium hyaluronate;

[0092] Although specific embodiments of the present invention have been described above, those skilled in the art will appreciate that these are merely illustrative and that the scope of the present invention is defined by the appended claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, and such changes and modifications are intended to fall within the scope of the present invention.

Claims

1. A vascular thrombectomy device, characterized in that: It includes: The tip of the device has a guide wire inserted inside; a first balloon capable of switching between an expanded and filled state and a deflated state under the action of an external force, wherein the distal end of the first balloon is connected to the tip portion and the proximal end of the first balloon is connected to the outside to achieve inflation or decompression; thrombectomy stents and catheters; Wherein, when the thrombectomy stent is released, the thrombectomy stent is in an expanded state, the thrombectomy stent is located between the first balloon and the catheter, and when the first balloon is in the expanded and filled state, the diameter of the first balloon is greater than the maximum outer diameter of the thrombectomy stent; The thrombus removal stent includes a thrombus crushing portion and a thrombus catching portion. The thrombus crushing portion is located at an end away from the first balloon and is used to crush the thrombus by cutting it. The thrombus catching portion is located at an end close to the first balloon and is used to catch the broken thrombus. The catheter is a multi-lumen catheter, the distal end of which is connected to the thrombectomy stent and the proximal end is connected to the outside for negative pressure suction or accessory delivery; The thrombus removal stent comprises a stent body and a capture membrane. The stent body is a mesh structure and comprises the thrombus crushing portion and the thrombus capturing portion. Both the thrombus crushing portion and the thrombus capturing portion are evacuation structures. The capture membrane is sleeved on the outside of the thrombus capturing portion and is provided with a plurality of capture holes for filtering blood and capturing broken thrombi. The capture membrane is coated with a first drug coating, which is composed of a drug for dissolving thrombus.

2. The vascular thrombectomy device according to claim 1, characterized in that: The plug-breaking portion is connected to the catheter by welding or bonding.

3. The vascular thrombectomy device according to claim 1, wherein: The thrombectomy stent is a self-expanding stent; Alternatively, the thrombus retriever stent is a balloon-expandable stent, and a second balloon is provided inside the thrombus retriever stent for expanding the thrombus retriever stent when the thrombus retriever stent is released.

4. The vascular thrombectomy device according to claim 3, characterized in that: The second balloon is a semi-compliant balloon or a non-compliant balloon.

5. The vascular thrombectomy device according to claim 1, wherein: The first balloon is a compliant balloon; And / or, the proximal end of the first balloon is adhesively connected to the tip portion.

6. The vascular thrombectomy device according to claim 1, wherein: The first balloon is coated with a lubricating coating; Alternatively, the first balloon is coated with a second drug coating, wherein the second drug coating is made of a drug that helps endothelialization.

7. The vascular thrombectomy device according to claim 6, characterized in that: The lubricating coating is made of polytetrafluoroethylene, pyrrolidone or sodium hyaluronate; The second drug coating is made of simvastatin, resveratrol or endothelial cell growth factor.

8. The vascular thrombectomy device according to any one of claims 1 to 7, characterized in that: The catheter is a single-layer uniform structure or a composite structure, and the composite structure includes an inner layer structure, an intermediate layer structure and an outer layer structure. The inner layer structure is fluoroplastic or elastomer, the intermediate layer structure is a braided structure, a spring wound or a hypotube cutting structure, and the outer layer structure is made of polyurethane or nylon.

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