Carotid artery flow reduction thrombus protection device

Abstract

The invention provides a carotid artery flow reduction thrombus protection device, and relates to the technical field of interventional medical instruments. The fixing assembly comprises a guide wire rod body, the guide wire rod body penetrates through the flow blocking part, and the flow blocking part is fixed to the guide wire rod body. The flow blocking part comprises a first opening located at the near end and a second opening located at the far end, the cross-sectional area of the second opening in the radial direction of the blood vessel is smaller than 30% of the cross-sectional area of the first opening in the radial direction of the blood vessel, and the flow blocking part reduces the blood flow in the carotid artery blood vessel when blood flows from the first opening to the second opening. The flow blocking part is arranged and provided with the first opening and the second opening, and the sectional area of the second opening in the radial direction of the blood vessel is smaller than half of the sectional area of the first opening in the radial direction of the blood vessel, so that the flow of blood is limited, and the pressure in the blood vessel is reduced; the problem that capillary injury is easily caused when blood flow directly recovers to the third level (mTICI level) is solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to a carotid artery flow reduction and thrombus protection device. Background Art

[0002] Ischemic stroke caused by blood clots in cerebral blood vessels is a difficult-to-treat disease that seriously endangers human health and life safety. Blood clots in blood vessels will hinder the normal flow of blood in the brain, causing ischemia and hypoxia of local brain tissue. If the ischemia time is too long, nerve cells will be damaged or even die due to lack of nutrition and oxygen. The number of deaths from stroke in China each year has exceeded that of tumors and cardiovascular diseases, becoming the leading cause of death. In order to solve the above-mentioned problem of ischemic stroke deaths caused by blood clots, interventional surgical thrombectomy has become a development trend in recent years.

[0003] After the blood clot is removed through interventional surgery, blood will flow into the originally blocked blood vessels and restore blood supply to the brain.

[0004] In the existing technology, the change of intracranial pressure is often not obtained in time, resulting in the inability to adjust the treatment plan according to the change of intracranial pressure during the treatment process. After the blood enters the originally blocked blood vessels, it may cause adverse reactions such as high or low intracranial pressure. Clinically, it is found that after the intracranial blood vessels are recanalized, the recovery effect of grade 2a (mTICI classification, the same below) is better than that of grade 3 recanalization. The reason is that after the blood vessels are recanalized, the blood flow is reperfused and the flow rate is greater than before recanalization, resulting in capillary damage and easy formation of cerebral hematoma infarction.

[0005] Therefore, the present application provides a carotid artery flow reduction and thrombus protection device. Summary of the invention

[0006] The purpose of the present invention is to provide a carotid artery flow reduction thrombus protection device to solve the problem that after the blood vessel is reopened, the blood flow is reperfused and the flow rate is greater than before the reopening, resulting in capillary damage and easy formation of cerebral hematoma infarction.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] A carotid artery flow reduction and thrombus protection device, comprising a fixing component and a flow blocking part;

[0009] The fixing assembly comprises a wire guide rod body, the wire guide rod body passes through the flow blocking portion, and the flow blocking portion is fixed on the wire guide rod body;

[0010] The blocking portion includes a first opening located at the proximal end and a second opening located at the distal end, the cross-sectional area of ​​the second opening in the radial direction of the blood vessel is less than 30% of the cross-sectional area of ​​the first opening in the radial direction of the blood vessel, and the blocking portion reduces the blood flow in the carotid artery when the blood flows from the first opening to the second opening.

[0011] Preferably, the flow blocking portion is a dense mesh and / or a membrane.

[0012] Preferably, the fixing assembly includes a nickel-titanium wire arranged along the circumference of a first opening of the blocking portion, and a second stainless steel tube arranged along the circumference of a second opening of the blocking portion.

[0013] Preferably, the diameter range of the first opening in the radial direction of the blood vessel is 4-6 mm, and the diameter range of the second opening in the radial direction of the blood vessel is less than or equal to 2 mm.

[0014] Preferably, the fixing assembly comprises a first stainless steel tube disposed on the guide wire rod body, and the proximal end of the flow blocking portion is fixedly connected to the first stainless steel tube.

[0015] Preferably, a developing spring is provided at the distal end of the guide wire rod body, and a metal welding ball is provided at the tail end of the developing spring.

[0016] Preferably, the surface of the flow blocking portion is provided with an adhesion coating.

[0017] Preferably, the adhesion coating is formed by a fusion of phosphorylcholine and anhydrous ethanol, and the adhesion coating is attached to the flow-blocking portion by means of dipping and volatilization.

[0018] Preferably, the first opening and the second opening are coaxially arranged.

[0019] Preferably, the first opening and the second opening are arranged off-axis.

[0020] Beneficial effects:

[0021] (1) The present invention provides a flow blocking portion, which blocks the blood flow. The flow blocking portion is provided with a first opening and a second opening. Since the cross-sectional area of ​​the second opening in the radial direction of the blood vessel is smaller than half of the cross-sectional area of ​​the first opening in the radial direction of the blood vessel, the blood flow is restricted, and the blood flow at the recanalized blood vessel is reduced, thereby reducing the pressure in the blood vessel. The blood flow is small, and the damage to the capillaries can be reduced, thereby solving the problem that the direct recovery of blood flow to level 3 is likely to cause capillary damage and easily form cerebral hematoma infarction;

[0022] (2) The present invention arranges a nickel-titanium wire in the circumference of the first opening and arranges a second stainless steel tube in the circumference of the second opening to maintain the stability of the first opening and the second opening, so that the blocking part is fixed on the inner wall of the blood vessel, thereby reducing the possibility of displacement of the blocking part;

[0023] (3) The present invention provides a developing spring at the distal end of the guide wire rod. After the developing spring is in place, the doctor can see the developing spring through X-ray fluoroscopy to assist in determining the position of the guide wire rod, thereby facilitating the doctor to make a correct judgment. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0025] Figure 1 It is a side view structural schematic diagram of a carotid artery flow reduction embolism protection device;

[0026] Figure 2 It is a schematic diagram of the side structure of the blocking part of the carotid artery flow reduction thrombus protection device, which is used to show the structure when the blocking part is a dense mesh;

[0027] Figure 3 It is a schematic diagram of the side structure of the flow blocking part of the carotid artery flow reduction thrombus protection device, which is used to show the structure when the flow blocking part is a membrane;

[0028] Figure 4 It is a schematic diagram of the side view structure of the blocking part of the carotid artery flow reduction thrombus protection device, which is used to show the structure when the blocking part is a membrane installed at the distal end of the dense net and covers one-half;

[0029] Figure 5 It is a schematic diagram of the side view structure of the blocking part of the carotid artery flow reduction thrombus protection device, which is used to show the structure when the blocking part is a membrane installed at the proximal end of the dense net and covers one-half;

[0030] Figure 6 This is a schematic diagram for illustrating a pointed cone structure in Example 5 of the present invention;

[0031] Figure 7 It is a schematic diagram of the side view of the structure of the flow blocking part, which is used to show the connection relationship between the flow blocking part and the nickel-titanium wire;

[0032] Figure 8 is a schematic diagram of a top view result when the flow blocking part is a braided mesh tube;

[0033] Fig. 9 is a side view of the developing spring;

[0034] Fig.10 Schematic diagram of a blood flow reduction device installed in a blood vessel in an embodiment of the present invention, wherein the dotted line represents the blood flow;

[0035] Fig.11 It is a schematic structural diagram for showing the coaxial arrangement of the first opening and the second opening in an embodiment of the present invention.

[0036] In the figure: 1, first stainless steel tube; 2, nickel-titanium wire; 3, flow-blocking part; 31, first opening; 32, second opening; 4, second stainless steel tube; 5, developing spring; 51, metal welding ball; 6, wire guide rod body. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0038] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0039] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0040] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more features.

[0041] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be internal connection between two elements, indirect connection, or an interactive relationship between two elements.

[0042] In the description of the present invention, "before use" refers to the state in which the carotid artery flow reduction and thrombosis protection device has not been used, has not entered the human body, or has not come into contact with body fluids such as blood, tissue fluid, etc. in the human body; and "during use" refers to the state in which the carotid artery flow reduction and thrombosis protection device has entered the human body or has come into contact with body fluids such as blood, tissue fluid, etc. in the human body.

[0043] In the description of the present invention, "in vivo environment" refers to the environment below the epidermis of the skin where body fluids exist, such as the dermis and subcutaneous tissue, or the inside of blood vessels and organs.

[0044] In the description of the present invention, "proximal end" refers to the end close to the operator during surgery, and "distal end" refers to the end farthest from the operator.

[0045] In the description of the present invention, grade 0, grade 1, grade 2a, grade 2b and grade 3 are based on mTICI classification. mTICI refers to a modified cerebral infarction classification system, which is currently an indicator for evaluating the angiographic results of patients with vascular occlusive ischemic stroke after thrombectomy. It should be noted that grade 2a describes partial blood perfusion (<50%) in the distal ischemic area, and grade 3 describes complete restoration of blood perfusion in the distal ischemic area.

[0046] The present invention will be described in detail below in conjunction with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0047] The present invention aims at the problem in the prior art that after the intracranial blood vessels are reopened, the blood flow is reperfused and the flow rate is greater than that before the reopening, which easily leads to capillary damage and cerebral hematoma infarction.

[0048] The present invention discloses a carotid artery flow reduction thrombus protection device, referring to Figure 1 and Figure 2 , including a fixing component; the fixing component is preferably a guide wire, which is placed at the rear end of the thrombus.

[0049] Reference Figures 1 to 5 The blocking part 3 is arranged on the fixed component; preferably, the blocking part 3 is a braided mesh tube, which is made of wires mixed with shape memory alloy and developing alloy and is closely woven. The weaving requirement is to make it difficult for blood to pass through the mesh opening of the braided mesh tube, and a small amount of blood can be allowed to seep out. The blocking part 3 is fixed to the fixed component by welding or bonding.

[0050] In another embodiment of the present application, the flow blocking part 3 is a membrane, preferably a PTFE membrane or a PET membrane. The PTFE membrane has good biocompatibility and chemical stability, and the PET membrane has high strength and toughness and can withstand the pressure in the blood vessel. Both the PTFE membrane and the PET membrane can have a good flow blocking effect.

[0051] In other embodiments of the present application, the flow blocking portion 3 includes a nickel-titanium laser engraved stent to form a hollow skeleton structure, and the stent surface is coated by a film, and the coating method is a pasting or a hot melt connection. The material of the film is PTFE or ePTFE, and the film does not completely cover the stent surface, and may only cover the proximal 1 / 2 position of the stent, or the distal 1 / 2 position.

[0052] Reference Figure 1 , Figure 2 and Figure 8, wherein the flow blocking part 3 includes a first opening 31 at the proximal end and a second opening 32 at the distal end, the cross-sectional area of ​​the second opening 32 in the radial direction of the blood vessel is smaller than the cross-sectional area of ​​the first opening 31 in the radial direction of the blood vessel, and in a preferred embodiment, the cross-sectional area of ​​the second opening 32 in the radial direction of the blood vessel is smaller than 30% of the cross-sectional area of ​​the first opening 31 in the radial direction of the blood vessel, and the flow blocking part 3 allows blood to flow from the first opening 31 to the second opening 32, thereby reducing the blood flow at the distal end of the flow blocking part. Specifically, the diameter range of the first opening 31 in the radial direction of the blood vessel is 4-6 mm, and the diameter range of the second opening 32 in the radial direction of the blood vessel is less than or equal to 2 mm.

[0053] It can be understood that the radial direction of the blood vessel refers to the direction of any diameter of the blood vessel when the cross-section of the blood vessel is circular; when the cross-section of the blood vessel is elliptical or irregular, it refers to the direction of any straight line starting from the center point of the blood vessel toward the blood vessel wall located in the plane.

[0054] Preferably, the fixing assembly includes a wire guide rod body 6, the wire guide rod body 6 passes through the blocking portion 3, and the blocking portion 3 is fixed on the wire guide rod body 6, and the nickel-titanium wire 2 is arranged at the first opening 31. The blocking portion 3 is laser welded or soldered on the wire guide rod body 6. By setting the wire guide rod body 6, during the installation process, the blocking portion 3 can be driven to move by the wire guide rod body 6, so that the blocking portion 3 reaches a suitable position.

[0055] It should be noted that the diameters of the first opening 31 and the second opening 32 in the radial direction of the blood vessel refer to the projected lengths of the first opening 31 and the second opening 32 in the axial direction with the axial direction of a certain part of the blood vessel as the axis.

[0056] After blood is recirculated, it first enters the blocking part 3 from the first opening 31. The blocking part 3 itself does not allow or only allows a small amount of blood to seep out. The blood will accumulate in the blocking part 3 and flow out from the second opening 32. Because the cross-sectional area of ​​the second opening 32 in the radial direction of the blood vessel is less than half of the cross-sectional area of ​​the first opening 31 in the radial direction of the blood vessel, the blood flow is limited, and the blood flow at the recirculated blood vessel is reduced. The blocking part 3 reduces the blood flow from a channel of 4-6mm to a maximum of 2mm, reduces the blood flow, and thus reduces the pressure in the blood vessel. At this time, the level is 2a in the mTICI classification, the blood flow is small, and the damage to the capillaries can be reduced, thereby solving the problem that the blood flow is directly restored to level 3, which is easy to cause capillary damage and easy to form cerebral hematoma infarction. Within two to three weeks of using this carotid artery flow reduction thrombus protection, the recirculated blood vessel returns to normal, and then the carotid artery flow reduction thrombus protection is removed to restore normal blood perfusion.

[0057] After the carotid artery flow-reducing thrombus protection device is placed in the blood vessel, after the blood vessel is reopened, the blood flow will gradually decrease through the carotid artery flow-reducing thrombus protection device, greatly reducing the blood vessel pressure after the blood flow is reopened, avoiding excessive blood pressure, resulting in blood vessel rupture or hematoma, and better helping the patient to recover. After the blood vessel has recovered its pressure resistance in two to three weeks, the carotid artery flow-reducing thrombus protection device can be removed to restore normal vascular perfusion.

[0058] Preferably, the fixing assembly includes a nickel-titanium wire 2 circumferentially along the first opening 31 of the flow-blocking part 3, and a second stainless steel tube 4 circumferentially arranged along the second opening 32 of the flow-blocking part 3. The nickel-titanium wire 2 is used to sew a circle on the circumferential edge of the first opening 31 of the flow-blocking part 3. The nickel-titanium wire 2 has a shape memory function, which can maintain the first opening 31 at the original design size, so that the first opening 31 is not easy to deform, and the stability of the first opening 31 is increased. It can be understood that the nickel-titanium wire 2 abuts against the inner wall of the blood vessel, so that the flow-blocking part 3 can be fixed on the inner wall of the blood vessel, reducing the possibility of displacement of the flow-blocking part 3. The second stainless steel tube 4 is made of stainless steel, and the hardness of stainless steel is relatively large, which can prevent the second opening 32 from expanding and maintain the flow-limiting effect of the flow-blocking part 3. The nickel-titanium wire 2 and the second stainless steel tube 4 are placed in the body and have little effect on the body fluid environment.

[0059] It can be understood that the circumferential direction refers to the direction along the outer edge of the opening, and the opening can be circular, square or other irregular shapes.

[0060] Preferably, the fixing assembly includes a first stainless steel tube 1 disposed on the guide wire rod body 6, and the proximal end of the flow blocking portion 3 is fixedly connected to the first stainless steel tube 1. The first stainless steel tube 1 and the guide wire rod body 6 are laser welded or soldered to improve the connection stability between the flow blocking portion 3 and the guide wire rod body 6.

[0061] The distal end of the guide wire rod body 6 is provided with a developing spring 5, and the tail end of the developing spring 5 is provided with a metal soldering ball 51. The developing spring 5 is formed by densely winding a 0.035 mm platinum-iridium wire, and the length dimension of the developing spring 5 is 10±0.5 mm, and the width dimension is 0.18±0.01 mm. After the developing spring 5 is formed, it is sleeved on the distal end of the guide wire rod body 6, and soldering is performed at 300±20°C to splice the guide wire rod body 6 and the developing spring 5 into one. Platinum-iridium alloy has a strong ability to block X-rays. The doctor can clearly see the position of the instrument in the blood vessel through X-ray perspective, ensuring the accuracy of the operation. Preferably, the metal soldering ball 51 is made of silver solder, which is used to enhance the connectivity and distal roundness of the developing spring 5, and to ensure that the head end has good developing properties and softness. In other embodiments of the present application, iron and copper can be used.

[0062] The surface of the flow blocking part 3 is provided with an adhesion coating, which is formed by fusion of phosphorylcholine and anhydrous ethanol. The method of setting the adhesion coating is: attaching it to the flow blocking part 3 by dipping and volatilizing. The purpose of setting the adhesion coating is to improve the biocompatibility, blood compatibility and anti-protein adsorption properties of the carotid artery flow reduction thrombosis protection device, so as to facilitate the subsequent removal of the carotid artery flow reduction thrombosis protection device.

[0063] In the preferred embodiment of the present invention, the first opening 31 and the second opening 32 are coaxially arranged. It is understandable that in this solution, there is no angle between the axial directions of the first opening 31 and the second opening 32, and the coaxially arranged flow blocking part 3 has good structural stability and can withstand high pressure, so that blood can flow stably.

[0064] In a preferred embodiment of the present invention, the first opening 31 and the second opening 32 are arranged off-axis. It can be understood that in this solution, there is a certain angle between the axial direction of the first opening 31 and the axial direction of the second opening 32. When thrombus occurs in a tortuous blood vessel with a variable diameter section, the off-axis flow blocking portion 3 can better adapt to the shape of the blood vessel, making it easier to install and remove.

[0065] The carotid artery flow reduction and thrombus protection device of the present invention is described in detail below through specific embodiments.

[0066] Example 1

[0067] This embodiment provides a carotid artery flow reduction thrombus protection device, such as Figure 1 , Figure 2 , Figure 7 and Figure 8 As shown, it includes a fixing component and a blocking portion 3 arranged on the fixing component.

[0068] The fixed component includes a guide wire rod body 6, which can be a stainless steel wire. A first stainless steel tube 1 is welded to the guide wire rod body 6, and the first stainless steel tube 1 surrounds itself to form a block. A developing spring 5 is welded to the distal end of the guide wire rod body 6, and the developing spring 5 is formed by a plurality of circles of platinum-iridium metal surrounding itself in a stacked shape, and its shape is similar to a tight spring. Platinum-iridium metal has good anti-X-ray function, allowing doctors to see the position of the guide wire rod body 6 through X-ray fluoroscopy, which is convenient for doctors to make correct judgments. Preferably, a metal solder ball 51 is provided at the distal end of the developing spring 5, and the material of the metal solder ball 51 is preferably silver-tin solder. The silver-tin solder ball is spherical and has strong self-stability, which is used to enhance the connectivity and distal roundness of the developing spring 5.

[0069] The blocking part 3 is welded to the wire guide rod body 6, and the proximal end of the blocking part 3 is connected to the first stainless steel tube 1. By arranging the first stainless steel tube 1 to be connected to the blocking part 3, the blocking part 3 and the wire guide rod body 6 are further fixed.

[0070] In this embodiment, there is a certain angle between the first opening 31 and the second opening 32, which is an off-axis setting. In this solution, there is a certain angle between the axial direction of the first opening 31 and the axial direction of the second opening 32. When the location where the carotid artery flow reduction thrombus protection device needs to be placed is in a tortuous and variable diameter section of the blood vessel, the off-axis setting of the flow blocking portion 3 can better adapt to the shape of the blood vessel, which is convenient for installation and removal.

[0071] Reference Figure 1 , Figure 2 and Figure 8 In this embodiment, the blocking portion 3 is provided with a first opening 31 and a second opening 32 in sequence from the proximal end to the distal end, and the coverage area of ​​the first opening 31 in the radial direction of the blood vessel is greater than the coverage area of ​​the second opening 32 in the radial direction of the blood vessel. It can be understood that the coverage area here refers to the projection area of ​​the first opening 31 and the second opening 32 on the radial plane of the blood vessel with the axial direction of the blood vessel as the axis. It should be particularly noted that the blocking portion 3 does not allow blood to seep out or allows a small amount of blood to seep out.

[0072] Specifically, the diameter of the first opening 31 in the radial direction of the blood vessel is in the range of 4-6 mm, while the diameter of the second opening 32 in the radial direction of the blood vessel is in the range of less than or equal to 2 mm.

[0073] In a preferred embodiment of the present application, the diameter of the first opening 31 in the radial direction of the blood vessel is 4 mm, and the diameter of the second opening 32 in the radial direction of the blood vessel is 1 mm.

[0074] In a preferred embodiment of the present application, the diameter of the first opening 31 in the radial direction of the blood vessel is 6 mm, and the diameter of the second opening 32 in the radial direction of the blood vessel is 2 mm.

[0075] In a preferred embodiment of the present application, the diameter of the first opening 31 in the radial direction of the blood vessel is 6 mm, and the diameter of the second opening 32 in the radial direction of the blood vessel is 1 mm.

[0076] Reference Figure 1 , Figure 2 , Figure 7 , Figure 8 and Fig.10 The blocking part 3 includes a nickel-titanium laser engraved bracket to form a hollow skeleton structure, and the surface of the blocking part 3 is coated by pasting or hot-melt connection. During operation, blood flows into the blocking part 3 from the first opening 31 and flows out from the second opening 32. The setting of the blocking part 3 is used to reduce the cross-sectional area of ​​blood flow in the radial direction of the blood vessel, thereby reducing the flow rate and reducing the impact of blood flow on the blood vessel after the blood vessel is reopened. After using this device for two to three weeks, the blood vessel returns to normal, and then the carotid artery flow reduction thrombus protection device is removed.

[0077] Example 2

[0078] Reference Figure 2 Based on the first embodiment, the present embodiment further elaborates the blocking part 3, which is a braided mesh tube, which is made of shape memory alloy and developing alloy materials interwoven and densely knitted, and the proximal mesh port of the braided mesh tube is supported on the inner wall of the carotid artery. Preferably, the proximal mesh port of the braided mesh tube does not allow blood to pass through.

[0079] Example 3

[0080] Reference Figure 3 Based on the first embodiment, the present embodiment further elaborates the blocking part 3, which is a membrane, preferably a PTFE membrane. The PTFE membrane has good biocompatibility and chemical stability, has a good blocking effect on blood flow, and can prevent blood from flowing out of the membrane.

[0081] In another embodiment of the present application, the membrane is made of PET film. The PET film has high strength and toughness and can withstand the pressure in the blood vessels. The PET film can have a good blocking effect on blood flow.

[0082] Example 4

[0083] Reference Figure 4 and Figure 5 Based on the first embodiment, the present embodiment further elaborates the flow blocking part 3, which is a nickel-titanium laser engraved stent with a hollow skeleton structure. The nickel-titanium laser engraved stent is coated with a film, and the film is preferably made of PTFE or PTE. The coating method is application or hot-melt connection. The film does not completely cover the surface of the nickel-titanium laser engraved stent, and may only cover the proximal half of the nickel-titanium laser engraved stent, or may only cover the distal half of the nickel-titanium laser engraved stent.

[0084] In other embodiments of the present application, the film may also cover one-third, two-thirds, etc. of the surface area of ​​the nickel-titanium laser engraved stent.

[0085] Example 5

[0086] This embodiment describes a method for manufacturing the flow blocking portion 3 based on the first embodiment.

[0087] Reference Figure 1 , Figure 2 , Figure 6 and Figure 7The flow blocking part 3 includes a braided mesh tube, which is made of a mixture of shape memory alloy and developing alloy. A position is selected on the braided mesh tube, and a pointed cone is used. The width of the pointed cone gradually decreases from the proximal end to the distal end. The tip of the pointed cone is rotated and inserted in one direction, and then the pointed cone is removed. The edge of the first opening 31 of the mesh tube is sewed with a 0.013mm nickel-titanium wire 2. Then, the second stainless steel tube 4 with an inner diameter of 0.2mm is inserted into the tip of the pointed cone and reinserted into the mesh tube. The second stainless steel tube 4 and the second opening 32 of the mesh tube are sewed together with nickel-titanium alloy wire. Finally, the braided mesh tube and the pointed cone are fixed with copper wire, and the quality is carried out at 515±5℃ for 10min to finally generate an uncoated braided mesh tube.

[0088] Example 6

[0089] Reference Fig.11 The first opening 31 and the second opening 32 are coaxially arranged. It can be understood that in this solution, there is no angle between the axial directions of the first opening 31 and the second opening 32. The coaxially arranged flow blocking part 3 has good structural stability and can withstand high pressure, so that blood can flow stably.

[0090] In summary: the steps of using the carotid artery flow reduction and thrombosis protection device are as follows: after blood is recirculated, it first enters the blocking part 3 from the first opening 31. The blocking part 3 itself does not allow or only allows a small amount of blood to seep out. The blood will accumulate in the blocking part 3 and flow out from the second opening 32. Because the cross-sectional area of ​​the second opening 32 in the radial direction of the blood vessel is less than half of the cross-sectional area of ​​the first opening 31 in the radial direction of the blood vessel, the blood flow is restricted, and the blood flow at the recirculated blood vessel is reduced. The blocking part 3 is reduced from a channel with a diameter of 4-6mm at the proximal end to a channel with a maximum diameter of 2mm at the distal end, which can reduce the blood flow, thereby reducing the pressure in the blood vessel and preventing the blood flow from directly returning to level 3, resulting in capillary damage and the easy formation of cerebral hematoma infarction. Within two to three weeks of using this device, the recirculated blood vessel returns to normal, and then the blood flow carotid artery flow reduction and thrombosis protection device is removed to restore normal blood perfusion.

[0091] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A carotid artery flow reduction and thrombus protection device, characterized in that: It comprises a fixing assembly and a flow blocking part (3); The fixing assembly comprises a wire guide rod body (6), the wire guide rod body (6) passes through the flow blocking portion (3), and the flow blocking portion (3) is fixed on the wire guide rod body (6); The blocking portion (3) comprises a first opening (31) located at the proximal end and a second opening (32) located at the distal end, wherein the cross-sectional area of ​​the second opening (32) in the radial direction of the blood vessel is less than 30% of the cross-sectional area of ​​the first opening (31) in the radial direction of the blood vessel, and the blocking portion (3) reduces the blood flow in the carotid artery when the blood flows from the first opening (31) to the second opening (32).

2. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: The flow blocking part (3) is a dense mesh and / or a membrane.

3. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: The fixing assembly comprises a nickel-titanium wire (2) arranged circumferentially along a first opening (31) of the flow blocking portion (3), and a second stainless steel tube (4) arranged circumferentially along a second opening (32) of the flow blocking portion (3).

4. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: The diameter range of the first opening (31) in the radial direction of the blood vessel is 4-6 mm, and the diameter range of the second opening (32) in the radial direction of the blood vessel is less than or equal to 2 mm.

5. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: The fixing assembly comprises a first stainless steel tube (1) arranged on the guide wire rod body (6), and the proximal end of the flow blocking portion (3) is fixedly connected to the first stainless steel tube (1).

6. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: A developing spring (5) is arranged at the distal end of the wire guide rod body (6), and a metal welding ball (51) is arranged at the tail end of the developing spring (5).

7. The carotid artery flow reduction and thrombus protection device according to claim 1, characterized in that: The surface of the flow blocking portion (3) is provided with an adhesion coating.

8. The carotid artery flow reduction and thrombus protection device according to claim 7, characterized in that: The adhesion coating is formed by the fusion of phosphorylcholine and anhydrous ethanol, and the adhesion coating is attached to the flow-blocking portion (3) by means of dipping and volatilization.

9. The carotid artery flow reduction and thrombus protection device according to any one of claims 1 to 8, characterized in that: The first opening (31) and the second opening (32) are coaxially arranged.

10. The carotid artery flow reduction and thrombus protection device according to any one of claims 1 to 8, characterized in that: The first opening (31) and the second opening (32) are arranged off-axis.

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