Embolism protection device

Abstract

The utility model relates to the field of medical instruments, and discloses an embolism protection device which comprises a guide wire, a balloon assembly, a filter membrane and an outer tube, the balloon assembly is arranged on the guide wire in a sleeving mode and provided with a blood flow channel, the far end of the balloon assembly is fixedly connected with the guide wire, a plurality of filter holes are formed in the filter membrane, and the filter membrane is provided with an opening end and a tail end; the filter membrane wraps the outer surface of the balloon assembly, the open end wraps the near end of the balloon assembly, the tail end of the filter membrane wraps the far end, the guide wire is sleeved with the outer tube, the outer tube is located on one side of the near end, a charging and discharging channel is formed between the outer tube and the guide wire, and the near end is communicated with the charging and discharging channel. The filter membrane is arranged on the outer surface of the balloon assembly, the balloon assembly is filled and collided to support the filter membrane, the filter membrane is tightly attached to the inner wall of the blood vessel, thrombus is prevented from escaping from the gap between the filter membrane and the inner wall of the blood vessel, the filter holes are formed in the filter membrane, the thrombus in blood is filtered through the filter membrane, and the thrombus is prevented from escaping.

Description

TECHNICAL FIELD

[0001] The present application relates to the embolism treatment field, and particularly to an embolism protection device. BACKGROUND

[0002] Ischemic stroke is a serious cerebrovascular disease, and its incidence is closely related to carotid stenosis. Carotid stent implantation is an effective means for treating carotid stenosis, but the micro embolus fragments generated during the operation pose a potential threat to the brain and may cause stroke or brain nerve function damage. Therefore, embolism protection devices have emerged as the times require, aiming to capture these micro emboli and ensure the safety of the operation.

[0003] The current mainstream filter screen type embolism protection device is divided into two categories according to the forming method of the filter screen framework: one type uses nickel-titanium alloy pipe cutting or wire winding forming, and covers a high polymer film to achieve embolus filtration; the other type uses a woven umbrella structure, which has both filtering and liquid permeability. However, due to individual differences in the diameter of the patient's carotid artery, the existing protection device is difficult to completely conform to the blood vessel wall, resulting in the possibility of emboli escaping to the distal blood vessels and causing complications. CONTENT OF THE UTILITY MODEL

[0004] Therefore, the purpose of the present application is to overcome the deficiencies in the prior art, and to provide an embolism protection device.

[0005] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0006] The present application provides:

[0007] An embolism protection device, comprising:

[0008] A guide wire;

[0009] A balloon assembly, the balloon assembly is sleeved on the guide wire, the balloon assembly has a blood flow channel, and the distal end of the balloon assembly is fixedly connected with the guide wire;

[0010] A filter membrane, a plurality of filter holes are formed on the filter membrane, the filter membrane has an open end and a tail end, the filter membrane is wrapped on the outer surface of the balloon assembly, the open end of the filter membrane is wrapped on the proximal end of the balloon assembly, and the tail end of the filter membrane wraps the distal end of the balloon assembly;

[0011] An outer tube, the outer tube is sleeved on the guide wire, the outer tube is located on the proximal end side of the balloon assembly, a balloon assembly inflation and drainage channel is formed between the outer tube and the guide wire, and the proximal end of the balloon assembly is in communication with the inflation and drainage channel.

[0012] Further, the balloon assembly comprises:

[0013] Multiple balloons, each balloon having an inflation cavity, are fixedly connected to each other and surround each other to form a first channel;

[0014] A first connector is disposed at the connection between the proximal end of the balloon and the distal end of the outer tube and the guidewire. The first connector communicates with the inflation cavity of the balloon and with the inflation and deflation channel of the balloon.

[0015] The second connector is disposed at the distal end of the balloon and connected to the balloon, and the second connector is fixedly connected to the guidewire.

[0016] Furthermore, a second channel is defined between two adjacent balloons, and the first channel and the second channel form the blood flow channel.

[0017] Furthermore, a first developing element is sleeved on the guide wire, and the first developing element is located at the position of the first connector.

[0018] Furthermore, a second developing element is sleeved on the guide wire, and the second developing element is located at the position of the second connector.

[0019] Furthermore, an elastic element is provided at the distal end of the guidewire.

[0020] Furthermore, the pore size of the filter pores gradually decreases from the opening end of the filter membrane to the tail end of the filter membrane.

[0021] Furthermore, the pore size of the filter is D, which satisfies: 50μm≤D≤250μm.

[0022] Furthermore, the proximal and / or distal ends of the balloon assembly are tapered.

[0023] Furthermore, the outer surface of the guidewire is coated with a lubricating coating.

[0024] This application provides a filter membrane on the outer surface of a balloon assembly. The balloon assembly inflates to support the filter membrane, ensuring it adheres tightly to the inner wall of the blood vessel. This prevents thrombi from escaping through the gap between the filter membrane and the vessel wall. Furthermore, filter pores are created on the filter membrane to filter thrombi in the blood, further preventing thrombus escape. Simultaneously, the compliant balloon assembly design significantly reduces the stimulation of the blood vessel by the embolism protection device, preventing vasospasm.

[0025] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 A schematic diagram of the overall structure of the protection device of this application is shown;

[0028] Figure 2 A schematic diagram of the first shape of the balloon assembly of this application is shown;

[0029] Figure 3 A schematic diagram of the second shape of the balloon assembly of this application is shown;

[0030] Figure 4 A schematic cross-sectional view of the balloon assembly of this application is shown;

[0031] Figure 5 A schematic diagram of the first shape structure of the balloon of this application is shown;

[0032] Figure 6 A schematic diagram of the second shape structure of the balloon of this application is shown;

[0033] Figure 7 This diagram shows the protective device of this application in a non-deployed state within a blood vessel;

[0034] Figure 8 A schematic diagram of the protective device of this application in the deployed state within the first-shaped blood vessel is shown;

[0035] Figure 9 A schematic diagram of the protective device of this application unfolding in a second-shaped blood vessel is shown;

[0036] Figure 10 A schematic diagram of the protective device of this application deployed in a third-shaped blood vessel is shown;

[0037] Figure 11 A schematic diagram of the protection device in the present application in its recovery state is shown.

[0038] Key component symbols: 100-guidewire; 200-balloon assembly; 210-balloon; 211-filling cavity; 212-first channel; 213-second channel; 220-first connector; 230-second connector; 300-filter membrane; 310-filter pores; 400-outer tube; 500-first imaging element; 600-second imaging element; 700-elastic element; 800-catheter; 900-blood vessel; 1000-thrombus. Detailed Implementation

[0039] The embodiments of this application are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this application, and should not be construed as limiting this application.

[0040] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not 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 application.

[0041] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0042] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0043] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0044] Existing embolization protection structures are typically nickel-titanium skeletons, with a membrane covering the skeleton for thrombus filtration. However, due to individual differences in patient vessel diameter, it is difficult to ensure that the membrane on the outer surface of the nickel-titanium skeleton adheres tightly to the vessel wall, potentially allowing thrombi to escape through gaps between the membrane and the vessel wall. Furthermore, during surgical procedures, the nickel-titanium skeleton can irritate the vessel wall, easily triggering vasospasm. In other words, existing embolization devices suffer from poor membrane adhesion and susceptibility to vasospasm. To address this, this application uses a balloon assembly 200 as a support frame, with a filter membrane 300 having perforations 310 covering its outer surface. As the balloon assembly 200 inflates, the filter membrane 300 adheres completely to the vessel wall, preventing gaps that could allow thrombus escape and complications. Simultaneously, the compliant balloon assembly design, acting as a support frame for the filter membrane, significantly reduces irritation to the vessel wall during operation, preventing vasospasm.

[0045] This application provides an embolism protection device, specifically, the embolism protection device includes a guidewire 100, a balloon assembly 200, a filter membrane 300, and an outer tube 400.

[0046] The balloon assembly 200 is sleeved on the guidewire 100. The balloon assembly 200 has a blood flow channel. The distal end of the balloon assembly 200 is fixedly connected to the guidewire 100. The filter membrane 300 has multiple filter holes 310. The filter membrane 300 has an open end and a tail end. The filter membrane 300 covers the outer surface of the balloon assembly 200. The open end of the filter membrane covers the proximal end of the balloon assembly 200, and the tail end of the filter membrane covers the distal end of the balloon assembly 200. The outer tube 400 is sleeved on the guidewire 100. The outer tube 400 is located on the proximal side of the balloon assembly 200. An inflation-deflation channel is formed between the outer tube 400 and the guidewire 100. The proximal end of the balloon assembly 200 communicates with the inflation-deflation channel.

[0047] Please see Figure 1 As shown, blood flows through the blood flow channel of the balloon assembly 200 so that blood can pass through. After passing through, the blood flows downstream through the filter holes 310 on the filter membrane 300. During the flow, the filter holes 310 block and filter any thrombi that may be present in the blood to prevent thrombus escape and cause complications.

[0048] Furthermore, during use, fluid is first introduced into the balloon assembly 200 through the inflation / deflation channel formed between the outer tube 400 and the guidewire 100, causing it to inflate and increase in diameter. This allows the filter membrane 300 located on the outer surface of the balloon assembly 200 to adhere tightly to the inner wall of the blood vessel 900, preventing gaps from forming between the filter membrane 300 and the inner wall of the blood vessel 900, which could allow thrombi to escape and flow downstream, leading to complications.

[0049] Understandably, blood flows from the proximal end to the distal end of the balloon assembly 200. The filter membrane 300 can cover and seal the distal end of the balloon assembly 200, so that blood can only flow through the filter holes 310 to the distal end, thereby achieving the filtration and interception of thrombi through the filter holes 310.

[0050] In this embodiment, the liquid entering the balloon assembly 200 through the inflation / deflation channel can be physiological saline. This application uses the balloon assembly 200 to support the blood vessel, resulting in less irritation to the inner wall of the blood vessel and reducing the risk of vascular spasm. To further prevent spasm during surgery, an antispasmodic drug can be coated on the outer surface of the filter membrane 300. The antispasmodic drug can be atropine, papaverine hydrochloride, heparin, or other water-soluble antispasmodic drugs.

[0051] The balloon assembly 200 includes multiple balloons 210, a first connector 220, and a second connector 230.

[0052] Specifically, the balloon 210 has an inflation cavity 211. Multiple balloons 210 are fixedly connected and surround each other to form a first channel 212. A first connector 220 is disposed at the connection point between the proximal end of the balloon 210 and the distal end of the outer tube 400 and the guidewire 100. The first connector 220 communicates with the inflation cavity 211, and the end of the first connector 220 away from the balloon 210 communicates with the inflation / deflation channel. A second connector 230 is disposed at the distal end of the balloon 210 and connected to the balloon 210. The second connector 230 is fixedly connected to the guidewire.

[0053] See Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, to facilitate smoother blood flow, the balloon assembly 200 is composed of multiple balloons 210. The first channel 212 formed by the multiple balloons 210 provides ample space for blood from upstream to flow through. To enable the entire balloon assembly 200 to inflate, each balloon 210 has an inflation cavity 211. The inflation / deflation channel injects appropriate liquid into the inflation cavity 211 through the first connector 220, causing the balloon 210 to inflate. This, in turn, increases the diameter of the entire balloon assembly 200, thereby causing the filter membrane 300 to adhere tightly to the inner wall of the blood vessel 900.

[0054] Please continue reading. Figures 1 to 4As shown, each balloon 210 has a first connector 220 connected to its end facing the outer tube 400. The first connector 220 is connected to the inflation cavity 211 and the inflation-deflation channel. That is, the inflation cavity 211 of the balloon 210 is connected to the inflation-deflation channel through the first connector 220.

[0055] Furthermore, the first connector 220 is tubular and connected to the end of the outer tube 400. The first connector 220 is fixed to the outer surface of the guidewire 100. Each balloon 210 is connected to a first tube foot, which is hollow. The first tube foot is fixedly connected to the outer surface of the guidewire 100. One end of the first tube foot communicates with the inflation cavity 211 of the balloon 210, and the other end of the first tube foot communicates with the first connector 220. Since the first connector 220 communicates with the inflation and deflation channel, liquid is transported to the inflation cavity 211 of each balloon 210 through the channel formed by the inflation and deflation channel, the first connector 220, and the first tube foot. This increases the diameter of the balloon assembly 200, thereby making the filter membrane 300 on its surface adhere tightly to the inner wall of the blood vessel and improving its adhesion.

[0056] In this embodiment, the balloon 210 has only one entrance and exit, that is, the port of the inflation cavity 211 facing the second connector 230 is closed. Furthermore, the distal end of the balloon 210 is fixedly connected to the surface of the guidewire 100 through the second connector 230.

[0057] Please continue reading. Figure 1 and Figure 2 As shown, the second connector 230 is located at the distal end of the balloon 210. The second connector 230 is fixedly connected to the guide wire 100, and each balloon 210 is also provided with a second tube at the distal end. The second tube is connected to the second connector 230, that is, the distal end of the balloon 210 is fixedly connected to the second connector through the second tube.

[0058] It should be noted that in order to allow blood to flow smoothly, there should be a gap between adjacent first pins. Similarly, there should also be a gap between adjacent second pins to allow blood to flow.

[0059] The number of balloons 210 can be an even number, such as 2, 4, 6, 8, or 10. In practice, different numbers can be set according to actual needs, and there is no limit here.

[0060] The proximal and / or distal ends of the balloon assembly 200 are conical. The proximal end of the balloon assembly 200 is where the first connector 220 is located, and the distal end of the balloon assembly 200 is where the second connector 230 is located. That is, the shape of the first connector 220 can be conical, and the shape of the second connector 230 can also be conical. The specific design can be made according to the needs. In this embodiment, both the first connector 220 and the second connector 230 are conical.

[0061] For example, the balloon 210 of the balloon assembly 200 can be made of flexible materials such as polyurethane or polyether block amide (Pebax) to reduce irritation to the vascular endothelium.

[0062] Understandably, the balloon 210 can be of different shapes, such as Figure 2 The balloon assembly 200 shown consists of a balloon 210 with parallel segments, a conical first connector 220, and a conical second connector 230, as follows: Figure 3 The balloon assembly 200 shown comprises a cone-shaped balloon 210, a cone-shaped first connector 220, and a cone-shaped second connector 230. Furthermore, Figure 5 What is shown is a single parallel balloon 210. Figure 6 The image shows a single cone-shaped balloon 210.

[0063] Please continue reading. Figure 4 As shown, a second channel 213 is defined between two adjacent balloons 210, and the first channel 212 and the second channel 213 form the blood flow channel. In order to further improve blood flow and reduce the influence of the balloon assembly 200 on blood flow, when two adjacent balloons 210 are connected, a second channel 213 can be formed between them, thereby increasing the area for blood flow and allowing blood to flow smoothly.

[0064] The guide wire 100 is fitted with a first developing element 500, which is located at the position of the first connector 220; the guide wire 100 is fitted with a second developing element 600, which is located at the position of the second connector 230.

[0065] See Figure 1 As shown, during the operation, in order to accurately determine the position of the balloon assembly 200 and the filter membrane 300 in the blood vessel, a first imaging element 500 and a second imaging element 600 are set on the guidewire 100. With the help of imaging technology, the position of the balloon assembly 200 and the filter membrane 300 can be accurately obtained, thereby determining whether the predetermined position has been reached.

[0066] Specifically, the first developing element 500 and the second developing element 600 are made of metals that do not project lines, such as gold, platinum-tungsten alloy, platinum-iridium alloy, etc.

[0067] An elastic element 700 is provided on the end of the guidewire 100 away from the balloon assembly 200.

[0068] Please see Figures 1 to 3 As shown, when the entire device is inserted into the blood vessel 900, in order to prevent the end of the guidewire 100 from damaging the inner wall of the blood vessel, an elastic element 700 is provided at the tip of the guidewire 100 to prevent damage to the inner wall of the blood vessel.

[0069] Furthermore, the elastic element 700 contains non-projected metal powder, thereby enabling positioning to be achieved to a certain extent through the elastic element 700.

[0070] In this embodiment, to make the guidewire 100 easier to push, a lubricating coating is applied to the surface of the guidewire 100. The lubricating coating can be selected as needed and is not limited here.

[0071] The pore size of the filter pore 310 gradually decreases from the opening end of the filter membrane to the tail end of the filter membrane; the pore size of the filter pore 310 is D, which satisfies: 50μm≤D≤250μm.

[0072] See Figure 1 As shown, by using a gradually changing pore size, thrombi can be captured without affecting the flow of blood within the blood vessel. The size of the pore size D can be 50μm, 100μm, 150μm, 200μm, 250μm, etc.

[0073] See Figure 7 As shown, when it is necessary to place the embolization protection device into the blood vessel, the embolization protection device can be compressed into the catheter 800 first. When the thrombus 1000 is reached, the catheter 800 can be withdrawn, and normal saline can be injected into the balloon assembly 200 through the inlet of the outer tube 400. After the balloon assembly 200 is filled with normal saline, it expands, so that the filter membrane 300 on its outer surface is tightly attached to the inner wall of the blood vessel 900. The thrombus in the blood can be blocked and filtered through the filter pores 310 of the filter membrane 300.

[0074] See Figure 8 , Figure 9 as well as Figure 10 As shown, it can be understood that the embolization protection device can be deployed in blood vessels 900 of different shapes. The size of the inflation of the balloon 210 can be controlled by the volume of liquid injected into the balloon 210, thus adapting to blood vessels 900 of different diameters and improving adaptability.

[0075] See Figure 11 As shown, after use, the saline solution in the balloon assembly 200 is released and extracted through the inlet of the inflation / deflation channel. At this time, there is no saline solution in the balloon assembly 200, so the balloon assembly 200 contracts and the catheter 800 is pushed forward to draw the balloon assembly 200 and the filter membrane 300 located on the outer surface of the balloon assembly 200 into its interior, thereby achieving recovery.

[0076] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0077] Although embodiments of this application have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting this application. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of this application.

Claims

1. An embolism protection device, characterized in that, include: Guide wire (100); A balloon assembly (200) is sleeved on the guidewire (100), the balloon assembly (200) has a blood flow channel, and the distal end of the balloon assembly (200) is fixedly connected to the guidewire (100); A filter membrane (300) has a plurality of filter pores (310) formed thereon. The filter membrane (300) has an open end and a tail end. The filter membrane (300) covers the outer surface of the balloon assembly (200). The open end of the filter membrane covers the proximal end of the balloon assembly (200), and the tail end of the filter membrane covers the distal end of the balloon assembly (200). An outer tube (400) is sleeved on the guidewire (100). The outer tube (400) is located on the proximal side of the balloon assembly (200). An inflation-deflation channel is formed between the outer tube (400) and the guidewire (100). The proximal end of the balloon assembly (200) is connected to the inflation-deflation channel.

2. The embolism protection device according to claim 1, characterized in that, The balloon assembly (200) includes: Multiple balloons (210) having an inflation cavity (211) are fixedly connected to each other and surround each other to form a first channel (212); A first connector (220) is disposed at the connection between the proximal end of the balloon (210) and the distal end of the outer tube (400) and the guidewire (100). The first connector (220) communicates with the inflation cavity (211), and the end of the first connector (220) away from the balloon (210) communicates with the inflation channel. The second connector (230) is disposed at the distal end of the balloon (210) and connected to the balloon (210), and the second connector (230) is fixedly connected to the guide wire (100).

3. The embolism protection device according to claim 2, characterized in that, A second channel (213) is defined between two adjacent balloons (210), and the first channel (212) and the second channel (213) form the blood flow channel.

4. The embolism protection device according to claim 2, characterized in that, The guide wire (100) is fitted with a first developing element (500), which is located at the position of the first connector (220).

5. The embolism protection device according to claim 2, characterized in that, The guide wire (100) is fitted with a second developing element (600), which is located at the position of the second connector (230).

6. The embolism protection device according to claim 1, characterized in that, An elastic element (700) is provided at the distal end of the guide wire (100).

7. The embolism protection device according to claim 1, characterized in that, The pore size of the filter pore (310) gradually decreases from the opening end of the filter membrane (300) to the tail end of the filter membrane (300).

8. The embolism protection device according to claim 1 or 7, characterized in that, The pore size of the filter (310) is D, which satisfies: 50μm≤D≤250μm.

9. The embolism protection device according to claim 1, characterized in that, The proximal and / or distal ends of the balloon assembly (200) are tapered.

10. The embolism protection device according to claim 1, characterized in that, The outer surface of the guide wire (100) is coated with a lubricating coating.

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