Method of making a thrombectomy device
By using a push rod design in the thrombus removal device that integrates a plastic layer formed by hot-melt filling of a plastic tube with a slender tube, the problem of unreliable connection between the thrombectomy stent and the push rod is solved, achieving reliable connection and efficient thrombus removal.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-07-19
- Publication Date
- 2026-04-07
AI Technical Summary
In existing thrombus removal devices, the connection between the thrombectomy stent and the push rod is unreliable, especially when the thrombus is withdrawn, it is easy to fall off, which affects the removal effect and the burden on the patient.
By setting a fixing groove on the connector, a plastic layer is formed by hot-melting a plastic tube and fusing it with a slender tube to form a protrusion that engages with the fixing groove, thus achieving a tight fit between the push rod and the connector and ensuring a reliable connection.
This improved the reliability of the connection between the push rod and the thrombectomy stent, reduced the risk of dislodgement, and increased the success rate and safety of thrombus removal.
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Figure CN116650064B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the technical field of medical devices, and more particularly to a method for preparing a thrombus removal device. Background Technology
[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.
[0003] Embolism is the phenomenon where an abnormal substance insoluble in blood appears in the circulating blood and travels to a distant location to block a blood vessel. The substance blocking the blood vessel is called an embolus. Emboli can be solid (such as a thrombus that breaks off from the blood vessel wall), liquid (such as a lipid droplet from a fracture), or gaseous (such as air entering the bloodstream during a venous injury). Embolism caused by detached thrombi is the most common, such as deep vein embolism, pulmonary embolism, and cerebral embolism.
[0004] Deep vein thrombosis (DVT) occurs when an embolus forms and develops within one of the body's deep veins (e.g., the iliac vein). These emboli can detach from the vein wall, cross the heart, and embed themselves in the pulmonary artery, potentially causing a pulmonary embolism. The main causes of DVT are damage to the vein wall, slow blood flow, and a hypercoagulable state.
[0005] Pulmonary embolism (PE) is a clinical and pathophysiological syndrome caused by the blockage of the pulmonary artery or its branches by endogenous or exogenous emboli, resulting in pulmonary circulatory disturbances. The most common and prevalent type is pulmonary thromboembolism (PTE).
[0006] Deep vein thrombosis is the main source of thrombi that cause pulmonary thromboembolism. It can cause embolism by circulating to the pulmonary artery and lead to the patient's death.
[0007] Cerebral artery embolism can lead to stroke, which in severe cases can cause disability or death, seriously affecting people's quality of life.
[0008] Therefore, there is a need for a thrombus removal device to reduce the likelihood of thrombi and their fragments becoming lodged in the vascular system.
[0009] Existing thrombectomy devices typically connect a thrombectomy stent to a pusher. During use, a certain force is applied to push the thrombectomy stent into the catheter. After the thrombectomy stent is delivered to the embolism site through the catheter, it is pushed out of the catheter and pushed to the distal end of the thrombus. Then, the thrombectomy stent is withdrawn to bring the thrombus into the catheter, thereby clearing the thrombus from the blood vessel.
[0010] For existing thrombus removal devices, the main indicators of concern in the field include the amount of thrombus removed in a single session, the success rate of thrombus removal in a single session, and ease of operation, while the connection performance between the thrombus removal stent and the push rod is rarely considered.
[0011] However, thrombectomy stents are generally made of metal to provide sufficient radial support and prevent collapse within the blood vessel, thus hindering thrombus interception. During deployment, while maintaining performance, a flexible pusher is chosen to facilitate passage through curved blood vessels. Therefore, pushers are typically made of polymer materials to ensure the flexibility of the thrombus removal device. Consequently, the reliability of the connection between the metal thrombectomy stent and the polymer pusher is crucial. Connecting two different materials, metal and polymer, is more difficult than connecting materials of the same type. An unreliable connection can lead to the stent detaching from the pusher during retraction. This is especially true when the thrombus is hard; the retraction force required to bring the thrombus into the catheter is greater, necessitating a higher pulling force on the pusher, increasing the risk of detachment. Once detachment occurs, not only is thrombus removal impossible, but additional retraction of the stent into the catheter is required, increasing the burden on the patient. Summary of the Invention
[0012] Therefore, it is necessary to provide a method for preparing a thrombus removal device with good connection reliability.
[0013] A method for preparing a thrombus removal device includes the following steps:
[0014] A thrombectomy bracket and a connector are provided. The thrombectomy bracket includes a proximal constrictor. The connector includes a first connecting portion and a second connecting portion connected to the first connecting portion. A fixing groove is provided on the second connecting portion. The first connecting portion passes through the proximal constrictor and is connected to the proximal constrictor. The second connecting portion extends axially proximally.
[0015] A plastic tube and a first heat shrink tube are provided, the plastic tube is sleeved on the second connecting part, and the first heat shrink tube is sleeved on the plastic tube;
[0016] The heat treatment melts the plastic tube but the first heat shrink tube does not melt. The first heat shrink tube shrinks and covers the surface of the connector. The molten plastic tube fills the fixing groove.
[0017] The curing process causes the molten plastic tube to form a plastic layer that snaps into the fixing groove. The inner wall of the plastic layer has a protrusion and a recess corresponding to the protrusion. The protrusion is embedded in the fixing groove, and the surface of the recess is in contact with the outer surface of the connector.
[0018] Peel off the first heat shrink tubing to provide a slender tube and a second heat shrink tubing. Sleeve the slender tube onto the plastic layer, and sleeve the second heat shrink tubing onto the distal end of the slender tube. The second heat shrink tubing is radially opposite to the plastic layer.
[0019] Heat treatment fuses the plastic layer with the slender tube to form a push rod with protrusions and recesses on the inner wall of the area fitted onto the connector.
[0020] In one embodiment, the first connecting portion abuts against the distal end face of the proximal condenser, and the outer wall of the first connecting portion abuts against the inner wall of the proximal condenser to connect the first connecting portion to the proximal condenser; or, the first connecting portion and the proximal condenser are connected by welding or bonding.
[0021] In one embodiment, the proximal constrictor is annular, and the first connecting portion includes a fixing segment and an abutting segment connected to the fixing segment; the fixing segment and the abutting segment are cylindrical, and the bottom diameter of the abutting segment is larger than the bottom diameter of the fixing segment; or, the fixing segment is cylindrical, the abutting segment is frustum-shaped, the end of the abutting segment with a smaller bottom area is connected to the fixing segment, and the diameter of the end of the abutting segment with a smaller bottom area is larger than the diameter of the fixing segment.
[0022] In one embodiment, there are multiple fixing grooves, which are distributed at intervals along the axial direction of the connector.
[0023] In one embodiment, the thrombectomy stent further includes a proximal net, a distal net, a central convergence member, and a distal convergence member, wherein the proximal end of the proximal net is converged to the proximal convergence member, the distal end of the proximal net is converged to the central convergence member, the proximal end of the distal net is converged to the central convergence member, and the distal end of the distal net is converged to the distal convergence member.
[0024] In one embodiment, the following steps are also included:
[0025] A filter membrane is provided and the filter membrane is fixed inside the distal mesh.
[0026] In one embodiment, the distal end of the filter membrane is a closed end, and the distal end of the filter membrane is fixedly connected to the distal end gathering member. The proximal end of the filter membrane is wavy, and the proximal end of the filter membrane is fixed to the distal end net. The proximal end of the filter membrane is an open end, and the open end unfolds as the distal end net unfolds.
[0027] In one embodiment, the plastic tube is a Pebax tube, and the first heat shrink tube and the second heat shrink tube are FEP tubes.
[0028] In one embodiment, the outer diameter of the second connecting portion is smaller than the inner diameter of the elongated tube, and the overall outer diameter of the plastic layer and the second connecting portion is larger than the inner diameter of the elongated tube. Before the elongated tube is fitted onto the plastic layer, the method further includes the step of expanding the distal end of the elongated tube to tightly fit the elongated tube onto the plastic layer.
[0029] In one embodiment, the outer diameter of the second connector is 0.2-0.4 mm smaller than the inner diameter of the elongated tube, and the overall outer diameter of the plastic layer and the second connector is 0.1-0.2 mm larger than the inner diameter of the elongated tube.
[0030] In the preparation method of the above-mentioned thrombus removal device, the connector is connected to the thrombectomy stent, the connector is provided with a fixing groove, the push rod is sleeved on the connector, a plastic layer is formed by hot-melt filling of the surface of the connector with a plastic tube, and the plastic layer is fused with the slender tube to form a protrusion that engages with the fixing groove, and the push rod with the recessed part that fits against the surface of the connector, so as to achieve a tight fit between the push rod and the connector, so as to reliably connect the push rod and the connector, and thus achieve a reliable connection between the push rod and the thrombectomy stent. Attached Figure Description
[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0032] in:
[0033] Figure 1 This is a schematic diagram of the structure of a thrombus removal system according to one embodiment;
[0034] Figure 2 This is a schematic diagram of the structure of a thrombus removal device according to one embodiment;
[0035] Figure 3 This is a schematic diagram of the radial unfolding of the proximal mesh of a thrombectomy stent according to one embodiment;
[0036] Figure 4 This is a schematic diagram of the radial unfolding of the distal mesh of a thrombectomy stent according to one embodiment;
[0037] Figure 5 This is a schematic diagram of the structure of a thrombectomy stent according to one embodiment;
[0038] Figure 6 This is a schematic diagram of the structure of a connector according to one embodiment;
[0039] Figure 7 for Figure 6A sectional view along line AA;
[0040] Figure 8 This is a cross-sectional schematic diagram of a push rod according to one embodiment;
[0041] Figure 9 This is a schematic diagram of the thrombus removal device according to another embodiment;
[0042] Figure 10 This is a schematic diagram of the structure of a reinforced pipe joint according to one embodiment;
[0043] Figure 11 This is a schematic diagram of the structure of a catheter assembly according to one embodiment;
[0044] Figures 12A-12C These are schematic diagrams of the catheters in different embodiments;
[0045] Figure 13 This is a schematic diagram showing the thrombectomy stent portion of a thrombus removal device according to an embodiment being housed in a catheter.
[0046] Figure 14 This is a schematic diagram of the structure of a suction device according to one embodiment;
[0047] Figures 15-16 This is a schematic diagram of the thrombectomy process;
[0048] Figure 17 This is a schematic diagram of the thrombus removal device according to another embodiment. Detailed Implementation
[0049] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0050] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of 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, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0051] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.
[0052] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, and "radial direction" generally refers to the direction perpendicular to the "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.
[0053] Please see Figure 1 One embodiment of the thrombus removal system 100 includes a thrombus removal device 1 and a suction device 2. The thrombus removal device 1 and the suction device 2 are used together to remove thrombi from blood vessels.
[0054] Please see Figure 2 The thrombus removal device 1 includes a thrombectomy stent 10 and a push rod 30A. The thrombectomy stent 10 is connected to the distal end of the push rod 30A, and the push rod 30A is used to push the thrombectomy stent 10 into the blood vessel for thrombectomy.
[0055] Please continue reading. Figure 2 In one embodiment, the thrombectomy stent 10 includes a proximal net 110 and a distal net 120 connected to the proximal net 110. Both the proximal net 110 and the distal net 120 have a structure that is larger in the middle and smaller at both ends, so that the distal end of the thrombectomy stent 110 is constricted, which is conducive to the thrombectomy stent 10 passing through the thrombus; the proximal end is also constricted, so as to facilitate the retraction of the thrombectomy stent 110 into the catheter and remove the intercepted thrombus from the body.
[0056] Please refer to the following: Figure 2 and Figure 3 In one embodiment, the proximal network 110 includes a first support portion 111, a first proximal connection portion 112 and a first distal connection portion 113, with the two ends of the first support portion 111 connected to the first proximal connection portion 112 and the first distal connection portion 113, respectively.
[0057] The first support portion 111 includes a plurality of first support units 1111, which are connected to form a circumferentially closed grid structure. In one embodiment, the first support unit 1111 includes two first proximal rods 1111A, two first intermediate rods 1111B, and two first distal rods 1111C. The two first proximal rods 1111A are connected at their proximal ends to form a first proximal connection point 1111a. The two first distal rods 1111C are connected at their distal ends to form a first distal connection point 1111c. Of the two first intermediate rods 1111B, the two ends of one first intermediate rod 1111B are respectively connected to the end of a first proximal rod 1111A away from the first proximal connection point 1111a and the end of a first distal rod 1111C away from the first distal connection point 1111c; the two ends of the other first intermediate rod 1111B are respectively connected to the end of another first proximal rod 1111A away from the first proximal connection point 1111a and the end of another first distal rod 1111C away from the first distal connection point 1111c, and the two first intermediate rods 1111B are parallel. Two adjacent first support units 1111 share one first intermediate rod 1111B.
[0058] The first proximal connecting portion 112 includes a plurality of first proximal connecting rods 1121. In one embodiment, the first proximal connecting rods 1121 are strip-shaped rods. Furthermore, the number of first proximal connecting rods 1121 is equal to the number of first support rod units 1111, with each of the plurality of first proximal connecting rods 1121 corresponding to one of the plurality of first support units 1111. One end of each first proximal connecting rod 1121 is connected to a first proximal connecting point 1111a of the first support unit 1111.
[0059] It is understood that in other embodiments, the first proximal connecting rod 1121 is not limited to a strip rod, but can be other shapes. For example, it can be a wavy rod, an S-shaped rod, etc.
[0060] Please refer to the following: Figure 2 and Figure 3 The thrombectomy bracket 10 also includes a proximal constriction member 130. The ends of the plurality of first proximal connecting rods 1121 that are away from the first proximal connection point 1111a converge on the proximal constriction member 130 and are connected to the proximal constriction member 130, so that the thrombectomy bracket 10 is constricted from the first support portion 111 to the proximal constriction member 130.
[0061] The first distal connection portion 113 includes a plurality of first distal connection rods 1131. In one embodiment, such as Figure 3As shown, the first distal connecting rod 1131 is a Y-shaped rod, including a straight section 1131A and two branch sections 1131B connected to the straight section 1131A. The number of first support units 1111 is twice the number of the first distal connecting rods 1131, with one first distal connecting rod 1131 corresponding to two adjacent first support units 1111. The ends of the two branch sections 1131B furthest from the straight section 1131A are respectively connected to two adjacent first distal connection points 1111c.
[0062] It should be noted that in other embodiments, the first distal connecting rod 1131 is not limited to a Y-shaped rod, but can be a connecting rod of other shapes. For example, the shape of the first distal connecting rod 1131 can be the same as the shape of the first proximal connecting rod 1121.
[0063] The first proximal connecting rod 1121 is configured as a strip rod, and the number of the first proximal connecting rods 1121 is equal to the number of the first support units 1111. On the one hand, this allows the first proximal connecting portion 112 to better support the first support portion 111, which helps maintain the first support portion 111 in a radially expanded state and prevents collapse that could cause thrombus escape. On the other hand, during the process of retracting the thrombectomy stent 10 to bring the thrombus into the catheter, the first proximal connecting portion 112 directly contacts the thrombus. The presence of a larger number of first proximal connecting rods 1121 results in a higher density of the first proximal connecting portion 112, which can intercept more thrombi and increase the amount of thrombus that can be retrieved in a single procedure.
[0064] Please refer to them again. Figure 2 and Figure 3 The thrombectomy bracket 10 also includes a central convergence member 140 and a distal convergence member 150. The ends of the straight sections 1131A of the plurality of first distal connecting rods 1131, which are furthest from the branch sections 1131B, converge onto the central convergence member 140 and are fixedly connected to the central convergence member 140, so that the thrombectomy bracket 10 is in a convergent shape from the first support portion 111 to the central convergence member 140.
[0065] Setting the first distal connecting rod 1131 as a Y-shaped rod has two advantages. First, it ensures that each first distal connection point 1111c of the first support part 111 is supported, which helps the first support part 111 maintain a radially expanded state and avoids collapse that could cause thrombus escape. Second, it reduces the number of connection points with the central constriction member 140, which helps improve the flexibility of the middle part of the thrombectomy stent 10.
[0066] Please refer to the following: Figure 2 and Figure 4 In one embodiment, the remote network 120 includes a second support portion 121, a second proximal connection portion 122, and a second remote connection portion 123, with the two ends of the second support portion 121 connected to the second proximal connection portion 122 and the second remote connection portion 123, respectively.
[0067] The second support portion 121 includes a plurality of second support units 1211, which are connected to form a circumferentially closed grid structure. In one embodiment, the second support unit 1211 includes two second proximal rods 1211A, two second intermediate rods 1211B, and two second distal rods 1211C. The two second proximal rods 1211A are connected at their proximal ends to form a second proximal connection point 1211a. The two second distal rods 1211C are connected at their distal ends to form a second distal connection point 1211c. Of the two second intermediate rods 1211B, one second intermediate rod 1211B has its two ends connected to the end of a second proximal rod 1211A away from the second proximal connection point 1211a and the end of a second distal rod 1211C away from the second distal connection point 1211c, respectively; the other second intermediate rod 1211B has its two ends connected to the end of another second proximal rod 1211A away from the second proximal connection point 1211a and the end of another second distal rod 1211C away from the second distal connection point 1211c, respectively, and the two second intermediate rods 1211B are parallel. Two adjacent second support units 1211 share one second intermediate rod 1211B.
[0068] The second proximal connection portion 122 includes a plurality of second proximal connecting rods 1221. In one embodiment, the second proximal connecting rod 1221 is a Y-shaped rod, including a straight section 1221A and two branch sections 1221B connected to the straight section 1221A. The number of second support units 1211 is twice the number of second proximal connecting rods 1221, with one second proximal connecting rod 1221 corresponding to two adjacent second support units 1211. The ends of the two branch sections 1221B that are away from the straight section 1221A are respectively connected to two adjacent second proximal connection points 1211a.
[0069] The second distal connection portion 123 includes a plurality of second distal connection rods 1231. In one embodiment, the second distal connection rod 1231 is a Y-shaped rod, including a straight section 1231A and two branch sections 1231B connected to the straight section 1231A. The number of second support units 1211 is twice the number of second distal connection rods 1231, and one second distal connection rod 1231 corresponds to two adjacent second support units 1211. The ends of the two branch sections 1231B that are away from the straight section 1231A are respectively connected to two adjacent second distal connection points 1211c.
[0070] Please refer to the following: Figure 2 and Figure 4In one embodiment, the ends of the straight segments 1221A of the plurality of second proximal connecting rods 1221, away from the branch segments 1221B, converge onto the central convergence member 140 and are fixedly connected to the central convergence member 140, so that the thrombectomy bracket 10 is converged from the second support portion 121 to the central convergence member 140. The ends of the straight segments 1231A of the plurality of second distal connecting rods 1231, away from the branch segments 1231B, converge onto the distal convergence member 150 and are fixedly connected to the distal convergence member 150, so that the thrombectomy bracket 10 is converged from the second support portion 121 to the distal convergence member 150.
[0071] In one embodiment, the proximal condenser 130, the middle condenser 140, and the distal condenser 150 are all annular. In the natural state (unstressed state), the diameter of the circumscribed circle of the first support portion 111 of the proximal net 110 and the diameter of the circumscribed circle of the second support portion 121 of the distal net 120 are both larger than the diameters of the proximal condenser 130, the middle condenser 140, and the distal condenser 150.
[0072] In one embodiment, regardless of the shape of the first distal connecting rod 1131 and the second proximal connecting rod 1221, the first distal connecting rod 1131 and the second proximal connecting rod 1221 are radially misaligned in the central converging member 140. That is, a second proximal connecting rod 1221 is disposed between the two first distal connecting rods 1131, and a first distal connecting rod 1131 is disposed between the two second proximal connecting rods 1221, which improves the flexibility of the thrombectomy stent 10. Furthermore, the radial misalignment of the first distal connecting rod 1131 and the second proximal connecting rod 1221 allows the second proximal connecting rod 1221 between the two first distal connecting rods 1131 to intercept thrombi escaping from the gap between the two first distal connecting rods 1131 to a certain extent, thereby increasing the amount of thrombus removed in a single procedure.
[0073] In one embodiment, when both the first distal connecting rod 1131 and the second proximal connecting rod 1221 are Y-shaped rods, the straight segments 1131A of the first distal connecting rod 1131 and the straight segments 1221A of the second proximal connecting rod 1221 are radially misaligned in the middle converging member 140 (e.g., Figure 5 As shown), it provides better support for the first support part 111 and the second support part 121, and makes the middle part of the thrombectomy bracket 10 more flexible, which is conducive to increasing the amount of thrombectomy in a single operation.
[0074] Please continue reading. Figure 5 In one embodiment, the proximal net 110 is provided with a plurality of circumferentially distributed capture elements 114 to improve the capture performance of the proximal net 110, enabling it to capture more thrombi and prevent thrombi from escaping.
[0075] Each capture element 114 extends from the proximal end to the distal end of the first support 111.
[0076] In one embodiment, a plurality of gripping elements 114 are located outside the proximal net 110. In another embodiment, the plurality of gripping elements 114 are located outside the proximal net 110, and in the stretched state, the length of the gripping elements 114 is less than the length of the first support unit 1111, such that in the stretched state, the gripping elements 114 do not overlap the first support portion 111 or the first distal connection portion 113, thereby avoiding increasing the conveying profile and rigidity and causing conveying difficulties.
[0077] In other embodiments, multiple capture elements 114 are located inside the near-end net 110. The multiple capture elements 114 located inside the near-end net 110 can also improve the interception performance of the near-end net 110, thereby helping to increase the number of thrombi removed in a single operation.
[0078] In one embodiment, the near-end net 110, the far-end net 120, the near-end condenser 130, the middle condenser 140, and the far-end condenser 150 are an integral structure. For example, they can be formed by cutting a metal tube and then shaping it.
[0079] In one embodiment, the thrombectomy stent 10 is made of shape memory material, which gives the thrombectomy stent 10 self-expanding properties, allowing it to self-expand after being pushed out of the catheter.
[0080] It should be noted that in other embodiments, the proximal network 110 and the distal network 120 are not limited to the above-described structures, and can be other structures capable of intercepting thrombi. For example, in another embodiment, both the first support unit 1111 and the second support unit 1211 are rhomboid structures.
[0081] It should also be noted that in other embodiments, the distal net 120 is omitted, that is, the thrombectomy bracket 10 does not include the distal net 120, and the proximal net 110 is provided with a plurality of circumferentially distributed capture elements 114. Alternatively, the thrombectomy bracket 10 does not include the distal net 120, and the proximal net 110 is not provided with capture elements 114.
[0082] The simultaneous arrangement of the proximal mesh 110 and the distal mesh 120 improves the capture performance of the thrombectomy stent 10 and increases the amount of thrombectomy performed in a single session. However, omitting the distal mesh 120 results in a shorter axial length for the thrombectomy stent 10. When the embolism site is close to the closed end of the blood vessel or near the section where the vessel diameter decreases, the shorter axial length of the thrombectomy stent 10 can penetrate the thrombus and be located distal to the thrombus, thus enabling thrombectomy.
[0083] Please continue reading. Figure 5The thrombus removal device 1 also includes a connector 50. The connector 50 connects the thrombectomy stent 10 and the push rod 30A. The connector 50 passes through and is connected to the proximal constrictor 130, and extends axially proximally. The push rod 30A is sleeved on and connected to the connector 50.
[0084] Please refer to the following: Figure 6 and Figure 7 The connector 50 includes a first connecting portion 510 and a second connecting portion 520, which are connected together. A through hole 530 extending axially along the connector 50 passes through both the first connecting portion 510 and the second connecting portion 520. A fixing groove 521 is provided on the second connecting portion 520. The opening of the fixing groove 521 is located outside the second connecting portion 520.
[0085] The first connecting part 510 is connected to the proximal constriction 130 of the thrombectomy bracket 10, and the second connecting part 520 extends axially proximally.
[0086] In one embodiment, such as Figure 6 As shown, the first connecting portion 510 includes a fixing section 511 and an abutting section 512 connected to the fixing section 511. The fixing section 511 is cylindrical, and the abutting section 512 is also cylindrical, with the bottom diameter of the abutting section 512 being larger than the bottom diameter of the fixing section 511. Alternatively, the fixing section 511 is cylindrical, and the abutting section 512 is frustum-shaped, with the end of the abutting section 512 with a smaller bottom area connected to the fixing section 511, and the diameter of the end of the abutting section 512 with a smaller bottom area being larger than the diameter of the fixing section 511.
[0087] The connector 50 passes through the proximal fascicle 130, with the abutting section 512 abutting against the distal end face of the proximal fascicle 130. At least a portion of the outer surface of the retaining section 511 abuts against the inner surface of the proximal fascicle 130, thus connecting the retaining section 511 to the proximal fascicle 130. Alternatively, the retaining section 511 can be fixedly connected to the proximal fascicle 130 by welding. The second connecting portion 520 of the connector 50 extends axially proximally.
[0088] The push rod 30A is sleeved on the connector 50. Specifically, the push rod 30A completely covers the second connecting part 520. Please refer to the attached document. Figure 7 and Figure 8The push rod 30A includes a region A1 covering the second connecting portion 520 and a region A2 not covering the second connecting portion 520 and extending axially away from region A1. The inner wall of region A1 has a protrusion 301A and a corresponding recess 302A. The protrusion 301A is embedded in the fixing groove 521 of the second connecting portion 520, and the recess 302A is in contact with the outer surface of the second connecting portion 520, so that the push rod 30A is tightly fitted onto the second connecting portion 520 and engaged with it, thereby achieving a fixed connection between the push rod 30A and the thimble-removing bracket 10.
[0089] Specifically, the connection process between the push rod 30A and the thrombectomy bracket 10 is as follows: The connector 50 is passed through the proximal end retainer 130 of the thrombectomy bracket 10, and the thrombectomy bracket 10 and the proximal end retainer 130 are fixedly connected by welding or bonding. Then, a plastic tube is sleeved on the proximal end retainer 130, and a heat shrink tube is sleeved on the plastic tube. Heat treatment is performed to melt the plastic tube but not the heat shrink tube. The heat shrink tube shrinks and tightly covers the surface of the connector 50, preventing the molten plastic from falling off. Due to the covering and shaping effect of the heat shrink tube, the molten plastic tube fills the fixing groove 521. After solidification, it forms a plastic layer that snaps into the fixing groove 521. The inner wall of the plastic layer has protrusions and corresponding recesses. The protrusions are embedded in the fixing groove 521, and the surface of the recesses is in contact with the inner surface of the connector 50. Furthermore, after peeling off the heat shrink tubing, a thin tube is fitted onto the plastic layer, and another heat shrink tubing is fitted onto the distal end of the thin tube, with the heat shrink tubing radially opposite the plastic layer. Heat treatment continues, fusing the plastic layer and the thin tube together to form a push rod 30A with protrusions 301A and recesses 302A on the inner wall of the area fitted onto the connector 50. Finally, the heat shrink tubing is peeled off, thus achieving the connection between the push rod 30A and the bolt retrieval bracket 10. A reliable connection between the push rod 30A and the bolt retrieval bracket 10 is achieved through a tight fit and locking mechanism using the fixing groove 521.
[0090] In one embodiment, the plastic tube is a Pebax tube, and the heat shrink tubing is made of fluorinated ethylene propylene copolymer (FEP).
[0091] Please see Figure 7 In one embodiment, the outer diameter of the second connecting portion 520 is R. R is slightly smaller than the inner diameter of the elongated tube. The plastic tube is sleeved on the second connecting portion 520. After heat treatment and peeling off the heat shrink tubing, the plastic fills the fixing groove 521 and covers the surface of the second connecting portion 520. The overall outer diameter of the plastic layer and the second connecting portion becomes larger, slightly larger than the inner diameter of the elongated tube. Before sleeved on the plastic layer, the distal end of the elongated tube is enlarged to tightly sleeve the elongated tube on the plastic layer. After heat treatment, the push rod 30A, formed by fusing the plastic layer and the elongated tube as one piece, is reliably connected to the connector 50.
[0092] In one embodiment, the outer diameter R of the second connecting portion 520 is 0.2 to 0.4 mm smaller than the inner diameter of the elongated tube (i.e., the inner diameter of the push rod 30A). After a plastic layer is formed on the second connecting portion 520, the overall outer diameter of the plastic layer and the second connecting portion is 0.1 to 0.2 mm larger than the inner diameter of the elongated tube. This allows the distal end of the elongated tube to be reasonably enlarged and fitted onto the plastic layer without damaging the elongated tube. Furthermore, after heat treatment, the push rod 30A formed by the fusion of the plastic layer and the elongated tube can tightly cover the surface of the second connecting portion 520, ensuring a reliable connection.
[0093] In one embodiment, the fixing groove 521 is an annular groove. The fixing groove 521 surrounds the circumference of the second connecting part 520, so that the inner wall of the push rod 30A has a larger engagement area with the fixing groove 521, which is beneficial to improving the connection reliability.
[0094] In one embodiment, the fixing groove 521 is an annular groove, and there are two fixing grooves 521. The two fixing grooves 521 are arranged between each other along the axial direction of the second connecting part 520 to ensure a certain connection area and to make the length of the connecting member 50 moderate to ensure a certain degree of flexibility.
[0095] It is understood that in other embodiments, the fixing groove 521 is not limited to an annular groove, but can be other shapes. The number of fixing grooves 521 is also not limited to two. For example, it can be a plurality of square grooves, circular grooves, etc., spaced apart along the circumference of the second connecting portion 520.
[0096] Please see Figure 9 In one embodiment, the thrombus removal device 1 further includes a reinforcing tube 30B, which is sleeved on and fixedly connected to the push rod 30A. The length of the reinforcing tube 30B is moderate, so that it only covers a portion of the proximal end of the push rod 30A. This ensures that during thrombectomy, the reinforcing tube 30B is located outside the body, thus not affecting the flexibility of the portion of the push rod 30A located inside the body. Therefore, the push rod 30A and the reinforcing tube 30B work together to provide the thrombus removal device 1 with a certain degree of flexibility, facilitating its access to the embolism site through tortuous blood vessels. Furthermore, the combination of the push rod 30A and the reinforcing tube 30B provides sufficient pushing performance to facilitate thrombectomy, especially when removing harder thrombi, making the retraction of the thrombectomy stent 10 easier.
[0097] The push rod 30A is a hollow tube, and the reinforcing tube 30B is also a hollow tube. The reinforcing tube 30B is sleeved on the proximal end of the push rod 30A, and the inner cavities of the reinforcing tube 30A and the push rod 30A are connected.
[0098] In one embodiment, the push rod 30A is a hollow three-layer composite tube, comprising, from the inside out, a first polymer layer, a metal braided mesh layer, and a second polymer layer. In one embodiment, the first polymer layer is made of polytetrafluoroethylene or Pebax, the metal braided mesh layer is made of stainless steel, and the second polymer layer is made of Pebax. The reinforcing tube 30B is a hollow stainless steel tube.
[0099] In one embodiment, a reinforcing tube connector 30C is provided at the end of the reinforcing tube 30B away from the push rod 30A, and the reinforcing tube connector 30C is sleeved on the reinforcing tube 30B. Please refer to the following: Figure 10 The reinforcing pipe joint 30C has an axially extending inner cavity 301, which is connected to the reinforcing pipe 30B.
[0100] Please continue reading. Figure 10 In one embodiment, the reinforced connector 30C includes a gripping portion 302, a distal connecting portion 303, and a proximal connecting portion 304. The distal connecting portion 303 and the proximal connecting portion 304 are respectively connected to both ends of the gripping portion 302 and are located on the left and right sides of the gripping portion 302. The inner cavity 301 extends through the distal connecting portion 303, the gripping portion 302, and the proximal connecting portion 304.
[0101] The remote connection part 304 is sleeved on the reinforcing tube 30B and is fixedly connected to the reinforcing tube 30B.
[0102] The grip portion 302 has two opposing grip surfaces 302A ( Figure 10 (Only one is displayed) so that the operator can hold the grip 302 to perform the operation.
[0103] The proximal end of the proximal connection portion 304 is provided with a connector 3041. In one embodiment, the connector 3041 is a Luer connector.
[0104] The reinforced pipe connector 30C serves as both a connection and an operating handle, making the thrombus removal device 1 more compact and smaller in size.
[0105] Please return Figure 9 In one embodiment, the thrombus removal device 1 further includes a Y-shaped valve 30D, the distal end of which is detachably connected to the connector 3041 of the proximal connection portion 304.
[0106] The Y-shaped valve 30D includes a first valve body 301D and a second valve body 302D connected to the first valve body 301D in a Y-shape. In the open state, both the first valve body 301D and the second valve body 302D are connected to the reinforcing tube connector 30C. During thrombectomy, the first valve body 301D allows the guidewire to pass through, while the second valve body 302D serves as an inlet for saline solution, contrast agents, etc., facilitating procedures such as venting and contrast imaging.
[0107] Please return Figure 2 In one embodiment, the thrombus removal device 1 further includes a filter membrane 70 disposed on the distal mesh 120. The filter membrane 70 is made of a material that allows blood to pass through but not thrombi, and is used to intercept thrombi escaping from the thrombectomy stent 10, thereby increasing the amount of thrombus removed in a single session and the success rate of thrombectomy in one session.
[0108] The filter membrane 70 is disposed inside the remote network 120 or wrapped around the remote network 120.
[0109] In one embodiment, a filter membrane 70 is disposed inside the distal mesh 120. The distal end of the filter membrane 70 is fixedly connected to the distal convergence portion 150 via a fastener 72, and the proximal end of the filter membrane 70 is fixed to the second support portion 121. The proximal end of the filter membrane 70 is an open end, and the distal end is a closed end. When the distal mesh 120 is radially expanded, the open end of the filter membrane 70 also expands along with the distal mesh to intercept thrombi.
[0110] The filter membrane 70 is positioned inside the distal mesh 120. After thrombus interception, when the thrombectomy stent 10 is retracted to place the stent 10 and the thrombus containment catheter, the filter membrane 70 is compressed radially with the thrombectomy stent 10. This helps prevent the filter membrane 70 from being squeezed together, which would increase the resistance to entering the catheter. Consequently, it reduces the retraction force required to withdraw the thrombectomy stent 10, avoiding excessive pulling on the push rod 30A and preventing the thrombectomy stent 10 from detaching from the push rod 30A, thus improving reliability and safety. Simultaneously, it prevents the thrombus from being squeezed due to high sheath entry resistance, thus avoiding secondary fragmentation and escape, which helps increase the amount of thrombus retrieved in a single session and the success rate of thrombectomy in one attempt.
[0111] In one embodiment, the proximal end of the filter membrane 70 is wavy, which further helps to avoid the accumulation of the proximal end of the filter membrane 70 when the thrombectomy stent 10 is withdrawn into the catheter, thereby increasing the resistance to entering the catheter. This reduces the withdrawal force and improves reliability and safety, while preventing thrombus fragmentation and escape, and increasing the amount of thrombectomy performed in a single session and the success rate of thrombectomy in a single session.
[0112] Please see Figure 11 In one embodiment, the thrombus removal device 1 further includes a catheter assembly 90, which includes a catheter 910 and a catheter connector 920 connected to the catheter 910. Both the catheter 910 and the catheter connector 920 have open lumens at both ends, and the catheter 910 and the catheter connector 920 are in communication. The catheter 910 and the catheter connector 920 are connected by a connection method commonly used in the art, such as adhesive bonding.
[0113] The catheter 910 is used to establish a channel for the thrombectomy stent 10 to enter the blood vessel. The pusher 30A is slidably disposed in the catheter 910 to push the thrombectomy stent 10 into and out of the catheter 910.
[0114] Please see Figure 12A In one embodiment, the catheter 910 includes an isodiameter section 911 and a flared section 912 connected to the distal end of the isodiameter section 911. The inner diameter of the flared section 912 gradually increases from the proximal end to the distal end. Providing the flared section 912 at the distal end facilitates bringing the thrombus into the catheter 910 for removal from the body after the thrombectomy stent 10 captures the thrombus.
[0115] Please see Figure 12B In another embodiment, the catheter 910 includes a first equal-diameter section 913, a second equal-diameter section 914, and a transition section 915, with the two ends of the transition section 915 connected to the first equal-diameter section 913 and the second equal-diameter section 914, respectively. The inner diameter of the second equal-diameter section 914 is larger than that of the first equal-diameter section 913, and the inner diameter of the transition section 915 gradually increases from the end connected to the first equal-diameter section 913 to the end connected to the second equal-diameter section 914. The wall thicknesses of the first equal-diameter section 913, the second equal-diameter section 914, and the transition section 915 are equal. Providing a second equal-diameter section 914 with a larger inner diameter at the distal end facilitates carrying the thrombus into the catheter 910 for removal from the body after the thrombectomy stent 10 captures the thrombus.
[0116] Please see Figure 12C In another embodiment, the catheter 910 is a tube with a constant outer diameter but unequal inner diameter, including a constant inner diameter section 916 and an unequal inner diameter section 917 connected to the distal end of the constant inner diameter section 916. The inner diameter of the unequal inner diameter section 917 gradually increases from the end connected to the constant inner diameter section 916 to the end away from the constant inner diameter section 916. Providing a unequal inner diameter section 917 with a larger distal inner diameter facilitates carrying the thrombus into the catheter 910 for removal from the body after the thrombectomy stent 10 captures the thrombus.
[0117] The above Figures 12A to 12C The catheter 910 of the illustrated embodiment employs a distally flared structure to facilitate the retraction of the thrombectomy stent 10, which captures the thrombus, into the catheter 910. This reduces the retraction force and prevents the thrombectomy stent 10 from detaching from the push rod 30A. The thrombectomy stent 10 and the push rod 30A are connected to the distally flared catheter 910 via the connector 50, allowing for smoother retraction of the thrombectomy stent 10 into the catheter 910 and smoother introduction of the thrombus into the catheter 910. Furthermore, using a distally flared catheter 910, rather than enlarging both the outer and inner diameters of the catheter as a whole, helps prevent the catheter 910 from kinking, thereby improving reliability and ensuring successful thrombus removal.
[0118] Please return Figure 11The catheter assembly 90 also includes a seal (not shown) and a locking cap 930. The seal is housed within the locking cap 930, which is connected to the catheter connector 920. The locking cap 930 is hollow, and its inner cavity communicates with the catheter connector 920 and the catheter 910.
[0119] The conduit assembly 90 also includes an exhaust pipe 940 and a sealing valve 950. The exhaust pipe 940 is connected to and communicates with the conduit connector 920 and the conduit 910. The sealing valve 950 is connected to the end of the exhaust pipe 940 away from the conduit connector 920 and is used to seal or open the exhaust pipe 940.
[0120] Please see Figure 13 In use, guided by guidewire 200, catheter 910 is inserted into a blood vessel. Thrombectomy stent 10 is passed along guidewire 200 through locking cap 930 and seal, and further pushed into catheter 910, with only retainer 72 protruding outside catheter 910, the rest of thrombectomy stent 10 remaining inside catheter 910. Locking cap 930 is tightened, causing seal to radially compress pusher rod 30A to achieve a seal.
[0121] Please see Figure 14 In one embodiment, the aspiration device 2 includes a delivery sheath 20, a sheath connector 40, and an aspiration assembly 60. The delivery sheath 20 is connected to and communicates with the sheath connector 40. The aspiration assembly 60 includes an aspiration tube 61, an aspirator 62 connected to the aspiration tube 61, and a latch 63. The latch 63 is fitted onto the aspiration tube 61. When the latch 63 is locked, the aspiration tube 61 is closed; when the latch 63 is opened, the aspirator 62, the aspiration tube 61, the sheath connector 40, and the delivery sheath 20 are connected, so that the thrombus in the blood vessel can be aspirated to the outside of the body through the aspirator 62.
[0122] In one embodiment, the aspirator 62 is a syringe, including a syringe barrel 621 and a plunger 622, the plunger 622 being capable of piston-like motion within the syringe barrel 621.
[0123] Please see Figure 15 In use, guided by the guidewire 200, the delivery sheath 20 is inserted into the blood vessel. The buckle 63 is opened, and saline solution is injected into the delivery sheath 20 through the aspiration device 62 to expel air. The buckle 63 is then locked. Next, the guidewire 200 is passed through the thrombectomy stent 10 and the push rod 30A. Figure 15 (Not shown), catheter 910, catheter connector 920, reinforcing tube connector 30C and first valve body 301D, and push the thrombectomy stent 10 and catheter 910 into the delivery sheath 20 along the guide wire 200, and inject physiological saline into the push rod 30A through the second valve body 302D to vent air.
[0124] During the push, only the retainer 72 protrudes from the outside of the catheter 910, while the rest of the thrombectomy stent 10 remains inside the catheter 910. Maintaining the relative position of the thrombectomy stent 10 and the catheter 910, continue pushing the catheter 910 and pusher rod 30A distally simultaneously, so that the radially constricted thrombectomy stent 10 passes through the thrombus 300 and is located distal to the thrombus 300. Figure 15 As shown.
[0125] Next, pull the push rod 622 of the suction device 62 outward to its maximum stroke (e.g., Figure 16 As shown, a negative pressure is created inside the syringe 621 so that the thrombus 300 can be drawn into the syringe 621 during the thrombectomy process.
[0126] Furthermore, keeping the position of the push rod 30A unchanged, retract the catheter 910, causing the thrombectomy stent 10 to release and expand radially, as shown. Figure 16 As shown. Next, the push rod 30A is withdrawn to receive the thrombectomy stent 10 and the captured thrombus 300 into the catheter 910.
[0127] Finally, open the latch 63 of the aspirator 60 to connect the aspirator 60 and the delivery sheath 20, so that the residual thrombus that was not captured by the thrombectomy stent 10 can be drawn into the syringe 621 under negative pressure.
[0128] By using the thrombus removal device 1 and the thrombus aspiration device 2 together, the amount of thrombus removed in a single session and the success rate of thrombus removal in one session can be increased.
[0129] It should be noted that the thrombus removal device 1 can be used alone.
[0130] In one embodiment, the aspiration device 2 is omitted, but the thrombus removal system 100 also includes a delivery sheath 20, the inner diameter of which is larger than the outer diameter of the catheter 910, and the catheter 910 is movably axially inserted through the delivery sheath 20. During thrombectomy, the delivery sheath 20 is first implanted into the blood vessel, the thrombectomy stent 10 is loaded into the catheter 910, the catheter 910 loaded with the thrombectomy stent 10 is advanced to the target position through the delivery sheath 20, the thrombectomy stent 10 is pushed out of the catheter 910, and the catheter 910 is withdrawn before the thrombectomy operation is performed. Then the thrombectomy stent 10 containing the thrombus is retrieved into the delivery sheath 20 and withdrawn from the body along with the delivery sheath 20.
[0131] By using the catheter 910 in conjunction with the delivery sheath 20, on the one hand, it is convenient to deliver the thrombectomy stent 10 to the target location, avoiding the use of a catheter 910 with a larger outer and inner diameter to pass through the thrombus and cut the thrombus. After the thrombus is cut, small thrombi are generated, which can easily cause the thrombus to escape. On the other hand, the delivery sheath 20 has a larger inner diameter and less resistance to insertion, making it easier to take the thrombectomy stent 10 with the thrombus intercepted into the delivery sheath 20, which facilitates the operation and avoids the thrombus fragmentation caused by squeezing at the delivery sheath 20 during insertion.
[0132] Please see Figure 17 In another embodiment, this disclosure also provides a thrombus removal device 1', including a thrombectomy stent 10' and a push rod 30A'. The distal end of the thrombectomy stent 10' is connected to the push rod 30A', and the push rod 30A' is used to push the thrombectomy stent 10' into the blood vessel for thrombectomy. The connection method between the push rod 30A' and the thrombectomy stent 10' is the same as the connection method between the push rod 30A and the thrombectomy stent 10.
[0133] Unlike the thrombus removal device 1, the thrombectomy stent 10' includes a single intercepting net, rather than two axially connected intercepting nets, such as a proximal net 110 and a distal net 120 connected axially. Specifically, the thrombectomy stent 10' includes an intercepting net 110', the structure of which is roughly the same as that of the proximal net 110. The difference is that the distal end of the intercepting net 110' converges to the fixation member 130', rather than converging to the annular central constriction member 140. The fixation member 130' has the same structure as the fixation member 72, and will not be described in detail here.
[0134] The interceptor net 110' is equipped with multiple circumferentially distributed capture components 120' to improve capture performance. The structure of the capture component 120' is the same as that of the capture component 114, and the connection method is the same, so it will not be described in detail here.
[0135] The thrombus removal device 1' in this embodiment includes only one intercepting net 110' in the axial direction, and its axial length is relatively short, which is beneficial for removing thrombi near the closed end of the blood vessel or near the reduced diameter part of the blood vessel.
[0136] Understandably, in this embodiment, a filter membrane can be provided on the interception net 110' to improve interception performance. The filter membrane is provided in the same way as the filter membrane 70 is provided on the distal net 120, that is, the distal end of the filter membrane is connected to the distal end of the interception net 110' through the fastener 130', and the proximal end of the filter membrane is fixed to the expansion portion of the interception net 110' by stitching. Further details will not be provided here.
[0137] It should be noted that the thrombus removal device 1' in this embodiment can replace the thrombus removal device 1 and be used in conjunction with other components or devices, such as in conjunction with the thrombus aspiration device 2, etc., which will not be elaborated further here.
[0138] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0139] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.
Claims
1. A method for preparing a thrombus removal device, characterized in that, Includes the following steps: A thrombectomy bracket and a connector are provided. The thrombectomy bracket includes a proximal constrictor. The connector includes a first connecting portion and a second connecting portion connected to the first connecting portion. A fixing groove is provided on the second connecting portion. The first connecting portion passes through the proximal constrictor and is connected to the proximal constrictor. The second connecting portion extends axially proximally. A plastic tube and a first heat shrink tube are provided, the plastic tube is sleeved on the second connecting part, and the first heat shrink tube is sleeved on the plastic tube; The heat treatment melts the plastic tube but the first heat shrink tube does not melt. The first heat shrink tube shrinks and covers the surface of the connector. The molten plastic tube fills the fixing groove. The curing process causes the molten plastic tube to form a plastic layer that snaps into the fixing groove. The inner wall of the plastic layer has a protrusion and a recess corresponding to the protrusion. The protrusion is embedded in the fixing groove, and the surface of the recess is in contact with the outer surface of the connector. Peel off the first heat shrink tubing to provide a slender tube and a second heat shrink tubing. Sleeve the slender tube onto the plastic layer, and sleeve the second heat shrink tubing onto the distal end of the slender tube. The second heat shrink tubing is radially opposite to the plastic layer. Heat treatment fuses the plastic layer with the slender tube to form a push rod with protrusions and recesses on the inner wall of the area fitted onto the connector.
2. The method for preparing the thrombus removal device according to claim 1, characterized in that, The first connecting portion abuts against the distal end face of the proximal condenser, and the outer wall of the first connecting portion abuts against the inner wall of the proximal condenser, thereby connecting the first connecting portion to the proximal condenser; or, the first connecting portion and the proximal condenser are connected by welding or bonding.
3. The method for preparing the thrombus removal device according to claim 2, characterized in that, The proximal converging member is annular, and the first connecting portion includes a fixing section and an abutting section connected to the fixing section; the fixing section and the abutting section are cylindrical, and the bottom diameter of the abutting section is larger than the bottom diameter of the fixing section; or, the fixing section is cylindrical, the abutting section is frustum-shaped, the end of the abutting section with a smaller bottom area is connected to the fixing section, and the diameter of the end of the abutting section with a smaller bottom area is larger than the diameter of the fixing section.
4. The method for preparing the thrombus removal device according to claim 1, characterized in that, There are multiple fixing grooves, and the multiple fixing grooves are distributed at intervals along the axial direction of the connector.
5. The method for preparing the thrombus removal device according to claim 1, characterized in that, The thrombectomy stent further includes a proximal net, a distal net, a central convergent member, and a distal convergent member. The proximal end of the proximal net is converged to the proximal convergent member, the distal end of the proximal net is converged to the central convergent member, the proximal end of the distal net is converged to the central convergent member, and the distal end of the distal net is converged to the distal convergent member.
6. The method for preparing the thrombus removal device according to claim 5, characterized in that, It also includes the following steps: A filter membrane is provided and the filter membrane is fixed inside the distal mesh.
7. The method for preparing the thrombus removal device according to claim 6, characterized in that, The distal end of the filter membrane is a closed end, and the distal end of the filter membrane is fixedly connected to the distal end gathering member. The proximal end of the filter membrane is wavy, and the proximal end of the filter membrane is fixed to the distal end net. The proximal end of the filter membrane is an open end, and the open end unfolds as the distal end net unfolds.
8. The method for preparing the thrombus removal device according to claim 1, characterized in that, The plastic tube is a Pebax tube, and the first heat shrink tube and the second heat shrink tube are FEP tubes.
9. The method for preparing the thrombus removal device according to claim 1, characterized in that, The outer diameter of the second connecting part is smaller than the inner diameter of the slender tube, and the overall outer diameter of the plastic layer and the second connecting part is larger than the inner diameter of the slender tube. Before the slender tube is fitted onto the plastic layer, the method further includes the step of expanding the distal end of the slender tube to tightly fit the slender tube onto the plastic layer.
10. The method for preparing the thrombus removal device according to claim 9, characterized in that, The outer diameter of the second connecting part is 0.2-0.4 mm smaller than the inner diameter of the slender tube, and the overall outer diameter of the plastic layer and the second connecting part is 0.1-0.2 mm larger than the inner diameter of the slender tube.
Citation Information
Patent Citations
Thrombus removing device and thrombus removing system
CN115068162A