Thrombus aspiration system

Abstract

The utility model relates to a kind of thrombus suction systems, comprising: suction catheter, including the main body section extending along length direction and the pre-bending section being set in the distal end side of main body section;Tray, including bottom plate and the side wall being set in the periphery of bottom plate, the bottom plate is provided with catheter placement slot extending along length direction, the distal end side of the bottom plate has catheter distal end placement area, the catheter distal end placement area is provided with multiple interval settings along length direction accommodating portion, the catheter placement slot extends along length direction and sequentially with each The accommodating portion is communicated;The main body section of the suction catheter is located in the catheter placement slot, and the pre-bending section is located in one of multiple accommodating portions.The utility model can realize the tray of one length specification compatible with different length specifications suction catheter, improve the compatibility and utilization of packaging.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a thrombus aspiration system. Background Technology

[0002] The Thrombus Aspiration Catheter System (TACS) is one of the core devices in interventional treatment of embolic diseases such as acute ischemic stroke, deep vein thrombosis, and peripheral arterial occlusion. Its basic task is to remove the thrombus blocking the blood vessel completely or in segments in the shortest possible time, restoring distal blood flow.

[0003] In percutaneous mechanical thrombectomy (PMT), physicians need to select aspiration catheters of different working lengths (e.g., 90cm, 110cm, 135cm, etc.) based on the patient's vascular anatomy and lesion length. Currently, commercially available thrombectomy system packaging boxes generally adopt a "single-size fixed slot" design, meaning that one size of packaging box can only package one size of aspiration catheter, resulting in poor packaging compatibility. Utility Model Content

[0004] Based on this, it is necessary to provide a thrombus aspiration system to address the above problems, comprising: an aspiration catheter including a main body extending along the length direction and a pre-bent section disposed at the distal end of the main body; a tray including a base plate and side walls disposed around the base plate, wherein the base plate is provided with a catheter placement groove extending along the length direction, the distal end of the base plate has a catheter distal placement area, the catheter distal placement area is provided with a plurality of clearance portions spaced apart along the length direction, the catheter placement groove extends along the length direction and communicates sequentially with each of the clearance portions; the main body of the aspiration catheter is disposed in the catheter placement groove, and the pre-bent section is disposed in one of the plurality of clearance portions.

[0005] Furthermore, the base plate has a protrusion assembly, the protrusion assembly includes a plurality of protrusion units spaced apart along the length direction, the sidewall includes a longitudinal sidewall, and the conduit placement groove is formed between the longitudinal sidewall and the protrusion assembly.

[0006] Furthermore, the protrusion assembly includes a plurality of L-shaped protrusions located in the distal placement area of ​​the catheter, the plurality of L-shaped protrusions being spaced apart along the length direction, the L-shaped protrusions having corner portions, and the area between the corner portions and the longitudinal sidewall forming a clearance portion.

[0007] Furthermore, the protrusion assembly includes a plurality of I-shaped protrusions located in the distal placement area of ​​the catheter, the plurality of I-shaped protrusions being spaced apart along the length direction, and the area located on the distal side of the I-shaped protrusion and adjacent to it forming a clearance portion.

[0008] Furthermore, the protrusion assembly includes at least one I-shaped protrusion and at least one L-shaped protrusion with a corner located in the distal placement area of ​​the catheter, the area between the corner and the longitudinal sidewall forming one clearance portion, and the area located on the distal side of the I-shaped protrusion and adjacent to it forming another clearance portion.

[0009] Furthermore, it also includes a waste liquid box, and the base plate is provided with a waste liquid box mounting groove on the proximal side of the distal end placement area of ​​the conduit, and the waste liquid box is placed in the waste liquid box mounting groove.

[0010] Furthermore, the waste liquid box includes a base and a top cover that cooperate with each other, the top cover having two filter areas spaced apart from each other.

[0011] Furthermore, the base is made of transparent material and has scale lines, which are used to measure the volume of liquid entering the base.

[0012] Furthermore, the tray has a catheter fitting placement area on its proximal side, which includes a tubing and a hemostatic valve. The hemostatic valve includes a side branch, the end of which has a pagoda connector for connecting to the tubing.

[0013] Furthermore, the outer periphery of the pagoda connector has a first tooth, and the inner wall of the hose has a second tooth that engages with the first tooth.

[0014] Furthermore, the catheter fitting placement area is also provided with a shaping needle, at least a portion of the outer periphery of which is color-marked.

[0015] Furthermore, the catheter fitting placement area is also provided with a tearable guide sheath, the insertion end of which has a wedge-shaped surface.

[0016] Furthermore, it also includes a first cover plate and / or a second cover plate, the first cover plate being disposed over the catheter fitting placement area, and the second cover plate being disposed over the distal catheter placement area.

[0017] The technical solution of this utility model has the following beneficial effects:

[0018] The tray of this utility model has a tube placement groove extending along the length direction and multiple clearance portions at different length positions, so that a tray of one specification length can be compatible with multiple specifications and lengths of suction tubes, thereby improving packaging utilization and compatibility. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the overall structure of a thrombus aspiration system;

[0020] Figure 2This is a structural diagram of the aspiration catheter and catheter accessories;

[0021] Figure 3 An exploded view of a thrombus aspiration system;

[0022] Figure 4 A schematic diagram of the thrombus aspiration system after the cover plate has been removed;

[0023] Figure 5-6 This is a diagram of the tray structure in an optional embodiment;

[0024] Figure 7 This is an exploded view of the waste liquid container;

[0025] Figure 8 This is a structural diagram of a pagoda-shaped connector;

[0026] Figure 9 This is a structural diagram of the open end of the hose; Detailed Implementation

[0027] To make the above-mentioned objectives, features, and advantages of this utility model more apparent and understandable, the specific embodiments of this utility model are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a full understanding of this utility model. However, this utility model can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this utility model. Therefore, this utility model is not limited to the specific embodiments disclosed below.

[0028] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intermediate element present. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element present. The terms "upper," "lower," "left," "right," and similar expressions used to indicate orientation are for illustrative purposes only and do not represent the only possible implementation.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0030] It should be noted that, for medical devices, the end of the device relatively closer to the operator is generally called the "proximal end," and the end relatively farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of the delivery system are defined. Furthermore, based on this, the proximal and distal ends of the tray in this application are defined as follows: the side of the tray used to place the distal portion of the aspiration catheter is the distal end, and the side used to place the proximal portion of the aspiration catheter is the proximal end. "Axial" or "longitudinal axis" refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; "radial" or "lateral" refers to the direction perpendicular to the axial direction.

[0031] See Figure 1 As shown, this embodiment provides a thrombus aspiration system 100, including a tray 10, with a first cover plate 20 and a second cover plate 40 covering the upper end of the tray 10. A waste liquid box 30 is also provided between the first cover plate 20 and the second cover plate 40.

[0032] See Figure 2 As shown, a suction tube 50 and a tube fitting 60 are disposed inside the tray 10. The first cover plate 20 and the second cover plate 40 cooperate with the tray 10 to confine the suction tube 50 and the tube fitting 60 within the tray 10. The tray 10 can be configured as a blister box as part of the packaging box, which is used to package the suction tube 50 and the tube fitting 60.

[0033] The aspiration catheter 50 includes a main body segment 51, a pre-bent section 52 at the distal end of the main body segment 51, and a catheter seat 53 at the proximal end. In this embodiment, the aspiration catheter 50 is a double-lumen catheter, including a guidewire lumen and an aspiration lumen, which communicate with two branches of the catheter seat 53, respectively. In other embodiments, the aspiration catheter can also be configured as a single-lumen catheter, in which case the catheter seat 53 has only one branch.

[0034] The catheter accessory 60 includes an extension tube 61, a tearable guide sheath 62, a shaping needle 63, a straight-through valve 64, a hemostatic valve 65, and a negative pressure injector 66. The extension tube 61 includes a flexible tube 611, with connectors at one or both ends for connection to other components. The tearable guide sheath 62 guides the corresponding instruments through the hemostatic valve 65. To facilitate insertion into the hemostatic valve 65, the insertion end of the tearable guide sheath 62 in this embodiment has a wedge-shaped surface, thereby increasing the pressure on the sealing gasket in the hemostatic valve 65 when inserted into the sheath seat. This allows for rapid insertion of the tearable guide sheath without the need for a dilator, establishing a channel for subsequent instrument placement and improving surgical efficiency. The shaping needle 63 is a flexible filament structure used to insert into the distal lumen of the aspiration catheter 50 to shape the aspiration catheter 50 into a pre-bent section 52. Considering the small size of the shaping needle 63 and its surface color being similar to that of the tray, at least a portion of the outer periphery of the shaping needle 63 is color-coded for easy operator identification. For example, black or red markings can be provided on the rod-shaped portion or handle portion of the shaping needle 63. The opening valve 64 is a two-way valve used to control the opening and closing of the extension tube 61. The hemostatic valve 65 includes a main tube 651 and a branch tube 652 disposed on one side of the outer periphery of the main tube 651, with a pagoda connector 653 at the open end of the branch tube 652. The negative pressure injector 66 is used to provide negative pressure to achieve aspiration of the thrombus by the aspiration catheter 50.

[0035] In actual use, the hemostatic valve 65 is connected to the proximal end of the aspiration catheter 50 via the catheter seat 53. The branch tube 652, extension tube 61, connecting valve 64, and negative pressure injector 66 of the hemostatic valve 65 are connected in sequence. Before the operation, air is vented externally. After the air venting, the connecting valve 64 is closed. Then, the aspiration catheter 50 enters the blood vessel along the guidewire to reach the lesion location. The negative pressure injector 66 is operated to maintain a negative pressure state. Then, the connecting valve 64 is opened to provide negative pressure, so that the aspiration catheter 50 can perform negative pressure aspiration. The thrombus in the blood vessel is aspirated along the aspiration chamber of the aspiration catheter through the extension tube 61 into the negative pressure injector 66, thereby achieving the purpose of aspirating the thrombus in the blood vessel.

[0036] See Figure 3-4The structure of the tray 10 and the placement of the suction tube 50 and tube fittings 60 within the tray are described below. The tray 10 has a generally rectangular disc-shaped structure, including a base plate 11 and side walls 12 surrounding the base plate. The tray 10 can be integrally thermoformed, and its material can be PETG. Integral thermoforming allows for one-time forming of the entire tray, improving forming efficiency and simplifying the manufacturing process. In other embodiments, the tray can also be made of other materials, such as aluminum alloy or other metals, and extruded in one step. The side walls 12 include a longitudinal side wall 121 extending along the length direction and a transverse side wall 122 extending along the width direction. From the distal end to the proximal end, the tray 10 sequentially includes a distal tube placement area 10a, a waste liquid container placement area 10b, and a tube fittings placement area 10c. The distal tube placement area 10a is located on the distal side and is mainly used for placing the distal portion of the suction tube 50 and the pre-bent section 51. The catheter accessory placement area 10c is located on the proximal side and is used to place the various accessories of the catheter accessory 60. The waste fluid container placement area 10b is located between the distal catheter placement area 10a and the catheter accessory placement area 10c and is used to place the waste fluid container 30. The tray 10 integrates all the accessories required for thrombus aspiration, including the aspiration catheter 50, catheter accessories 60, and waste fluid container 30. When in use, each accessory can be taken out from the packaging with the tray, which greatly reduces the overall packaging volume, facilitates storage and transportation, and realizes the integration of thrombus aspiration and collection and filtration of thrombus waste fluid.

[0037] A protrusion assembly 13 is provided on the base plate 11. The protrusion assembly 13 includes a plurality of protruding units spaced apart along the length direction. The plurality of protruding units are aligned along the length direction and spaced apart from the longitudinal sidewall 121, thereby forming a conduit placement groove 15 and an extension tube placement groove 17 between the longitudinal sidewall 121 and the protruding units. The conduit placement groove 15 and the extension tube placement groove 17 extend along the length direction and are respectively located on both sides of the protrusion assembly 13 along the width direction. The main body section 51 of the suction conduit 50 is placed in the conduit placement groove 15, while the extension tube 61 is placed in the extension tube placement groove 17, so that the suction conduit 50 and the extension tube 61 are respectively located on both sides of the tray 10. Among them, the protruding units located in the conduit distal placement area 10a constitute a plurality of clearance portions 14. Specifically, the protruding unit located in the distal catheter placement area 10a includes at least one I-shaped protrusion 13a and at least one L-shaped protrusion 13b. The I-shaped protrusion 13a and the L-shaped protrusion 13b are disposed on the distal side of the tray 10, thereby combining with the base plate 11 to form a clearance portion 14. The I-shaped protrusion 13a is a generally rectangular protrusion, and its sides on both sides in the width direction of the tray are substantially parallel to the longitudinal sidewall 121. In this application, "substantially parallel" means that the included angle between the two is between 0 and 5 degrees. The L-shaped protrusion is formed by providing a notch on one side of the rectangular protrusion, and it has a corner portion 131, which is disposed towards the catheter placement groove 15.

[0038] For each I-shaped protrusion 13a, the region located on the distal side of the I-shaped protrusion 13a and adjacent to it (see...) Figure 4 The dashed box in the diagram (which is only illustrative and does not indicate that the area is limited to only the area within the dashed box) constitutes a clearance portion 14.

[0039] For each L-shaped protrusion 13b, the area between the corner 131 and the longitudinal sidewall 121 (see the dashed box) constitutes another clearance portion 14. One L-shaped protrusion 13b or I-shaped protrusion 13a constitutes one clearance portion 14. Multiple L-shaped protrusions 13b and I-shaped protrusions 13a will form multiple clearance portions 14 spaced along the length direction on the base plate 11, and each clearance portion 14 communicates with a conduit placement groove 15, thereby allowing the conduit placement groove 15 extending along the length direction to communicate sequentially with each clearance portion 14. Because multiple clearance portions 14 are spaced along the length direction on the base plate 11, the tray 10 can load suction conduits 50 with pre-bent sections of different lengths. Alternatively, the tray 10 can also load suction conduits 50 without pre-bent sections of different lengths. For example, see [link to relevant documentation]. Figure 4 As shown, the suction tube 50 has three length specifications, and the pre-bent sections 51 of the suction tubes of different length specifications extend to different positions on the base plate 11. For a specific specification of suction tube 50, its main body section 51 is confined in the tube placement groove 15, while the pre-bent section 51 on the distal side can extend through the placement groove 15 to a corresponding relief portion 14. This allows a tray of one length specification to meet the packaging needs of suction tubes 50 of multiple length specifications, improving the utilization rate and compatibility of packaging with this tray and reducing the number of tray specifications. In this embodiment, the tray includes at least one I-shaped protrusion 13a and at least one L-shaped protrusion 13b, with the I-shaped protrusion 13a located on the distal side of the L-shaped protrusion 13b. In other embodiments, the I-shaped protrusion 13a may also be located on the proximal side of the L-shaped protrusion 13b.

[0040] As an alternative embodiment, see Figure 5 As shown, only I-shaped protrusions 13a can be provided on the far end side of the base plate 11 without L-shaped protrusions, and multiple I-shaped protrusions are spaced apart along the length direction to form multiple clearance portions 14. Since only one type of I-shaped protrusion 13a is included, the manufacturing process can be simplified and the manufacturing cost can be reduced.

[0041] As another alternative embodiment, see Figure 6 As shown, only L-shaped protrusions 13b can be provided at the far end of the base plate 11 without I-shaped protrusions, and multiple L-shaped protrusions are spaced apart along the length direction to form multiple clearance portions 14. Since only one type of L-shaped protrusion 13b is included, the manufacturing process can be simplified and the manufacturing cost can be reduced.

[0042] See also Figure 3 As shown, the raised units located in the catheter fitting placement area 10c form mounting grooves, which are also matched with the specific shape of the corresponding catheter fittings for mounting each fitting. For example, the shaping needle 63 in the catheter fittings is located in the mounting groove formed by two adjacent raised units.

[0043] See Figure 7 The structure of the waste liquid container 30 is described below. The waste liquid container 30 includes a base 32 and a top cover 31 that cooperate with each other. The top cover 31 is positioned over the open end of the base 32. The top cover 31 itself is also disc-shaped, including two mutually isolated filter areas 311, each filter area 311 having multiple mesh openings 312. Additionally, a handle 313 is provided on one side of the top cover 31, allowing the operator to move the top cover 31. The base 32 is made of a transparent material, such as PETG (polyethylene terephthalate) or glass, and its surface has graduated lines (not shown in the figure) for measuring the volume of liquid entering the base. When the negative pressure syringe 66 has aspirated blood containing thrombi, this blood can be injected into the top cover 31. After being filtered by the filter areas 311, the thrombi remain on the top cover while the blood flows into the base 32. In this embodiment, the base 31 is made of transparent material and features graduated lines, allowing for direct observation of the extracted blood volume and facilitating effective control of blood loss by the operator. Furthermore, since the upper cover 31 has two isolated filter areas 311, different batches of aspirated blood and thrombus mixtures can be injected into different filter areas 311 respectively. This allows for comparison of the amount of thrombus in different batches of aspirated blood, facilitating assessment of the thrombus aspiration effect and progress, timely adjustment of the aspiration strategy, and improvement of the surgical success rate.

[0044] See Figure 8The connection method between the hemostatic valve 65 and the extension tube 61 is explained as shown. The free end of the side branch 651 of the hemostatic valve 65 has a pagoda connector 652, which is a conical connector with a first tooth 653 on its outer circumference. When connecting the pagoda connector 652 to the extension tube 61, the pagoda connector 652 can be directly inserted into the flexible tube 611 of the extension tube 61. The first tooth 653 increases the friction between the pagoda connector 652 and the inner wall of the flexible tube, thus achieving a firm connection between the outer surface of the pagoda connector 652 and the inner surface of the flexible tube 611. When it is necessary to separate the hemostatic valve 65 from the extension tube 61, the pagoda connector 652 can be directly pulled out of the flexible tube 611. Since the Luer connector is a standard part, it only has specific size specifications. These specific size specifications mean that it has a specific inner diameter, which to some extent limits the connection area when using a Luer connector, resulting in a smaller cross-sectional area at the connection point and increased resistance to fluid flow through the Luer connector. In this embodiment, a pagoda connector 652 is used to connect with the extension tube 61. The pagoda connector 652 is a non-standard part, and its size can be flexibly varied and set according to actual needs. Compared with the structure of the same standard Luer connector, it can obtain a larger cross-sectional area of ​​the inner lumen at the connection, avoid thrombus getting stuck at the connection between the catheter hemostasis valve and the extension tube, and reduce the risk of tube blockage.

[0045] In an alternative embodiment, see Figure 9 As shown, the distal opening of the flexible hose 611 has a tapered inner cavity with a second tooth 612 on its inner wall. This second tooth 612 can engage with the first tooth 653, forming a hook structure. The two teeth can move towards each other to achieve connection. However, because the first tooth 653 and the second tooth 612 are engaged, they cannot move in opposite directions, thus preventing them from loosening and ensuring a tight connection.

[0046] The embodiments described above are merely examples of several implementations of this utility model, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the utility model patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this utility model, and these all fall within the protection scope of this utility model. The protection scope of this utility model patent should be determined by the appended claims.

Claims

1. A thrombus aspiration system, characterized in that, include: The suction catheter includes a main body section extending along its length and a pre-bent section disposed at the distal end of the main body section; The tray includes a base plate and side walls disposed around the perimeter of the base plate. The base plate is provided with a conduit placement groove extending along the length direction. The distal end of the base plate has a conduit distal placement area. The conduit distal placement area is provided with a plurality of clearance portions spaced apart along the length direction. The conduit placement groove extends along the length direction and communicates sequentially with each of the clearance portions. The main body section of the suction conduit is disposed in the conduit placement groove, and the pre-bent section is disposed in one of the plurality of clearance portions.

2. The thrombus aspiration system according to claim 1, characterized in that, The base plate has a protruding assembly, which includes a plurality of protruding units spaced apart along the length direction. The sidewall includes a longitudinal sidewall, and the conduit placement groove is formed between the longitudinal sidewall and the protruding assembly.

3. The thrombus aspiration system according to claim 2, characterized in that, The protrusion assembly includes a plurality of L-shaped protrusions located in the distal placement area of ​​the catheter. The plurality of L-shaped protrusions are spaced apart along the length direction. The L-shaped protrusions have corner portions. The area between the corner portions and the longitudinal sidewall constitutes a clearance portion.

4. The thrombus aspiration system according to claim 2, characterized in that, The protrusion assembly includes a plurality of I-shaped protrusions located in the distal placement area of ​​the catheter. The plurality of I-shaped protrusions are spaced apart along the length direction, and the area located on the distal side of the I-shaped protrusion and adjacent to it constitutes a clearance portion.

5. The thrombus aspiration system according to claim 2, characterized in that, The protrusion assembly includes at least one I-shaped protrusion and at least one L-shaped protrusion with a corner located in the distal placement area of ​​the catheter. The area between the corner and the longitudinal sidewall constitutes one clearance portion, and the area located on the distal side of the I-shaped protrusion and adjacent to it constitutes another clearance portion.

6. The thrombus aspiration system according to any one of claims 1-5, characterized in that, It also includes a waste liquid box, and the base plate is provided with a waste liquid box mounting groove on the proximal side of the distal end placement area of ​​the conduit, and the waste liquid box is placed in the waste liquid box mounting groove.

7. The thrombus aspiration system according to claim 6, characterized in that, The waste liquid box includes a base and a top cover that cooperate with each other, the top cover having two filter areas spaced apart from each other.

8. The thrombus aspiration system according to claim 7, characterized in that, The base is made of transparent material and has scale lines, which are used to measure the volume of liquid entering the base.

9. The thrombus aspiration system according to any one of claims 1-5, characterized in that, The tray has a catheter fitting placement area on its proximal side, which includes a tubing and a hemostatic valve. The hemostatic valve includes a side branch, the end of which has a pagoda connector for connecting to the tubing.

10. The thrombus aspiration system according to claim 9, characterized in that, The outer periphery of the pagoda connector has a first tooth, and the inner wall of the hose has a second tooth that engages with the first tooth.

11. The thrombus aspiration system according to claim 9, characterized in that, The catheter fitting placement area is also provided with a shaping needle, at least a portion of the outer periphery of which is color-marked.

12. The thrombus aspiration system according to claim 9, characterized in that, The catheter fitting placement area is also provided with a tearable guide sheath, the insertion end of which has a wedge-shaped surface.

13. The thrombus aspiration system according to claim 9, characterized in that, It also includes a first cover plate and / or a second cover plate, the first cover plate being disposed over the catheter fitting placement area and the second cover plate being disposed over the distal catheter placement area.

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