A device for removing a thrombus

Abstract

This invention provides a thrombectomy device, comprising a handle with an outer tube drive unit and a support adjustment unit slidably disposed thereon; a support fixing tube, the proximal end of which is fixedly connected to the handle; an outer tube, the proximal end of which is slidably connected to the handle; a support adjustment tube, the proximal end of which is slidably connected to the handle; the outer tube, the support fixing tube, and the support adjustment tube are sequentially sleeved from the outside in; a thrombectomy support, the proximal end of which is connected to the distal end of the support fixing tube, and the distal end of which is connected to the support adjustment tube; the outer tube drive unit slides along the handle to control the thrombectomy support to extend out of or retract into the outer tube; the support adjustment unit slides along the handle to control the distal end of the thrombectomy support to move closer to or further away from the proximal end of the thrombectomy support, and to change the expansion state of the thrombectomy support. The device of this invention can adjust the size of the thrombectomy support at multiple scales and ensures the stability of the adjusted radial dimension.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to a thrombectomy device. Background Technology

[0002] Thrombosis is a major cause of acute and chronic cardiovascular, cerebrovascular, and peripheral vascular diseases. Current thrombectomy techniques involve using medical imaging to control a device to embed and remove the thrombus. However, the braided stents used in these techniques are made by weaving nickel-titanium wire and then heat-setting. When the braided stent passes through a narrowed vessel or thrombotic lesion, it cannot fully expand due to its self-expansion force, failing to scrape away the thrombus adhering to the vessel wall. Existing techniques also employ cut stents, which are made by laser cutting of nickel-titanium tubes and then heat-setting, offering improved radial support compared to braided stents. However, the diameter of both braided and cut stents is determined during heat setting, making intraoperative adjustment impossible. Larger vessels require larger stents, increasing surgical complexity and patient burden; furthermore, both structures have limited radial support. Additionally, in current thrombectomy techniques, the instrument pushes the thrombus along the vessel wall to scrape it away, easily leading to vessel rupture. Summary of the Invention

[0003] In order to overcome at least one of the many problems in the related art, the present invention provides a thrombus removal device.

[0004] The thrombectomy device includes a handle, on which an outer tube drive unit and a bracket adjustment unit are slidably disposed respectively.

[0005] A bracket fixing tube, the proximal end of which is fixedly connected to the handle;

[0006] The outer tube, the proximal end of which is slidably connected to the handle;

[0007] The support adjustment tube has its proximal end slidably connected to the handle;

[0008] The outer tube, the support fixing tube, and the support adjusting tube are sequentially sleeved from the outside to the inside;

[0009] A thrombectomy stent, wherein the proximal end of the thrombectomy stent is connected to the distal end of the stent fixing tube, and the distal end of the thrombectomy stent is connected to the stent adjustment tube.

[0010] The outer tube drive unit slides along the handle to control the bolt retrieval bracket to extend out of or retract into the outer tube;

[0011] The bracket adjustment part slides along the handle to control the distal end of the thrombectomy bracket to move closer to or further away from the proximal end of the thrombectomy bracket, and to change the expansion state of the thrombectomy bracket.

[0012] In an alternative embodiment, the handle is rotated to drive the thrombectomy bracket to rotate.

[0013] In one optional embodiment, a tapered head is further included, which is disposed at the distal end of the thrombectomy device and connected to the distal end of the support adjustment tube and / or the distal end of the thrombectomy support.

[0014] In one optional embodiment, a bracket fixing part is further included, one end of which is connected to a bracket fixing tube and the other end is connected to a handle.

[0015] In one optional embodiment, a first vent valve is further included, which is slidably disposed on the handle and communicates with the outer pipe;

[0016] The vent valve is connected to the outer tube drive unit and slides along the handle following the sliding of the outer tube drive unit.

[0017] In one optional embodiment, a bracket adjustment and fixing part is further included, which is slidably disposed on the handle;

[0018] The bracket adjustment and fixing part is connected to the bracket adjustment tube and the bracket adjustment part respectively, and can slide along the handle as the bracket adjustment part slides.

[0019] In one optional embodiment, a second vent valve is further included, which is slidably disposed on the handle and communicates with the bracket adjustment tube.

[0020] In one optional embodiment, the handle is provided with a first slide groove, and the two ends of the first slide groove are respectively provided with limiting parts;

[0021] The outer tube drive unit is slidably disposed in the first slide groove, and a first boss is provided at each end. The first boss cooperates with the limiting part to limit the sliding stroke of the outer tube drive unit.

[0022] In one optional embodiment, the handle is provided with a second sliding groove, and a plurality of limiting grooves are distributed at intervals on the second sliding groove;

[0023] The bracket adjustment part is slidably disposed in the second slide groove, and a second protrusion is provided on the side wall. The second protrusion cooperates with the limiting groove to change the expansion state of the thrombectomy bracket.

[0024] In one optional embodiment, the thrombectomy bracket has a hollow structure and multiple telescopic sections distributed along the circumference.

[0025] In one alternative embodiment, the telescopic portion includes a wave shape and has at least two wave crests distributed along the axis.

[0026] In one optional embodiment, the telescopic portion includes a first protrusion and a second protrusion distributed circumferentially, wherein the first protrusion and the second protrusion do not intersect the circumferential contour of the thrombectomy bracket.

[0027] The first protrusion protrudes in a first direction toward the circumference, and the second protrusion protrudes in a second direction toward the circumference, wherein the first direction is opposite to the second direction.

[0028] In one optional embodiment, at least one of the bracket fixing tube and the outer tube is a metal composite braided tube; and / or, the bracket adjusting tube is made of metal.

[0029] The technical solution of the present invention has the following advantages or beneficial effects:

[0030] (1) In this invention, the outer tube, stent fixation tube, and stent adjustment tube are sequentially nested from the outside in; a thrombectomy stent is present, with its proximal end connected to the distal end of the stent fixation tube, and its distal end connected to the stent adjustment tube; the outer tube drive unit slides along the handle to control the thrombectomy stent to extend out of or retract into the outer tube; the stent adjustment unit slides along the handle to control the distal end of the thrombectomy stent to move closer to or further away from the proximal end of the thrombectomy stent; the nested arrangement of the above-mentioned tubing and the installation of the operating structure on the handle greatly facilitate the operator's control of the positional relationship between the thrombectomy stent and the outer tube stent, realizing the switching of the thrombectomy stent's operating state. Furthermore, this invention does not require replacement of the thrombectomy stent; it only requires controlling the expansion state of the thrombectomy stent through the adjustment mechanism on the handle to adapt it to blood vessels of various sizes. When the position of the stent adjustment unit is adjusted to the correct position and fixed, the expansion state of the thrombectomy stent will also remain fixed, that is, the diameter of the thrombectomy stent within the body will remain unchanged, thereby enabling stable thrombectomy operations. It effectively solves the problem that the radial dimensions of existing thrombectomy stents are unstable and cannot be adjusted, making them unsuitable for various blood vessels of different diameters.

[0031] (2) The first vent valve of the present invention is slidably mounted on the handle and communicates with the outer tube; the vent valve is connected to the outer tube drive unit and slides along the handle following the sliding of the outer tube drive unit. It also includes a second vent valve, which is slidably mounted on the handle and communicates with the bracket adjustment tube. The two vent valves vent gas from the device from multiple angles, effectively preventing gas from entering the human body. Furthermore, both vent valves can move along the pipeline on the handle, improving the adaptability of the venting operation.

[0032] (3) The outer tube drive unit of the present invention is slidably disposed in the first slide groove, and a first protrusion is provided at each end. The first protrusion cooperates with the limiting part to limit the sliding stroke of the outer tube drive unit. This makes it convenient for the user to control the thrombectomy device to fully extend or fully retract the outer tube, reducing the difficulty of operation for the operator. The first protrusion and the limiting part are connected by a snap-fit ​​connection. When the two are engaged, the sound generated by the engagement not only reminds the user that the outer tube drive unit has moved to the limit position, but also constrains the position of the outer tube drive unit, preventing it from moving at the limit position. This keeps the position of the thrombectomy bracket relative to the outer tube stable, making it convenient for the operator to adjust the shape of the thrombectomy bracket.

[0033] (4) When the second boss of the present invention mates with different limiting grooves, the retraction dimension of the support adjusting tube relative to the support fixing tube can be determined. Since the proximal end of the thrombectomy support is fixed on the support fixing tube, its axial and radial dimensions will continuously change as the distal end of the thrombectomy support moves towards the proximal end with the support adjusting tube. Therefore, when the support adjusting part slides to different positions, the thrombectomy support will have different expansion dimensions. That is, different radial dimensions of the thrombectomy support can be obtained by mates of the second boss with different limiting grooves. This greatly facilitates the operator in adjusting and fixing the radial dimension of the thrombectomy support.

[0034] (5) This invention features at least two wave crests. These crests, in contact with the thrombus, provide sufficient contact area and scraping force. Simultaneously, the crests abut against the vessel wall to support the thrombectomy stent, ensuring smooth forward or reverse rotation with the handle. More advantageously, the use of multiple wave-shaped telescopic sections, evenly distributed circumferentially to form a cage-like structure, allows the scraped thrombus to be collected within the telescopic sections. After the scraping operation is completed, the thrombectomy stent can be released, causing the telescopic sections to gradually lengthen. The circumferential distance between adjacent telescopic sections gradually decreases, and the wave-shaped telescopic sections prevent the thrombus from falling out of the thrombectomy stent during the lengthening process.

[0035] (6) The first and second protrusions allow the thrombus to be scraped off in stages, and a certain amount of thrombus is scraped off each time, avoiding the problem of excessive tearing force caused by scraping off a large volume of blood vessel wall at one time, thus avoiding blood vessel rupture and effectively improving the safety of the surgical operation. Attached Figure Description

[0036] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0037] Figure 1 This is a top view schematic diagram of the thrombectomy device according to an embodiment of the present invention;

[0038] Figure 2This is a front view schematic diagram of the thrombectomy device according to an embodiment of the present invention;

[0039] Figure 3 This is another top view schematic diagram of the thrombectomy device according to an embodiment of the present invention;

[0040] Figure 4 This is a partial schematic diagram of the distal end of the thrombectomy device according to an embodiment of the present invention;

[0041] Figure 5 This is another top view schematic diagram of the thrombectomy device according to an embodiment of the present invention;

[0042] Figure 6 This is a partial schematic diagram of the expanded state of the thrombectomy bracket at the distal end of the thrombectomy device according to an embodiment of the present invention;

[0043] Figure 7 This is an exploded schematic diagram of the thrombectomy device according to an embodiment of the present invention;

[0044] Figure 8 This is a partial schematic diagram of the bottom of the upper housing of the thrombectomy device according to an embodiment of the present invention;

[0045] Figure 9 This is a partial schematic diagram of the top of the upper housing of the thrombectomy device according to an embodiment of the present invention;

[0046] Figure 10 This is a schematic diagram of the working state of the thrombectomy device according to an embodiment of the present invention. Detailed Implementation

[0047] The following description, in conjunction with the accompanying drawings, illustrates exemplary embodiments of the present invention, including various details to aid understanding. These details should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the invention. Similarly, for clarity and brevity, descriptions of well-known functions and structures are omitted in the following description.

[0048] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0049] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0050] Thrombosis is a major cause of acute and chronic cardiovascular, cerebrovascular, and peripheral vascular diseases. Thrombotic diseases, including stroke, myocardial infarction, pulmonary embolism, and lower extremity deep vein thrombosis, are among the most common and serious clinical conditions. They not only reduce patients' quality of life and seriously threaten their lives but also increase their economic burden. Under the influence of various risk factors (such as vascular wall damage, changes in blood rheology, and alterations in blood composition), the balance between coagulation and anticoagulation in the systemic or local coagulation systems becomes imbalanced, leading to the formation of arterial thrombi, venous thrombi, atrial thrombi, or microvascular thrombi. If this imbalance occurs in the arterial system (such as cerebral arteries and coronary arteries), white thrombi are mainly formed; if the imbalance occurs in the venous system or the left and right atria, red thrombi are mainly formed. Thrombi in different locations have different compositions, and their molecular mechanisms of formation also differ.

[0051] For thrombosis treatment, current techniques primarily employ surgery. However, the instruments used in these surgeries still fall short of current needs. For instance, the braided stents used in existing techniques are made by braiding nickel-titanium wires and then heat-setting them. When the braided stent passes through a narrowed vessel (such as the iliac vein) or a thrombus lesion, the stent cannot fully expand due to its own expansion force, thus failing to remove the thrombus adhering to the vessel wall. Cut stents, on the other hand, are made by laser-cutting nickel-titanium tubes and then heat-setting them. Compared to braided stents, cut stents offer stronger radial support; however, the performance improvement is limited. The diameter of both braided and cut stents is determined during heat setting and cannot be adjusted intraoperatively. If a larger vessel is encountered, a larger stent is required, increasing the complexity of the surgery and the burden on the patient.

[0052] To address at least one of the aforementioned problems, the present invention provides a thrombectomy device. The thrombectomy device includes a handle with an outer tube drive unit and a support adjustment unit slidably disposed thereon; a support fixing tube, the proximal end of which is fixedly connected to the handle; an outer tube, the proximal end of which is slidably connected to the handle; and a support adjustment tube, the proximal end of which is slidably connected to the handle; the outer tube, the support fixing tube, and the support adjustment tube are sequentially sleeved from the outside in; a thrombectomy support, the proximal end of which is connected to the distal end of the support fixing tube, and the distal end of which is connected to the support adjustment tube; the outer tube drive unit slides along the handle to control the thrombectomy support to extend out of or retract into the outer tube; the support adjustment unit slides along the handle to control the distal end of the thrombectomy support to move closer to or further away from the proximal end of the thrombectomy support, and to change the expansion state of the thrombectomy support.

[0053] like Figures 1 to 7 As shown, in one embodiment, the thrombectomy device includes a handle, which can be composed of an upper housing 706 and a lower housing 707. The upper and lower housings can be injection molded separately and then assembled into a complete handle. An outer tube drive unit 306 and a support adjustment unit 305 are slidably disposed on the handle. The outer tube drive unit is used to drive the outer tube 302 to move forward or backward along the axial direction. The forward and backward movement of the outer tube allows the thrombectomy support enclosed inside the outer tube to be exposed or retracted into the outer tube. It also includes a support fixing tube 401, the proximal end of which is fixedly connected to the handle, thereby fixing the support fixing tube relative to the handle. The outer tube 302, the proximal end of which is slidably connected to the handle. Figure 7 The outer tube is controlled by the outer tube drive unit, and its proximal end can slide back and forth along the axial direction within the handle. The support adjustment tube 704 has its proximal end slidably connected to the handle, allowing it to slide back and forth along the axial direction relative to the handle. The outer tube, support fixing tube, and support adjustment tube are sequentially nested from the outside in, i.e., the outer tube is the outermost layer, the support adjustment tube is the innermost layer, and the support fixing tube is positioned between the outer tube and the support adjustment tube. In some optional embodiments, a stress expansion tube 303 is also sleeved outside the proximal end of the outer tube, and the proximal end of the stress expansion tube is connected to the distal end of the handle. It should be noted that both the distal and proximal ends are relative to the operator. Specifically, the end of the device or component closer to the operator is the proximal end, and the end farther from the operator is the distal end. The operator operates the device at the proximal end to control the working state of the thrombectomy device. The thrombectomy device also includes a thrombectomy bracket, the proximal end of which is connected to the distal end of the support fixing tube 401, as detailed below. Figure 6The illustrated embodiment. Since the support fixing tube is fixed relative to the handle, the above connection method ensures that the proximal end of the thrombectomy support is fixed relative to the handle. The distal end of the thrombectomy support is connected to the support adjustment tube 704. Figure 6 As shown, when the stent adjustment tube slides back and forth along the axis relative to the stent fixation tube, the distal end of the thrombectomy stent will also slide accordingly. That is, the distance between the distal and proximal ends of the thrombectomy stent is adjustable, thereby controlling the stretching or compression of the thrombectomy stent. The outer tube drive unit slides along the handle to control the thrombectomy stent to extend out of or retract into the outer tube; the stent adjustment unit slides along the handle to control the distal end of the thrombectomy stent to move closer to or further away from the proximal end, and to change the expansion state of the thrombectomy stent. The expansion state refers to the adjustable radial dimension of the thrombectomy stent, allowing it to adapt to blood vessels of different diameters and to perform thrombectomy operations. The device of this invention does not require replacing the thrombectomy stent; it only requires controlling the expansion state of the thrombectomy stent through the adjustment mechanism on the handle to adapt it to blood vessels of various sizes. Furthermore, when the stent adjustment unit is positioned and fixed, the expansion state of the thrombectomy stent will also remain fixed, meaning the diameter of the thrombectomy stent within the body will remain constant, thus enabling stable thrombectomy operations. It effectively solves the problem that the radial dimensions of existing thrombectomy stents are unstable and cannot be adjusted, making them unsuitable for various blood vessels of different diameters.

[0054] In one optional embodiment, the handle is rotated to drive the thrombectomy stent to rotate. In practice, since thrombi are randomly distributed within blood vessels without a fixed distribution pattern, they are often non-uniformly distributed. Therefore, in order for the thrombectomy stent to capture the thrombus at the target location, in some embodiments, the thrombectomy stent is rotatable. Specifically, the operator needs to control the thrombectomy stent to move forward and reach the target location, such as by observing the position of the thrombectomy stent in real time using auxiliary equipment such as CT. After reaching the target location, the outer tube can be retracted by the outer tube drive unit to expose the distal end of the outer tube; then, the distal end of the thrombectomy stent is moved proximally by the stent adjustment unit to obtain the desired thrombectomy stent expansion state. Generally, it is advisable to make the diameter of the expanded thrombectomy stent approximately equal to the diameter of the blood vessel at the target location. Finally, the operator keeps the position and expansion state of the thrombectomy stent unchanged and rotates the handle. Since the thrombectomy stent is fixed to the stent fixation tube, and the stent fixation tube is further fixed to the handle, the rotation of the handle will synchronously drive the thrombectomy stent to rotate, thereby using the thrombectomy stent to scrape away the thrombus attached to the blood vessel wall. In actual use, operators can repeatedly rotate the handle clockwise or counterclockwise, or adjust the expansion state and position of the thrombectomy stent, to thoroughly remove the thrombus at the target location. Of course, during the above operation, operators can use auxiliary equipment such as CT scans to observe the removal effect in real time, adjust the instrument status, and perform multiple thrombectomy procedures.

[0055] In one optional embodiment, a conical head 301 is further included. This conical head is positioned at the distal end of the thrombectomy device and connected to the distal end of the stent adjustment tube and / or the distal end 402 of the thrombectomy stent. As mentioned earlier, the distal end of the thrombectomy device comprises multiple nested tubular structures. Since the end face shape of these tubular structures is unfavorable for the thrombectomy stent to intervene in the target environment, in some embodiments, a conical head is added to the distal end of the thrombectomy device. During installation, the conical head, in its installed state, has its tip pointing towards the distal end of the thrombectomy device, and the end of the conical head opposite the tip is connected to the thrombectomy device. Specifically, the conical head can be connected to the distal end of the stent adjustment tube and / or the distal end of the thrombectomy stent; that is, the three can be connected to each other to achieve the positioning of the conical head. Alternatively, the thrombectomy stent can be fixed to both the conical head and the stent adjustment tube. In actual use, the conical head cooperates with the guide wire to guide the thrombectomy device smoothly to the target position.

[0056] In one optional embodiment, a stent fixing part 702 is further included. One end of the stent fixing part is connected to the stent fixing tube, and the other end is connected to the handle. In practice, the stent fixing tube 401 is often a tube of uniform diameter. Therefore, the diameter of the tube usually needs to be adapted to the stenotic diameter of the blood vessel to achieve the goal of carrying the thrombectomy stent to the target location. Based on this, when the stent fixing tube is directly fixed to the handle, the internal structure of the handle often needs to be specially designed, otherwise it is difficult to connect the stent fixing tube to the handle. However, such a design will increase the processing difficulty of the handle. To this end, in one embodiment of the present invention, a stent fixing part 702 is designed, and the stent fixing tube and the handle are connected through the stent fixing part. That is, one end of the stent fixing part is connected to the proximal end of the stent fixing tube, and the other end is connected to the inside of the handle, thereby achieving the indirect connection of the stent fixing tube to the handle. For example, a groove can be provided inside the handle, and the stent fixing part can be provided with a corresponding snap-fit ​​part to snap-fit ​​the stent fixing part and the groove on the handle. It should be noted that the above is only an example, and any structure that can achieve the same function can be used here, which does not constitute a limitation on the scope of protection of the present invention.

[0057] In one optional embodiment, a first vent valve 304 is further included. The first vent valve is slidably mounted on the handle and communicates with the outer tube. The first vent valve is connected to the outer tube drive unit and slides along the handle following the sliding of the outer tube drive unit. Figure 3 and 7 In the illustrated embodiment, the thrombectomy device is further equipped with a first vent valve 304 to vent the outer tube, thereby preventing gas from entering the body during intervention. The first vent valve is fixedly connected to the proximal end of the outer tube, and the internal space of the outer tube communicates with the venting channel of the first vent valve. Further, the first vent valve is located inside the handle, specifically between the upper housing 706 and the lower housing 707 of the handle. At least one of the upper and lower housings has a groove to accommodate a portion of the first vent valve. Figure 7As shown, the portion of the exhaust pipe of the first vent valve extending out of the handle housing is slidably mounted within the groove and can slide along the groove; in other words, the groove guides the movement of the first vent valve. Further, at least one of the upper or lower housing is provided with a vent valve guide groove, and the first vent valve is provided with a guide protrusion that cooperates with the vent valve guide groove. The vent valve guide groove and guide protrusion work together to further improve the stability of the sliding movement of the first vent valve. Further, the upper housing of the handle is also provided with a groove for installing an outer tube drive unit (this groove will be described in detail later), and the outer tube drive unit can slide along the groove. In some embodiments, the outer tube drive unit has at least one groove, preferably two. The outer tube drive unit extends into the interior of the upper housing through the groove. The portion extending into the interior of the upper housing is connected to the first vent valve. Therefore, when the outer tube drive unit slides along the handle, the first vent valve slides synchronously with the outer tube. When the outer tube slides proximally, the thrombectomy bracket protrudes from the outer tube; when the outer tube slides distally, the thrombectomy bracket retracts into the sheath bracket.

[0058] In one optional embodiment, a bracket adjustment and fixing part 703 is further included, which is slidably disposed on the handle; the bracket adjustment and fixing part is connected to both the bracket adjustment tube 704 and the bracket adjustment part, and can slide along the handle following the sliding of the bracket adjustment part. Figure 7 In the illustrated embodiment, the thrombectomy device further includes a bracket adjustment and fixing part, which is used to fix the bracket adjustment tube and guide its movement. Specifically, at least one of the upper and lower housings of the handle is provided with a guide groove, and the bracket adjustment and fixing part is slidably disposed within the guide groove. When the bracket adjustment and fixing part is manipulated to slide along the guide groove to the distal or proximal end, the bracket adjustment tube will move synchronously accordingly. Further, at least one of the upper or lower housings of the handle is provided with a bracket adjustment guide groove, and the bracket adjustment part is slidably disposed within the bracket adjustment guide groove. The bracket adjustment guide groove includes at least one, preferably two. When the bracket adjustment part cooperates with the two guide grooves, its movement stability can be improved, making it easier for the operator to use. Further, the bracket adjustment part is connected to the bracket adjustment and fixing part, so that the operator can control and adjust the position of the bracket adjustment tube through the bracket adjustment part.

[0059] In one optional embodiment, a second vent valve 307 is further included, which is slidably mounted on the handle and communicates with the stent adjustment tube. In practice, since a thrombectomy stent is provided at the distal end of the stent adjustment tube, which is used to adjust the expansion shape of the thrombectomy stent to obtain the required radial dimension, if the stent adjustment tube carries gas, the gas will enter the human body and cause problems such as air embolism. To solve the above problems, in one embodiment of the present invention, a second vent valve is provided at the proximal end of the stent adjustment tube, thereby venting the gas in the stent adjustment tube through the second vent valve to prevent it from entering the human body. In one optional embodiment, the second vent valve is located at the proximal end of the handle after assembly and protrudes from the handle. When the stent adjustment tube moves back and forth, the second vent valve also moves synchronously towards or away from the handle.

[0060] In one optional embodiment, the handle is provided with a first sliding groove, and each end of the first sliding groove is provided with a limiting part 804; the outer tube drive part is slidably disposed in the first sliding groove, and each end is provided with a first boss 805, the first boss cooperating with the limiting part to limit the sliding stroke of the outer tube drive part. In practice, the change in the position of the outer tube is mainly used to control whether the thrombectomy bracket extends out of the outer tube. In order to facilitate the operator to easily and quickly extend the thrombectomy bracket completely out of the outer tube, or retract it completely into the outer tube, it is necessary to reasonably control the stroke of the outer tube drive part. For this purpose, the handle is provided with a first sliding groove, and each end of the first sliding groove is provided with a limiting part, thereby controlling the stroke of the outer tube through the limiting part. For example, when the outer tube drive part previously moves to the limiting part at the distal end, it will not be able to move further, and the outer tube will cover the thrombectomy bracket inside it; while when the outer tube drive part moves to the proximal end and abuts against the limiting part at the proximal end, the thrombectomy bracket will extend completely out of the outer tube. Preferably, the outer tube drive unit is slidably disposed within the first groove, and each end is provided with a first protrusion. The first protrusion cooperates with the limiting part to restrict the sliding stroke of the outer tube drive unit. Preferably, the first protrusion and the limiting part are connected by a snap-fit ​​connection. When the two are engaged, the sound generated by the engagement not only alerts the user that the outer tube drive unit has moved to its limit position, but also constrains the position of the outer tube drive unit, preventing it from moving at its limit position. This keeps the position of the thrombectomy bracket relative to the outer tube stable, facilitating the operator to adjust the shape of the thrombectomy bracket. In other embodiments, the limiting part may be disposed on the outer tube drive unit, and the first protrusions may be disposed at both ends of the first groove.

[0061] In one optional embodiment, the handle is provided with a second sliding groove, and a plurality of limiting grooves 802 are distributed at intervals on the second sliding groove; the bracket adjustment part is slidably disposed in the second sliding groove, and a second protrusion 801 is provided on its side wall. The second protrusion cooperates with the limiting grooves to change the expansion state of the thrombectomy bracket. Convenient and quick adjustment of the shape of the thrombectomy bracket while maintaining its radial dimension stability is an important prerequisite for improving the thrombectomy operation. Therefore, in one embodiment of the present invention, this problem is solved by providing a second sliding groove on the handle, with a plurality of limiting grooves distributed at intervals on the second sliding groove, and a corresponding second protrusion on the bracket adjustment part, selectively engaging the second protrusion with the limiting groove. Figure 8 As shown, the upper housing of the handle is provided with a second sliding groove, and multiple limiting grooves are discretely distributed along the axial direction of the second sliding groove. When the second boss mates with different limiting grooves, the retraction dimension of the support adjustment tube relative to the support fixing tube can be determined. Since the proximal end of the thrombectomy bracket is fixed to the support fixing tube, its axial and radial dimensions will continuously change as the distal end of the thrombectomy bracket moves towards the proximal end with the support adjustment tube. Therefore, when the support adjustment part slides to different positions, the thrombectomy bracket will have different expansion dimensions. That is, different radial dimensions of the thrombectomy bracket can be obtained by mates of the second boss with different limiting grooves. In practice, the dimensions of the thrombectomy bracket under different displacements of the support adjustment part can be calibrated by experiment. The calibration results can then be expressed in a scale manner (see...). Figure 9 The markings on the handle allow operators to easily observe the scale on the handle to understand the shape and size of the thrombectomy stent within the body. In practice, when high-precision adjustment of the thrombectomy stent size is required, the density of the scale lines per unit length in the direction of movement of the stent adjustment part can be appropriately increased, and the resolution of the scale lines can be improved. Preferably, the second protrusion and the limiting groove adopt a snap-fit ​​engagement method. The snap-fit ​​engagement can remind the user that the engagement is complete through a snap-fit ​​sound, and at the same time, the snap-fit ​​engagement prevents uncontrolled movement of the stent adjustment tube, enabling the thrombectomy stent to maintain a stable radial dimension. In some embodiments, the second slide groove can be provided in multiple ways, and the stent adjustment part has a guide mechanism that engages with the multiple second slide grooves to improve the movement stability of the stent adjustment part. Preferably, the number of the second slide grooves is two.

[0062] In one optional embodiment, the thrombectomy bracket has a hollow structure and multiple telescopic sections distributed along its circumference. For example... Figure 4 and 6 In the illustrated embodiment, the thrombectomy bracket has a hollow structure and multiple telescopic portions 602. The hollow structure and telescopic portions ensure that the thrombectomy bracket can be extended from... Figure 4 The stretched state shown shrinks to Figure 6The expansion state is shown. In other words, the telescopic portion gives the thrombectomy bracket sufficient elasticity to change shape across multiple scales to achieve the desired radial dimensions. The telescopic portion can be machined into a wave shape to provide sufficient flexibility. In some embodiments, the thrombectomy pieces can be cut from metal. The manufacturing method described herein is merely an example and is not intended to limit the scope of protection of this invention.

[0063] In one optional embodiment, the telescopic portion includes a wave shape and has at least two wave crests distributed along the axis. For example... Figure 6 In the illustrated embodiment, the telescopic portion exhibits a wave-like shape in the compressed state. Preferably, the wave-like shape has at least two crests 601. In actual use, the thrombectomy stent primarily scrapes the thrombus through these crests to achieve thrombectomy. When two or more crests are provided, the contact between the crests and the thrombus not only provides sufficient contact area and scraping force, but also provides support to the thrombectomy stent against the vessel wall, ensuring smooth forward or reverse rotation of the handle. More advantageously, the use of multiple wave-shaped telescopic portions, evenly distributed circumferentially to form a cage-like structure, allows the scraped thrombus to be collected inside the telescopic portion. After the scraping operation is completed, the thrombectomy stent can be released, causing the telescopic portion to gradually lengthen, and the circumferential distance between adjacent telescopic portions to gradually decrease. The wave-shaped telescopic portion prevents the thrombus from falling out of the thrombectomy stent during the lengthening process. When contracted to... Figure 4 Once the desired shape is achieved, the outer tube can be controlled to move distally, covering the thrombectomy stent and preventing thrombi from falling into the bloodstream during the stent's removal from the body.

[0064] In one optional embodiment, the telescopic portion includes a first protrusion and a second protrusion distributed circumferentially, wherein the first and second protrusions do not intersect the circumferential contour of the thrombectomy bracket; the first protrusion protrudes in a first direction toward the circumference, and the second protrusion protrudes in a second direction toward the circumference, wherein the first direction and the second direction are opposite. Figure 10 In the illustrated embodiment, when the thrombectomy stent scrapes away the thrombus 1003 within the blood vessel, because the base of the thrombus is tightly adhered to the inner wall of the vessel, if the outermost edge 1001 of the thrombectomy stent is used directly to scrape away the thrombus, this edge will be in prolonged contact with the vessel wall, continuously rubbing against it, causing the thrombus to detach in large quantities. Especially at the moment the thrombus detaches from the vessel wall, the vessel wall not only has to withstand the tearing force of thrombus separation but also the scraping force of the outermost edge 1001. It is understandable that directly scraping away a large volume of thrombus against the vessel wall in one go requires applying a significant force to the thrombus, inevitably causing considerable tearing force on the blood vessel. In summary, the aforementioned combined forces can easily lead to vessel wall rupture, posing a significant surgical risk. Therefore, Figure 10 In the illustrated embodiment, the telescopic portion includes a first protrusion 1002 and a second protrusion 1004 distributed circumferentially, wherein the first and second protrusions do not intersect the circumferential contour of the thrombectomy stent. In other words, neither the first nor the second protrusion is on the outermost circumference between thrombectomies. Preferably, the first protrusion protrudes in a first direction toward the circumference, and the second protrusion protrudes in a second direction toward the circumference, wherein the first and second directions are opposite. Because the first and second protrusions are protruding, during thrombus removal, regardless of whether the rotation is along the first or second direction, the first or second protrusion first contacts the non-vascular wall portion of the thrombus and pushes the thrombus away from the vessel wall, avoiding the problem of excessive load on the vessel caused by directly scraping away a large volume of thrombus from the vessel wall. Figure 10 As shown, when along the first direction (i.e. Figure 10 When the thrombectomy stent is rotated counterclockwise, the first protrusion 1002 first separates most of the thrombus from the vessel wall, and then the outermost part 1001 scrapes away any remaining thrombi adhering to the vessel wall; in other words, the thrombus is peeled off from the vessel wall in stages, thereby reducing the force applied to the thrombus in a single operation. Of course, it is also possible to first rotate it in the second direction (i.e., counterclockwise). Figure 10 Rotate the thrombectomy stent clockwise. At this time, the second protrusion 1002 first separates most of the thrombus from the blood vessel wall, and then the outermost part 1001 scrapes away the few thrombi adhering to the blood vessel wall. Figure 10 In the structure shown, the thrombus is scraped off in stages, with a certain amount of thrombus being scraped off each time. This avoids the problem of excessive tearing force caused by scraping off a large volume of thrombus against the blood vessel wall at once, thus preventing blood vessel rupture and effectively improving the safety of the surgical procedure.

[0065] In one optional embodiment, at least one of the stent fixation tube and the outer tube is a metal composite braided tube; and / or, the stent adjustment tube is made of metal. In a preferred embodiment, at least one of the stent fixation tube and the outer tube is braided from metal wire and a polymer composite material. This manufacturing method improves the torsion control, delivery performance, and support performance of such tubing, and can reduce the size of the tubing. The metal material can be stainless steel, nickel-titanium wire, etc., and the polymer material can be Pebax, nylon, PTFE, etc. Preferably, the stent adjustment tube is made of metal, thereby giving it a certain degree of toughness, facilitating its insertion into tortuous blood vessels. Furthermore, the side material of the metal stent adjustment tube can be removed to increase its flexibility.

[0066] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art, after considering the specification and practicing the technical solutions disclosed in this application, will readily conceive of other embodiments of this disclosure. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary technical means in the art not disclosed in this disclosure. The specification and embodiments are considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0067] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A thrombus removal device, Its features are: Includes a handle, on which an outer tube drive unit and a bracket adjustment unit are slidably mounted; A bracket fixing tube, the proximal end of which is fixedly connected to the handle; The outer tube, the proximal end of which is slidably connected to the handle; The support adjustment tube has its proximal end slidably connected to the handle; The outer tube, the support fixing tube, and the support adjusting tube are sequentially sleeved from the outside to the inside; A thrombectomy stent, wherein the proximal end of the thrombectomy stent is connected to the distal end of the stent fixing tube, and the distal end of the thrombectomy stent is connected to the stent adjustment tube. The outer tube drive unit slides along the handle to control the bolt retrieval bracket to extend out of or retract into the outer tube; The bracket adjustment part slides along the handle to control the distal end of the thrombectomy bracket to move closer to or further away from the proximal end of the thrombectomy bracket, and to change the expansion state of the thrombectomy bracket. The thrombectomy bracket has a hollow structure and multiple telescopic parts distributed discretely along the circumference; Each of the aforementioned telescopic sections includes a wave shape, and each has at least two wave peaks distributed along the axis; The telescopic part includes a first protrusion and a second protrusion distributed along the circumference, wherein the first protrusion and the second protrusion do not intersect with the circumferential outline of the thrombectomy bracket. The first protrusion protrudes in a first direction toward the circumference, and the second protrusion protrudes in a second direction toward the circumference, wherein the first direction is opposite to the second direction.

2. The thrombectomy device according to claim 1, characterized in that, The handle is rotated to drive the thrombectomy bracket to rotate.

3. The thrombectomy device according to claim 1, characterized in that, It also includes a tapered head, which is located at the distal end of the thrombectomy device and connected to the distal end of the support adjustment tube and / or the distal end of the thrombectomy support.

4. The thrombectomy device according to claim 1, characterized in that, It also includes a bracket fixing part, one end of which is connected to the bracket fixing tube and the other end is connected to the handle.

5. The thrombectomy device according to claim 1, characterized in that, It also includes a first vent valve, which is slidably mounted on the handle and connected to the outer pipe; The first vent valve is connected to the outer tube drive unit and slides along the handle following the sliding of the outer tube drive unit.

6. The thrombectomy device according to claim 1, characterized in that, It also includes a bracket adjustment and fixing part, which is slidably mounted on the handle; The bracket adjustment and fixing part is connected to the bracket adjustment tube and the bracket adjustment part respectively, and can slide along the handle as the bracket adjustment part slides.

7. The thrombectomy device according to claim 1, characterized in that, It also includes a second vent valve, which is slidably mounted on the handle and connected to the bracket adjustment tube.

8. The thrombectomy device according to claim 1, characterized in that, The handle is provided with a first sliding groove, and the two ends of the first sliding groove are respectively provided with limiting parts; The outer tube drive unit is slidably disposed in the first slide groove, and a first boss is provided at each end. The first boss cooperates with the limiting part to limit the sliding stroke of the outer tube drive unit.

9. The thrombectomy device according to claim 1, characterized in that, The handle is provided with a second sliding groove, and multiple limiting grooves are distributed at intervals on the second sliding groove; The bracket adjustment part is slidably disposed in the second slide groove, and a second protrusion is provided on the side wall. The second protrusion cooperates with the limiting groove to change the expansion state of the thrombectomy bracket.

10. The thrombectomy device according to claim 1, characterized in that, At least one of the bracket fixing tube and the outer tube is a metal composite braided tube; and / or, the bracket adjustment tube is made of metal.

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