Thrombus aspiration device

Abstract

This invention provides a thrombus aspiration device. The device includes: a thrombus collection stent, an aspiration catheter, a blood flow blocking structure, and a control component. The thrombus collection stent is an expandable and contractible stent structure. The blood flow blocking structure is disposed at the distal end of the aspiration catheter and can expand and contract radially to block the blood flow channel between the aspiration catheter and the vessel wall. The control component is connected to the thrombus collection stent and cooperates with the blood flow blocking structure. The control component can accommodate the contracted thrombus collection stent, release the thrombus collection stent to the distal end of the aspiration catheter, and control the expansion and contraction of the blood flow blocking structure. In this embodiment, the thrombus collection stent can dislodge and gather the thrombus to the aspiration port of the aspiration catheter, reducing the difficulty of thrombus aspiration. Simultaneously, the blood flow blocking structure blocks the blood flow channel between the aspiration catheter and the vessel wall, increasing suction force and reducing blood loss.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a thrombus aspiration device. Background Technology

[0002] In healthy individuals, there exists an intrinsic balance between procoagulation (clotting), anticoagulation, and fibrinolysis. Many genetic, acquired, and environmental factors can tilt this balance towards a procoagulant state, leading to pathological thrombosis in veins (e.g., deep vein thrombosis [DVT]), arteries (e.g., myocardial infarction, ischemic stroke), or the atria. Thrombi can obstruct blood flow at the site of thrombosis or detach and block distal vessels (e.g., pulmonary embolism, embolic stroke).

[0003] Currently, thrombectomy is frequently used in clinical practice to remove thrombi. This involves placing a catheter at the site of the thrombus and using negative pressure suction to remove it, thus restoring blood flow. While thrombectomy has wide applications in thrombus treatment, it also presents certain challenges. Clinically, thrombectomy can result in significant blood loss during the procedure, and some stubborn thrombi are difficult to remove. Summary of the Invention

[0004] The purpose of this invention is to provide a thrombus aspiration device that can reduce the difficulty of thrombus aspiration and increase the thrombus extraction rate, thereby reducing intraoperative blood loss.

[0005] To solve the above-mentioned technical problems, embodiments of the present invention provide a thrombus aspiration device, including: a thrombus collection stent, which is a stent structure that can expand and contract;

[0006] Aspiration catheter;

[0007] A blood flow occlusion structure, disposed at the distal end of the aspiration catheter, is capable of radial expansion and contraction to block the blood flow channel between the aspiration catheter and the vessel wall; and

[0008] A control component, which is connected to the thrombus collection stent and cooperates with the blood flow occlusion structure, is capable of accommodating the thrombus collection stent in a contracted state, releasing the thrombus collection stent to the distal end of the aspiration catheter, and controlling the expansion and contraction of the blood flow occlusion structure.

[0009] In addition, the thrombus aspiration device also includes a thrombus guiding stent whose proximal end is connected to the distal end of the aspiration catheter.

[0010] In addition, the blood flow occlusion structure includes: a balloon that is sealed around the distal outer peripheral wall of the aspiration catheter; wherein, the balloon is prefabricated to cover the thrombus guiding stent when it is in a contracted state and to make the thrombus guiding stent contracted, and the balloon can retract and release the thrombus guiding stent to an inflated state when it is inflated.

[0011] Optionally, the balloon is a rounded rectangle or a sphere;

[0012] Optionally, the balloon is a compliant balloon.

[0013] In addition, the blood flow occlusion structure includes: a covered stent disposed on the peripheral wall of the distal end of the aspiration catheter, the covered stent being capable of radial expansion and contraction;

[0014] The film-coated stent includes a stent body and a film; the film covers and fixes the stent body.

[0015] In addition, the stent body includes a plurality of circumferentially spaced struts, the proximal end of which is connected to the outer peripheral wall of the aspiration catheter, and the distal end of which is integrally connected to the proximal end of the thrombus guiding stent or to the outer peripheral wall of the aspiration catheter; the struts are capable of radial expansion and contraction, and the plurality of struts are respectively fixedly connected to the membrane.

[0016] Optionally, the covered support is spherical or spindle-shaped.

[0017] In addition, the blood flow occlusion structure includes: a foldable membrane sleeve that is movably fitted onto the distal end of the aspiration catheter, the foldable membrane sleeve having openings at both ends, and the distal end of the foldable membrane sleeve being connected to the distal end of the aspiration catheter, the proximal end of the foldable membrane sleeve being connected to the control component, and the control component being able to drive the foldable membrane sleeve to move axially relative to the aspiration catheter in order to control the radial expansion or contraction of the foldable membrane sleeve.

[0018] In addition, the thrombus collection stent includes: a collection segment and a plurality of connecting rods; the proximal end of the collection segment is connected to the distal end of the plurality of connecting rods, the distal end of the collection segment and the proximal end of the plurality of connecting rods are respectively connected to the distal end of the control component, and the plurality of connecting rods are circumferentially spaced around the center of the collection segment;

[0019] Optionally, the collecting section is disc-shaped.

[0020] Additionally, the control assembly includes an inner tube and a delivery sheath. The distal end of the inner tube passes through the thrombus collection stent, and both the distal and proximal ends of the thrombus collection stent are connected to the inner tube. The proximal end of the inner tube passes through the delivery sheath, which is used to receive the thrombus collection stent in a contracted state and is axially movable relative to the delivery sheath to release the thrombus collection stent.

[0021] Optionally, the thrombus aspiration device further includes a conical head that is smaller at the distal end and larger at the proximal end, the proximal end of which is connected to the distal end of the inner tube.

[0022] In addition, the thrombus collection stent is made by integrally weaving braided wire or laser engraving.

[0023] In addition, the thrombus-guided stent is cone-shaped or trumpet-shaped, with a larger distal end and a smaller proximal end;

[0024] Optionally, the thrombus guiding stent is coaxially arranged with the aspiration catheter.

[0025] As can be seen from the above technical solution, the present invention has at least the following advantages and positive effects:

[0026] The thrombus aspiration device of this invention can gather thrombi to the aspiration port of the aspiration catheter through the thrombus collection stent, which helps to reduce the difficulty of thrombus aspiration. At the same time, the blood flow blocking structure blocks the blood flow channel between the aspiration catheter and the blood vessel wall, which not only helps to concentrate the suction force, but also reduces blood loss. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. It is understood that the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the thrombus aspiration device provided in Embodiment 1 of the present invention;

[0029] Figure 2a This is a schematic diagram of the thrombus collection stent of the thrombus aspiration device provided in Embodiment 1 of the present invention in its stored state;

[0030] Figure 2b for Figure 2a A schematic diagram of the expanded state of the thrombus collection stent in the middle;

[0031] Figure 3a This is a schematic diagram of the thrombus-guided stent and rectangular balloon in their stored state according to Embodiment 1 of the present invention;

[0032] Figure 3b for Figure 3a A schematic diagram of the thrombus-guided stent and the inflated state of the rectangular balloon.

[0033] Figure 3c A schematic diagram of the expanded state of the thrombus-guided stent and the spherical balloon provided in an embodiment of the present invention;

[0034] Figure 4 A schematic diagram of the expanded state of the thrombus-guided stent and the covered stent provided in an embodiment of the present invention;

[0035] Figure 5a A schematic diagram of the conveying state of the foldable film sleeve provided in an embodiment of the present invention;

[0036] Figure 5b for Figure 5a A schematic diagram of the expanded state of the foldable membrane sleeve in the middle;

[0037] Figure 5c A schematic diagram of the expanded state of the thrombus-guided stent and the foldable membrane sheath provided in an embodiment of the present invention;

[0038] Figure 6a A schematic diagram of the thrombus aspiration device provided in an embodiment of the present invention in its delivery state in a blood vessel;

[0039] Figure 6b A schematic diagram of the structure of the thrombus guiding stent and thrombus sealing component of the thrombus aspiration device provided in the embodiment of the present invention, which are released to an expanded state and the thrombus collecting stent passing over the thrombus.

[0040] Figure 6c This is a schematic diagram of the thrombus collection stent of the thrombus aspiration device provided in an embodiment of the present invention being released to the distal end of the thrombus;

[0041] Figure 6d This is a schematic diagram of the structure of the thrombus aspiration device provided in the embodiment of the present invention, which gathers thrombi into the aspiration port of the aspiration catheter after the thrombus collection stent is retracted.

[0042] Figure 6e This is a schematic diagram of the blood flow direction during thrombus aspiration using the thrombus aspiration device provided in this embodiment of the invention. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the various embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been presented in the various embodiments of the present invention to enable the reader to better understand the present invention. However, the technical solutions claimed in the present invention can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0044] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for 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. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0045] It should be noted that, unless otherwise explicitly stated, the terms “connected” and “linked” should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components.

[0046] In the description of this invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction 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 in its natural state. The above definitions are for ease of expression only and should not be construed as limiting the invention.

[0047] Please see Figure 1 As shown, this embodiment of the invention provides a thrombus aspiration device for rapidly and efficiently aspirating thrombi from the body. The thrombus aspiration device of this embodiment includes: a thrombus collection stent 1, an aspiration catheter 2, a thrombus occlusion structure 3, and a control component.

[0048] The thrombus collection stent 1 is an expandable and contractible stent structure. The thrombus collection stent 1 can dislodge and gather the thrombus to be aspirated near the aspiration port of the aspiration catheter 2, enabling the aspiration catheter 2 to accurately aspirate the thrombus.

[0049] A blood flow blocking structure 3 is located at the distal end of the aspiration catheter 2. This structure can expand and contract radially to block the blood flow channel between the aspiration catheter 2 and the vessel wall. The diameter of the aspiration catheter 2 is smaller than the inner diameter of the vessel 5. During thrombus aspiration, a blood flow channel is formed between the distal peripheral wall of the aspiration catheter 2 and the inner wall of the vessel 5. The suction force of the aspiration catheter 2 causes normal blood to be drawn into the catheter through this channel, resulting in lateral suction loss. This also disperses and reduces the suction force, increasing the difficulty of thrombus aspiration and decreasing the thrombus retrieval rate. By using the blood flow blocking structure 3, its expansion allows it to adhere tightly to the inner wall of the vessel 5, blocking the blood flow channel and preventing blood from entering the aspiration catheter 2. This increases the suction force of the aspiration catheter 2 on the thrombus, reduces blood loss, and improves the thrombus retrieval rate.

[0050] The control component is connected to the thrombus collection stent 1. The control component can accommodate the thrombus collection stent 1 in a contracted state and can also release the thrombus collection stent 1 to the distal end of the aspiration catheter 2. The control component can also cooperate with the blood flow blocking structure 3 and can control the expansion and contraction of the blood flow blocking structure 3. Thus, the thrombus can be gathered into the aspiration port of the aspiration catheter 2 using the thrombus collection stent 1, and the blood flow blocking structure 3 can block the blood flow between the aspiration catheter 2 and the blood vessel wall, thereby achieving precise aspiration of the thrombus.

[0051] Please see Figure 2a as well as Figure 2b As shown, the thrombus collection stent 1 includes a collection segment 11 and multiple connecting rods 12. The proximal end of the collection segment 11 is connected to the distal end of the multiple connecting rods 12. The distal end of the collection segment 11 and the proximal ends of the multiple connecting rods 12 are respectively connected to the distal end of a control component. The distal end of the collection segment 11 and the proximal ends of the multiple connecting rods 12 are all connected to the inner tube 13 of the control component (see below). The multiple connecting rods 12 are circumferentially spaced around the center of the collection segment 11. When the thrombus collection stent 1 is withdrawn, the multiple connecting rods 12 can cut the thrombus, and the collection segment 11 can adhere tightly to the inner wall of the blood vessel 5, and the thrombus is dissected and collected near the aspiration port of the aspiration catheter 2. Exemplarily, the collection segment 11 can be disc-shaped, compact in size, and can effectively dissect the thrombus. The thrombus collection stent 1 can be integrally woven from braided wire. Alternatively, the thrombus collection stent 1 can also be made of shape memory alloy, such as nickel-titanium tubing, and manufactured after laser cutting and heat setting. It is understood that this embodiment does not impose specific limitations on the structure and manufacturing process of the thrombus collection stent 1.

[0052] The control assembly may include an inner tube 13, a delivery sheath 14, and a conical head 15. The distal end of the inner tube 13 extends into the thrombus collection stent 1, and is connected to the proximal end of the conical head 15. The conical head has a tapered structure, smaller distally and larger proximally, facilitating the advancement of the thrombus collection stent's delivery structure within the blood vessel. Both the distal and proximal ends of the thrombus collection stent 1 are connected to the inner tube 13. Specifically, the distal end of the collecting segment 11 is connected to the proximal end of the conical head 15, and the proximal ends of multiple connecting rods 12 are connected to the inner tube 13. The proximal end of the inner tube 13 extends into the delivery sheath 14, which houses the thrombus collection stent 1 in a contracted state and is axially movable relative to the delivery sheath 14 to release the thrombus collection stent 1. See also... Figure 2a As shown, the thrombus collection stent 1 in a contracted state is loaded within the delivery sheath 14. Please refer to [link / reference]. Figure 2b As shown, when the thrombus collection stent 1 reaches the target position, the delivery sheath 14 is retracted to release the thrombus collection stent 1. After release, the thrombus collection stent 1 can recover to its inflated state by relying on its own memory performance. In some cases, the expansion and contraction of the thrombus collection stent 1 can also be controlled by manually pulling on the proximal and distal ends of the thrombus collection stent 1.

[0053] The thrombus aspiration device may further include a thrombus guiding stent 1 whose proximal end is connected to the distal end of the aspiration catheter 2. The thrombus guiding stent 4 in a contracted state can be accommodated by the thrombus occlusion structure 3 or the control component, and the thrombus guiding stent 4 can be released into an expanded state. The thrombus guiding stent 4 may be frustoconical or trumpet-shaped, with a larger distal end and a smaller proximal end. The thrombus guiding stent 4 and the aspiration catheter 2 may be coaxially arranged so that the aspiration catheter 2 is centered for aspiration. The thrombus guiding stent 4 may be manufactured using a braiding process or a laser engraving process.

[0054] The blood flow occlusion structure 3 may include a balloon that is sealed around the distal peripheral wall of the aspiration catheter 2. The flow of blood outside the aspiration catheter 2 can be controlled by adjusting the balloon's contraction and expansion. Simultaneously, the thrombus guiding stent 1 and the balloon can contract and expand synchronously, simplifying the surgical procedure. For details, please refer to... Figure 3a As shown, when the balloon is pre-contracted, it can cover the thrombus-guided stent 4 and compress it. After compression, the outer wall of the thrombus-guided stent 4 is flush with the aspiration catheter 2, facilitating delivery to the target blood vessel. Please refer to [link to relevant documentation]. Figure 3b As shown, when the balloon inflates, it can retract and release the thrombus-guiding stent 4 to its inflated state. At this point, the blood flow channel outside the aspiration catheter 2 is blocked. A compliant balloon can be used, and the balloon can be rounded rectangular. Please refer to [link to relevant documentation]. Figure 3c As shown, the balloon can also be spherical. It is understood that this embodiment does not impose specific limitations on the balloon's shape. The balloon can be sealed to the outer wall of the aspiration catheter 2 using a heat-sealing process. An inflation channel can be provided between the outer wall of the aspiration catheter 2 and the balloon, and this inflation channel communicates with the inflation channel on the side wall of the aspiration catheter 2. The balloon inflates by injecting liquid or gas into the inflation channel and contracts by withdrawing the liquid or gas. It is understood that this embodiment does not impose specific limitations on the balloon's inflation structure, as long as the inflation and contraction of the balloon can be controlled.

[0055] As an alternative example, please refer to Figure 4As shown, the blood flow occlusion structure 3 may include a covered stent disposed on the distal peripheral wall of the aspiration catheter 2, the covered stent being capable of radial expansion and contraction. The covered stent may include a stent body 31 and a covering 32. The covering 32 covers and fixes the stent body 31. The stent body 31 may include multiple circumferentially spaced struts, the proximal ends of which are connected to the peripheral wall of the aspiration catheter 2, and the distal ends of which may be integrally connected to the proximal end of the thrombus guiding stent 4, i.e., the thrombus guiding stent 4 and the covered stent are an integral structure. Alternatively, the distal ends of the struts may be connected to the peripheral wall of the aspiration catheter 2, and the thrombus guiding stent 4 and the covered stent may be separate structures. The struts are capable of radial expansion and contraction, and multiple struts are respectively fixedly connected to the covering. For example, the covered stent may be spindle-shaped or spherical. The control assembly may include a control sheath (not shown), within which the aspiration catheter 2 can be inserted. The control sheath houses the thrombus-guided stent 4 and the covered stent in a contracted state, and retracting the control sheath releases the thrombus-guided stent 4 and the covered stent into an expanded state, thereby achieving synchronous contraction and expansion of the thrombus-guided stent 4 and the covered stent. This embodiment does not impose specific limitations on the structure of the stent body. The stent body can be formed by braiding filaments, laser engraving, or 3D printing. The covering can be made of a material capable of blocking blood flow, including but not limited to: polyethylene terephthalate (PTE), polytetrafluoroethylene (PTFE), nylon (PA), or polyurethane (PU).

[0056] As another alternative example, please refer to Figures 5a-5c As shown, the blood flow occlusion structure 3 may include: a foldable membrane sheath movably fitted at the distal end of the aspiration catheter 2, with openings at both ends. The distal end of the foldable membrane sheath is connected to the distal end of the aspiration catheter 2, and the proximal end of the foldable membrane sheath is connected to a control component. The control component can drive the foldable membrane sheath to move axially relative to the aspiration catheter 2 to control the radial expansion or contraction of the foldable membrane sheath. The control component may include a control outer tube 16 slidably fitted outside the aspiration catheter 2, with the distal end of the control outer tube 16 connected to the proximal end of the foldable membrane sheath. The foldable membrane sheath is initially in a straight state for easy delivery. During the procedure, pushing the control outer tube 16 distally causes the straight foldable membrane sheath to be compressed and folded, resulting in radial expansion, thereby occluding the blood flow channel outside the aspiration catheter 2. The two ends of the foldable membrane sheath can be fixedly connected to the aspiration catheter and the control outer tube 16 respectively by heat fusion. When the blood flow occlusion structure 3 is a foldable membrane sheath, the thrombus guiding stent 4 can be controlled to expand and contract through a separate component.

[0057] The following is combined Figures 6a-6e The method of using the thrombus aspiration device according to an embodiment of the present invention is described below:

[0058] Please see Figure 6a As shown, the thrombus aspiration device of this embodiment is inserted into the blood vessel 5 until the aspiration port of the aspiration catheter 2 is a certain distance from the proximal end of the thrombus 6. Please refer to [link to relevant documentation]. Figure 6b As shown, the blood flow occlusion structure 3 and the thrombus guiding stent 4 expand synchronously. Then, the thrombus collection stent housed in the delivery sheath 14 extends out of the aspiration catheter 2, and the conical head 15 and the thrombus collection stent pass over the thrombus 6. Please refer to [link to relevant documentation]. Figure 6c As shown, retract the delivery sheath 14 to allow the thrombus collection stent 1 to expand and open naturally. Please refer to [link to previous text]. Figure 6d As shown, the entire thrombus collection stent 1 is pulled back, drawing the thrombus 6 to the aspiration port of the aspiration catheter 2. Please refer to [link / reference]. Figure 6e As shown, the suction catheter 2 is finally connected to the negative pressure generating device to draw the thrombus out of the body.

[0059] Compared with the prior art, the thrombus aspiration device of this invention first cuts and peels off stubborn and hard thrombi using a thrombus collection stent and collects them near the aspiration port of the aspiration catheter, which can greatly reduce the difficulty of aspiration. At the same time, the thrombus blocking structure blocks the blood flow outside the aspiration catheter, which can not only avoid the dispersion of suction force but also reduce blood loss, effectively improving the thrombus aspiration effect.

[0060] Those skilled in the art will understand that the above embodiments are specific examples of implementing the present invention, and in practical applications, various changes in form and detail may be made without departing from the spirit and scope of the present invention.

Claims

1. A thrombus aspiration device, characterized by, The thrombus suction device comprises: a thrombus collecting stent which is a stent structure capable of expansion and contraction; a suction catheter; a blood flow blocking structure arranged at the distal end of the suction catheter, the blood flow blocking structure being capable of radial expansion and contraction and used for blocking the blood flow passage between the suction catheter and the blood vessel wall; and a control assembly connected with the thrombus collecting stent and cooperating with the blood flow blocking structure, the control assembly being capable of accommodating the thrombus collecting stent in the contracted state, releasing the thrombus collecting stent to the distal side of the suction catheter and controlling the expansion and contraction of the blood flow blocking structure. The thrombus suction device further comprises a thrombus guide stent connected with the distal end of the suction catheter. The blood flow blocking structure comprises a covered stent arranged on the peripheral wall of the distal end of the suction catheter, the covered stent being capable of radial expansion and contraction. The covered stent comprises a stent body and a cover, the cover being fixedly arranged on the stent body. The stent body comprises a plurality of circumferentially spaced stent struts, the proximal end of the stent strut being connected with the peripheral wall of the suction catheter, and the distal end of the stent strut being integrally connected with the proximal end of the thrombus guide stent; the stent strut is capable of radial expansion and contraction, and the plurality of stent struts are respectively fixedly connected with the cover.

2. The thrombus aspiration device of claim 1, wherein, The covered stent is spherical or fusiform.

3. The thrombus aspiration device of claim 1, wherein, The thrombus collecting stent comprises a collecting segment and a plurality of connecting rods, the proximal end of the collecting segment being connected with the distal end of the plurality of connecting rods, the distal end of the collecting segment and the proximal end of the plurality of connecting rods being respectively connected with the distal end of the control assembly, and the plurality of connecting rods being circumferentially spaced around the center of the collecting segment; the collecting segment is disc-shaped.

4. The thrombus aspiration device of claim 1, wherein, The control assembly comprises an inner tube and a delivery sheath, the distal end of the inner tube being arranged in the thrombus collecting stent, and the distal end and the proximal end of the thrombus collecting stent being connected with the inner tube, the proximal end of the inner tube being arranged in the delivery sheath, the delivery sheath being used for accommodating the thrombus collecting stent in the contracted state and being capable of moving axially relative to the delivery sheath to release the thrombus collecting stent; the thrombus suction device further comprises a tapered head with a large proximal end and a small distal end, the proximal end of the tapered head being connected with the distal end of the inner tube.

5. The thrombus aspiration device of claim 4, wherein, The thrombus collecting stent is integrally woven by woven wires or made by laser engraving.

6. The thrombus aspiration device of claim 1, wherein, The thrombus guide stent is tapered or trumpet-shaped with a large distal end and a small proximal end; the thrombus guide stent is coaxially arranged with the suction catheter.

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