Thrombus filter device

Abstract

The present disclosure provides a thrombus filter device. The thrombus filter device comprises a support rod, a closing execution mechanism, a frame and a filter element arranged on and covering the frame. The frame comprises a distal guide wire and a proximal guide wire, at least one of the distal guide wire and the proximal guide wire comprises a first guide wire segment and a second guide wire segment. The second guide wire segment is provided with a first ring, and a first end of the first guide wire segment is connected to a distal end of the support rod. A second end of the first guide wire segment passes through the first ring and extends to be fixedly connected to the closing execution mechanism, and a portion of the first guide wire segment between the first end of the first guide wire segment and the first ring forms an end opening of the deployable frame with the second guide wire segment, and the closing execution mechanism is configured to at least pull the first guide wire segment to close the end opening. The device filters and collects emboli, and can also achieve the closure of the end opening by stretching the guide wire of the frame, such as adding a closing design to the distal opening, avoiding the escape of emboli from the distal end that is not closed, and avoiding the risk of blood vessel blockage.

Description

Technical Field

[0001] This disclosure relates to a thrombus filtration device. Background Technology

[0002] Transcatheter aortic valve replacement (TAVR) is a treatment for patients with moderate to severe aortic stenosis. With the increasing indications for TVR, attention to intraoperative adverse events and complications is also growing, with stroke being one of the most serious complications. Currently available transcatheter aortic valve replacement devices have an average stroke rate of 2%-6% within 30 days post-procedure; therefore, brain protection is one of the urgent issues to be addressed in TVR research.

[0003] Stroke is divided into ischemic stroke and hemorrhagic stroke. Ischemic stroke is caused by an embolus flowing into the blood vessels of the brain and blocking them, resulting in local blood vessel ischemia. Stroke has a very high mortality rate and neurological morbidity. Ischemic stroke accounts for 60%-70% of all stroke patients and mainly includes cerebral thrombosis and cerebral embolism.

[0004] Cerebral embolism is caused by emboli in the blood vessels supplying the brain, leading to arterial embolism. These emboli mainly originate from acute thrombosis caused by instruments in the aortic arch or aortic valve, as well as tissue detachment from the vessel wall, arterial wall debris, atherosclerotic plaques, valve leaflet tissue, cations, and calcified deposits. The procedure and instruments used in transcatheter aortic valve replacement surgery are among the main causes of arterial embolism. Current technologies employ a series of measures to reduce the risk of stroke associated with transcatheter aortic valve replacement surgery, including perioperative anticoagulation therapy, minimizing manipulation of the aortic arch and aortic valve position, and using cerebral embolism protection devices. Summary of the Invention

[0005] This disclosure provides at least one embodiment of a thrombus filtration device, including a support rod, a closing actuator, a frame, and a filter element disposed on and covering the frame. The support rod is connected at both ends to the closing actuator and the frame, respectively, and is located on one side of the filter element and extends axially along the filter element. The frame includes a distal guidewire and a proximal guidewire. At least one of the distal and proximal guidewires includes a first guidewire segment and a second guidewire segment. The second guidewire segment has a first loop. The first guidewire segment includes a first end and a second end opposite each other along its length. The first end of the first guidewire segment is connected to the support rod, and the second end of the first guidewire segment passes through the first loop and extends until it is fixedly connected to the closing actuator. A portion of the first guidewire segment from its first end to the first loop cooperates with at least a portion of the second guidewire segment to form an end opening of an expandable frame. The closing actuator is configured to at least pull the first guidewire segment to close the end opening.

[0006] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the second guidewire segment includes a first end and a second end opposite to each other along the length of the wire. The first end of the second guidewire segment is connected to one end of the support rod near the end opening, and the first ring is located at the second end of the second guidewire segment.

[0007] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, a first ring is integrally formed on a second guidewire segment.

[0008] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the second guidewire segment includes a first end and a second end opposite to each other along the length of the wire. The first end of the first guidewire segment is provided with a second ring, which is connected to one end of a support rod near the end opening, such that the first guidewire segment is connected to the support rod through the second ring. The first end of the second guidewire segment passes through the second ring and extends until it is fixedly connected to a closing actuator. The first ring is located at the second end of the second guidewire segment, and the second guidewire segment is configured to be pulled by the closing actuator to close the end opening.

[0009] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the first ring is integrally formed on the second guidewire segment, and the second ring is integrally formed on the first guidewire segment.

[0010] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the distal guidewire includes the first guidewire segment, the second guidewire segment, and the third guidewire segment described above. The third guidewire segment includes a first end and a second end relative to each other along the length of the wire. The first end of the third guidewire segment is connected to the first loop, and the second end of the third guidewire segment is fixedly connected to the closing actuator.

[0011] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the distal guidewire includes the aforementioned first guidewire segment and the aforementioned second guidewire segment. The distal guidewire is also provided with a third ring, which is fixed to the support rod and located between the distal end and the proximal end of the support rod. The second end of the first guidewire segment extends through the first ring of the second guidewire segment and through the third ring until it is fixedly connected to the closing actuator.

[0012] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the distal guidewire includes the aforementioned first guidewire segment and the aforementioned second guidewire segment. The distal guidewire is also provided with a third ring, which is fixed to the support rod and located between the distal end and the proximal end of the support rod. The first end of the second guidewire segment extends through the second ring of the first guidewire segment and through the third ring until it is fixedly connected to the closing actuator.

[0013] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the distal guidewire includes the aforementioned first guidewire segment and the aforementioned second guidewire segment, with a distal opening at the end. The proximal guidewire includes a fourth guidewire segment, which includes a first end and a second end opposite to each other along the length direction. A fourth ring is provided at the first end of the fourth guidewire segment, and the fourth ring is connected to the proximal end of a support rod, such that the fourth guidewire segment is connected to the proximal end of the support rod through the fourth ring. The fourth guidewire segment extends around the first end of the fourth guidewire segment to form the proximal opening of the frame, and the second end of the fourth guidewire segment passes through the fourth ring and extends until it is fixedly connected to the closing actuator.

[0014] For example, at least one embodiment of the present disclosure provides a thrombus filtering device that further includes a first sheath, wherein the first sheath is configured to provide space for accommodating a frame and a filtering element.

[0015] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the support member is a hollow mandrel, which is used to thread a guide wire.

[0016] For example, at least one embodiment of the present disclosure provides a thrombus filtering device that further includes at least one connector, wherein the connector includes a multi-lumen tube disposed at the distal end of a mandrel and the mandrel passing through the multi-lumen tube, and the multi-lumen tube is configured to allow the proximal end of a distal guidewire and the proximal end of a proximal guidewire to pass through.

[0017] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the multi-lumen tube is a two-lumen hollow tube, which includes a first cavity and a second cavity arranged sequentially from the inside to the outside. The first cavity is configured to allow the mandrel to pass through, and the second cavity is configured to allow the proximal end of the distal guidewire and the proximal end of the proximal guidewire to pass through.

[0018] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the filter element includes a filter membrane, which has a porous structure and is fixed to the outside of a frame and wraps around the frame.

[0019] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the diameter of the pores in the porous structure of the filter membrane ranges from 50 μm to 200 μm, and the thickness of the porous structure of the filter membrane ranges from 0.005 mm to 0.30 mm.

[0020] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the filter membrane comprises one or more of the following materials: polymer or metal.

[0021] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, an antithrombus coating is provided on the inner side of the filter membrane.

[0022] For example, in a thrombus filtration device provided in at least one embodiment of this disclosure, the distal guidewire and / or proximal guidewire comprises: medical shape memory alloy material and / or medical superelastic material.

[0023] Compared with the prior art, the beneficial effects of at least one embodiment of this disclosure include: the thrombus filtering device of this disclosure filters and collects emboli through a frame and filtering elements on the frame, and can also effectively close the end opening by stretching the guidewire of the frame based on the special structural design of the guidewire of the frame, avoiding a series of problems caused by the port not being closed. For example, the thrombus filtering device can add a closing design to the distal opening, so that the thrombus filtering device closes the distal opening before recycling, which can prevent emboli from escaping from the unclosed distal end and avoid the risk of vascular blockage. For example, it can prevent particles with low adhesion on the filter membrane at the cerebral blood vessel from detaching from the distal opening. As another example, the thrombus filtering device can add a closing design to the proximal opening, which on the one hand can prevent emboli from escaping from the proximal end of the thrombus filtering device and entering the systemic circulation, thereby reducing the risk of blockage of small blood vessels in the upper and lower limbs, and on the other hand, it can also improve the recycling efficiency and effect of the thrombus filtering device after the proximal opening is closed, and can also avoid damage to the blood vessel wall. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 A front view of a thrombus filtering device provided in some embodiments of this disclosure;

[0026] Figure 2 Provided for some embodiments of this disclosure Figure 1 A partial schematic diagram of the distal side of the thrombus filtration device;

[0027] Figure 3 Other embodiments provided for this disclosure Figure 1 A partial schematic diagram of the distal side of the thrombus filtration device;

[0028] Figure 4 Provided for some embodiments of this disclosure Figure 1 A partial schematic diagram of the mid-to-far end taper;

[0029] Figure 5 A front view of a frame with a single-filament closure at the distal end, provided in some embodiments of this disclosure;

[0030] Figure 6 A front view of a frame with a double-wire closing method for the distal opening provided in some embodiments of this disclosure;

[0031] Figure 7A A front view of a frame with a multi-wire closing method for the distal opening provided in some embodiments of this disclosure;

[0032] Figure 7B A front view of a frame with a multi-wire closure at the distal end, provided in some other embodiments of this disclosure;

[0033] Figure 8 A partial schematic diagram of a frame with a monofilament closure at the proximal end, provided in some embodiments of this disclosure;

[0034] Figure 9 A partial schematic diagram of a frame with a proximal opening and a double-wire closing method provided in some embodiments of this disclosure;

[0035] Figure 10 A partial schematic diagram of a frame with a retractable proximal opening provided for other embodiments of this disclosure;

[0036] Figure 11 This is a cross-sectional schematic diagram of the connector of a thrombus filtering device provided in some embodiments of this disclosure. Detailed Implementation

[0037] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0038] Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of this disclosure shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. It should also be understood that terms such as those defined in a common dictionary shall be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and shall not be interpreted in an idealized or highly formalized sense, unless expressly defined in the embodiments of this disclosure.

[0039] The terms "first," "second," and similar terms used in this disclosure do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "an," "a," or "the" do not indicate a quantity limitation, but rather indicate the presence of at least one. Similarly, terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect.

[0040] A typical embolism protection device (such as a cerebral embolism protection device) is used to block or collect emboli generated during transcatheter aortic valve replacement surgery, preventing them from entering the brain or other parts of the body (systemic circulation) through the aortic arch, causing complications such as stroke, neurocognitive decline, pulmonary embolism, and lower extremity arteriovenous embolism. This embolism protection device can also be called a thrombus filtering device, and in this article, we will refer to them all as thrombus filtering devices.

[0041] The inventors of this disclosure have discovered that some existing technical solutions cannot achieve dual protection, such as protection of the brain's blood vessels and systemic circulation. While other technical solutions can achieve full protection of both the brain and systemic circulation, these existing technologies do not offer a convenient and effective method for capturing emboli and preventing their escape. The inventors of this disclosure have found that incomplete emboli capture or escape is mainly due to the fact that the distal and proximal openings of the thrombus filtering device in existing technologies are not closed before retrieval, which can lead to many problems. For example, during the retrieval of the thrombus filtering device, emboli can easily escape from the unclosed distal opening, thus posing a risk of vascular blockage. Furthermore, because the proximal opening of the thrombus filtering device has a certain aperture, if the proximal opening is not closed during retrieval, it not only affects the smooth retrieval of the thrombus filtering device but also easily leads to damage to the blood vessel wall.

[0042] This disclosure provides at least one embodiment of a thrombus filtration device, including a support rod, a closing actuator, a frame, and a filter element disposed on and covering the frame. The two ends of the support rod are respectively connected to the closing actuator and the frame. The support rod is located on one side of the filter element and extends axially along the filter element. The frame includes a distal guidewire and a proximal guidewire, at least one of which includes a first guidewire segment and a second guidewire segment. The second guidewire segment is provided with a first loop. The first guidewire segment includes a first end and a second end opposite each other along its length. The first end of the first guidewire segment is connected to the support rod, and the second end of the first guidewire segment passes through the first loop and extends until it is fixedly connected to the closing actuator. A portion of the first guidewire segment from the first end to the first loop cooperates with at least a portion of the second guidewire segment to form an end opening of an deployable frame. The closing actuator is configured to at least pull the first guidewire segment to close the end opening.

[0043] The thrombus filtration device of the above embodiments of this disclosure filters and collects emboli through a frame and filter elements on the frame. Furthermore, based on the special structural design of the guidewire in the frame, the end opening can be effectively closed by stretching the guidewire, avoiding a series of problems caused by unclosed ports. For example, the thrombus filtration device can add a constriction design to the distal opening, allowing the thrombus filtration device to close the distal opening before retrieval, preventing emboli from escaping from the unclosed distal end and avoiding the risk of vascular blockage. For instance, it can prevent small particles with low adhesion on the filter membrane at the cerebral blood vessel from detaching from the distal opening. As another example, the thrombus filtration device can add a constriction design to the proximal opening. On the one hand, this prevents emboli from escaping from the proximal end of the thrombus filtration device into the systemic circulation, thereby reducing the risk of blockage of small distal blood vessels such as those in the upper and lower limbs. On the other hand, it allows for retrieval of the thrombus filtration device after the proximal opening is closed, improving the retrieval efficiency and effectiveness of the thrombus filtration device and avoiding damage to the blood vessel wall.

[0044] The embodiments and examples of this disclosure will now be described in detail with reference to the accompanying drawings.

[0045] For the sake of clarity and conciseness, the following explanation mainly uses the aortic arch as an example. However, this disclosure does not limit the types of vessels to which it applies. That is, this disclosure can also be applied to other vessels that require embolization protection. This disclosure does not limit or elaborate on this.

[0046] For example, regarding the definition of direction, for ease of description, at least one embodiment of this disclosure refers to the side closer to the operator (surgeon) as the proximal end or proximal side and the side farther from the operator (surgeon) as the distal end or distal side. However, the distal end and proximal end in this disclosure are relative orientations of elements or actions relative to each other and are not restrictive.

[0047] In addition, for ease of description, in the embodiments of this disclosure, for example, inside the blood vessel of the aortic arch 600, the side closer to the central axis of the blood vessel is the inner side, and the side farther away from the central axis of the blood vessel is the outer side. The orientations involved in this disclosure are all relative positions and do not affect the orientation in actual applications, nor do they impose any limitations on this disclosure.

[0048] Figure 1 This is a front view of a thrombus filtering device provided in some embodiments of this disclosure. Figure 1 The image shows the frame 100 of the thrombus filtering device placed inside a blood vessel, for example, the aortic arch 600, and expanded. Figure 2 Provided for some embodiments of this disclosure Figure 1 A partial schematic diagram of the distal side of the thrombus filtration device. Figure 3 Other embodiments provided for this disclosure Figure 1 A partial schematic diagram of the distal side of the thrombus filtration device. Figure 4 Provided for some embodiments of this disclosure Figure 1 A partial schematic diagram of the mid-to-far end taper. Now, combined with... Figures 1 to 4 Describe a thrombus filtration device.

[0049] For example, such as Figure 1 As shown, at least one embodiment of this disclosure provides a thrombus filtration device including a support rod, a closing actuator, a frame 100, and a filter element. The two ends of the support rod are respectively connected to the closing actuator and the frame 100. The frame 100 includes a distal guidewire 111 and a proximal guidewire 121. At least a portion of the distal guidewire 111 is supported at the distal end of the thrombus filtration device, forming a distal opening 110. At least a portion of the proximal guidewire 121 is supported at the proximal end of the thrombus filtration device, forming a proximal opening 120.

[0050] In some examples, the distal opening 110 and / or the proximal opening 120 are substantially annular. Here, the annular shape is not limited to a circular ring, but can also be a regular or irregular closed shape enclosed by arcs, such as an ellipse, olive, or teardrop shape, and is not limited to a planar closed shape, but can also be a closed shape enclosed by arcs that are not on the same plane.

[0051] In some examples, the filter element is a filter membrane 200, which has a porous structure for filtering blood and preventing emboli from passing through. The filter membrane 200 is disposed on and covers the frame 100, which is configured to support the filter membrane 200.

[0052] For example, the filter membrane 200 is fixedly connected to the outside of the frame 100 and wraps around the frame 100 to conform to the blood vessel wall 610. Alternatively, the filter membrane 200 is fixedly connected to the inside of the frame 100 and conforms to the frame 100 to conform to the blood vessel wall 610.

[0053] For example, the filter membrane 200 can be fixed to the frame 100 in various ways. For example, the filter membrane 200 can be attached to the frame 100 by means of adhesive or sewing. For example, when the frame 100 is expanded, the filter membrane 200 will also expand, and when the frame 100 is contracted and retracted, the filter membrane 200 will also contract and retract.

[0054] For example, such as Figure 1 As shown, when the filter membrane 200 is expanded, it presents an arch-shaped tube structure that matches the aortic arch. Therefore, the extension path of the frame 100 also needs to be able to support the filter membrane 200 to form the corresponding shape.

[0055] In some examples, the support rod is a hollow mandrel 300, to which at least a portion of the frame 100 is connected. The mandrel 300 is located within the filter membrane 200 and extends through the filter membrane 200 along its length. The mandrel 300 is supported and abuts against the interior of the aortic arch 600. For example, the mandrel 300 is used to thread a guide wire 310, which has a certain rigidity to provide support, so that the mandrel 300 is supported and abuts against the interior of the aortic arch 600, thereby supporting the entire thrombus filtration device against the interior of the aortic arch. In other examples, the support rod is a non-hollow structure, possessing its own rigidity and support properties; this is not limited here.

[0056] For example, Figure 1 A partial sectional view of the aortic arch 600 is shown. Figure 1 Taking the shown location as an example, three cerebral arteries originate from the dorsal side of the aortic arch 600, from left to right: the brachiocephalic artery 620, the left common carotid artery 630, and the left subclavian artery 640. Blood flowing through the aortic arch 600 enters the brachiocephalic artery 620, the left common carotid artery 630, and the left subclavian artery 640.

[0057] For example, such as Figure 1 As shown, in some embodiments of this disclosure, the thrombus filtering device is anchored to the aortic arch 600 by applying a radial force to the vessel wall 610, creating a good seal between the device and the vessel wall of the aortic arch 600, thereby preventing blood or emboli from flowing through the outer edge of the thrombus filtering device. Blood and emboli in the blood simultaneously flow into the thrombus filtering device through the distal opening 110. The filter membrane 200 directly blocks the emboli in the blood from entering the cerebral artery of the aortic arch 600. Subsequently, the proximal end of the thrombus filtering device captures the emboli, and finally, the emboli are removed from the patient's body along with the thrombus filtering device.

[0058] For example, the spindle 300 and the closing actuator (not shown) of the above embodiments of this disclosure can be understood as at least a part of the delivery system 1000 of the thrombus filtration device, that is, the delivery system 1000 is a delivery system of the thrombus filtration device itself, and the delivery system 1000 is in Figure 1 The diagram is not fully illustrated. It should be noted that in the above embodiments of this disclosure, the technical solution of the thrombus filtration device is described by dividing it into elements or objects for performing corresponding functions. However, those skilled in the art will understand that the functions performed by each element or object can be performed under the above-described division or under other division methods, which does not limit the scope of protection of this disclosure.

[0059] In some examples, the delivery system 1000 also includes a sheath 700, which may also be referred to as an embolization protection sheath, configured to provide space for accommodating the frame 100 and the filter membrane 200. It should be noted that the sheath 700 refers to the first sheath of this disclosure. For example, the sheath 700 may be configured to place and deliver a compressed frame 100 and filter membrane 200, which are subsequently released and expanded by being pushed out of the sheath 700, for example, by actuating a closing actuator to push the mandrel 300 to push the frame 100 together with the filter membrane 200 out of the sheath 700. After the treatment procedure is completed, the frame 100 and filter membrane 200 of the thrombus filtering device may also be retrieved within the sheath 700; that is, the sheath 700 may be configured to allow passage of the frame 100 and mandrel 300 of the thrombus filtering device during retrieval after expansion.

[0060] In some examples, the frame 100 and filter membrane 200 of the thrombus filtering device can return to a preset shape and abut against the vessel wall 610 after being released from the sheath 700, for example, the preset shape is an arc-shaped tube.

[0061] Thus, the delivery system 1000 can be used to perform the insertion, release, and retrieval of the frame 100 and filter membrane 200 of the thrombus filtration device.

[0062] In some examples, the guide wire 310 inserted inside the mandrel 300 is configured to guide the path of the delivery system 1000 in the patient's body, so that the delivery system 1000 can slowly enter the aortic arch position along the guide wire 310 that has been pre-placed in the blood vessel when entering the body.

[0063] In some examples, the thrombus filtering device also includes a radiographically visible ring (not shown) mounted on the frame 100, allowing the location of the thrombus filtering device to be clearly identified under CT irradiation, facilitating its positioning and release. For example, the thrombus filtering device is inserted into the body via the delivery system 1000, its location is determined by the radiographically visible ring with the aid of medical imaging, and then the thrombus filtering device is released, causing its frame to unfold into a pre-defined tubular filter. The distal opening of the thrombus filtering device remains open and fully conforms to the vessel wall, filtering and collecting emboli.

[0064] In some examples, the thrombus filtering device is also used in conjunction with another therapeutic device delivery system 2000, such as a TAVI delivery system. For example, as Figure 1 As shown, the treatment device delivery system 2000 includes a sheath 800, which may also be referred to as a TAVI device sheath. It should be noted that the sheath 800 refers to the second sheath of this disclosure. The sheath 800 can pass through the opening of the proximal opening 120 into the aortic arch 600. For example, after the thrombus filtering device is released, the sheath 800 passes through the opening of the proximal opening 120 into the filter membrane 200. For example, a guide wire 810 may be inserted inside the sheath 800, and an artificial prosthesis (not shown) may be placed inside the sheath 800, such as an artificial heart valve. The sheath 800 is configured to deliver and release the artificial heart valve to a corresponding location in the body. Thus, the thrombus filtering device of some embodiments of this disclosure can be used as a filter protector, i.e., as an embolism protection device, during TAVI surgery.

[0065] It should be noted that the thrombus filtering device disclosed herein can be used not only as a protective filter during TAVI / TAVR procedures, but also during other cardiac surgeries of the left ventricular system, such as left atrial appendage occlusion, atrial fibrillation ablation, mitral valve repair or replacement, or other cardiac surgeries with or without pumps. For example, with appropriate adjustments, the filtering device can also be used to leave the device in the aorta after cardiac surgery. The embodiments of this disclosure do not limit the applicable scenarios of the thrombus filtering device, and will not be exhaustively described here.

[0066] Some embodiments of this disclosure, based on the mandrel 300 and the closing actuator, may incorporate a closing design at the distal opening 110 of the frame 100. This allows the thrombus filtering device to close the distal opening before retrieval, preventing emboli from escaping from the unclosed distal end and avoiding the risk of vascular blockage. See the description below for details. Other embodiments of this disclosure, based on the mandrel 300 and the closing actuator, may also incorporate a closing design at the proximal opening 120 of the frame 100. This allows the thrombus filtering device to be retrieved after the proximal opening is closed, improving the retrieval efficiency and effectiveness of the thrombus filtering device and also preventing damage to the vessel wall. See the description below for details.

[0067] For example, such as Figures 1-4 As shown, the distal guidewire 111 includes guidewire segment 111a and guidewire segment 111b. Guidewire segment 111b is provided with a ring O1. Guidewire segment 111a includes a first end and a second end along the wire length direction. The first end T1 of guidewire segment 111a is connected to the distal end of mandrel 300. The second end T2 of guidewire segment 111a passes through ring O1 and extends until it is fixedly connected to a closing actuator. The portion S1 of guidewire segment 111a from the first end T1 to ring O1 cooperates with guidewire segment 111b to form a distal opening 110 of the frame. The closing actuator is configured to at least pull guidewire segment 111a to close the distal opening 110. It should be noted that... Figures 1-4 In this context, guidewire segment 111a refers to the first guidewire segment of this disclosure, guidewire segment 111b refers to the second guidewire segment of this disclosure, and ring O1 refers to the first ring of this disclosure.

[0068] Therefore, in the above-described embodiment of this disclosure, the first end of the guidewire segment 111a is connected to the distal end of the mandrel 300. When the closing actuator is operated to pull the guidewire segment 111a, the guidewire segment 111a will be subjected to tension, causing it to be stretched and straightened. Moreover, due to the constraint of the ring O1, the guidewire segments 111a and 111b will move closer to each other, closing the distal opening 110, thereby achieving the closure of the distal opening 110 of the thrombus filtering device. Thus, after the distal opening 110 is closed, when the thrombus filtering device recycles the frame 100 and the filter membrane 200, it can prevent the re-release of emboli with low adhesion, avoid emboli from escaping from the distal end, and thus smoothly and effectively complete the filtration, collection, and recycling of emboli and the thrombus filtering device.

[0069] In some examples, when pulling, for example, the guidewire segment 111a, by manipulating the closing actuator, the distal opening 110 of the frame 100 is first closed. After the distal opening 110 is closed, by continuing to pull, for example, the guidewire segment 111a, the frame 100 and the filter membrane 200 are lifted, leaning against the arch of the aortic arch 600, and tending to form an elongated structure, so that they can be retracted into the sheath 700, for example, axially retracted into the sheath 700 when the mandrel 300 is withdrawn. The following... Figures 5-8 The example of how to close the opening can be similarly referred to in this content, and will not be repeated in this article.

[0070] It should be noted that, in the embodiments of this disclosure, after the distal opening 110 is closed, the retrieval of the frame 100 and the filter membrane 200 can be achieved not only by continuing to stretch the corresponding guidewire segment, but also by combining the stretching of the guidewire segment with the manipulation of the sheath 700. For example, by manipulating the closing actuator to control the sheath 700 to move along its own axis towards the proximal opening 120, causing it to move relative to the guidewire segment of the frame 100, the frame 100 and the filter membrane 200 can also be retrieved into the sheath 700. The specific operation method for retrieving the thrombus filtration device can be selected according to the actual situation in the embodiments of this disclosure, and no limitations or elaborations are made here.

[0071] In some examples, the closing actuator (not shown in this disclosure) is a handle, which is operated to extend the corresponding guide wire segment, such as pulling guide wire segment 111a. The handle can be rotated to drive the guide wire segment, or it can be pulled by a push-pull key, depending on the actual structural design of the handle. The embodiments of this disclosure do not limit or elaborate on this.

[0072] It should be noted that the above embodiments of this disclosure... Figure 1 The frame 100 of the thrombus filtering device is illustrated using a monofilament-sealed method, but this is merely an illustration and may also represent, for example, the following attachments. Figure 6 , Figure 7A , Figure 7B and Figure 8 A specific example of the closing method, namely Figures 6-8 Examples can also be used with Figure 1 The thrombus filtration device is described in conjunction with this.

[0073] For example, such as Figures 1-3 As shown, the thrombus filtration device may also include a tip 500, with the distal end of the spindle 300 fixedly connected inside the tip 500. The tip 500 may be made of a flexible material to prevent damage to the vessel wall 610 from the distal end of the delivery system 1000.

[0074] For example, such as Figure 2As shown, at least a portion of the distal guidewire 111 of the frame 100 is fixedly connected to the tip 500. For example, one end of the distal guidewire 111 near the distal end of the mandrel 300 is fixedly connected to the tip 500.

[0075] In some examples, one end of the guidewire segment 111a of the distal guidewire 111 is fixedly connected to the tip 500, that is, the first end T1 of the guidewire segment 111a is fixedly connected to the distal end of the mandrel 300, as shown in the following example. Figure 6 As shown. In other examples, one end of guidewire segments 111a and 111b of the distal guidewire 111 is fixedly connected to the tip 500, that is, one end of guidewire segments 111a and 111b is fixedly connected to the tip 500 at the distal end of the mandrel 300, as shown in the figure. Figure 5 As shown.

[0076] Specifically, for cases where one end of guidewire segment 111a and guidewire segment 111b are both fixedly connected to the tip 500: for example, one end of guidewire segment 111a and guidewire segment 111b is welded or riveted together, and the two guidewire segments are then fixed to the tip 500. Another example is that one end of guidewire segment 111a and guidewire segment 111b is welded to the same location for fixation, for example, at the tip 500. Yet another example is that guidewire segment 111a and guidewire segment 111b are not welded or riveted but are inserted into the tip 500 and fixed with glue.

[0077] In other examples, such as Figure 3 As shown, at least a portion of the distal guidewire 111 of the frame 100 is connected to a position P1 on the distal end of the mandrel 300 near the tip 500. Position P1 is merely a general indication and is intended to represent any location on the mandrel 300 relatively close to the tip 500. For example, one end of the guidewire segment 111a of the distal guidewire 111 is connected to position P1 (e.g., ...). Figure 6 As shown), or for example, one end of guidewire segment 111a and one end of guidewire segment 111b are respectively connected to position P1 (as shown). Figure 5 (As shown).

[0078] It should be noted that the connection between at least a portion of the distal guide wire 111 of the frame 100 and the distal position P1 of the mandrel 300 in the embodiments of this disclosure includes, but is not limited to, a fixed connection. For example, a fixing ring is fixedly connected to the distal position P1 of the mandrel 300, and one end of the guide wire segments 111a and 111b, or one end of the guide wire segment 111a, is hung on the fixing ring and can slide on the fixing ring when stretched, as long as it does not escape from position P1 when operating the closing actuator and can achieve distal opening closure. As another example, a ring (such as a ring pre-bent by the guide wire segment itself) is provided on one end shared by the guide wire segments 111a and 111b, or on one end of the guide wire segment 111a, and the ring is hooked into a hole designed at the distal position P1 of the mandrel 300, as long as it does not escape from position P1 when stretched and can achieve distal opening closure. This is merely an example and is not intended to limit the scope of this disclosure; further details will not be provided here. It should also be noted that, for ease of description, these embodiments of the present disclosure can all be uniformly described as having a loop at one end of the corresponding guidewire segment. For example, this could include a case where one end of the guidewire segment itself includes a loop, or a case where the guidewire segment is connected to a loop.

[0079] Figure 5 This is a front view of a frame with a single-wire closure at the distal end, provided in some embodiments of this disclosure.

[0080] For example, for monofilament closing methods with a distal opening, such as Figure 5 As shown, the distal guidewire 111 includes guidewire segments 111a and 111b. Guidewire segment 111a includes a first end and a second end along the wire length direction. Guidewire segment 111b includes a first end and a second end along the wire length direction. Guidewire segment 111b is provided with a ring O1. The first end T1 of guidewire segment 111a is fixedly connected to the distal end P1 of mandrel 300. The first end T1' of guidewire segment 111b is fixedly connected to the distal end P1 of mandrel 300. The second end T2 of guidewire segment 111a passes through ring O1 and extends until it is fixedly connected to the closing actuator, and ring O1 is located at the second end T2' of guidewire segment 111b. The portion S1 of guidewire segment 111a from the first end T1 to ring O1 cooperates with guidewire segment 111b to form the distal opening 110 of the frame. The guidewire segment 111a is configured to be pulled by a closing actuator to close the distal opening 110. Therefore, the embodiments of this disclosure achieve distal opening closure through a single-wire closing method, preventing emboli from escaping from the distal end during retrieval of the thrombus filtration device after distal opening closure, thus avoiding the risk of vascular blockage. Furthermore, this single-wire closing method is convenient to operate, and the structural design of the distal guidewire is simple, resulting in a smaller overall frame and filter membrane volume, which is beneficial for the delivery and retrieval of the thrombus filtration device. It should be noted that... Figure 5 In this context, guidewire segment 111a refers to the first guidewire segment of this disclosure, guidewire segment 111b refers to the second guidewire segment of this disclosure, and ring O1 refers to the first ring of this disclosure.

[0081] In some examples, the ring O1 is integrally formed on the guidewire segment 111b, for example, the guidewire segment 111b itself is pre-bent into the ring O1. This results in good structural stability, a short manufacturing process, and high manufacturing precision. In other examples, the ring O1 is fixedly connected to the guidewire segment 111b; the embodiments of this disclosure are not limited to this.

[0082] For example, such as Figure 5 As shown, the distal guidewire 111 is also provided with a ring O3, which is fixed on the mandrel 300. The ring O3 is located between the distal end and the proximal end of the mandrel 300. The ring O3 allows the guidewire segment 111a to pass through and allows the guidewire segment 111a to slide on the ring O3 without falling off. The second end T2 of the guidewire segment 111a extends through the ring O1 and through the ring O3 until it is fixedly connected to the closing actuator. Thus, in the embodiment of this disclosure, the distal guidewire extends to the closing actuator through the fixed ring in the middle path to achieve single-wire closing, which not only effectively closes the distal opening 110 of the frame 100, but also facilitates the smooth retraction of the frame 100. It should be noted that... Figure 5 The O3 ring in this disclosure refers to the third ring.

[0083] It should also be noted that the number of rings O3 can be one or more, and can be freely adjusted according to the actual situation, as long as the distal opening 110 of the frame 100 can be closed smoothly. No restrictions or elaborations are made here.

[0084] It is worth noting that the guidewire segments 111a and 111b in the embodiments of this disclosure are intended to represent two different guidewire segments. That is, guidewire segments 111a and 111b can be two different parts on a complete guidewire, or they can be two independent complete guidewires. The embodiments of this disclosure do not limit this.

[0085] In some examples, for cases where guidewire segments 111a and 111b are two different parts of a complete guidewire: for example, guidewire segments 111a and 111b are fixed at the junction of the complete guidewire at the tip 500, or guidewire segments 111a and 111b are connected at the junction of the complete guidewire at position P1.

[0086] In other examples, the guidewire segments 111a and 111b are two separate complete guidewires: for example, the ends of guidewire segments 111a and 111b that are close to each other are connected at the same location, such as at the tip 500 or at position P1.

[0087] It should be noted that, regardless of whether guidewire segment 111a and guidewire segment 111b refer to two different parts on a complete guidewire, or guidewire segment 111a and guidewire segment 111b refer to an independent complete guidewire, this disclosure refers to the closing method of the corresponding example as the single-wire closing method, and this will not affect the protection scope of this disclosure.

[0088] Figure 6 This is a front view of a frame with a double-wire closure at the distal end, provided in some embodiments of this disclosure.

[0089] For example, for a double-wire closing method with a distal opening, such as Figure 6 As shown, the distal guidewire 111 includes guidewire segments 111a and 111b. Guidewire segment 111a includes a first end and a second end along the wire length direction. Guidewire segment 111b includes a first end and a second end along the wire length direction. Guidewire segment 111b is provided with a ring O1, for example, the ring O1 is located at end T2' of guidewire segment 111b, that is, end T2' is the second end of guidewire segment 111b described below. The first end T1 of guidewire segment 111a is connected to the distal end of mandrel 300 at position P1. The first end T1 of guidewire segment 111a is provided with a ring O2, which is connected to the distal end of mandrel 300, such that guidewire segment 111a is connected to the distal end of mandrel 300 through ring O2. The second end T2 of guidewire segment 111a passes through ring O1 and extends until it is fixedly connected to the closing actuator. The first end T1' of guide wire segment 111b passes through ring O2 and extends until it is fixedly connected to the closing actuator, and ring O1 is located at the second end T2' of guide wire segment 111b. The portion of guide wire segment 111a from the first end T1 to ring O1 and the portion of guide wire segment 111b from ring O2 to the second end T2' of guide wire segment 111b cooperate to form the distal opening 120 of the frame. Guide wire segments 111a and 111b are configured to be pulled by the closing actuator to close the distal opening 110. Therefore, the embodiments of this disclosure achieve distal opening closure through a dual-wire closure method, preventing emboli from escaping from the distal end during retrieval of the thrombus filtering device, thereby avoiding the risk of vascular blockage. Furthermore, this dual-wire closure method achieves distal opening closure by pulling on the two interlaced distal guidewires, effectively improving closure efficiency and allowing for effective control of closure and retrieval effects by separately controlling the pulling force of the two distal guidewires. It should be noted that... Figure 6 In this document, guidewire segment 111a refers to the first guidewire segment of this disclosure, guidewire segment 111b refers to the second guidewire segment of this disclosure, ring O1 refers to the first ring of this disclosure, and ring O2 refers to the second ring of this disclosure.

[0090] In some examples, the ring O2 is integrally formed on the guide wire segment 111a, for example, the guide wire segment 111a itself is pre-bent into the ring O2. This results in good structural stability, a short manufacturing process, high manufacturing efficiency, and high manufacturing precision. In other examples, the ring O2 is fixedly connected to the guide wire segment 111a; the embodiments of this disclosure do not limit this. Similarly, the ring O1 can also be integrally formed on the guide wire segment 111b; for details, please refer to the above-described content regarding the integral formation of the ring O2 on the guide wire segment 111a, which will not be repeated here.

[0091] For example, in Figure 6 In the example, the distal guidewire 111 is also provided with a ring O3, which is fixed on the mandrel 300. The ring O3 is located between the distal end and the proximal end of the mandrel 300. The ring O3 allows the guidewire segment 111b to pass through and allows the guidewire segment 111b to slide on the ring O3 without falling off. The first end T1' of the guidewire segment 111b extends through the ring O2 and then through the ring O3 until it is fixedly connected to the closing actuator. Thus, in the embodiment of this disclosure, the distal guidewire extends to the closing actuator through the fixed ring in the middle path to achieve double-wire closing, which not only effectively closes the distal opening of the frame 100 but also facilitates the smooth retraction of the frame. It should be noted that... Figure 6 The O3 ring in this disclosure refers to the third ring.

[0092] It should be noted that the embodiments of this disclosure are mainly illustrated by reasonable numerical markings of the structural features of the guidewire of the frame, for example, for Figures 4-5 Examples and Figure 6 For example, guidewire segments 111a and 111b are in Figures 4-5 The position and shape shown in the diagram are related to the position and shape in the diagram. Figure 6 The positions and shapes shown in the illustrations differ, but this does not affect the understanding of the technical solutions of the embodiments of this disclosure by those skilled in the art. Furthermore... Figures 4-6 The accompanying drawings are merely a simple and intuitive illustration to aid the reader's understanding and do not limit the scope of this disclosure. The specific solutions of the embodiments of this disclosure need to be understood in conjunction with the text.

[0093] Figure 7A This is a front view of a frame with a multi-wire closure at the distal end, provided in some embodiments of this disclosure. Figure 7B This is a front view of a frame with a multi-wire closing method for the distal opening provided in some other embodiments of this disclosure. The multi-wire closing method refers to a multi-guide wire closing method that is different from a two-wire closing method, such as a three-wire closing method for the distal opening.

[0094] For example, for multi-filament closure methods with distal openings, such as Figure 7AAs shown, the distal guidewire 111 includes guidewire segments 111a and 111b. Guidewire segment 111a includes a first end and a second end along the wire length direction. Guidewire segment 111b includes a first end and a second end along the wire length direction. Guidewire segment 111b is provided with a ring O1, for example, the ring O1 is located at end T2' of guidewire segment 111b, that is, end T2' is the second end of guidewire segment 111b described below. The first end T1 of guidewire segment 111a is fixedly connected to the distal end position P1 of mandrel 300. The second end T2 of guidewire segment 111a passes through the ring O1 and extends until it is fixedly connected to the closing actuator. The first end T1' of guidewire segment 111b is fixedly connected to the distal end position P1 of mandrel 300, and the ring O1 is located at the second end T2' of guidewire segment 111b. The portion of guidewire segment 111a from its first end T1 to the ring O1 mates with guidewire segment 111b to form the distal opening 110 of the frame. The distal guidewire 111 also includes guidewire segment 111c, which has a first end and a second end along its length. The first end T1” of guidewire segment 111c is connected to the ring O1, and the second end T2” of guidewire segment 111c is fixedly connected to a closing actuator. Guidewire segments 111a and 111c are configured to be pulled by the closing actuator to close the distal opening 110.

[0095] As can be seen from the above, this disclosure... Figure 7A The example distal guidewire 111 is in Figure 5 Based on the example distal guidewire 111, at least one guidewire segment 111c is added to the ring O1. This not only effectively achieves the closure of the distal opening 110, but also makes the closure efficiency of the distal opening 110 higher, the force on the distal opening 110 more balanced during closure, and the closure of the distal opening 110 more stable, resulting in a better closure effect.

[0096] It should be noted that the embodiments disclosed herein are not limited to those described above. Figure 7A The diagram shows one guidewire segment 111c, but there can be two or more guidewire segments 111c. The lengths of the two or more guidewire segments 111c can be the same or different, and can be freely selected according to the actual application. For example, the size of the distal opening 110, the shape of the distal opening 110, and the degree of non-interference between the guidewire segments are all considered. No restrictions or details are given here.

[0097] For example, for multi-threaded closure methods with distal openings, such as... Figure 7BAs shown, the distal guidewire 111 includes guidewire segments 111a and 111b. Guidewire segment 111a includes a first end and a second end along the wire length direction. Guidewire segment 111b includes a first end and a second end along the wire length direction. Guidewire segment 111b is provided with a ring O1, for example, the ring O1 is located at end T2' of guidewire segment 111b, that is, end T2' is the second end of guidewire segment 111b described below. The first end T1 of guidewire segment 111a is connected to the distal end of mandrel 300 at position P1. The first end T1 of guidewire segment 111a is provided with a ring O2, which is connected to the distal end of mandrel 300, such that guidewire segment 111a is connected to the distal end of mandrel 300 through ring O2. The second end T2 of guidewire segment 111a passes through ring O1 and extends until it is fixedly connected to the closing actuator. The first end T1' of guide wire segment 111b passes through ring O2 and extends until it is fixedly connected to the closing actuator, and ring O1 is located at the second end T2' of guide wire segment 111b. The portion of guide wire segment 111a from the first end T1 to ring O1 and the portion of guide wire segment 111b from ring O2 to the second end T2' of guide wire segment 111b cooperate to form the distal opening 120 of the frame. The distal guide wire 111 also includes guide wire segment 111c, which includes a first end and a second end along the wire length direction. The first end T1" of guide wire segment 111c is connected to ring O1 and the second end T2" of guide wire segment 111c is fixedly connected to the closing actuator. Guide wire segments 111a, 111b, and 111c are configured to be pulled by the closing actuator to close the distal opening 110.

[0098] It should be noted that, in Figure 7A and Figure 7B In this document, guidewire segment 111a refers to the first guidewire segment of this disclosure, guidewire segment 111b refers to the second guidewire segment of this disclosure, guidewire segment 111c refers to the third guidewire segment of this disclosure, ring O1 refers to the first ring of this disclosure, and ring O2 refers to the second ring of this disclosure.

[0099] As can be seen from the above, this disclosure... Figure 7B The example distal guidewire 111 is in Figure 6 Based on the example distal guidewire 111, at least one guidewire segment 111c is added to the ring O1. This not only effectively closes the distal opening 110, but also makes the distal opening 110 more efficient in closing, the distal opening 110 is more balanced in force when closing, and the closure of the distal opening 110 is more stable and the closing effect is better.

[0100] It should be noted that the embodiments disclosed herein are not limited to those described above. Figure 7B The diagram shows one guidewire segment 111c, but there can be two or more guidewire segments 111c. The lengths of the two or more guidewire segments 111c can be the same or different, and can be freely selected according to the actual application. No restrictions or details are given here.

[0101] It should also be noted that the embodiments of this disclosure only apply to the multi-filament closing method for distal openings. Figure 5 and Figure 6 The example is an improved design based on the example, but the multi-wire closing method of the distal opening in the embodiments of this disclosure is not limited to this. Corresponding examples can also be obtained by making corresponding improvements based on similar inventive concepts, which will not be listed here.

[0102] In some examples, the thrombus filtering device of the above embodiments of this disclosure can have a constriction design not only at the distal opening but also at the proximal opening. This can, to some extent, avoid the problem of difficulty in retrieving the frame and filter membrane caused by the presence of the annular proximal opening, thus facilitating the retrieval function of the thrombus filtering device and preventing damage to the blood vessel wall. For example, the constriction design of the proximal opening is similar to that of the distal opening, and can be referred to the constriction design of the distal opening described above. Specific examples will be provided below. At the same time, adding a constriction design to the proximal opening can also prevent thrombi from escaping from the proximal end of the thrombus filtering device and entering the systemic circulation, thereby avoiding the risk of blockage of small distal blood vessels in the upper and lower limbs.

[0103] For example, the closing method of the proximal opening 120 can also include a monofilament closing method, a double-filament closing method, and a multifilament closing method, similar to the closing method of the distal opening.

[0104] Figure 8 This is a partial schematic diagram of a frame with a monofilament closure at the proximal end, provided for some embodiments of this disclosure.

[0105] For example, for monofilament closing methods with proximal openings, such as Figure 8 As shown, the proximal guidewire 121 includes guidewire segments 121a and 121b. Guidewire segment 121a includes a first end and a second end opposite each other along the wire length direction. Guidewire segment 121b is provided with a ring O4. The first end K1 of guidewire segment 121a is connected to the proximal end of mandrel 300. The first end K1' of guidewire segment 121b is connected to the proximal end of mandrel 300, and ring O4 is located at the second end K2' of guidewire segment 121b. The second end K2 of guidewire segment 121a passes through ring O4 and extends until it is fixedly connected to a closing actuator. The portion of guidewire segment 121a from the first end K1 to ring O4 cooperates with guidewire segment 121b to form a proximal opening 120 of frame 100. Guidewire segment 121a is configured to be pulled by the closing actuator to close the proximal opening. Therefore, the embodiments of this disclosure achieve proximal opening closure through a single-wire closing method, which facilitates the recovery of the frame and filter membrane of the thrombus filtration device after the proximal opening is closed. Furthermore, the proximal guidewire has a simple structural design, and the single-wire closing method is convenient to operate. It should be noted that... Figure 8 In this context, guidewire segment 121a refers to the first guidewire segment of this disclosure, guidewire segment 121b refers to the second guidewire segment of this disclosure, and ring O4 refers to the first ring of this disclosure.

[0106] Figure 9 This is a partial schematic diagram of a frame with a proximal opening and a double-wire closing method, provided for some embodiments of this disclosure.

[0107] In some examples, for the double-wire closing method with a proximal opening, such as Figure 9 As shown, the proximal guidewire 121 includes guidewire segments 121a and 121b. Guidewire segment 121a includes a first end and a second end opposite to each other along the wire length direction, and guidewire segment 121b includes a first end and a second end opposite to each other along the wire length direction. Guidewire segment 121b is provided with a ring O4, for example, the ring O4 is located at the K2' end of guidewire segment 121b, that is, the K2' end is the second end of guidewire segment 121b described below. The first end K1 of guidewire segment 121a is provided with a ring O5, and the ring O5 is connected to the proximal end of mandrel 300, such that the first end K1 of guidewire segment 121a is connected to the proximal end of mandrel 300 through the ring O5. The second end K2 of guidewire segment 121a passes through the ring O4 and extends until it is fixedly connected to the closing actuator. The first end K1' of guidewire segment 121b passes through ring O5 and extends until it is fixedly connected to the closing actuator, and ring O4 is located at the second end K2' of guidewire segment 121b. The portion of guidewire segment 121a from the first end K1 to ring O4 and the portion of guidewire segment 121b from ring O5 to the second end K2' of guidewire segment 121b cooperate to form the proximal opening 120 of frame 100. Guidewire segments 121a and 121b are configured to be pulled by the closing actuator to close the proximal opening 120. Therefore, the embodiments of this disclosure achieve proximal opening closure through a dual-wire closing method, which facilitates the recovery of the frame and filter membrane of the thrombus filtration device after the proximal opening is closed. Furthermore, this dual-wire closing method achieves proximal closure by pulling on two interlaced proximal guidewires, effectively improving closure efficiency and allowing for effective control of closure and recovery by separately controlling the pulling force of the two proximal guidewires. It should be noted that... Figure 9 In this context, guidewire segment 121a refers to the first guidewire segment of this disclosure, guidewire segment 121b refers to the second guidewire segment of this disclosure, ring O4 refers to the first ring of this disclosure, and ring O5 refers to the second ring of this disclosure.

[0108] In some examples, for multi-filament closure methods with proximal openings, in Figure 8 and / or Figure 9Based on the example, the proximal guidewire 121 may also include another guidewire segment, such as the third guidewire segment (not shown) corresponding to the proximal opening 120, which also refers to the third guidewire segment of this disclosure. For example, the first end of the third guidewire segment of the proximal guidewire 121 is connected to the ring O4 and the second end of the third guidewire segment of the proximal guidewire 121 is fixedly connected to the closing actuator. For details, please refer to the description of the multi-wire closing method of the distal opening above. Further details regarding the figures and text will not be provided here.

[0109] It should be noted that the guidewire segments 121a and 121b of the proximal guidewire 121 in the embodiments of this disclosure are intended to represent two different guidewire segments. For example, guidewire segments 121a and 121b can be two different parts on a complete guidewire, or they can be two independent complete guidewires, as long as the proximal opening can be closed. The embodiments of this disclosure do not limit this. For details, please refer to the above-mentioned content on the closure of the distal opening, which will not be repeated here.

[0110] Figure 10 This is a partial schematic diagram of a frame with a retractable proximal opening, provided for other embodiments of this disclosure. Figure 10 The mandrel 300 is not shown in the image; it will be discussed below. Figure 1 and Figure 10 The following is an example illustration.

[0111] In addition, for monofilament closing methods with proximal openings, the following other examples may also be included: such as Figure 1 and Figure 10 As shown, the proximal guidewire 121 includes a guidewire segment 121d, which has a first end and a second end opposite each other along its length. The first end H1 of the guidewire segment 121d is provided with a loop O6, which is connected to the proximal end of the mandrel 300, such that the first end H1 of the guidewire segment 121d is connected to the proximal end of the mandrel 300 via the loop O6. The guidewire segment 121d extends circumferentially around the vessel wall 610 from the first end H1 to form a proximal opening 120 of the frame 100, and the second end H2 of the guidewire segment 121d passes through the loop O6 and extends until it is fixedly connected to the closing actuator. The guidewire segment 121d is configured to be pulled by the closing actuator to close the proximal opening 120. Therefore, the embodiments of this disclosure utilize a continuous guidewire or guidewire segment at the proximal opening for closure, which facilitates the delivery and retrieval of the frame and filter membrane of the thrombus filtration device after closure. Furthermore, the proximal guidewire has a simple structural design and the closure operation is convenient. It should be noted that... Figure 10 In this context, guidewire segment 121d refers to the fourth guidewire segment of this disclosure, and ring O6 refers to the fourth ring of this disclosure.

[0112] It should be noted that the guide wire segment 121d in the above embodiments of this disclosure is intended to represent a continuous guide wire or guide wire segment. For example, guide wire segment 121d is a complete guide wire integrally formed during processing. Alternatively, guide wire segment 121d can be formed by splicing multiple sub-guide wire segments to create a longer continuous guide wire segment. This disclosure does not impose any limitations on this. It should also be noted that the meaning and function of the elements or objects in the above embodiments of this disclosure are not limited to their names and cannot be interpreted in an idealized or highly formalized sense.

[0113] In some examples, the thrombus filtering device of this disclosure can simultaneously incorporate the aforementioned closing design at both the distal and proximal openings. For instance, the distal opening can be closed first by manipulating the closing actuator, followed by closing the proximal opening, and then the thrombus filtering device can be retrieved. As another example, the distal opening can be closed first by manipulating the closing actuator, and then the proximal opening can be closed and the thrombus filtering device retrieved simultaneously.

[0114] For example, such as Figure 1 , Figure 5 and Figure 7A As shown, the thrombus filtering device of this disclosure embodiment further includes a connector 400. The connector 400 is disposed at the distal end of the mandrel 300, and the connector 400 includes a multi-lumen tube configured for passage of the mandrel 300. The multi-lumen tube may also be configured for passage of the proximal ends of the distal guidewire 111 and the proximal ends of the proximal guidewire 121.

[0115] For example, in Figure 7A In the deployed state, the thrombus filtering device shown has the connector 400 positioned between the sheath 700 and the proximal opening 120, configured to allow passage of the mandrel 300, distal guidewire 111, and proximal guidewire 121. Thus, by providing a connector 400 with a multi-lumen conduit, the embodiments of this disclosure can avoid unnecessary interference between the mandrel 300, distal guidewire 111, and proximal guidewire 121.

[0116] Figure 11 This is a cross-sectional schematic diagram of the connector of a thrombus filtering device provided in some embodiments of this disclosure.

[0117] For example, such as Figure 11 As shown, the multi-cavity tube of the connector 400 is a two-cavity hollow tube, which includes a first cavity 401 and a second cavity 402 arranged sequentially from the inside to the outside. The first cavity 401 is configured for the mandrel 300 to pass through, and the second cavity 402 is configured for the proximal ends of the distal guidewire 111 and the proximal ends of the proximal guidewire 121 to pass through. For example, in Figure 7A and Figure 11In the example, the second cavity 402 may be configured to allow passage of the extension portion of the distal guidewire 111 extending from the proximal opening 110 and the extension portion of the proximal guidewire 121.

[0118] For example, in other examples, the multi-cavity tube of connector 400 can also be a three-cavity hollow tube (not shown). This three-cavity hollow tube includes a first cavity, a second cavity, and a third cavity arranged sequentially from the inside out. The first cavity is configured for the mandrel 300 to pass through, the second cavity is configured for the extension portion of the distal guidewire 111 extending from the proximal opening 110 to pass through, and the third cavity is configured for the extension portion of the proximal guidewire 121 to pass through. It should be noted that the correspondence between the first cavity, the second cavity, and the third cavity and the mandrel 300, the extension portion of the distal guidewire 111, and the extension portion of the proximal guidewire 121 can be arbitrary, as long as the mandrel 300, the extension portion of the distal guidewire 111, and the extension portion of the proximal guidewire 121 each pass through their respective cavities to avoid mutual interference. This is merely an example to aid the reader's understanding and does not imply any limitation on this disclosure. Further examples and elaborations are not provided here.

[0119] In some examples, the distal guidewire 111 and / or the proximal guidewire 121 comprise medical shape memory alloy materials and / or medical hyperelastic materials.

[0120] In some examples, the filter membrane 200 of the thrombus filtration device of the present disclosure is a mesh-like porous material, for example, made by weaving, knitting, or laser perforation on a film. For example, the pore diameter of the porous structure of the filter membrane 200 ranges from 50 μm to 200 μm, which is used to prevent emboli larger than the pores from passing through, thereby achieving the purpose of filtering blood.

[0121] For example, the filter membrane 200 is configured as a membrane having pores with uniform or non-uniform spacing.

[0122] In some examples, the thickness of the filter membrane 200 of the thrombus filtration device of the embodiments of the present disclosure ranges from 0.005 mm to 0.30 mm. For example, the thickness of the filter membrane 200 may be uniform or non-uniform, and the present disclosure does not limit this.

[0123] In some examples, the filter membrane 200 can be pre-shaped to form a predetermined shape, for example, the heat setting temperature in the pre-forming process is 120°C-300°C, and the heat setting time is set to 10s-30s. This is merely exemplary and is not a limitation of this disclosure.

[0124] In some examples, the filter membrane 200 of the thrombus filtration device of embodiments of this disclosure comprises one or more of the following materials: polymers or metals. For example, the filter membrane 200 is made of a low-friction and flexible polymer or metal material.

[0125] For example, the polymer material of the filter membrane 200 includes one or more of the following: PEEK (polyether ether ketone), PU (polyurethane), PA (polyamide), PTFE (polytetrafluoroethylene), PE (polyethylene), PC (polycarbonate), PP (polypropylene), and PLA (polylactic acid). This is merely exemplary and not a limitation of this disclosure. The filter membrane 200 may also include other polymer materials and / or other metallic materials, such as biodegradable polymer materials or biodegradable metallic materials, which will not be elaborated here.

[0126] For example, the metallic material of the filter membrane 200 includes one or more of the following: Ni-Ti (nickel-titanium) and 304 stainless steel. This is merely exemplary and is not intended to limit the scope of this disclosure.

[0127] In some examples, an antithrombotic coating is provided on the inner side of the filter membrane 200. Thus, by applying the antithrombotic coating to the filter membrane 200, the coated membrane inhibits thrombin activity, achieving anticoagulation and ultimately preventing blood from clotting and clogging the membrane pores, thus avoiding an increase in transmembrane pressure gradient. For example, the antithrombotic coating may contain heparin.

[0128] In other examples, the outer surface of the filter membrane 200 may also be coated with a coating that reduces frictional resistance and has good biocompatibility, preventing the thrombus filtering device from rubbing against the vessel wall of the aortic arch and facilitating smooth and stable movement of the thrombus filtering device along the vessel wall of the aortic arch. It should be noted that the embodiments of this disclosure may also selectively coat the filter membrane 200 with coatings having other properties, not limited to the antithrombotic coating and low friction coefficient coating described herein, and adjustments can be made according to actual conditions.

[0129] At least one embodiment of this disclosure provides a surgical system with a thrombus filtering device, the surgical device including a treatment instrument delivery system and a thrombus filtering device.

[0130] For example, the thrombus filtering device included in the surgical system can be any of the thrombus filtering devices described in the examples above, and the thrombus filtering device can refer to... Figures 1-10 The thrombus filtering device is shown. For example, the treatment device delivery system can be the treatment device delivery system 2000 described above, such as an artificial prosthesis delivery system. For example, the surgical system may also include a guide wire 310, with the support of the thrombus filtering device being a hollow mandrel 300, through which the guide wire 310 passes.

[0131] The technical effects of the surgical system disclosed herein can be found in the description of the thrombus filtration device above, and will not be repeated here.

[0132] The following points need to be explained:

[0133] (1) The accompanying drawings of the embodiments of this disclosure only involve the structures involved in the embodiments of this disclosure. Other structures can be referred to the general design.

[0134] (2) Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

[0135] The above description is merely a specific embodiment of this disclosure, but the scope of protection of this disclosure is not limited thereto. The scope of protection of this disclosure should be determined by the scope of protection of the claims.

Claims

1. A thrombus filtration device, characterized in that, The device includes a support rod, a closing actuator, a frame, and a filter element disposed on and covering the frame. The support rod is connected at both ends to the closing actuator and the frame, respectively. The support rod is located on one side of the filter element and extends along the axial direction of the filter element. The frame includes a distal guidewire and a proximal guidewire, at least one of which includes a first guidewire segment and a second guidewire segment. The second guide wire segment is provided with a first ring. The first guide wire segment includes a first end and a second end opposite to each other along the wire length direction. The first end of the first guide wire segment is connected to the support rod. The second end of the first guide wire segment passes through the first ring and extends until it is fixedly connected to the closing actuator. The portion of the first guide wire segment from the first end to the first ring cooperates with at least a portion of the second guide wire segment to form an end opening of the deployable frame. The closing actuator is configured to at least pull the first guide wire segment to close the end opening.

2. The thrombus filtering device as described in claim 1, wherein, The second guide wire segment includes a first end and a second end opposite to each other along the wire length direction. The first end of the second guide wire segment is connected to the end of the support rod near the end opening, and the first ring is located at the second end of the second guide wire segment.

3. The thrombus filtering device as described in claim 2, wherein, The first ring is integrally formed on the second guidewire segment.

4. The thrombus filtering device as described in claim 1, wherein, The second guide wire segment includes a first end and a second end opposite to each other along the wire length direction. The first end of the first guide wire segment is provided with a second ring. The second ring is connected to the end of the support rod near the end opening, so that the first guide wire segment is connected to the support rod through the second ring. The first end of the second guide wire segment passes through the second ring and extends until it is fixedly connected to the closing actuator. The first ring is located at the second end of the second guide wire segment. The second guide wire segment is configured to be pulled by the closing actuator to close the end opening.

5. The thrombus filtering device as described in claim 4, wherein, The first ring is integrally formed on the second guidewire segment; The second ring is integrally formed on the first guidewire segment.

6. The thrombus filtering device as described in claim 1, 2, or 4, wherein, The distal guidewire includes a first guidewire segment, a second guidewire segment, and a third guidewire segment. The third guidewire segment includes a first end and a second end that are opposite each other along the wire length direction. The first end of the third guidewire segment is connected to the first loop, and the second end of the third guidewire segment is fixedly connected to the closing actuator.

7. The thrombus filtering device as described in claim 2, wherein, The distal guidewire includes the first guidewire segment and the second guidewire segment; The distal guidewire is also provided with a third ring, which is fixed to the support rod and located between the distal end and the proximal end of the support rod; The second end of the first guide wire segment extends through the first ring and through the third ring until it is fixedly connected to the closing actuator.

8. The thrombus filtering device as described in claim 4, wherein, The distal guidewire includes the first guidewire segment and the second guidewire segment; The distal guidewire is also provided with a third ring, which is fixed to the support rod and located between the distal end and the proximal end of the support rod; The first end of the second guide wire segment extends through the second ring and through the third ring until it is fixedly connected to the closing actuator.

9. The thrombus filtering device as described in claim 1, wherein, The distal guidewire includes the first guidewire segment and the second guidewire segment, and the end opening is a distal opening; The proximal guidewire includes a fourth guidewire segment, which includes a first end and a second end that are opposite each other along the wire length direction. The first end of the fourth guidewire segment is provided with a fourth ring, which is connected to the proximal end of the support rod, so that the fourth guidewire segment is connected to the proximal end of the support rod through the fourth ring. The fourth guidewire segment wraps around the first end of the fourth guidewire segment to form a proximal opening of the frame, and the second end of the fourth guidewire segment passes through the fourth ring and extends until it is fixedly connected to the closing actuator.

10. The thrombus filtering device according to any one of claims 1-5, 7-9, further comprising a first sheath, wherein, The first sheath is configured to provide space for accommodating the frame and the filter element.

11. The thrombus filtering device as claimed in claim 10, wherein, The support rod is a hollow mandrel, which is used to thread the guide wire.

12. The thrombus filtering device of claim 11, further comprising at least one connector, wherein, The connector includes a multi-cavity tube, which is disposed at the distal end of the mandrel and through which the mandrel passes; The multi-lumen cannula is also configured to allow passage of the proximal end of the distal guidewire and the proximal end of the proximal guidewire.

13. The thrombus filtering device as claimed in claim 12, wherein, The multi-lumen tube is a two-lumen hollow tube, which includes a first cavity and a second cavity arranged sequentially from the inside to the outside. The first cavity is configured to allow the mandrel to pass through, and the second cavity is configured to allow the proximal end of the distal guidewire and the proximal end of the proximal guidewire to pass through.

14. The thrombus filtering device as claimed in claim 1, wherein, The filter element includes a filter membrane, which has a porous structure and is fixed to the outside of the frame and wraps around the frame. The pore diameter of the porous structure of the filter membrane ranges from 50 μm to 200 μm, and the thickness of the porous structure of the filter membrane ranges from 0.005 mm to 0.30 mm. The filter membrane comprises one or more of the following materials: polymer or metal; The inner side of the filter membrane is provided with an antithrombotic coating.

15. The thrombus filtering device as claimed in claim 1, wherein, The materials of the distal guidewire and / or the proximal guidewire include: medical shape memory alloy materials and / or medical superelastic materials.

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