Thrombus filter device and delivery device therefor

Abstract

The application relates to the technical field of medical devices, and provides a thrombus filtering device and a conveying device thereof, wherein the thrombus filtering device comprises a support frame which can be intervened into a blood vessel and through which blood can pass, the support frame has a contracted state and an expanded state, the support frame comprises an abutting portion which is located at a distal end of the support frame and can abut against a blood vessel wall in the expanded state, and a connecting portion which is located at a proximal end and can be connected with an anchor portion; the abutting portion is an arc surface with multiple holes. Through the technical scheme, larger particle substances such as thrombus in blood flow can be filtered, normal blood flow can be ensured, the space of the aorta occupied is smaller, and the operation convenience of the operation is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a thrombus filtration device and its delivery device. Background Technology

[0002] Current brain protection devices consist of a flexible metal frame covered with a polymer membrane or woven mesh. This mesh structure is used to seal the three branch vessels of the aortic arch, as disclosed in Chinese Patent Application No. CN201880000296.3. Covering the three branch vessels of the aortic arch requires a relatively large filter membrane or mesh structure. However, the stable anchoring of the aforementioned brain protection device in the aortic arch requires covering a large area, which limits the operating space during surgery and requires relatively precise positioning. Summary of the Invention

[0003] The technical problem to be solved by this application is to provide a thrombus filtration device and its delivery device, which can filter larger particles such as thrombi in the blood flow, while ensuring normal blood flow, occupying less space in the aorta, and improving the convenience of surgical operation.

[0004] To solve the above-mentioned technical problems, this application adopts the following technical solution:

[0005] In a first aspect, this application provides a thrombus filtration device, including a support frame that can be inserted into a blood vessel and allows blood to pass through. The support frame has a contracted state and an expanded state. The support frame includes an abutment portion located at the distal end of the support frame that can abut against the blood vessel wall in the expanded state, and a connecting portion located at the proximal end that can be connected to an anchor portion. The abutment portion is a porous arcuate shape.

[0006] In the implementation of the above technical solution, the thrombus filtration device includes a support frame that can be inserted into the blood vessel and allows blood to pass through, ensuring normal blood flow during surgery. The support frame can contract and expand, facilitating delivery and positioning within the blood vessel. The support frame includes a distal abutment portion. In the expanded state, the abutment portion can abut against the blood vessel wall, thereby achieving initial positioning of the support frame within the blood vessel. Since the abutment portion is a porous arc-shaped surface, its contact with the blood vessel wall does not require specific positioning; any part of the arc surface abuts against the blood vessel wall. Therefore, when the support frame is released, angle adjustments are reduced, improving the convenience of surgical operations.

[0007] In one embodiment, the support frame includes an anchor portion, the anchor portion including at least one occlusion disc, the occlusion disc being conformable to the inner or outer side of the blood vessel wall.

[0008] In the implementation of the above technical solution, the support frame includes an anchor part located at the proximal end. The anchor part can be anchored in the blood vessel when the support frame is expanded, which improves the accuracy of the thrombus filtration device in the blood vessel and also improves the stability between the support frame and the blood vessel. The anchor part includes at least one occlusion disc, which can be attached to the inner or outer side of the blood vessel wall, thereby playing the role of blocking blood and stopping bleeding. In addition, the occlusion disc is set in a disc-shaped structure, which also facilitates the contraction of the anchor part.

[0009] In one embodiment, the anchor portion includes two occlusion discs, which are respectively configured to adhere to the inner and outer sides of the blood vessel wall as a first occlusion disc and a second occlusion disc, and the first occlusion disc and the second occlusion disc are interconnected.

[0010] In the implementation of the above technical solution, the anchor part includes two sealing discs. The two sealing discs are respectively configured as a first sealing disc and a second sealing disc for fitting to the inner and outer sides of the blood vessel wall. The first sealing disc and the second sealing disc are connected to each other, so that the inner and outer walls of the blood vessel puncture site can be sealed, thereby achieving the hemostasis effect.

[0011] In one implementation, the radial dimension of the first sealing disc is smaller than that of the second sealing disc.

[0012] In the implementation of the above technical solution, the radial dimension of the first sealing disc is smaller than that of the second sealing disc. Since blood flows out of the blood vessel from the inside to the outside, the radial dimension of the second sealing disc, located on the outer wall of the blood vessel, is larger than that of the first sealing disc. This increases the sealing area of ​​the second sealing disc, thereby further improving the sealing effect of the anchor.

[0013] In one implementation, the first occlusion disc and the second occlusion disc are connected by a connecting segment that can pass through a puncture hole in the blood vessel wall.

[0014] In the implementation of the above technical solution, the first occlusion disc and the second occlusion disc are connected by a connecting section. The connecting section can pass through the puncture hole on the blood vessel wall, so that the first occlusion disc and the second occlusion disc are located on the inner and outer sides of the blood vessel wall, respectively, thereby playing a clamping role on the blood vessel wall.

[0015] In one embodiment, the anchor portion has a mesh structure.

[0016] In the implementation of the above technical solution, the anchor part has a mesh structure, which makes it easier to block the puncture site on the blood vessel wall; on the other hand, it also facilitates the expansion and contraction of the anchor part.

[0017] In one implementation, the support frame is spherical.

[0018] In the implementation of the above technical solution, the support frame is a spherical structure. Since the spherical structure is axially symmetric, the support frame does not require angle adjustment during placement. Release at any angle ensures the stent is stably anchored within the blood vessel lumen. Therefore, the device can be placed blindly without the aid of imaging techniques such as X-rays or ultrasound.

[0019] In one embodiment, both the anchor and the support frame are elastic elements.

[0020] In the implementation of the above technical solution, both the anchor and the support frame are designed as elastic components. This structure is in a contracted state when constrained by the sheath tube, and unfolds into a spherical state under its own elastic force after the constraint is removed. At the same time, the support frame is a spherical structure, and the top of the anchor is disc-shaped, which can meet the characteristics of a small diameter in the contracted state and expansion along the diameter in the expanded state. The placement process does not require positioning and adjustment, and the operation is simple.

[0021] In one embodiment, the support frame is a spherical structure woven from at least one metal wire, with the wires crossing at the distal end to form the anchor portion.

[0022] In the implementation of the above technical solution, the support frame is a spherical structure woven from at least one metal wire, which is easy to deform for transport by the delivery device. When transported to the predetermined position, the metal wire can quickly return to its original shape, improving the reliability of the thrombus filtering device at the vascular puncture site. In addition, the metal wires are crossed at the distal end to form an anchor part, which on the one hand allows blood to flow normally and reduces obstruction to blood; on the other hand, it also increases the contact area between the anchor part and the blood vessel wall, improving the stability between the thrombus filtering device and the blood vessel wall.

[0023] In one embodiment, the support frame is further provided with at least one filter element for filtering blood clots.

[0024] In the implementation of the above technical solution, at least one filter element is provided within the support frame. This filter element can filter large emboli while ensuring normal blood flow.

[0025] Secondly, this application provides a delivery device for a thrombus filtration device, including the thrombus filtration device provided in the first aspect; a sheath housing the thrombus filtration device; and a push rod for pushing the thrombus filtration device.

[0026] In the implementation of the above technical solution, the thrombus filtering device can be housed in a sheath, and the delivery device also includes a push rod that can push the thrombus filtering device into the blood vessel.

[0027] In one embodiment, a support is included that is connected to the proximal end of the sheath, the push rod is movable within the support, and the distal end of the push rod is in contact with the thrombus filtering device.

[0028] In the implementation of the above technical solution, the delivery device also includes a support member connected to the proximal end of the sheath. The push rod can move within the support member, and the support member can guide the push rod, so that the push rod can push the thrombus filtering device into the blood vessel, so that the distal end of the push rod contacts the thrombus filtering device, thereby pushing the vascular filtering device from the sheath into the blood vessel. Attached Figure Description

[0029] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This is a schematic diagram of the thrombus filtration device provided in the embodiments of this application;

[0031] Figure 2 for Figure 1 A magnified schematic diagram of the local structure;

[0032] Figure 3 A schematic diagram of the assembly structure of the thrombus filtering device and the sheath provided in the embodiments of this application;

[0033] Figure 4 This is a schematic diagram of the structure of the conveying device provided in the embodiments of this application;

[0034] Figure 5 This is a schematic diagram of the intervention process of the thrombus filtering device provided in the embodiments of this application;

[0035] Figure 6 This is a schematic diagram of the intervention process of the thrombus filtering device provided in the embodiments of this application.

[0036] Icons: 1-Support frame; 2-Filter element; 4-Anchor pin part; 41-First sealing plate; 42-Second sealing plate; 43-Connecting section; 5-Abutment part; 6-Sheath tube; 7-Support element; 8-Push rod; 9-Connecting part. Detailed Implementation

[0037] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0038] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, the term "distal" refers to the end of the delivery device closer to the heart tissue, and "proximal" refers to the end of the delivery device closer to the operator. The terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0039] In the first aspect, this application provides a thrombus filtration device that can filter larger particles such as thrombi in arterial blood flow through external intervention, while ensuring that the normal blood flow volume is small. After being placed in a blood vessel, the area it covers and occupies in the aortic arch is very small, thereby reducing the difficulty of the operation.

[0040] like Figure 1 As shown, the thrombus filtration device includes a support frame 1, which can be inserted into a blood vessel to ensure normal blood flow during surgery. The support frame 1 can contract and expand, facilitating delivery and positioning within the blood vessel. The support frame 1 includes an abutment portion 5 located at its distal end. When the support frame 1 is inserted into the blood vessel, it is in an expanded state. In the expanded state, the abutment portion 5 can abut against the blood vessel wall, thereby achieving initial positioning of the support frame 1 within the blood vessel. Since the abutment portion 5 is a porous arc-shaped surface, its contact with the blood vessel wall does not require specific positioning; any part of the arc surface abuts against the blood vessel wall. Therefore, when the support frame 1 is released, the angle adjustment is reduced, improving the convenience of surgical operation.

[0041] The porous structure also facilitates blood flow and reduces obstruction to blood flow.

[0042] Optionally, the support frame 1 includes a spherical support body. In some cases, a connecting part 9 may be provided at the proximal end of the support body, or the connecting part 9 may not be provided. That is, the anchor part 4 and the support body are integrally formed and can be woven from metal wire.

[0043] Optionally, the support frame 1 has a hollow structure, which can reduce obstruction to blood flow. The support body includes multiple arc-shaped support parts, which can be formed by at least one metal wire. The multiple support parts can be interconnected, thereby forming multiple holes of different sizes and shapes on the surface of the support frame 1 to facilitate blood flow.

[0044] Optionally, the support frame 1 can be inserted into the blood vessel via an external intervention.

[0045] Optionally, the support frame 1 is made of a material with elastic characteristics, such as nickel-titanium alloy, and its structure can meet the characteristics of a smaller diameter in the contracted state and an expanded diameter in the expanded state.

[0046] Optionally, the radial dimension of the support body is larger than the radial dimension of the blood vessel. In this way, when the support frame 1 is compressed, under its own elastic force, the support frame 1 expands in the blood vessel and can abut against the blood vessel wall.

[0047] Optionally, the multiple holes of the abutment portion 5 can be formed by a woven mesh structure, which can increase the contact area with the blood vessel wall, improve stability, and also allow blood to flow normally.

[0048] like Figure 2 As shown, optionally, the support frame 1 includes an anchor part 4 located at the proximal end, and the anchor part 4 and the support frame 1 can be connected by a connecting part 9. Of course, in some cases, the support body can also be directly connected to the anchor part 4 to reduce the production steps in the manufacture of the thrombus filtration device.

[0049] like Figure 1 As shown, in one embodiment, the support frame includes an anchor portion 4 located at the proximal end, which is connected to the support body. The anchor portion 4 can be anchored in the blood vessel when the support frame 1 is expanded, improving the accuracy of the thrombus filtration device in the blood vessel and also improving the stability between the support frame and the blood vessel. The anchor portion 4 and the abutment portion 5 cooperate with each other to improve the stability between the support frame 1 and the blood vessel. A connecting portion 9 can also be provided at the proximal end of the support frame 1, which can be connected to the anchor portion 4, thereby realizing the connection between the anchor portion 4 and the support body. The anchor portion 4 includes at least one occlusion disc, which can be fitted to the inner or outer side of the blood vessel wall, thereby blocking blood flow and stopping bleeding at the puncture site of the blood vessel. In addition, the occlusion disc is designed in a disc shape, which also facilitates the contraction of the anchor portion 4.

[0050] Optionally, the thrombus filtering device of this application embodiment can be delivered and positioned in the ascending aorta. In this case, interventional procedures for heart valves typically use a channel outside the ascending aorta as the interventional channel. In other embodiments, the thrombus filtering device of the present invention can also be positioned in other blood vessels that need filtering. Therefore, the thrombus filtering device of this application embodiment has a wide range of applications.

[0051] Optionally, the anchor part 4 is made of a material with elastic characteristics, such as nickel-titanium alloy, and its structure can meet the characteristics of a small diameter in the contracted state and an expanded diameter in the expanded state.

[0052] Optionally, the anchor part 4 can be connected to the support body by a metal ring, which can be done by welding or gluing; the anchor part 4 and the support body can also be integrally formed.

[0053] like Figure 1 and 2 As shown, in one embodiment, the anchor part 4 includes two sealing discs. The two sealing discs are respectively configured to adhere to the inner and outer sides of the blood vessel wall as a first sealing disc 41 and a second sealing disc 42. The first sealing disc 41 and the second sealing disc 42 are connected to each other, so that the inner and outer walls of the blood vessel puncture site can be sealed, thereby achieving the hemostasis effect.

[0054] Optionally, the first sealing disc 41 and the second sealing disc 42 can be woven from a single metal wire or from two separate metal wires, and the connection can be achieved by welding or gluing.

[0055] Optionally, the first sealing plate 41, the second sealing plate 42, and the support body can also be woven together by a single metal wire.

[0056] Optionally, the areas of the first sealing plate 41 and the second sealing plate 42 can be the same.

[0057] In one implementation, the radial dimension of the first sealing disc 41 is smaller than that of the second sealing disc 42. Since blood flows out of the blood vessel from the inside to the outside, the radial dimension of the second sealing disc 42, located on the outer wall of the blood vessel, is larger than that of the first sealing disc 41. This increases the sealing area of ​​the second sealing disc 42, thereby further improving the sealing effect of the anchor portion 4.

[0058] like Figure 2 As shown, in one embodiment, the first occlusion disc 41 and the second occlusion disc 42 are connected by a connecting section 43. The connecting section 43 can pass through the puncture hole on the blood vessel wall, so that the first occlusion disc 41 and the second occlusion disc 42 are located on the inner and outer sides of the blood vessel wall, respectively, thereby clamping the blood vessel wall.

[0059] Optionally, the connecting section 43, the first sealing plate 41, and the second sealing plate 42 can be woven together by a single metal wire.

[0060] Optionally, the length of the connecting segment 43 can be less than the wall thickness of the blood vessel, so that the first occlusion disc 41 and the second occlusion disc 42 can be attached to the inner and outer sides of the blood vessel wall respectively, thereby clamping the blood vessel wall.

[0061] As one implementation method, the anchor part 4 has a mesh structure, which makes it easier to seal the puncture site on the blood vessel wall; on the other hand, it also facilitates the expansion and contraction of the anchor part 4.

[0062] In one implementation, the support frame 1 is a spherical structure. Since the spherical structure is axially symmetric, the support frame 1 does not require angle adjustment during placement; it can be released at any angle to ensure stable anchoring of the stent within the blood vessel lumen. Therefore, the above device does not require the assistance of imaging techniques such as X-rays or ultrasound during placement, and can achieve blind release.

[0063] Optionally, the supporting body of the supporting frame 1 is a spherical structure.

[0064] In one implementation, both the anchor pin 4 and the support frame 1 are designed as elastic elements. This structure is in a contracted state when constrained by the sheath tube 6, and unfolds into a spherical state under its own elastic force after the constraint is removed. At the same time, the support frame 1 is a spherical structure with a disc-shaped top, which can meet the characteristics of a small diameter in the contracted state and expansion along the diameter in the expanded state. The placement process does not require positioning and adjustment, and the operation is simple.

[0065] like Figure 2 As shown, the anchor part 4 can also be connected to the support body through the connecting part 9, which can increase the stability between the anchor part 4 and the support body.

[0066] In one embodiment, the support frame 1 is a spherical structure woven from at least one metal wire, which is easy to deform for transport by the delivery device. When transported to the predetermined position, the metal wire can quickly return to its original shape, improving the reliability of the thrombus filtering device at the vascular puncture site. In addition, the metal wires are crossed at the distal end to form the anchor part 4, which on the one hand allows blood to flow normally and reduces obstruction to blood; on the other hand, it also increases the contact area between the anchor part 4 and the blood vessel wall, improving the stability between the thrombus filtering device and the blood vessel wall.

[0067] like Figure 1 and 2 As shown, in one embodiment, at least one filter element 2 is provided in the support frame 1. The filter element 2 is capable of filtering large emboli while ensuring normal blood flow.

[0068] Optionally, multiple filters 2 can be provided, and the multiple filters 2 are arranged in a cross manner, so as to filter emboli in multiple directions in the blood vessels, and the cross positions can be sewn together with thread.

[0069] Optionally, the filter element 2 can be connected to the support body by sewing.

[0070] Optionally, filter element 2 can be made of polymer material or textile material.

[0071] like Figure 3 and 4As shown, in a second aspect, embodiments of this application provide a delivery device for a thrombus filtration device, including the thrombus filtration device provided in the first aspect, and further including a sheath 6, wherein the thrombus filtration device can be housed in the sheath 6, and the delivery device further includes a push rod 8 capable of pushing the thrombus filtration device, thereby enabling the thrombus filtration device to be pushed into a blood vessel.

[0072] like Figure 3 and 4 As shown, in one embodiment, the delivery device also includes a support 7 connected to the proximal end of the sheath 6. The push rod 8 can move within the support 7, thereby guiding the push rod 8 to push the thrombus filtering device into the blood vessel, so that the distal end of the push rod 8 contacts the thrombus filtering device, thereby pushing the vascular filtering device from the sheath 6 into the blood vessel.

[0073] Optionally, a handle can be provided at the proximal end of the push rod 8 for easy operation by medical staff.

[0074] Optionally, during the thrombus filter release and anchoring process, the sheath 6, equipped with the thrombus filter, is inserted into the blood vessel. The puncture direction is perpendicular to the axis of the blood vessel, and the insertion depth is approximately two-thirds to one-third of the vessel diameter. The portion of the delivery device not entering the blood vessel consists of the support 7 and the push rod 8. The push rod 8 passes through the support 7, is inserted into the interior of the sheath 6, and extends to the position where the thrombus filter is mounted. The distal end of the push rod 8 is close to the second occlusion disc 42 of the thrombus filter.

[0075] After completing the first step of puncture, push the push rod 8 while slowly retracting the support member 7. The support member 7 and the push rod 8 work together to release the support frame 1 of the thrombus filtering device into the blood vessel. At this time, the pushing distance of the push rod 8 is greater than the retraction distance of the support member 7. This is to ensure that the support frame 1 is inserted into the blood vessel.

[0076] like Figure 5 As shown, after the support frame 1 is released, the fixed support 7 is fixed and the push rod 8 pushes the first occlusion disc 41 of the thrombus filtering device out of the sheath tube 6. At this time, the port of the sheath tube 6 is located inside the blood vessel wall. After the push is completed, the first occlusion disc 41 unfolds and adheres to the blood vessel wall under its own elasticity.

[0077] like Figure 6 As shown, after the above-mentioned release action is completed, the support frame 1 and the first occlusion disc 41 of the thrombus filtering device are both released into the blood vessel. At this time, the fixed push rod 8 is pulled back proximally, causing the support member 7 to be released under its own elasticity, freed from the constraint of the sheath 6. The released second occlusion disc 42 then adheres to the outer wall of the blood vessel. At this time, the puncture point is sealed by the clamping action of the inner and outer occlusion discs, preventing blood leakage.

[0078] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0079] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0080] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A thrombus filtration device, characterized in that, include: A support frame that can be inserted into a blood vessel and allows blood to pass through, the support frame having a contracted state and an expanded state; the support frame includes an abutment portion located at the distal end of the support frame that can abut against the blood vessel wall in the expanded state and a connecting portion located at the proximal end that can be connected to an anchor portion; the abutment portion is a porous arc-shaped surface; in the expanded state, the abutment portion can abut against the blood vessel wall, thereby achieving the initial positioning of the support frame in the blood vessel.

2. The thrombus filtering device according to claim 1, characterized in that, The support frame includes an anchor portion, which includes at least one occlusion disc that can be fitted to the inner or outer side of the blood vessel wall.

3. The thrombus filtering device according to claim 2, characterized in that, The anchor portion includes two occlusion discs, which are respectively configured to adhere to the inner and outer sides of the blood vessel wall as a first occlusion disc and a second occlusion disc, and the first occlusion disc and the second occlusion disc are interconnected.

4. The thrombus filtering device according to claim 3, characterized in that, The radial dimension of the first sealing disc is smaller than that of the second sealing disc.

5. The thrombus filtering device according to claim 3 or 4, characterized in that, The first occlusion disc and the second occlusion disc are connected by a connecting segment that can pass through a puncture hole in the blood vessel wall.

6. The thrombus filtering device according to any one of claims 1 to 4, characterized in that, The anchor part has a mesh structure.

7. The thrombus filtering device according to any one of claims 1 to 4, characterized in that, The support frame is spherical.

8. The thrombus filtering device according to any one of claims 1 to 4, characterized in that, Both the anchor and the support frame are elastic components.

9. The thrombus filtering device according to any one of claims 1 to 4, characterized in that, The support frame is a spherical structure woven from at least one metal wire, with the wires crossing at the distal end to form the anchor portion.

10. The thrombus filtering device according to any one of claims 1 to 4, characterized in that, The support frame also includes at least one filter element for filtering blood clots.

11. A delivery device for a thrombus filtration device, characterized in that, Includes the thrombus filtering device as described in any one of claims 1 to 10, a sheath housing the thrombus filtering device, and a push rod for pushing the thrombus filtering device.

12. The conveying device according to claim 11, characterized in that, It includes a support member connected to the proximal end of the sheath, the push rod is movable within the support member, and the distal end of the push rod is in contact with the thrombus filtering device.

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