Embolic protection and collection device

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to an embolus protection and collection device. It includes a tubular filter, a self-expandable stent arranged in the filter, and a retracting and releasing mechanism for pushing and / or recovering the filter and the stent. The filter is provided with a channel for the passage of a catheter, a guide wire and / or a sheath from one end to the other end. One or both ends of the filter are provided with at least one leak-proof net, and the leak-proof net is a net extending from the end surface to the inside of the filter. The leak-proof net is located between the inner part of the filter and the filter, leaving a gap. The technical solution provided by the present invention has a structure for preventing emboli from entering other blood vessels, and at the same time has a structure for collecting and removing emboli. It can effectively prevent emboli from entering other branches during valve replacement and repair surgery, greatly reducing the occurrence of stroke.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an embolus protection and collection device. Background Art

[0002] In some surgeries involving the heart and aorta, platelet aggregates may form during instrument operation, such as thrombi, clots, lipid droplets, small pieces of tissue, calcified fragments or other foreign bodies, or atheromas that break off from the arterial wall. These substances may be transmitted to the brain, radial artery and innominate artery with the blood flow, causing stroke or vascular occlusion. Therefore, it is necessary to set up protective devices during surgery to reduce the occurrence of this problem.

[0003] Chinese patent CN105658174 provides an embolic protection device, which prevents embolism from entering the downstream organs of the aortic arch blood vessels by placing a mesh tube structure with three layers of woven mesh layers in the patient's aorta.

[0004] Chinese patent CN211834869 provides a novel anti-embolism protection device, which prevents blood clots from entering the brain, etc. by covering part of the inner wall of the blood vessel with a double-layer woven dense mesh.

[0005] However, the thrombus protection devices in the above schemes all adopt the form of short-term protection, and only filter during the operation to prevent thrombi from entering the brain. The radial artery and the innominate artery cannot collect thrombi, that is, thrombi will still return to the blood vessels from the protection device, and stroke events may still occur after the thrombus protection device is removed after the operation. The incidence of stroke is high in transcatheter heart valve replacement surgery, so there is an urgent need for a device that can protect thrombi from entering other branch vessels and collect and remove thrombi at the same time. Summary of the invention

[0006] The present invention provides an embolus protection and collection device, which is used to solve the problem that the current protection device can only filter and block thrombus but cannot collect it.

[0007] In order to solve the above technical problems, the technical solution of the present invention is: the embolus protection and collection device includes a tubular filter, a self-expandable stent arranged in the filter, and a retracting and releasing mechanism for pushing and / or recovering the filter and the stent, the filter is provided with a channel for the catheter, guide wire and / or sheath tube to pass from one end to the other end, and at least one anti-leakage net is provided at one end or both ends of the filter, and the anti-leakage net is a net extending from the end surface to the inside of the filter, and the anti-leakage net is located between the internal part of the filter and the filter with a gap left.

[0008] The filter effectively prevents emboli from entering the downstream organs of the aortic arch blood vessels, and the anti-leakage net makes it easy for emboli in the blood to enter the filter, but it becomes difficult for them to flow out of the filter again, that is, they are restricted in the filter, thereby achieving the purpose of collecting emboli, and they will be removed together with the filter when the filter is removed.

[0009] Optionally, the bracket includes circular rings arranged at both ends of the filter and a supporting structure fixed between the two circular rings.

[0010] Optionally, the support structure is a single helix structure or a double helix structure.

[0011] Optionally, the leakage-proof net is in a closed-end shape or a multi-petal shape, and the opening of the closed-end leakage-proof net at the end surface is larger than the opening located inside.

[0012] Optionally, the closed-end leak-proof net includes a large opening arranged on the end surface of the filter screen, a small opening located inside the filter screen, and a leak-proof net body extending from the large opening to the small opening.

[0013] Optionally, the multi-petal anti-leakage net is composed of a multi-petal mesh, one end of the mesh is fixed to the end surface of the filter, and the other end is a free end, and the free end is located inside the filter.

[0014] Optionally, the part of the leak-proof net located inside the filter is limited in position inside the filter by a fixing line, one end of the fixing line is fixed to the leak-proof net, and the other end is fixed to the filter or another leak-proof net.

[0015] The fixing line can prevent the problem that the anti-leakage net cannot effectively prevent the escape of the plugs in the filter due to the retraction of the anti-leakage net.

[0016] Optionally, the filter screen is made of a material selected from a metal woven mesh, a polymer fiber woven or spun mesh, a polymer mixed metal material woven or spun mesh, or a porous polymer membrane, and the pore size of the filter screen is 0.1-0.5 mm.

[0017] Optionally, the end of the filter away from the operator is the distal end, and the end of the filter close to the operator is the proximal end. When the distal end is provided with an anti-leakage net, the proximal end is provided with an anti-leakage net or with a closing opening with a diameter gradually decreasing. When the distal end is not provided with an anti-leakage net, the distal end face is fully open and the proximal end is provided with an anti-leakage net.

[0018] Optionally, a clamping sealing structure is provided at the channel opening at the proximal end of the channel of the filter screen, so as to prevent a gap for emboli to pass through between the channel opening and the catheter, guide wire and / or sheath.

[0019] Optionally, the clamping sealing structure is an expandable and contractible ring-shaped object, and the material of the clamping sealing structure is a shape memory material or an elastic material. It is in a contracted state in a natural state and can expand and accommodate a catheter, a guide wire and / or a sheath when the catheter, the guide wire and / or the sheath pass through.

[0020] The clamping sealing structure can be a ring made of elastic material, which has a certain expansibility due to the elastic material itself; it can be a non-closed ring made of shape memory material, which has a certain expansibility due to being non-closed, and achieves a clamping sealing effect due to its own shape memory. It can also be a folded, spring-shaped, or interwoven mesh ring. In summary, as long as the structure and material design have their own contraction force and are expandable under the action of external force, they all belong to the clamping sealing structure mentioned in the present invention.

[0021] Optionally, a traction mechanism is provided at the proximal end of the filter, and the traction mechanism is at least one traction line and / or at least one traction net, one end of the traction line is fixedly connected to the filter or the bracket, and the other end is connected to the retracting mechanism through a connecting ring; the traction net extends from at least part of the circumference of the proximal end of the filter, and then is connected to the retracting mechanism through a connecting ring.

[0022] Optionally, the retractable mechanism includes a catheter for accommodating the filter and the stent, and a guide wire passing through the catheter to push or retract the filter and the stent, and the guide wire is connected to the traction mechanism.

[0023] Optionally, an embolus picker is also included, one end of which is fixed in the retractable mechanism, and the other end of which passes through the filter net, so as to actively bring the embolus in the blood into the filter net.

[0024] Optionally, the filter has an anticoagulant function, specifically, the filter surface is coated with an anticoagulant coating or the filter material is mixed with anticoagulant drugs.

[0025] The technical solution provided by the present invention has the following advantages over the prior art: it has a structure to prevent emboli from entering other blood vessels, and at the same time has a structure to collect and remove emboli, which can effectively protect emboli from entering other branches during valve replacement and repair surgery, greatly reducing the occurrence of stroke. The technical solution of the present invention can be applied to carotid artery thrombosis protection and thrombus removal, peripheral and intracranial vascular thrombus removal and thrombus protection, and the superior vena cava / inferior vena cava as a vena cava filter to collect and remove thrombi. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a schematic diagram of the embolic protection and collection device of the present invention being arranged at the working position of the aortic arch;

[0027] Figure 2 It is a structural schematic diagram of a specific implementation method of the embolic protection and collection device of the present invention when it is introduced;

[0028] Figure 3 is a schematic diagram of the structure of the embolic protection and collection device described in Example 1;

[0029] Figure 4 is a schematic diagram of the structure of the bracket described in Example 1;

[0030] Figure 5 is a schematic diagram of the structure of the embolic protection and collection device of Example 1 without the stent portion;

[0031] Figure 6a and 6b is a schematic diagram of the structure of other configurations of the fixing line described in Example 1;

[0032] Figure 7a , 7b 7c is a schematic diagram of the structure of the clamping sealing structure described in Example 1;

[0033] Figure 8 This is a schematic diagram of an implementation method of the clamping sealing structure described in Example 1 being arranged on a leak-proof net;

[0034] Figure 9a and 9b is a structural schematic diagram of other configurations of the traction mechanism described in Example 1;

[0035] Fig.10a and 10b It is a schematic diagram of the structure of the embolic protection and collection device described in Example 2, which mainly reflects the implementation method of the multi-petal anti-leakage net;

[0036] Fig.11a and 11b It is a schematic diagram of the structure of the embolus protection and collection device described in Example 3, which mainly reflects the implementation method of setting a leak-proof net on one side and setting multiple leak-proof nets on one end.

[0037] As shown in the figure:

[0038] 01-embolus protection and collection device, 10-filter, 11-distal end, 12-proximal end, 13-through hole, 20-bracket, 21-ring, 22-support structure, 30-retracting and releasing mechanism, 31-catheter, 32-guide wire, 40-traction mechanism, 41-connecting ring, 50-leakage-proof net, 51-large opening, 52-small opening, 53-leakage-proof net body, 54-fixing line, 55-clamping sealing structure, 56-mesh, 60-embolus extractor. DETAILED DESCRIPTION

[0039] For ease of understanding, the embolic protection and collection device is described below in conjunction with embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0040] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation and positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0041] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0042] like Figure 1 As shown, three main blood vessels branch out from the aortic arch and lead to the brain, namely the brachiocephalic artery, the left common carotid artery and the left subclavian artery. The embolic protection and collection device 01 of the present invention is arranged at the position shown in the figure, which can cover these three main blood vessels, thereby preventing the clot from flowing to the brain and causing a stroke.

[0043] like Figure 2 As shown, the embolic protection and collection device 01 comprises a tubular filter 10, a self-expandable stent 20 disposed in the filter 10, and a retracting mechanism 30 for pushing and / or recovering the filter and the stent, wherein the retracting mechanism 30 comprises a catheter 31 for accommodating the filter 10 and the stent 20, and a guide wire 32 passing through the catheter 31 for pushing or recovering the filter 10 and the stent 20. The end of the filter close to the heart is the distal end 11, and the end of the filter away from the operator is the proximal end 12, and the guide wire 32 is connected to the traction mechanism 40 of the proximal end 12.

[0044] When the filter and stent are pushed out of the catheter, there is no catheter restraint. The stent and filter expand by themselves and fit the blood vessel. When retrieving, the guide wire pulls the filter stent and the embolus collected in the stent back into the catheter.

[0045] In addition to the implementation of the above-mentioned embodiment, the retractable mechanism of the present invention can be used in the present invention in any retractable design currently used for stent implantation. The implementation of other parts except the retractable mechanism is described in detail below. In the following embodiments, the left side is assumed to be the distal end 11 and the right side is assumed to be the proximal end 12.

[0046] Example 1

[0047] like Figure 3 As shown, the embolus protection and collection device 01 removes other parts of the retracting and releasing mechanism, specifically including a filter 10, a bracket 20 disposed in the filter 10, a traction mechanism 40 disposed at the proximal end of the filter 10, and two anti-leakage nets 50 disposed at both ends of the filter.

[0048] In this embodiment, the support 20 includes a ring 21 disposed at both ends of the filter screen 10 and a support structure 22 fixed between the two rings 21. The support structure 22 is in the form of a double helix. Figure 4 As shown, the support structure 22 may also be a single spiral structure with good retractability.

[0049] For clear display, the bracket is removed. Figure 5 As shown, the anti-leakage net 50 located on the two end faces in this embodiment has the same structure, and the anti-leakage net is closed inside, roughly in the shape of a trumpet. It should be pointed out that any shape with a large outer opening and a small inner opening with a closed opening is acceptable, such as a trapezoidal, pyramidal, funnel-shaped, etc. The anti-leakage net 50 extends from the end face to the interior of the filter 10, including a large opening 51 arranged on the end face of the filter 10, a small opening 52 located inside the filter 10, and an anti-leakage net body 53 extending from the large opening 51 to the small opening 52. In this embodiment, only one anti-leakage net 50 is provided on the end face, and the large opening 51 is also the end opening. From the distal end to the proximal end, the channel between the filter end faces for the catheter, guide wire and / or sheath tube to pass through is from the large opening 51 at one end to the small opening 52 and then through the inside of the filter 10 through the small opening 52 and the large opening 51 at the other end. Since the end of the filter 10 is provided with an anti-leakage net with a large outside and a small inside, after the embolus enters the filter 10, it runs into the gap between the anti-leakage net body 53 and the filter 10, so the possibility of escaping again is greatly reduced.

[0050] Continue to see Figure 5 The part of the anti-leakage net 50 located in the filter 10 is limited in position in the filter 10 by a fixing line 54. In this embodiment, one end of the fixing line 54 is fixed to the small opening 52 of the anti-leakage net, and the other end is fixed to the side wall of the filter 10. Figure 6a As shown, the other end of the fixing line 54 can also be fixed at the middle position of the filter screen 10, such as Figure 6b As mentioned above, the fixing line 54 can also be set in a manner that both ends are fixed on two opposite small openings 52 respectively. As long as the anti-leakage net body 53 can be unfolded in the filter screen to ensure that as many emboli as possible are blocked, any fixing method is considered acceptable.

[0051] A clamping seal structure 55 is provided on the small opening 52 at the proximal end. After the catheter, guide wire and / or sheath are inserted into the channel, the clamping seal structure 55 can prevent emboli from escaping from the filter screen 10 through the channel. Figure 7a As shown, the clamping sealing structure 55 is a non-closed ring, the diameter of which can be expanded under the action of force, and the ring has two circles, such as Figure 7b As shown, the expanded diameters of the two circles of rings may be consistent or inconsistent, such as Figure 7c As shown, the clamping sealing structure 55 can also be a ring that can be expanded or contracted to a certain extent by folding. This ring can extend from the small opening 52 to the outer wall of the anti-leakage net 50, or it can be located only in the area near the small opening 52. When it covers a larger area, it can be designed in conjunction with the anti-leakage net shape, for example, Figure 8 In the manner shown, at this time, since the clamping sealing structure 55 supports the entire anti-leakage net 50, the fixing line 54 can be omitted.

[0052] Continue to see Figure 3 In this embodiment, the traction mechanism 40 is a traction net, which narrows and extends from the circumference of the proximal end of the filter screen 10, and then a connecting ring (not shown in the figure) is provided at the proximal end of the traction net to connect with the retracting mechanism 30.

[0053] The traction mechanism 40 may be a traction line in addition to the traction net in the above-mentioned solution, such as Figure 9a As shown, one end of the traction line is fixedly connected to the filter screen 10 or the bracket 20 , and the other end is connected to the retractable mechanism 30 via a connecting ring 41 .

[0054] like Figure 9b As shown, in addition to the above-mentioned solution, the traction mechanism 40 can also be a traction net that narrows and extends from a part of the circumference of the proximal end of the filter screen 10, and then is connected to the retracting mechanism 30 through a connecting ring 41.

[0055] The material 10 of the filter screen is selected from metal weaving, polymer material weaving or spinning mesh, polymer mixed metal material weaving or spinning mesh, or a membrane with holes, and the pore size of the filter screen is 0.1-0.5 mm.

[0056] In order to actively collect emboli in the blood vessels into the filter 10, the embolus protection and collection device also includes an embolus picker 60, one end of which is arranged in the catheter 31, and the other end passes through the channel in the filter 10. The material of the passing end is shape memory material or elastic material, and it unfolds into an umbrella shape with a spiral skeleton.

[0057] The filter screen has an anticoagulant function, specifically, the filter screen surface is coated with an anticoagulant coating or the filter screen material is mixed with an anticoagulant drug.

[0058] Example 2

[0059] like Fig.10aAs shown, the difference from Example 1 is that the leakage-proof net is in a multi-petal shape, specifically, the leakage-proof net at the distal end of the filter 10 is in a multi-petal shape, which is composed of a multi-petal mesh 56, one end of which is fixed on the outer circumference of the filter 10, and the other end is a free end, and the free end is located inside the filter 10. The leakage-proof net 50 at the proximal end of the filter 10 is still in a closed shape, and a through hole 13 is provided on the distal end surface of the filter 10 in this scheme. The passage between the end surfaces of the filter 10 for the catheter, guide wire and / or sheath tube to pass through is a small opening 52 and a large opening 51 from the through hole 13 at one end and then through the filter 10 inside the filter 10 through the leakage-proof net 50 at the other end.

[0060] like Fig.10b As shown, the mesh 56 can also be arranged in another way, where one end of the mesh 56 is fixed to the end surface of the filter screen 10 and the other end is a free end. Specifically, three meshes 56 are arranged in a spiral blade shape.

[0061] In addition, in this embodiment, the traction mechanism 40 is composed of four traction wires evenly distributed on the circular ring 21 of the proximal bracket 20.

[0062] It should be pointed out that Fig.10a and 10b In order to clearly reflect the anti-leakage net 50, the internal support structure 22 is not drawn.

[0063] Example 3

[0064] The anti-leakage net 50 in the embolic protection and collection device can be provided at only one end, and multiple anti-leakage nets 50 can be provided at one end surface, such as Fig.11a As shown, the leak-proof net 50 is only arranged at the proximal end 12. At this time, the opening of the leak-proof net 50 does not serve as a channel, so there can be no small opening. The distal end 11 of the leak-proof net 50 is fully open, and the proximal end 12 end face is closed. A through hole 13 and two closed leak-proof nets are provided on the closed surface. The channel between the end faces of the filter screen 10 for the catheter, guide wire and / or sheath to pass through is directly through the distal end face, and then through the through hole 13 on the proximal end face through the inside of the filter screen 10. The large openings 51 of the two leak-proof nets are located on the end face of the proximal end 12 and are no longer used for passing the catheter, guide wire and / or sheath. The small openings 52 are located inside the filter screen 10, and the small openings 52 are connected by fixed lines 54. At the same time, the small openings 52 are also connected to the filter screen 10 through the fixed lines 54. The small openings 52 are respectively provided with clamping sealing structures (not shown in the figure).

[0065] like Fig.11b As shown, the anti-leakage net 50 can also be set only at the distal end 11. In this case, the end face of the distal end 11 is closed, and a through hole 13 and two closed-end anti-leakage nets 50 are set on the closed surface. It should be emphasized that at this time, the proximal end 12 needs to be closed, and the closed end is left with a diameter for the catheter, guide wire and / or sheath to pass through. A clamping sealing structure (not shown in the figure) can be provided at the closed end.

[0066] It should be pointed out that Fig.11a and 11b In order to clearly reflect the anti-leakage net 50, the internal support structure 22 is not drawn.

[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the above embodiments, a person skilled in the art should understand that the technical solutions described in the above embodiments can still be modified, or some or all of the technical features can be replaced by equivalents, and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An embolic protection and collection device, comprising a tubular filter, a self-expandable stent disposed in the filter, and a retracting mechanism for pushing and / or recovering the filter and the stent, wherein a channel for a catheter, a guide wire and / or a sheath tube to pass through is provided from one end to the other end of the filter, characterized in that: The filter screen is provided with an anti-leakage net at each end, the anti-leakage net is a net extending from the end surface to the inside of the filter screen, and a gap is left between the anti-leakage net and the filter screen; The part of the anti-leakage net located in the filter screen is limited in position in the filter screen by a fixing line, one end of the fixing line is fixed to the anti-leakage net, and the other end is fixed to the filter screen or another anti-leakage net; The support comprises circular rings arranged at both ends of the filter screen and a supporting structure fixed between the two circular rings, wherein the supporting structure is a single helix structure or a double helix structure.

2. The embolic protection and collection device according to claim 1, characterized in that: The anti-leakage net is in a closed-end shape or a multi-petal shape, and the opening of the closed-end anti-leakage net at the end surface is larger than the opening located inside.

3. The embolic protection and collection device according to claim 2, characterized in that: The closed-end leak-proof net comprises a large opening arranged on the end surface of the filter net, a small opening located inside the filter net, and a leak-proof net body extending from the large opening to the small opening.

4. The embolic protection and collection device according to claim 2, characterized in that: The multi-petal anti-leakage net is composed of a multi-petal mesh sheet, one end of which is fixed on the end surface of the filter screen, and the other end is a free end, and the free end is located inside the filter screen.

5. The embolic protection and collection device according to claim 1, characterized in that: The material of the filter is selected from a metal woven mesh, a polymer fiber woven or spun mesh, a polymer mixed metal material woven or spun mesh, or a porous polymer membrane, and the pore size of the filter is 0.1-0.5 mm.

6. The embolic protection and collection device according to claim 1, characterized in that: The channel of the filter screen is provided with a clamping sealing structure at the channel opening at the proximal end, so as to prevent a gap from being left between the channel opening and the catheter, guide wire and / or sheath tube for emboli to pass through.

7. The embolic protection and collection device according to claim 6, characterized in that: The clamping sealing structure is an expandable and contractible ring-shaped object. The material of the clamping sealing structure is a shape memory material or an elastic material. It is in a contracted state in a natural state and can expand and accommodate a catheter, a guide wire and / or a sheath when the catheter, the guide wire and / or the sheath pass through it.

8. The embolic protection and collection device according to claim 1, characterized in that: A traction mechanism is provided at the proximal end of the filter, and the traction mechanism is at least one traction line and / or at least one traction net. One end of the traction line is fixedly connected to the filter or the bracket, and the other end is connected to the retractable mechanism through a connecting ring; the traction net is narrowed and extended from at least part of the circumference of the proximal end of the filter, and then connected to the retractable mechanism through a connecting ring.

9. The embolic protection and collection device according to claim 8, characterized in that: The retractable mechanism comprises a catheter for accommodating the filter screen and the stent, and a guide wire passing through the catheter to push or retract the filter screen and the stent, and the guide wire is connected to the traction mechanism.

10. The embolus protection and collection device according to claim 1 further comprises an embolus picker, one end of which is fixed in the retractable mechanism, and the other end of which passes through the filter net, so as to actively bring the embolus in the blood into the filter net.

11. According to the embolic protection and collection device of claim 1, the filter has an anticoagulant function, specifically, the filter surface is coated with an anticoagulant coating or the filter material is mixed with anticoagulant drugs.

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