CN114431996A - Anti-embolism protection device and medical instrument - Google Patents

Abstract

The invention relates to a medical instrument and an anti-embolism protection device. Wherein anti embolic protection device includes braced frame and filters piece, and wherein braced frame includes lower floor's frame and at least one upper frame that sets gradually from bottom to top, and upper frame includes connecting portion and free portion, connecting portion are connected with the distal end of adjacent frame, and anti embolic protection device has natural state and release state, and under release state, the free portion is towards the direction perk of keeping away from lower floor's frame. The filter member is connected with the support frame and covers the upper frame. The anti-embolism protection device is good in stability and adherence, and can effectively avoid embolism escape.

Description

Anti-embolism protection device and medical instrument

Technical Field

The invention relates to the technical field of medical instruments, in particular to an anti-embolism protection device and a medical instrument.

Background

Some procedures involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, aortic surgery, etc., involve the formation of platelet polymers (e.g., emboli, lipid droplets, bacterial clots and/or other foreign bodies, tumor cells or other small tissue fragments) or broken off atherosclerotic debris and debris from the arterial wall, which, as it is transported through the blood stream, can enter the cerebral blood circulation and other important systemic arterial systems as embolic material for embolizing blood vessels. Embolic material entering the cerebral blood circulation can block arterioles, thereby causing local cerebral vascular embolization, which is now an important complication of cardiac and aortic surgery. While substances entering the downstream blood circulation can cause downstream organ embolism, which can lead to organ failure or organ failure.

Generally, to prevent complications caused by embolism, it is often necessary to divert, capture or collect an embolism, such as plaque, debris or an embolism, from flowing forward during a surgical procedure using an anti-embolic protection device to prevent the formation of an embolism. However, the conventional anti-embolism protection device has poor stability and adherence, and is easy to slip and dislocate in the using process, so that embolism escapes.

Disclosure of Invention

Therefore, there is a need for an anti-embolism protection device and a medical apparatus, wherein the anti-embolism protection device has good stability and adherence and can effectively prevent embolism from escaping.

An anti-embolic protection device comprising:

the anti-embolism protection device comprises a support frame, wherein the support frame comprises a lower layer frame and at least one upper layer frame which are sequentially arranged from bottom to top, each upper layer frame comprises a connecting part and a free part, each connecting part is connected with the far end of an adjacent frame, the anti-embolism protection device has a natural state and a release state, and in the release state, the free parts tilt towards the direction far away from the lower layer frame;

a filter member connected with the support frame and covering the upper frame.

In one embodiment, when the anti-embolic protection device is in the natural state, the free portion is bent away from the underlying frame

In one embodiment, the lower frame and the upper frame are each a closed loop structure, and the connecting portion extends along a distal portion of the lower frame.

In one embodiment, in the natural state, a straight distance from a distal end point to a proximal end point of the lower frame is greater than a straight distance from a distal end point to a proximal end point of the upper frame.

In one embodiment, the supporting frame comprises a plurality of upper frames which are sequentially arranged from bottom to top, and in the natural state, the linear distance from the far-end point to the near-end point of the upper frame is sequentially reduced along the direction away from the lower frame.

In one embodiment, the filter member is attached at its periphery to the lower frame or the upper frame.

In one embodiment, the lower frame and/or the upper frame is provided with a developing element.

A medical device, comprising:

the anti-embolic protection device described above, and,

the conveying mechanism comprises a pushing piece, and the pushing piece is connected with the near end of the lower layer frame and/or the near end of the upper layer frame.

In one embodiment, the proximal end of the lower frame and the free portion of the upper frame are both movably connected to the pusher.

In one embodiment, the supporting frame comprises a plurality of upper frames, one upper frame farthest from the lower frame is rotatably connected with the pushing member, and the lower frame and the rest upper frames are slidably connected with the pushing member; or the upper layer frames are connected with the pushing pieces in a sliding mode, and the lower layer frames are connected with the pushing pieces in a rotating mode.

In one embodiment, the conveying mechanism further comprises a connecting piece, one end of the connecting piece is connected with the pushing piece, and the other end of the connecting piece is rotatably connected with the lower layer frame.

An anti-embolic protection device comprising:

the supporting frame comprises a lower layer frame and at least one upper layer frame which are sequentially arranged from bottom to top, the upper layer frame comprises a connecting part and a free part, the connecting part is connected with the far end of the adjacent frame, the free part is separable from the lower layer frame, and the free part can tilt towards the direction far away from the lower layer frame under the action of force;

and the filtering piece is connected with the supporting frame and covers the upper layer frame.

In the anti-embolism protection device and the medical apparatus adopting the anti-embolism protection device, the support frame comprises a lower layer frame and at least one upper layer frame which are arranged from bottom to top in sequence, when the anti-embolism protection device is released to an aortic arch, the near end and the far end of the lower layer frame can be automatically bent downwards under the influence of the arched inner wall of the aortic arch, so that a certain tension force is formed, the anti-embolism protection device is fixed in the aortic arch, and the free part of the upper layer frame is separated from the near end of the lower layer frame due to the fixed connection of the connecting part of the upper layer frame and the far end of the lower layer frame, so that the free part of the upper layer frame can be upwards tilted (namely, in the direction away from the lower layer frame) when the lower layer frame is bent downwards and deformed, the free part can effectively support the arched structure of the filter element, and ensure that the filter element can be better attached to the inner wall of the aortic arch, effectively reducing the phenomenon of plug escape caused by filter collapse. Meanwhile, the near end and the far end of the lower-layer frame which are bent downwards and the near end of the free part which is tilted upwards enable the anti-embolism protection device to form a multi-point positioning support structure, so that the stability of the anti-embolism protection device in an aortic arch is improved, and the displacement phenomenon of the anti-embolism protection device caused by pulsating contraction and high-flow blood scouring is avoided.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention.

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic view of an embodiment of an anti-embolic protection device in a released state;

FIG. 2 is a schematic view of the anti-embolic protection device shown in FIG. 1 in the aortic arch;

FIG. 3 is a schematic view of the anti-embolic protection device shown in FIG. 1 in its natural state;

FIG. 4 is a schematic structural view of a support frame of the anti-embolic protection device shown in FIG. 1;

FIG. 5 is a schematic structural view of a support frame of another embodiment of an anti-embolic protection device;

FIG. 6 is a top view of the support frame shown in FIG. 5;

FIG. 7 is a schematic structural view of another embodiment of an anti-embolic protection device in a released state;

FIG. 8 is a schematic structural view of a medical device according to an embodiment;

FIG. 9 is a schematic structural view of an embodiment of an anti-embolic protection device and a pusher;

FIG. 10 is a schematic structural view of another embodiment of an anti-embolic protection device and a pusher;

FIG. 11 is a schematic structural diagram of a support frame according to an embodiment;

FIG. 12 is a schematic structural view of a support frame according to another embodiment;

fig. 13 is a schematic structural diagram of a pushing member according to an embodiment.

10. An anti-embolic protection device; 11. a lower layer frame; 111. a proximal end; 112. a distal end; 12. an upper frame; 121. a connecting portion; 122. a free portion; 123. a switching part; 13. a filter member; 21. an outer sheath tube; 22. A pushing member; 221. hooking; 222. a flexible section; 223. a connecting member; 40. the aortic arch; 41. the left subclavian artery; 42. the left common carotid artery; 43. the brachiocephalic trunk artery.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

Referring to fig. 1-2, fig. 1 is a schematic diagram showing the structure of an anti-embolic protection device 10 according to an embodiment of the present invention, the anti-embolic protection device 10 is used for being released by a delivery mechanism to be placed at the aortic arch 40 during the operation of the heart and aorta, and functions to deflect the flow of emboli generated during the operation, and to filter the blood flowing to the brain to prevent the emboli from entering the brain. Specifically, fig. 2 illustrates a structural schematic diagram of the anti-embolism protection device 10 in a schematic diagram of an aortic arch 40, wherein a convex side of the aortic arch 40 is communicated with 3 larger arteries, which are sequentially divided into a brachiocephalic trunk 43, a left common carotid artery 42 and a left subclavian artery 41 from right to left, and the anti-embolism protection device 10 provided in this embodiment can be released to a place where an aorta ascends and/or the aortic arch 40 and/or a descending aorta to play a role in filtering ascending blood flow of the brachiocephalic trunk 43, the left common carotid artery 42 and the left subclavian artery 41, so as to prevent embolism generated in a surgical procedure from entering the brain through the brachiocephalic trunk 43, the left common carotid artery 42 and the left subclavian artery 41.

Specifically, an embodied anti-embolism protection device 10 includes a support frame and a filter element 13, wherein the support frame includes a lower frame 11 and at least one upper frame 12 arranged in sequence from bottom to top, the upper frame 12 includes a connection portion 121 and a free portion 122, the connection portion 121 is connected to a distal end of an adjacent frame, for example, the connection portion 121 is connected to a distal end 112 of the adjacent lower frame 11, or the connection portion 121 of the upper frame 12 is connected to a connection portion 121 of another adjacent upper frame 12. Specifically, when the support frame includes a lower frame 11 and an upper frame arranged in sequence from bottom to top, the connection portion 121 of the upper frame 12 is connected to the distal end 112 of the lower frame 11. When the support frame includes a lower frame 11 and two or more upper frames 12 arranged in sequence from bottom to top, the connection portion 121 of one upper frame 12 closest to the lower frame 11 is connected to the distal end 112 of the lower frame 11, and the connection portions 121 of the remaining upper frames 12 are connected to the connection portion 121 of the adjacent other upper frame 12. The free portion 122 of the upper frame 12 is separable from the lower frame 121, and the free portion 122 can be tilted away from the lower frame 11 under a force. Further, the support frame has a natural state and a released state for fixation into the aortic arch 40 in which the free portion 122 is tilted away from the underlying frame 11.

The filter member 13 is connected to the support frame and covers the upper frame 12. The filter 13 is used to cover the brachiocephalic trunk 43, left common carotid artery 42 and/or left subclavian artery 41.

Further, as shown in fig. 1, in order to describe the structural features of the present application more clearly, the terms "proximal end 111" and "distal end 112" are used as the directional terms, wherein "proximal end 111" represents the end that is close to the operator during the operation (i.e., the end that is far from the heart after the anti-embolic protection device 10 is released into position); "distal end 112" means the end that is distal from the operator (i.e., the end that is closer to the heart after the anti-embolic protection device 10 is released into position). The proximal end 111 of the lower frame 11 and the proximal end 111 of the upper frame 12 are adapted to be coupled to the pusher member 22 of the delivery mechanism. Further, the connection portion 121 of the upper frame 12 is located on the distal end 112 side of the upper frame 12, and the free portion 122 of the upper frame 12 is located on the proximal end 111 side of the upper frame 12.

Above-mentioned anti embolism protection device 10 is through setting up filter piece 13 on braced frame, filter piece 13 can cover the communication mouth of brachiocephalic trunk artery 43, left common carotid artery 42 and/or left subclavian artery 41 and aorta to filter the ascending blood flow that flows into brachiocephalic trunk artery, left common carotid artery 42 and left subclavian artery 41 from the aorta, prevent to get into the brain via brachiocephalic trunk artery 43, left common carotid artery 42 and left subclavian artery 41 because of the embolism that produces among the operation process, the risk of patient's cerebral apoplexy has been reduced. And the support frame includes a lower frame 11 and at least one upper frame 12 stacked on the lower frame 11, after the anti-embolic protection device 10 is released into the aortic arch 40, the proximal 111 and distal 112 ends of the lower frame 11 will automatically bend downward under the influence of the arcuate inner walls of the aortic arch 40, thereby creating a tension that secures the anti-embolic protection device 10 within the aortic arch 40, and since the connection portion 121 of the upper frame 12 is connected with the distal end 112 of the lower frame 11 or with another connection portion 11 adjacent thereto, and the free part of the upper layer frame can tilt towards the direction far away from the lower layer frame under the releasing state, and then make free portion 122 can carry out effective support to filtering piece 1, guarantee to filter piece 13 can better laminating and the inner wall of aortic arch 40, effectively reduced because of filtering piece 13 sinks the embolism escape phenomenon that leads to. Meanwhile, the proximal and distal ends of the downwardly curved lower frame 11 and the upwardly raised free portion 122 enable the anti-embolic protection device 10 to form a multi-point positioning support structure, improving the stability of the anti-embolic protection device 10 in the aortic arch 40, and avoiding displacement of the anti-embolic protection device 10 due to pulsatile contraction and high-flow blood washout.

Further, referring to fig. 1-3, in a natural state, the lower frame 11 and the upper frame 12 are both planar ring structures, so that the embolic protection device 10 is more easily retracted into the sheath 21 of the delivery mechanism when not in use or after use. Further, referring to fig. 1, in the released state, the proximal end 111 of the lower frame 11 and the free portion 122 of the upper frame 12 are bent and raised in opposite directions, respectively. Specifically, after the anti-embolism protection device 10 is released into the aortic arch 40, the two ends of the supporting frame are respectively subjected to the opposite forces applied by the aortic arch 40, so that the proximal end 111 and the distal end 112 of the lower frame 11 automatically bend downwards, and since the connecting portion 121 of the upper frame 12 is fixedly connected with the distal end 112 of the lower frame 11, the connecting portion 121 follows the distal end 112 of the lower frame 11 to bend downwards, and the free portion 122 of the upper frame 12 is separated from the lower frame 11, i.e. the free portion 122 of the upper frame 12 can move freely, due to the lever principle, when the connecting portion 121 bends downwards, the free portion 122 automatically tilts in the opposite direction (upwards), so that the free portion 122 can support the filter element 13 and prevent the arch structure of the filter element 13 from collapsing.

It is worth mentioning that in a further embodiment, the free portion 122 of the upper frame 12 has a pre-curved shape in a direction away from the lower frame 11. Specifically, in the natural state of the anti-embolism protection device 10, the lower layer frame 11 is still in a plane structure, and the free portion 122 of the upper layer frame 12 is predetermined to be in a three-dimensional structure bending in a direction away from the lower layer frame 11, so that after the filtering membrane is covered on the supporting frame, the free portion 122 can also play a role of supporting the filtering membrane, and the pre-shaped free portion 122 is easier to warp in the release state, so as to cooperate with the proximal end 111 and the distal end 112 of the lower layer frame 11 to form a multi-point support against the anti-embolism protection device 10.

Specifically, referring to fig. 4, the lower frame 11 and the upper frame 12 are both closed ring structures, for example, the lower frame 11 and the upper frame 12 may be closed ring structures having a circular shape, an oval shape, a heart shape, or a drop shape. Further, the connection portion 121 of the upper frame 12 extends along the distal end portion of the lower frame 11. In other words, the projection of the connecting portion 121 of the upper frame 12 on the plane of the lower frame 11 overlaps with the contour of the portion of the lower frame 11 near the distal end 112, so that the connecting portion 121 and the lower frame 11 are more compact, thereby facilitating the penetration of the subsequent surgical instruments through the anti-embolic protection device 10 and the sheathing of the anti-embolic protection device 10. Further, the lower frame 11 and the upper frame 12 are both of a closed ring structure formed by one or more different or same arcs, so that the lower frame 11 and the upper frame 12 can adapt to different aortic arches and diameters, and can better fit the upper wall of the aortic arch 40 and support the filter member 13. Further, the connection portion 121 of the upper frame 12 and the lower frame 11 may be fixed by laser welding, and preferably, a plurality of welding points may be disposed between the connection portion 121 and the lower frame 11, and the welding points are disposed at intervals along the connection portion 121. Further, the connection portion 121 and the lower frame 11 may be integrally linearly welded. Further, the connection portion 121 and the lower frame 11 may be connected by a socket.

With continued reference to fig. 4, the distal end 112 of the connecting portion 121 is flush with the distal end 112 of the lower frame 11, and in the natural state of the anti-embolic protection device 10, the linear distance from the distal end 112 of the lower frame 11 to the proximal end 111 of the lower frame 11 is greater than the linear distance from the distal end 112 of the connecting portion 121 to the proximal end 111 of the free portion 122. Further, referring to fig. 5 to 6, when the support frame includes a plurality of upper frames 12 arranged in sequence from bottom to top, the linear distance from the distal end 112 of the connecting portion 121 to the proximal end 111 of the free portion 122 of each upper frame 12 decreases in sequence in a direction away from the lower frame 11, so that after the anti-embolic protection device 10 is released into the subject's aorta, the free portion 122 of each upper frame 12 can form an arch-like frame structure, thereby better supporting the filter member 13, so that the support member 13 forms an arch-like structure more adapted to the configuration of the aortic blood vessels. Preferably, the distance from the distal end 112 to the proximal end 111 of the lower frame 11 is 80mm to 120mm, and the maximum width of the lower frame 11 is 40mm to 90 mm. The distance from the distal end 112 of the connecting part 121 of the upper frame 12 to the proximal end 111 of the free part 122 ranges from 30mm to 90mm, and the maximum width of the upper frame 12 is 40mm to 90mm consistent with that of the lower frame 11, so that the supporting frame structure with the size can better adapt to the anatomical structure of the aorta.

Specifically, in one embodiment, the material of the lower frame 11 and the upper frame 12 are both wires, for example, the lower frame 11 and the upper frame 12 may be a composite wire wound by a single wire or multiple wires. And the wire diameter of the lower layer frame 11 is larger than that of the upper layer frame 12, so that the interference of the subsequent surgical instruments caused by the oversize of the upper layer frame 12 is avoided. Preferably, the diameter of the wire is 0.6mm-0.2mm, and the height of the integral overlapped part of the support frame is not more than 1.2 mm. The material of the lower frame 11 and the upper frame 12 may be made of one or more of a pipe material or a laser-cut sheet material. Preferably, the material for manufacturing the lower frame 11 and the upper frame 12 may be a biocompatible material such as metal, polymer, or inorganic nonmetal.

Further, the filter member 13 is attached at its periphery to the lower frame 11 or the upper frame 12. Specifically, referring to fig. 7, in the present embodiment, the filter member 13 is overlaid on one upper frame 12 closest to the lower frame 11, so that the filter member 13 can be wrapped around all the upper frames 12, so that the upper frame 12 can better support the filter member 13. In other embodiments, the filter element 13 may also be covered on the lower frame 11. The filtering member 13 is connected to a single upper frame 12 or to the lower frame 11, thereby preventing the phenomenon that the filtering member 13 cannot enter the sheath due to the different compression ratios of the filtering member 13 and each frame when the filtering member 13 is simultaneously connected to a plurality of frames. Preferably, the filter material and the upper frame 12 or the bottom layer are connected to each other by one or more methods such as sewing, gluing, hot pressing, ultrasonic welding, laser welding, high frequency welding, etc

Further, the lower frame 11 and/or the upper frame 12 are provided with a developing element (not shown) which can be captured by medical images to obtain a position image, so that a doctor can clearly distinguish the position of the anti-embolism protection device 10 in the release state during the operation, and particularly, the doctor can conveniently observe whether the form of the free portion 122 of the upper frame 12 is in place or not when the anti-embolism protection device 10 is in the release state. Further, the developing element may be a developing wire wound on the lower frame 11 and the upper frame 12, the developing element may also be a ring-shaped or tubular structure, the developing element is directly sleeved on the lower frame 11 and the upper frame 12, and the developing element may be made of noble metal such as tantalum, platinum, gold, tungsten, and the like. In addition, the lower frame 11 and the upper frame 12 may be made of nickel titanium wire material having developing property.

Further, the filter member 13 may be pre-shaped in a dome shape, or may be supported by the free portion 122 of the upper frame 12 in a released state to form a dome shape. Further, the filtering member 13 may be a single-layer filtering net, so as to reduce the material consumption and the cost. In other embodiments, the filtering member 13 may also include at least two layers of filtering net, and at least two layers are stacked in a staggered manner, so as to improve the filtering effect of the filtering member 13. Furthermore, at least two layers of filter screens can be overlapped and combined in the modes of laser welding, glue bonding, hot pressing and the like. Furthermore, the mesh aperture size of the filter element 13 can be 30um-250um, which can not only block the embolism from passing, but also ensure that the blood flow velocity is not affected. The open area of the meshes of the filter screen is-70% of the whole area. Furthermore, the maximum height of the arch structure of the filtering piece 13 is 10mm-50mm, so that the filtering piece 13 is easier to be accommodated in the outer sheath tube 21, and the conveying convenience is improved.

Further, the filter 13 is made of a woven film or a laser-punched film, such as a polymer material such as PET (Polyethylene terephthalate), PEEK (polyether ether ketone), PA (Polyamide, nylon) or other non-polymer materials. But also a wire mesh of nickel titanium, stainless steel, tantalum, etc., it is preferred that the filter member 13 is an elastic membrane material, for example, the filter member 13 is a knitted PET membrane, so that when the anti-embolic protection device 10 is contracted inside the outer sheath 21, the elastic membrane material can be stretched, and when the anti-embolic protection device 10 is released out of the outer sheath 21, the elastic membrane can be restored to its original shape. Compared with the filtering piece 13 using the non-elastic membrane material, the filtering piece 13 using the elastic membrane material can reduce the usage amount of the membrane material, thereby reducing the whole volume of the anti-embolism protection device 10 and enabling the anti-embolism protection device 10 to enter the outer sheath tube 21 more easily.

Further, the surface of the filter member 13 is provided with an anticoagulant coating. Preferably, the anticoagulant coating comprises an anticoagulant such as heparin, an anticoagulant, or the like, to prevent the plug from accumulating and clogging filter element 13 during surgery. The anticoagulant coating may be formed on the surface of the filter member 13 by a process such as dip coating or spray coating. In other embodiments, filter element 13 may be made of a material having an anti-clotting agent.

Further, referring to fig. 8, an embodiment of the present application also provides a medical device. In particular, the medical device of an embodiment includes the anti-embolic protection device 10 of any of the embodiments described above, and a delivery mechanism for delivering the anti-embolic protection device 10 from the femoral vessel lumen into the aortic arch 40. The delivery mechanism includes a pusher 22, and the pusher 22 is coupled to the proximal end of the lower frame 11 and/or the proximal end of the upper frame 12. Preferably, the delivery mechanism further comprises an outer sheath 21, a pushing member 22 is movably arranged in the outer sheath 21, and the pushing member 22 is used for accommodating the anti-embolism protection device 10 in the outer sheath 21 or pushing the anti-embolism protection device 10 out of the outer sheath 21.

Specifically, during delivery, the anti-embolic protection device 10 is retracted within the sheath 21, thereby facilitating delivery of the anti-embolic protection device 10 to the aortic arch 40. When the anti-embolic protection device 10 is delivered to a predetermined location in the aortic arch 40, the anti-embolic protection device 10 is released to the aortic arch 40 into a released state by relative movement of the sheath 21 and the pusher 22. When the procedure is completed, the anti-embolic protection device 10 is again retracted within the outer sheath 21 by relatively moving the outer sheath 21 and pusher 22.

The embolism protection device adopts the anti-embolism protection device 10, the anti-embolism protection device 10 can cover the communication ports of the brachiocephalic trunk 43, the left common carotid artery 42 and the left subclavian artery 41 and the aorta by arranging the filter element 13 on the support frame, thereby filtering the ascending blood flow flowing into the brachiocephalic trunk from the aorta, the left common carotid artery 42 and the left subclavian artery 41, preventing the embolism generated in the operation process from entering the brain through the brachiocephalic trunk 43, the left common carotid artery 42 and the left subclavian artery 41, and reducing the risk of cerebral apoplexy of the patient. And the supporting frame comprises a lower layer frame 11 and at least one layer of upper layer frame 12 stacked on the lower layer frame 11, when the anti-embolism protection device 10 is released to the aortic arch 40, the near end 111 and the far end 112 of the lower layer frame 11 can be automatically bent downwards under the influence of the arched inner wall of the aortic arch 40, so that a certain tension force is formed, the anti-embolism protection device 10 is fixed in the aortic arch 40, and the connecting part 121 of the upper layer frame 12 can be tilted towards the direction far away from the lower layer frame 11 when being arranged in the aorta of a subject, so that the free part 122 can effectively support the arched structure of the filtering piece 13, the filtering piece 13 can be better attached to the inner wall of the aortic arch 40, and the embolism escape phenomenon caused by the collapse of the filtering piece 13 is effectively reduced. Meanwhile, the proximal end 111 and the distal end 112 of the lower frame 11 bent downward and the proximal end 111 of the free portion 122 raised upward enable the anti-embolic protection device 10 to form a multi-point positioning support structure, thereby improving the stability of the anti-embolic protection device 10 in the aortic arch 40 and avoiding the displacement phenomenon of the anti-embolic protection device 10 caused by pulsatile contraction and high-flow blood washout.

Further, referring to fig. 9-10, the proximal end 111 of the lower frame 11 and the free portion 122 of the upper frame 12 are movably connected to the pushing member 22, so that after the operation is completed, the upturned free portion 122 can be restored to the natural state by the pushing member 22, and the anti-embolic protection device 10 is integrally retracted into the outer sheath 21, thereby preventing the upturned free portion 122 from blocking the anti-embolic protection device 10 from being retracted into the outer sheath 21. Specifically, when the support frame comprises the lower frame 11 and the upper frame 12, the pushing member 22 is slidably connected to the proximal end 111 of the lower frame 11, and the pushing member 22 is fixedly or rotatably connected to the free portion 122 of the upper frame 12, so that the anti-embolic protection device 10 can freely adapt to the curvature of the aortic arch 40 after being released into the aortic arch 40 without being constrained by the pushing member 22. Further, when the supporting frame comprises a plurality of upper frames 12, one upper frame 12 farthest from the lower frame 11 (i.e. the uppermost upper frame 12) is fixedly or rotatably connected with the pushing member 22, and the lower frame 11 and the rest of the upper frames 12 are slidably connected with the pushing member 22, so that the embolic obstruction device can be smoothly delivered and unfolded to be in a release state and recovered into the sheath 21.

Further, referring to fig. 11-13, the proximal end 111 of the lower frame 11 and/or the free portion 122 of the upper frame 12 are provided with a circular ring or arc-shaped adaptor 123, the distal end 112 of the pushing member 22 is provided with a hook 221 or a circular ring or the like to connect to the upper frame 12, the pushing member 22 is rotatably connected to the adaptor 123 of the upper frame 12 (i.e., the uppermost upper frame 12) farthest from the lower frame 11 through the hook 221 or the circular ring of the distal end 112, and the pushing member 22 slidably passes through the lower frame and the adaptor 123 of the remaining upper frames 12.

In another embodiment, the upper frame 12 is slidably connected to the pushing member 22, and the lower frame 11 is rotatably connected to the pushing member 22. Preferably, the proximal end of the lower frame 11 is provided with a coupling sleeve, the pushing member 22 is rotatably inserted into the coupling sleeve, and the coupling sleeve 22 can limit the pushing member to move axially along itself, so that the lower frame can rotate axially around the pushing member but is fixed to move in the axial direction of the pushing member.

Further, the conveying mechanism further comprises a connecting piece 223, one end of the connecting piece 223 is connected with the pushing piece 22, and the other end of the connecting piece 223 is rotatably connected with the lower layer frame 11, so that the movement synchronism of the pushing piece 22 and the anti-embolism protection device 10 is kept, the degree of freedom of the lower layer frame 11 is guaranteed, and the anti-embolism protection device 10 can more smoothly enter and exit the outer sheath tube 21. Preferably, the connecting member 223 may be a metal filament or a polymer filament.

Further, the pushing member 22 is provided with a guide wire hole penetrating through the axial direction of the pushing member, and the guide wire hole is used for penetrating a guide wire, so that the embolic protection device can enter the aortic arch 40 along the guide wire pre-embedded in the aorta. In another embodiment, the pusher 22 may also be a solid rod with some rigidity. Preferably, the pusher 22 may be a stainless steel or nickel titanium or polymeric tube or rod. Further, the pusher member 22 is pre-shaped to have a curvature that allows the device to adhere more to the wall during delivery by shaping to different curvature angles to accommodate the shape of the aortic arch 40.

Further, referring to FIG. 13, the distal end 112 of the pusher member 22 is provided with a flexible segment 222, such as a helical configuration at the distal end 112 of the pusher member 22 or a design with a thinner distal end 112 and a thicker proximal end 111 such that the flexible segment 222 is formed at the distal end 112 of the pusher member 22. The flexible section 222 of the pusher member 22 allows the pusher member 22 to freely conform to the curvature of the vessel in the aortic arch 40 and to conform to the upper wall of the aortic arch 40. Further, the flexible section 222 of the distal end 112 of the pushing member 22 is not limited to be cut directly on the tube in a spiral manner, but may be formed by splicing a spring section made of a wire wound and the tube, and the distal end 112 of the pushing member 22 may be pre-bent, wherein the curvature radius of the distal end 112 of the pushing member 22 is a curvature radius generally similar to the aortic arch 40. Further, referring to fig. 10, the pushing member 22 may further penetrate the anti-embolic protection device 10, and the pushing member 22 abuts against the highest point of the filtering member 13, so as to facilitate the filtering member 13 to adhere to the inner wall of the aortic arch 40. Preferably, the pusher 22 may be a tube or rod of stainless steel, nickel titanium or polymeric material.

Further, the delivery mechanism may further comprise a handle, the proximal end 111 of the outer sheath 21 is fixedly connected with the distal end 112 of the handle, and the proximal end 111 of the pushing member 22 is movably passed through the handle and connected with the distal end 112 of the handle, so that the outer sheath 21 and the pushing member 22 are relatively moved by pushing and pulling the handle, thereby releasing the anti-embolism protection device 10 out of the outer sheath 21 or retracting the anti-embolism protection device back into the outer sheath 21.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Claims (12)

1. An anti-embolic protection device, comprising:

the anti-embolism protection device comprises a support frame, wherein the support frame comprises a lower layer frame and at least one upper layer frame which are sequentially arranged from bottom to top, each upper layer frame comprises a connecting part and a free part, each connecting part is connected with the far end of an adjacent frame, the anti-embolism protection device has a natural state and a release state, and in the release state, the free parts tilt towards the direction far away from the lower layer frame;

a filter member coupled with the support frame and covering the upper frame.

2. The anti-embolic protection device of claim 1, wherein the free portion is curved away from the underlying frame when the anti-embolic protection device is in the natural state.

3. The anti-embolic protection device of claim 2, wherein the lower frame and the upper frame are each a closed loop structure, and the connecting portion extends along a distal portion of the lower frame.

4. The anti-embolic protection device of claim 1, wherein in the natural state, a linear distance from a distal end point to a proximal end point of the lower frame is greater than a linear distance from a distal end point to a proximal end point of the upper frame.

5. The embolic protection device of claim 4, wherein said support frame comprises a plurality of said upper frames arranged in sequence from bottom to top, and in said natural state, the linear distance from the distal end point to the proximal end point of said upper frames decreases in sequence in the direction away from said lower frames.

6. An anti-embolic protection device as in claim 1, wherein the perimeter of the filter element is attached to the lower or upper frame.

7. The anti-embolic protection device of claim 1, wherein the lower frame and/or the upper frame is provided with a visualization element.

8. A medical device comprising an anti-embolic protection device as in any of claims 1-8, and,

the conveying mechanism comprises a pushing piece, and the pushing piece is connected with the near end of the lower layer frame and/or the near end of the upper layer frame.

9. The medical device of claim 8, wherein the pusher is movably coupled to the proximal end of the lower frame and the proximal end of the upper frame.

10. The medical device of claim 9, wherein the support frame comprises a plurality of the upper frames, one of the upper frames furthest from the lower frame being pivotally coupled to the pusher, the lower frame and the remaining upper frames being slidably coupled to the pusher; or the upper layer frames are connected with the pushing pieces in a sliding mode, and the lower layer frames are connected with the pushing pieces in a rotating mode.

11. The medical device of claim 9, wherein the delivery mechanism further comprises a connector, one end of the connector is connected to the pusher, and the other end of the connector is rotatably connected to the lower frame.

12. An anti-embolic protection device, comprising:

the supporting frame comprises a lower layer frame and at least one upper layer frame which are sequentially arranged from bottom to top, the upper layer frame comprises a connecting part and a free part, the connecting part is connected with the far end of the adjacent frame, the free part is separable from the lower layer frame, and the free part can tilt towards the direction far away from the lower layer frame under the action of force;

and the filtering piece is connected with the supporting frame and covers the upper layer frame.

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