CN112022427B

CN112022427B - Anti-embolism protection device and medical instrument

Info

Publication number: CN112022427B
Application number: CN202011224827.2A
Authority: CN
Inventors: 倪尊张; 孙剑峰; 张子衡; 王石萍; 金巧蓉; 罗七一
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: Shanghai Weidun Medical Technology Co.,Ltd.
Priority date: 2020-11-05
Filing date: 2020-11-05
Publication date: 2021-03-23
Anticipated expiration: 2040-11-05
Also published as: CN112022427A; WO2022095582A1; CN112914789A

Abstract

The invention relates to an anti-embolism protection device and a medical instrument. The anti-embolism protection device comprises a support frame and a filter piece, wherein the support frame comprises a main body part, and a first support part and a second support part which are connected with the far end of the main body part. The first support portion is located below the second support portion, and in the expanded state, the first support portion is bent downward of the main body portion. The filter piece covers the main body part and the second supporting part. The anti-embolism protection system and the medical apparatus have good coverage and high stability.

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 matter, tumor cells or other small tissue fragments) or broken off of arterial walls from blood by surgical instruments that are transported through the blood stream into the cerebral blood circulation and other important systemic arterial systems as embolizing vascular material. 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.

Generally, to prevent complications from occurring due to emboli, it is often necessary to place an anti-embolic protection device at the aortic arch during surgery to filter emboli such as plaque, debris, or thrombus in the blood flow to the brain to prevent the formation of emboli. The traditional anti-embolism protection device is easy to deflect in the process of being conveyed to an aortic arch, and cannot be completely unfolded due to inaccurate positioning when being released at the aortic arch, so that the anti-embolism protection device cannot completely cover branch blood vessels on the aortic arch after being released at the aortic arch, and emboli can escape into the branch blood vessels.

Disclosure of Invention

Therefore, how to ensure that the anti-embolism protection device completely covers three branch vessels on the aortic arch and avoid the problem of embolus escape is needed, and the anti-embolism protection device and the medical instrument which have good coverage and can be accurately positioned are provided.

An anti-embolic protection device comprising:

a support frame including a body portion, and first and second support portions connected to a distal end of the body portion;

the filtering piece covers the area enclosed by the main body part and the second supporting part;

the first support portion is located below the second support portion, and in a deployed state, the first support portion is bent downward of the main body portion, and the second support portion is bent upward of the main body portion.

In one embodiment, the main body portion is a U-shaped frame, the main body portion includes a first end point and a second end point at a distal end, and the second support portion is connected to the main body portion through the first end point and the second end point.

In one embodiment, the first end point, the second end point, and the proximal end point of the body portion define a first plane; the second supporting part is a U-shaped frame, the first end point, the second end point and the far end point of the second supporting part define a second plane, and an included angle formed by the first plane and the second plane is 100-170 degrees.

In one embodiment, the first supporting part is a U-shaped frame, and a middle portion and/or a portion far away from the main body part of the first supporting part define a third plane, and the third plane is extended from the first plane to form an included angle of 50-150 °.

In one embodiment, the first supporting portion and/or the second supporting portion and the main body portion are of an integral structure.

In one embodiment, the first support part and/or the second support part is connected with the main body part through a sleeve, and the sleeve is sleeved on the distal end of the main body part and the proximal end of the first support part and/or the second support part; or the far end of the main body part is connected with the near end of the first supporting part and/or the second supporting part in a laser welding mode.

In one embodiment, the body portion is arched away from the first support portion.

In one embodiment, the circumferential length of the first support portion is less than or equal to the circumferential length of the second support portion.

A medical device, comprising:

the anti-embolic protection device described above; and the number of the first and second groups,

the delivery device comprises an outer sheath and a pushing member movably arranged in the outer sheath in a penetrating mode, the pushing member is connected with the anti-embolism protection device, and the pushing member is used for accommodating the anti-embolism protection device into the outer sheath or pushing the anti-embolism protection device out of the outer sheath; the anti-embolic protection device imparts a curved shape to the outer sheath when the anti-embolic protection device is received within the outer sheath.

In one embodiment, the pushing member is located below the main body and extends out from the middle of the first supporting portion and the second supporting portion.

In one embodiment, the pushing element is coupled to the proximal end of the filter element or the proximal end of the body portion.

In one embodiment, the distal portion of the pusher is a hypotube that is positioned below the filter.

The anti-embolism protection device and the medical apparatus have the following beneficial effects:

the first support portion is bent downward of the main body portion, so that the outer sheath tube can be formed into a bent shape by the influence of the main body portion and the first support portion after the embolic protection device is received in the outer sheath tube. In the process of conveying the anti-embolism protection device to the aortic arch through the conveying device, the outer sheath tube with the curved shape can be matched with the aortic arch with the arch structure, so that the anti-embolism protection device in the outer sheath tube and the outer sheath tube is prevented from twisting in the process of conveying the anti-embolism protection device to the aortic arch, the anti-embolism protection device can be unfolded in the correct direction after being released at the aortic arch, and the situation that the head arm trunk artery, the left common carotid artery and the left subclavian artery can be completely covered after the anti-embolism protection device is unfolded is ensured.

The second supporting part is bent towards the upper part of the main body part, and after the anti-embolism protection device is released at the aortic arch, the second supporting part is abutted against the upper wall of the aortic arch, so that downward force is applied to the main body part, and the whole supporting frame has a sinking trend. Because the aortic arch is of an arch structure, the internal cross-sectional area of the aortic arch is smaller near the top of the branch vessel, and if the anti-embolism protection device is positioned at the position and released, the anti-embolism protection device is easily limited by the vessel wall of the aortic arch and cannot be completely unfolded. Set up the second supporting part of bending to the top through the distal end at this somatic part, thereby make anti embolic protection device receive the decurrent thrust effect of second supporting part at the deployment in-process, make anti embolic protection device's position sink to the great region of aortic arch internal cross sectional area, the expansion of having avoided anti embolic protection device receives the restriction of aortic arch vascular wall, and then guaranteed that anti embolic protection device can expand completely, anti embolic protection device's coverage area has been improved, guarantee that anti embolic protection device can cover the brachiocephalic trunk artery completely after expanding, artery under left common carotid artery and the left clavicle, the side leakage risk has been reduced.

Meanwhile, the second supporting part and the first supporting part bend towards the direction away from each other, so that the second supporting part and the first supporting part are combined to form a fishmouth-shaped annular frame, and the second supporting part and the first supporting part jointly form an opening for the passage of subsequent surgical instruments. The fish-mouth-shaped annular frame can resist the embolic protection device to form annular supporting force so as to enhance the anchoring force of the embolic protection device, and can keep a large opening state to facilitate the passage of subsequent surgical instruments.

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 anti-embolic protection device in an aortic arch according to an embodiment of the present invention;

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

FIG. 3 is a front view of an anti-embolic protection device according to an embodiment of the present invention;

FIG. 4 is a front view of an anti-embolic protection device according to another embodiment of the present invention;

FIG. 5 is a front elevational view of an anti-embolic protection device according to yet another embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a supporting frame according to an embodiment of the present invention;

FIG. 7 is a front view of the support frame shown in FIG. 6;

FIG. 8 is a schematic structural diagram of a support frame according to another embodiment of the present invention;

FIG. 9 is a schematic structural view of a medical device according to an embodiment.

Description of reference numerals:

10. an anti-embolic protection device; 11. a support frame; 111. a main body portion; 112. a first support section; 12. a second support portion; 122. a connecting portion; 13. a filter member; 14. a sleeve; 15. a switching part; 21. a pushing member; 40. the aortic arch; 41. the brachiocephalic trunk artery; 42. the left common carotid artery; 43. the left subclavian artery; 51. a first plane; 511. a first endpoint; 512. a second endpoint; 52. a second plane; 53. a third plane.

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, fig. 1 shows a schematic view of an anti-embolic protection device in an aortic arch according to an embodiment of the present invention. The upper wall of the aortic arch 40 is connected with three larger branches, which are a left subclavian artery 43, a left common carotid artery 42 and a brachiocephalic artery 41 from right to left. The anti-embolic protection device 10 provided in this embodiment can be released at the aortic arch 40 to filter the ascending blood flow of the left subclavian artery 43, the left common carotid artery 42 and the brachiocephalic artery 41, and prevent emboli generated during the operation from entering the brain.

Referring to fig. 2 and 3, the anti-embolic protection device 10 of the present embodiment includes a support frame 11 and a filter member 13, wherein the support frame 11 includes a main body portion 111 and a first support portion 112 and a second support portion 12 connected to a distal end of the main body portion 111. The first support part 112 is located below the second support part 12, and in the deployed state, the first support part 112 is bent downward of the body part 111. After the anti-embolic protection device 10 is released at the aortic arch 40, the first support portion 112 is used to abut against the lower wall of the aortic arch 40, and the second support portion 12 and the frame of the main body portion 111 are used to fit against the upper wall of the aortic arch 40. The filter member 13 covers the area surrounded by the main body 111 and the second support portion 12.

Further, in order to more clearly describe the structural features of the present application, the terms "proximal" and "distal" are used as terms of orientation, wherein "proximal" refers to the end that is closer to the operator during the procedure (i.e., the end that is further from the heart after the anti-embolic protection device 10 is released into position); "distal" 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). Further, the proximal end of the body 111 is used for connecting with the pusher of the delivery device, and the first support 112 is located at the distal end of the body 111. Preferably, the first supporting portion 112 of the supporting frame 11 and the main body portion 111 are integrally formed, and the first supporting portion 112 and the main body portion 111 are connected to form a closed loop structure. Similarly, the second support portion 12 is connected to the main body portion 111 to form a closed loop structure, thereby better adapting to the configuration of the aortic arch 40 and supporting the filtering element 13.

The anti-embolism protection device 10 is provided with the filter element 13 in the area enclosed by the main body part 111 and the second support part 12, so that the filter element 13 can completely cover the communication ports of the left subclavian artery 43, the left common carotid artery 42 and the brachiocephalic artery 41 and the aorta, thereby filtering the ascending blood flow flowing from the aorta into the left subclavian artery 43, the left common carotid artery 42 and the brachiocephalic artery 41, preventing embolus generated in the operation process from entering the brain through the left subclavian artery 43, the left common carotid artery 42 and the brachiocephalic artery 41, and reducing the risk of cerebral apoplexy of the patient.

The first support part 112 of the support frame 11 is bent downward of the body part 111, so that the outer sheath tube can be formed into a downwardly bent shape by the influence of the first support part 112 after the embolic protection device 10 is received in the outer sheath tube. In the process of delivering the anti-embolism protection device 10 to the aortic arch 40 through the delivery device, the outer sheath tube with the curved shape can be matched with the aortic arch 40 with the arch structure, so that torsion of the outer sheath tube and the anti-embolism protection device 10 in the outer sheath tube is avoided in the delivery process, the anti-embolism protection device can be unfolded according to the correct direction after being released at the aortic arch, and the left subclavian artery 43, the left common carotid artery 42 and the brachiocephalic artery 41 can be completely covered after the anti-embolism protection device 10 is unfolded.

In addition, after the anti-embolism protection device 10 is released at the aortic arch 40, the first supporting portion 112 can be abutted against the lower wall of the aortic arch 40 to provide a certain supporting force for the reconstruction frame consisting of the second supporting portion 12 and the main body portion 111, so that the frames of the main body portion 111 and the second supporting portion 12 and the filtering piece 13 covering the area enclosed by the main body portion 111 and the second supporting portion 12 are still tightly attached to the inner wall of the aortic arch 40 under the scouring of blood flow, and the adherence of the anti-embolism protection device 10 is improved. Meanwhile, the main body part 111, the first supporting part 112 and the second supporting part 12 can form a three-point positioning structure, so that the anti-embolism protection device 10 is anchored, the anti-embolism protection device 10 is prevented from displacement caused by pulsating contraction and scouring of high-flow blood flow, and the stability of the anti-embolism protection device 10 is improved.

Further, the second support portion 12 is bent upward of the main body portion 111, and specifically, the anti-embolic protection device 10 is contracted inside the outer sheath during transportation, and is small in volume, and referring to fig. 1, since the aortic arch 40 has an arch-shaped structure, the cross-sectional area inside the aortic arch 40 is small near the top of the branch vessel, if the anti-embolic protection device 10 is released there. The anti-embolic protection device 10, when deployed, is susceptible to being constrained by the vessel wall of the aortic arch 40 and not being fully deployed. The utility model provides an anti embolic protection device 10 is through the second supporting part 12 that sets up bending to the top at the distal end of this somatic part 111, thereby make anti embolic protection device 10 receive the decurrent thrust effect of second supporting part 12 in the deployment process, make anti embolic protection device 10's position sink to the great region of aortic arch 40 internal cross-sectional area, the expansion of having avoided embolic protection device receives the restriction of aortic arch vascular wall, and then guaranteed that embolic protection device 10 can expand completely, the coverage area of embolic protection device 10 has been improved, guarantee that anti embolic protection device 10 can cover the brachiocephalic trunk artery 41 completely after expanding, artery 43 under left common carotid artery 42 and the left clavicle, the side leakage risk has been reduced.

Meanwhile, as the first support part 112 and the second support part are bent towards the direction away from each other, the second support part 12 and the first support part 112 can be combined to form a fish-mouth-shaped annular frame, and the second support part 12 and the first support part 112 together form an opening for the subsequent passing of surgical instruments. The fish-mouth-shaped annular frame can not only form an annular supporting force against the embolic protection device 10 to enhance the anchoring force of the embolic protection device 10, but also maintain a large opening state to facilitate the passage of subsequent surgical instruments.

It should be noted that, referring to fig. 5, in another embodiment, the area enclosed by the second supporting portion 12 and the main body portion 111 may also be a plane structure, that is, the second supporting portion 12 is not bent above the main body portion 111, and the purpose of supporting the filtering element 13 can also be achieved.

Further, referring to fig. 6 and 7, the main body 111 is a U-shaped frame, the main body 111 includes a first end 511 and a second end 512 at distal ends, and the second support portion 12 is connected to the main body 111 through the first end 511 and the second end 512. First end 511, second end 512 and the proximal end of body portion 111 define a first plane 51. The main body part 111 is arched in the direction away from the first supporting part 112, so that the supporting frame 11 integrally forms a streamline frame structure, the streamline frame structure conforms to the inner wall anatomical structure of the aortic arch 40, and the adherence of the supporting frame 11 is improved. Referring to fig. 4, it should be noted that, in another embodiment, the frame of the main body 111 may not be arched, that is, the area defined by the main body 111 is a planar structure, and also can function to support and anchor the filter element 13, and at the same time, reduce the difficulty of the process.

Preferably, referring to fig. 6 and 7, the first support part is a U-shaped frame, and the middle portion of the first support part and/or a portion of the third plane 53 far from the main body part form an included angle a of 50 ° to 150 ° with the third plane 53 extending from the first plane 51. Further, the equivalent length of the supporting frame 11 is 60mm-120mm, wherein the equivalent length of the supporting frame 11 is the length of the connecting line between the proximal end point and the distal end point of the supporting frame 11 in the unbent state. The maximum width of the support frame 11 is 30mm to 100 mm. The length of the first support part 112 in an unbent state is 1/5-1/2 of the equivalent length of the support frame 11.

Preferably, referring to fig. 6-7, the second support portion 12 is a U-shaped frame, the first end 511, the second end 512 and the distal end of the second support portion 12 define a second plane 52, and the first plane 51 forms an angle b of 100-170 ° with the second plane 52. Preferably, the first plane 51 and the second plane 52 form an included angle b of 115-165 °

Further, in one embodiment, the circumferential length and width of the second support portion 12 are consistent with the circumferential length and width of the first support portion 112. In another embodiment, the width of the first support portion 112 is consistent with the width of the second support portion 12, but the circumferential length of the first support portion 112 is less than the circumferential length of the second support portion 12. For example, the circumferential length of the first support portion 112 is 5mm to 20mm shorter than the circumferential length of the second support portion 12.

Further, referring to fig. 6, the main body 111 and the second support portion 12 are both U-shaped frames, and the radius of the arc where the main body 111 is bent is greater than or equal to the radius of the arc where the second support portion 12 is bent. The main body 111 and the second support portion 12 are connected to form a closed loop structure, which may be circular, oval, heart-shaped, or drop-shaped. It should be noted that, referring to fig. 8, in another embodiment, a distal end of the second supporting portion 12 is provided with a connecting portion 122, and the connecting portion 122 is stacked on the main body portion 111 and is fixedly connected with the main body portion 111, so as to improve the connection strength between the second supporting portion 12 and the main body portion 111.

Further, in one embodiment, the first supporting portion 112 and/or the second supporting portion 12 are integrated with the main body portion 111. Referring to fig. 4, in another embodiment, the first support portion 112 and/or the second support portion 12 are connected to the main body portion 111 through a sleeve 14, and the sleeve 14 is sleeved on the distal end of the main body portion 111 and the proximal end of the first support portion 112 and/or the second support portion 12. Furthermore, the first supporting portion 112 and/or the second supporting portion 12 and the main body portion 111 may be connected by welding, for example, laser welding. By adopting the laser welding mode, the connecting part of the first supporting part 112 and/or the second supporting part 12 and the main body part 111 has smaller outer diameter size, so that sheathing is facilitated, the frame at the connecting part is subjected to fillet treatment, and the transition is smooth by glue. Preferably, referring to fig. 8, a plurality of welding points may be disposed between the connection portion 122 and the support frame 11, and the plurality of welding points are spaced along the connection portion 122. Further, the connection portion 122 and the support frame 11 may be integrally linearly welded.

Further, in one embodiment, the material of the main body 111, the first support 112 and the second support 12 is a wire material, for example, the main body 111, the first support 112 and the second support 12 may be a composite wire material formed by winding a single wire or multiple wires. In addition, the material of the main body 111, the first support 112 and the second support 12 may be made of one or more of a tube material or a laser-cut sheet material. Preferably, the main body 111, the first supporting portion 112 and the second supporting portion 12 are made of a biocompatible material such as metal, polymer, inorganic nonmetal, or the like.

Further, the filter element 13 may be pre-shaped in an arch-shaped configuration or may be supported in a released state by the pusher element 13 in an arch-shaped configuration. 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 embolus from passing through, but also ensure that the blood flow velocity is not affected. The open area of the meshes of the filter screen is 30-70% of the whole area. Furthermore, the maximum height of the arch structure of the filter element 13 is 5mm-50mm, so that the filter element 13 is easier to be accommodated in the outer sheath, 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., preferably, the filter element 13 is an elastic membrane material, for example, the material of the filter element 13 is a woven PET (Polyethylene terephthalate) membrane, so that when the anti-embolism protection device 10 is contracted in the outer sheath tube, the elastic membrane material can be elongated, and when the anti-embolism protection device 10 is released out of the outer sheath tube, the elastic membrane material 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 more easily. Preferably, the filter element 13 and the support frame are connected to each other by one or more means of stitching, glue, heat pressing, ultrasonic welding, laser welding, high frequency welding, etc.

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 emboli 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, the main body 111, the first supporting portion 112 and/or the second supporting portion 12 are provided with a developing element (not shown), which can be captured by medical images to obtain position images, 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 observe whether the anti-embolism protection device 10 is in place in the release state. Further, the developing element may be a developing wire wound around the main body 111, the first support 112, and the second support 12, or may be an annular or tubular structure, the developing element is directly sleeved on the main body 111, the first support 112, and the second support 12, and the developing element may be made of noble metal such as tantalum, platinum, gold, and tungsten. In addition, the main body 111, the first support portion 112 and the second support portion 12 may be made of nickel titanium wire having developing performance.

Further, referring to fig. 9, an embodiment of the present application also provides a medical device. Specifically, the medical device of the present embodiment includes the anti-embolic protection device 10 of any of the above embodiments, and a delivery device for delivering the anti-embolic protection device 10 from the femoral vessel lumen into the aortic arch 40. The delivery device comprises an outer sheath and a pushing member 21 movably arranged in the outer sheath in a penetrating way, the pushing member 21 is connected with the anti-embolism protection device 10, and the pushing member 21 is used for accommodating the anti-embolism protection device 10 into the outer sheath or pushing the anti-embolism protection device 10 out of the outer sheath. When the anti-embolic protection device 10 is received within the outer sheath, the anti-embolic protection device 10 causes the outer sheath to have a curved shape.

Specifically, during delivery, the anti-embolic protection device 10 is retracted within the outer sheath, 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 target location within 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 and the pusher 21. When the procedure is completed, the anti-embolic protection device 10 is again retracted within the outer sheath by moving the outer sheath relative to the pusher 21.

Specifically, the pushing member 21 is connected to the proximal end of the filter element 13 or the proximal end of the main body 111, and the pushing member 21 is located below the main body 111 and extends out from between the first support portion 112 and the second support portion 12. Further, referring to fig. 9, the main body 111 is movably connected to the pushing member 21, and specifically, referring to fig. 6, an adaptor portion 15 is disposed on the proximal end of the main body 111, the pushing member 21 is provided with an abutting portion, and the adaptor portion 15 is rotatably connected to the abutting portion. Preferably, the adapter 15 may be a ring or an arc structure, and the docking portion may be a hook structure, so that the pushing member 21 and the main body 111 can be rotatably connected by embedding the hook in the ring or the arc structure.

Furthermore, the delivery device also comprises a connecting piece, one end of the connecting piece is fixedly connected with the pushing piece 21, and the other end of the connecting piece is rotatably connected with the near end of the supporting frame 11, so that the movement synchronism of the pushing piece 21 and the anti-embolism protection device 10 is favorably kept, the freedom degree of the supporting frame 11 is ensured, and the anti-embolism protection device 10 can more smoothly enter and exit the outer sheath tube. Preferably, the connecting member may be a metal filament or a polymer filament.

Further, the pushing member 21 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 anti-embolism protection device 10 can enter the aortic arch 40 along the guide wire pre-embedded in the aorta. In another embodiment, the pusher 21 may also be a solid rod with a certain stiffness. Preferably, the pusher 21 may be a tube or rod of stainless steel or nitinol or polymer. Further, the pusher 21 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, the distal end of the pushing member 21 includes a flexible segment, which may be a laser-engraved structure with a special pattern, such as a hypotube, and the flexible segment is located below the filter member 13 to make the distal end of the pushing member 21 have a certain flexibility, so that the pushing member 21 can freely adapt to the curvature of the blood vessel in the aortic arch 40 and fit on the upper wall of the aortic arch 40. Further, the structure of the flexible section at the distal end of the pushing member 21 is not limited to be cut directly on the tube in a spiral form, but may also be formed by splicing a spring section made by winding a wire with the tube, and the distal end of the pushing member 21 may also be pre-bent, and the curvature radius of the distal end of the pushing member 21 is a curvature radius of a general aortic arch 40 type. Preferably, the pusher 21 may be a tube or rod of stainless steel, nitinol or polymeric material.

Further, the delivery device may further comprise a handle, wherein the proximal end of the outer sheath is fixedly connected to the distal end of the handle, and the proximal end of the pushing member 21 is movably inserted through the handle and connected to the distal end of the handle, so that the outer sheath and the pushing member 21 are relatively moved by pushing and pulling the handle to release the anti-embolic protection device 10 out of the outer sheath or retract the anti-embolic protection device into the outer sheath.

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

1. An anti-embolic protection device, comprising:

the supporting frame comprises a main body part, a first supporting part connected with the far end of the main body part and a second supporting part connected with the far end of the main body part;

2. The embolic protection device of claim 1, wherein said body portion is a U-shaped frame, said body portion comprising a first end point and a second end point at distal ends, said second support portion being connected to said body portion by said first end point and said second end point.

3. The anti-embolic protection device of claim 2, wherein the first end point, the second end point, and the proximal end point of the body portion define a first plane; the second supporting part is a U-shaped frame, the first end point, the second end point and the far end point of the second supporting part define a second plane, and an included angle formed by the first plane and the second plane is 100-170 degrees.

4. The anti-embolic protection device of claim 2, wherein the first end point, the second end point, and the proximal end point of the body portion define a first plane; the first supporting part is a U-shaped frame, a third plane is defined by the middle part of the first supporting part and/or the part far away from the main body part, and the included angle formed by the third plane and the first plane after the third plane and the first plane are extended is 50-150 degrees.

5. The anti-embolic protection device of claim 1, wherein the first support portion and/or the second support portion is of unitary construction with the body portion.

6. The embolic protection device of claim 1, wherein the first support and/or the second support are connected to the body portion by a sleeve, the sleeve being disposed over a distal end of the body portion and a proximal end of the first support and/or the second support; or the far end of the main body part is connected with the near end of the first supporting part and/or the second supporting part in a laser welding mode.

7. An anti-embolic protection device as in claim 1, wherein the body portion is arched away from the first support portion.

8. The anti-embolic protection device of claim 1, wherein the circumferential length of the first support is less than or equal to the circumferential length of the second support.

9. A medical device, comprising:

an anti-embolic protection device as in any of the preceding claims 1-8; and the number of the first and second groups,

10. The medical device of claim 9, wherein the pusher is positioned below the body portion and extends out from between the first support and the second support.

11. The medical device of claim 9, wherein the pusher member is coupled to a proximal end of the filter element or a proximal end of the body portion.

12. The medical device of claim 9, wherein the distal portion of the pusher is a hypotube that is positioned below the filter.