CN217430253U

CN217430253U - Anti-embolism protection device

Info

Publication number: CN217430253U
Application number: CN202220937196.7U
Authority: CN
Inventors: 韩彬彬; 罗建方; 吴斯蔚; 李宏卫; 宋佳伟; 金巧蓉
Original assignee: Minimally Invasive Investment Holdings Ltd
Current assignee: Minimally Invasive Investment Holdings Ltd
Priority date: 2022-04-21
Filing date: 2022-04-21
Publication date: 2022-09-16
Anticipated expiration: 2032-04-21

Abstract

The utility model provides an anti embolism protection device, first from the expansion filter element compression set up in first sheath intraductally, but the flexible sheath pipe is located first sheath intraductally and stretches out from the distal end of first sheath pipe, and the second sets up in but the expansion filter element compression in the flexible sheath pipe, can release first from the expansion filter element and the second from the expansion filter element respectively through the handle to control but the at least part of first sheath pipe of flexible sheath pipe stretches out is crooked. The first self-expansion filter element and the second self-expansion filter element in the utility model have different axial positions, so that the overall external diameter of the anti-embolism protection device can be reduced, the intervention wound of a patient is small, and the release processes are mutually independent and do not interfere with each other and can be respectively released in different target arteries; meanwhile, the bendable sheath can be bent, the direction can be accurately adjusted in the aortic arch, time and labor are saved, the target artery can be accurately entered, the flexible sheath adapts to the complex physiological structure of the aortic arch, and embolic materials are prevented from entering cerebral blood vessels.

Description

Anti-embolism protection device

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to an anti embolism protection device.

Background

In some procedures involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, and aortic surgery, the instrument operation can form platelet polymers (such as thrombi, lipid droplets, bacterial clots and/or other foreign matter, tumor cells or other small tissue) or break-up and break-off atheromatous debris and debris from the arterial wall, which are transported with the blood stream into the cerebral blood circulation and other important systemic arterial systems as embolic material of the blood vessels. Embolic material entering the cerebral blood circulation can occlude small arteries leading to local cerebral vascular embolization, which has become a significant complication of cardiac and aortic surgery.

Cerebral vascular embolization can now be prevented by anti-embolic protection devices, which are typically accessed through the radial and femoral arteries, and then release the self-expanding filter element into the aortic arch. Because the aortic arch has three arteries, namely a brachiocephalic artery, a left common carotid artery and a left subclavian artery, the three arteries are at an angle and are not in the same plane, the conventional anti-embolism protection device cannot effectively adapt to the complicated physiological structure of the aortic arch, so that the self-expansion filter element cannot be attached to the wall effectively, and therefore, embolic substances cannot be prevented from entering cerebral vessels effectively.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an anti embolism protection device to solve the unable bow-shaped complicated physiological structure of aorta of effectively adapting to of current anti embolism protection device, lead to unable effectively preventing embolic material to get into brain blood vessel scheduling problem.

In order to achieve the above object, the present invention provides an anti-embolism protection device, comprising:

a first filter assembly comprising a first outer sheath and a first self-expanding filter element, the first self-expanding filter element being compressively disposed within the first outer sheath;

a second filter assembly comprising a flexible sheath positioned within the first outer sheath and extending from a distal end of the first outer sheath and a second self-expanding filter element compressively disposed within the flexible sheath; and (c) a second step of,

and the handle is connected with the first filtering component and the second filtering component and used for respectively releasing the first self-expansion filtering element and the second self-expansion filtering element and controlling at least part of the bendable sheath which can extend out of the first outer sheath to be bent.

Optionally, the proximal end of the first self-expandable filter element is connected to the outer wall of the bendable sheath, and the distal end of the first self-expandable filter element is connected to or butts against the inner wall of the first sheath.

Optionally, the first filter assembly includes a first connection tube, the first connection tube is located inside the first outer sheath tube and is capable of moving axially relative to the first outer sheath tube, the bendable sheath tube is located inside the first connection tube, the first self-expanding filter element is located at the distal end of the first connection tube, the proximal end of the first self-expanding filter element is connected to the outer wall of the first connection tube, and the distal end of the first self-expanding filter element is connected to the inner wall of the first outer sheath tube or abuts against the inner wall of the first outer sheath tube.

Optionally, the handle is attached to the proximal end of the first outer sheath for releasing the first self-expanding filter element by driving the first outer sheath to move axially relative to the first self-expanding filter element.

Optionally, the second filter assembly further includes a push rod, the push rod is located in the bendable sheath and can move axially relative to the bendable sheath, the second self-expandable filter element is connected to the push rod, and when the bendable sheath is bent, the corresponding portion of the push rod is also bent accordingly.

Optionally, the handle is connected to the proximal end of the push rod, and the push rod is driven to axially move relative to the bendable sheath to release the second self-expandable filter element.

Optionally, the pushing rod is sleeved with a proximal connecting piece and a distal connecting piece, and the proximal end and the distal end of the second self-expansion filter element are connected to the proximal connecting piece and the distal connecting piece respectively.

Optionally, the proximal end and the distal end of the second self-expanding filter element are directly connected to the proximal connector and the distal connector, respectively; alternatively, the proximal end of the second self-expanding filter element is connected to the proximal connector by a connecting wire, and the distal end of the second self-expanding filter element is directly connected to the distal connector.

Optionally, the push rod is further sleeved with two near-end limiting parts and two far-end limiting parts, the near-end connecting part is located between the two near-end limiting parts and can be opposite to the push rod in the axial direction, and the far-end connecting part is located between the two far-end limiting parts and can be opposite to the push rod in the axial direction.

Optionally, the bendable sheath includes a second connecting pipe and a second sheath pipe, the second connecting pipe is located inside the first sheath pipe, the second sheath pipe extends out from the distal end of the first sheath pipe, and the second self-expansion filter element is compressed and disposed inside the second sheath pipe.

Optionally, the outer diameter of the first outer sheath is the same as the outer diameter of the second outer sheath, and the distal end of the first outer sheath is in seamless butt joint with the proximal end of the second outer sheath.

Optionally, the outer diameter of the first outer sheath is different from the outer diameter of the second outer sheath, and the distal end of the first outer sheath is in smooth transition with the proximal end of the second outer sheath.

Optionally, the handle is attached to the proximal end of the flexible sheath for releasing the second self-expanding filter element by driving the flexible sheath to move axially relative to the first outer sheath.

Optionally, the handle is connected to the proximal end of the second connecting tube, and is configured to drive the bendable sheath to rotate along the axial direction.

Optionally, the bendable part of the bendable sheath tube has flexibility, the second filter assembly further comprises a control wire, the distal end of the control wire is connected with the distal end of the bendable part, the proximal end of the control wire is connected with the handle, and the control wire is pulled by the handle to control the bending of the bendable part of the bendable sheath tube.

Optionally, the bendable portion of the bendable sheath includes a first section and a second section that are axially connected, the first section and the second section are both flexible, and when the control wire is pulled by the handle, the first section and the second section are bent in different directions.

Optionally, the first section and the second section are both made of flexible materials, the pipe walls of the first section and the second section are both provided with a support section extending along the axial direction, the rigidity of the support section is greater than that of the rest part of the pipe walls of the first section and the second section, and the support section of the first section and the support section of the second section are different in position in the circumferential direction.

Optionally, the first section is closer to the handle than the second section, a plurality of slits distributed along the axial direction are arranged on a tube wall of the first section, positions of the slits in the circumferential direction are the same, the second section is made of a flexible material, and a connecting portion between a distal end of the control wire and a distal end of the bendable portion is not overlapped with the slits in the circumferential direction.

Optionally, the pipe walls of the first section and the second section are both provided with a plurality of slits distributed along the axial direction, the circumferential positions of each slit of the first section are the same, the circumferential positions of all slits of the second section are the same, and the slits of the first section and the slits of the second section are not overlapped in the circumferential direction.

Optionally, the control wire is located in an accommodating space between the outer wall of the pushing rod and the inner wall of the bendable sheath tube; or, the outer wall of the push rod and the accommodating space between the inner walls of the bendable sheath tubes are internally provided with control channels, and the control wires are located in the control channels.

Optionally, the open end of the first self-expanding filter element and/or the second self-expanding filter element has a section of cylindrical structure after being released.

Optionally, the first self-expansion filter element and/or the second self-expansion filter element include a filter screen and a self-expansion support frame, the open end of the filter screen is connected to the self-expansion support frame, an end of the filter screen different from the open end of the filter screen is fixed, and after the first self-expansion filter element and/or the second self-expansion filter element is released, the filter screen is supported by the self-expansion support frame.

Optionally, the first self-expanding filter element and/or the second self-expanding filter element is a partially or wholly woven stent.

Optionally, the first self-expanding filter element and/or the second self-expanding filter element is partially or wholly developable.

The utility model provides an among the anti embolism protection device, first from the compression of inflation filter element set up in first sheath intraductally, but the flexible sheath pipe is located first sheath is intraductal and follow stretch out the distal end of first sheath pipe, the second from the compression of inflation filter element set up in but in the flexible sheath, can release respectively through the handle first from inflation filter element and second from the inflation filter element to it is crooked to control but the flexible sheath pipe can stretch out the at least part of first sheath pipe. The first self-expansion filter element and the second self-expansion filter element in the utility model have different axial positions, so that the overall external diameter of the anti-embolism protection device can be reduced, the intervention wound of a patient is small, and the release processes of the first self-expansion filter element and the second self-expansion filter element are mutually independent and do not interfere with each other and can be respectively released in different target arteries; meanwhile, the bendable sheath can be bent, the direction can be accurately adjusted in the aortic arch, the flexible sheath can enter a target artery in a time-saving, labor-saving and accurate manner, the flexible sheath can adapt to the complex physiological structure of the aortic arch, and embolic substances can be effectively prevented from entering cerebral vessels; and after the anti-embolism protection device is released, less structures are left in the aortic arch, the volume is smaller, and the possibility of interference with other surgical instruments can be reduced.

Drawings

Fig. 1 is a schematic structural diagram of an anti-embolism protection device according to an embodiment of the present invention;

fig. 2 is a schematic view of the first self-expanding filter element according to an embodiment of the present invention after release;

fig. 3 is another schematic view of the first self-expanding filter element according to an embodiment of the present invention after release;

fig. 4 is a schematic view illustrating the transition portion being matched with the distal end of the first sheath according to an embodiment of the present invention;

fig. 5 is a schematic view illustrating a first sheath tube and a second sheath tube according to an embodiment of the present invention;

fig. 6a is a schematic view of the second self-expanding filter element being secured to the push rod according to an embodiment of the present invention;

fig. 6b is another schematic view of the second self-expanding filter element secured to the push rod in accordance with an embodiment of the present invention;

fig. 6c is another schematic view of the second self-expanding filter element secured to the push rod in accordance with an embodiment of the present invention;

fig. 7 is a schematic structural diagram of the second sheath according to an embodiment of the present invention;

fig. 8 is a schematic view illustrating the second sheath tube bent according to an embodiment of the present invention;

fig. 9 is a schematic view of another two types of the cutting slits according to the first embodiment of the present invention;

fig. 10a is a schematic cross-sectional view of the second sheath tube and the push rod along the radial direction according to an embodiment of the present invention

Fig. 10b is another schematic cross-sectional view of the second sheath tube and the pushing rod along the radial direction according to an embodiment of the present invention;

fig. 11 is a schematic structural view of an aortic arch according to an embodiment of the present invention;

fig. 12a to 12c are flowcharts illustrating the operation of an anti-embolism protection device according to an embodiment of the present invention;

fig. 13 is a schematic structural diagram of a first filter assembly according to a second embodiment of the present invention;

fig. 14 is a schematic view of a second embodiment of the present invention after release of a first self-expanding filter element;

wherein the reference numerals are:

10-a first filter assembly; 101-a first outer sheath; 102-a first connection pipe; 103-a first self-expanding filter element; 1031-self-expanding scaffold; 1032-a filter screen; 20-a second filter assembly; 201-bendable sheath; 211-a second connection tube; 221-a second sheath tube; 2211-first section; 2212-second segment; 2213-cutting and sewing; 2214-control wire; 2215-control the channel; 202-a push rod; 212-a proximal connector; 222-a distal connector; 213-a proximal stop; 223-a distal stop; 203-a second self-expanding filter element; 30-a pilot tip;

a-brachiocephalic trunk artery; b-left common carotid artery; c-left subclavian artery.

Detailed Description

The anti-embolism protection device and the medical apparatus provided by the invention are further described in detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention. Further, the structures illustrated in the drawings are intended to be part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently. It should be further understood that the terms "first," "second," "third," and the like in the description are used for distinguishing between various components, elements, steps, and the like, and are not intended to imply a logical or sequential relationship between various components, elements, steps, or the like, unless otherwise indicated or indicated.

In this document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not limiting, but "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, and "distal" generally refers to the end that is first introduced into the patient.

Example one

Fig. 1 is a schematic structural diagram of the anti-embolism protection device provided in this embodiment. As shown in fig. 1, the anti-embolic protection device comprises a first filter assembly 10, a second filter assembly 20, and a handle (the handle is not shown in fig. 1) connecting the first filter assembly 10 and the second filter assembly 20 for manipulating the first filter assembly 10 and the second filter assembly 20.

Specifically, in the present embodiment, the first filter assembly 10 includes a first sheath 101, a first connecting pipe 102, and a first self-expanding filter element 103. The first connecting pipe 102 and the first sheath 101 are both tubular hollow structures, the first connecting pipe 102 is located in the first sheath 101 and can move axially relative to each other, and the outer diameter of the first connecting pipe 102 is smaller than the inner diameter of the first sheath 101, so that an accommodating space is formed between the outer wall of the first connecting pipe 102 and the inner wall of the first sheath 101. Further, the first self-expanding filter element 103 is located at the distal end of the first connecting tube 102, the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the first connecting tube 102, the distal end of the first self-expanding filter element 103 is abutted against the inner wall of the first outer sheath 101 (but not connected to the inner wall of the first outer sheath 101), and the opening of the first self-expanding filter element 103 faces away from the direction of the handle.

Fig. 2 is a schematic view of the first self-expanding filter element 103 provided in this embodiment after release. In this embodiment, as shown in fig. 2, the handle is connected to the proximal end of the first sheath 101, and the handle can control the axial movement (direction shown by arrow in the figure) of the first sheath 101 relative to the first connecting tube 102, so as to release or recover the first self-expandable filter element 103. Specifically, the first outer sheath 101 moves in a direction close to the handle until the first self-expanding filter element 103 leaves the first outer sheath 101, the first self-expanding filter element 103 is released, the released first self-expanding filter element 103 is umbrella-shaped (can also be regarded as circular truncated cone-shaped), and the first self-expanding filter element 103 adheres to the wall by the radial tension of the first self-expanding filter element 103, so that the thrombus is effectively captured and prevented from escaping; similarly, the first outer sheath 101 is moved in a direction away from the handle until the first self-expanding filter element 103 enters the first outer sheath 101, and the first self-expanding filter element 103 is recovered.

Further, the first self-expanding filter element 103 may be a partially or wholly woven stent.

Specifically, referring to fig. 2, in the present embodiment, the first self-expandable filter element 103 is an integral woven stent, and after the first self-expandable filter element 103 is released, an open end (the open end refers to a distal end of the first self-expandable filter element 103) of the first self-expandable filter element has a section of cylindrical structure, so that the shape of a blood vessel can be matched more effectively, the adherence effect is better, and the effectiveness of embolic filtering is improved. Alternatively, the open end of the first self-expanding filter element 103 may have a cylindrical structure with the same outer diameter, so as to further improve the adherence effect.

Further, the first self-expandable filter element 103 can be partially developed or developed integrally, and a partial contour or an entire contour of the first self-expandable filter element 103 can be seen under a perspective device, so that the development design is more beneficial to accurately judging the position and/or adherence of the first self-expandable filter element 103 in the clinical operation process.

Based on this, the first self-expanding filter element 103 can be woven by memory developing wire materials, the memory developing wire materials can be composite wire materials of memory metal and developing materials, such as core materials of nickel-titanium alloy, and developing materials of tantalum, gold, platinum, tungsten and the like wrapped on the outer layer; the memory developing wire material can also be a composite wire material of memory metal, a developing material and a high polymer material. The first self-expanding filter element 103 may be formed by weaving a memory metal wire and a developing material wire in a mixed manner, the memory metal wire may be a nickel-titanium alloy wire, and the developing material wire may be a metal wire of tantalum, gold, platinum, tungsten, or the like. The first self-expanding filter element 103 may also be woven from a mixture of polymer filaments, memory metal filaments and developing material filaments.

The braided wire material of the first self-expanding filter element 103 can be flat wire or round wire, and the mesh size on the first self-expanding filter element 103 can be uniform or gradual; the woven mesh of the first self-expanding filter element 103 may be one or more layers and will not be described in detail herein.

Fig. 3 is another schematic view of the first self-expanding filter element 103 provided in this embodiment after release. As shown in fig. 3, as an alternative embodiment, the first self-expanding filter element 103 is a partially woven stent, which includes a self-expanding support frame 1031 and a filter mesh 1032, the self-expanding support frame 1031 is located at the distal end of the first self-expanding filter element 103, the periphery of the open end of the filter mesh 1032 (the open end refers to the distal end of the filter mesh 1032) is attached to the self-expanding support frame 1031, and the end of the filter mesh 2032 different from the open end thereof (the end different from the open end thereof refers to the proximal end of the filter mesh 1032) can be connected to the first connection tube 102 to achieve fixation. The self-expanding support frame 1031 is made of a memory material, when the first self-expanding filter element 103 is compressed in the first sheath 101, the self-expanding support frame 1031 is also compressed, and when the first self-expanding filter element 103 is released, the self-expanding support frame 1031 returns to adhere to the wall in a natural state, thereby providing support for the filter mesh 1032.

Further, the filtering net 1032 can be made by laser drilling of a membrane material or weaving of a wire material, the membrane material can be a polymer material (PU) or the like, and the weaving wire material can be a metal material (nickel titanium, stainless steel or the like) or a polymer material (PEEK) or the like. The knitting yarn may be flat yarn or round yarn, and the mesh size on the filtering net 2032 may be uniform or gradually changed, which is not described in detail herein.

With continued reference to fig. 1, the second filter assembly 20 includes a flexible sheath 201 and a second self-expanding filter element 203. The bendable sheath 201 comprises a second connecting pipe 211 and a second sheath 221 which are axially connected, and the second connecting pipe 211 and the second sheath 221 are both tubular hollow structures. Further, the second connection pipe 211 is located inside the first sheath 101, and the second connection pipe 211 also passes through the first self-expanding filter element 103 and protrudes into the first connection pipe 102; the proximal end of the second sheath 221 is connected to the distal end of the second connection tube 211, the second sheath 221 extends from the distal end of the first sheath 101, and the second self-expanding filter element 203 is compressed and disposed in the second sheath 221.

In this embodiment, the second connection pipe 211 and the second sheath pipe 221 are coaxially disposed, the inner diameter of the second sheath pipe 221 is larger than the inner diameter of the second connection pipe 211, the outer diameter of the second sheath pipe 221 is larger than the outer diameter of the second connection pipe 211, the second self-expansion filter element 203 is compressed and disposed in the second sheath pipe 221, and the first self-expansion filter element 103 and the second self-expansion filter element 203 are axially misaligned (the first self-expansion filter element 103 and the second self-expansion filter element 203 are different in position in the axial direction), so that the overall outer diameter of the anti-embolism protection apparatus can be reduced.

It should be understood that the inner diameter of the second outer sheath 221 may also be equal to the inner diameter of the second connection pipe 211, or the outer diameter of the second outer sheath 221 may also be equal to the outer diameter of the second connection pipe 211, and therefore, redundant description is not repeated herein.

In this embodiment, the second connection tube 211 and the second sheath tube 221 are separate structures, for example, the inner wall of the proximal end of the second sheath tube 221 and the outer wall of the distal end of the second connection tube 211 may be bonded together; however, it should be understood that the second connection tube 211 and the second sheath tube 221 may be a single body structure.

Referring to fig. 1, in the present embodiment, the outer diameter of the second outer sheath 221 is equal to the outer diameter of the first outer sheath 101, but since the outer diameter of the second outer sheath 221 is larger than the outer diameter of the second connecting pipe 211, the second outer sheath 221 may have a transition portion that is connected to the second connecting pipe 211, the transition portion may be arc-shaped, and the inner wall of the distal end of the first outer sheath 101 may also be arc-shaped, so that the transition portion may be matched with the distal end of the first outer sheath 101. Fig. 4 is a schematic view of the transition portion being matched with the distal end of the first outer sheath 101 according to this embodiment, and as shown in fig. 4, when the first outer sheath 101 is butted with the second outer sheath 221, the inner wall of the distal end of the first outer sheath 101 may be matched with the shape of the transition portion, so that the distal end of the first outer sheath 101 and the proximal end of the second outer sheath 221 may smoothly transition without steps, and may achieve a gap-free matching in both radial and axial directions, and the anti-embolism protection apparatus may not cause additional damage to the patient during the course of the internal diameter of the patient; moreover, since the outer diameter of the second outer sheath 221 is equal to the outer diameter of the first outer sheath 101, the size design space of the second self-expanding filter element 203 is larger, and more blood vessel sizes can be adapted.

Fig. 5 is a schematic diagram of the first sheath 101 and the second sheath 221 provided in this embodiment. As shown in fig. 5, as an alternative embodiment, the second sheath 221 may also have no transition portion interfacing with the second connection tube 211, and an outer wall of a proximal end of the second sheath 221 is a right angle. In this way, when the first outer sheath 101 and the second outer sheath 221 are butted, the first outer sheath 101 and the second outer sheath 221 can be matched without gaps in the radial direction and the axial direction.

Certainly, the first outer sheath 101 and the second outer sheath 221 do not necessarily need to be in seamless butt joint in the axial direction, and a certain distance in the axial direction between the two does not affect the implementation of the present invention; the outer diameter of the first sheath may be different from the outer diameter of the second sheath, as long as the distal end of the first sheath and the proximal end of the second sheath are smoothly transitioned.

With continued reference to fig. 1, the second filter assembly 20 further includes a push rod 202, the push rod 202 being configured to secure the second self-expanding filter element 203. The push rod 202 is located in the bendable sheath 201 and can move axially relative to the bendable sheath, the proximal end of the push rod 202 passes through the second connecting tube 211 and is connected to the handle, the distal end of the push rod 202 extends out of the second sheath 221 and is connected to a guide tip 30, and the second self-expanding filter element 203 is fixed on the push rod 202 in the second sheath 221.

Fig. 6a is a schematic view of the second self-expanding filter element 203 provided in this embodiment being fixed to the push rod 202. As shown in fig. 6a, the proximal and distal ends of the second self-expanding filter element 203 are secured to the push rod 202 by proximal and

distal connectors

212 and 222, respectively, with the opening of the second self-expanding filter element 203 facing in the direction of the handle.

In this embodiment, the proximal connector 212 and the distal connector 222 are annular cylindrical structures, the proximal connector 212 and the distal connector 222 are sleeved on the outer wall of the pushing rod 202, and the proximal end and the distal end of the second self-expanding filter element 203 can be connected to the outer walls of the proximal connector 212 and the distal connector 222, respectively.

Fig. 6b is another schematic view of the second self-expanding filter element 203 provided in this embodiment secured to the push rod 202. As an alternative embodiment, as shown in FIG. 6b, the proximal end of the second self-expanding filter element 203 may be connected to the proximal connector 212 by a connecting wire, while the distal end of the second self-expanding filter element 203 remains connected to the outer wall of the distal connector 222. In this way, the connecting wire can guide the second self-expanding filter element 203 into the sheath smoothly, and the volume of the second self-expanding filter element 203 can be effectively reduced.

Fig. 6c is another schematic view of the second self-expanding filter element 203 provided in this embodiment being fixed to the push rod 202. As shown in fig. 6c, as an alternative embodiment, on the basis of fig. 6a or fig. 6b, two proximal end limiting members 213 and two distal end limiting members 223 may be further sleeved on the pushing rod 202. A certain distance is provided between the two proximal limiting members 213 in the axial direction, the proximal connecting member 212 is located between the two proximal limiting members 213, a certain distance is provided between the two distal limiting members 223 in the axial direction, and the distal connecting member 222 is located between the two distal limiting members 223. Further, the inner diameters of the proximal connector 212 and the distal stopper 223 are both larger than the outer diameter of the pushing rod 202, the proximal connector 212 and the distal stopper 223 can both slide relative to the pushing rod 202, the two proximal stoppers 213 can limit the sliding range of the proximal connector 212 relative to the pushing rod 202, and the two distal stoppers 223 can limit the sliding range of the distal connector 222 relative to the pushing rod 202. As such, when the push rod 202 moves axially within a certain range, the second self-expanding filter element 203 will not be displaced, which improves the stability of the second self-expanding filter element 203 and improves the usability of the product.

With continued reference to fig. 1, the guiding tip 30 is located at the distal end of the second sheath 221 and connected to the distal end of the pushing rod 202, and the guiding tip 30 is used to guide the entire anti-embolic protection device to move in the body of the patient. In this embodiment, the guide tip 30 may be made of a flexible material to prevent additional trauma to the patient.

In this embodiment, the proximal end of the push rod 202 may be connected to the handle, and the handle controls the axial movement of the push rod 202 relative to the bendable sheath 201, and the second self-expanding filter element 203 and the guide tip 30 are simultaneously moved axially, thereby releasing or recovering the second self-expanding filter element 203. Specifically, when the pushing rod 202 moves in a direction away from the handle, the second self-expanding filter element 203 and the guide tip 30 move synchronously in the direction away from the handle until the second self-expanding filter element 203 leaves the second sheath tube 221, the second self-expanding filter element 203 is released, and the released second self-expanding filter element 203 is umbrella-shaped and adheres to the wall by the radial tension of the second self-expanding filter element 203, so that the thrombus is effectively captured and prevented from escaping; similarly, when the push rod 202 moves in a direction close to the handle, the second self-expanding filter element 203 and the guide tip 30 are simultaneously moved in a direction close to the handle until the second self-expanding filter element 203 enters the second sheath tube 221, and the second self-expanding filter element 203 is recovered.

As an alternative embodiment, the handle does not need to release the second self-expandable filter element 203 by manipulating the push rod 202, for example, the handle may be connected to the proximal end of the second connection tube 211, and the handle controls the flexible sheath 201 to move axially relative to the first sheath 101 through the proximal end of the second connection tube 211 (the second connection tube 211 and the second sheath 221 move axially in synchronization), thereby releasing or recovering the second self-expandable filter element 203. Specifically, when the bendable sheath 201 moves in a direction close to the handle, the pushing rod 202 does not move until the second self-expandable filter element 203 leaves the second sheath 221, the second self-expandable filter element 203 is released, and the released second self-expandable filter element 203 is umbrella-shaped and adheres to the wall by the radial tension of the second self-expandable filter element 203, so that the thrombus is effectively captured and prevented from escaping; similarly, when the bendable sheath 201 is moved in a direction away from the handle, the push rod 202 is not moved until the second self-expanding filter element 203 enters the second sheath 221, and the second self-expanding filter element 203 is retracted. It should be understood that this solution requires a certain gap to be reserved between the first sheath 101 and the second sheath 221 in the axial direction, and if the first sheath 101 and the second sheath 221 are seamless in the axial direction, the first self-expanding filter element 103 needs to be released first, so that a certain gap is reserved between the first sheath 101 and the second sheath 221, and then the second self-expanding filter element 203 needs to be released.

It should be understood that the specific structure and released shape of the second self-expanding filter element 203 in this embodiment can refer to the specific structure and released shape of the first self-expanding filter element 103 in fig. 2 or 3, but it should be noted that the opening direction of the second self-expanding filter element 203 and the first self-expanding filter element 103 should be opposite, and therefore, the description is not given here.

Alternatively, the second self-expanding filter element 203 may be a partially or wholly woven stent, and the second self-expanding filter element 203 may also be partially or wholly developed.

Further, the handle can also control at least part of the bendable sheath 201 which can be extended out of the first outer sheath 101 to be bent, so that the orientations of the bendable sheath 201 and the guide tip 30 can be adjusted, the direction can be accurately adjusted in the aortic arch, the time and labor can be saved, the target artery can be accurately entered, and the complex physiological structure of the aortic arch can be adapted. It is to be understood that although the second connection pipe 211 is described as being positioned inside the first outer sheath 101 and the second outer sheath 221 is extended from the distal end of the first outer sheath 101, it is understood that when the first self-expandable filter element 103 is released, the second connection pipe 211 is partially extended from the distal end of the first outer sheath 101 since the first outer sheath 101 is moved in a direction close to the handle. Therefore, the bendable portion of the bendable sheath 201 is not limited to be located only on the second sheath 221, and may be located on the second connection pipe 211, or both the second sheath 221 and the second connection pipe 211. For convenience of description, the bendable portion of the bendable sheath 201 will be described in detail below by taking the second sheath 221 as an example of the bendable portion of the bendable sheath 201 (i.e., the second sheath 221 is bendable as a whole).

Fig. 7 is a schematic structural diagram of the second sheath 221 provided in this embodiment. As shown in fig. 7, in this embodiment, the second sheath 221 may be integrally divided into two axially connected segments, namely a first segment 2211 and a second segment 2212, wherein the first segment 2211 is closer to the handle than the second segment 2212. The first segment 2211 has a plurality of slits 2213 axially arranged on the tube wall, and the position and length of each slit 2213 in the circumferential direction are the same, so that the first segment 2211 has flexibility and can be bent in one direction. Further, the second segment 2212 is made of a flexible material, has flexibility, and can be bent at will, and the flexible material may be, for example, a flexible polymer material, such as PVC (polyvinyl chloride), K resin, or the like. A proximal end of the manipulation wire 2214 is connected to the handle, a distal end is connected to a distal end of the second segment 2212, and a connection portion of the distal end of the manipulation wire 2214 to the distal end of the second segment 2212 is circumferentially non-overlapping with the slit 2213, thereby ensuring that the first segment 2211 and the second segment 2212 can bend in different directions when the manipulation wire 2214 is pulled (when the connection portion of the distal end of the manipulation wire 2214 to the distal end of the second segment 2212 is circumferentially overlapping with the slit 2213, the bending directions of the first segment 2211 and the second segment 2212 are the same when the manipulation wire 2214 is pulled).

Fig. 8 is a schematic view of the second sheath 221 provided in this embodiment when it is bent. As shown in fig. 8, when the control wire 2214 is pulled by the handle, since the connection portion of the distal end of the control wire 2214 and the distal end of the second segment 2212 is not overlapped with the slit 2213 in the circumferential direction, the first segment 2211 and the second segment 2212 of the second sheath tube 221 are bent in opposite directions, so that the anti-embolic protection device can be flexibly bent during the course of the approach to better adapt to the complex physiological structure of the aortic arch.

Alternatively, the slits 2213 may or may not extend through the wall of the first segment 2211, but only extend into the wall of the first segment 2211. In addition, in order to secure the structural strength of the second sheath 221, the length of the slit 2213 in the circumferential direction should not exceed 4/5 of the circumference of the first segment 2211.

In this embodiment, the slits 2213 are in a strip shape, but not limited thereto, and fig. 9 is a schematic diagram of another two kinds of slits 2213 provided in this embodiment. As shown in fig. 9, the slits 2213 may have other shapes such as an i-shape or a V-shape, and the shape of the slits 2213 may be designed to improve the pressure-bearing capacity of the first segment 2211 during bending, which will not be explained herein.

As an alternative, the first segment 2211 and the second segment 2212 can be made of a flexible material, such as the above-mentioned flexible polymer material, the tube wall of the first segment 2211 and the second segment 2212 has a supporting segment extending along the axial direction, the rigidity of the supporting segment is greater than that of the rest of the tube wall of the first segment 2211 and the second segment 2212, and the supporting segments of the first segment 2211 and the second segment 2212 are different in position in the circumferential direction. As such, when the control wire 2214 is pulled by the handle, other portions of the tube wall of the first segment 2211 and the second segment 2212 may deform before the support segment due to the higher rigidity of the support segment of the first segment 2211 and the second segment 2212, forming a bending in a fixed direction, and the bending directions of the first segment 2211 and the second segment 2212 may also be different due to the different positions of the support segments of the first segment 2211 and the second segment 2212 in the circumferential direction.

As an alternative embodiment, the second sheath 221 may be made of a flexible material, such that the distal end of the control wire 2214 is connected to the distal end of the second sheath 221, the proximal end of the control wire 2214 is connected to the handle, and the second sheath 221 may be controlled to bend in one direction by pulling the control wire 2214 through the handle.

As an alternative embodiment, a plurality of slits 2213 distributed along the axial direction may be disposed on the tube wall of the first segment 2211 and the second segment 2212, the position and size of each slit 2213 of the first segment 2211 in the circumferential direction are the same, the position of each slit 2213 of the second segment 2212 in the circumferential direction is the same, and the slits 2213 of the first segment 2211 and the slits 2213 of the second segment 2212 do not overlap in the circumferential direction. The direction of bending of the first and

second segments

2211 and 2212 may also be different when the control wire 2214 is pulled by the handle.

It can be understood that, since the pushing rod 202 is disposed through the bendable sheath 201, a portion of the pushing rod 202 corresponding to the bendable portion of the bendable sheath 201 should also be bendable, and when the bendable portion of the bendable sheath 201 is bent, a corresponding portion of the pushing rod 202 is also bent accordingly.

Fig. 10a is a schematic cross-sectional view of the second sheath 221 and the push rod 202 provided in this embodiment along the radial direction. As an alternative embodiment, as shown in fig. 10a, the control wire 2214 can directly pass through the region between the inner wall of the second sheath 221 and the outer wall of the push rod 202 to connect with the handle, so that the push rod 202 has a larger radial movement space.

Fig. 10b is another schematic cross-sectional view of the second sheath 221 and the push rod 202 provided in this embodiment along the radial direction. As shown in fig. 10b, as an alternative embodiment, a manipulation channel 2215 may be disposed in a receiving space between an inner wall of the second sheath tube 221 and an outer wall of the push rod 202, and the manipulation wire 2214 passes through the manipulation channel 2215 to be connected to the handle, so that the manipulation wire 2214 and the push rod 202 do not interfere with each other.

It is understood that the manipulation wire 2214 in fig. 10a and 10b is a flat wire, but not limited thereto, and the manipulation wire 2214 may be a round wire or a wire with other shapes.

Further, when the handle can be connected to the proximal end of the second connection tube 211, the handle can further control the bendable sheath 201 to rotate in the axial direction, for example, control the bendable sheath 201 to rotate 360 degrees in the axial direction, so as to better change the orientation of the bendable sheath 201.

Referring to fig. 1, in the present embodiment, the first outer sheath 101 and the second outer sheath 221 may be polymer sheaths, for example, made of polymer materials such as Pebax (polyether block polyamide), and structures such as a metal braid or a metal spring may be disposed in the tube walls of the first outer sheath 101 and the second outer sheath 221 for composite reinforcement to improve tensile or bending resistance; the second connection tube 211, the first connection tube 102 and the push rod 202 may be made of a material with good biocompatibility, such as polymer material such as PA (nylon), PC (polycarbonate) and POM (polyoxymethylene), or metal material such as stainless steel and nickel titanium.

Fig. 11 is a schematic structural diagram of an aortic arch according to this embodiment. As shown in fig. 11, the aortic arch has three arteries, namely, a brachiocephalic artery a, a left common carotid artery b and a left subclavian artery c, and next, the present embodiment will be described by taking as an example that the anti-embolic protection device enters the aortic arch from the radial artery via the brachiocephalic artery a and releases the first self-expandable filter element 103 and the second self-expandable filter element 203 at the brachiocephalic artery a and the left common carotid artery b, respectively. It should be understood, however, that the present invention is not limited thereto, and that the anti-embolic protection device may also enter the aortic arch via the left subclavian artery c and release the first and second self-expanding

filter elements

103 and 203 at the left subclavian artery c and the left common carotid artery b, respectively; of course, the present invention is not limited to the first self-expandable filter element 103 and the second self-expandable filter element 203 being released at the brachiocephalic trunk artery a and the left common carotid artery b or at the left subclavian artery c and the left common carotid artery b, respectively, and also being released at the brachiocephalic trunk artery a and the left subclavian artery c, respectively.

Fig. 12a to 12c are flowcharts illustrating the operation of the anti-embolism protection device according to the present embodiment. As shown in fig. 12a, the anti-embolic protection device is advanced to the brachiocephalic trunk a, where a portion of the second sheath 221 enters the aortic arch. As shown in fig. 12b, the first sheath 101 is controlled by the handle to move in a direction close to the handle, and the first self-expandable filter element 103 is released at the brachiocephalic trunk a. As shown in fig. 12c, the second sheath 221 is rotated and bent by the handle until the guide tip 30 is aligned with the entrance of the left common carotid artery b, and then a portion of the second sheath 221 is delivered to the left common carotid artery b. As shown in fig. 12d, the second sheath 221 is controlled by the handle to move in a direction close to the handle (or the pushing rod 202 is controlled to move in a direction away from the handle), and the second self-expanding filter element 203 is released at the left common carotid artery b.

Optionally, the second connection tube 211, the first connection tube 102 and the pushing rod 202 between the first self-expandable filter element 103 and the handle may be designed with a detachable structure, after the first self-expandable filter element 103 and the second self-expandable filter element 203 are released, the second connection tube 211, the first connection tube 102 and the pushing rod 202 are detached from the rest, so that less structure is left in the aortic arch, and the possibility of interference with other surgical instruments can be reduced.

It should be understood that although the first self-expanding filter element 103 is released first and the second self-expanding filter element 203 is released later in fig. 12 a-12 c, in practice the second self-expanding filter element 203 may be released first and the first self-expanding filter element 103 released second.

Example two

Fig. 13 is a schematic structural diagram of the first filter assembly provided in this embodiment. As shown in fig. 13, the difference from the first embodiment is that in the present embodiment, the proximal end of the first self-expandable filter element 103 is connected to the outer wall of the first connecting tube 102, and the distal end of the first self-expandable filter element 103 is connected to the inner wall of the first outer sheath 101.

Fig. 14 is a schematic view of the first self-expanding filter element 103 provided in this embodiment after release. As shown in fig. 14, when the first sheath 101 moves in a direction close to the handle, since the distal end of the first self-expandable filter element 103 is connected to the inner wall of the first sheath 101, the first sheath 101 pulls the distal end of the first self-expandable filter element 103 until one part of the first self-expandable filter element 103 is folded back and the other part is folded, the first self-expandable filter element 103 is released, the released first self-expandable filter element 103 is umbrella-shaped (may also be regarded as circular truncated cone-shaped), and the opening of the first self-expandable filter element 103 faces away from the handle.

EXAMPLE III

The difference between the first and second embodiments is that, in the present embodiment, the first filter assembly 10 does not include the first connection pipe, and the first self-expansion filter element 103 is compressed and disposed in the receiving space between the second connection pipe 211 and the first sheath 101.

As an alternative embodiment, the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the second connection tube 211, and the distal end of the first self-expanding filter element 103 is abutted against the inner wall of the first outer sheath 101 (but not connected to the inner wall of the first outer sheath 101), and the releasing process and releasing configuration of the first self-expanding filter element 103 can be referred to fig. 2.

As an alternative embodiment, the proximal end of the first self-expandable filter element 103 is connected to the outer wall of the second connection tube 211, and the distal end of the first self-expandable filter element 103 is connected to the inner wall of the first sheath 101, and the releasing process and releasing configuration of the first self-expandable filter element 103 can refer to fig. 14.

Compared with the first and second embodiments, this embodiment omits the first connection tube, has a simpler structure, and can reduce the outer diameter of the first outer sheath 101.

It is to be understood that the "axial direction" referred to herein is a direction along the center line of the first outer sheath (or the bendable sheath), the "radial direction" referred to herein is a direction perpendicular to the "axial direction", and the "circumferential direction" referred to herein is a circumferential direction that surrounds the first outer sheath (or the bendable sheath) once.

In summary, in the anti-embolism protection device provided by the embodiment of the present invention, the first self-expandable filter element is compressed and disposed inside the first outer sheath, the bendable sheath is located inside the first outer sheath and extends from the distal end of the first outer sheath, the second self-expandable filter element is compressed and disposed inside the bendable sheath, the first self-expandable filter element and the second self-expandable filter element can be respectively released through the handle, and the bendable sheath is controlled to stretch out of at least part of the first outer sheath. The first self-expansion filter element and the second self-expansion filter element in the utility model have different axial positions, so that the overall external diameter of the anti-embolism protection device can be reduced, the intervention wound of a patient is small, and the release processes of the first self-expansion filter element and the second self-expansion filter element are mutually independent and do not interfere with each other and can be respectively released in different target arteries; meanwhile, the bendable sheath can be bent, the direction can be accurately adjusted in the aortic arch, the flexible sheath can enter a target artery in a time-saving, labor-saving and accurate manner, the flexible sheath can adapt to the complex physiological structure of the aortic arch, and embolic substances can be effectively prevented from entering cerebral vessels; and after the anti-embolism protection device is released, the structure left in the aortic arch is less, the volume is smaller, and the possibility of interference with other surgical instruments can be reduced.

It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments may be referred to each other. For the system disclosed by the embodiment, the description is relatively simple because the system corresponds to the method disclosed by the embodiment, and the relevant points can be referred to the method part for description.

It should be noted that, although the present invention has been described with reference to the preferred embodiments, the above-mentioned embodiments are not intended to limit the present invention. To anyone skilled in the art, without departing from the scope of the present invention, the technical solution disclosed above can be used to make many possible variations and modifications to the technical solution of the present invention, or to modify equivalent embodiments with equivalent variations. Therefore, any simple modification, equivalent change and modification made to the above embodiments by the technical entity of the present invention all still belong to the protection scope of the technical solution of the present invention, where the technical entity does not depart from the content of the technical solution of the present invention.

It should be further understood that the terms "first," "second," "third," and the like in the description are used for distinguishing between various components, elements, steps, and the like, and are not intended to imply a logical or sequential relationship between various components, elements, steps, or the like, unless otherwise indicated or indicated.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood to have the definition of a logical "or" rather than the definition of a logical "exclusive or" unless the context clearly dictates otherwise. Further, implementation of the methods and/or apparatus of embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. An anti-embolic protection device, comprising:

a second filter assembly comprising a flexible sheath positioned within the first outer sheath and extending distally from the first outer sheath, and a second self-inflating filter element compressively disposed within the flexible sheath; and the number of the first and second groups,

2. The embolic protection device of claim 1, wherein the proximal end of the first self-expanding filter element is attached to the outer wall of the bendable sheath, and the distal end of the first self-expanding filter element is attached to or against the inner wall of the first sheath.

3. The anti-embolic protection device of claim 1, wherein the first filter assembly comprises a first connection tube positioned within the first outer sheath and axially movable relative thereto, the bendable sheath is positioned within the first connection tube, the first self-expanding filter element is positioned at a distal end of the first connection tube, and a proximal end of the first self-expanding filter element is connected to an outer wall of the first connection tube, and a distal end of the first self-expanding filter element is connected to or against an inner wall of the first outer sheath.

4. The anti-embolic protection device of any of claims 1-3, wherein the handle is attached to the proximal end of the first outer sheath and releases the first self-expanding filter element by driving the first outer sheath to move axially relative to the first self-expanding filter element.

5. An embolic protection device as in claim 1, wherein the second filter assembly further comprises a push rod disposed within the flexible sheath and axially movable relative to each other, the second self-expanding filter element being connected to the push rod, and wherein upon bending of the flexible sheath, a corresponding portion of the push rod is bent.

6. The embolic protection device of claim 5, wherein said handle is connected to a proximal end of said pusher rod for releasing said second self-expanding filter element by driving said pusher rod to move axially relative to said flexible sheath.

7. The embolic protection device of claim 5, wherein said push rod sheath is provided with a proximal connector and a distal connector, and wherein said second self-expanding filter element is attached at its proximal end and distal end to said proximal connector and said distal connector, respectively.

8. The anti-embolic protection device of claim 7, wherein the proximal and distal ends of the second self-expanding filter element are directly connected to the proximal connector and the distal connector, respectively; alternatively, the proximal end of the second self-expanding filter element is connected to the proximal connector by a connecting wire, and the distal end of the second self-expanding filter element is directly connected to the distal connector.

9. The embolic protection device of claim 7 or 8, wherein said pushing rod is further sleeved with two proximal stoppers and two distal stoppers, said proximal connector is located between said two proximal stoppers and is capable of moving axially relative to said pushing rod, and said distal connector is located between said two distal stoppers and is capable of moving axially relative to said pushing rod.

10. The embolic protection device of claim 1, wherein said flexible sheath comprises a second connecting tube axially connected to a second outer sheath, said second connecting tube being disposed within said first outer sheath, said second outer sheath extending from a distal end of said first outer sheath, said second self-expanding filter element being compressively disposed within said second outer sheath.

11. The embolic protection device of claim 10, wherein the first outer sheath has the same outer diameter as the second outer sheath, and wherein the distal end of the first outer sheath seamlessly interfaces with the proximal end of the second outer sheath.

12. The anti-embolic protection device of claim 10, wherein the first outer sheath has a different outer diameter than the second outer sheath, and wherein the distal end of the first outer sheath smoothly transitions with the proximal end of the second outer sheath.

13. The anti-embolic protection device of any of claims 1, 5, 7, 8, 10, 11, 12, wherein the handle is attached to the proximal end of the bendable sheath for releasing the second self-expanding filter element by driving the bendable sheath to move axially relative to the first outer sheath tube.

14. An anti-embolic protection device as in any of claims 1, 5, 7, 8, 10, 11, 12, wherein the handle is connected to the proximal end of the bendable sheath for driving the bendable sheath to rotate in an axial direction.

15. The embolic protection device of claim 5, wherein the bendable portion of the bendable sheath is flexible, the second filter assembly further comprising a steering wire, a distal end of the steering wire being connected to a distal end of the bendable portion, a proximal end of the steering wire being connected to the handle, the steering wire being pulled by the handle to control the bending of the bendable portion of the bendable sheath.

16. The embolic protection device of claim 15, wherein the bendable portion of the bendable sheath comprises first and second segments axially connected, each of the first and second segments having flexibility, the first and second segments bending in different directions when the steering wire is pulled by the handle.

17. An anti-embolic protection device as in claim 16, wherein the first and second sections are each made of a flexible material, the tube walls of the first and second sections each have an axially extending support section having a stiffness greater than the remaining portion of the tube walls of the first and second sections, and the support sections of the first and second sections are circumferentially differently located.

18. The embolic protection device of claim 16, wherein the first section is closer to the handle than the second section, the first section has a plurality of slits axially disposed on the wall of the first section, all of the slits are circumferentially located at the same position, the second section is made of a flexible material, and the connecting portion of the distal end of the steering wire and the distal end of the bendable portion does not circumferentially overlap with the slits.

19. An embolic protection device as in claim 16, wherein the first and second segments each have slits formed in the wall of the tube, the slits of the first segment having the same circumferential location and the slits of the second segment having the same circumferential location, the slits of the first segment and the slits of the second segment not overlapping in the circumferential direction.

20. The anti-embolic protection device of any of claims 15-19, wherein the steering wire is located in the accommodation space between the outer wall of the push rod and the inner wall of the bendable sheath; or, the outer wall of the push rod and the accommodating space between the inner walls of the bendable sheath tubes are internally provided with control channels, and the control wires are located in the control channels.

21. An anti-embolic protection device as in claim 1, wherein the open end has a segment of a cylindrical structure after the first self-expanding filter element and/or the second self-expanding filter element is released.

22. The embolic protection device of claim 1, wherein the first and/or second self-expanding filter elements comprise a filter mesh and a self-expanding support frame, wherein an open end of the filter mesh is connected to the self-expanding support frame, wherein an end of the filter mesh other than the open end of the filter mesh is fixed, and wherein the self-expanding support frame supports the filter mesh after the first and/or second self-expanding filter elements are released.

23. An embolic protection device as in claim 1, wherein the first self-expanding filter element and/or the second self-expanding filter element is a partially or wholly woven stent.

24. An anti-embolic protection device as in claim 1 or 23, wherein the first self-expanding filter element and/or the second self-expanding filter element is partially or entirely developable.