CN116965970A - Anti-embolic protection device - Google Patents

Abstract

The invention provides an anti-embolism protection device. The first self-expanding filter element is compressed and arranged in the first outer sheath tube. The bendable sheath tube is located in the first outer sheath tube and extends from the distal end of the first outer sheath tube. The third The two self-expanding filter elements are compressed and arranged in the flexible sheath tube. The first self-expanding filter element and the second self-expanding filter element can be released respectively through the handle, and the flexible sheath tube can be controlled to extend out of at least part of the first outer sheath tube. . The first self-expanding filter element and the second self-expanding filter element in the present invention have different axial positions, which can reduce the overall outer diameter of the anti-embolism protection device, make the patient's intervention wound small, and the release processes are independent of each other. The interference can be released separately in different target arteries; at the same time, the flexible sheath can be bent and can accurately adjust the direction in the aortic arch, saving time and effort, accurately entering the target artery, adapting to the complex physiological structure of the aortic arch, and preventing embolic materials from entering the brain. blood vessels.

Description

Anti-embolic protection device

Technical field

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

Background technique

Some surgeries involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional heart surgery, and aortic surgery, may form platelet aggregates (such as thrombus, grease droplets, bacterial coagulation) during instrument operation. and/or other foreign bodies, tumor cells or other small pieces of tissue) or broken off from the arterial wall, atherosclerotic fragments and debris. These materials are transported with the blood flow into the cerebral blood circulation and other important systemic arterial systems and become Substances that clog blood vessels. Embolic materials entering the cerebral blood circulation will block small arteries and cause local cerebral vascular embolism. Cerebral vascular embolism has become an important complication of heart and aortic surgery.

Cerebral vascular embolism can currently be prevented by anti-embolic protection devices, usually through radial and femoral artery access, followed by release of self-expanding filter elements into the aortic arch. Since the aortic arch has three arteries: the brachiocephalic trunk artery, the left common carotid artery, and the left subclavian artery. There are angles between the three arteries and they are not on the same plane. Current anti-embolism protection devices cannot effectively adapt to the complex physiological structure of the aortic arch. As a result, the self-expanding filter element cannot effectively adhere to the wall and cannot effectively prevent embolic materials from entering the brain blood vessels. If the size of the self-expanding filter element is increased, the outer diameter of the overall system will be increased, which will increase the patient's interventional wound and remain in the aortic arch. Excessive size of structures such as self-expanding filter elements may also interfere with other surgical instruments (such as TAVI (aortic valve replacement) instruments).

Contents of the invention

The purpose of the present invention is to provide an anti-embolism protection device to solve the problem that the existing anti-embolism protection device cannot effectively adapt to the complex physiological structure of the aortic arch, resulting in the inability to effectively prevent embolic materials from entering the brain blood vessels.

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

The first filter assembly includes a first outer sheath tube and a first self-expanding filter element. The first self-expanding filter element is compressed and arranged in the first outer sheath tube;

The second filter assembly includes a bendable sheath tube and a second self-expanding filter element. The bendable sheath tube is located in the first outer sheath tube and extends from the distal end of the first outer sheath tube. Two self-expanding filter elements are compressed and arranged in the flexible sheath; and,

A handle, connected to the first filter component and the second filter component, used to release the first self-expanding filter element and the second self-expanding filter element respectively, and to control the extension of the bendable sheath tube At least part of the first outer sheath is curved.

Optionally, the proximal end of the first self-expanding filter element is connected to the outer wall of the flexible sheath, and the distal end of the first self-expanding filter element is connected to the inner wall of the first outer sheath or against the The inner wall of the first outer sheath.

Optionally, the first filter assembly includes a first connecting tube, the first connecting tube is located in the first outer sheath tube and the two can move axially relative to each other, and the bendable sheath tube is located in the first outer sheath tube. In the connecting pipe, the first self-expanding filter element is located at the distal end of the first connecting pipe, and the proximal end of the first self-expanding filter element is connected to the outer wall of the first connecting pipe, and the first self-expanding filter element The distal end of the filter element is connected to the inner wall of the first outer sheath tube or against the inner wall of the first outer sheath tube.

Optionally, the handle is connected to the proximal end of the first outer sheath, and the first self-expanding filter element is released 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 the two can move axially relative to each other, and the second self-expanding filter element is connected to the push rod, so When the bendable sheath tube bends, the corresponding part of the push rod also bends.

Optionally, the handle is connected to the proximal end of the push rod, and the second self-expanding filter element is released by driving the push rod to move axially relative to the bendable sheath.

Optionally, the push rod outer cover is provided with a proximal connector and a distal connector, and the proximal and distal ends of the second self-expanding filter element are respectively connected to the proximal connector and the distal connector. on the piece.

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; or, the proximal end of the second self-expanding filter element The proximal connecting piece is connected through a connecting wire, and the distal end of the second self-expanding filter element is directly connected to the distal connecting piece.

Optionally, the push rod is also equipped with two proximal end limiters and two distal end limiters, and the proximal connecting piece is located between the two proximal end limiters and can be opposite to each other. The push rod moves axially, and the distal connecting piece is located between the two distal limiting parts and can move axially relative to the push rod.

Optionally, the flexible sheath tube includes a second connecting tube and a second outer sheath tube that are axially connected. The second connecting tube is located in the first outer sheath tube, and the second outer sheath tube is connected from the second outer sheath tube. The distal end of the first outer sheath extends out, and the second self-expanding filter element is compressed and arranged in the second outer sheath.

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 not in contact with the proximal end of the second outer sheath. seam butt joint.

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 and the proximal end of the second outer sheath smoothly transition. .

Optionally, the handle is connected to the proximal end of the flexible sheath, and the second self-expanding filter element is released 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 used to drive the flexible sheath tube to rotate in the axial direction.

Optionally, the bendable portion of the bendable sheath is flexible, and the second filter assembly further includes a control wire, the distal end of the control wire is connected to the distal end of the bendable portion, and the control wire is The proximal end is connected to the handle, and the control wire is pulled through the handle to control the bending of the bendable portion of the bendable sheath.

Optionally, the bendable portion of the bendable sheath tube includes a first section and a second section that are axially connected. Both the first section and the second section are flexible, and the manipulation is pulled by the handle. When the wire is formed, the first section and the second section are bent in different directions.

Optionally, both the first section and the second section are made of flexible material, and the pipe walls of the first section and the second section each have an axially extending support section, and the support section The stiffness of the segment is greater than the stiffness of the remaining portion of the pipe wall of the first segment and the second segment, and the support segment of the first segment and the support segment of the second segment are circumferentially The location is different.

Optionally, the first section is closer to the handle than the second section, and the tube wall of the first section is provided with a number of slits distributed along the axial direction, each of the slits extending in the circumferential direction. are in the same position, the second section is made of flexible material, and the connecting portion between the distal end of the control wire and the distal end of the bendable portion does not overlap in the circumferential direction with the slit.

Optionally, the pipe walls of the first section and the second section are provided with a number of slits distributed along the axial direction, and each of the slits of the first section has the same position in the circumferential direction, All the slits of the second section are at the same position in the circumferential direction, and the slits of the first section and the slits of the second section do not overlap in the circumferential direction.

Optionally, the control wire is located in the accommodation space between the outer wall of the push rod and the inner wall of the bendable sheath; or, between the outer wall of the push rod and the inner wall of the bendable sheath, There is a control channel in the accommodation space, and the control wire is located in the control channel.

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-expanding filter element and/or the second self-expanding filter element includes a filter screen and a self-expanding support frame, the open end of the filter screen is connected to the self-expanding support frame, and the One end of the filter screen other than its open end is fixed. After the first self-expanding filter element and/or the second self-expanding filter element are released, the self-expanding support frame supports the filter screen.

Optionally, the first self-expanding filter element and/or the second self-expanding filter element is a partial or integral braided stent.

Optionally, the first self-expanding filter element and/or the second self-expanding filter element can be partially developed or fully developed.

In the anti-embolism protection device provided by the present invention, the first self-expanding filter element is compressed and arranged in the first outer sheath tube, and the bendable sheath tube is located in the first outer sheath tube and extends from the distal end of the first outer sheath tube. Extend, the second self-expanding filter element is compressed and arranged in the flexible sheath tube. The first self-expanding filter element and the second self-expanding filter element can be released respectively through the handle, and the flexible sheath tube can be controlled to extend out of the second self-expanding filter element. At least part of an outer sheath is curved. The first self-expanding filter element and the second self-expanding filter element in the present invention have different axial positions, which can reduce the overall outer diameter of the anti-embolism protection device, and the patient's intervention wound is small, and the first self-expanding filter element and The release process of the second self-expanding filter element is independent of each other, does not interfere with each other, and can be released in different target arteries respectively; at the same time, the bendable sheath can be bent, and the direction can be adjusted accurately in the aortic arch, saving time, effort, and accurate entry. The target artery can adapt to the complex physiological structure of the aortic arch and effectively prevent embolic materials from entering the brain blood vessels. Moreover, after the anti-embolism protection device is released, there are fewer structures left in the aortic arch and the volume is smaller, which can reduce the need for interaction with other surgical instruments. Possibility of interference.

Description of the drawings

Figure 1 is a schematic structural diagram of an anti-embolism protection device provided by Embodiment 1 of the present invention;

Figure 2 is a schematic diagram of the first self-expanding filter element after release according to Embodiment 1 of the present invention;

Figure 3 is another schematic diagram after the first self-expanding filter element is released according to Embodiment 1 of the present invention;

Figure 4 is a schematic diagram of the transition part provided by Embodiment 1 of the present invention matching the distal end of the first outer sheath;

Figure 5 is a schematic diagram of the matching of the first outer sheath tube and the second outer sheath tube provided in Embodiment 1 of the present invention;

Figure 6a is a schematic diagram of the second self-expanding filter element fixed on the push rod according to Embodiment 1 of the present invention;

Figure 6b is another schematic diagram of the second self-expanding filter element being fixed on the push rod according to Embodiment 1 of the present invention;

Figure 6c is another schematic diagram of the second self-expanding filter element being fixed on the push rod according to Embodiment 1 of the present invention;

Figure 7 is a schematic structural diagram of the second outer sheath provided in Embodiment 1 of the present invention;

Figure 8 is a schematic diagram of the second outer sheath tube when it is bent according to Embodiment 1 of the present invention;

Figure 9 is a schematic diagram of two other types of slits provided in Embodiment 1 of the present invention;

Figure 10a is a schematic cross-sectional view along the radial direction of the second outer sheath tube and the push rod provided in Embodiment 1 of the present invention.

Figure 10b is another schematic cross-sectional view along the radial direction of the second outer sheath tube and the push rod provided in Embodiment 1 of the present invention;

Figure 11 is a schematic structural diagram of the aortic arch provided in Embodiment 1 of the present invention;

Figures 12a to 12c are work flow charts of the anti-embolic protection device provided by Embodiment 1 of the present invention;

Figure 13 is a schematic structural diagram of the first filter component provided in Embodiment 2 of the present invention;

Figure 14 is a schematic diagram of the first self-expanding filter element after release according to Embodiment 2 of the present invention;

Among them, the reference marks are:

10-First filter component; 101-First outer sheath tube; 102-First connecting tube; 103-First self-expanding filter element; 1031-Self-expanding support frame; 1032-Filter; 20-Second filter component; 201-bendable sheath tube; 211-second connecting tube; 221-second outer sheath tube; 2211-first section; 2212-second section; 2213-slit; 2214-control wire; 2215-control channel; 202 -Push rod; 212-proximal connector; 222-distal connector; 213-proximal stopper; 223-distal stopper; 203-second self-expanding filter element; 30-guide tip;

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

Detailed ways

The anti-embolic protection device and medical device proposed by the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use imprecise proportions, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions. It should also be understood that, unless otherwise specified or pointed out, the terms "first", "second", "third" and other descriptions in the specification are only used to distinguish various components, elements, steps, etc. in the specification, rather than Used to express the logical relationship or sequential relationship between various components, elements, steps, etc.

In this application document, "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal" "End" is not limiting, but "proximal" generally refers to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that first enters the patient's body.

Embodiment 1

Figure 1 is a schematic structural diagram of the anti-embolism protection device provided in this embodiment. As shown in Figure 1, the anti-embolism protection device includes a first filter assembly 10, a second filter assembly 20 and a handle (the handle is not shown in Figure 1), and the handle is connected to the first filter assembly 10 and the second filter component 20 for operating the first filter component 10 and the second filter component 20 .

Specifically, in this embodiment, the first filter assembly 10 includes a first outer sheath tube 101 , a first connecting tube 102 and a first self-expanding filter element 103 . Wherein, the first connecting tube 102 and the first outer sheath tube 101 are both tubular hollow structures, and the first connecting tube 102 is located in the first outer sheath tube 101 and can be axially opposite to each other. movement, the outer diameter of the first connecting tube 102 is smaller than the inner diameter of the first outer sheath 101 , so that there is room between the outer wall of the first connecting tube 102 and the inner wall of the first outer sheath 101 space. Further, the first self-expanding filter element 103 is located at the distal end of the first connecting pipe 102, and the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the first connecting pipe 102. The distal end of a self-expanding filter element 103 resists the inner wall of the first outer sheath 101 (but is not connected to the inner wall of the first outer sheath 101), and the opening of the first self-expanding filter element 103 Point away from the handle.

Figure 2 is a schematic diagram of the first self-expanding filter element 103 after release according to this embodiment. As shown in Figure 2, in this embodiment, the handle is connected to the proximal end of the first outer sheath tube 101, and the handle can control the first outer sheath tube 101 relative to the first connecting tube 102. Axial movement (the direction indicated by the arrow in the figure), thereby releasing or recovering the first self-expanding 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 , and the first self-expanding filter element 103 After being released, the first self-expanding filter element 103 has an umbrella shape (which can also be considered as a truncated cone shape) and adheres to the wall through the radial tension of the first self-expanding filter element 103, thereby effectively capturing thrombus and preventing Thrombus escapes; similarly, the first outer sheath 101 moves 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 enters the first outer sheath 101. The filter element 103 is recycled.

Further, the first self-expanding filter element 103 may be a partial or entire braided stent.

Specifically, please continue to refer to Figure 2. In this embodiment, the first self-expanding filter element 103 is an integral braided stent. After the first self-expanding filter element 103 is released, its open end (the open end here is It means that the distal end of the first self-expanding filter element 103 has a cylindrical structure, which can more effectively match the shape of blood vessels, achieve better wall adhesion, and improve the effectiveness of embolization filtration. Optionally, the open end of the first self-expanding filter element 103 may have a cylindrical structure with the same outer diameter, thereby further improving the wall-adhering effect.

Furthermore, the first self-expanding filter element 103 can be partially developed or fully developed, and the partial outline or the entire outline of the first self-expanding filter element 103 can be seen under fluoroscopic equipment. This developable design is more beneficial. Accurately determine the position and/or adhesion of the first self-expanding filter element 103 during clinical operations.

Based on this, the first self-expanding filter element 103 can be woven from memory developing wire material. The memory developing wire material can be a composite wire material of memory metal and developing material. For example, the core material is nickel-titanium alloy and the outer layer is wrapped with tantalum, Gold, platinum, tungsten and other developing materials; the memory developing wire can also be a composite wire of memory metal, developing material and polymer material. The first self-expanding filter element 103 can also be woven by a mixture of memory metal wire and developing material wire. The memory metal wire can be nickel-titanium alloy wire, and the developing material wire can be tantalum, gold, platinum, or tungsten. etc. metal wire. The first self-expanding filter element 103 can also be woven by a mixture of polymer wires, memory metal wires and developer material wires.

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 gradient; the first self-expanding filter element 103 The braided mesh of the filter element 103 may be one layer or multiple layers, which will not be described in detail here.

Figure 3 is another schematic diagram after the first self-expanding filter element 103 is released according to this embodiment. As shown in Figure 3, as an optional embodiment, the first self-expanding filter element 103 is a partially braided stent, which includes a self-expanding support frame 1031 and a filter screen 1032. The self-expanding support frame 1031 is located on the first The distal end of the self-expanding filter element 103, the open end of the filter mesh 1032 (the open end here refers to the distal end of the filter mesh 1032) is peripherally attached to the self-expanding support frame 1031, and the filter mesh The end of 2032 different from its open end (the end different from its open end here refers to the proximal end of the filter 1032) can be connected to the first connecting tube 102 to achieve fixation. The self-expanding support frame 1031 is made of memory material. When the first self-expanding filter element 103 is compressed in the first outer sheath 101, the self-expanding support frame 1031 is also compressed. When the third self-expanding filter element 103 is compressed, After a self-expanding filter element 103 is released, the self-expanding support frame 1031 returns to its natural state and adheres to the wall, thereby providing support for the filter screen 1032 .

Further, the filter 1032 can be made of laser-drilled membrane material or woven wire material. The membrane material can be polymer material (PU), etc., and the woven wire material can be metal material (nickel titanium, stainless steel, etc.) or Polymer materials (PEEK), etc. The braided wire may be a flat wire or a round wire, and the mesh size on the filter 2032 may be uniform or gradient, which will not be described in detail here.

Please continue to refer to FIG. 1 , the second filter assembly 20 includes a bendable sheath 201 and a second self-expanding filter element 203 . The flexible sheath tube 201 includes a second connecting tube 211 and a second outer sheath tube 221 that are axially connected. Both the second connecting tube 211 and the second outer sheath tube 221 are tubular hollow structures. Further, the second connecting tube 211 is located in the first outer sheath 101 , and the second connecting tube 211 also passes through the first self-expanding filter element 103 and extends into the first connecting tube. 102; the proximal end of the second outer sheath tube 221 is connected to the distal end of the second connecting tube 211, and the second outer sheath tube 221 extends from the distal end of the first outer sheath tube 101, so The second self-expanding filter element 203 is compressed and disposed in the second outer sheath 221 .

In this embodiment, the second connecting tube 211 and the second outer sheath tube 221 are coaxially arranged, and the inner diameter of the second outer sheath tube 221 is larger than the inner diameter of the second connecting tube 211 . The outer diameter of the second outer sheath tube 221 is larger than the outer diameter of the second connecting tube 211. The second self-expanding filter element 203 is compressed and arranged in the second outer sheath tube 221. The first self-expanding filter element 103 and the second self-expanding filter element 203 are axially misaligned (the first self-expanding filter element 103 and the second self-expanding filter element 203 have different axial positions), which can reduce the The overall outer diameter of the anti-embolic protection device.

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 connecting tube 211 , or the outer diameter of the second outer sheath 221 may also be equal to the inner diameter of the second connecting tube 211 The outer diameters are the same, so I won’t go into details here.

In this embodiment, the second connecting tube 211 and the second outer sheath tube 221 have separate structures. For example, the inner wall of the proximal end of the second outer sheath tube 221 and the second connecting tube can be connected. The outer walls of the distal ends of 211 are bonded together; however, it should be understood that the second connecting tube 211 and the second outer sheath tube 221 may actually be an integral structure.

Please continue to refer to FIG. 1 . In this embodiment, the outer diameter of the second outer sheath 221 is equal to the outer diameter of the first outer sheath 101 . However, since the outer diameter of the second outer sheath 221 is larger than The outer diameter of the second connecting tube 211, so the second outer sheath tube 221 may have a transition portion that interfaces with the second connecting tube 211, and the transition portion may be arc-shaped, and the first outer sheath tube 221 may have an arc shape. The inner wall of the distal end of the tube 101 can also be curved, so that the transition portion can match the distal end of the first outer sheath tube 101 . Figure 4 is a schematic diagram of the transition portion provided in this embodiment matching the distal end of the first outer sheath tube 101. As shown in Figure 4, the first outer sheath tube 101 and the second outer sheath tube 101 are connected to each other. When the sheath tube 221 is docked, the inner wall of the distal end of the first outer sheath tube 101 can match the shape of the transition portion. In this way, the distal end of the first outer sheath tube 101 and the second outer sheath tube 101 can be connected to each other. The proximal end of the outer sheath tube 221 can be smoothly transitioned without steps, and can achieve gap-free matching in both the radial and axial directions. The anti-embolism protection device will not cause additional pain to the patient during its movement in the patient's body. damage; and, 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 can be adapted. More vessel sizes.

FIG. 5 is a schematic diagram of the matching of the first outer sheath tube 101 and the second outer sheath tube 221 provided in this embodiment. As shown in FIG. 5 , as an optional embodiment, the second outer sheath tube 221 may not have a transition portion that interfaces with the second connecting tube 211 , and the outer wall of the proximal end of the second outer sheath tube 221 is in the shape of Right angle. In this way, when the first outer sheath tube 101 and the second outer sheath tube 221 are docked, the first outer sheath tube 101 and the second outer sheath tube 221 are also connected in the radial and axial directions. Gap-free matching is possible.

Of course, the first outer sheath tube 101 and the second outer sheath tube 221 do not necessarily need to be seamlessly connected in the axial direction, and a certain distance between them in the axial direction does not affect the implementation of the present invention. ; The outer diameter of the first outer sheath tube and the outer diameter of the second outer sheath tube may also be different, as long as the distal end of the first outer sheath tube and the proximal end of the second outer sheath tube are smooth Just transition.

Please continue to refer to FIG. 1 , the second filter assembly 20 further includes a push rod 202 , the push rod 202 is used to fix the second self-expanding filter element 203 . The push rod 202 is located in the flexible sheath 201 and can move axially relative to the push rod 202, and 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 outer sheath 221 and is connected to a guide tip 30. The second self-expanding filter element 203 is fixed on the push rod 202 in the second outer sheath 221. superior.

Figure 6a is a schematic diagram of the second self-expanding filter element 203 provided in this embodiment being fixed on the push rod 202. As shown in Figure 6a, the proximal end and the distal end of the second self-expanding filter element 203 are respectively fixed on the push rod 202 through the proximal connector 212 and the distal connector 222, and the second self-expanding filter element 203 The opening of the filter element 203 faces in the direction of the handle.

In this embodiment, the proximal connector 212 and the distal connector 222 are annular tubular structures, and the proximal connector 212 and the distal connector 222 are sleeved on the push rod 202 On the outer wall, 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.

Figure 6b is another schematic diagram of the second self-expanding filter element 203 provided in this embodiment being fixed on the push rod 202. As shown in Figure 6b, as an optional embodiment, the proximal end of the second self-expanding filter element 203 can be connected to the proximal connector 212 through a connecting wire, and the distal end of the second self-expanding filter element 203 Still connected to the outer wall of the distal connecting piece 222. In this way, the connecting wire can guide the second self-expanding filter element 203 to smoothly enter the sheath, and can also effectively reduce the volume of the second self-expanding filter element 203.

Figure 6c is another schematic diagram of the second self-expanding filter element 203 provided in this embodiment being fixed on the push rod 202. As shown in Figure 6c, as an optional embodiment, on the basis of Figure 6a or Figure 6b, two proximal end limiters 213 and two distal end limiters 223 can also be set on the push rod 202. There is a certain distance between the two proximal limiters 213 in the axial direction, the proximal connector 212 is located between the two proximal limiters 213, and the two distal limiters There is a certain distance between the pieces 223 in the axial direction, and the distal connecting piece 222 is located between the two distal limiting pieces 223 . Further, the inner diameter of the proximal connecting piece 212 and the distal limiting piece 223 is larger than the outer diameter of the push rod 202, and both the proximal connecting piece 212 and the distal limiting piece 223 can Sliding relative to the push rod 202, the two proximal limiters 213 can limit the sliding range of the proximal connector 212 relative to the push rod 202, and the two distal limiters 223 can limit the sliding range of the proximal connector 212 relative to the push rod 202. The sliding range of the distal connecting piece 222 relative to the push rod 202. In this way, when the push rod 202 moves axially within a certain range, the second self-expanding filter element 203 will not be displaced, thereby improving the stability of the second self-expanding filter element 203 and improving Product availability.

Please continue to refer to FIG. 1 . The guide tip 30 is located at the distal end of the second outer sheath 221 and is connected to the distal end of the push rod 202 . The guide tip 30 is used to guide the entire anti-embolic protection device. Move within the patient's body. In this embodiment, the guide tip 30 may be made of flexible material to prevent additional damage to the patient.

In this embodiment, the proximal end of the push rod 202 can be connected to the handle, and the handle controls the axial movement of the push rod 202 relative to the bendable sheath 201. The second self-expanding filter element 203 and The guide tip 30 also moves axially simultaneously, thereby releasing or recovering the second self-expanding filter element 203. Specifically, when the push rod 202 moves in the direction away from the handle, the second self-expanding filter element 203 and the guide tip 30 move simultaneously in the direction away from the handle until the The second self-expanding filter element 203 leaves the second outer sheath 221, and the second self-expanding filter element 203 is released. After release, the second self-expanding filter element 203 has an umbrella shape, and passes through the second self-expanding filter element 203. The radial tension of the self-expanding filter element 203 adheres to the wall, thereby effectively capturing the thrombus and preventing the thrombus from escaping; similarly, when the push rod 202 moves in the direction close to the handle, the second self-expanding filter element 203 and The guide tip 30 then moves synchronously in a direction close to the handle until the second self-expanding filter element 203 enters the second outer sheath 221 and the second self-expanding filter element 203 is recovered.

As an optional embodiment, the handle does not need to operate the push rod 202 to release the second self-expanding filter element 203. For example, the handle can be connected to the proximal end of the second connecting tube 211. The handle controls the axial movement of the flexible sheath tube 201 relative to the first outer sheath tube 101 through the proximal end of the second connecting tube 211 (the second connecting tube 211 and the second outer sheath tube 221 are synchronized axial movement), thereby releasing or recovering the second self-expanding filter element 203. Specifically, when the bendable sheath 201 moves in the direction close to the handle, the push rod 202 does not move until the second self-expanding filter element 203 leaves the second outer sheath 221, The second self-expanding filter element 203 is released. After release, the second self-expanding filter element 203 takes an umbrella shape and adheres to the wall through the radial tension of the second self-expanding filter element 203, thereby effectively capturing thrombus. Prevent thrombus from escaping; similarly, when the flexible sheath 201 moves in the direction away from the handle, the push rod 202 does not move until the second self-expanding filter element 203 enters the second outer sheath Tube 221, the second self-expanding filter element 203 is recovered. It should be understood that this solution requires a certain gap to be reserved in the axial direction between the first outer sheath tube 101 and the second outer sheath tube 221. If the first outer sheath tube 101 and the second outer sheath tube 221 are If the tubes 221 are seamlessly connected in the axial direction, the first self-expanding filter element 103 needs to be released first so that there is a certain gap between the first outer sheath tube 101 and the second outer sheath tube 221 The second self-expanding filter element 203 is then released.

It should be understood that the specific structure and shape after release of the second self-expanding filter element 203 in this embodiment can be referred to the specific structure and shape after release of the first self-expanding filter element 103 in Figure 2 or Figure 3. shape, but it should be noted that the opening directions of the second self-expanding filter element 203 and the first self-expanding filter element 103 should be opposite, and no examples will be given here.

Optionally, the second self-expanding filter element 203 can be a partial or entire braided scaffold, and the second self-expanding filter element 203 can also be partially or entirely developed.

Further, the handle can also control at least part of the bending of the bendable sheath 201 to extend out of the first outer sheath 101, thereby adjusting the orientation of the bendable sheath 201 and the guide tip 30, It can accurately adjust the direction in the aortic arch, save time and effort, and accurately enter the target artery, and can adapt to the complex physiological structure of the aortic arch. It can be understood that although it is described above that the second connecting tube 211 is located within the first outer sheath tube 101 and the second outer sheath tube 221 extends from the distal end of the first outer sheath tube 101, However, it should be understood that when the first self-expanding filter element 103 is released, since the first outer sheath 101 will move in a direction close to the handle, a part of the second connecting tube 211 will also move from The distal end of the first outer sheath tube 101 extends. Therefore, the bendable portion of the bendable sheath 201 is not limited to being located only on the second outer sheath 221, but may also be located on the second connecting tube 211, or both at the same time. and the second connecting pipe 211. For the convenience of description, the bendable portion of the bendable sheath 201 will be described in detail below by taking the second outer sheath 221 as the bendable portion of the bendable sheath 201 as an example. The second outer sheath tube 221 is bendable as a whole).

FIG. 7 is a schematic structural diagram of the second outer sheath tube 221 provided in this embodiment. As shown in Figure 7, in this embodiment, the second outer sheath tube 221 can be divided into two axially connected sections, called the first section 2211 and the second section 2212. The first section 2211 is smaller than the first section 2211. The second section 2212 is closer to the handle. The pipe wall of the first section 2211 has a number of slits 2213 arranged along the axial direction. The position and length of each slit 2213 in the circumferential direction are the same. In this way, the first section 2211 can It is flexible and can be bent in one direction. Furthermore, the second section 2212 is made of a flexible material, which is also flexible and can be bent at will. The flexible material can be, for example, a flexible polymer material, such as PVC (polyvinyl chloride), K resin and other materials. The proximal end of the control wire 2214 is connected to the handle, the distal end is connected to the distal end of the second section 2212, and the connection portion between the distal end of the control wire 2214 and the distal end of the second section 2212 is connected to the cutter. The slits 2213 do not overlap in the circumferential direction, thereby ensuring that when the control wire 2214 is pulled, the first section 2211 and the second section 2212 can bend in different directions (when the distal end of the control wire 2214 is in contact with the When the connecting portion of the distal end of the second section 2212 overlaps the slit 2213 in the circumferential direction, and when the control wire 2214 is pulled, the bending directions of the first section 2211 and the second section 2212 are the same).

FIG. 8 is a schematic diagram of the second outer sheath tube 221 when bent according to this embodiment. As shown in FIG. 8 , when the control wire 2214 is pulled through the handle, the connection portion between the distal end of the control wire 2214 and the distal end of the second section 2212 is in the circumferential direction with the slit 2213 . Without overlapping, the first section 2211 and the second section 2212 of the second outer sheath 221 will bend in opposite directions, so that the anti-embolism protection device can bend flexibly during its movement, which is better. Adapt to the complex physiological structure of the aortic arch.

Optionally, the slit 2213 may penetrate the pipe wall of the first section 2211, or may not penetrate, but only extend into the pipe wall of the first section 2211. In addition, in order to ensure the structural strength of the second outer sheath 221, the length of the slit 2213 in the circumferential direction should not exceed 4/5 of the circumference of the first section 2211.

In this embodiment, the slits 2213 are in a strip shape, but this should not be limiting. Figure 9 is a schematic diagram of two other slits 2213 provided in this embodiment. As shown in Figure 9, the slit 2213 can also be in other shapes such as an I-shape or a V-shape. By designing the shape of the slit 2213, the pressure-bearing capacity of the first section 2211 during bending can be improved. Here No more explanations one by one.

As an optional embodiment, the first section 2211 and the second section 2212 can both be made of flexible materials, such as the above-mentioned flexible polymer materials. Each pipe wall has a support section extending along the axial direction, the stiffness of the support section is greater than the stiffness of the remaining portion of the pipe wall of the first section 2211 and the second section 2212, and the first section 2211 and the second section 2212 The positions of the support sections of the second section 2212 in the circumferential direction are different. In this way, when the control wire 2214 is pulled by the handle, due to the higher stiffness of the support sections of the first section 2211 and the second section 2212, the first section 2211 and the second section 2212 Other parts of the pipe wall will deform before the support section, forming a bend in a fixed direction, and because the positions of the support sections of the first section 2211 and the second section 2212 are different in the circumferential direction, the The bending directions of the first section 2211 and the second section 2212 may also be different.

As an optional embodiment, the second outer sheath tube 221 can be made entirely of flexible material, so that the distal end of the control wire 2214 is connected to the distal end of the second outer sheath tube 221 , and the control wire 2214 has a distal end. The proximal end is connected to the handle, and by pulling the control wire 2214 through the handle, the entire second outer sheath tube 221 can also be controlled to bend in one direction.

As an optional embodiment, a plurality of axially distributed slits 2213 may be provided on the pipe walls of the first section 2211 and the second section 2212, and each of the slits 2213 of the first section 2211 The position and size of each slit 2213 in the second section 2212 are the same in the circumferential direction. The slits 2213 of the first section 2211 and the slits 2213 of the second section 2212 are the same. The slits 2213 do not overlap in the circumferential direction. When the control wire 2214 is pulled through the handle, the bending directions of the first section 2211 and the second section 2212 may also be different.

It can be understood that since the push rod 202 is inserted into the bendable sheath 201, the portion of the push rod 202 corresponding to the bendable portion of the bendable sheath 201 should also be bendable. When the bendable portion of the bendable sheath 201 bends, the corresponding portion of the push rod 202 will also bend.

Figure 10a is a schematic cross-sectional view along the radial direction of the second outer sheath 221 and the push rod 202 provided in this embodiment. As shown in Figure 10a, as an optional embodiment, the control wire 2214 can directly pass through the area between the inner wall of the second outer sheath 221 and the outer wall of the push rod 202 until it is connected to the handle, In this way, the push rod 202 can have a larger radial movement space.

Figure 10b is another schematic cross-sectional view along the radial direction of the second outer sheath 221 and the push rod 202 provided in this embodiment. As shown in Figure 10b, as an optional embodiment, a control channel 2215 can be provided in the accommodation space between the inner wall of the second outer sheath 221 and the outer wall of the push rod 202, and the control wire 2214 passes through Through the control channel 2215 until connected with the handle, in this way, the control wire 2214 and the push rod 202 will not interfere with each other.

It can be understood that the control wire 2214 in Figures 10a and 10b is a flat wire, but is not limited thereto. The control wire 2214 can also be a round wire or other shaped wire.

Further, when the handle can be connected to the proximal end of the second connecting tube 211, the handle can also control the flexible sheath 201 to rotate in the axial direction, for example, control the flexible sheath 201 to rotate along the axial direction. Axial rotation 360 degrees, thereby better changing the orientation of the flexible sheath 201.

Please continue to refer to FIG. 1 . In this embodiment, the first outer sheath 101 and the second outer sheath 221 may be polymer sheaths. For example, polymers such as Pebax (polyether block polyamide) may be used. Made of materials, the walls of the first outer sheath tube 101 and the second outer sheath tube 221 can be provided with structures such as metal braiding layers or metal springs for composite reinforcement to improve tensile or bending resistance; The second connecting tube 211 , the first connecting tube 102 and the pushing rod 202 can be made of materials with good biocompatibility, such as PA (nylon), PC (polycarbonate), POM (polyoxymethylene) and other polymer materials or metal materials such as stainless steel and nickel-titanium.

Figure 11 is a schematic structural diagram of the aortic arch provided in this embodiment. As shown in Figure 11, the aortic arch has three arteries: the brachiocephalic artery a, the left common carotid artery b, and the left subclavian artery c. Next, in this embodiment, the anti-embolism protection device is used to approach the radial artery. As an example, enter the aortic arch via the brachiocephalic artery a, and release the first self-expanding filter element 103 and the second self-expanding filter element 203 at the brachiocephalic artery a and the left common carotid artery b respectively. Be explained. However, it should be understood that the present invention is not limited thereto. The anti-embolism protection device may also enter the aortic arch via the left subclavian artery c and be located at the left subclavian artery c and the left common carotid artery b respectively. Release the first self-expanding filter element 103 and the second self-expanding filter element 203; of course, the present invention is not limited to releasing the first self-expanding filter element 103 and the second self-expanding filter element 203 respectively. 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, it can also be released at the brachiocephalic trunk artery a and the left common carotid artery b respectively. Left subclavian arteryc.

Figures 12a to 12c are working flow charts of the anti-embolism protection device provided in this embodiment. As shown in Figure 12a, the anti-embolism protection device is pushed to the brachiocephalic artery a, and at this time, part of the second outer sheath 221 enters the aortic arch. As shown in Figure 12b, the first outer sheath 101 is controlled by the handle to move in a direction close to the handle, and the first self-expanding filter element 103 is released at the brachiocephalic artery a. As shown in Figure 12c, the second outer sheath 221 is controlled to rotate and bend through the handle until the guide tip 30 is aligned with the entrance of the left common carotid artery b, and then the second outer sheath is Part 221 is sent into the left common carotid artery b. As shown in Figure 12d, the second outer sheath tube 221 is controlled by the handle to move in a direction close to the handle (or the push rod 202 is controlled to move in a direction away from the handle). The second self-expanding filter element 203 is released at the common artery b.

Optionally, the portions of the second connecting pipe 211, the first connecting pipe 102 and the push rod 202 between the first self-expanding filter element 103 and the handle can be designed with a detachable structure. After releasing the first self-expanding filter element 103 and the second self-expanding filter element 203, detach the second connecting pipe 211, the first connecting pipe 102 and the excess parts of the push rod 202, only Leaving less structure within the aortic arch reduces the potential for interference with other surgical instruments.

It should be understood that although the first self-expanding filter element 103 is released first and then the second self-expanding filter element 203 is released in Figures 12a to 12c, in fact, the second self-expanding filter element 203 can also be released first. The first self-expanding filter element 103 is then released.

Embodiment 2

Figure 13 is a schematic structural diagram of the first filter component provided in this embodiment. As shown in Figure 13, the difference from Embodiment 1 is that in this embodiment, the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the first connecting pipe 102, and the first self-expanding filter element The distal end of 103 is connected to the inner wall of the first outer sheath 101 .

Figure 14 is a schematic diagram of the first self-expanding filter element 103 provided in this embodiment after release. As shown in Figure 14, when the first outer sheath 101 moves in the direction close to the handle, since the distal end of the first self-expanding filter element 103 is connected to the inner wall of the first outer sheath 101, The first outer sheath 101 will pull the distal end of the first self-expanding filter element 103 until a part of the first self-expanding filter element 103 is folded back and folded with another part. The filter element 103 is released. After release, the first self-expanding filter element 103 is in the shape of an umbrella (which can also be considered to be in the shape of a truncated cone), and the opening of the first self-expanding filter element 103 faces away from the handle.

Embodiment 3

The difference from Embodiment 1 and Embodiment 2 is that in this embodiment, the first filter assembly 10 does not include a first connecting pipe, and the first self-expanding filter element 103 is compressed and arranged in the second connecting pipe. 211 and the first outer sheath tube 101.

As an optional embodiment, the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the second connecting tube 211 , and the distal end of the first self-expanding filter element 103 resists the first outer sheath tube 101 (but not connected to the inner wall of the first outer sheath 101). At this time, the release process and release form of the first self-expanding filter element 103 can be referred to Figure 2.

As an optional embodiment, the proximal end of the first self-expanding filter element 103 is connected to the outer wall of the second connecting tube 211 , and the distal end of the first self-expanding filter element 103 is connected to the first outer sheath tube 101 At this time, the release process and release form of the first self-expanding filter element 103 can be referred to Figure 14.

Compared with Embodiment 1 and Embodiment 2, this embodiment omits the first connecting tube, has a simpler structure, and can reduce the outer diameter of the first outer sheath tube 101 .

It should be understood that the "axial direction" referred to herein refers to the direction along the centerline of the first outer sheath (or the flexible sheath), and the "radial direction" referred to herein refers to Perpendicular to the "axial" direction, the "circumferential direction" referred to herein refers to the circumferential direction surrounding the first outer sheath (or the flexible sheath).

To sum up, in the anti-embolism protection device provided by the embodiment of the present invention, the first self-expanding filter element is compressed and arranged in the first outer sheath tube, and the bendable sheath tube is located in the first outer sheath tube and passes from the first outer sheath tube. The distal end of the sheath extends, and the second self-expanding filter element is compressed and arranged in the flexible sheath. The first self-expanding filter element and the second self-expanding filter element can be released respectively through the handle, and the flexible sheath can be controlled. The tube may extend beyond at least part of the bend of the first outer sheath. The first self-expanding filter element and the second self-expanding filter element in the present invention have different axial positions, which can reduce the overall outer diameter of the anti-embolism protection device, and the patient's intervention wound is small, and the first self-expanding filter element and The release process of the second self-expanding filter element is independent of each other, does not interfere with each other, and can be released in different target arteries respectively; at the same time, the bendable sheath can be bent, and the direction can be adjusted accurately in the aortic arch, saving time, effort, and accurate entry. The target artery can adapt to the complex physiological structure of the aortic arch and effectively prevent embolic materials from entering the brain blood vessels. Moreover, after the anti-embolism protection device is released, there are fewer structures left in the aortic arch and the volume is smaller, which can reduce the need for interaction with other surgical instruments. Possibility of interference.

It should be noted that each embodiment in this specification is described in a progressive manner, and each embodiment focuses on its differences from other embodiments. The same and similar parts between the various embodiments can be referred to each other. For the system disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple. For relevant details, please refer to the description in the method section.

It should also be noted that although the present invention has been disclosed above in preferred embodiments, the above embodiments are not intended to limit the present invention. For any person familiar with the art, without departing from the scope of the technical solution of the present invention, they can use the technical content disclosed above to make many possible changes and modifications to the technical solution of the present invention, or modify it into equivalent changes. Example. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

It should also be understood that, unless otherwise specified or pointed out, the terms "first", "second", "third" and other descriptions in the specification are only used to distinguish various components, elements, steps, etc. in the specification, rather than Used to express the logical relationship or sequential relationship between various components, elements, steps, etc.

Furthermore, it should be appreciated that the terminology described herein is used only to describe particular embodiments and is not intended to limit the scope of the invention. It must be noted that, as used herein and in the appended claims, the singular forms "a", "an" and "an" include plural referents unless the context clearly dictates a contrary meaning. For example, a reference to "a step" or "a means" means a reference to one or more steps or means, and may include secondary steps as well as secondary means. All conjunctions used should be understood in their broadest sense. and, the word "or" shall be understood to have the definition of a logical "or" and not the definition of a logical "exclusive-or" unless the context clearly indicates the contrary. Furthermore, implementation of methods and/or devices in embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims (24)

1. An embolic protection device, comprising:

a first filter assembly comprising a first outer sheath and a first self-expanding filter element disposed in compression within the first outer sheath;

a second filter assembly comprising a pliable sheath 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 pliable sheath; the method comprises the steps of,

And the handle is connected with the first filtering component and the second filtering component and is 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 tube which can extend out of the first outer sheath tube to bend.

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

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

4. An embolic protection device as in any of claims 1-3, wherein the handle is coupled to the proximal end of the first outer sheath, the first self-expanding filter element being released by actuating 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 coupled to the push rod, the push rod also bending with a corresponding portion of the push rod as the flexible sheath is bent.

6. An embolic protection device as in claim 5, wherein the handle is coupled to the proximal end of the push rod, the second self-expanding filter element being released by actuating the push rod axially relative to the bendable sheath.

7. An embolic protection device as in claim 5, wherein the push rod sheath is provided with a proximal connector and a distal connector, the proximal and distal ends of the second self-expanding filter element being connected to the proximal connector and the distal connector, respectively.

8. The embolic protection device of claim 7, wherein the proximal and distal ends of said second self-expanding filter element are directly attached to said proximal connector and said 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. An embolic protection device as in claim 7 or 8, wherein the pusher rod is further sleeved with two proximal stoppers and two distal stoppers, the proximal connector being positioned between the two proximal stoppers and being axially movable relative to the pusher rod, the distal connector being positioned between the two distal stoppers and being axially movable relative to the pusher rod.

10. The embolic protection device of claim 1, wherein said bendable sheath comprises a second connective tube and a second outer sheath axially connected, said second connective tube being positioned 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 compressively disposed within said second outer sheath.

11. The embolic protection device of claim 10, wherein 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 seamlessly abutted with the proximal end of the second outer sheath.

12. The embolic protection device of claim 10, wherein an outer diameter of said first outer sheath is different from an outer diameter of said second outer sheath, and wherein a distal end of said first outer sheath smoothly transitions with a proximal end of said second outer sheath.

13. An embolic protection device as in any of claims 1, 5, 7, 8, 10, 11, 12, wherein the handle is coupled to the proximal end of the flexible sheath, the second self-expanding filter element being released by actuating the flexible sheath axially relative to the first outer sheath.

14. An embolic protection device as in any of claims 1, 5, 7, 8, 10, 11, 12, wherein the handle is coupled to the proximal end of the flexible sheath for driving the flexible sheath in axial rotation.

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

16. An embolic protection device as in 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 through the handle.

17. An embolic protection device as in claim 16, wherein the first and second sections are each formed of a flexible material, the walls of the first and second sections each have an axially extending support section, the support section having a stiffness greater than the stiffness of the remainder of the walls of the first and second sections, and the support sections of the first and second sections being circumferentially positioned differently.

18. An embolic protection device as in claim 16, wherein the first section is closer to the handle than the second section, wherein a plurality of axially-distributed slits are provided in the wall of the first section, wherein all of the slits are circumferentially equally positioned, wherein the second section is formed of a flexible material, and wherein the portion of the distal end of the steering wire that connects to the distal end of the deflectable portion does not circumferentially overlap the slits.

19. An embolic protection device as in claim 16, wherein the walls of the first and second segments are each provided with a plurality of axially-distributed slits, each of the slits of the first segment being circumferentially identical, each of the slits of the second segment being circumferentially identical, the slits of the first segment not circumferentially overlapping the slits of the second segment.

20. An embolic protection device as in any of claims 15-19, wherein the steering wire is located in the receiving space between the outer wall of the push rod and the inner wall of the bendable sheath; or, a control channel is arranged in the accommodating space between the outer wall of the pushing rod and the inner wall of the bendable sheath tube, and the control wire is positioned in the control channel.

21. An embolic protection device as in claim 1, wherein the first self-expanding filter element and/or the second self-expanding filter element has a one-piece cylindrical configuration at the open end after being released.

22. An embolic protection device as in claim 1, wherein the first self-expanding filter element and/or the second self-expanding filter element comprises a filter mesh and a self-expanding support frame, the filter mesh having an open end connected to the self-expanding support frame, the filter mesh being secured at an end other than the open end thereof, the self-expanding support frame supporting the filter mesh after the first self-expanding filter element and/or the second self-expanding filter element 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 integrally woven stent.

24. An 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 wholly developable.