An embolic protection device

Abstract

The present invention discloses an embolization protection device, belonging to the technical field of interventional therapy instruments, comprising: a catheter; a delivery assembly including an outer tube movably disposed within the catheter and an inner tube movably disposed within the outer tube; a filter connected to the delivery assembly, having a recovery state received within the catheter and a release state extending outside the catheter; the filter includes a filter membrane and a filter membrane support, the distal end of the filter membrane is a closed end, and the proximal end of the filter membrane is an open end; the filter membrane support includes a support fixed section fixed to the outer tube and a support variable diameter section not fixed to the outer tube, and the proximal end of the filter membrane is connected to the support variable diameter section; a transmission member connected or abutted to the support variable diameter section is fixed to the inner tube. When the filter is in the release state, the inner tube drives the transmission member to move, and the transmission member can drive the support variable diameter section to radially expand or retract relative to the outer tube, thereby realizing the adjustment of the outer diameter after the release of the filter membrane support, enhancing the versatility of the embolization protection device and making it applicable to blood vessels of different diameters.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional treatment devices, and particularly relates to an embolism protection device. Background Art

[0002] When atherosclerotic stenosis occurs in peripheral blood vessels, coronary arteries, and carotid arteries, balloon angioplasty or stent implantation is usually clinically used to restore the normal lumen and blood flow of the blood vessels. However, during this process, the plaque at the stenotic site is subjected to the external force of the balloon or stent and may be broken or detached. Once these broken plaques drift with the blood to the distal blood vessels, especially into the cerebral blood vessels, embolism may be triggered, leading to ischemic stroke, thus seriously threatening the life, health, and safety of patients.

[0003] Therefore, an embolism protection device has been invented. Without affecting blood perfusion, a filter screen is opened at the distal end of the diseased blood vessel segment to intercept and collect the plaques detached during the operation. After the operation is completed, the embolism protection device together with the emboli intercepted in the embolism protection device is withdrawn from the human body. The use of the embolism protection device effectively reduces the embolism risk of the distal blood vessels and improves the success rate of the operation.

[0004] However, the outer diameter of the filter screen used to intercept emboli in the existing embolism protection device is fixed after expansion, and embolism filters with different outer diameters are required to match blood vessels with different diameters. The existing embolism protection devices have poor versatility. Summary of the Invention

[0005] In view of this, the present invention provides an embolism protection device to solve the defect that the existing embolism protection device cannot be used to match blood vessels with different outer diameters and has poor versatility, thereby providing an embolism protection device.

[0006] To solve the above technical problems, the technical solution of the present invention is as follows:

[0007] An embolism protection device includes:

[0008] A catheter;

[0009] A delivery assembly, including an outer tube movably inserted into the catheter and an inner tube movably inserted into the outer tube;

[0010] A filter, connected to the delivery assembly, having a recovery state received in the catheter and a release state extending outside the catheter. The filter includes a filter membrane and a filter membrane support; the distal end of the filter membrane is a closed end, and the proximal end of the filter membrane is an open end; the filter membrane support includes a support fixed section fixedly connected to the outer tube and a support variable diameter section not fixedly connected to the outer tube, and the proximal end of the filter membrane is connected to the support variable diameter section;

[0011] The inner tube is fixedly connected with a transmission member connected to or abutted against the variable-diameter section of the bracket. When the filter is in the release state, the transmission member drives the variable-diameter section of the bracket and the filter membrane thereon to expand radially outward or retract inward relative to the outer tube along with the axial movement of the inner tube.

[0012] Further, the transmission member is an annular body slidably sleeved on the outer tube along the axial direction of the outer tube. A chute is provided on the outer tube, penetrating through the tube wall of the outer tube and extending along the length direction of the outer tube. The annular body is fixed on the inner tube through a pin passing through the chute.

[0013] Further, there are two chutes, and the two chutes are arranged on opposite sides of the outer tube.

[0014] Further, filter holes are provided on the filter membrane, and the aperture of the filter holes is 80 microns to 180 microns.

[0015] Further, the filter membrane bracket includes a plurality of support wires circumferentially arranged around the catheter; the parts of the plurality of support wires fixedly connected to the outer tube are the bracket fixed sections, and the parts of the plurality of support wires not fixedly connected to the outer tube are the bracket variable-diameter sections.

[0016] Further, the filter membrane bracket is a single-conical bracket, and the opening of the filter membrane bracket is located at the distal end; the bracket fixed section is located at the proximal end of the filter membrane bracket. The bracket variable-diameter section includes a conical bracket transition section and a cylindrical bracket support section. The bracket support section is located at the distal end of the filter membrane bracket, and the bracket transition section is connected between the bracket fixed section and the bracket support section; the proximal end of the filter membrane is connected to the bracket support section. The transmission member is slidably arranged on the outer tube at the distal end of the bracket fixed section, and the transmission member abuts against the inner wall of the bracket transition section.

[0017] Further, the filter membrane includes a filter membrane proximal section at the proximal end and a filter membrane distal section at the distal end. The filter membrane proximal section is cylindrical, and the filter membrane distal section is conical; the distal end of the filter membrane distal section is directly fixed on the outer tube or the distal end of the filter membrane distal section is fixed on the outer tube through a distal fixing ring.

[0018] Further, an orbit for inserting the bracket support section is provided inside the filter membrane proximal section, and the bracket support section is slidably connected to the orbit along its own axial direction.

[0019] Further, the filter membrane support is a double-cone support with conical ends and a cylindrical middle; the fixed section of the support is located at the distal end of the filter membrane support, and the variable-diameter section of the support includes a cylindrical main body section in the middle, a distal support transition section connected between the fixed section of the support and the main body section and in a conical shape, and a proximal support transition section connected to the proximal end of the main body section and in a conical shape; the proximal end of the proximal support transition section is fixed on the transmission member.

[0020] Further, the filter membrane includes a proximal filter membrane section at the proximal end and a distal filter membrane section at the distal end. The proximal filter membrane section is cylindrical, and the distal filter membrane section is conical; the distal support transition section of the support is supported on the inner wall of the distal filter membrane section, and at least a part of the main body section of the support is supported on the inner wall of the proximal filter membrane section.

[0021] The technical solution of the present invention has the following advantages: The filter of this embolization protection device is housed in the catheter in the retracted state. After the catheter is implanted into the target blood vessel segment, by pulling the catheter proximally, the filter extends out from the distal opening of the catheter and is in the released state. Then, the inner tube is moved, and the inner tube drives the transmission member to slide axially along the outer tube. The transmission member can drive the variable-diameter section of the support to expand radially outward or retract inward relative to the outer tube, thereby realizing the adjustment of the outer diameter after the filter membrane support is released, enhancing the versatility of the embolization protection device and making it applicable to blood vessels of different diameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0023] Figure 1 Schematic diagram of the filter in the embolization protection device in the retracted state in Embodiment 1 of the present invention;

[0024] Figure 2 For Figure 1 Enlarged view of part A in

[0025] Figure 3 Schematic diagram of the embolization protection device implanted in a blood vessel in Embodiment 1 of the present invention;

[0026] Figure 4 Schematic diagram of the filter in the embolization protection device in the released state in Embodiment 1 of the present invention;

[0027] Figure 5 Front view of the embolization protection device in Embodiment 1 of the present invention;

[0028] Figure 6 This is a cross-sectional view of the embolization protection device in the first embodiment of the present invention;

[0029] Figure 7 is Figure 6 an enlarged view of part B in

[0030] Figure 8 This is a three-dimensional structural schematic diagram of the filter in the embolization protection device in the second embodiment of the present invention in a released state;

[0031] Figure 9 This is a front view of the embolization protection device in the second embodiment of the present invention;

[0032] Figure 10 This is a cross-sectional view of the embolization protection device in the second embodiment of the present invention;

[0033] Figure 11 is Figure 10 an enlarged view of part C in

[0034] Explanation of reference numerals: 1. Catheter; 2. Outer tube; 21. Slide groove; 3. Inner tube; 4. Filter membrane; 41. Proximal section of the filter membrane; 42. Distal section of the filter membrane; 5. Filter membrane support; 5a. Support wire; 51. Fixed section of the support; 52. Diameter-changing section of the support; 521. Transition section of the support; 522. Support section of the support; 523. Main body section of the support; 524. Distal transition section of the support; 525. Proximal transition section of the support; 6. Ring body; 8. Proximal fixing ring; 9. Distal fixing ring; 10. Blood vessel wall. Detailed implementation manners

[0035] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0036] In the description of the present application, it should be understood that the terms "proximal" and "distal" throughout the text refer to near and far relative to the operator. When the present invention is in use, the end close to the doctor or the operator is the "proximal end", that is, the end where the operator is located, and the end far from the doctor or the operator is the "distal end", that is, the end where the balloon is located. The above-mentioned orientation description is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0037] Embodiment 1

[0038] AsFigures 1-7 An embolization protection device as shown includes a catheter 1, a delivery assembly, a filter, and a transmission member. Among them, the catheter 1 is used to realize the release and recovery of the filter in the blood vessel. The delivery assembly includes an outer tube 2 and an inner tube 3. The outer tube 2 is movably disposed within the catheter 1, and the inner tube 3 is movably disposed within the outer tube 2; the filter is connected to the delivery assembly. The inner cavity of the inner tube 3 allows a guide wire (not shown in the figure) to pass through, and the embolization protection device can be delivered to the target position in the blood vessel through the guide wire. The filter has a recovery state received within the catheter 1 and a release state extending outside the catheter 1; the filter is a deformable structure with one end fixed to the outer tube 2 and the other end capable of changing its shape. The transmission member is fixedly connected to the inner tube 3 and abuts against the deformable part of the filter. When the filter is released from the catheter 1, the inner tube 3 can drive the transmission member to move towards the fixed end of the filter, and the transmission member can drive the filter to change its shape during the movement, thereby realizing the adjustment of the outer diameter of the filter to adapt to blood vessels of different diameters and improving the versatility of the embolization protection device.

[0039] As Figure 2 、 Figure 3 and Figure 4 shown, the filter includes a filter membrane 4 and a filter membrane support 5. The distal end of the filter membrane 4 is a closed end, and the proximal end of the filter membrane 4 is an open end. The open end of the filter membrane 4 is connected to the distal end of the filter membrane support 5.

[0040] In some embodiments, the proximal end of the filter membrane support 5 is fixed to the outer tube 2 through a proximal fixing ring 8, and the closed end of the filter membrane 4 is fixed to the outer tube 2 through a distal fixing ring 9. In an alternative embodiment, the proximal end of the filter membrane support 5 may be directly fixed to the outer tube 2 without passing through the proximal fixing ring 8, and the closed end of the filter membrane 4 may also be directly fixed to the outer tube 2 without passing through the distal fixing ring 9.

[0041] In some embodiments, as Figure 4 and Figure 5 shown, the filter membrane support 5 includes a plurality of support wires 5a circumferentially and evenly spaced around the catheter 1. The filter membrane support 5 is specifically a single conical support composed of a plurality of support wires 5a, and the open side of the filter membrane support 5 is located at the distal end. This filter membrane support 5 composed of a plurality of support wires 5a, since the plurality of support wires 5a are independent of each other and one end is fixed to the outer tube 2, is prone to bending when the parts of the plurality of support wires 5a not directly fixed to the outer tube 2 are subjected to external forces, and can realize the shape change of the filter membrane support 5 after release. In an alternative embodiment, the filter membrane support 5 may also be a braided mesh structure woven from one or more metal wires and capable of radially expanding or contracting under external forces.

[0042] As Figure 5As shown, the filter membrane 4 includes a proximal filter membrane segment 41 at the proximal end and a distal filter membrane segment 42 at the distal end; when the filter is in a radially expanded state after release, the proximal filter membrane segment 41 is cylindrical and the distal filter membrane segment 42 is conical. The distal filter membrane segment 42 is fixed on the outer tube 2, and the proximal filter membrane segment 41 is connected to the distal ends of a plurality of support wires 5a. The filter membrane 4 is provided with filter holes, and the aperture of the filter holes is 80 microns to 180 microns; to ensure that blood flow can pass through smoothly while preventing thrombus from leaking through. Specifically, the filter membrane 4 is made by punching and shaping a high molecular thin film material, and the high molecular thin film material can be any one or a mixture of polypropylene (PP), polyvinyl chloride (PVC), polyamide (nylon), polyurethane, polyester, polyethylene terephthalate tetrafluoride, polyether ether ketone (PEEK), polyether block amide (PEBA), polytetrafluoroethylene (PTFE).

[0043] In some embodiments, as Figure 6 and Figure 7 shown, the filter membrane support 5 includes a connected support fixing segment 51 and a support diameter-changing segment 52. The support fixing segment 51 is located at the proximal end of the filter membrane support 5 and is fixed on the outer tube 2. The support diameter-changing segment 52 is located at the distal end of the filter membrane support 5 and is not directly fixedly connected to the outer tube 2. The proximal filter membrane segment 41 is connected to the support diameter-changing segment 52. That is, the part of the plurality of support wires 5a fixedly connected to the outer tube 2 is the support fixing segment 51, and the part of the plurality of support wires 5a not fixedly connected to the outer tube 2 is the support diameter-changing segment 52; the support diameter-changing segment 52 is suspended outside the outer tube 2, and the support diameter-changing segment 52 is the deformable part of the filter. The support diameter-changing segment 52 includes a support transition segment 521 and a support segment 522. The support segment 522 is located at the distal end of the filter membrane support 5, and the support transition segment 521 is connected between the support segment 522 and the support fixing segment 51. When the filter is in a radially expanded state, the support transition segment 521 is conical and the support segment 522 is cylindrical, and the proximal filter membrane segment 41 is connected to the support segment 522.

[0044] In some embodiments, as Figure 6 and Figure 7As shown, the transmission member is specifically an annular body 6 that is slidably sleeved on the outer tube 2 along the axial direction of the outer tube 2. The annular body 6 is slidably arranged on the outer tube 2 at the distal end of the bracket fixed section 51. A chute 21 that penetrates the tube wall of the outer tube 2 and extends along the length direction of the outer tube 2 is provided on the outer tube 2. The annular body 6 is fixed to the inner tube 3 through a pin 7 that passes through the chute 21. By moving the inner tube 3 proximally, the inner tube 3 drives the annular body 6 to move proximally. The bracket transition section 521 expands outward under the abutting force of the annular body 6 inside it, and the outer diameter of the bracket support section 522 increases as the bracket transition section 521 expands. Therefore, by controlling the distance that the inner tube 3 and the annular body 6 move proximally, the adjustment of the outer diameter of the filter membrane bracket 5 after expansion can be achieved, enhancing the versatility of the embolism protection device and making it applicable to blood vessels of different diameters. In an alternative embodiment, the transmission member is not limited to the structural form of the annular body 6, and any transmission structure that can move with the inner tube 3 and apply an outward expansion force to the filter membrane bracket 5 when the inner tube 3 moves relative to the outer tube 2 belongs to the protection scope of this application.

[0045] In some embodiments, as Figure 6 and Figure 7 shown, two chutes 21 are provided on the outer tube 2, and the two chutes 21 are arranged on opposite sides of the outer tube 2; the pin 7 passes through the two chutes 21 and the inner tube 3 to realize the fixed connection between the inner tube 3 and the annular body 6. It can be understood here that the number of chutes 21 on the outer tube 2 is not limited to two, and the pin 7 for fixing the annular body 6 and the inner tube 3 can be one or more.

[0046] As Figure 6 and Figure 7 shown, in some embodiments, a track (not shown in the figure) for inserting the bracket support section 522 is provided inside the filter membrane proximal section 41. The bracket support section 522 is slidably connected to the track along its own axial direction. With such a setting, a certain position movement in the axial direction between the bracket support section 522 and the filter membrane proximal section 41 can be allowed. When the filter membrane bracket 5 is radially expanded under force, the resistance of the filter membrane 4 to the expansion of the filter membrane bracket 5 can be reduced, facilitating the adjustment of the filter membrane bracket 5 to the required outer diameter size.

[0047] When the embolism protection device in the above-mentioned first embodiment is in use, in the initial state, the filter is housed in the catheter 1, and the filter is in a retracted state. Move the catheter 1 proximally. After the filter extends out of the opening at the distal end of the catheter 1, it is in a released state. Then, pull the inner tube 3 proximally. The annular body 6 moves from the distal end to the proximal end on the outer tube 2. The annular body 6 pushes the bracket transition section 521 of the filter membrane bracket 5 to expand outward, and further enables the bracket support section 522 of the filter membrane bracket 5 and the filter membrane 4 thereon to fit well with the blood vessel wall 10; free thrombus in the blood vessel is easily intercepted by the filter membrane 4. After the balloon dilation or stent implantation is completed, the embolism protection device together with the thrombus inside the device can be withdrawn from the human body.

[0048] Embodiment 2

[0049] As Figures 8-11 shown, a kind of embolization protection device, which is different from that in Embodiment 1 in that the filter membrane stent 5 is a double-cone stent with both ends being conical and the middle being cylindrical. The distal ends of multiple support wires 5a in the filter membrane stent 5 are fixed on the outer tube 2, and the proximal ends of the multiple support wires 5a are fixed on the ring body 6. Specifically, the stent fixing section 51 is located at the distal end of the filter membrane stent 5. The stent diameter-changing section 52 includes a stent main body section 523 located in the middle and being cylindrical, a stent distal transition section 524 connected between the stent fixing section 51 and the stent main body section 523 and being conical, and a stent proximal transition section 525 connected to the proximal end of the stent main body section 523 and being conical. The proximal end of the stent proximal transition section 525 is fixed on the ring body 6. The stent distal transition section 524 supports on the inner wall of the distal section 42 of the filter membrane, and a part of the stent main body section 523 supports on the inner wall of the proximal section 41 of the filter membrane.

[0050] During the process of adjusting the outer diameter of the filter, when pushing the inner tube 3 distally, the inner tube 3 drives the ring body 6 to move distally. The ring body 6 pushes the stent proximal transition section 525 to move distally, and the stent diameter-changing section 52 expands radially outward along the outer tube 2, so that the stent main body section 523 of the filter membrane stent 5 and the filter membrane 4 thereon can fit well with the blood vessel wall 10, realizing the adjustment of the outer diameter after the filter membrane stent 5 is deployed.

[0051] In summary, for the embolization protection device provided in the embodiment of the present invention, after the catheter 1 is implanted into the position of the target blood vessel segment, by pulling the catheter 1 proximally, the filter is in a released state after extending out from the distal opening of the catheter 1. Then, move the inner tube 3, and the inner tube 3 drives the ring body 6 to slide axially along the outer tube 2. The ring body 6 can drive the stent diameter-changing section 52 to expand or retract radially outward relative to the outer tube 2, so as to realize the adjustment of the outer diameter after the filter membrane stent 5 is released, enhancing the versatility of the embolization protection device and making it applicable to blood vessels of different diameters.

[0052] Obviously, the above embodiments are only examples clearly described and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation manners here. And the obvious changes or modifications derived therefrom are still within the protection scope of the present invention.

Claims

1. An embolic protection device, characterized in that: include: Catheter (1); A conveying assembly, comprising an outer tube (2) movably inserted into the catheter (1) and an inner tube (3) movably inserted into the outer tube (2); A filter, connected to the conveying assembly, having a recovery state in which the filter is contained in the catheter (1) and a release state in which the filter is extended out of the catheter (1); the filter comprises a filter membrane (4) and a filter membrane support (5), the distal end of the filter membrane (4) being a closed end, and the proximal end of the filter membrane (4) being an open end; the filter membrane support (5) comprising a support fixing section (51) whose relative position to the outer tube (2) is fixed, and a support diameter-changing section (52) whose relative position to the outer tube (2) is variable, the proximal end of the filter membrane (4) being connected to the support diameter-changing section (52); the filter membrane support (5) comprising a plurality of support wires (5a) circumferentially arranged around the catheter (1); the portion of the plurality of support wires (5a) fixedly connected to the outer tube (2) being the support fixing section (51), and the portion of the plurality of support wires (5a) not fixedly connected to the outer tube (2) being the support diameter-changing section (52); The support diameter-changing section (52) comprises a support transition section (521) and a support support section (522), wherein the support support section (522) is located at the distal end of the filter membrane support (5), the support transition section (521) is connected between the support fixing section (51) and the support support section (522), and the proximal end of the filter membrane (4) is connected to the support support section (522); the filter membrane (4) comprises a filter membrane proximal section (41) located at the proximal end and a filter membrane distal section (42) located at the distal end; a track for inserting the support support section (522) is provided inside the filter membrane proximal section (41), and the support support section (522) is connected to the track by sliding along its own axial direction; The inner tube (3) is fixedly connected with a transmission member connected to or abutting against the support diameter-changing section (52); when the filter is in the released state, the transmission member moves axially with the inner tube (3) to drive the support diameter-changing section (52) and the filter membrane (4) thereon to expand outward or retract inward relative to the radial direction of the outer tube (2); The transmission member is a ring body (6) which is slidably sleeved on the outer tube (2) along the axial direction of the outer tube (2); the outer tube (2) is provided with a slide groove (21) which passes through the tube wall of the outer tube (2) and extends along the length direction of the outer tube (2); the ring body (6) is fixed to the inner tube (3) by a pin passing through the slide groove (21).

2. The embolic protection device according to claim 1, characterized in that: There are two slide grooves (21), and the two slide grooves (21) are arranged on opposite sides of the outer tube (2).

3. The embolic protection device according to claim 1, characterized in that: The filter membrane (4) is provided with filter holes, and the pore size of the filter holes is 80 micrometers to 180 micrometers.

4. The embolic protection device according to any one of claims 1 to 3, characterized in that: The filter membrane support (5) is a single-conical support, the opening of which is located at the distal end, and the support fixing section (51) is located at the proximal end of the filter membrane support (5); the transmission member is slidably arranged on the outer tube (2) at the distal end of the support fixing section (51), and the transmission member abuts against the inner wall of the support transition section (521).

5. The embolic protection device according to claim 4, characterized in that: The distal end of the filter membrane distal section (42) is directly fixed on the outer tube (2), or the distal end of the filter membrane distal section (42) is fixed on the outer tube (2) via a distal fixing ring (9).

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