Embolism protection device

Abstract

The invention discloses an embolism protection device, and belongs to the technical field of interventional therapy instruments. The conveying assembly comprises an outer pipe movably arranged in the guide pipe in a penetrating manner and an inner pipe movably arranged in the outer pipe in a penetrating manner; the filter is connected to the conveying assembly and has a recovery state in which the filter is accommodated in the catheter and a release state in which the filter extends out of the catheter; the filter comprises a filter membrane and a filter membrane support, the far end of the filter membrane is a closed end, and the near end of the filter membrane is an open end; the filter membrane bracket comprises a bracket fixing section fixed with the outer tube and a bracket reducing section unfixed with the outer tube, and the near end of the filter membrane is connected to the bracket reducing section; the inner pipe is fixedly provided with a transmission piece connected with or abutting against the variable-diameter section of the support. When the filter is in a release state, the inner tube drives the transmission part to move, and the transmission part can drive the stent reducing section to expand outwards or retract inwards relative to the radial direction of the outer tube, so that the outer diameter is adjusted after the filter membrane stent is released, the universality of the embolism protection device is enhanced, and the embolism protection device can be suitable for blood vessels with different diameters.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional treatment instruments, and in particular to an embolic 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 used clinically to restore the normal lumen and blood flow of the blood vessels. However, in this process, the plaques at the stenotic site are subject to the external force of the balloon or stent, and may break or fall off. Once these broken plaques drift with the blood to the distal blood vessels, especially into the cerebral blood vessels, they may cause embolism and lead to ischemic stroke, which seriously threatens the life, health, and safety of the patient.

[0003] To this end, people have invented an embolic protection device. Without affecting blood perfusion, a filter is opened at the distal end of the diseased segment of the blood vessel to intercept and collect plaques that fall off during the operation. After the operation is completed, the embolic protection device together with the emboli intercepted in the embolic protection device is removed from the human body. The use of the embolic protection device effectively reduces the risk of embolism in distal blood vessels and improves the success rate of the operation.

[0004] However, the outer diameter of the filter used to intercept emboli in the existing embolic protection device is fixed after being deployed, and blood vessels with different diameters need to be matched with embolic filters with different outer diameters, so the existing embolic protection device is not very universal. Summary of the invention

[0005] In view of this, the present invention provides an embolic protection device to solve the defects of the existing embolic protection device that it cannot match blood vessels with different outer diameters and has low versatility, thereby providing an embolic protection device.

[0006] In order to solve the above technical problems, the technical solution of the present invention is as follows: An embolic protection device, comprising: catheter; The delivery assembly comprises an outer tube movably inserted into the catheter and an inner tube movably inserted into the outer tube; A filter is connected to the delivery assembly, and has a recovery state in which the filter is accommodated in the catheter and a release state in which the filter is extended out of 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 fixing section fixedly connected to the outer tube and a support diameter-changing section not fixedly connected to the outer tube, and the proximal end of the filter membrane is connected to the support diameter-changing section. The inner tube is fixedly connected with a transmission member connected to or abutting against the variable diameter section of the bracket. When the filter is in the released state, the transmission member moves axially with the inner tube to drive the variable diameter section of the bracket and the filter membrane thereon to expand outward or retract radially inward relative to the outer tube.

[0007] Furthermore, the transmission member is a ring body slidably sleeved on the outer tube along the axial direction of the outer tube, the outer tube is provided with a slide groove penetrating the tube wall of the outer tube and extending along the length direction of the outer tube, and the ring body is fixed to the inner tube by a pin passing through the slide groove.

[0008] Furthermore, there are two slide grooves, and the two slide grooves are arranged on opposite sides of the outer tube.

[0009] Furthermore, the filter membrane is provided with filter holes, and the pore size of the filter holes is 80 microns to 180 microns.

[0010] Furthermore, the filter membrane support includes a plurality of support wires circumferentially arranged around the catheter; the portion where the plurality of support wires are fixedly connected to the outer tube is the support fixing section, and the portion where the plurality of support wires are not fixedly connected to the outer tube is the support variable diameter section.

[0011] Furthermore, the filter membrane support is a single-conical support, and the opening of the filter membrane support is located at the distal end; the support fixing section is located at the proximal end of the filter membrane support, the support variable section includes a conical support transition section and a cylindrical support support section, the support support section is located at the distal end of the filter membrane support, and the support transition section is connected between the support fixing section and the support support section; the proximal end of the filter membrane is connected to the support support section, and the transmission member is slidably arranged on the outer tube at the distal end of the support fixing section, and the transmission member is against the inner wall of the support transition section.

[0012] Furthermore, the filter membrane includes a proximal segment of the filter membrane located at the proximal end and a distal segment of the filter membrane located at the distal end, the proximal segment of the filter membrane is cylindrical, and the distal segment of the filter membrane is conical; the distal end of the distal segment of the filter membrane is directly fixed on the outer tube or the distal end of the distal segment of the filter membrane is fixed on the outer tube via a distal fixing ring.

[0013] Furthermore, a track for inserting the stent support segment is provided inside the proximal end section of the filter membrane, and the stent support segment is connected to the track by sliding along its own axial direction.

[0014] Furthermore, the filter membrane bracket is a double-conical bracket with conical ends and a cylindrical middle; the bracket fixing section is located at the distal end of the filter membrane bracket, and the bracket variable diameter section includes a bracket main body section located in the middle and cylindrical, a bracket distal transition section connected between the bracket fixing section and the bracket main body section and in a conical shape, and a bracket proximal transition section connected to the proximal end of the bracket main section and in a conical shape; the proximal end of the bracket proximal transition section is fixed on the transmission member.

[0015] Furthermore, the filter membrane includes a proximal segment of the filter membrane located at the proximal end and a distal segment of the filter membrane located at the distal end, the proximal segment of the filter membrane is cylindrical, and the distal segment of the filter membrane is conical; the distal transition segment of the bracket is supported on the inner wall of the distal segment of the filter membrane, and at least a portion of the main body segment of the bracket is supported on the inner wall of the proximal segment of the filter membrane.

[0016] The technical solution of the present invention has the following advantages: the filter of the embolic protection device is housed in the catheter in a recovered state, and when the catheter is implanted at the position of the target blood vessel segment, the filter is extended from the distal opening of the catheter by pulling the catheter proximally and is in a released state, and then the inner tube is moved, and the inner tube drives the transmission member to slide along the axial direction of the outer tube, and the transmission member can drive the stent variable diameter section to expand outward or retract inward relative to the radial direction of the outer tube, thereby realizing the adjustment of the outer diameter of the filter membrane stent after release, so that the versatility of the embolic protection device is enhanced and it can be applied to blood vessels of different diameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 It is a schematic diagram of a filter in the embolic protection device in the first embodiment of the present invention in a recovery state; Figure 2 for Figure 1 The enlarged view of point A in the middle; Figure 3 This is a schematic diagram of the embolic protection device in Embodiment 1 of the present invention when it is implanted in a blood vessel; Figure 4 It is a schematic diagram of a filter in a released state in the embolic protection device in the first embodiment of the present invention; Figure 5 It is a front view of the embolic protection device in the first embodiment of the present invention; Figure 6 is a cross-sectional view of the embolic protection device in Embodiment 1 of the present invention; Figure 7 for Figure 6 The enlarged view of point B in the middle; Figure 8 It is a schematic diagram of the three-dimensional structure of the filter in the embolic protection device in the second embodiment of the present invention in a released state; Fig. 9 It is a front view of the embolic protection device in the second embodiment of the present invention; Fig.10 is a cross-sectional view of the embolic protection device in the second embodiment of the present invention; Fig.11 for Fig.10 Enlarged view of point C in the middle.

[0019] Explanation of the reference numerals in the accompanying drawings: 1. catheter; 2. outer tube; 21. slide groove; 3. inner tube; 4. filter membrane; 41. proximal section of filter membrane; 42. distal section of filter membrane; 5. filter membrane bracket; 5a. support wire; 51. bracket fixing section; 52. bracket variable diameter section; 521. bracket transition section; 522. bracket support section; 523. bracket main section; 524. bracket distal transition section; 525. bracket proximal transition section; 6. ring body; 8. proximal fixing ring; 9. distal fixing ring; 10. blood vessel wall. DETAILED DESCRIPTION

[0020] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] In the description of this application, it should be understood that the terms "proximal end" and "distal end" used throughout the text refer to near and far relative to the operator. When the present invention is used, the end close to the doctor or operator is the "proximal end", that is, the end where the operator is located, and the end away from the doctor or operator is the "distal end", that is, the end where the balloon is located. The above-mentioned description of the orientation is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0022] Embodiment 1 like Figure 1-Figure 7The embolic protection device shown in the figure comprises a catheter 1, a delivery assembly, a filter and a transmission member. The catheter 1 is used to realize the release and recovery of the filter in the blood vessel. The delivery assembly comprises an outer tube 2 and an inner tube 3, wherein the outer tube 2 is movably arranged in the catheter 1, and the inner tube 3 is movably arranged in the outer tube 2; the filter is connected to the delivery assembly. The inner cavity of the inner tube 3 can be used for a guide wire (not shown in the figure) to pass through, and the embolic protection device can be delivered to the target position in the blood vessel through the guide wire. The filter has a recovery state accommodated in the catheter 1 and a release state extending out of the catheter 1; the filter is a deformable structure with one end fixed on 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 the transmission member is against the deformable part of the filter. When the filter is released from the catheter 1, the transmission member can be driven by the inner tube 3 to move toward the end where the filter is fixed, 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 improve the versatility of the embolic protection device.

[0023] like Figure 2 , Figure 3 and Figure 4 As 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, the proximal end of the filter membrane 4 is an open end, and the open end of the filter membrane 4 is connected to the distal end of the filter membrane support 5.

[0024] In some embodiments, the proximal end of the filter membrane support 5 is fixed to the outer tube 2 via a proximal fixing ring 8, and the closed end of the filter membrane 4 is fixed to the outer tube 2 via a distal fixing ring 9. In alternative embodiments, the proximal end of the filter membrane support 5 may be directly fixed to the outer tube 2 without 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 the distal fixing ring 9.

[0025] In some embodiments, Figure 4 and Figure 5 As shown, the membrane support 5 includes a plurality of support wires 5a uniformly spaced around the catheter 1. The membrane support 5 is specifically a single cone support composed of a plurality of support wires 5a, and the opening side of the membrane support 5 is located at the distal end. The membrane support 5 composed of a plurality of support wires 5a is independent of each other and one end is fixed to the outer tube 2. When the portion of the plurality of support wires 5a that is not directly fixed to the outer tube 2 is subjected to an external force, it is easy to bend, so that the shape of the membrane support 5 can be changed after release. In an alternative embodiment, the membrane support 5 can also be a woven mesh structure woven from one or more metal wires and capable of radial expansion or contraction under the action of an external force.

[0026] like Figure 5As shown, the filter membrane 4 includes a filter membrane proximal section 41 located at the proximal end and a filter membrane distal section 42 located at the distal end; when the filter is in a radially expanded state after release, the filter membrane proximal section 41 is cylindrical and the filter membrane distal section 42 is conical. The filter membrane distal section 42 is fixed on the outer tube 2, and the filter membrane proximal section 41 is connected to the distal ends of multiple support wires 5a. The filter membrane 4 is provided with filter holes, and the pore size of the filter hole is 80 microns to 180 microns; to ensure that the blood flow will not leak through the thrombus and can flow smoothly. Specifically, the filter membrane 4 is made of a polymer film material after punching and shaping, and the polymer film material can be a mixture of any one or more of polypropylene (PP), polyvinyl chloride (PVC), polyamide (nylon), polyurethane, polyester, polytetrafluoroethylene glycol, polyetheretherketone (PEEK), polyether block amide (PEBA), and polytetrafluoroethylene (PTFE).

[0027] In some embodiments, Figure 6 and Figure 7 As shown, the membrane support 5 includes a connected support fixing section 51 and a support reducing section 52. The support fixing section 51 is located at the proximal end of the membrane support 5 and fixed on the outer tube 2. The support reducing section 52 is located at the distal end of the membrane support 5 and is not directly fixedly connected to the outer tube 2. The membrane proximal section 41 is connected to the support reducing section 52. That is, the part where the multiple support wires 5a are fixedly connected to the outer tube 2 is the support fixing section 51, and the part where the multiple support wires 5a are not fixedly connected to the outer tube 2 is the support reducing section 52; the support reducing section 52 is suspended on the outer periphery of the outer tube 2, and the support reducing section 52 is the deformable part of the filter. The support reducing section 52 includes a support transition section 521 and a support support section 522. The support support section 522 is located at the distal end of the membrane support 5, and the support transition section 521 is connected between the support support section 522 and the support fixing section 51. When the filter is in a radially expanded state, the support transition section 521 is conical, the support support section 522 is cylindrical, and the filter membrane proximal section 41 is connected to the support support section 522 .

[0028] In some embodiments, Figure 6 and Figure 7As shown, the transmission member is specifically a ring body 6 that is slidably sleeved on the outer tube 2 along the axial direction of the outer tube 2, and the ring body 6 is slidably arranged on the outer tube 2 at the distal end of the stent fixing section 51. The outer tube 2 is provided with a slide groove 21 that penetrates the tube wall of the outer tube 2 and extends along the length direction of the outer tube 2, and the ring body 6 is fixed to the inner tube 3 by a pin passing through the slide groove 21. By moving the inner tube 3 toward the proximal end, the inner tube 3 drives the ring body 6 to move toward the proximal end, and the stent transition section 521 is expanded outward under the abutment force of the inner ring body 6, and the outer diameter of the stent support section 522 increases with the expansion of the stent transition section 521. Therefore, by controlling the distance that the inner tube 3 and the ring body 6 move toward the proximal end, the radial outer diameter of the membrane stent 5 after expansion can be adjusted, so that the versatility of the embolic protection device is enhanced and it can be applied to blood vessels of different diameters. In an alternative embodiment, the transmission member is not limited to the structural form of the ring body 6. Any transmission structure that can move with the inner tube 3 and apply an outward expansion force to the filter membrane support 5 when the inner tube 3 moves relative to the outer tube 2 falls within the protection scope of this application.

[0029] In some embodiments, Figure 6 and Figure 7 As shown, two slide grooves 21 are provided on the outer tube 2, and the two slide grooves 21 are arranged on opposite sides of the outer tube 2; the pin passes through the two slide grooves 21 and the inner tube 3 to achieve a fixed connection between the inner tube 3 and the ring body 6. It can be understood here that the number of the slide grooves 21 on the outer tube 2 is not limited to two, and the pin used to fix the ring body 6 and the inner tube 3 can be one or more.

[0030] like Figure 6 and Figure 7 As shown, in some embodiments, a track (not shown) is provided inside the proximal end section 41 of the filter membrane for inserting the support section 522, and the support section 522 is connected to the track by sliding along its own axial direction. Such a configuration allows the support section 522 and the proximal end section 41 of the filter membrane to move in a certain position in the axial direction, and when the filter membrane support 5 is radially expanded outward under force, the resistance of the filter membrane 4 to the expansion of the filter membrane support 5 can be reduced, so that the filter membrane support 5 can be adjusted to the required outer diameter size.

[0031] When the embolic protection device in the above-mentioned embodiment 1 is in use, in the initial state, the filter is accommodated in the catheter 1, and the filter is in a retracted state. The catheter 1 is moved toward the proximal end, and the filter is extended from the opening at the distal end of the catheter 1 and is in a released state. Then the inner tube 3 is pulled toward the proximal end, and the ring body 6 moves from the distal end to the proximal end on the outer tube 2. The ring body 6 pushes the stent transition section 521 of the filter membrane stent 5 to expand outward, so that the stent support section 522 of the filter membrane stent 5 and the filter membrane 4 thereon can fit well with the blood vessel wall 10; the free thrombus in the blood vessel is easily intercepted by the filter membrane 4. After the balloon dilatation or stent implantation is completed, the embolic protection device together with the thrombus in the device can be withdrawn from the human body.

[0032] Embodiment 2 like Figure 8-Figure 11 The embolic protection device shown is different from the first embodiment in that the filter membrane support 5 is a double-conical support with conical ends and a cylindrical middle, the distal ends of the multiple support wires 5a in the filter membrane support 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 support fixing section 51 is located at the distal end of the filter membrane support 5, and the support diameter reducing section 52 includes a support main body section 523 located in the middle and in a cylindrical shape, a support distal transition section 524 connected between the support fixing section 51 and the support main body section 523 and in a conical shape, and a support proximal transition section 525 connected to the proximal end of the support main body section 523 and in a conical shape; the proximal end of the support proximal transition section 525 is fixed on the ring body 6. The support distal transition section 524 is supported on the inner wall of the filter membrane distal section 42, and a part of the support main body section 523 is supported on the inner wall of the filter membrane proximal section 41.

[0033] During the process of adjusting the outer diameter of the filter, this embolic protection device pushes the inner tube 3 toward the distal end, and the inner tube 3 drives the ring body 6 to move toward the distal end. The ring body 6 pushes the proximal transition section 525 of the stent to move toward the distal end, and the stent variable diameter section 52 expands outward along the radial direction of 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, thereby realizing the adjustment of the outer diameter of the filter membrane stent 5 after expansion.

[0034] In summary, the embolic protection device provided by the embodiment of the present invention, when the catheter 1 is implanted at the position of the target blood vessel segment, by pulling the catheter 1 proximally, the filter extends from the distal opening of the catheter 1 and is in a released state, and then the inner tube 3 is moved, 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 variable diameter section 52 to expand outward or retract inward relative to the radial direction of the outer tube 2, thereby realizing the adjustment of the outer diameter of the filter membrane stent 5 after release, so that the versatility of the embolic protection device is enhanced, and it can be applied to blood vessels of different diameters.

[0035] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled 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 methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the 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 is connected to the conveying assembly and has a recovery state in which it is accommodated in the catheter (1) and a release state in which it 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) is a closed end, and the proximal end of the filter membrane (4) is an open end; the filter membrane support (5) comprises a support fixing section (51) whose relative position to the outer tube (2) is fixed and a support variable diameter section (52) whose relative position to the outer tube (2) is variable, and the proximal end of the filter membrane (4) is connected to the support variable diameter section (52); The inner tube (3) is fixedly connected with a transmission member connected to or abutting against the support variable diameter section (52); when the filter is in the released state, the transmission member moves axially with the inner tube (3) to drive the support variable diameter section (52) and the filter membrane (4) thereon to expand outwardly or retract inwardly relative to the radial direction of the outer tube (2).

2. The embolic protection device according to claim 1, characterized in that: 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).

3. The embolic protection device according to claim 2, 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).

4. 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.

5. The embolic protection device according to claim 1, characterized in that: The filter membrane support (5) comprises a plurality of support wires (5a) circumferentially arranged around the catheter (1); the portion where the plurality of support wires (5a) are fixedly connected to the outer tube (2) is the support fixing section (51), and the portion where the plurality of support wires (5a) are not fixedly connected to the outer tube (2) is the support variable diameter section (52).

6. The embolic protection device according to any one of claims 1 to 5, 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 support variable section (52) includes a support transition section (521) and a support support section (522), the support support section (522) is located at the distal end of the filter membrane support (5), and the support transition section (521) is connected between the support fixing section (51) and the support support section (522); the proximal end of the filter membrane (4) is connected to the support support section (522), and 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).

7. The embolic protection device according to claim 6, characterized in that: The filter membrane (4) comprises a filter membrane proximal segment (41) located at the proximal end and a filter membrane distal segment (42) located at the distal end; the distal end of the filter membrane distal segment (42) is directly fixed to the outer tube (2) or the distal end of the filter membrane distal segment (42) is fixed to the outer tube (2) via a distal fixing ring (9).

8. The embolic protection device according to claim 6, characterized in that: A track for inserting the support section (522) is provided inside the filter membrane proximal section (41), and the support section (522) is connected to the track by sliding along its own axial direction.

9. The embolic protection device according to any one of claims 1 to 5, characterized in that: The filter membrane support (5) is a double-conical support with conical ends and a cylindrical middle; the support fixing section (51) is located at the distal end of the filter membrane support (5), and the support variable diameter section (52) includes a support main body section (523) located in the middle, a support distal transition section (524) connected between the support fixing section (51) and the support main body section (523), and a support proximal transition section (525) connected to the proximal end of the support main body section (523); the proximal end of the support proximal transition section (525) is fixed to the transmission member.

10. The embolic protection device according to claim 9, characterized in that: 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; the support distal transition section (524) is supported on the inner wall of the filter membrane distal section (42), and at least a part of the support main section (523) is supported on the inner wall of the filter membrane proximal section (41).

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