An embolic protection device

Abstract

This invention discloses an embolism protection device, belonging to the field of interventional therapy device technology. It includes: a slender support body and a filter assembly sleeved around the slender support body. The filter assembly includes a proximal filter membrane support and a filter membrane. The proximal end of the filter membrane is an open end, and the distal end is a closed end. The proximal end of the filter membrane is connected to the slender support body via the proximal filter membrane support. The open end forms an opening for thrombi to enter the filter membrane, and the closed end forms a seal to trap the thrombus. The filter membrane includes a recessed portion formed from the closed end towards the proximal end, and the recessed portion is fixedly connected to the slender support body. With this configuration, when the filter membrane intercepts thrombi, the recessed portion guides the intercepted thrombi to be more dispersed within the filter membrane around the recessed portion. Compared to the closed end of a traditional conical filter, the closed end of the filter membrane is less prone to thrombus accumulation, reducing the risk of blood flow obstruction due to excessive thrombus buildup.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and specifically to an embolism protection device. Background Technology

[0002] When atherosclerotic stenosis occurs in peripheral blood vessels, coronary arteries, and carotid arteries, balloon angioplasty or stent implantation is commonly used clinically to restore normal lumen and blood flow. However, during this process, the plaque at the stenotic site may break or detach due to the external force of the balloon or stent. If these broken plaques drift with the blood to distal blood vessels, especially into cerebral vessels, they can cause embolism, leading to ischemic stroke, which seriously threatens the patient's life and health.

[0003] To address this, an embolization protection device was invented. Without affecting blood flow, a filter is opened at the distal end of the lesion to intercept and collect thrombi that break off during the procedure. After the procedure, the embolization protection device, along with the thrombi intercepted within it, is removed from the body. The use of this embolization protection device effectively reduces the risk of distal vascular embolism and improves the success rate of the procedure.

[0004] Embolism protection devices mainly consist of a guidewire and a filter connected distally to the guidewire. The opening of the unfolded filter is located proximally, allowing intravascular thrombi to enter the filter through this proximal opening. However, existing embolism protection devices typically use a conical filter with an open proximal end and a conical closed distal end. This can lead to excessive thrombus buildup within the conical tip of the filter, potentially obstructing blood flow. Summary of the Invention

[0005] In view of this, the present invention provides an embolism protection device to solve the problem that thrombi easily accumulate in the filter screen of existing embolism protection devices, which can easily block blood flow channels.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: An embolism protection device includes: an elongated support body; A first filter assembly is sleeved on the outer periphery of the elongated support body and has an expanded configuration that extends radially outward relative to the elongated support body. The first filter assembly includes a first proximal filter membrane support and a first filter membrane. The proximal end of the first filter membrane is a first open end, and the distal end of the first filter membrane is a first closed end. The proximal end of the first filter membrane is connected to the elongated support body through the first proximal filter membrane support. When the first filter assembly is in the expanded configuration, the first open end forms an opening for thrombi to enter the first filter membrane, and the first closed end forms a seal to trap thrombi. The first filter membrane includes a first filter membrane recess formed from the first closed end toward the proximal end, and the first filter membrane recess is fixedly connected to the elongated support body.

[0007] Furthermore, the first filter membrane is provided with a plurality of first filter holes, at least some of which are located in the recessed portion of the first filter membrane; when the first filter assembly is in the unfolded configuration, the space inside the first filter membrane is a first retention cavity, the space surrounding the first filter membrane recessed portion outside the elongated support body is a first flow guiding cavity, the first filter membrane recessed portion separates the first retention cavity and the first flow guiding cavity, and the first filter holes on the first filter membrane recessed portion keep the first retention cavity and the first flow guiding cavity unobstructed.

[0008] Furthermore, the central axis of the first filter membrane recess coincides with the central axis of the elongated support body, and the proximal end of the first filter membrane recess is gathered and fixed to the outer periphery of the elongated support body.

[0009] Furthermore, the first filtration assembly also includes a distal filter membrane support, and the first filter membrane recess is fixedly connected to the outer periphery of the elongated support body via the distal filter membrane support.

[0010] Furthermore, the distal filter membrane support is fixed to the outer wall of the first filter membrane recess and arranged circumferentially around the elongated support body. When the first filter assembly is in the unfolded configuration, the distal filter membrane support provides radial support for the first filter membrane recess.

[0011] Furthermore, the distal filter membrane support includes a distal filter membrane support fixing section and a distal filter membrane support supporting section. The distal filter membrane support fixing section is fixedly connected to the outer periphery of the elongated support body, and the proximal end of the first filter membrane recess is fixed to the distal filter membrane support fixing section. One end of the distal filter membrane support supporting section is connected to the proximal end of the distal filter membrane support fixing section, and the distal filter membrane support supporting section supports the outer wall of the first flow guide cavity formed by the first filter membrane recess. The distal filter membrane support supporting section can be radially outward relative to the elongated support body to maintain the unfolded configuration of the first filter membrane recess.

[0012] Furthermore, the distal filter membrane support section includes a distal filter membrane support section and a second distal filter membrane support section, wherein the distal filter membrane support section is connected between the distal filter membrane support fixing section and the second distal filter membrane support section; when the first filtration assembly is in the unfolded configuration, the distal filter membrane support section is conical and the second distal filter membrane support section is cylindrical.

[0013] Furthermore, the distal filter membrane support is a self-expanding support that can radially expand and unfold after the external force is removed; and / or, the first proximal filter membrane support is a self-expanding support that can radially expand and unfold after the external force is removed.

[0014] Furthermore, the embolism protection device further includes a second filter assembly sleeved on the outer periphery of the elongated support body. The second filter assembly has an expanded configuration that extends radially outward relative to the elongated support body. The second filter assembly includes a second proximal filter membrane support and a second filter membrane. The proximal end of the second filter membrane is a second open end, and the distal end of the second filter membrane is a second closed end. The proximal end of the second filter membrane is connected to the elongated support body through the second proximal filter membrane support. When the second filter assembly is in the expanded configuration, the second open end forms an opening for the thrombus to enter the second filter membrane, and the second closed end forms a seal to trap the thrombus. At least a portion of the second filter membrane is located inside the first filter membrane. The first filter membrane has a plurality of first filter pores, and the second filter membrane has a plurality of second filter pores. The pore diameter of the second filter pores is larger than the pore diameter of the first filter pores.

[0015] Furthermore, the second filter membrane includes a second filter membrane recess formed by a depression from the second closed end toward the proximal end, the central axis of the second filter membrane recess coincides with the central axis of the elongated support body, and the proximal end of the second filter membrane recess is gathered and fixed to the outer periphery of the elongated support body.

[0016] Furthermore, when the second filter assembly is in the unfolded configuration, the space inside the second filter membrane is the second retention cavity, the space surrounding the second filter membrane recess is the second flow guiding cavity, the second filter membrane recess separates the second retention cavity and the second flow guiding cavity, and the second filter pore on the second filter membrane recess keeps the second retention cavity and the second flow guiding cavity unobstructed.

[0017] Furthermore, when the second filter assembly is in the unfolded configuration, the second filter membrane recess is a trumpet shape with a diameter that gradually decreases from the distal end to the proximal end.

[0018] Furthermore, the inner wall surface of the second filter membrane recess is adapted to guide the thrombus in the second retention cavity into the farthest end of the second retention cavity, so that a portion of the second filter pore on the second filter membrane recess remains unobstructed.

[0019] Furthermore, at least a portion of the second filter pore is located on the distal surface of the second filter membrane; the second filter pore on the distal surface of the second filter membrane allows thrombi with a size smaller than the second filter pore to pass through.

[0020] Furthermore, the second proximal filter membrane support is a self-expanding support that can radially expand and unfold after the external force is removed.

[0021] Furthermore, when both the second filter assembly and the first filter membrane assembly are in the deployed configuration, the outer diameter and axial length of the second filter membrane are both smaller than those of the first filter membrane.

[0022] Furthermore, both the first proximal filter membrane support and the second proximal filter membrane support have multiple support bars arranged circumferentially around the elongated support body; the multiple support bars of the first proximal filter membrane support and the multiple support bars of the second proximal filter membrane support are staggered in the circumferential direction of the elongated support body.

[0023] Furthermore, the embolism protection device also includes a turbine fan and a sheath. The turbine fan is connected to the elongated support body and located near the proximal end of the first filter assembly. The sheath is sleeved around the outer periphery of the elongated support body. The turbine fan includes a turbine fan body sleeved and fixed around the outer periphery of the elongated support body, and multiple elastic blades connected around the outer periphery of the turbine fan body. The multiple elastic blades have a retracted state within the sheath and an extended state that expands radially outward relative to the turbine fan body after the sheath is withdrawn. When the elastic blades are in the extended state, they can guide the thrombus to flow more rapidly toward the first filter assembly.

[0024] Furthermore, when the elastic fan blades are in the deployed state, the multiple elastic fan blades form a passive turbulence shape, and the blood clots in the blood flow are guided by the elastic fan blades to accelerate their flow toward the first filter component.

[0025] Furthermore, the turbofan body is equipped with a power device for driving the rotation of multiple elastic fan blades. The power device is connected to an external power source via wires. When the elastic fan blades are in the unfolded state, the power device can drive the multiple elastic fan blades to rotate circumferentially around the slender support body to accelerate the flow of blood clots toward the first filter assembly.

[0026] The technical solution of this invention has the following advantages: The first filtering component of this embolism protection device uses a combination of a first filter membrane and a first proximal filter membrane support to replace the traditional mesh-like conical filter screen for intercepting and collecting thrombi. The filter membrane is generally made of flexible polymer material, which makes it easier to adjust the shape of the filter membrane compared to traditional wire mesh filters. The first proximal filter membrane support provides support for the first filter membrane at its open end, ensuring the first filter membrane maintains its shape stability in the unfolded state. Simultaneously, the first filter membrane includes a proximal concave section at its first closed end. The first filter membrane is formed by a recess, which is fixedly connected to the slender support body. When the first filter membrane intercepts thrombi, the recess can guide the intercepted thrombi into the farthest part of the inner wall of the first filter membrane. This means that the thrombi can be more dispersed in the first filter membrane around the recess. Compared with the traditional filter mesh with a conical closed end, this type of first filter membrane is less prone to thrombus accumulation, reducing the surgical risk caused by excessive thrombus accumulation blocking the blood flow channel in the embolism protection device.

[0027] In addition, some of the first filter holes are located on the recessed part of the first filter membrane. Since the shape of the recessed part of the first filter membrane has a certain guiding effect on the thrombus in the first filter membrane, the thrombus in the first filter membrane is less likely to accumulate on the surface of the recessed part of the first filter membrane. The first filter holes on the recessed part of the first filter membrane are more likely to remain unobstructed. While the first filter membrane can intercept the thrombus, it can also maintain a certain degree of patency, reducing the surgical risk caused by the blockage of the blood flow channel due to excessive thrombus accumulation in the embolism protection device. Attached Figure Description

[0028] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0029] Figure 1 This is a three-dimensional structural diagram of the embolism protection device in Embodiment 1 of the present invention; Figure 2 This is a front view of the embolism protection device in Embodiment 1 of the present invention; Figure 3 This is a cross-sectional view of the embolism protection device in Embodiment 1 of the present invention; Figure 4 for Figure 3 Enlarged view of point A in the middle; Figure 5 This is a remote view of the embolism protection device in Embodiment 1 of the present invention; Figure 6 This is a schematic diagram of the working state of the embolism protection device in the blood vessel to intercept thrombi in Embodiment 1 of the present invention; Figure 7 This is a three-dimensional structural diagram of the embolism protection device in Embodiment 2 of the present invention, which intercepts thrombi in blood vessels. Figure 8 This is a near-end view of the embolism protection device in Embodiment 2 of the present invention when the first filter component and the second filter component are in the deployed configuration and the turbofan is in the deployed state. Figure 9 This is a schematic diagram of the working state of the embolism protection device in the second embodiment of the present invention, in which the first and second filter components are in the deployed configuration and the turbine fan is in the deployed state, and the embolism protection device intercepts thrombi in the blood vessel. Figure 10 This is a near-end view of the embolism protection device in Embodiment 2 of the present invention, in which both the first and second filter components are in an extended configuration and the turbine fan is in a retracted state. Figure 11 This is a schematic diagram of the working state of the embolism protection device in the second embodiment of the present invention, in which both the first and second filter components are in an extended configuration and the turbine fan is in a retracted state, thus showing the device intercepting thrombi in the blood vessel. Figure 12 This is a schematic diagram showing the positional relationship between the turbofan and the sheath in the embolism protection device of Embodiment 2 of the present invention when the turbofan is in the retracted state. Part of the sheath has been removed to show the specific structure of the internal turbofan. Figure 13 for Figure 12 Enlarged view of point B in the middle; Figure 14 This is a schematic diagram showing the positional relationship between the turbofan and the sheath in the embolism protection device of Embodiment 2 of the present invention when the turbofan is in the deployed state; Figure 15 for Figure 14 The front view; Figure 16 for Figure 15 Enlarged view of point C in the middle.

[0030] Explanation of reference numerals in the attached drawings: 1. Slender support body; 2. First filter assembly; 21. First proximal filter membrane support; 21a. Support fixing section; 21b. Support unfolding section; 21c. Support connecting section; 22. First filter membrane; 22a. First open end; 22b. First closed end; 22c. First filter membrane recess; 221. First filter pore; 23. Distal filter membrane support; 231. Distal filter membrane support fixing section; 232. First distal filter membrane support supporting section; 232. Second distal filter membrane support supporting section; 3. Second filter assembly; 31. Second filter membrane support; 32. Second filter membrane; 32a. Second open end; 32b. Second closed end; 32c. Second filter membrane recess; 321. Second filter pore; 4. Blood vessel; 5. Thrombus; 6. Turbofan; 61. Turbofan body; 62. Elastic fan blade; 63. Wire; 7. Sheath. Detailed Implementation

[0031] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] In the description of this application, it should be understood that the terms "proximal" and "distal" throughout refer to near and far relative to the operator. In use, the end closer to the doctor or operator is the "proximal" end, i.e., the end where the operator is located, and the end farther from the doctor or operator is the "distal" end, i.e., the end where the balloon is located. The above descriptions of orientation are for ease of description and simplification only, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on this application.

[0033] Example 1 like Figure 1 and Figure 2An embolism protection device is shown, comprising an elongated support body 1, a first filter assembly 2, and an external catheter (not shown). The first filter assembly 2 is sleeved and connected to the outer periphery of the distal end of the elongated support body 1, and the inner lumen of the external catheter allows the elongated support body 1 to pass through. The elongated support body 1 is used to deliver the first filter assembly 2 to a target location within the blood vessel for release. The elongated support body 1 can be a slender guidewire or a slender catheter. The first filter assembly 2 is a deformable structure fixed to the outer periphery of the elongated support body 1. The first filter assembly 2 has a retracted state under external force, retracting to the outer periphery of the elongated support body 1, and an extended state, radially outwardly unfolded relative to the elongated support body 1, after the external force is removed. When the external force on the first filter assembly 2 is removed, the first filter assembly 2 expands radially outward relative to the elongated support body 1 into its extended configuration.

[0034] like Figure 1 and Figure 2 As shown, the first filtration assembly 2 includes a first proximal filter membrane support 21 and a first filter membrane 22. The proximal end of the first proximal filter membrane support 21 is fixedly connected to the elongated support body 1, and the proximal end of the first filter membrane 22 is connected to the distal end of the first proximal filter membrane support 21. Specifically, the first filter membrane 22 is a polymer film attached proximally to the first proximal filter membrane support 21. The first filter membrane 22 has multiple first filter pores 221, with a pore size ranging from 80 micrometers to 180 micrometers, to ensure that blood flow is unimpeded while preventing thrombus leakage. The proximal end of the first filter membrane 22 is a first open end 22a, and the distal end of the first filter membrane 22 is a first closed end 22b. When the first filter assembly 2 is in its deployed configuration, the first open end 22a forms an opening for the thrombus to enter the first filter membrane 22, and the first closed end 22b forms a seal to trap the thrombus. The distal end of the first proximal filter membrane support 21 provides radial support to the first filter membrane 22, so that the first filter membrane 22 can adhere to the inner wall of the blood vessel as closely as possible. The first filter assembly 2 uses a combination of filter membrane and filter membrane support to replace the traditional mesh-like conical metal filter to intercept and collect thrombi. Furthermore, since the filter membrane is generally made of flexible polymer material, it is easier to adjust the shape of the filter membrane after its distal end is deployed compared to traditional woven metal wire filters.

[0035] Specifically, the first filter membrane 22 is made of a polymer film material after being perforated and shaped. The material of the first filter membrane 22 can be polypropylene (PP), polyvinyl chloride (PVC), polyamide (nylon), polyurethane, polyester, polyethylene terephthalate (PET), polyether block amide (PEBA), polytetrafluoroethylene (PTFE) or a mixture, blend or combination thereof.

[0036] like Figure 2 , Figure 3 and Figure 6As shown, the first proximal filter membrane support 21 is a self-expanding support that can expand radially after the external force is removed. The self-expanding support can be a shape memory alloy support with shape memory function. The first proximal filter membrane support 21 can also be a deformable support that can expand radially outward under the action of external force. As long as the first proximal filter membrane support 21 can expand radially outward relative to the slender support body 1 on the outer periphery of the slender support body 1, it is acceptable. When the first proximal filter membrane support 21 expands radially outward, the first proximal filter membrane support 21 drives the first filter membrane 22 to expand. After expanding radially outward, the first proximal filter membrane support 21 has a single conical configuration with the opening located at the distal end.

[0037] like Figure 2 , Figure 3 and Figure 6 As shown, in some embodiments, the first proximal filter membrane stent 21 includes multiple support strips evenly spaced around the elongated support body 1. The proximal ends of the multiple support strips are fixed to the outer periphery of the elongated support body 1, and the proximal end of the first filter membrane 22 is connected to the distal ends of the multiple support strips. This first proximal filter membrane stent 21, composed of multiple support strips, is prone to bending when the portions of the multiple support strips not directly fixed to the elongated support body 1 are subjected to external force, as the multiple support strips are independent of each other and their proximal ends are fixed to the elongated support body 1. This allows for shape changes of the first proximal filter membrane stent 21 after release, facilitating further adjustment of the opening angle of the first proximal filter membrane stent 21 after the first filter assembly 2 is released, so that the first filter membrane 22 can adhere to the inner wall of the blood vessel 4 as closely as possible. In alternative embodiments, the first proximal filter membrane stent 21 can also be a woven mesh stent made of one or more metal wires that can expand or contract radially under external force.

[0038] like Figure 2 , Figure 3 and Figure 6 As shown, in some embodiments, the first proximal filter membrane support 21 includes a support fixing section 21a, a support unfolding section 21b, and a support connecting section 21c, all of which are integral structures. The support fixing section 21a is the portion of the first proximal filter membrane support 21 whose proximal end is fixed to the outer periphery of the elongated support body 1; that is, the portion where multiple support bars are fixedly connected to the elongated support body 1. The support connecting section 21c is the portion where the distal end of the first proximal filter membrane support 21 connects to the first filter membrane 22 and provides radial support to the first filter membrane 22. The support unfolding section 21b is the portion of the first proximal filter membrane support 21 connected between the support fixing section 21a and the support connecting section 21c. When the first filter assembly 2 is in the unfolded configuration, the support unfolding section 21b is conical, and the support connecting section 21c is cylindrical.

[0039] like Figure 1 , Figure 3 and Figure 6As shown, the first filter membrane 22 includes a first filter membrane recess 22c formed by recessing from the first closed end 22b towards the proximal end. The first filter membrane recess 22c is a part of the first filter membrane 22, and the proximal end of the first filter membrane recess 22c is fixedly connected to the elongated support body 1. A portion of the first filter holes 221 are provided on the portion of the filter membrane forming the first filter membrane recess 22c, and another portion of the first filter holes 221 are provided on the portion of the filter membrane forming the first closed end 22b. When the first filter membrane 22 intercepts the thrombus 5 in the blood vessel 4, the recessed portion 22c of the first filter membrane can guide the intercepted thrombus 5 into the farthest end of the inner wall of the first filter membrane 22. That is, the thrombus 5 can be more dispersed in the first filter membrane 22 around the recessed portion 22c. Compared with the traditional filter screen with a conical shape at the distal end, the first filter component 2 with this structure is less prone to thrombus 5 accumulation inside the first filter membrane 22. During the operation, the risk of blood flow channel blockage caused by excessive accumulation of thrombus 5 in the first filter membrane 22 can be reduced.

[0040] like Figure 1 , Figure 3 and Figure 6 As shown, in some embodiments, the first filter membrane 22 includes only one first filter membrane recess 22c, and the central axis of the first filter membrane recess 22c coincides with the central axis of the elongated support body 1. The proximal end of the first filter membrane recess 22c is tapered and glued to the outer periphery of the elongated support body 1. When the first filter assembly 2 is in the unfolded configuration, the space inside the first filter membrane 22 is the first retention cavity, and the space enclosed by the first filter membrane recess 22c around the elongated support body 1 is the first flow guiding cavity. The first filter membrane recess 22c separates the first retention cavity and the first flow guiding cavity. The first flow guiding cavity has a trumpet-shaped shape with a large distal opening and a small proximal opening. The multiple first filter holes 221 on the first filter membrane recess 22c allow blood flow to remain unobstructed between the first retention cavity and the first flow guiding cavity. In an alternative embodiment, the first filter membrane 22 includes a plurality of first filter membrane recesses 22c formed by recessing from the first closed end 22b toward the proximal end. The plurality of first filter membrane recesses 22c are arranged circumferentially around the elongated support body 1. The plurality of first filter membrane recesses 22c are all fixedly connected to the outer periphery of the elongated support body 1. The plurality of first filter membrane recesses 22c are provided with a plurality of first filter holes 221 for blood flow to pass through.

[0041] like Figure 3 , Figure 4 and Figure 6As shown, since the blood flow in the blood vessel 4 is from the first open end 22a to the first closed end 22b of the first filter membrane 22, some of the first filter holes 221 on the first closed end 22b can allow the blood flow to pass smoothly. When there are many thrombi 5 intercepted in the first filter membrane 22, some of the first filter holes 221 on the first closed end 22b may be blocked by the thrombi 5, but the blood flow can still pass smoothly through the multiple first filter holes 221 on the recessed part 22c of the first filter membrane.

[0042] like Figure 3 , Figure 4 , Figure 5 and Figure 6 As shown, when too much thrombus 5 is trapped in the first retention cavity of the first filter membrane 22, the first filter membrane recess 22c located at the center of the first filter membrane 22 will still be subjected to lateral compression from some of the thrombus 5. To prevent the first filter membrane recess 22c from being crushed and deformed, the first filter assembly 2 also includes a distal filter membrane support 23 that provides radial support for the first filter membrane recess 22c. The distal filter membrane support 23 is fixedly connected to the outer periphery of the slender support body 1, and the first filter membrane recess 22c is glued to the distal filter membrane support 23. The distal end of the first filter membrane recess 22c is fixedly connected to the outer periphery of the slender support body 1 through the distal filter membrane support 23. When the first filter assembly 2 is in the unfolded configuration, the distal filter membrane support 23 provides radial support for the first filter membrane recess 22c to maintain the preset shape of the first filter membrane recess 22c and prevent the first filter membrane recess 22c from deforming under the action of thrombus 5 or blood flow.

[0043] like Figure 3 , Figure 4 , Figure 5 and Figure 6 As shown, in some embodiments, the distal filter membrane support 23 is fixed to the outer wall of the first filter membrane recess 22c forming the first flow guiding cavity, and the distal filter membrane support 23 is arranged circumferentially around the elongated support body 1. In alternative embodiments, the distal filter membrane support 23 can also be fixed to the inner wall of the first filter membrane recess 22c forming the first retention cavity, and the distal filter membrane support 23 can also be inserted into the interior of the first filter membrane recess 22c, as long as the distal filter membrane support 23 can provide radial support to the first filter membrane recess 22c.

[0044] like Figure 3 , Figure 4 and Figure 6As shown, the distal filter membrane holder 23 includes a distal filter membrane holder fixing section 23a and a distal filter membrane holder support section, which are integral structures. The distal filter membrane holder fixing section 23a is fixedly connected to the outer periphery of the elongated support body 1. The proximal end of the first filter membrane recess 22c is adhesively fixed to the gap between the distal filter membrane holder fixing section 23a and the elongated support body 1. The distal filter membrane holder fixing section 23a extends a certain length along the axial direction of the elongated support body 1 to increase the adhesive fixing area between the proximal end of the first filter membrane recess 22c and the distal filter membrane holder fixing section 23a, thereby improving the connection reliability of the first filter membrane recess 22c. One end of the distal filter membrane support section is connected to the proximal end of the distal filter membrane support fixing section 23a. The distal filter membrane support section supports the outer wall of the first filter membrane recess 22c to form the first flow guide cavity. The first filter membrane 22 and the distal filter membrane support section are attached to each other. The distal filter membrane support section can be relatively long and thin and expand radially outward to maintain the expanded configuration of the first filter membrane recess 22c.

[0045] like Figure 3 , Figure 4 and Figure 6 As shown, the distal filter membrane support section includes a first distal filter membrane support section 231 and a second distal filter membrane support section 232. The first distal filter membrane support section 231 is connected between the distal filter membrane support fixing section 23a and the second distal filter membrane support section 232. When the first filter assembly 2 is in the deployed configuration, the first distal filter membrane support section 231 is a frustum shape with a large distal opening and a small proximal opening, and the second distal filter membrane support section 232 is cylindrical. The first distal filter membrane support section 231 allows the portion of the filter membrane attached to the first distal filter membrane support section 231 to be conical. This conical portion of the filter membrane forms a flow-guiding structure within the first filter membrane 21, which reduces the blood flow pressure on the proximal end of the first filter membrane recess 22c and helps the first filter membrane recess 22c maintain morphological stability in the blood flow environment for a long time. The second distal filter membrane support section 232 allows the portion of the filter membrane attached to the first filter membrane recess 22c to also be cylindrical, resulting in a larger flow space in the first flow cavity within the first filter membrane recess 22c. This prevents thrombi from accumulating in the first flow cavity and facilitates smooth blood flow.

[0046] like Figure 3 , Figure 4 and Figure 6As shown, the distal filter membrane stent 23 can be a self-expanding stent composed of multiple independent support wires, or it can be a woven mesh self-expanding stent made of one or more support wires. When the first filter assembly 2 is released, the first proximal filter membrane stent 21 expands or unfolds under external force to drive the proximal portion of the first filter membrane 22 to expand radially outward, and the distal filter membrane stent 23 expands to drive the first filter membrane recess 22c of the first filter membrane 22 to expand radially outward. The purpose of the first proximal filter membrane stent 21 providing radial support force to the first filter membrane 22 is to improve the vascular adhesion of the first filter membrane 22, and the purpose of the distal filter membrane stent 23 providing radial support force to the first filter membrane recess 22c is to maintain the unfolded configuration of the first filter membrane recess 22c, so that blood flow can pass smoothly through the first filter pore 221 on the first filter membrane recess 22c.

[0047] like Figure 3 , Figure 4 and Figure 6 As shown, the embolism protection device also includes a second filter assembly 3 sleeved on the outer periphery of the elongated support body 1. The structure of the second filter assembly 3 is similar to that of the first filter assembly 2, but its overall size is smaller than that of the first filter assembly 2. The second filter assembly 3 is also a deformable structure fixed on the outer periphery of the elongated support body 1, and it has an outwardly expanding configuration relative to the elongated support body 1. It should be understood that using a combination of the first filter assembly 2 and the second filter assembly 3 to intercept thrombi is only one preferred embodiment of this application. Alternatively, using a single first filter assembly 2 with a first filter membrane recess 22c on the elongated support body 1 to intercept thrombi is also an embodiment of this application.

[0048] like Figure 3 , Figure 4 and Figure 6 As shown, the second filtration assembly 3 includes a second proximal filter membrane support 31 and a second filter membrane 32. The proximal end of the second proximal filter membrane support 31 is fixedly connected to the elongated support body 1, and the proximal end of the second filter membrane 32 is connected to the distal end of the second proximal filter membrane support 31. Specifically, the second filter membrane 32 is a polymer film attached proximal to the second proximal filter membrane support 31. The second filter membrane 32 has multiple second filter pores 321, with a pore size ranging from 80 micrometers to 180 micrometers. The pore size of the second filter pores 321 is larger than that of the first filter pores 221, allowing thrombi 5 smaller than the size of the second filter pores 321 to pass through. The proximal end of the second filter membrane 32 is a second open end 32a, and the distal end of the second filter membrane 32 is a second closed end 32b. The second open end 32a forms an opening for the thrombus 5 to enter the second filter membrane 32, and the second closed end 32b forms a seal to trap the thrombus 5.

[0049] like Figure 3 , Figure 4 and Figure 6 As shown, when both the first filter assembly 2 and the second filter assembly 3 are in the deployed configuration, the first filter membrane 22 is deployed under the radial support of the first proximal filter membrane support 21, and the second filter membrane 32 is deployed under the radial support of the second proximal filter membrane support 31. The outer diameter of the second filter membrane 32 in the deployed configuration is smaller than the outer diameter of the first filter membrane 22 in the deployed configuration, and the axial length of the second filter membrane 32 in the deployed configuration is smaller than the axial length of the first filter membrane 22 in the deployed configuration. Furthermore, part or all of the second filter membrane 32 is located within the first interception cavity of the first filter membrane 22. Specifically, the inner second filter membrane 32 is used to intercept some larger thrombi 5, while the outer first filter membrane 22 is used to intercept some smaller thrombi 5. This embolism protection device uses two sets of filter components, one inside and one outside, to intercept thrombi 5. On the one hand, the two filter membranes can achieve graded interception of thrombi 5 of different sizes, intercepting more thrombi 5. On the other hand, the second filter membrane 32 is located in the middle of the open end of the first filter membrane 22. The second filter membrane 32 has a certain obstruction effect on the blood flow, and the blood flow is not easy to directly impact the first filter membrane recess 22c of the first filter membrane 22. The blood flow passing through the outer peripheral gap of the second filter membrane 32 will flow along the inner wall of the first filter membrane 22 and will not impact the first filter membrane recess 22c. These settings are conducive to preventing the first filter membrane recess 22c from deforming under the action of blood flow. The first filter membrane recess 22c can stably maintain its own shape. The first filter hole 221 on the first filter membrane recess 22c can always maintain good patency of the first filter membrane 22, preventing the accumulation of thrombi 5 in the first filter membrane 22 and reducing the blockage of the blood flow channel in the blood vessel 4 due to the accumulation of thrombi 5 at the distal end of the first filter membrane 22.

[0050] like Figure 3 , Figure 4 and Figure 6 As shown, the second proximal filter membrane support 31 can adopt the same structure as the first proximal filter membrane support 21, which will not be described in detail here. The position where the proximal end of the first proximal filter membrane support 21 is fixed to the slender support body 1 is located at the far end of the position where the proximal end of the second proximal filter membrane support 31 is fixed to the slender support body 1, and the entire second proximal filter membrane support 31 is located within the space enclosed by the first proximal filter membrane support 21.

[0051] like Figure 3 , Figure 4 and Figure 6As shown, the second filter membrane 32 includes a second filter membrane recess 32c formed from the second closed end 32b towards the proximal end. The central axis of the second filter membrane recess 32c coincides with the central axis of the elongated support body 1. The proximal end of the second filter membrane recess 32c is closed and glued to the outer periphery of the elongated support body 1. When the second filter assembly 3 is in the unfolded configuration, the space inside the second filter membrane 32 is the second retention cavity, and the space enclosed by the second filter membrane recess 32c around the elongated support body 1 is the second flow guiding cavity. The second filter membrane recess 32c separates the second retention cavity and the second flow guiding cavity. When the second filter assembly 3 is in the unfolded configuration, the second filter membrane recess 32c is a trumpet shape with a diameter that gradually decreases from the distal end to the proximal end. A portion of the second filter holes 321 are provided on the portion of the filter membrane forming the second filter membrane recess 32c, and another portion of the second filter holes 221 are provided on the portion of the filter membrane forming the second closed end 32b. The second filter pores 321 on the recessed portion 32c of the second filter membrane allow blood flow to remain unobstructed in the second retention chamber and the second diversion chamber. The proximal end of the second closed end 32b can be fixed to the slender support body 1 at intervals by a bracket, or the proximal end of the second closed end 32b can be directly glued to the slender support body 1.

[0052] like Figure 3 , Figure 4 and Figure 6 As shown, the inner wall surface of the second filter membrane recess 32c forming the second retention cavity is an arc-shaped curved surface. This arc-shaped curved surface is suitable for guiding the thrombus 5 within the second filter membrane 32 into the farthest end of the second retention cavity, so that a portion of the second filter pores 321 on the second filter membrane recess 32c remains unobstructed. The second filter pores 321 on the portion of the filter membrane forming the second closed end 32b allow some thrombi 5 smaller than the second filter pore 321 to pass through. The second proximal filter membrane stent 31 is a self-expanding stent capable of radially expanding and unfolding after the external force is removed.

[0053] like Figure 3 , Figure 4 and Figure 6 As shown, the first proximal filter membrane support 21 and the second proximal filter membrane support 31 both have multiple support bars arranged circumferentially around the slender support body 1; the multiple support bars of the first proximal filter membrane support 21 and the multiple support bars of the second proximal filter membrane support 31 are staggered in the circumferential direction of the slender support body 1.

[0054] In summary, the embolism protection device provided in Embodiment 1 of the present invention, through its structural design of two layers of filter membranes, can accommodate more thrombi 5; the different pore sizes of the filter pores on the two layers of filter membranes allow for graded filtration of thrombi 5; and the structural design of the closed ends of both layers of filter membranes including inwardly recessed filter membrane portions can prevent thrombi 5 from accumulating at the distal end of the filter membrane and blocking the blood flow channel.

[0055] Example 2 like Figures 7 to 16 The embolism protection device shown differs from Embodiment 1 in that it further includes a turbine fan 6 and a sheath 7. The turbine fan 6 is fixedly connected to the elongated support body 1 and is located near the proximal end of the first filter assembly 2. The sheath 7 is sleeved around the outer periphery of the elongated support body 1. The turbine fan 6 includes a turbine fan body 61 sleeved and fixed around the outer periphery of the elongated support body 1, and three elastic blades 62 connected to the outer periphery of the turbine fan body 61. The three elastic blades 62 are evenly spaced along the circumference of the turbine fan body 61. The three elastic blades 62 have a retracted state within the sheath 7 and an extended state that expands radially outward relative to the turbine fan body 61 after the sheath 7 is withdrawn. When the three elastic blades 62 are in the extended state, they can guide the thrombus 5 to flow more rapidly towards the first filter assembly 2 and the second filter assembly 3. In some embodiments, the turbofan body 61 is provided with a power device for driving the three elastic fan blades 62 to rotate. The power device is connected to an external power source via wires 63, and the power device can be a micro motor.

[0056] During the collection of thrombus 5 within the blood vessel 4, in this embolism protection device, after the first filter membrane 22 of the first filter assembly 2 and the second filter membrane 33 of the second filter assembly 3 are deployed, the sheath 7 is retracted. The three elastic fan blades 62 in the turbine fan 6, which were originally constrained by the sheath 7, expand radially outward relative to the turbine fan body 61 under their own elastic force. The three elastic fan blades 62 are evenly arranged along the circumference of the slender support body 1 after deployment. Driven by the power device, the three elastic fan blades 62 rotate circumferentially. During the rotation of the three elastic fan blades 62, the blood in the blood vessel 4 can be accelerated, so that the thrombus 5 in the blood can flow to the first filter assembly 2 and the second filter assembly 3 more quickly, thereby reducing the thrombus collection time of the embolism protection device.

[0057] In some alternative embodiments, when the three elastic fan blades 62 are in the deployed state, the three elastic fan blades 62 form a passive turbulence shape. The thrombus 4 in the blood flow is guided by the elastic fan blades 62 and flows faster toward the first filter component 2 and the second filter component 3. The way of passively accelerating the blood flow by using the shape of the three elastic fan blades 62 can simplify the structure of the turbofan 6, eliminating the need to set up a power device in the turbofan body 61, thereby reducing the structural complexity of the turbofan 6. However, the effect of the elastic fan blades 62 passively accelerating the flow of thrombus is weaker than the effect of the elastic fan blades 62 actively accelerating the flow of thrombus by rotation.

[0058] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An embolism protection device, characterized in that, include: Slender supporting body (1); The first filter assembly (2) is sleeved on the outer periphery of the elongated support body (1) and has an expanded configuration that expands radially outward relative to the elongated support body (1). The first filter assembly (2) includes a first proximal filter membrane support (21) and a first filter membrane (22). The proximal end of the first filter membrane (22) is a first open end (22a), and the distal end of the first filter membrane (22) is a first closed end (22b). The proximal end of the first filter membrane (22) is connected to the elongated support body (1) through the first proximal filter membrane support (21). When the first filter assembly (2) is in the expanded configuration, the first open end (22a) forms an opening for thrombus to enter the first filter membrane (22), and the first closed end (22b) forms a seal to trap thrombus. The first filter membrane (22) includes a first filter membrane recess (22c) formed from the first closed end (22b) toward the proximal end, and the first filter membrane recess (22c) is fixedly connected to the elongated support body (1).

2. The embolism protection device according to claim 1, characterized in that, The first filter membrane (22) is provided with a plurality of first filter holes (221), at least some of the first filter holes (221) are located in the first filter membrane recess (22c); when the first filter assembly (2) is in the unfolded configuration, the space inside the first filter membrane (22) is a first retention cavity, and the space enclosed by the first filter membrane recess (22c) outside the elongated support body (1) is a first flow guiding cavity. The first filter membrane recess (22c) separates the first retention cavity and the first flow guiding cavity, and the first filter holes (221) on the first filter membrane recess (22c) keep the first retention cavity and the first flow guiding cavity unobstructed.

3. The embolism protection device according to claim 2, characterized in that, The central axis of the first filter membrane recess (22c) coincides with the central axis of the elongated support body (1), and the proximal end of the first filter membrane recess (22c) is gathered around the outer periphery of the elongated support body (1); the first filter assembly (2) also includes a distal filter membrane support (23), and the first filter membrane recess (22c) is fixedly connected to the outer periphery of the elongated support body (1) through the distal filter membrane support (23); the distal filter membrane support (23) is fixed to the outer wall of the first filter membrane recess (22c) and arranged circumferentially around the elongated support body (1). When the first filter assembly (2) is in the unfolded configuration, the distal filter membrane support (23) provides radial support for the first filter membrane recess (22c).

4. The embolism protection device according to claim 3, characterized in that, The distal filter membrane support (23) includes a distal filter membrane support fixing section (23a) and a distal filter membrane support supporting section. The distal filter membrane support fixing section (23a) is fixedly connected to the outer periphery of the elongated support body (1), and the proximal end of the first filter membrane recess (22c) is fixed to the distal filter membrane support fixing section (23a). One end of the distal filter membrane support supporting section is connected to the proximal end of the distal filter membrane support fixing section (23a), and the distal filter membrane support supporting section supports the first filter membrane recess (22c) to form the outer wall of the first flow guide cavity. The distal filter membrane support supporting section can be radially outward relative to the elongated support body (1) to maintain the unfolded configuration of the first filter membrane recess (22c).

5. The embolism protection device according to claim 4, characterized in that, The distal filter membrane support (23) is a self-expanding support that can expand radially after the external force is removed; and / or, the first proximal filter membrane support (21) is a self-expanding support that can expand radially after the external force is removed.

6. The embolism protection device according to any one of claims 1-5, characterized in that, The embolism protection device further includes a second filter assembly (3) sleeved on the outer periphery of the slender support body (1). The second filter assembly (3) has an outwardly expanding configuration relative to the slender support body (1). The second filter assembly (3) includes a second proximal filter membrane support (31) and a second filter membrane (32). The proximal end of the second filter membrane (32) is a second open end (32b), and the distal end of the second filter membrane (32) is a second closed end (32a). The proximal end of the second filter membrane (32) is connected to the slender support body (1) through the second proximal filter membrane support (31). Long support body (1); when the second filter assembly (3) is in the unfolded configuration, the second open end (32b) forms an opening for the thrombus to enter the second filter membrane (32), the second closed end (32a) forms a seal to catch the thrombus, and at least a portion of the second filter membrane (32) is located inside the first filter membrane (22); the first filter membrane (22) is provided with a plurality of first filter holes (221), the second filter membrane (32) is provided with a plurality of second filter holes (321), and the pore size of the second filter holes (321) is larger than the pore size of the first filter holes (221).

7. The embolism protection device according to claim 6, characterized in that, The second filter membrane (32) includes a second filter membrane recess (32c) formed from the second closed end (32a) towards the proximal end. The central axis of the second filter membrane recess (32c) coincides with the central axis of the elongated support body (1). The proximal end of the second filter membrane recess (32c) is closed and fixed to the outer periphery of the elongated support body (1).

8. The embolism protection device according to claim 7, characterized in that, Both the first proximal filter membrane support (21) and the second proximal filter membrane support (31) have multiple support bars arranged circumferentially around the elongated support body (1); the multiple support bars of the first proximal filter membrane support (21) and the multiple support bars of the second proximal filter membrane support (31) are staggered in the circumferential direction of the elongated support body (1).

9. The embolism protection device according to any one of claims 1-5, characterized in that, The embolism protection device further includes a turbine fan (6) and a sheath (7). The turbine fan (6) is connected to the elongated support body (1) and located at the proximal end of the first filter assembly (2). The sheath (7) is sleeved on the outer periphery of the elongated support body (1). The turbine fan (6) includes a turbine fan body (61) sleeved and fixed on the outer periphery of the elongated support body (1) and multiple elastic blades (62) connected to the outer periphery of the turbine fan body (61). The multiple elastic blades (62) have a folded state that is folded into the sheath (7) and an unfolded state that is radially outward relative to the turbine fan body (61) after the sheath (7) is withdrawn. When the elastic blades (62) are in the unfolded state, the elastic blades (62) can guide the thrombus to flow faster toward the first filter assembly (2).

10. The embolism protection device according to claim 9, characterized in that, The turbine body (61) is equipped with a power device for driving the rotation of multiple elastic fan blades (62). The power device is connected to an external power source via a wire (63). When the elastic fan blades (62) are in the unfolded state, the power device can drive the multiple elastic fan blades (62) to rotate around the circumference of the slender support body (1) so that the thrombus flows faster toward the first filter assembly (2). or, When the elastic fan blades (62) are in the unfolded state, the multiple elastic fan blades (62) form a passive turbulence shape, and the thrombus in the blood flow is guided by the elastic fan blades (62) and flows faster toward the first filter component (2).

Images