A method of manufacturing an embolus protection filter and an embolus protection filter

Abstract

The application provides an anti-embolism filter manufacturing method and an anti-embolism filter. The method comprises the following steps: step one, performing hole processing treatment on a polymer film to form a filter film with filter holes; step two, providing a stent for an interventional operation; and step three, performing solidification treatment on the filter film and the stent to form an anti-embolism filter. The anti-embolism filter manufactured by the method has filter holes that can cover the entire filter film, and the porosity and consistency are improved, so that the blood flow circulation and the capture of thrombus particles can be considered during the interventional operation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a method for manufacturing an anti-embolism filter and an anti-embolism filter. Background Technology

[0002] Thrombi, atherosclerotic plaques, and embolic particles generated during cardiac interventional procedures can be expelled into the bloodstream through surgery or catheter manipulation, potentially causing embolisms in the brain or other downstream vital organs. Cerebral embolism, in particular, can lead to neuropsychological deficits, stroke, and even death. Therefore, arterial blood flow filtration is necessary during surgery to prevent embolic particles from reaching the brain.

[0003] Most current anti-embolism filters consist of a frame and a filter membrane attached to the frame. The manufacturing process for these membrane-attached anti-embolism filters involves coating the frame with a polymer material to form the filter membrane, followed by laser or mechanical processing to create the filter pores. This pore processing requires avoiding the frame, necessitating a complex manufacturing process. Furthermore, forming pores on the membrane near the frame is difficult; precise positioning is also required, resulting in higher production costs. Summary of the Invention

[0004] The technical problem to be solved by this application is that existing filter pore processing requires avoiding the skeleton, thus requiring the design of a relatively complex processing procedure, and at the same time, it is difficult to form filter pores in the filter membrane part close to the skeleton; secondly, it also requires precise positioning, thus resulting in high production costs.

[0005] To solve the above-mentioned technical problems, this application provides a method for manufacturing an anti-embolism filter, comprising the following steps: Step 1: processing a polymer membrane to form a filter membrane with filter pores; Step 2: providing a stent for interventional surgery; Step 3: curing the filter membrane and the stent together to form an anti-embolism filter.

[0006] This application first processes a polymer membrane to form multiple filter pores, and then solidifies the filter membrane with the processed filter pores together with a support to form an anti-embolism filter. In this processing method, the polymer membrane is processed with pores separately, without being restricted by the support, so that filter pores can also be formed on the polymer membrane close to the skeleton. This makes processing easier, better meets the requirements for filter pore consistency, and the porosity can be easily adjusted. The anti-embolism filter manufactured by this method has good filter pore consistency, which can take into account both blood flow and thrombus capture during interventional surgery.

[0007] In some embodiments, step three includes the following steps: step three (a): forming a thin film on the surface of the skeleton constituting the support, and fixing the thin film to the skeleton; step three (b): curing the filter membrane and the thin film.

[0008] In some embodiments, generating a thin film in step three (a) refers to attaching organic materials to the scaffold surface.

[0009] In some embodiments, the curing in step three (b) refers to fixing the filter membrane and the thin film together by microneedle dispensing adhesive at the overlap.

[0010] In some embodiments, the thin film, the filter membrane, and the dispensing material are the same.

[0011] In some embodiments, the hole processing in step one refers to forming filter holes by thermal cutting, mechanical cutting, or optical cutting of the polymer membrane.

[0012] This application also provides an anti-embolism filter prepared by the anti-embolism filter manufacturing method described in any of the above embodiments. The anti-embolism filter includes: a support, the skeleton of which forms a plurality of grids; and a filter membrane attached to the skeleton of the support, the filter membrane having a plurality of filter holes uniformly distributed throughout the grids.

[0013] This application first perforates a polymer membrane to form a filter membrane, and then attaches the filter membrane to a stent. The anti-embolism filter prepared by this manufacturing process is not limited by the stent skeleton. Multiple filter pores can be evenly distributed on the entire filter membrane. When attached to the stent, the part close to the stent skeleton has filter pores, thus increasing the porosity and improving blood permeability.

[0014] In some embodiments, a thin film is attached to the surface of the skeleton.

[0015] In some embodiments, the filter membrane is fixedly connected to the thin film.

[0016] In some embodiments, the filter membrane and the thin film are made of the same material.

[0017] In some embodiments, the inner surface of the filter membrane is attached to the outer surface of the support; or, the outer surface of the filter membrane is attached to the inner surface of the support.

[0018] In some embodiments, the contact area between the filter membrane and the support is adhered by an adhesive.

[0019] In some embodiments, the adhesive is made of the same material as the filter membrane.

[0020] In some embodiments, the filter membrane is a polymer filter membrane.

[0021] This application also provides an anti-embolism filter prepared by the anti-embolism filter manufacturing method described in any of the above embodiments. The anti-embolism filter includes: a support; a filter membrane, the filter membrane being attached to the support, the filter membrane having a plurality of filter holes, and some of the filter holes overlapping with the skeleton of the support.

[0022] In this embodiment, a filter membrane is formed by first perforating a polymer membrane and then attaching the filter membrane to a stent. This manufacturing process allows the anti-embolism filter to be manufactured without being limited by the stent skeleton. Multiple filter pores can be evenly distributed across the entire filter membrane. When attached to the stent, filter pores are also distributed in the skeleton part close to the stent, thus increasing the porosity and improving blood permeability.

[0023] In some embodiments, the skeleton of the support forms a plurality of closed grids, which divide the filter membrane into a plurality of filter units, each of which is provided with a plurality of filter pores.

[0024] In some embodiments, a portion of the filter holes in at least one of the filter units are close to the edge of the skeleton.

[0025] In some embodiments, the distance between a portion of the filter holes in the filter unit and the edge of the skeleton is less than or equal to 0.6 mm to 1 mm.

[0026] In some embodiments, the plurality of closed grids may have the same or different shapes.

[0027] In some embodiments, a thin film is attached to the surface of the skeleton.

[0028] In some embodiments, the filter membrane is fixedly connected to the thin film.

[0029] In some embodiments, the filter membrane and the thin film are made of the same material. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1 A flowchart illustrating a method for manufacturing an anti-embolism filter provided in this application embodiment;

[0032] Figure 2 This is a schematic diagram of a partial structure of an anti-embolism filter provided in an embodiment of this application;

[0033] Figure 3 A cross-sectional view of an anti-embolism filter provided in an embodiment of this application;

[0034] Figure 4 Provided for the embodiments of this application Figure 3 A partially enlarged schematic diagram of the anti-embolism filter A. Detailed Implementation

[0035] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0036] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0037] In the fabrication of anti-embolism filters, it is necessary to create multiple pores in the polymer membrane. In previous technologies, the polymer membrane attached to the skeleton was directly processed by laser cutting. Due to the presence of the skeleton, it is necessary to avoid the skeleton to prevent accidental damage. This results in a large clearance space between the pores on the polymer membrane and the edge of the skeleton, which affects the porosity of the polymer membrane. Furthermore, the consistency of the pores on the polymer membrane is also affected by the skeleton. During interventional procedures, this may lead to the risk of poor blood flow and / or failure to capture thrombus particles.

[0038] In view of the above-mentioned problems, the present application embodiment adopts a manufacturing method that first forms filter pores on the polymer membrane and then fixes it together with the support, which eliminates the need to consider the interference problem of the support and improves the consistency and porosity of the filter pores.

[0039] Please refer to Figure 1 and Figure 2 , Figure 1 A flowchart illustrating a method for manufacturing an anti-embolism filter provided in this application embodiment; Figure 2 This is a schematic diagram of a partial structure of an anti-embolism filter provided in an embodiment of this application.

[0040] This application provides a method for manufacturing an anti-embolism filter, including the following steps:

[0041] Step 1: Perform pore processing on the polymer membrane to form a filter membrane 20 with filter pores 201;

[0042] Step 2: Provide one stent for interventional surgery (10).

[0043] Step 3: Curing the filter membrane 20 and the support 10 together to form an anti-embolism filter.

[0044] In this embodiment, the polymer membrane is first processed to form multiple filter pores, and then the filter membrane with the processed filter pores is solidified together with the support to form an anti-embolism filter. In this processing method, the polymer membrane is processed with pores separately, without being limited by the support, which improves the consistency of the filter pores formed on the polymer membrane and the porosity can be easily adjusted. The anti-embolism filter manufactured by this method has good filter pore consistency and can take into account both blood flow and thrombus capture during interventional surgery.

[0045] For example, in step one, the processing of the polymer membrane pores can be achieved by thermal cutting, mechanical cutting, or optical cutting of the polymer membrane to form filter pores. Since there is no support interference, the polymer membrane has individually cut pores, and the filter pores can be uniformly or irregularly distributed throughout the entire polymer membrane according to a certain pattern. The pore size consistency of each filter pore is good, and compared with existing technologies, cutting is more convenient and efficient.

[0046] In some embodiments, step three includes the following steps:

[0047] Step 3(a): A thin film 22 is generated on the surface of the skeleton constituting the support 10, and the thin film 22 is fixed to the skeleton.

[0048] Step 3(b): Curing the filter membrane 20 with the thin film.

[0049] The filter membrane 20 is fixed to the support frame 10 by the film 22 on the support frame 10. Compared with the filter membrane 20 being directly attached to the frame, the film 22 and the filter membrane 20 are made of similar materials, and the two are more firmly fixed together.

[0050] For example, in step three(a), generating the thin film refers to attaching organic material to the surface of the support frame. The organic material is similar in material to the filter membrane 20, making it easier to bond and fix.

[0051] Organic materials can be attached to the surface of the scaffold skeleton by means of organic solvent coating or spraying.

[0052] Furthermore, the membrane 22 and the filter membrane 20 can be made of the same material. For example, both can be high-molecular organic materials, which makes them easy to bond together, thereby improving the bonding strength.

[0053] For example, in step 3(b), curing refers to fixing the filter membrane 20 and the thin film 22 at the overlap by microneedle dispensing.

[0054] The adhesive can be applied along the contact area between the skeleton with the thin film 22 and the filter membrane 20 using microneedle injection. The amount applied should be carefully controlled, and the mixture should be dried and cured at a specific temperature. The organic solution forming the connection points during the bonding process allows for localized coating, reducing the impact on the pores of the filter membrane 20.

[0055] Alternatively, the membrane 22, filter membrane 20, and adhesive dispensing 21 can be made of the same material. Using the same material for all three components makes them more securely fixed.

[0056] In some embodiments, this application provides a method for manufacturing an anti-embolism filter, including:

[0057] Step 1: Multiple filter pores can be formed on the polymer membrane by thermal cutting, mechanical cutting, or optical cutting. Multiple filter pores can be evenly distributed across the entire polymer membrane.

[0058] Step 2: Apply the coating to the surface of the skeleton by means of organic solvent coating or spraying, and after it dries and solidifies, a thin film 22 is formed.

[0059] Step 3: Place the skeleton on the outer surface of the filter membrane. After the organic solution cures, connection points are formed, which bond the filter membrane 20 and the film 22 attached to the skeleton surface together. Apply the organic solvent or an organic solvent containing a polymer membrane using microneedle injection along the contact area between the skeleton with film 22 and the filter membrane 20, controlling the amount applied, and then dry and cure it at a specific temperature. After the organic solution cures, connection points are formed, which bond the filter membrane 20 and the film 22 attached to the skeleton surface together. The materials of film 22, filter membrane 20, and adhesive 21 can be the same.

[0060] Reference Figures 2 to 4 This application also provides an anti-embolism filter prepared by the anti-embolism filter manufacturing method of any of the above embodiments. The anti-embolism filter includes: a support 10, the skeleton of which forms a plurality of grids; and a filter membrane 20 attached to the skeleton of the support 10, the filter membrane 20 having a plurality of filter holes 201 evenly distributed throughout the grid. The grid may be rhomboid in shape.

[0061] In previous technologies, perforation was performed on the filter membrane attached to the support. However, due to the constraints of the support frame that forms the mesh, the perforation process had to avoid the frame, resulting in the entire mesh not being able to be filled with filter pores and poor porosity. In this embodiment, the filter membrane is first perforated to form a filter membrane, and then the filter membrane is attached to the support. The anti-embolism filter prepared by this process is not limited by the support frame, and multiple filter pores 201 can be evenly distributed across the entire filter membrane 20, thus improving porosity.

[0062] In some embodiments, a thin film 22 is attached to the surface of the skeleton. The filter membrane 20 is fixed to the skeleton by the thin film 22 attached to the skeleton. The filter membrane 20 and the thin film 22 can be made of the same material. The filter membrane 20 can be a polymer filter membrane. The thin film 22 can also be a polymer organic material, so that the two can be easily bonded together, thereby improving the bonding strength.

[0063] In one example, the inner surface of the filter membrane 20 is attached to the outer surface of the support 10; or, the outer surface of the filter membrane 20 is attached to the inner surface of the support. The filter membrane 20 can be attached to the outside of the support 10 or to the inside of the support 10.

[0064] In some embodiments, the contact area between the filter membrane 20 and the support 10 is bonded with an adhesive. The adhesive can be applied via microneedle injection along the contact area between the skeleton with the film 22 and the filter membrane 20, with careful control of the amount applied, and then dried and cured at a specific temperature. The organic solution forming the connection points during the bonding process allows for localized coating, reducing the impact on the pores of the filter membrane 20. The adhesive material is the same as the filter membrane material.

[0065] This application also provides an anti-embolism filter prepared by the anti-embolism filter manufacturing method of any of the above embodiments, comprising: a support 10; a filter membrane 20, the filter membrane 20 being attached to the support 10, the filter membrane 20 having a plurality of filter holes 201, some of the filter holes 201 overlapping with the skeleton of the support 10.

[0066] In previous technologies, perforation was performed on the filter membrane attached to the stent. Due to the constraints of the stent's framework, perforation had to avoid the framework, resulting in poor porosity. In this embodiment, the polymer membrane is first perforated to form the filter membrane, which is then attached to the stent. This manufacturing process allows the anti-embolism filter to be manufactured without being restricted by the stent framework, enabling multiple filters 21 to be evenly distributed across the entire filter membrane 20. When attached to the stent, the portion close to the stent framework has filter pores 201, thus increasing porosity and improving blood permeability.

[0067] In some embodiments, the framework of the support 10 forms a plurality of closed grids, which divide the entire filter membrane 20 into a plurality of filter units, each filter unit having a plurality of filter pores. The pore size and / or porosity of the filter pores in each filter unit may be consistent.

[0068] In some embodiments, a portion of the filter pores 201 in at least one filter unit are close to the edge of the support structure. Since perforation on the polymer membrane is not restricted by the support structure, unlike existing technologies, the filter pores 201 in this embodiment can be closer to the edge of the support structure, thus increasing porosity.

[0069] In one example, the distance between some filter holes 201 in the filter unit and the edge of the frame is less than or equal to 0.6 mm to 1 mm. In the prior art, due to the limitations of the frame, the filter holes must avoid the frame when drilling, and the distance between the filter holes 201 and the edge of the frame is at least 1 mm, which limits the porosity of the filter holes on the filter membrane 20. The anti-embolism filter prepared by the above method in the embodiments of this application allows the distance between the filter holes 201 and the edge of the frame to be within 0.6 mm to 1 mm, which improves the porosity compared with the existing structure.

[0070] In some embodiments, the shapes of the multiple closed grids formed by the support frame 10 may be consistent or inconsistent.

[0071] In existing technologies, to improve the porosity and uniformity of the filter membrane, the consistency of the multiple closed grid shapes formed by the support skeleton is required, leading to difficulties in skeleton fabrication and low efficiency. The anti-embolism filter prepared by the method described in this application is not limited by the support skeleton, can form uniform filter pores on the filter membrane, has lower requirements for the consistency of the multiple closed grid shapes formed by the skeleton, and improves manufacturing efficiency.

[0072] In some embodiments, a thin film is attached to the surface of the frame of the support 10. The filter membrane 20 is fixed to the frame by a thin film 22 attached to the frame. The filter membrane 20 and the thin film 22 can be made of the same material. The filter membrane 20 can be a polymer filter membrane. The thin film 22 can also be a polymer organic material, so that the two can be easily bonded together, thereby improving the bonding strength.

[0073] In one example, the inner surface of the filter membrane 20 is attached to the outer surface of the support 10; or, the outer surface of the filter membrane 20 is attached to the inner surface of the support. The filter membrane 20 can be attached to the outside of the support 10 or to the inside of the support 10.

[0074] In some embodiments, the contact area between the filter membrane 20 and the support 10 is bonded with an adhesive. The adhesive can be applied via microneedle injection along the contact area between the skeleton with the film 22 and the filter membrane 20, with careful control of the amount applied, and then dried and cured at a specific temperature. The organic solution forming the connection points during the bonding process allows for localized coating, reducing the impact on the pores of the filter membrane 20. The adhesive material is the same as the filter membrane material.

[0075] This application provides an anti-thrombotic filter manufactured by the method described in any of the above embodiments, comprising a support 10 and a filter membrane 20 attached to the support 10. The skeleton of the support 10 forms multiple closed grids, which divide the entire filter membrane 20 into multiple filter units. Each filter unit may have filter pores 201 evenly distributed. The pore size and / or porosity of the filter pores 201 can be almost uniform. Some of the filter pores 201 are close to the edge of the skeleton, and the distance between these filter pores 201 and the edge of the skeleton can be within 0.6mm to 1mm. Other filter pores 201 are blocked by the skeleton of the support 10. This significantly improves the porosity of the anti-thrombotic filter compared to the prior art. The support 10 and the filter membrane 20 can be attached together by a thin film 22 of the same material as the filter membrane 20. Then, adhesive is applied along the contact area between the skeleton with the thin film 22 and the filter membrane 20 using microneedle injection. The amount of adhesive is controlled, and the film is dried and cured at a certain temperature. This results in a more firmly fixed porosity of the anti-thrombotic filter.

[0076] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application. It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0077] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the aforementioned scope of rights.

[0078] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A method for manufacturing an anti-embolism filter, characterized in that, Includes the following steps: Step 1: Perform pore processing on the polymer membrane to form a filter membrane with filter pores; Step 2: Provide a stent for interventional surgery; Step 3: Curing the filter membrane and the support together to form an anti-embolism filter; Step three includes the following steps: Step 3(a): A thin film is generated on the surface of the skeleton constituting the support, and the thin film is fixed to the skeleton. Step 3(b): Curing the filter membrane and the thin film.

2. The method for manufacturing the anti-embolism filter according to claim 1, characterized in that, The formation of the thin film in step 3(a) refers to attaching organic materials to the surface of the scaffold skeleton.

3. The method for manufacturing the anti-embolism filter according to claim 1, characterized in that, The curing in step three (b) refers to fixing the filter membrane and the thin film together by applying adhesive through microneedles at the overlap.

4. The method for manufacturing the anti-embolism filter according to claim 3, characterized in that, The thin film, the filter membrane, and the adhesive dispensing are made of the same material.

5. The method for manufacturing the anti-embolism filter according to claim 1, characterized in that, The hole processing in step one refers to forming filter holes by thermal cutting, mechanical cutting, or optical cutting of the polymer membrane.

6. An anti-embolism filter prepared by the manufacturing method of any one of claims 1-5, characterized in that, The anti-embolism filter includes: The support (10) has a skeleton that forms multiple grids; A filter membrane (20) is attached to the skeleton of the support, and the filter membrane is provided with a plurality of filter holes (21), which are evenly distributed throughout the entire mesh.

7. The anti-embolism filter according to claim 6, characterized in that, A thin film is attached to the surface of the skeleton.

8. The anti-embolism filter according to claim 7, characterized in that, The filter membrane is fixedly connected to the thin film.

9. The anti-embolism filter according to claim 8, characterized in that, The filter membrane and the thin film are made of the same material.

10. The anti-embolism filter according to claim 6, characterized in that, The inner surface of the filter membrane is attached to the outer surface of the support; or, The outer surface of the filter membrane is attached to the inner surface of the support.

11. The anti-embolism filter according to claim 6, characterized in that, The filter membrane is bonded to the support at the contact point using an adhesive.

12. The anti-embolism filter according to claim 11, characterized in that, The adhesive is made of the same material as the filter membrane.

13. The anti-embolism filter according to claim 6, characterized in that, The filter membrane is a polymer filter membrane.

14. An anti-embolism filter prepared by the manufacturing method of any one of claims 1-5, characterized in that, The anti-embolism filter includes: support; A filter membrane is attached to the support, and the filter membrane has multiple filter holes, some of which overlap with the skeleton of the support.

15. The anti-embolism filter according to claim 14, characterized in that, The frame of the support forms multiple closed grids, which divide the filter membrane into multiple filter units, and each filter unit is provided with multiple filter holes.

16. The anti-embolism filter according to claim 15, characterized in that, At least a portion of the filter holes in the filter unit are close to the edge of the skeleton.

17. The anti-embolism filter according to claim 16, characterized in that, The distance between a portion of the filter holes in the filter unit and the edge of the skeleton is less than or equal to 0.6mm to 1mm.

18. The anti-embolism filter according to claim 15, characterized in that, The multiple closed grids may have the same or different shapes.

19. The anti-embolism filter according to any one of claims 14-18, characterized in that, A thin film is attached to the surface of the skeleton.

20. The anti-embolism filter according to claim 19, characterized in that, The filter membrane is fixedly connected to the thin film.

21. The anti-embolism filter according to claim 20, characterized in that, The filter membrane and the thin film are made of the same material.

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