Choke flow film

Abstract

The utility model provides a flow choking film. The flow choking film comprises a micro-nano developing film, an endothelialization promoting coating and a hydrophilic coating, wherein the endothelialization promoting coating and the hydrophilic coating are sequentially arranged on the surface of the micro-nano developing film; and the thickness of the coating for promoting endothelialization is 50nm-8mu m. According to the utility model, the specific structural design is adopted for the flow choking membrane, namely, the endothelialization promoting coating and the hydrophilic coating are sequentially arranged on the surface of the micro-nano developing membrane, and the thickness of the endothelialization promoting coating is controlled to be within a specific range, so that the flow choking membrane has a good developing effect, and can inhibit thrombosis and promote endothelialization creeping of cells.

Description

Technical Field

[0001] The utility model belongs to the technical field of implantable devices for treating congenital heart disease, and in particular relates to a flow-blocking membrane. Background Art

[0002] At present, medical devices such as heart occluders used to treat congenital heart diseases such as atrial septal defect, ventricular septal defect, patent foramen ovale, patent ductus arteriosus, and left atrial appendage closure have a skeleton made of nickel-titanium alloy and a flow-blocking membrane made of polyester non-woven fabric to prevent arteriovenous shunting of blood. However, this polyester non-woven fabric makes it difficult for cells to crawl on the skin and is prone to thrombosis on the surface of the flow-blocking membrane.

[0003] The third generation of absorbable heart occluders are currently on the market in China. The flow barrier is made of L-polylactic acid material, which has good biocompatibility. It can be degraded into small molecules within the tissue within one year after implantation, and finally absorbed by tissue cells and converted into carbon dioxide and water and excreted from the body. However, it also has the problem of easy thrombosis and slow heart diaphragm skin creeping.

[0004] For example, CN115153685A discloses a bilateral rivet-free atrial septal defect degradable cardiac occluder, the occluder comprises a main body, a flow blocking component, a suture and a rivet-free flat end face connector, the main body is a mesh structure, the mesh structure comprises a first disc-shaped portion, a second disc-shaped portion and a tubular portion, the flow blocking component is a degradable membrane of at least two layers for blocking blood flow, the suture is a degradable suture used to sew the flow blocking component to the main body and as a closing line, and the rivet-free flat end face connector comprises a threaded hole and a delivery disk. The cardiac occluder can achieve the effect of re-delivery and the purpose of reducing the incidence of thrombosis without rivets, and the rivet-free flat end face connector is degradable. During the processing, it is woven on the mesh, which is convenient, safe and fast; however, the flow blocking membrane still has the problem of easy formation of thrombus and slow skin climbing of the heart septum.

[0005] Therefore, developing a flow-blocking membrane that can effectively inhibit thrombosis and promote cell endothelialization is an urgent problem to be solved in this field. Utility Model Content

[0006] In view of the shortcomings of the prior art, the utility model aims to provide a flow-blocking membrane that can promote the endothelialization of pericardial cells, effectively inhibit the formation of thrombus on the surface of the flow-blocking membrane, and can be developed under X-ray or B-ultrasound with good development effect.

[0007] To achieve this purpose, the utility model adopts the following technical solutions:

[0008] In a first aspect, the utility model provides a flow-blocking film, which includes a micro-nano developing film and an endothelialization-promoting coating and a hydrophilic coating sequentially arranged on the surface of the micro-nano developing film; the thickness of the endothelialization-promoting coating is 50nm to 8μm.

[0009] In the utility model, by adopting a specific structural design, that is, endothelialization-promoting coating and hydrophilic coating are sequentially arranged on the surface of the micro-nano developing film, and the thickness of the endothelialization-promoting coating is controlled within a specific range, the flow-blocking film has a good development effect, can inhibit thrombosis, and promote cell endothelialization.

[0010] In the present invention, the thickness of the endothelialization promoting coating is 50nm to 8μm, for example, it can be 50nm, 60nm, 80nm, 100nm, 200nm, 400nm, 600nm, 800nm, 1μm, 2μm, 3μm, 4μm, 5μm, 6μm, 7μm, 8μm, etc.

[0011] In the utility model, the endothelialization promoting coating and the hydrophilic coating arranged in sequence are arranged on one surface or two surfaces of the flow-blocking membrane.

[0012] In the utility model, the flow-blocking film comprises a micro-nano developing film, an endothelialization promoting coating and a hydrophilic coating stacked in sequence; or comprises a first hydrophilic coating, a first endothelialization promoting coating, a micro-nano developing film, a second endothelialization promoting coating and a second hydrophilic coating stacked in sequence.

[0013] In the present invention, the micro-nano developing film includes a micro-nano film and a developing film sheet; the number of layers of the micro-nano film is ≥1, for example, it can be 1, 2, 3, 4, 5, 6, 7, 8, etc.; the developing film sheet is distributed in at least one of the inner layer, upper surface or lower surface of the micro-nano film.

[0014] In the utility model, all the materials used are commercially available; in the micro-nano developing film, the micro-nano film is composed of micro-nano silk threads formed by electrostatic spinning of polymers; the developing film is formed by a developer or a composite material of a developer and a polymer; the developing film is adsorbed on the surface of the micro-nano film by electrostatic action, or adsorbed in the interlayer of two micro-nano films.

[0015] In the present invention, the diameter of the micro-nano wire is 1nm to 500nm, for example, it can be 1nm, 2nm, 5nm, 10nm, 20nm, 40nm, 60nm, 80nm, 100nm, 150nm, 200nm, 250nm, 300nm, 350nm, 400nm, 450nm, 500nm, etc.

[0016] In the present invention, the thickness of the developing film is 100-600 μm, for example, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, etc.; the area is 4-100 mm 2 , for example, it can be 4mm 2 、6mm 2 , 8mm 2 , 10mm 2 , 20mm 2 , 30mm 2 , 40mm 2 , 50mm 2 、60mm 2 , 70mm 2 , 80mm 2 、90mm 2 , 100mm 2 The shape of the developing film includes at least one of a square, a circle, a triangle or an irregular pattern.

[0017] In the utility model, the surface of the developing film also has a convex structure.

[0018] In the present invention, the height of the protruding structure is 0.05-0.1 mm, for example, it can be 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, etc.

[0019] In the utility model, the shape of the protrusion structure is at least one of a pyramid, a prism or a frustum.

[0020] In the utility model, the developing film can be prepared by the following method, which includes: mixing a developer with a polymer, forming a film, and obtaining the developing film; the film forming method includes blow molding or coating film forming; the blow molding film forming includes mixing the developer with the polymer, extruding granulation, and then blow molding the film; the coating film forming step includes: mixing the developer with the polymer and a solvent, and coating the developer with a film on a film forming mold after the developer is completely dissolved, and the film thickness can be controlled according to the number of coatings; the solvent includes a mixed solvent of hexafluoroisopropanol and N,N-dimethylformamide in a volume ratio of 5 to 15:1.

[0021] In the utility model, a developing film with a convex structure on the surface can be obtained by forming a developing material and a polymer into a film; and the convex structure adopts a specific shape and the convex height is within a specific range, which can effectively reflect sound waves and improve the developing performance.

[0022] In the present invention, the thickness of the hydrophilic coating is 1 to 100 nm, for example, it can be 1 nm, 2 nm, 4 nm, 6 nm, 8 nm, 10 nm, 20 nm, 30 nm, 40 nm, 50 nm, 60 nm, 70 nm, 80 nm, 90 nm, 100 nm, etc.

[0023] In the utility model, the thickness of the baffle film is 150-800 μm, for example, it can be 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, 650 μm, 700 μm, 750 μm, 800 μm, etc.

[0024] However, it is not limited to the listed values, and other unlisted values ​​within the numerical range are also applicable.

[0025] The system refers to an equipment system, a device system or a production device.

[0026] Compared with the prior art, the beneficial effects of the utility model are:

[0027] The flow-blocking membrane provided by the utility model adopts a specific structural design, that is, an endothelialization-promoting coating and a hydrophilic coating are sequentially arranged on the surface of the micro-nano developing membrane, and the thickness of the endothelialization-promoting coating is controlled within a specific range, so that the flow-blocking membrane has a good developing effect, can inhibit thrombosis, and promote cell endothelialization, and can be used to make a cardiac occluder. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a slice image of the myocardium around the inner membrane patch of the occluder obtained using the flow-blocking membrane provided in Example 1.

[0029] Figure 2 A schematic diagram of the structure of the flow-blocking membrane provided in Example 1 of the utility model;

[0030] Among them, 1-first hydrophilic coating; 2-first endothelialization-promoting coating; 3-micro-nano developing film; 4-second endothelialization-promoting coating; 5-second hydrophilic coating. DETAILED DESCRIPTION

[0031] It should be understood that, in the description of the present utility model, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, which is only for the convenience of describing the present utility model 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 the present utility model. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present utility model, unless otherwise specified, "multiple" means two or more.

[0032] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0033] The technical solution of the utility model is further explained below with reference to the accompanying drawings and through specific implementation methods.

[0034] Example 1

[0035] This embodiment provides a flow-blocking film, and its structural schematic diagram is as follows Figure 2 As shown, it includes a micro-nano developing film 3 and a first endothelialization promoting coating 2, a first hydrophilic coating 1, a second endothelialization promoting coating 4, and a second hydrophilic coating 5 arranged on the two surfaces of the micro-nano developing film in sequence; the micro-nano developing film includes a micro-nano film formed by micro-nano wires and a developing film adsorbed on the surface of the micro-nano wires; the material of the micro-nano wires is L-polylactic acid and polylactic acid-glycolic acid copolymer with a mass ratio of 1:1; in terms of mass percentage, the material of the developing film includes 50% L-polylactic acid and 50% barium sulfate; the thickness of the developing film is 200μm and the area is 4mm 2 The surface has a triangular pyramid protrusion structure with a height of 0.08 mm; the thickness of the endothelialization-promoting coating is 4 μm, and the material is CD133 antibody and heparin with a mass ratio of 60:40; the thickness of the hydrophilic coating is 50 nm, and the material is polyvinyl pyrrolidone; the thickness of the flow-blocking membrane is 300 μm.

[0036] This embodiment provides a method for preparing a flow-blocking film, which specifically includes the following steps:

[0037] (1) mixing L-polylactic acid and polylactic acid-glycolic acid copolymer with a solvent to obtain a spinning solution; electrospinning the spinning solution, and adding a developing film sheet at half of the total spinning time to obtain a micro-nano developing film;

[0038] (2) heat treating the micro-nano developer film obtained in step (1) at 40° C. for 90 min, slicing it, and performing plasma treatment. The plasma treatment process is as follows: frequency of 40 kHz, temperature of 30° C., treatment time of 30 min, activation gas of nitrogen, gas flow rate of 100 mL / min, to obtain a treated micro-nano developer film;

[0039] (3) spraying the endothelialization-promoting material on both surfaces of the micro-nano developer film obtained in step (2) at a spraying rate of 10 mL / min for 50 s to obtain a film provided with an endothelialization-promoting coating;

[0040] (4) The film provided with the endothelialization-promoting coating obtained in step (3) is immersed in a polyvinyl pyrrolidone solution for 3 minutes, and then cured by ultraviolet light for 60 seconds to obtain the flow-blocking film.

[0041] Example 2

[0042] The present embodiment provides a flow-blocking film, which includes a micro-nano developing film and an endothelialization-promoting coating and a hydrophilic coating sequentially arranged on two surfaces of the micro-nano developing film; the micro-nano developing film includes a micro-nano film formed by micro-nano wires and a developing film adsorbed on the surface of the micro-nano wires; the material of the micro-nano wires is polycaprolactone; in terms of mass percentage, the material of the developing film includes 40% polydioxanone and 60% iopamidol; the thickness of the developing film is 150 μm and the area is 20 mm 2 The surface has a quadrangular prism protrusion structure with a height of 0.1 mm; the thickness of the endothelialization-promoting coating is 8 μm, and the material is CD133 antibody and heparin with a mass ratio of 80:20; the thickness of the hydrophilic coating is 80 nm, and the material is polyvinyl pyrrolidone; the thickness of the flow-blocking membrane is 320 μm.

[0043] Example 3

[0044] The present embodiment provides a flow-blocking film, which includes a micro-nano developing film and an endothelialization-promoting coating and a hydrophilic coating sequentially arranged on two surfaces of the micro-nano developing film; the micro-nano developing film includes a micro-nano film formed by micro-nano wires and a developing film adsorbed on the surface of the micro-nano wires; the material of the micro-nano wires is L-polylactic acid, polydioxanone and polycaprolactone in a mass ratio of 1:1:1; in terms of mass percentage, the material of the developing film includes 60% of polylactic acid-glycolic acid copolymer and 40% of bismuth basic carbonate; the thickness of the developing film is 210 μm and the area is 20 mm 2 The surface has a hexagonal pyramidal protrusion structure with a height of 0.05 mm; the thickness of the endothelialization-promoting coating is 1 μm, and the material is CD133 antibody and heparin with a mass ratio of 80:20; the thickness of the hydrophilic coating is 10 nm, and the material is polyvinyl pyrrolidone; the thickness of the flow-blocking membrane is 271 μm.

[0045] Example 4

[0046] This embodiment provides a flow-blocking film, which is different from the embodiment 1 only in that the height of the protruding structure of the developing film is 0.2 mm, and the other structures are the same as those of the embodiment 1.

[0047] Example 5

[0048] This embodiment provides a flow-blocking membrane, which is different from the embodiment 1 only in that the thickness of the hydrophilic coating is 200 nm, and the other structures are the same as those of the embodiment 1.

[0049] Example 6

[0050] This embodiment provides a flow-blocking film, which is different from the embodiment 1 only in that there is no protruding structure on the surface of the developing film, and the other structures are the same as those in the embodiment 1.

[0051] Comparative Example 1

[0052] This comparative example provides a flow-blocking membrane, which is different from Example 1 only in that the thickness of the endothelialization-promoting coating is 15 μm, and the other structures are the same as those of Example 1.

[0053] Comparative Example 2

[0054] This comparative example provides a flow-blocking membrane, which is different from Example 1 only in that the flow-blocking membrane does not have an endothelialization-promoting coating, and the other structures are the same as those of Example 1.

[0055] Comparative Example 3

[0056] This comparative example provides a flow-blocking membrane, which is different from Example 1 only in that the flow-blocking membrane does not have a hydrophilic coating, and the other structures are the same as those of Example 1.

[0057] Comparative Example 4

[0058] This comparative example provides a flow-blocking membrane, which is different from Example 1 only in that the flow-blocking membrane does not have an endothelialization-promoting coating and a hydrophilic coating, and the other structures are the same as those of Example 1.

[0059] Application Examples

[0060] A heart occluder is composed of a metal mesh, an upper end, a lower end, a flow-blocking membrane and a suture line.

[0061] Test Example 1

[0062] Taking the flow-blocking membrane provided in Example 1 as an example, a cardiac occluder was prepared from it and implanted in a Labrador dog for 30 days to observe the changes in the myocardium around the membrane patch inside the occluder. The results are as follows: Figure 1 shown by Figure 1 It can be seen that the myocardial fibers are evenly colored, the cells are clearly demarcated and have a consistent direction, there are no abnormalities in the interstitial blood vessels, and no obvious pathological changes are observed, indicating that the flow-blocking membrane can not only block tissue defects, but also effectively inhibit thrombosis.

[0063] Test Example 2

[0064] Taking the flow-blocking membrane provided in Example 1 as an example, a cardiac occluder was prepared from it, and implanted in a Labrador dog for 30 days, and then developed under B-ultrasound. The cardiac occluder prepared by the utility model has excellent development effect under B-ultrasound.

[0065] Test Example 3

[0066] Taking the flow-blocking membrane provided in Example 1 as an example, a cardiac occluder was prepared from it and implanted in a Labrador dog for 30 days, and the changes in myocardial cells were observed. After 30 days, the myocardial cells had basically completely covered the micro-nano membrane in the occluder, while the traditional metal occluder polyester flow-blocking membrane and PLA flow-blocking membrane completed the crawling in 6-12 months, while the flow-blocking membrane provided by the utility model can be completed in 1 month, indicating that the flow-blocking membrane can promote cell endothelialization and crawling, and the effect is significant.

[0067] The applicant declares that the above is only a specific implementation method of the present utility model, but the protection scope of the present utility model is not limited thereto. The technicians in the relevant technical field should understand that any changes or substitutions that can be easily thought of by the technicians in the relevant technical field within the technical scope disclosed in the present utility model fall within the protection scope and disclosure scope of the present utility model.

Claims

1. A flow-blocking film, characterized in that: The flow-blocking film comprises a micro-nano developing film and an endothelialization-promoting coating and a hydrophilic coating sequentially arranged on the surface of the micro-nano developing film; The thickness of the endothelialization-promoting coating is 50 nm to 8 μm.

2. The flow-blocking film according to claim 1, characterized in that: The endothelialization-promoting coating and the hydrophilic coating arranged in sequence are arranged on one surface or both surfaces of the flow-blocking membrane.

3. The flow-blocking film according to claim 1, characterized in that: The micro-nano developing film comprises a micro-nano film and a developing film sheet; the number of layers of the micro-nano film is ≥1; the developing film sheet is distributed in at least one of the inner layer, upper surface or lower surface of the micro-nano film.

4. The flow-blocking film according to claim 3, characterized in that: The thickness of the developing film is 100-600 μm and the area is 4-100 mm 2 .

5. The flow-blocking film according to claim 3, characterized in that: The shape of the developing film includes at least one of a square, a circle, a triangle or an irregular pattern.

6. The flow-blocking film according to claim 3, characterized in that: The surface of the developing film also has a convex structure.

7. The flow-blocking film according to claim 6, characterized in that: The height of the protruding structure is 0.05-0.1 mm.

8. The flow-blocking film according to claim 6, characterized in that: The protrusion structure has a shape of at least one of a pyramid, a prism or a frustum.

9. The flow-blocking film according to claim 1, characterized in that: The thickness of the hydrophilic coating is 1-100 nm.

10. The flow-blocking film according to claim 1, characterized in that: The thickness of the flow-blocking film is 150-800 μm.

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