Occluder with reinforced choked flow film

Abstract

The invention relates to the technical field of medical equipment, in particular to a plugging device with a reinforced choked flow membrane. Comprising a framework which is of an elastic net-shaped structure; the flow choking film is arranged on the framework; a reinforcing coating formed by a coating material is arranged on the outer surface of the flow choking film; the degradation period of the coating material is longer than the degradation period of the flow blocking film. The reinforcing coating is located on the outer side of the flow blocking film, gradient degradation can be achieved, the degradation period of the reinforcing coating on the outer layer is long, the degradation time of the flow blocking film on the inner layer is short, after the plugging device is released, the flow blocking film makes contact with tissue, tissue regeneration is induced and promoted, and the reinforcing coating on the outer layer makes contact with blood, so that tissue regeneration is promoted. The mechanical property of the flow choking film is enhanced, meanwhile, the problem that the flow choking film is degraded in advance and then falls down is avoided, and degradation safety and flow choking effectiveness are guaranteed. And loss of reinforcement of mechanical properties of the choked flow membrane before regeneration tissues are formed on the choked flow membrane is prevented.

Description

Technical Field

[0001] The invention relates to the technical field of medical equipment, and in particular to an occluder reinforced with a flow-blocking membrane. Background Art

[0002] The occluder can be loaded into a thin tubular delivery sheath and then pushed to the implantation site through the delivery sheath. After the delivery sheath releases the occluder, the occluder blocks the blood flow.

[0003] The flow-blocking membrane is generally provided with a reinforcing coating formed by a coating material, but the existing occluders do not pay attention to the setting and comparison of the degradation cycle of the coating material and the degradation cycle of the flow-blocking membrane. If the degradation cycle of the coating material is shorter than the degradation cycle of the flow-blocking membrane, and the coating material degrades before the flow-blocking membrane, it may lead to the loss of the function of reinforcing the mechanical properties of the flow-blocking membrane before the regenerated tissue is formed on the flow-blocking membrane. Summary of the invention

[0004] Therefore, the present invention aims to overcome the technical problems in the prior art, thereby providing an occluder reinforced with a flow-blocking membrane.

[0005] The present invention provides a flow-blocking membrane reinforced occluder, comprising:

[0006] A skeleton, wherein the skeleton is an elastic mesh structure;

[0007] A flow-blocking film, wherein the flow-blocking film is arranged on the framework;

[0008] The outer surface of the flow-blocking film is provided with a reinforcement coating formed by a coating material;

[0009] The degradation period of the coating material is longer than the degradation period of the flow-blocking film.

[0010] Furthermore, the coating material is a polymer material.

[0011] Furthermore, the flow-blocking membrane is sutured to the inner side or the outer side of the frame by means of sutures, and the flow-blocking membrane has perforations caused by the sutures.

[0012] Furthermore, the melting point of the coating material is lower than the melting point of the flow-blocking film.

[0013] Furthermore, the reinforcement coating is formed by melting the heated coating material on the outer surface of the flow-blocking film.

[0014] Furthermore, the coating material is a material that can be dissolved by a dissolving solvent.

[0015] Furthermore, the flow-blocking film is insoluble in the dissolving solvent.

[0016] Furthermore, the reinforcement coating is formed by spin coating the dissolving solvent containing the coating material on the outer surface of the blocking film.

[0017] Furthermore, the shape and position of the reinforcement coating are set based on the motion stress of the flow-blocking membrane.

[0018] Furthermore, the reinforcement coating is arranged at the edge of the outer surface of the flow-blocking membrane, at the suture line and at the perforation.

[0019] The technical solution of the present invention has the following advantages:

[0020] The present invention provides an occluder reinforced with a flow-blocking membrane, wherein the reinforcement coating is located on the outside of the flow-blocking membrane, and can achieve gradient degradation. The degradation period of the outer reinforcement coating is long, and the degradation time of the inner flow-blocking membrane is short. After the occluder is released, the flow-blocking membrane contacts the tissue to induce and promote tissue regeneration, and the outer reinforcement coating contacts the blood, which enhances the mechanical properties of the flow-blocking membrane while avoiding the problem of premature degradation of the flow-blocking membrane and resulting in fragmentation, thereby ensuring the safety of degradation and the effectiveness of flow blocking. It prevents the loss of reinforcement of the mechanical properties of the flow-blocking membrane before the regenerated tissue is formed on the flow-blocking membrane.

[0021] The skeleton is an elastic mesh structure, which can be easily loaded into the delivery sheath. The skeleton can support the flow-blocking membrane. When it is in the delivery sheath, the skeleton and the flow-blocking membrane are squeezed into the delivery sheath in a columnar form. After the occluder is released, the skeleton opens the flow-blocking membrane under the action of elasticity, so that the flow-blocking membrane blocks the flow. The reinforcement coating can reinforce the surface layer of the flow-blocking membrane, increase the mechanical properties of the flow-blocking membrane, make the flow-blocking membrane not easy to tear and have holes under the action of stretching and squeezing, and ensure the flow-blocking effect of the flow-blocking membrane.

[0022] The present invention provides a flow-blocking membrane reinforced occluder, wherein the coating material is a polymer material, and conventional polymer materials used for flow-blocking membrane reinforced coatings are easy to obtain and have low cost.

[0023] The present invention provides a flow-blocking membrane reinforced occluder, wherein the melting point of the coating material is lower than the melting point of the flow-blocking membrane. When forming the reinforced coating, the following methods can be used: 1. First, the coating material is evenly arranged on the flow-blocking membrane, and then the coating material is heated. The heating temperature during heating is higher than the melting point of the coating material, but lower than the melting point of the flow-blocking membrane. The coating material melts on the flow-blocking membrane, and forms a reinforced coating after cooling. 2. Use a mold to apply the melted coating material to the outer layer of the flow-blocking membrane to form a reinforced coating. This method is relatively convenient to obtain a reinforced coating.

[0024] The present invention provides a flow-blocking membrane reinforced occluder, wherein the coating material is a material that can be dissolved by a dissolving solvent, and the flow-blocking membrane is insoluble in the dissolving solvent. When forming the reinforced coating, the dissolving solvent in which the coating material is dissolved is spin-coated on the outer surface of the flow-blocking membrane, and the coating material can form a reinforced coating on the outer surface of the flow-blocking membrane after the dissolving solvent precipitates. This method can effectively protect the flow-blocking membrane without heating, and prevent heating from having adverse effects on the flow-blocking membrane.

[0025] The present invention provides a flow-blocking membrane reinforced occluder, wherein the shape and position of the reinforcement coating are set based on the specific motion stress conditions of the flow-blocking membrane. If the flow-blocking membrane is torn into a rectangle due to stress, the reinforcement coating should be a rectangle located at the tearing position; if the flow-blocking membrane is torn into a circle due to stress, the reinforcement coating should be a circle located at the tearing position. The reinforcement coating should be located at the stress concentration point, which can minimize the problem of tearing the flow-blocking membrane and generating holes caused by stress concentration.

[0026] The present invention provides an occluder reinforced with a flow-blocking membrane, wherein the reinforcement coating is arranged at the edge of the outer surface of the flow-blocking membrane, at the suture line stitching and at the perforation. Stress concentration is easily generated at the edge, at the suture line stitching and at the perforation, which may cause tearing and produce holes, so special attention needs to be paid to setting the reinforcement coating at these positions. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 It is a schematic diagram of the structure of the present invention;

[0029] Figure 2 A schematic diagram of the distribution of the reinforcement coating at the perforation of the present invention;

[0030] Figure 3 This is a schematic diagram of the distribution of the circular reinforcement area at the edge of the present invention;

[0031] Figure 4 Schematic diagram of the distribution of the rectangular reinforcement area at the edge of the present invention.

[0032] Description of reference numerals;

[0033] 1. Skeleton; 2. Flow-blocking membrane; 3. Reinforcement area; 4. Non-reinforcement area; 5. Perforation. DETAILED DESCRIPTION

[0034] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0036] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "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 according to specific circumstances.

[0037] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0038] Example

[0039] like Figures 1 to 4 A specific embodiment of a flow-blocking membrane reinforced occluder is shown, and the flow-blocking membrane reinforced occluder comprises:

[0040] A skeleton 1, wherein the skeleton 1 is an elastic mesh structure;

[0041] A baffle 2, wherein the baffle 2 is sutured on the frame 1 by means of sutures, the baffle 2 is arranged on the outside or inside of the frame 1, and the baffle 2 has perforations 5 for sutures;

[0042] The outer surface of the flow-blocking film 2 is provided with a reinforcement coating formed by a coating material.

[0043] The skeleton 1 is a resilient mesh structure, which can be conveniently loaded into the delivery sheath. The skeleton 1 can support the flow-blocking membrane 2. When located in the delivery sheath, the skeleton 1 is squeezed into the delivery sheath in a columnar form with the flow-blocking membrane 2. After the occluder is released, the skeleton 1 opens with the flow-blocking membrane 2 under the action of elasticity, so that the flow-blocking membrane 2 blocks the flow. The reinforcement coating can reinforce the surface layer of the flow-blocking membrane 2, increase the mechanical properties of the flow-blocking membrane 2, make the flow-blocking membrane 2 not easy to tear and produce holes under the action of stretching and squeezing, and ensure the flow-blocking effect of the flow-blocking membrane 2. By setting the reinforcement coating to enhance the wear resistance and tear resistance of the flow-blocking membrane 2, the reliability of the occluder can be improved without changing the original performance of the flow-blocking membrane 2.

[0044] It should be noted that the reinforcement coating may be provided with a portion of the flow-blocking film 2 or the entire flow-blocking film 2. This embodiment is not limited thereto. When the reinforcement coating is provided with a portion of the flow-blocking film 2, the portion provided on the flow-blocking film 2 is the reinforcement area 3, and the portion not provided is the non-reinforcement area 4, and the mechanical properties of the reinforcement area 3 are stronger than those of the non-reinforcement area 4.

[0045] Furthermore, the coating material is a polymer material. Conventional polymer materials used for reinforcing the coating of the flow-blocking film 2 are easy to obtain and have low cost.

[0046] Furthermore, the degradation period of the coating material is longer than the degradation period of the flow-blocking film 2. The coating material can be a degradable material such as PCL, PDO and PLGA, or a non-degradable material.

[0047] The reinforcement coating is located on the outside of the flow-blocking membrane 2, and can achieve gradient degradation. The degradation period of the outer reinforcement coating is long, and the degradation time of the inner flow-blocking membrane 2 is short. After the occluder is released, the flow-blocking membrane 2 contacts the tissue to induce and promote tissue regeneration. The outer reinforcement coating contacts the blood, which enhances the mechanical properties of the flow-blocking membrane 2 while avoiding the problem of premature degradation of the flow-blocking membrane 2 and resulting in fragmentation, ensuring the safety of degradation and the effectiveness of flow blocking. It prevents the loss of reinforcement of the mechanical properties of the flow-blocking membrane 2 before the regenerated tissue is formed on the flow-blocking membrane 2.

[0048] Furthermore, the melting point of the coating material is lower than the melting point of the flow-blocking film 2 .

[0049] Furthermore, the reinforcement coating is formed by melting the heated coating material on the outer surface of the flow-blocking film 2. When forming the reinforcement coating, the following methods can be used: 1. First, evenly arrange the coating material on the flow-blocking film 2, and then heat the coating material. The heating temperature during heating is higher than the melting point of the coating material, but lower than the melting point of the flow-blocking film 2. The coating material melts on the flow-blocking film 2, and forms a reinforcement coating after cooling. 2. Use a mold to apply the melted coating material to the outer layer of the flow-blocking film 2 to form a reinforcement coating. This method is more convenient to obtain a reinforcement coating.

[0050] Furthermore, the coating material is a material that can be dissolved by a dissolving solvent.

[0051] Furthermore, the flow-blocking film 2 is insoluble in the dissolving solvent.

[0052] Furthermore, the reinforcement coating is formed by spin coating a dissolving solvent containing the coating material on the outer surface of the blocking film 2 .

[0053] The coating material is a material that can be dissolved by a dissolving solvent, and the flow-blocking film 2 is insoluble in the dissolving solvent. When forming the reinforcement coating, the dissolving solvent containing the coating material is spin-coated on the outer surface of the flow-blocking film 2, and the coating material can form a reinforcement coating on the outer surface of the flow-blocking film 2 after the dissolving solvent precipitates. In this method, the flow-blocking film 2 can be effectively protected without heating, and the heating can be prevented from having adverse effects on the flow-blocking film 2.

[0054] Further, the shape and position of the reinforcement coating are set based on the motion stress of the flow-blocking film 2. The shape and position of the reinforcement coating are set based on the specific motion stress of the flow-blocking film 2. If the tearing of the flow-blocking film 2 is rectangular, the reinforcement coating should be a rectangle located at the tearing position. If the tearing of the flow-blocking film 2 is circular, the reinforcement coating should be a circle located at the tearing position. The position of the reinforcement coating should be located at the stress concentration point, which can minimize the problem of tearing and generating holes in the flow-blocking film 2 caused by stress concentration.

[0055] Furthermore, the reinforcement coating is arranged at the edge of the outer surface of the blocking film 2, the suture line stitching and the perforation 5. Among them, the edge of the blocking film 2, the suture line stitching and the perforation 5 are prone to stress concentration and tearing to produce holes, so it is necessary to pay special attention to the arrangement of the reinforcement coating at these locations. When the reinforcement coating is arranged on a part of the blocking film 2, and the blocking film 2 is divided into the reinforcement area 3 and the non-reinforcement area 4, Figure 2 This is a schematic diagram of the reinforcement coating distribution at perforation 5. Figure 3 This is a schematic diagram of the distribution of the circular reinforcement area 3 at the edge. Figure 4 Schematic diagram of the distribution of the rectangular reinforcement area 3 at the edge.

[0056] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A flow-blocking membrane reinforced occluder, characterized in that: include: A skeleton (1), wherein the skeleton (1) is an elastic mesh structure; A flow-blocking film (2), wherein the flow-blocking film (2) is arranged on the frame (1); The outer surface of the flow-blocking film (2) is provided with a reinforcement coating formed by a coating material; The degradation period of the coating material is longer than the degradation period of the flow-blocking film (2).

2. The flow-blocking membrane reinforced occluder according to claim 1, characterized in that: The coating material is a polymer material.

3. The flow-blocking membrane reinforced occluder according to claim 1, characterized in that: The flow-blocking film (2) is sewn to the inner side or the outer side of the frame (1) by means of sutures, and the flow-blocking film (2) has perforations (5) formed by the sutures.

4. The flow-blocking membrane reinforced occluder according to claim 1, characterized in that: The melting point of the coating material is lower than the melting point of the flow-blocking film (2).

5. The flow-blocking membrane reinforced occluder according to claim 4, characterized in that: The reinforcement coating is formed by melting the heated coating material on the outer surface of the flow-blocking film (2).

6. The flow-blocking membrane reinforced occluder according to claim 1, characterized in that: The coating material is a material that can be dissolved by a dissolving solvent.

7. The flow-blocking membrane reinforced occluder according to claim 6, characterized in that: The flow-blocking film (2) is insoluble in the dissolving solvent.

8. The flow-blocking membrane reinforced occluder according to claim 6, characterized in that: The reinforcement coating is formed by spin coating the dissolving solvent containing the coating material on the outer surface of the blocking film (2).

9. The flow-blocking membrane reinforced occluder according to claim 1, characterized in that: The shape and position of the reinforcement coating are set based on the motion stress conditions of the flow-blocking membrane (2).

10. The flow-blocking membrane reinforced occluder according to claim 3, characterized in that: The reinforcement coating is arranged at the edge of the outer surface of the flow-blocking membrane (2), at the suture line stitching and at the perforation (5).

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