A flow-blocking membrane-reinforced occluder

Abstract

The application relates to the technical field of medical devices, in particular to a blockage device reinforced by a flow resistance film. The blockage device comprises a framework which is a net-shaped structure with elasticity; a flow resistance film which is arranged on the framework; a reinforcing coating formed by a coating material is arranged on the outer surface of the flow resistance film; and the degradation period of the coating material is longer than that of the flow resistance film. The reinforcing coating is located on the outer side of the flow resistance film, can realize gradient degradation, the degradation period of the reinforcing coating on the outer layer is long, the degradation time of the flow resistance film on the inner layer is short, the flow resistance film is in contact with tissues after the blockage device is released, can induce and promote tissue regeneration, the reinforcing coating on the outer layer is in contact with blood, can enhance the mechanical property of the flow resistance film while avoiding the problem that the flow resistance film is degraded in advance and then falls off, and can guarantee the safety of degradation and the effectiveness of flow resistance. The mechanical property of the flow resistance film is prevented from being reinforced before regenerative tissues are formed on the flow resistance film.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a choke membrane reinforced occluder. Background Technology

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

[0003] The flow-blocking membrane is generally coated with a reinforcing coating material. However, existing plugging devices 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 that of the flow-blocking membrane, and the coating material degrades before the flow-blocking membrane, it may lose its function of reinforcing the mechanical properties of the flow-blocking membrane before the formation of regenerated tissue on the flow-blocking membrane. Summary of the Invention

[0004] Therefore, the present invention aims to overcome the technical problems in the prior art and provide a flow-blocking membrane-reinforced plug.

[0005] This invention provides a flow-blocking membrane-reinforced plugging device, comprising:

[0006] The skeleton is an elastic mesh structure;

[0007] A flow-blocking membrane, wherein the flow-blocking membrane is disposed on the skeleton;

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

[0009] The degradation cycle of the coating material is longer than that of the flow-blocking membrane.

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

[0011] Furthermore, the flow-blocking membrane is sewn onto the inner or outer side of the skeleton by sutures, and the flow-blocking membrane has perforations for the sutures during the sewing process.

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

[0013] Furthermore, the reinforcing coating is formed by melting the heated coating material onto the outer surface of the flow-blocking membrane.

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

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

[0016] Furthermore, the reinforcing coating is formed by spin-coating the solvent containing the coating material onto the outer surface of the flow-blocking membrane.

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

[0018] Furthermore, the reinforcing coating is applied at the edges, seams, and perforations of the outer surface of the flow-blocking membrane.

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

[0020] This invention provides a flow-blocking membrane-reinforced occluder. The reinforcing coating is located on the outer side of the flow-blocking membrane, enabling gradient degradation. The outer reinforcing coating has a long degradation cycle, while the inner flow-blocking membrane degrades quickly. After release, the occluder allows the flow-blocking membrane to contact the tissue, inducing and promoting tissue regeneration. The outer reinforcing coating then contacts the blood. This enhances the mechanical properties of the flow-blocking membrane while preventing premature degradation and subsequent fragmentation, ensuring safe degradation and effective flow blocking. It also prevents the loss of mechanical reinforcement of the flow-blocking membrane before regenerated tissue forms on it.

[0021] The skeleton is an elastic mesh structure that can be easily inserted into the delivery sheath. The skeleton supports the flow-blocking membrane. When located within the delivery sheath, the skeleton, along with the flow-blocking membrane, is compressed into the sheath in a columnar form. After the plug is released, the skeleton, under its elastic force, opens along with the flow-blocking membrane, allowing the membrane to block flow. The reinforcing coating strengthens the surface of the flow-blocking membrane, increasing its mechanical properties and making it less prone to tearing and porosity under tensile and compressive forces, thus ensuring the flow-blocking effect of the membrane.

[0022] The present invention provides a flow-blocking membrane reinforced plug, wherein the coating material is a polymer material. Conventional polymer materials used for flow-blocking membrane reinforcement coatings are readily available and have low cost.

[0023] This invention provides a flow-blocking membrane-reinforced plugging device. The melting point of the coating material is lower than that of the flow-blocking membrane. The reinforcing coating can be formed using the following methods: 1. First, the coating material is uniformly applied to the flow-blocking membrane. Then, the coating material is heated to a temperature higher than the melting point of the coating material but lower than that of the flow-blocking membrane. The coating material melts on the flow-blocking membrane and, after cooling, forms the reinforcing coating. 2. The molten coating material is applied to the outer layer of the flow-blocking membrane using a mold to form the reinforcing coating. This method is relatively convenient for obtaining the reinforcing coating.

[0024] This invention provides a flow-blocking membrane reinforcement plug, wherein the coating material is soluble in a solvent, while the flow-blocking membrane is insoluble in the solvent. During the formation of the reinforcement coating, a solvent containing the coating material is spin-coated onto the outer surface of the flow-blocking membrane. After the solvent precipitates, the coating material forms a reinforcement coating on the outer surface of the flow-blocking membrane. This method eliminates the need for heating, effectively protecting the flow-blocking membrane and preventing adverse effects from heating.

[0025] This invention provides a flow-blocking membrane-reinforced plugging device. The shape and position of the reinforcing coating are set based on the specific dynamic stress conditions of the flow-blocking membrane. If the stress-induced tear of the flow-blocking membrane is rectangular, the reinforcing coating should be a rectangle located at the tear location; if the stress-induced tear of the flow-blocking membrane is circular, the reinforcing coating should be a circle located at the tear location. The reinforcing coating should be positioned at stress concentration points to minimize the problems of flow-blocking membrane tearing and void formation caused by stress concentration.

[0026] The present invention provides a flow-blocking membrane reinforced plug, wherein the reinforcing coating is applied at the edge, suture seam, and perforation of the outer surface of the flow-blocking membrane. The edge, suture seam, and perforation are prone to stress concentration, which can lead to tearing and hole formation. Therefore, special attention should be paid to applying the reinforcing coating at these locations. Attached Figure Description

[0027] 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.

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

[0029] Figure 2 This is a schematic diagram showing the distribution of the reinforcing coating at the perforation point of the present invention;

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

[0031] Figure 4 This is a schematic diagram showing the distribution of rectangular reinforcement areas at the edges of the present invention.

[0032] Explanation of reference numerals in the attached figures;

[0033] 1. Skeleton; 2. Flow barrier membrane; 3. Reinforced area; 4. Unreinforced area; 5. Perforation. Detailed Implementation

[0034] 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.

[0035] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, 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 the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0036] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0037] Furthermore, 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 The illustrated embodiment of a flow-restricting membrane-reinforced plug includes:

[0040] The skeleton 1 is an elastic mesh structure;

[0041] A flow-blocking membrane 2 is sewn onto the skeleton 1 by sutures. The flow-blocking membrane 2 is disposed on the outside or inside of the skeleton 1. The flow-blocking membrane 2 has perforations 5 for sewing by sutures.

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

[0043] The skeleton 1 is an elastic mesh structure that can be easily inserted into the delivery sheath. The skeleton 1 supports the flow-blocking membrane 2. When located in the delivery sheath, the skeleton 1, along with the flow-blocking membrane 2, is compressed into the sheath in a columnar form. After the blocker is released, the skeleton 1, under its elasticity, opens along with the flow-blocking membrane 2, allowing the membrane 2 to block flow. The reinforcing coating strengthens the surface of the flow-blocking membrane 2, increasing its mechanical properties and making it less prone to tearing and pore formation under tension and compression, thus ensuring its flow-blocking effect. By adding a reinforcing coating to enhance the wear resistance and tear resistance of the flow-blocking membrane 2, the reliability of the blocker can be improved without altering the original properties of the membrane 2.

[0044] It should be noted that the reinforcing coating may consist of a portion or all of the flow-blocking membrane 2. This embodiment is not limited to this. When the reinforcing coating consists of a portion of the flow-blocking membrane 2, the portion of the flow-blocking membrane 2 is designated as the reinforced area 3, and the unreinforced portion is designated as the unreinforced area 4. The mechanical properties of the reinforced area 3 are stronger than those of the unreinforced area 4.

[0045] Furthermore, the coating material is a polymer material. Conventional polymer materials used for reinforcing the flow-blocking membrane 2 are readily available and inexpensive.

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

[0047] The reinforcing coating is located on the outer side of the flow-blocking membrane 2, enabling gradient degradation. The outer reinforcing coating has a long degradation cycle, while the inner flow-blocking membrane 2 degrades quickly. After the occluder is released, the flow-blocking membrane 2 comes into contact with the tissue, inducing and promoting tissue regeneration. The outer reinforcing coating comes into contact with the blood, enhancing the mechanical properties of the flow-blocking membrane 2 while preventing premature degradation and subsequent fragmentation, thus ensuring safe degradation and effective flow blocking. This prevents the loss of reinforcement of the mechanical properties of the flow-blocking membrane 2 before regenerated tissue forms on it.

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

[0049] Furthermore, the reinforcing coating is formed by melting the heated coating material onto the outer surface of the flow-restricting membrane 2. The reinforcing coating can be formed using the following methods: 1. First, uniformly apply the coating material onto the flow-restricting membrane 2, then heat the coating material at a temperature higher than its melting point but lower than the melting point of the flow-restricting membrane 2. The coating material melts onto the flow-restricting membrane 2, and after cooling, a reinforcing coating is formed. 2. Use a mold to apply the melted coating material onto the outer layer of the flow-restricting membrane 2 to form the reinforcing coating. This method is relatively convenient for obtaining the reinforcing coating.

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

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

[0052] Furthermore, the reinforcing coating is formed by spin-coating the outer surface of the flow-blocking membrane 2 with a solvent containing the coating material.

[0053] The coating material is soluble in a solvent, while the flow-restricting membrane 2 is insoluble in this solvent. During the formation of the reinforcing coating, the solvent containing the coating material is spin-coated onto the outer surface of the flow-restricting membrane 2. After the solvent precipitates, the coating material forms a reinforcing coating on the outer surface of the flow-restricting membrane 2. This method eliminates the need for heating, effectively protecting the flow-restricting membrane 2 and preventing adverse effects from heating.

[0054] Furthermore, the shape and position of the reinforcing coating are set based on the dynamic stress conditions of the flow-restricting membrane 2. Specifically, if the stress-induced tear of the flow-restricting membrane 2 is rectangular, the reinforcing coating should be a rectangle located at the tear location; if the stress-induced tear of the flow-restricting membrane 2 is circular, the reinforcing coating should be a circle located at the tear location. The reinforcing coating should be positioned at stress concentration points to minimize the tearing of the flow-restricting membrane 2 and the formation of holes caused by stress concentration.

[0055] Furthermore, the reinforcing coating is applied to the edges, seam seams, and perforations 5 on the outer surface of the flow-blocking membrane 2. The edges, seam seams, and perforations 5 are prone to stress concentration, which can lead to tearing and voids; therefore, special attention must be paid to applying the reinforcing coating to these locations. When the reinforcing coating is applied to a portion of the flow-blocking membrane 2, dividing the flow-blocking membrane 2 into a reinforced area 3 and a non-reinforced area 4, Figure 2 This is a schematic diagram showing the distribution of the reinforcing coating at perforation 5. Figure 3 This is a schematic diagram showing the distribution of the circular reinforcement zone 3 at the edge. Figure 4 This is a schematic diagram of the distribution of the rectangular reinforcement zone 3 at the edge.

[0056] 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. A flow-blocking membrane-reinforced plug, characterized in that, include: The skeleton (1) is an elastic mesh structure; A flow-blocking membrane (2) is disposed on the skeleton (1); The outer surface of the flow-blocking membrane (2) is separately provided with a reinforcing coating formed by a coating material. The reinforcing coating is in contact with blood, and the flow-blocking membrane (2) is in contact with tissue to induce and promote tissue regeneration. The degradation cycle of the coating material is longer than that of the flow-blocking membrane (2). The reinforcing coating reinforces the surface of the flow-blocking membrane (2) to increase the mechanical properties of the flow-blocking membrane (2) and prevent the flow-blocking membrane (2) from tearing and cavitating under the action of stretching and extrusion. The melting point of the coating material is lower than that of the flow-blocking membrane (2), and the reinforcing coating is formed by melting the heated coating material on the outer surface of the flow-blocking membrane (2); Alternatively, the coating material may be a material that can be dissolved by a solvent, and the flow-blocking membrane (2) may be insoluble in the solvent. The reinforcing coating may be formed by spin-coating the solvent containing the coating material onto the outer surface of the flow-blocking membrane (2). The reinforcing coating is provided with a portion of flow-blocking film (2), the part provided is the reinforced area (3), and the part not provided is the unreinforced area (4). The mechanical properties of the reinforced area (3) are stronger than those of the unreinforced area (4). The flow-blocking membrane (2) is sewn to the inner or outer side of the skeleton (1) by sutures, and the flow-blocking membrane (2) has perforations (5) when the sutures are sewn. The reinforcing coating is applied at the edge of the outer surface of the flow-blocking membrane (2), at the suture seam, and at the perforation (5).

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

3. The flow-blocking membrane-reinforced plugging device according to claim 1, characterized in that, The shape and position of the reinforcing coating are set based on the motion and stress conditions of the flow-blocking membrane (2).

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