Controllable differential endothelialization occlusion device

Abstract

The application relates to the field of medical devices, in particular to a controllable differential endothelialization occlusion device. The occlusion device comprises a first occlusion unit, a second occlusion unit and a waist structure connecting the two, the exposed area surfaces of the first occlusion unit and the second occlusion unit are covered with a first film, the surface or periphery of the waist structure is covered with a second film, the first film and the second film are different in material, the endothelialization promoting speed of the second film is greater than that of the first film, and the first film and the second film are respectively provided with a first micropore structure and a second micropore structure.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a closure device for controllable differential endothelialization. Background Technology

[0002] The foramen ovale (PFO) is a physiological passage in the atrial septum during embryonic development. Around 5-7 months after birth, in most individuals, the primordial and secondary septa of the atrial septum adhere and fuse to form a permanent atrial septum. If fusion fails, a patent foramen ovale (PFO) is formed. Studies have shown a close link between PFO and unexplained stroke. Through a patent foramen ovale, the following emboli can enter the left ventricular system, causing corresponding clinical symptoms: 1. Thrombosis in the deep veins of the lower extremities or pelvic veins; 2. Air emboli caused by decompression sickness or diving; 3. Fat emboli formed after surgery or trauma. Furthermore, the risk of recurrent thrombotic events remains high for patients with a history of PFO. Therefore, treating the underlying cause and closing the open foramen ovale in high-risk individuals may reduce the incidence of these conditions. Additionally, research has found that PFO is associated with decompression sickness, migraines, and other conditions; closing the foramen ovale may also benefit patients with these conditions.

[0003] Currently, most interventional devices used for closing the foramen ovale are double-disc occlusion devices. However, the anatomical structure and thickness of defects vary depending on the location of the defect in different congenital heart diseases. Generally, the left and right discs of the occlusion device do not fit well against the left and right sides of the cardiac septum after deployment. Furthermore, the disc surfaces of the occlusion devices are made of metal with many grids or gaps, making endothelial cell adhesion and migration difficult. The grid-like surface also leaves no space for secondary interventional procedures, and the presence of multiple metal implants hinders patient recovery. In addition, there are occlusion devices on the market that include two single-disc structures. This design makes the occluder non-retrievable after deployment, resulting in low operability. There are also designs with a single disc in the left atrium and a double disc in the right atrium, but these designs still suffer from the disadvantages of the aforementioned double-disc occlusion devices.

[0004] Meanwhile, the waist structure of existing occlusion devices used to connect the left and right discs is generally designed as a rod. The waist structure has low compliance. For different patients with different shapes of foramen ovale tunnels, cavities will be formed between the waist structure, foramen ovale tissue and the left and right discs, creating channels through which blood can pass, resulting in poor occlusion effect and hindering the endothelialization of the encapsulation device. Furthermore, because the overall coating of the occlusion device adopts the same design, it is easy to cause problems such as excessive endothelialization of the occlusion device, even the formation of blood clots on the surface of the occlusion disc, as well as problems such as the edge of the disc lifting outward due to excessive endothelialization and failure to adhere to the tissue, or the endothelialization speed being too slow, resulting in poor occlusion effect and easy leakage.

[0005] As can be seen from the above, the existing technology has the following problems: 1. The mechanical fit of the occlusion device is not good; 2. It is difficult to perform a second puncture surgery at the implantation site of the occlusion device; 3. The right atrial occlusion disc is not easy to be retrieved after being released during the operation; 4. The amount of metal implanted is increased due to the design of the retrieval function; 5. Excessive endothelialization or endothelialization speed is too slow.

[0006] Therefore, those skilled in the art are dedicated to researching a closure device that can control differential endothelialize without affecting the fit, without affecting secondary puncture, can be recovered after release, has a small amount of metal implantation, and can be endothelialized but not excessively endothelialized in the blood-contacting part while rapidly endothelializing in the tunnel. Summary of the Invention

[0007] The purpose of this invention is to provide a closure device with controllable differential endothelialization to solve the problems mentioned in the background art.

[0008] To solve the above-mentioned technical problems, this application provides the following technical solution: a closure device for controllable differential endothelialization, the closure device comprising a first closure unit, a second closure unit, and a waist structure connecting the two, wherein the exposed areas of the first closure unit and the second closure unit are covered with a first membrane, and the surface or periphery of the waist structure is covered with a second membrane, wherein the first membrane and the second membrane are made of different materials, the second membrane has a higher endothelialization rate than the first membrane, and the first membrane and the second membrane are respectively provided with a first microporous structure and a second microporous structure.

[0009] In one embodiment, the pore diameter or internode distance of the first microporous structure is the first microporous size, the pore diameter or internode distance of the second microporous structure is the second microporous size, the first microporous size ranges from 6um to 60um, and the second microporous size ranges from 60um to 3000um; and the second microporous size is larger than the first microporous size.

[0010] In one embodiment, the first microporous structure is a plurality of pores on the first membrane, and the second microporous structure is a plurality of pores on the second membrane.

[0011] In one embodiment, the density of the second microporous structure is greater than that of the first microporous structure, making it easier for cardiac tissue to enter the waist structure through the second membrane.

[0012] In one embodiment, the first membrane is further provided with a plurality of auxiliary microporous structures penetrating the first membrane. The pore size or internode distance of the auxiliary microporous structures is the auxiliary microporous size, which ranges from 30um to 1000um. The area ratio of the auxiliary microporous structures on the first membrane is 10% to 50%. The auxiliary microporous structures allow water molecules to pass through quickly, but restrict the passage of blood cells.

[0013] In one embodiment, the lumbar structure is located in the foramen ovale tunnel after implantation, and the second membrane has a good procoagulant effect, which can accelerate endothelialization.

[0014] In one embodiment, the first membrane is breathable but not water-permeable, while the second membrane is both breathable and water-permeable.

[0015] In one embodiment, the first membrane is anticoagulant.

[0016] In one embodiment, the waist structure is cylindrical in shape.

[0017] In one embodiment, the cross-section of the waist structure is two C-shaped sections.

[0018] In one embodiment, the second membrane of the waist structure is stacked.

[0019] In one embodiment, the second membrane of the waist structure is flexible and conforms to the shape of the fovea ovale tissue.

[0020] In one embodiment, the waist structure is sealed, and the distal and proximal surfaces of the waist structure are also covered with the second membrane.

[0021] In one embodiment, the first sealing unit includes a first support frame, the first support frame including a first support structure and a first bonding structure; and the second membrane is connected to the first support structure.

[0022] In one embodiment, the second membrane of the waist structure is disposed at the junction of the first support structure and the first bonding structure.

[0023] In one embodiment, the first support structure includes a plurality of radially diverging first support members, each of which includes a first curved section and a second curved section.

[0024] In one embodiment, the first support structure and the first bonding structure are integrally woven from metal wires.

[0025] In one embodiment, the second membrane of the waist structure is connected to the first support member.

[0026] In one embodiment, the first bonding structure includes a plurality of bonding wires, the diameter of which is smaller than the diameter of the first support member, and the bonding wires have good conformability.

[0027] In one embodiment, the pre-defined direction of the bonding thread is toward the tissue to be closed; and the bonding thread moves to adhere to the first membrane connected to it to the tissue to be closed.

[0028] In one embodiment, the first support member is made of several strands of metal wire.

[0029] In one embodiment, the first support frame includes a connector, a first bent segment is connected to the connector, and a second bent segment is connected to the first bent segment.

[0030] In one embodiment, the radius of curvature of the first curved segment is smaller than the radius of curvature of the second curved segment.

[0031] In one embodiment, the first curved segment has a large curvature, while the second curved segment has a small curvature.

[0032] In one embodiment, the bending direction of the first bending segment is opposite to that of the second bending segment.

[0033] In one embodiment, the first curved segment at least partially fills the oval-shaped tunnel.

[0034] In one embodiment, after the occlusion device is implanted, the first curved segment at least partially enters the foramen ovale tunnel, serving a certain filling function, while the second curved segment undergoes slight deformation and adheres to the left atrial surface of the foramen ovale.

[0035] In one embodiment, after the occlusion device is implanted, the first occlusion unit is sheet-like on the left atrial surface.

[0036] In one embodiment, in its natural state, the connector is located at the distal end of the outer end of the second curved segment.

[0037] In one embodiment, after the occlusion device is implanted, the connector is located in the proximal direction of the outer end of the second curved segment.

[0038] In one embodiment, the second sealing unit includes a second support frame and a third support frame, wherein the second support frame is larger than the third support frame; and the second membrane is connected to the third support frame.

[0039] In one embodiment, the center of the third support frame is covered with a second membrane, and the outer periphery is covered with a first membrane.

[0040] In one embodiment, both the second and third support frames are covered by a polymer membrane.

[0041] In one embodiment, both the distal and proximal surfaces of the first support frame are covered with the first membrane.

[0042] In one embodiment, the distal and proximal surfaces of the second support frame are both covered with the first membrane; and the proximal and / or distal surfaces of the third support frame are at least partially covered with the second membrane.

[0043] In one embodiment, the second membrane on the periphery of the waist structure and the second membrane on the third support frame together form a bottle shape, thereby enhancing the flow resistance effect; or the second membrane on the periphery of the waist structure, the second membrane on the third support frame, and the first membrane on the first support frame together form a closed capsule shape, thereby enhancing the flow resistance effect.

[0044] In one embodiment, the first support frame, the second support frame, and the third support frame do not directly contact the heart tissue, and the foramen ovale tissue only adheres to the first membrane or the second membrane.

[0045] In one embodiment, the second support frame includes a second support structure and a second fitting structure, the second fitting structure forming an annular structure with the first membrane; and, after the occlusion device is implanted, the annular structure fits against the right atrial surface.

[0046] In one embodiment, a ring structure is also formed on the first support frame.

[0047] In one embodiment, the second support frame includes a plurality of radially diverging second support members.

[0048] In one embodiment, the second support member and the third support member at least partially overlap in axial projection.

[0049] In one embodiment, the second blocking unit further includes a constraint structure connecting the second support frame and the third support frame. The constraint structure is disposed in the middle part or near the edge of the second support frame. The third support frame includes a radially disposed third support member. The outer end of the third support member is provided with a connecting unit. The constraint structure is movably connected to the connecting unit and restricts the range of motion of the restricting unit.

[0050] In one embodiment, the constraint structure includes a connecting unit and a guiding unit, the connecting unit being connected to the second support frame and / or the third support frame; and the guiding unit being at a certain angle to the connecting unit.

[0051] In one embodiment, the surface extending toward the outer end of the second support member and forming a critical surface is the guide unit disposed on the far end side of the critical surface or within the critical surface.

[0052] In one embodiment, the second membrane of the waist structure is connected to the constraint structure.

[0053] In one embodiment, the first support structure is the same as or similar to the second support structure.

[0054] In one embodiment, the width of the annular structure is one-fifth to one-half of the radius of the second blocking unit.

[0055] In one embodiment, the width of the annular structure shall not exceed one-half the radius of the second blocking unit.

[0056] In one embodiment, the first bonding structure is the same as or similar to the second bonding structure.

[0057] In one embodiment, the width of the annular structure is one-third of the radius of the second blocking unit.

[0058] In one embodiment, the radius of the second support member is two-thirds of the radius of the second support frame.

[0059] In one embodiment, the constraint structure is disposed at the connection position between the second support structure and the second fitting structure.

[0060] In one embodiment, at least a portion of the surface of the first support frame, the second support frame, or the third support frame is provided with a connecting membrane, and the connecting membrane is connected by means of binding, wrapping, or bonding; and the first membrane or the second membrane is fixedly connected to the connecting membrane.

[0061] In one embodiment, at least a portion of the surface of the second support structure or the second bonding structure is provided with a connecting membrane, the connecting membrane being connected by binding, wrapping, or bonding; the connecting membrane is strip-shaped and has a first micropore size; and the first membrane is fixedly connected to the connecting membrane.

[0062] In one embodiment, the surface of the connecting membrane is provided with micropores.

[0063] In one embodiment, the second plugging unit further includes a plug head connected to the delivery system; and the surface of the plug head is covered with a first membrane.

[0064] In one embodiment, the first membrane includes an elastic structure; and the elastic structure is square, rectangular, rhomboid, or other quadrilateral in shape.

[0065] In one embodiment, the material of the first membrane includes ePTFE, PU, ​​PET, PEEK or PI; the material of the second membrane includes PET, PPDO, PCL, PGA, PLA, nonwoven fabric or other biodegradable materials.

[0066] In one embodiment, the outer edge of the first membrane is provided with a developing structure; and the size of the developing structure is larger than the size of the first aperture.

[0067] In one embodiment, the connector includes a fixing member and a guide member.

[0068] In one embodiment, the guide member has a cavity.

[0069] In one embodiment, the fastener secures the first support members together, and the fastener is located at the center of the first sealing unit.

[0070] In one embodiment, the waist structure includes a connector that passes through a cavity in the guide and connects to the connector head.

[0071] In one embodiment, the connector is connected at both ends to the first sealing unit and the third support frame, respectively; and the connector is not connected to the second membrane, the radial dimension of the second membrane being much larger than that of the connector.

[0072] In one embodiment, the connector is a flexible wire.

[0073] In one embodiment, the third support frame also includes a connector.

[0074] In one embodiment, the connector connects the third support frame to the first support frame.

[0075] In another embodiment, the first blocking unit and the second blocking unit have the same structure; the blocking device has a symmetrical structure.

[0076] In one embodiment, the first sealing unit is a single-layer disk, and the second sealing unit is a one-and-a-half-layer disk.

[0077] In one embodiment, the exposed area includes the outer and inner surfaces of a first occlusion unit and a second occlusion unit, the inner surface being in contact with cardiac tissue, and the outer surface being visible on the left and right atrial surfaces.

[0078] In one embodiment, the first sealing unit is attached to the left room surface, and the second sealing unit is attached to the right room surface.

[0079] In one embodiment, the delivery system includes an outer sheath and a control tube connected to the plug head; and the sealing device is pre-installed inside the outer sheath.

[0080] In one embodiment, the connector is an elastic element.

[0081] Compared with the prior art, the advantages of the present invention are as follows:

[0082] 1. In existing technologies, the membranes of occlusion devices are connected to their metal skeletons, and the membranes are generally made of endothelialization-promoting materials. After implantation, excessive endothelialization may occur, not only within the foramen ovale tunnel but also on the surface of the occlusion disc, resulting in a large amount of tissue covering the disc surface. This tissue detachment poses a risk of further injury to the patient. This application addresses these issues by using membranes of different materials at different locations within the occlusion device. The occlusion device includes a first occlusion unit, a second occlusion unit, and a waist structure connecting them. The exposed areas of the first and second occlusion units are covered with a first membrane, while the surface of the waist structure is covered with a second membrane. The second membrane promotes endothelialization at a higher rate than the first membrane. The advantage of this design is that after implantation, the second membrane is located within the foramen ovale tunnel. The first membrane, with its procoagulant and endothelializing properties, allows the foramen ovale tissue to rapidly fuse with it, growing endothelial cells. The shape of the tunnel is irrelevant; the second membrane can fill the initial cavity between the lumbar structure, the foramen ovale tissue, and the occlusion unit, resulting in excellent filling. Furthermore, the first membrane is positioned on the outer and inner surfaces of the first and second occlusion units. Due to its low endothelialization rate and anticoagulant effect, the first membrane on the inner surface does not undergo excessive endothelialization with the adjacent atrial septum tissue, but rather adheres well to the secondary and primary septa. The first membrane on the outer surface does not grow tissue. Therefore, the first and second occlusion units adhere well to the secondary and primary septa tissues, and the lumbar structure attaches well to the foramen ovale tunnel. After implantation, the patent foramen ovale problem can be completely improved.

[0083] 2. Unlike existing technologies, the first membrane and the second membrane are respectively provided with a first microporous structure and a second microporous structure on their surfaces. The size of the second microporous structure is larger than that of the first microporous structure. The large pore size of the second membrane allows cardiac tissue to easily enter the interior of the lumbar structure. Furthermore, due to the good flexibility of the second membrane, it can adhere to the secondary septum and primary septum tissue, making it easy to fill the gaps. This allows the foramen ovale tunnel to be filled with endothelial cells, preventing blood from passing through the foramen ovale.

[0084] 3. Unlike existing technologies, the first occlusion unit includes a first support framework, which comprises a first support structure and a first fitting structure. The second membrane is connected to the first support structure. The advantage of this design is that the first support structure is located in the middle of the first support framework, while the first fitting structure is located on the periphery. After endothelial cells enter the lumbar structure through the second membrane, the first support structure, due to its high rigidity, can support the endothelial tissue without deformation. The first membrane on the first support structure can also prevent endothelial cells from growing onto the outer surface of the first support structure. At the same time, the first fitting structure is also covered by the first membrane. The first fitting structure will not undergo excessive endothelialization but will instead adhere to the secondary and primary septa of the left atrial surface. Therefore, the first support structure and the first fitting structure play the roles of support and adhesion, respectively.

[0085] 4. Unlike existing technologies, the first support structure includes several radially diverging first support members. The radial arrangement avoids the problem of being unable to perform secondary punctures due to the mesh metal wire on the disc surface. At the same time, the first support member of this application includes a first curved section and a second curved section. The first curved section is connected to the connector. After the occlusion device is implanted, the connector is located in the foramen ovale tunnel. The connector, along with the first curved section, allows at least part of the first curved section to enter the foramen ovale tunnel to fill it. Since the first support frame is close to the left atrial surface, the second curved section will undergo slight deformation and fit with the left atrial surface. Fortunately, the degree of curvature of the second curved section is small, and only slight deformation is required. Furthermore, the first fitting structure is set towards the direction of the tissue to be closed. When the first fitting structure and the second curved section fit with the tissue, the first occlusion member located on the left atrial surface is sheet-like with a smooth surface, minimizing the impact of implantation on the effect.

[0086] 5. In existing technologies, to ensure that the occlusion device simultaneously facilitates secondary puncture and is retrievable after release, the right disc typically uses a radially arranged support frame woven from metal wire, and the right disc is a double-disc structure. However, this design requires a large length of metal wire, and existing processes struggle to weave uniform rods. During the retrieval of the support frame, uneven weaving of the metal wire rods, or uneven friction between different rods and the delivery system components, makes it difficult to uniformly retract the support frame into the delivery system. This can lead to deformation, jamming, or breakage of the support frame, reducing the success rate of the surgery. This application avoids the above problems through the following technical solution. The title is as follows: First, the second sealing unit includes a second support frame and a third support frame. These two frames are not the same size and are not the traditional double-disc structure where the outer ends of the frames are connected. Instead, a constraint structure is set in the middle or near the edge of the second support frame, requiring less wire than an end-to-end connection. The third support frame includes a third support member, and the constraint structure is movably connected to the connecting unit of the third support member. This movable connection essentially gives the second sealing unit a "compensation" function. For example, when retracting the second support frame, if some members of the second support frame enter the outer sheath first, while others do not, the constraint structure connected to the already entered members will shift with the corresponding connecting unit and enter the outer sheath along with the remaining members. This prevents the second support frame from being pulled too hard and damaged, and also prevents the second support frame from "tilting" due to uneven sheath entry. On the other hand, since the third support member is not fixedly connected to the second support frame, there is a possibility that the outer end of the third support member may move to the outside of the outer surface of the second support frame when the second sealing unit is retracted. This would create a step between the third support member and the second support frame. This causes the third support to get stuck outside the outer sheath, preventing the retrieval of the second sealing unit. To avoid this problem, the constraint structure of this application, in addition to providing a movable connection function, can also limit the range of motion of the connecting unit, preventing the connecting unit from moving outside the first support frame and forming a step, thereby ensuring that the second sealing unit can be retrieved smoothly. In addition, the first sealing unit of this application is a single-disc structure, which can be directly retrieved. Moreover, the sealing device of this application has less than three layers in total, between 2.5 and 2.8 layers, which is the fewest layers and the fewest metal implants among the existing sealing devices that can be both retrieved and re-punctured.

[0087] 6. Unlike existing technologies, the second and third support skeletons of this application are two skeletons, and for the purpose of recycling, the plug head and connector head of the two are located at the distal and proximal ends of the skeleton, respectively. As a result, there is a certain gap between the second support structure and the third support skeleton, forming a cavity. Therefore, this application sets a second membrane on the surface of the third skeleton, so that the endothelial tissue can enter the cavity after passing through the waist structure, so that there is no gap between the first sealing unit and the second sealing unit, resulting in a good sealing effect.

[0088] 7. Unlike the prior art, the surface of the second support structure or the second bonding structure of this application is at least partially provided with a connecting film. That is, a connecting film is first wrapped around the surface of the second support member or the bonding wire, and then the connecting film is fused with the first film. The advantage of this design is that, since the connecting film is fixed on the surface of the support member, compared with the metal support member being directly burned with the first film, the connecting film is easier to fuse and connect with the first film, and the resulting support member will not be displaced from the first film, resulting in a better fixing effect.

[0089] 8. Unlike the prior art, the waist structure of this application is connected to the constraint structure of the second occlusion unit. On the one hand, the constraint structure provides a connection position for the second membrane of the waist structure. On the other hand, the second fitting structure is located on the outside of the constraint structure. The occlusion of the waist and the fitting of the atrial surface are connected very smoothly, resulting in a good occlusion effect. Attached Figure Description

[0090] Figure 1 This is a schematic diagram of the overall structure of the sealing device of the present invention.

[0091] Figure 2 This is a schematic diagram of the specific structure of the sealing device of the present invention.

[0092] Figure 3 and Figure 4 This is a schematic diagram of the waist structure of the present invention.

[0093] Figure 5 This is a schematic diagram of the structure of the first sealing unit of the present invention.

[0094] Figure 6 This is a schematic diagram of the structure of the first support member of the present invention.

[0095] Figure 7 and Figure 8 This is a schematic diagram of the first support member of the present invention in its natural state and after implantation.

[0096] Figure 9 This is a schematic diagram showing the connection between the second and third support frames of the present invention.

[0097] Figure 10 This is a schematic diagram of the coating on the third support frame of the present invention.

[0098] Figure 11 This is a schematic diagram of the structure of the second support frame of the present invention.

[0099] Figure 12 This is a schematic diagram of the constraint structure of the present invention.

[0100] Figure 13 This is a schematic diagram of the connector structure of the present invention.

[0101] Figure 14 and 15 This is a schematic diagram of the endothelialization of the waist structure in this invention.

[0102] Figure 16 This is another embodiment of the present invention.

[0103] Figure 17 This is a schematic diagram of the connecting membrane of the present invention.

[0104] Figure 18 This is a schematic diagram of the elastic structure of the present invention.

[0105] The locations indicated by the numbers in the attached diagram are as follows: 1 - First sealing unit. 2-Second sealing unit, 3-Waist structure, 31-Connector, 4-First membrane, 41-First microporous structure, 42-Auxiliary microporous structure, 43-Elastic structure, 5-Second membrane, 51-Second microporous structure, 6-First support skeleton, 61-First support structure, 611-First support member, 6111-First bending section, 6112-Second bending section, 62-First bonding structure, 621-Bonding wire, 63-Connector, 64-Fixing member, 65-Guide member, 66-Cavity, 7-Second support skeleton, 71-Second support structure, 711-Second support member, 712-Critical surface, 72-Second bonding structure, 73-Annular structure, 74-Connecting membrane, 75-Plug head, 8-Third support skeleton, 81-Third support member, 82-Connecting unit, 9-Constraint structure, 91-Connecting unit, 92-Guide unit. Implementation

[0106] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0107] In this application, the end closer to the surgical operator is defined as the "proximal end," and the end farther from the surgical operator is defined as the "distal end."

[0108] In this application, "exposed area" refers to the area where the sealing device is visible in its natural state. Specific Implementation Example 1

[0109] like Figure 1 and Figure 2As shown, during PFO interventional treatment, a controllable differential endothelialization occlusion device is used. The occlusion device includes a first occlusion unit 1, a second occlusion unit 2, and a waist structure 3 connecting the two. The exposed areas of the first occlusion unit 1 and the second occlusion unit 2 are covered with a first membrane 4, and the surface or periphery of the waist structure 3 is covered with a second membrane 5. Furthermore, the first membrane 4 and the second membrane 5 are made of different materials, and the endothelialization rate of the second membrane 5 is greater than that of the first membrane 4. The surfaces of the first membrane 4 and the second membrane 5 are respectively provided with a first microporous structure 41 and a second microporous structure 51.

[0110] In this embodiment, the first microporous structure 41 is a plurality of pores on the first membrane 4, and the second microporous structure 51 is a plurality of pores on the second membrane 5.

[0111] In this embodiment, the pore diameter or internode distance of the first microporous structure 41 is the first micropore size, and the pore diameter or internode distance of the second microporous structure 51 is the second micropore size. The range of the first micropore size is 6µm-60µm, and the range of the second micropore size is 60µm-3000µm; furthermore, the second micropore size is larger than the first micropore size, such as... Figure 5 and 3 As shown.

[0112] In this embodiment, the density of the second microporous structure 51 is greater than that of the first microporous structure 41, making it easier for heart tissue to enter the waist structure 3 through the second membrane 5.

[0113] In this embodiment, the first membrane 4 is further provided with a plurality of auxiliary microporous structures 42 penetrating the first membrane 4, such as Figure 5 As shown, the pore size or internode distance of the auxiliary microporous structure 42 is the auxiliary microporous size, which ranges from 30um to 1000um. The area ratio of the auxiliary microporous structure 42 on the first membrane is 10%-50%. The auxiliary microporous structure allows water molecules to pass through quickly, but restricts the passage of blood cells.

[0114] In this embodiment, the lumbar structure 3 is located in the foramen ovale tunnel after implantation, and the second membrane 5 has a good coagulation effect and can accelerate endothelialization.

[0115] In this embodiment, the cross-section of the waist structure 3 is two C-shaped structures, such as... Figure 3 As shown.

[0116] In this embodiment, the second membrane 5 of the waist structure 3 is flexible and can conform to the shape of the foramen ovale tissue, such as... Figure 4 As shown.

[0117] In this embodiment, the waist structure 3 is sealed, and the distal and proximal surfaces of the waist structure 3 are also covered with the second membrane 5.

[0118] In this embodiment, the first sealing unit 1 includes a first support frame 6, which includes a first support structure 61 and a first fitting structure 62, such as... Figure 5 As shown.

[0119] In this embodiment, the second membrane 5 of the waist structure 3 is connected to the first support structure 61; or, the second membrane 5 is disposed at the junction of the first support structure 61 and the first bonding structure 62.

[0120] In this embodiment, the first support structure 61 includes a plurality of radially diverging first support members 611, and each first support member 611 includes a first curved section 6111 and a second curved section 6112, such as... Figure 6 and 7 As shown.

[0121] In this embodiment, the first bonding structure 62 includes a plurality of bonding wires 621, the diameter of which is smaller than the diameter of the first support member 611, and the bonding wires 621 have good conformability; furthermore, the preset direction of the bonding wires 621 is toward the tissue to be closed; and the bonding wires 621 drive the first membrane 4 connected to them to bond with the tissue to be closed.

[0122] In this embodiment, the first support member 611 is made of several strands of metal wire.

[0123] In this embodiment, the first support frame 6 includes a connector 63, the first bent segment 6111 is connected to the connector 63, and the second bent segment 6112 is connected to the first bent segment 6111.

[0124] In this embodiment, the radius of curvature of the first curved segment 6111 is smaller than the radius of curvature of the second curved segment 6112.

[0125] In this embodiment, after the occlusion device is implanted, the first curved section 6111 enters at least partially into the foramen ovale tunnel, playing a certain filling function, while the second curved section 6112 undergoes slight deformation and fits against the left atrial surface of the foramen ovale.

[0126] In this embodiment, after the occlusion device is implanted, the first occlusion unit 1 is sheet-like on the left atrial surface, as shown below. Figure 8 As shown.

[0127] In this embodiment, in its natural state, the connector 63 is located at the distal end of the outer end of the second curved segment 6112, such as... Figure 7As shown; after the occlusion device is implanted, the connector 63 is located in the proximal direction of the outer end of the second curved section 6112, as shown. Figure 8 As shown.

[0128] In this embodiment, the second blocking unit 2 includes a second support frame 7 and a third support frame 8, such as... Figure 9 As shown, the second support frame 7 is larger than the third support frame 8; and the second membrane 5 is connected to the third support frame 8.

[0129] In this embodiment, the center of the third support frame 8 is covered with a second membrane 5, and the outer periphery is covered with a first membrane 4, such as... Figure 10 As shown, the advantage of this design is that it prevents the endothelial tissue from growing into the second bonding structure 62 and affecting the bonding effect.

[0130] In this embodiment, the distal and proximal surfaces of the first support frame 6 are both covered with the first membrane 4; the distal and proximal surfaces of the second support frame 7 are both covered with the first membrane 4; and the proximal and / or distal surfaces of the third support frame 8 are at least partially covered with the second membrane 5.

[0131] In this embodiment, the second support frame 7 includes a second support structure 71 and a second bonding structure 72. The second bonding structure 72 and the first membrane 4 form an annular structure 73, such as... Figure 11 As shown; and, after the sealing device is implanted, the annular structure 73 fits against the right room surface.

[0132] In this embodiment, the second support frame 7 includes a plurality of radially diverging second support members 711.

[0133] In this embodiment, the second blocking unit 2 further includes a constraint structure 9 connecting the second support frame 7 and the third support frame 8, such as... Figure 12 As shown, the constraint structure 9 is disposed in the middle part or near the edge of the second support frame 7. The third support frame 8 includes a radially disposed third support member 81. The outer end of the third support member 81 is provided with a connecting unit 82. The constraint structure 9 is movably connected to the connecting unit 82 and restricts the range of motion of the constraint unit.

[0134] In this embodiment, the constraint structure 9 includes a connecting unit 91 and a guiding unit 92. The connecting unit 91 is connected to the second support frame 7. Furthermore, the guiding unit 92 is at a certain angle to the connecting unit 91.

[0135] In this embodiment, the surface extending toward the outer end of the second support member 711 and forming a critical surface 712 is provided, and the guide unit 92 is disposed on the far end side of the critical surface 712 or within the critical surface 712.

[0136] In this embodiment, the second membrane 5 of the waist structure 3 is connected to the constraint structure 9.

[0137] In this embodiment, the width of the annular structure 73 is one-third of the radius of the second blocking unit 2; the radius of the second support member 711 is two-thirds of the radius of the second support frame 7, such as... Figure 11 As shown.

[0138] In this embodiment, the second sealing unit 2 further includes a plug head 75, which is connected to the delivery system; and the surface of the plug head 75 is covered with a first membrane 4.

[0139] In this embodiment, the material of the first membrane 4 includes ePTFE, PU, ​​PET, PEEK or PI; the material of the second membrane 5 includes PET, PPDO, PCL, PGA, PLA, non-woven fabric or other biodegradable materials.

[0140] In this embodiment, the connector 63 includes a fixing member 64 and a guide member 65; the guide member 65 has a cavity 66, such as... Figure 13 As shown.

[0141] In this embodiment, the fixing member 64 fixes the first support member 611 together, and the fixing member 64 is located at the center of the first sealing unit 1; the waist structure 3 includes a connector 31, which passes through the cavity 66 of the guide member 65 and is connected to the connector 63; the connector 31 is a flexible wire.

[0142] In this embodiment, the first occlusion unit 1 is attached to the left atrial surface, and the second occlusion unit 2 is attached to the right atrial surface; furthermore, if there is a gap between the lumbar structure 3 and the second occlusion unit 2 during implantation, the second membrane 5 of the lumbar structure 3 will quickly undergo endothelialization with the primary septum tissue, and the endothelial tissue will enter the lumbar structure 3 through the second microporous structure 51 on the lumbar structure 3, filling the foramen ovale channel, resulting in a good filling effect. Figure 14 and 15 As shown. Example 2

[0143] The difference from Embodiment 1 is that the shape and location of the waist structure 3 are different.

[0144] The composition and connection method of each component in this embodiment will be described in detail below with reference to the accompanying drawings:

[0145] During PFO interventional treatment, a controllable differential endothelialization occlusion device is used. The occlusion device includes a first occlusion unit 1, a second occlusion unit 2, and a waist structure 3 connecting the two. The exposed areas of the first occlusion unit 1 and the second occlusion unit 2 are covered with a first membrane 4, and the surface or periphery of the waist structure 3 is covered with a second membrane 5. Furthermore, the first membrane 4 and the second membrane 5 are made of different materials, and the endothelialization rate of the second membrane 5 is greater than that of the first membrane 4. The surfaces of the first membrane 4 and the second membrane 5 are respectively provided with a first microporous structure 41 and a second microporous structure 51.

[0146] In this embodiment, the middle portion of the waist structure 3 has a large diameter, while the two side portions have small diameters, such as... Figure 16 As shown.

[0147] In this embodiment, the second membrane 5 of the waist structure 3 is connected to the first support member 611 and the third support member 81.

[0148] In this embodiment, at least a portion of the surface of the second support structure 71 or the second bonding structure 72 is provided with a connecting film 74. The connecting film 74 is connected by binding, wrapping, or bonding. The connecting film 74 is strip-shaped. Furthermore, the first film 4 is fixedly connected to the connecting film 74, such as... Figure 17 As shown.

[0149] In this embodiment, the surface of the connecting membrane 74 is provided with micropores.

[0150] In this embodiment, the first membrane 4 includes an elastic structure 43, such as... Figure 18 As shown, the elastic structure 43 is in the shape of a square, rectangle, rhombus or other quadrilateral.

[0151] In this embodiment, the outer edge of the first membrane 4 is provided with a developing structure; and the size of the developing structure is larger than the size of the first aperture.

[0152] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations, structures, and / or steps disclosed. Obviously, based on the teachings above, those skilled in the art can make various modifications and improvements without departing from the inventive concept, and these all fall within the scope of protection of this invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A closure device for controllable differential endothelialization, the closure device comprising a first closure unit, a second closure unit, and a waist structure connecting the two, characterized in that: The exposed areas of the first and second sealing units are covered with a first membrane, and the surface or periphery of the waist structure is covered with a second membrane. The first and second membranes are made of different materials, and the second membrane promotes endothelialization at a higher rate than the first membrane. The first and second membranes are respectively provided with a first microporous structure and a second microporous structure. The pore size or intersegmental distance of the first microporous structure is the first microporous size, and the pore size or intersegmental distance of the second microporous structure is the second microporous size. The first microporous size ranges from 6µm to 60µm, and the second microporous size ranges from 60µm to 3000µm. Furthermore, the second microporous size is larger than the first microporous size. The first membrane also has multiple auxiliary microporous structures penetrating the first membrane. The pore size or intersegmental distance of the auxiliary microporous structures is the auxiliary microporous size, ranging from 30µm to 1000µm. The area occupied by the auxiliary microporous structures on the first membrane is 10%-50%. These auxiliary microporous structures allow water molecules to pass through rapidly, but restrict the passage of blood cells.

2. The occlusion device for controllable differential endothelialization according to claim 1, characterized in that: The first sealing unit includes a first support frame, which includes a first support structure and a first bonding structure; and the second membrane is connected to the first support structure; the distal and proximal surfaces of the first support frame are both covered with the first membrane.

3. The occlusion device for controllable differential endothelialization according to claim 2, characterized in that: The first support structure includes a plurality of radially diverging first support members, each first support member including a first curved section and a second curved section; and the radius of curvature of the first curved section is smaller than the radius of curvature of the second curved section; the first curved section at least partially fills the oval-shaped tunnel.

4. The occlusion device for controllable differential endothelialization according to claim 1, characterized in that: The second sealing unit includes a second support frame and a third support frame, wherein the second support frame is larger than the third support frame; and the second membrane is connected to the third support frame.

5. The occlusion device for controllable differential endothelialization according to claim 4, characterized in that: The distal and proximal surfaces of the second support frame are both covered with the first membrane; and the proximal and / or distal surfaces of the third support frame are at least partially covered with the second membrane.

6. The occlusion device for controllable differential endothelialization according to claim 4, characterized in that: The second membrane on the periphery of the waist structure and the second membrane on the third support frame together form a bottle shape, thereby enhancing the flow resistance effect; or the second membrane on the periphery of the waist structure, the second membrane on the third support frame, and the first membrane on the first sealing unit together form a closed sac shape, thereby enhancing the flow resistance effect.

7. The occlusion device for controllable differential endothelialization according to claim 4, characterized in that: The second support frame includes a second support structure and a second bonding structure, wherein the second bonding structure forms an annular structure with the first membrane; the width of the annular structure is one-fifth to one-half of the radius of the second sealing unit; Furthermore, after the sealing device is implanted, the annular structure fits into the right atrial surface.

8. The occlusion device for controllable differential endothelialization according to claim 4, characterized in that: The second sealing unit further includes a constraint structure connecting the second support frame and the third support frame. The constraint structure is disposed in the middle part or near the edge of the second support frame. The third support frame includes a radially disposed third support member. The outer end of the third support member is provided with a connecting unit. The constraint structure is movably connected to the connecting unit and restricts the range of motion of the connecting unit.

9. The occlusion device for controllable differential endothelialization according to claim 7, characterized in that: The surface of the second support structure or the second bonding structure is at least partially provided with a connecting membrane, and the connecting membrane is connected by binding, wrapping or bonding; the connecting membrane is strip-shaped and has a first micropore size; and the first membrane is fixedly connected to the connecting membrane.

10. The occlusion device for controllable differential endothelialization according to claim 4, characterized in that: The waist structure includes a connector, the two ends of which are connected to the first sealing unit and the third support frame, respectively; and the connector is not connected to the second membrane, the radial dimension of the second membrane is much larger than the connector.

11. The occlusion device for controllable differential endothelialization according to claim 1, characterized in that: The material of the first membrane includes ePTFE, PU, ​​PET, PEEK or PI; the material of the second membrane includes PET, PPDO, PCL, PGA, PLA, non-woven fabric or other biodegradable materials.

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