An occluder

Abstract

The present invention discloses an occluder, comprising a distal disc, a waist and a proximal disc formed in sequence; the proximal disc comprises a proximal disc surface, the periphery of the proximal disc surface is formed with a proximal bending zone, the proximal bending zone bends toward the distal disc, wherein the proximal bending zone surrounds the edge of the distal disc, and a stabilizing wire is also passed through the free end of the proximal bending zone, and the stabilizing wire can tighten the free end of the proximal bending zone toward the waist. The occluder provided by the present invention has good stability after being implanted in the body, is not easy to deform, can fit closely to the atrial septum, and is convenient for endothelialization.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an occluder. Background Art

[0002] The foramen ovale in the fetal period serves as a physiological channel for blood to flow from the right atrium to the left atrium, maintaining fetal blood circulation. The foramen ovale usually closes 5-7 months after birth as the pulmonary circulation is established and as the left atrial pressure increases. If the secondary diaphragm and the primary diaphragm at the oval fossa have not completely fused after the age of 3, leaving an oblique defect in the middle, it is called patent foramen ovale (PFO). About 20%-40% of the foramina ovale in adults are not completely closed, leaving a very small gap. Currently, interventional closure therapy is the preferred option for treating PFO for paradoxical embolism or unexplained stroke caused by patent foramen ovale.

[0003] At present, most of the occluders used for interventional treatment on the market are made of nickel-titanium alloy. Nickel-titanium alloy has good shape memory properties, but the metal nickel-titanium alloy is not degradable after being implanted in the human body and there is a risk of metal ion precipitation. Biodegradable occluders are new occluder products that can be completely biodegradable within a suitable time under the premise of effectively blocking the heart defect, and the degradation products can be completely metabolized by the human body. After the heart defect is repaired, there is no other substance left in the patient. Therefore, the degradability of occluders is a development trend, but because the mechanical properties of degradable materials cannot reach those of metal materials, the compliance and resilience of the occluders made are poor. After the occluder is released, the left and right discs cannot fit well on the left and right sides of the heart septal defect, resulting in poor blocking effect and even the risk of residual blood shunting. In addition, while the occluder cannot fit well with the heart septal tissue, it is also difficult for endothelial cells to adhere and crawl on this occluder, resulting in the process of endothelialization after the implantation of the occluder being not ideal in the short and long term. Summary of the invention

[0004] The purpose of the embodiments of the present invention is to overcome the defects described in the prior art, thereby providing an occluder which has good stability after implantation in the body, is not easily deformed, can fit closely to the atrial septum, and is easy to endothelialize. The specific technical solution is as follows:

[0005] An occluder comprises a distal disc, a waist and a proximal disc formed in sequence;

[0006] The proximal disk includes a proximal disk surface, and a proximal bending zone is formed on the periphery of the proximal disk surface. The proximal bending zone bends toward the distal disk, wherein the proximal bending zone surrounds the edge of the distal disk, and a stabilizing wire is also passed through the free end of the proximal bending zone, and the stabilizing wire can tighten the free end of the proximal bending zone toward the waist.

[0007] As an implementable manner, the diameter of the proximal disk is greater than the diameter of the distal disk, and the distal disk includes a distal disk surface, a peripheral edge of the distal disk surface is formed with a distal bending zone, the distal bending zone is arranged opposite to the proximal bending zone, and the free end of the distal bending zone extends into the proximal bending zone.

[0008] As an implementable manner, the proximal bending zone includes a proximal outer arc surface extending from the periphery of the proximal disk surface, the distance between the proximal end of the proximal outer arc surface and the axis of the waist is smaller than the distance between the distal end of the proximal outer arc surface and the axis of the waist, and the stabilizing wire is passed through the distal end of the proximal outer arc surface.

[0009] As an implementable manner, the proximal bending zone bulges away from the distal disk, and includes a proximal inner arc surface, a proximal bending arc and a proximal outer arc surface connected in sequence, the distal end of the proximal inner arc surface is connected to the proximal disk surface, the distal end of the proximal outer arc surface is penetrated by the stabilizing wire, and the distance between the proximal end of the proximal outer arc surface and the axis of the waist is smaller than the distance between the distal end of the proximal outer arc surface and the axis of the waist.

[0010] As an implementable manner, the value range of the supplementary angle α between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 170 degrees;

[0011] Preferably, the value range of the supplementary angle α between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 150 degrees;

[0012] Furthermore, when the stabilizing wire tightens the proximal bending zone, the curvature of the proximal bending arc is less than or equal to 90 degrees, and the value range of the supplementary angle α between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 120 degrees.

[0013] As an embodiment, the projection length of the proximal outer arc surface in the axial direction of the proximal disk surface is greater than or equal to 1 mm, and the projection length of the proximal outer arc surface in the radial direction of the proximal disk surface is less than half of the diameter of the proximal disk.

[0014] As an implementable manner, the distal bending zone includes a distal outer arc surface extending from the periphery of the distal disk surface, the distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the proximal outer arc surface and the axis of the waist, and the stabilizing wire is passed through the distal end of the proximal outer arc surface;

[0015] Preferably, the distal bending area bends and protrudes toward the proximal disk, and includes a distal inner arc surface, a distal bending arc, and a distal outer arc surface sequentially extended from the periphery of the distal disk surface, the proximal end of the distal inner arc surface is connected to the distal disk surface, and the distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the distal outer arc surface and the axis of the waist;

[0016] The free end of the distal outer arc surface extends into the proximal bending area.

[0017] As an implementable manner, the value range of the supplementary angle β of the angle between the distal outer arc surface and the distal disk surface is greater than 90 degrees and less than 170 degrees;

[0018] Preferably, the value range of the supplementary angle β between the distal outer arc surface and the distal disk surface is greater than 90 degrees and less than 150 degrees;

[0019] Furthermore, when the stabilizing wire tightens the distal bending zone, the curvature of the distal bending arc is less than or equal to 90 degrees, and the angle between the distal outer arc surface and the extended surface of the distal disk surface ranges from greater than 90 degrees to less than 120 degrees.

[0020] As an implementable manner, the projection length of the distal outer arc surface in the axial direction of the distal disk surface is greater than or equal to 1 mm, and the projection length of the distal outer arc surface in the radial direction of the distal disk surface is less than half of the diameter of the distal disk.

[0021] As an implementable manner, a stabilizing wire is also passed through the free end of the distal bending zone, and the stabilizing wire has one or more turns.

[0022] Preferably, the stabilizing wires are respectively passed through the distal end of the proximal outer arc surface and the proximal end of the distal outer arc surface.

[0023] As an implementable manner, the inner wall of the distal disk, the inner wall of the proximal disk, and between the proximal disk and the distal disk are all covered with a flow-blocking film.

[0024] As an practicable manner, the proximal disc, waist and distal disc are all made of degradable silk, and the occluder is also provided with a developing mark; preferably, the developing mark is a platinum wire or a platinum ring.

[0025] The technical solution provided by the present invention has at least the following beneficial effects:

[0026] The present application sets the proximal disk into two areas: the proximal disk surface and the proximal bending zone. The proximal disk surface relatively forms a sinking area, and the proximal bending zone is set as a part mainly used to provide locking force, so as to increase the recovery effect of the proximal disk surface shape. Specifically, the bending zone formed by the proximal bending zone can increase the fitting length of the proximal disk to the tissue surface, enhance the fitting and blocking effect, promote rapid endothelialization, and avoid residual shunt. The setting of the stabilizing wire can enable the proximal bending zone to provide centripetal force to the septal tissue, and ensure that the occluder can maintain the designed shape and size for a long time after implantation, and always stably fit the atrial septum. At the same time, the buckling and wrapping shape of the proximal bending zone of the proximal disk to the distal disk can further ensure that the occluder can clamp and fit the septal tissue after implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0028] Figure 1 A schematic diagram of a portion of the structure of an occluder provided by an embodiment of the present invention after being cut along the diameter;

[0029] Figure 2 A schematic diagram of the position relationship of the stabilizing wire in the occluder provided by one embodiment of the present invention;

[0030] Figure 3 A cross-sectional view of an occluder provided by an embodiment of the present invention after being cut along the diameter;

[0031] Figure 4 for Figure 3 Schematic diagram of the outline of the occluder in its natural state;

[0032] Figure 5 for Figure 3 A schematic diagram of the outline of the middle occluder in a locked state;

[0033] Figure 6 A schematic diagram of the structure of an occluder provided by an embodiment of the present invention after being implanted in a patent foramen ovale position and released;

[0034] Figure 7 This is a schematic diagram of the outline of an occluder provided in another embodiment of the present invention.

[0035] Description of reference numerals:

[0036] 100, proximal disk; 101, proximal disk surface; 102, proximal bending area; 103, proximal inner arc surface; 104, proximal bending arc; 105, proximal outer arc surface; 106, fixing rivet;

[0037] 200, distal disk; 201, distal disk surface; 202, distal bending zone; 203, distal inner arc surface; 204, distal bending arc; 205, distal outer arc surface;

[0038] 300, waist;

[0039] 400, flow barrier film;

[0040] 500, stable wire;

[0041] 600. Primary septum of atrial septum;

[0042] 700. Septum secundum of atrial septum. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be described clearly and completely below. It should be noted that the terms described below are defined in consideration of their functions in the present invention and may vary according to the intentions or practices of the users or operators. Therefore, the definition of such terms should be based on the overall content of this specification.

[0044] For example, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate positions or positional relationships based on the positions or positional relationships 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 operate 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.

[0045] 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.

[0046] 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.

[0047] In the related art, the occluder is an integrally formed mesh structure, including a proximal disk, a waist and a distal disk. After being implanted in the body, the waist passes through the tissue interval, and the proximal disk and the distal disk are respectively arranged on both sides of the tissue interval to block the defect. However, due to the poor compliance and resilience of the occluder, especially the biodegradable occluder, the proximal disk and / or the distal disk are easily deformed. After the occluder is released, the proximal disk and the distal disk cannot fit well on the left and right sides of the cardiac septal defect, resulting in poor blocking effect and even the risk of residual blood shunt.

[0048] Based on the analysis and discovery of the above problems, this application is proposed.

[0049] The present application provides an occluder, comprising a distal disc, a waist and a proximal disc formed in sequence;

[0050] The proximal disk includes a proximal disk surface, and a proximal bending zone is formed on the periphery of the proximal disk surface. The proximal bending zone bends toward the distal disk, wherein the proximal bending zone surrounds the edge of the distal disk, and a stabilizing wire is also passed through the free end of the proximal bending zone, and the stabilizing wire can tighten the free end of the proximal bending zone toward the waist.

[0051] The proximal disk of the occluder of the present application has a proximal bending zone. Based on the setting of the proximal bending zone, after the occluder is implanted in the body, the proximal bending zone of the proximal disk can wrap around the distal disk, and the proximal bending zone is bent toward the distal disk. Therefore, the free end of the proximal bending zone, that is, the edge of the proximal bending zone, forms an opening pointing to a closing of the distal disk. Based on one or more circles of retractable (by adjusting the length of the stabilizing wire at the free end of the bending zone, for example, tightening one end of the stabilizing wire to tie a knot and fix it, etc.) stabilizing wire passed through the free end (that is, the closing) of the proximal bending zone, therefore, when the stabilizing wire locks the proximal disk surface, the centripetal force of the proximal disk surface bending zone can be enhanced, and the buckling force of the proximal disk surface toward the waist direction can be enhanced.

[0052] The present application sets the proximal disk into two areas: the proximal disk surface and the proximal bending zone. The proximal disk surface relatively forms a sinking area, and the proximal bending zone is set as a part mainly used to provide locking force, so as to increase the recovery effect of the proximal disk surface shape. Specifically, the bending zone formed by the proximal bending zone can increase the fitting length of the proximal disk to the tissue surface, enhance the fitting and blocking effect, promote rapid endothelialization, and avoid residual shunt. The setting of the stabilizing wire can enable the proximal bending zone to provide centripetal force to the septal tissue, and ensure that the occluder can maintain the designed shape and size for a long time after implantation, and always stably fit the atrial septum. At the same time, the buckling and wrapping shape of the proximal bending zone of the proximal disk to the distal disk can further ensure that the occluder can clamp and fit the septal tissue after implantation.

[0053] In some optional embodiments, the diameter of the proximal disk is greater than the diameter of the distal disk, the distal disk includes a distal disk surface, the periphery of the distal disk surface is formed with a distal bending zone, the distal bending zone is arranged opposite to the proximal bending zone, and the free end of the distal bending zone extends into the proximal bending zone. In these embodiments, the distal disk is also configured as two regions, the distal disk surface and the distal bending zone, the distal bending zone and the proximal bending zone are arranged opposite to each other, and the free end of the distal bending zone extends into the proximal bending zone, thereby forming a form in which the proximal disk surrounds the distal disk, and the proximal disk and the distal disk are buckled with each other, the distal bending zone and the proximal bending zone of the occluder are buckled to the waist in the state of stable wire locking, and the buckling and wrapping form of the proximal disk surface and the distal disk surface ensures that the occluder can be clamped to the maximum extent and fit the atrial septum tissue of the heart after implantation.

[0054] In some optional embodiments, the proximal bending zone includes a proximal outer arc surface extending from the periphery of the proximal disk surface, the distance between the proximal end of the proximal outer arc surface and the axis of the waist is smaller than the distance between the distal end of the proximal outer arc surface and the axis of the waist, and the stabilizing wire is passed through the distal end of the proximal outer arc surface. In these embodiments, the longitudinal section of the proximal bending zone is roughly in the shape of a slope with the free end extending away from the waist. When the stabilizing wire on the edge of the proximal outer arc surface is tightened, the slope can generate a centripetal force to tighten the proximal disk toward the waist, thereby enhancing the snapping force of the proximal disk surface toward the waist and enhancing the rebound effect of the proximal disk surface.

[0055] In some optional embodiments, the proximal bending zone bulges away from the distal disk, and includes a proximal inner arc surface, a proximal bending arc and a proximal outer arc surface connected in sequence, the distal end of the proximal inner arc surface is connected to the proximal disk surface, the distal end of the proximal outer arc surface is penetrated by the stabilizing wire, and the distance between the proximal end of the proximal outer arc surface and the axis of the waist is smaller than the distance between the distal end of the proximal outer arc surface and the axis of the waist. In these embodiments, the longitudinal section of the proximal bending zone is roughly "V"-shaped, and the free end of the proximal outer arc surface extends outwardly in a direction away from the waist, that is, the proximal outer arc surface forms a slope relative to the proximal disk surface. When the stabilizing wire located on the edge of the proximal outer arc surface is tightened, the slope can generate a centripetal force to tighten the proximal disk toward the waist, thereby enhancing the snapping force of the proximal disk surface toward the waist and enhancing the rebound effect of the proximal disk surface. At the same time, due to the setting of the proximal inner arc surface, a bending arc is formed between the proximal inner arc surface and the proximal outer arc surface, thereby increasing the fitting length of the proximal disk to the tissue surface and further enhancing the fitting and sealing effect.

[0056] In some optional embodiments, the value range of the supplementary angle α of the angle between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 170 degrees; preferably, the value range of the supplementary angle α of the angle between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 150 degrees; further, when the stabilizing wire tightens the proximal bending zone, the curvature of the proximal bending arc is less than or equal to 90 degrees, and the value range of the supplementary angle α of the angle between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 120 degrees. In these embodiments, when the value range of the supplementary angle α of the angle between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 170 degrees, the clamping and fastening effect of the disk surface can be guaranteed. If the supplementary angle α is less than 90 degrees or greater than 170 degrees, the centripetal force cannot be generated or the centripetal force is too small, and the clamping and fastening effect is poor.

[0057] In some optional embodiments, the projection length of the proximal outer arc surface in the axial direction of the proximal disk surface is greater than or equal to 1 mm, and the projection length of the proximal outer arc surface in the radial direction of the proximal disk surface is less than half of the proximal disk diameter. In these embodiments, the projection length of the proximal outer arc surface relative to the axial direction of the proximal disk surface and the projection length relative to the radial direction of the proximal disk surface are limited because the applicant has found through multiple creative studies that if the value range of the projection length of the proximal outer arc surface in the radial direction of the proximal disk surface is greater than half of the proximal disk diameter, the disk surface will easily bend and cannot be restored; if the projection length of the proximal outer arc surface in the axial direction of the proximal disk surface is too short, the disk surface will easily be flat, and the clamping effect will be poor.

[0058] In some optional embodiments, the distal bending zone includes a distal outer arc surface extending from the periphery of the distal disk surface, the distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the proximal outer arc surface and the axis of the waist, and the stabilizing wire is passed through the distal end of the proximal outer arc surface;

[0059] Preferably, the distal bending zone bends toward the proximal disc and includes a distal inner arc surface, a distal bending arc, and a distal outer arc surface sequentially extended from the periphery of the distal disc surface, the proximal end of the distal inner arc surface is connected to the distal disc surface, the distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the distal outer arc surface and the axis of the waist; the free end of the distal outer arc surface extends into the proximal bending zone. In these embodiments, the structure of the distal bending zone is the same as that of the proximal bending zone, which can further enhance the blocking effect of the occluder.

[0060] In some optional embodiments, the complementary angle β of the angle between the distal outer arc surface and the distal disk surface is in the range of greater than 90 degrees and less than 170 degrees; preferably, the complementary angle β of the angle between the distal outer arc surface and the distal disk surface is in the range of greater than 90 degrees and less than 150 degrees; further, when the distal bending zone is tightened by the stabilizing wire, the curvature of the distal bending arc is less than or equal to 90 degrees, and the angle between the distal outer arc surface and the extended surface of the distal disk surface is in the range of greater than 90 degrees and less than 120 degrees.

[0061] In some optional embodiments, the projection length of the distal outer arc surface in the axial direction of the distal disk surface is greater than or equal to 1 mm, and the projection length of the distal outer arc surface in the radial direction of the distal disk surface has a value range less than one half of the diameter of the distal disk.

[0062] In some optional embodiments, a stabilizing wire is also provided on the free end of the distal bending zone, and the stabilizing wire is one or more turns. Preferably, the stabilizing wire is provided at the distal end of the proximal outer arc surface and the proximal end of the distal outer arc surface, respectively. In these embodiments, a stabilizing wire can also be provided at the edge of the distal bending zone at the same time. The stabilizing wire here plays the role of tightening the distal bending zone, so that the distal disk has a locking force toward the waist, and strengthens the fit of the distal disk to the tissue surface. At the same time, the stabilizing wire can also partially adjust the size of the occluder. By tightening or loosening and fixing the knot, the size and shape of the occluder disk surface can be adjusted to adapt to atrial septa of different sizes and shapes. Of course, the stabilizing wire is preferably woven up and down along the woven grid at the edge of the proximal bending zone or the distal bending zone, with at least one grid interval when weaving.

[0063] In some optional embodiments, the inner wall of the distal disk, the inner wall of the proximal disk, and between the proximal disk and the distal disk are covered with a flow-blocking film. Adding a flow-blocking film to the proximal disk surface, the distal disk surface, and the waist of the occluder can enhance the flow-blocking effect of the occluder.

[0064] In some optional embodiments, the proximal disk, waist and distal disk are all made of degradable wire, and the occluder is also provided with a developing mark; preferably, the developing mark is a platinum wire or a platinum ring. In these embodiments, the occluder is made of a degradable material, which is flexible and easy to deform and fit, and can also avoid wear. The setting of the developing mark allows the surgeon to clearly judge whether the occlusion process is locked during the surgical imaging process, so as to perform visual operations and increase the efficiency of the operation.

[0065] In order to more clearly understand the occluder provided by the embodiment of the present disclosure, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. In this process, the thickness of the lines or the size of the structural elements shown in the drawings may be shown in an exaggerated manner for the clarity and convenience of the description.

[0066] Example 1

[0067] In this application, the proximal end is defined as the end close to the operator during the surgical operation, and the proximal end is defined as the end away from the operator during the surgical operation. Figure 1-Figure 7 The inner side is based on the waist, the side close to the waist is defined as the inner side, and the side away from the waist is defined as the outer side. Figure 1 The present embodiment provides an occluder, which is made of a degradable material, including a skeleton and a flow-blocking membrane 400, wherein the skeleton is a closed mesh barrel woven from a single filamentary degradable material, which is flexible and easy to deform and fit, and the closed mesh barrel is heat-formed into a double-disc plus waist structure by a mold, specifically including a proximal disc 100, a distal disc 200, and a waist 300 connecting the proximal disc 100 and the distal disc 200, wherein at least one layer of flow-blocking membrane 400 is covered on the inner wall of the proximal disc 100, on the inner wall of the distal disc 200, and between the proximal disc 100 and the distal disc 200, and the material of the flow-blocking membrane 400 can be selected from degradable materials. In the present application, the degradable material involved can be amorphous polylactic acid, left-handed polylactic acid, right-handed polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid or polylactic acid-glycolic acid copolymer, etc. In the present embodiment, polydioxanone is preferably used. Ketone, polycaprolactone, polyglycolic acid, polylactic acid-glycolic acid copolymer or amorphous polylactic acid, left-handed polylactic acid and right-handed polylactic acid, any one or a blend of two or more thereof; the structure of the flow-blocking film 400 can be spunlace non-woven fabric, needle-punched non-woven fabric, spunbond non-woven fabric, heat-sealed non-woven fabric, wet non-woven fabric, woven fabric or electrostatic spinning fiber film; the number of layers of the flow-blocking film 400 can be 2-6 layers, and the flow-blocking film 400 is sutured and fixed to the skeleton of the occluder by sutures, and the multi-layer flow-blocking film 400 can increase the blocking effect. In addition, in order to facilitate the operator's visual operation, so that the operator can clearly judge whether the blocking process is locked during the surgical imaging process, a developing mark (not shown in the figure) can also be sewn into the flow-blocking film 400, and the developing mark can be a platinum wire or a platinum ring. Typically, the closing end of the closed net barrel is located at the center of the proximal disk 100 , and a fixing rivet 106 is provided at the closing end of the closed net barrel. The fixing rivet 106 is connected to an external conveying device to facilitate implantation of the occluder into the patient's body.

[0068] In this disclosure, see Figure 3-5The diameter of the proximal disk 100 is greater than or equal to the diameter of the distal disk 200. The proximal disk 100 includes a proximal disk surface 101 and a proximal bending zone 102. The edge of the proximal bending zone 102 is higher than the edge of the distal disk 200, forming a wrapping shape in which the proximal disk 100 wraps the distal disk 200. The proximal bending zone 102 is extended from the periphery of the proximal disk surface 101, and the proximal bending zone 102 bends toward the distal disk 200 to protrude. It can be understood that the proximal disk 100 includes a sinking zone and a bending zone. The proximal disk surface 101 constitutes the sinking zone, and the sinking depth is 0.5-3mm. The setting of the sinking zone can increase the shape recovery effect of the proximal disk 100. The proximal bending zone 102 constitutes the bending zone. The bending zone can extend the length of the proximal bending zone 102 and increase the length of the proximal disk 100 that fits the tissue surface, thereby enhancing the fitting and blocking effect. Please refer to Figure 4 The proximal bending zone 102 includes a proximal inner arc surface 103, a proximal bending arc 104 and a proximal outer arc surface 105 which are sequentially extended from the edge of the proximal disk surface 101. The proximal bending arc 104 is away from the waist 300. The proximal disk surface 101 protrudes in the direction of the proximal bending arc 104, the curvature of the proximal bending arc 104 is 30 degrees to 120 degrees, the proximal inner arc surface 103 and the proximal outer arc surface 105 both form a slope relative to the proximal disk surface 101, wherein the distance between the proximal end of the proximal outer arc surface 105 and the axis of the waist 300 is less than the distance between the distal end of the proximal outer arc surface 105 and the axis of the waist 300, that is, the free end of the proximal outer arc surface 105 is diffused outward relative to the waist 300, and the value range of the supplementary angle α of the angle between the proximal outer arc surface 105 and the proximal disk surface 101 is greater than 90 degrees and less than 170 degrees; in the present embodiment, the value range of the supplementary angle α of the angle between the proximal outer arc surface 105 and the proximal disk surface 101 is greater than 90 degrees and less than 150 degrees. The projection length of the proximal outer arc surface 105 in the axial direction of the proximal disk surface 101 is greater than or equal to 1 mm, and the projection length of the proximal outer arc surface 105 in the radial direction of the proximal disk surface 101 is less than half of the diameter of the proximal disk 100 .

[0069] See also Figure 2 In this embodiment, a stabilizing wire 500 is passed through the distal end of the proximal outer arc surface 105. The stabilizing wire 500 is one or more turns. Figure 4-6By tightening the stabilizing wire 500, the diameter of the proximal disk 101 can be reduced, the angle of the proximal bending arc 104 can be reduced, and the complementary angle α between the proximal outer arc surface 105 and the proximal disk surface 101 can be reduced to 90-120°. After the stabilizing wire 500 locks the proximal disk 101, the centripetal force of the proximal outer arc surface 105 is enhanced, and the buckling force of the proximal disk 100 toward the waist 300 is enhanced, so that the proximal disk 100 fits the tissue surface more closely, and the rebound effect of the proximal disk 100 is enhanced. At the same time, the stabilizing wire 500 can also partially adjust the size of the occluder. By tightening or loosening it and fixing it with a knot, the size and shape of the occluder disk can be adjusted to adapt to tissue defects of different sizes and shapes. When the stabilizing wire is inserted into the proximal bending area 102, it is best to weave up and down along the woven grid on the edge of the proximal bending area 102, and at least one grid is separated when weaving.

[0070] In this embodiment, the proximal disk 100 is configured as two regions, namely, the proximal disk surface 101 and the proximal bending zone 102. The proximal disk surface 101 forms a relatively sunken region, while the proximal bending zone 102 is configured as a portion mainly used to provide a locking force, thereby increasing the recovery effect of the shape of the proximal disk surface 101. Specifically, the bending zone formed by the proximal bending zone 102 can increase the length of the proximal disk 100 that fits the tissue surface, enhances the fit and blocking effect, promotes rapid endothelialization, and avoids residual shunt. The configuration of the stabilizing wire 500 can enable the proximal bending zone 102 to provide centripetal force to the septal tissue, and ensure that the occluder can maintain the designed shape and size for a long time after implantation, and always fit the atrial septum stably. At the same time, the buckling and wrapping shape of the proximal bending zone 102 of the proximal disk 100 to the distal disk 200 can further ensure that the occluder can clamp and fit the septal tissue after implantation.

[0071] Example 2

[0072] See also Figure 7 , different from the first embodiment, in this embodiment, the proximal bending zone 102 includes a proximal outer arc surface 105 extending from the periphery of the proximal disk surface 101, the distance between the proximal end of the proximal outer arc surface 105 and the axis of the waist 300 is smaller than the distance between the distal end of the proximal outer arc surface 105 and the axis of the waist 300, and the stabilizing wire 500 is passed through the distal end of the proximal outer arc surface 105. In this embodiment, the longitudinal section of the proximal bending zone 102 is generally in the shape of a slope with the free end extending away from the waist 300. When the stabilizing wire 500 located on the edge of the proximal outer arc surface 105 is tightened, the slope can generate a centripetal force to tighten the proximal disk 100 toward the waist 300, thereby enhancing the buckling force of the proximal disk surface 101 toward the waist 300 and enhancing the rebound effect of the proximal disk surface 101.

[0073] Example 3

[0074] See also Figure 4In the present embodiment, a bending area is also provided on the distal disk 200, that is, the distal disk 200 includes a distal disk surface 201 and a distal bending area 202, and the distal bending area 202 is formed by extending from the periphery of the distal disk surface 201, wherein the distal bending area 202 and the proximal bending area 102 are arranged opposite to each other, and the free end of the distal bending area 202 extends into the proximal bending area 102, thereby forming a wrapping shape in which the proximal disk surface 101 wraps the distal disk surface 201, and the distal bending area 202 and the proximal bending area 102 of the occluder are both buckled toward the waist 300 when the stabilizing wire 500 in the proximal bending area 102 is locked, and the buckling and wrapping shape of the proximal disk surface 101 and the distal disk surface 201 ensures that the occluder can clamp and fit the atrial septum tissue of the heart to the maximum extent after implantation.

[0075] The structure of the distal bending region 202 is the same as that of the proximal bending region 102. For example, see Figure 4The longitudinal section may be roughly in the shape of an inverted "V", that is, the distal bending zone 102 bends toward the proximal disk 100. The protrusion includes a distal inner arc surface 203, a distal bending arc 204 and a distal outer arc surface 205 which are sequentially extended from the periphery of the distal disk surface 201, and the free end of the distal outer arc surface 205 extends outwardly in a direction away from the waist 300, that is, the distance between the proximal end of the distal outer arc surface 205 and the axis of the waist 300 is greater than the distance between the distal end of the distal outer arc surface 205 and the axis of the waist 300, the distal outer arc surface 205 and the distal inner arc surface 203 form a slope relative to the distal disk surface 201, but the distal outer arc surface 205 is a slope that spreads outward with its proximal end relative to the waist 300, and the free end of the distal outer arc surface 205 extends into the proximal bending zone 102, thereby forming a mutually wrapped shape with the proximal bending zone 102. Of course, the structure of the distal disk 200 can also be that it only includes a distal outer arc surface 205 extending from the periphery of the distal disk surface 201, and the distance between the proximal end of the distal outer arc surface 205 and the axis of the waist 300 is greater than the distance between the distal end of the distal outer arc surface 205 and the axis of the waist 300. The stabilizing wire 500 is passed through the distal end of the distal outer arc surface 205, that is, the longitudinal section of the proximal bending zone 102 is roughly a slope type with the free end extending away from the waist 300. Regardless of the structure, the value range of the supplementary angle β of the angle between the distal outer arc surface 205 and the distal disk surface 201 is greater than 90 degrees and less than 170 degrees. In the present embodiment, the value range of the supplementary angle β of the angle between the distal outer arc surface 205 and the distal disk surface 201 is greater than 90 degrees and less than 150 degrees, thereby ensuring the clamping and snapping effect of the distal disk surface 201 and avoiding the problem that the angle is too large or too small to generate the centripetal force or the centripetal force is too small. The projection length of the distal outer arc surface 205 in the axial direction of the distal disk surface 201 is greater than or equal to 1 mm, avoiding the problem that the distal disk surface 201 is flat and the clamping effect is poor. The value range of the projection length of the distal outer arc surface 205 in the radial direction of the distal disk surface 201 is less than half of the diameter of the distal disk 200, avoiding the distal disk surface 201 from flanging and being unable to recover.

[0076] Example 3

[0077] See also Figure 2 In this embodiment, the free end of the distal bending zone 202 is also penetrated with a stabilizing wire 500, that is, the stabilizing wire 500 is respectively penetrated at the distal end of the proximal outer arc surface 105 and the proximal end of the distal outer arc surface 205. The stabilizing wire 500 is arranged at the free end of the distal bending zone 202 to tighten the distal bending zone 202, so that the distal disc 200 has a locking force to be retracted toward the waist 300, and the distal disc 200 is strengthened to fit the tissue surface. When the stabilizing wire 500 tightens the distal bending zone 202, the curvature of the distal bending arc 204 is less than or equal to 90 degrees, and the angle between the distal outer arc surface 205 and the extension surface of the distal disc surface 201 is greater than 90 degrees and less than 120 degrees.

[0078] Figure 6 This is a schematic diagram of the occlusion of the patent foramen ovale by implanting the occluder. Figure 6 The primary septum 600 of the middle atrial septum and the secondary septum 700 of the atrial septum are not completely fused, leaving an oblique defect in the middle. The occluder of the present application is implanted to clamp the atrial septal tissue. The distal disk 200 and the proximal disk 100 can be in close contact with the atrial septal tissue to promote rapid endothelialization and avoid residual shunt. The setting of the stabilizing wire 500 can ensure that the occluder maintains the designed shape and size for a long time after implantation, and always stably fits the atrial septum.

[0079] The above are only preferred embodiments of the present invention and are not intended to limit the protection scope of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An occluder, characterized in that: It includes a distal disc, a waist and a proximal disc formed in sequence; The proximal disk comprises a proximal disk surface, a proximal bending zone is formed at the periphery of the proximal disk surface, and the proximal bending zone is bent toward the distal disk, wherein the proximal bending zone surrounds the edge of the distal disk, and a stabilizing wire is also passed through the free end of the proximal bending zone, and the stabilizing wire can tighten the free end of the proximal bending zone toward the waist; The diameter of the proximal disk is greater than the diameter of the distal disk, the distal disk comprises a distal disk surface, a distal bending zone is formed on the periphery of the distal disk surface, the distal bending zone is arranged opposite to the proximal bending zone, and a free end of the distal bending zone extends into the proximal bending zone; The proximal bending area bulges away from the distal disk, and includes a proximal inner arc surface, a proximal bending arc and a proximal outer arc surface connected in sequence, the distal end of the proximal inner arc surface is connected to the proximal disk surface, the distal end of the proximal outer arc surface is penetrated by the stabilizing wire, and the distance between the proximal end of the proximal outer arc surface and the axis of the waist is smaller than the distance between the distal end of the proximal outer arc surface and the axis of the waist; The value range of the supplementary angle α between the proximal outer arc surface and the proximal disk surface is greater than 90 degrees and less than 120 degrees. When the stabilizing wire tightens the proximal bending zone, the curvature of the proximal bending arc is less than or equal to 90 degrees. The projection length of the proximal outer arc surface in the axial direction of the proximal disk surface is greater than or equal to 1 mm, and the projection length of the proximal outer arc surface in the radial direction of the proximal disk surface is less than half of the diameter of the proximal disk.

2. The occluder according to claim 1, characterized in that: The distal bending zone includes a distal outer arc surface extending from the periphery of the distal disk surface, the distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the proximal outer arc surface and the axis of the waist, and the stabilizing wire is passed through the distal end of the proximal outer arc surface.

3. The occluder according to claim 2, characterized in that: The distal bending zone bends toward the proximal disk and includes a distal inner arc surface, a distal bending arc and a distal outer arc surface which are sequentially extended from the periphery of the distal disk surface. The distance between the proximal end of the distal outer arc surface and the axis of the waist is greater than the distance between the distal end of the distal outer arc surface and the axis of the waist; the free end of the distal outer arc surface extends into the proximal bending zone.

4. The occluder according to claim 3, characterized in that: The value range of the supplementary angle β of the angle between the distal outer arc surface and the distal disk surface is greater than 90 degrees and less than 170 degrees.

5. The occluder according to claim 4, characterized in that: The value range of the supplementary angle β between the distal outer arc surface and the distal disk surface is greater than 90 degrees and less than 150 degrees; When the stabilizing wire tightens the distal bending zone, the curvature of the distal bending arc is less than or equal to 90 degrees, and the angle between the distal outer arc surface and the extended surface of the distal disk surface is greater than 90 degrees and less than 120 degrees; The projection length of the distal outer arc surface in the axial direction of the distal disk surface is greater than or equal to 1 mm, and the projection length of the distal outer arc surface in the radial direction of the distal disk surface is less than half of the diameter of the distal disk.

6. The occluder according to any one of claims 1 to 5, characterized in that: A stabilizing wire is also passed through the free end of the distal bending zone, and the stabilizing wire has one or more turns.

7. The occluder according to any one of claims 1 to 5, characterized in that: The inner wall of the distal disk, the inner wall of the proximal disk, and the space between the proximal disk and the distal disk are all covered with a flow-blocking film.

8. The occluder according to claim 7, characterized in that: The proximal disc, waist and distal disc are all made of degradable silk, and the occluder is also provided with a developing mark.

9. The occluder according to claim 8, characterized in that: The developing mark is a platinum wire or a platinum ring.

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