CN117398136A - Plugging device and patent foramen ovale plugging device - Google Patents

Abstract

The invention relates to the field of implanted medical instruments, and provides an occluder, in particular to an patent foramen ovale occluder, which comprises a left disc, a right disc and a waist part for connecting the left disc and the right disc, wherein the inner disc surface of the left disc is adjacent to the inner disc surface of the right disc and is connected with the inner disc surface of the right disc through the waist part, the inner disc surface of the left disc and the inner disc surface of the right disc are configured to form a first annular chamber surrounding the waist part in a surrounding way, and the first annular chamber is communicated with an external space through a first narrow cavity gap between the inner disc surface of the left disc and the inner disc surface of the right disc. The invention effectively utilizes and improves the close packing of the primary septum and the secondary septum near the waist of the occluder through the first annular chamber, forms an additional barrier body and improves the blocking effect of the PFO.

Description

Plugging device and patent foramen ovale plugging device

Technical Field

The invention relates to an implantable medical device, in particular to an interventional implanted occluder applicable to the field of structural heart diseases, and particularly relates to an patent foramen ovale occluder.

Background

Patent foramen ovale is a common congenital heart disease, which generally refers to that primary and secondary septa of infants are not completely fused in the development process, and a fissure-like channel is formed, namely PFO (Patent Foramen Ovale). Based on the relevant study data, adult PFOs have a considerable probability of occurrence, and studies have indicated that PFOs may be a blind source of embolism for stroke patients of unknown cause.

In the case of patent foramen ovale, left atrial pressure is higher than right atrium, primary septum is biased to the right atrium side in resting state, and right atrial pressure is higher than left atrium, primary septum is biased to the left atrium side in non-resting or abnormal breathing condition. When right atrium pressure is higher than left atrium, potentially pathogenic emboli in the venous system are more likely to enter the left atrium through the large PFO, causing abnormal embolism. Previous studies have suggested that when PFO width is greater than or equal to 2mm, the probability of occurrence of stroke of unknown cause will be greatly increased.

For patent foramen ovale, the current mainstream treatment is percutaneous (femoral vein) occlusion (i.e., PFO occlusion) using an occluder. PFO occluders typically comprise left and right discs braided from nitinol wires into a dense mesh structure with the left and right discs connected by a waist therebetween. The left disc, the right disc and the waist part can be integrally woven, or can be separately woven and then fixedly connected. An example of a typical PFO stopper is referred to in US5725552a.

PFO occlusion has been widely applied to patient treatment, but data studies have shown that in the real world, the proportion of residual shunts after PFO occlusion is still up to about 25% and fails to more effectively reduce or eliminate the risk to the patient.

Various new and improved PFO occluders have been proposed, such as chinese patent CN114795309A, CN112603449a, which mainly provide a buckling or bending structure at the edge of the occluder disc to enhance the occlusion effect.

Disclosure of Invention

The invention aims to provide an occluder, in particular to an patent foramen ovale occluder which can be used for closing PFO or tissues, organs and the like with similar structural gaps or openings so as to effectively reduce leakage and improve the closing and blocking effects.

Another object of the invention is to provide a method for the preparation of the occluder as described above.

It is a further object of the present invention to provide a method of closing a PFO or tissue, organ, etc. having similarly configured slits or openings.

Some embodiments of the occluder of the present invention comprise a left disc, a right disc and a waist connecting the left disc and the right disc; the inner disk surface of the left disk is adjacent to the inner disk surface of the right disk and is connected with the waist part; the inner disc surface of the left disc and the inner disc surface of the right disc are configured to enclose a first annular chamber around the waist, and the first annular chamber is communicated with an external space through a first narrow cavity gap between the inner disc surface of the left disc and the inner disc surface of the right disc.

In some embodiments, the inner disk surface of the left disk and the inner disk surface of the right disk are configured to form a second annular chamber in a radial direction around the first annular chamber, the first annular chamber and the second annular chamber being separated by the first narrow cavity, the second annular chamber being in communication with the external space via a second narrow cavity between the inner disk surface of the left disk and the inner disk surface of the right disk.

In certain embodiments, the inner disk surface of the left disk and/or the inner disk surface of the right disk is provided with protruding elastic outer protrusions, and the first narrow cavity is formed between one or more of the elastic outer protrusions or between the elastic outer protrusions and the inner disk surface of the left disk or the inner disk surface of the right disk.

In certain embodiments, the elastic outer tab is generally annular, encircling the waist.

The inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with the elastic outer protruding parts, and the elastic outer protruding parts of the left disc and the elastic outer protruding parts of the right disc are oppositely aligned.

Or the inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with the elastic outer protruding parts, and the elastic outer protruding parts of the left disc and the elastic outer protruding parts of the right disc are arranged in a staggered manner along the radial direction of the left disc or the right disc.

In other embodiments, the inner disk surface of the left disk and/or the inner disk surface of the right disk is provided with a plurality of discrete elastic outer protrusions arranged around the waist space at the inner disk surface of the left disk and/or the inner disk surface of the right disk.

In some embodiments, the plurality of discrete elastic outer protrusions provided on the inner disk surface of the left disk and the plurality of discrete elastic outer protrusions provided on the inner disk surface of the right disk are offset from each other such that one elastic outer protrusion of the left disk may face a gap between two adjacent elastic outer protrusions of the right disk.

In some embodiments, the plurality of dispersed elastic outer protrusions provided on the inner disk surface of the left disk and the plurality of dispersed elastic outer protrusions provided on the inner disk surface of the right disk are aligned opposite to each other, so that one elastic outer protrusion of the left disk may face one elastic outer protrusion of the right disk.

The diameters of the left disc and the right disc of the occluder and the specifications of the length, the diameter and the like of the waist can be selected adaptively according to the tissues or organs of the part to be occluded. For example, in certain embodiments as PFO occluders, the left and right discs are 15mm to 40mm in diameter, the waist is 1mm to 6mm in maximum diameter, the resilient outer projections have a width in the radial direction of the occluder, and the resilient outer projections have a width of 1mm to 6mm.

Preferably, the elastic outer protruding portion is spaced from the waist portion by a distance of 1mm to 20mm; or the distance between the elastic outer protruding part and the waist part is 2 mm-20 mm; or the elastic outer protruding portion is spaced from the waist portion by a distance of 5mm to 10mm.

In certain preferred embodiments, the inner disc of the left and/or right discs is in the shape of an inward depression.

In certain preferred embodiments, the resilient outer tab of the left disc and the resilient outer tab of the right disc have overlapping portions along the axial direction of the occluder.

The occluder described above can be prepared by a person skilled in the art in a manner known in the art.

For example, in some embodiments, the left and right discs and waist are integrally woven mesh structures of woven filaments, the left and/or right discs having tubular fasteners securing the free ends of the woven filaments.

In other embodiments, the left disc and the right disc are respectively in a knitting net structure formed by knitting yarns, the inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with tubular fixing pieces for fixing the free ends of the knitting yarns, and the tubular fixing pieces of the inner disc surface of the left disc are fixedly connected with the tubular fixing pieces of the inner disc surface of the right disc to form a waist.

Wherein the braided wires are made of metal materials, polymer materials or metal and polymer composite materials.

Preferably, a choke film is fixed on the inner, inner or outer disk surface of the left disk and/or the right disk.

In some embodiments of the present invention, the elastic outer protrusions are integrally woven with the inner disk surface.

Further preferably, the elastic outer protruding portion is coated with a flexible film material.

In other embodiments of the present invention, the resilient outer protrusions are flexible polymeric housing members or flexible braid members secured to the inner disk surface mesh.

In some embodiments, the waist is tapered with a diameter that tapers toward the left or right disk at the junction with the left or right disk.

Based on the aforementioned embodiments of the occluder configuration or any achievable combination thereof, the present invention provides an patent foramen ovale occluder, i.e. a PFO occluder.

In the embodiment of the invention, the elastic outer protruding part or the narrow cavity gap arranged near the waist can clamp two overlapped tissues with gaps or holes, so that the two tissues are clamped between the adjacent waist, the gaps among the tissues are avoided, and the residual split flow is effectively eliminated.

In the patent foramen ovale occluder embodiment, through the inside first narrow cavity that sets up near the waist of occluder, press from both sides primary septum and secondary septum near the waist of occluder tightly, this has utilized near the waist that especially is favorable primary septum and secondary septum have bigger area or volume to make the longitudinal being flattened of primary septum and secondary septum overlap position closely laminate, make the clearance diminish, reduce residual reposition of redundant personnel risk, simultaneously, avoided prior art to set up pressfitting structure at the occluder edge and perhaps can not effectively press to touch primary septum and secondary septum tissue, and form the clearance, produce residual reposition of redundant personnel. In addition, the elastic outer protruding part or the narrow cavity can also provide stronger pressing force, so that the close packing of the primary partition and the secondary partition near the waist is further improved, and the blocking effect is improved.

The invention will become more apparent from the following description taken in conjunction with the accompanying drawings which illustrate embodiments of the invention.

Drawings

Figure 1 is a simplified schematic of patent foramen ovale.

Fig. 2 is a schematic structural view of a PFO-occluder of the prior art.

Figure 3 is a schematic view of another prior art PFO stopper.

Fig. 4 is a schematic diagram of the residual shunt existing after the PFO is plugged by the PFO plugging device in the prior art, and the left disc and the right disc clamp the primary diaphragm and the secondary diaphragm on one side respectively.

Figure 5 is a simplified illustration of another angle of PFO occlusion by the occluder of figure 3 or 4 showing only partial primary and secondary diaphragms.

Fig. 6 is a partial cross-sectional schematic view of fig. 5, further with the left disc omitted to illustrate contact of the primary and secondary diaphragms at the lumbar region of the occluder.

Figure 7 is a schematic semi-sectional view of one embodiment of a PFO-occluder of the present invention.

Fig. 8 is a schematic perspective view of the embodiment of fig. 7.

Fig. 9 is a simplified schematic diagram of the embodiment of fig. 7.

Figure 10 is a schematic view of the embodiment of figure 7 for plugging a PFO.

Figure 11 is another angular schematic view of the embodiment of figure 7 occluding a PFO from a view of the right atrium from the left atrium or the left atrium from the right atrium.

Figure 12 is a schematic semi-sectional view of another embodiment of a PFO-occluder of the present invention.

Fig. 13 is a schematic perspective view of the embodiment of fig. 12.

Figure 14 is a schematic semi-sectional view of another embodiment of a PFO-occluder of the present invention.

Fig. 15 is a schematic perspective view of the embodiment of fig. 14.

Wherein reference numerals may be briefly described as follows:

a, primary diaphragm; b, secondary diaphragm; c, a superposition area;

1, a left disc; 2, right disc; 3, waist; 41, a first fixing piece, 42, a second fixing piece; 5, a first annular chamber; 6, a first narrow cavity; 7, a second annular chamber;

11, the inner disk surface of the left disk; 21, the inner disk surface of the right disk; 111, first resilient outer protrusions, 211.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.

As known to those skilled in the art, most of the primary a and secondary b septa of an foramen ovale do not exhibit a defect condition, but rather exhibit a septum patent condition as shown in fig. 1, with overlapping region c between the septa overlapping by a length.

Therefore, in the process of implanting the occluder, the two diaphragms can be spread by the connecting waist 3 in the middle of the occluder, and under the condition that the primary partition a and the secondary partition b are not completely attached, a gap formed between the waist 3 of the occluder and the primary partition a and the secondary partition b can become a blood flow channel, so that endothelialization is not facilitated, residual shunt is formed, and the operation effect is affected. Referring to fig. 4, a lateral residual shunt may form in the gap where the occluder waist 3 is in close apposition with the septum, as the primary diaphragm a is typically thinner in the as-formed anatomical structure, its convolution against the occluder waist 3 may not be sufficient to form a dense packing, but rather a gap channel. Referring further to fig. 5 and 6, axial residual flow may form in the non-tightly fitting gap of the primary and secondary septa through which blood flow may flow due to disturbances of the left and right discs 1, 2, which are generally difficult to tightly fit the diaphragm, particularly heart beat, in the vicinity of the waist. The two aforementioned shunts may occur singly or simultaneously, resulting in blood flow between the left atrium and the left atrium.

In view of this, the present invention provides improved occluder embodiments and methods of making the same.

Referring to fig. 7-9, or fig. 12-13, or fig. 14-15, respectively, there is shown an embodiment of the occluder of the present invention comprising a left disc 1, a right disc 2 and a waist 3 connecting the left disc 1 and the right disc 2, the inner disc face 11 of the left disc being adjacent to the inner disc face 21 of the right disc and being connected by the waist 3; the inner disc face 11 of the left disc and the inner disc face 21 of the right disc are configured to enclose a first annular chamber 5 around the waist 3 in the vicinity of the waist 3, the first annular chamber 5 being in communication with the external space via a first narrow cavity 6 between the inner disc face 11 of the left disc and the inner disc face 21 of the right disc.

The primary diaphragm a and the secondary diaphragm b are closely contacted and accumulated in the first annular chamber 5 to be in contact with the waist 3 or between the two diaphragms, so that the existence of gaps is reduced, and the blocking effect is improved.

In a preferred embodiment, the inner disc face 11 of the left disc and the inner disc face 21 of the right disc are configured to form a second annular chamber 7 in the radial direction in combination at the periphery of the first annular chamber 5, the first annular chamber 5 and the second annular chamber 7 being separated by a first narrow cavity 6, the second annular chamber 7 being in communication with the external space via a second narrow cavity between the inner disc face 11 of the left disc and the inner disc face of the right disc. Multiple annular chambers may be advantageous to provide more restricted space between the diaphragms, thereby increasing the axial and radial diaphragm tissue packing density and thus the occlusion effect. Furthermore, this also helps to provide a larger receiving space for the membrane end, to meet the PFO physiological anatomy with a larger overlap region c, and to improve the applicability of the device.

In a preferred embodiment, the inner disc face 11 of the left disc is provided with a first elastic outer projection 111 adjacent to the waist 3 and protruding towards the inner disc face 21 of the right disc, and/or the inner disc face 21 of the right disc is provided with a second elastic outer projection 211 protruding towards the inner disc face 11 of the left disc adjacent to the waist 3. The first narrow cavity 6 is formed between one or more elastic outer protrusions or between an elastic outer protrusion and the inner disc surface 11 of the left disc or the inner disc surface 21 of the right disc.

It will be appreciated that the gap remaining between the elastic outer projection and the waist 3 forms a first annular chamber 5, and the primary diaphragm a and the secondary diaphragm b are closely contacted and accumulated in the first annular chamber 5 to be in contact with the waist 3 or between the two diaphragms, so that the gap is reduced, and the plugging effect is improved.

Although the inner disc face 11 of the left disc and the inner disc face 21 of the right disc are each provided with an elastic outer protrusion facing the inner disc face of the opposite side disc adjacent to the waist portion 3 as shown in the drawings, it is alternatively possible to provide only the inner disc face 11 of the left disc with the first elastic outer protrusion 111 and not the inner disc face 21 of the right disc with the second elastic outer protrusion 211, or vice versa.

The resilient outer protrusions should be of sufficient size to meet the tight contact to the diaphragm. The elastic outer protrusions may be chosen to have a suitable height, but typically not more than two-thirds of the height of the waist, too high may affect the septum's access to the gap of the waist and the elastic outer protrusions.

In a preferred embodiment, the left disc 1 may have a smaller diameter while the right disc 2 has a larger diameter to facilitate the in vivo release operation. However, it should be understood that such a selection is not required.

Further, the first elastic outer protrusion 111 of the left disc 1 may be smaller in width or diameter, and smaller in height than the second elastic outer protrusion 211 of the right disc 2. This may be advantageous in certain aspects, such as enlarging the gap between the waist 3 and the elastic outer protrusions, providing a more suitable compaction space for the membrane.

In the embodiments of the figures, the elastic outer protrusions are generally annular and encircle the waist 3. Wherein the first elastic outer protrusion 111 of the left disc 1 and the second elastic outer protrusion 211 of the right disc 2 are arranged in a staggered manner along the radial direction of the left disc 1 or the right disc 2. This is very advantageous in terms of increasing the contact area with the diaphragm, keeping the diaphragm difficult to withdraw, so that the portions of the primary and secondary diaphragms a, b held within the first annular chamber 5 reduce mutual friction and sliding, reduce tissue damage, and ensure a sealing effect. On the other hand, the staggered arrangement is beneficial to reducing the axial length of the whole occluder, improving the transportation performance of the tube cavity, reducing the volume of the device and being more beneficial in the aspect of safety.

Although as shown in the drawings, the first elastic outer protrusion 111 of the left disc 1 and the second elastic outer protrusion 211 of the right disc 2 may alternatively be arranged to be aligned opposite to each other, which may provide a stronger clamping force in the axial direction.

The invention also provides other embodiments of the occluder, although not shown in the drawings, the inner disc face 11 of the left disc and/or the inner disc face 21 of the right disc are provided with a plurality of discrete resilient outer projections arranged at intervals around the waist 3 on the inner disc face 11 of the left disc and/or the inner disc face 21 of the right disc.

It will be appreciated that a plurality of discrete elastic outer protrusions may be provided on each of the inner disk surface 11 of the left disk and the inner disk surface 21 of the right disk, or a plurality of discrete first elastic outer protrusions 111 may be provided only on the inner disk surface 11 of the left disk, and no second elastic outer protrusions 211 may be provided on the inner disk surface 21 of the right disk, or vice versa.

Unlike the integral annular elastomeric outer protrusions shown in the embodiments of fig. 7-8, etc., a plurality of discrete elastomeric outer protrusions may be advantageous in facilitating penetration of the diaphragm into the first annular chamber and may reduce extrusion of the diaphragm, avoiding frictional damage to the diaphragm.

The plurality of discrete resilient outer projections may be selected to be 3 or more, such as 6, 8, 9, distributed at annular intervals. Depending on the number, the discrete resilient outer projections may be arcuate or substantially toothed.

In some embodiments, the plurality of discrete first resilient outer protrusions 111 provided on the inner disc surface 11 of the left disc and the plurality of discrete second resilient outer protrusions 211 provided on the inner disc surface 21 of the right disc are offset from each other such that one first resilient outer protrusion 111 of the left disc 1 may face a gap between two adjacent second resilient outer protrusions 211 of the right disc 2.

In other embodiments, the plurality of dispersed first elastic outer protrusions 111 provided on the inner disc surface 11 of the left disc and the plurality of dispersed second elastic outer protrusions 211 provided on the inner disc surface 21 of the right disc are aligned opposite to each other, so that one first elastic outer protrusion 111 of the left disc 1 can face one second elastic outer protrusion 211 of the right disc 2.

The diameters of the left disc 1 and the right disc 2 of the occluder and the specifications of the length, the diameter and the like of the waist can be selected adaptively according to the tissue or the organ of the part to be occluded.

For example, in the embodiment as PFO occlusion device, the diameters of the left disc 1 and the right disc 2 may be chosen between 15mm and 40 mm; the maximum diameter of the waist 3 can be selected between 1mm and 6 mm; the elastic outer protruding portion has a width in the radial direction of the stopper, and the width of the elastic outer protruding portion may be selected to be 1mm to 6mm.

Preferably, the elastic outer protrusions are spaced from the waist portion 3 by a distance of 1mm to 20mm, or the elastic outer protrusions are spaced from the waist portion 3 by a distance of 2mm to 20mm, or the elastic outer protrusions are spaced from the waist portion 3 by a distance of 5mm to 10mm.

In certain preferred embodiments, the inner disc surface 11 of the left disc and/or the inner disc surface 21 of the right disc are in the shape of an inner recess. Referring to fig. 7 or 12, the inner disk surface 21 of the right disk is shown in the shape of an inner depression. Referring again to fig. 14, the inner disc face 11 of the left disc and the inner disc face 21 of the right disc are shown as being concave in shape. The right disc 2 may also have a peripheral fold to form a secondary gripping closure to the septum at the edge of the occluder.

Referring to fig. 12 and 14 again, in both embodiments, the bent portion of the edge of the right disc 2 is enclosed with the inner disc 11 of the left disc to form a second annular chamber 7, which is separated from and communicated with the first annular chamber 5 by a first narrow cavity 6, and the bent portion of the edge of the right disc 2 forms a second narrow cavity with the edge of the inner disc 11 of the left disc, and the second annular chamber 7 is communicated with the external space through the second narrow cavity. Multiple annular chambers may be advantageous to provide more restricted space between the diaphragms, thereby increasing the axial and radial diaphragm tissue packing density and thus the occlusion effect. Furthermore, this also helps to provide a larger receiving space for the membrane end, to meet the PFO physiological anatomy with a larger overlap region c, and to improve the applicability of the device.

Unlike the embodiment shown in fig. 7, in which the first elastic outer protrusion 111 of the left disc 1 and the second elastic outer protrusion 211 of the right disc 2 tend to contact in the axial direction of the stopper, the first elastic outer protrusion 111 of the left disc 1 and the second elastic outer protrusion 211 of the right disc 2 are kept at a proper interval in the axial direction of the stopper in the embodiment shown in fig. 12. Although, as shown in the drawings, in some embodiments, the first elastic outer protrusion 111 of the left disc 1 and the second elastic outer protrusion 211 of the right disc 2 may have overlapping portions in the axial direction of the occluder.

In some embodiments, as shown in fig. 12 or 14, the waist portion 3 is tapered with a diameter gradually expanding toward the left disk 1 or the right disk 2 at the junction with the left disk 1 or the right disk 2. This particularly helps to improve the intimate contact of the waist 3 with the diaphragm and the stability of the device as a whole at the PFO.

The occluder described above can be prepared by a person skilled in the art in a manner known in the art.

For example, in some embodiments, the left disc 1, the right disc 2 and the waist 3 are integrally knitted with knitting wires to form a knitted mesh structure, the left disc 1 has a first tubular fixing member 41 for fixing the free ends of the knitting wires, and the right disc 2 has a second tubular fixing member 42 for fixing the free ends of the knitting wires.

In other embodiments, the left disc 1 and the right disc 2 are respectively a woven net structure formed by weaving woven wires, the left disc 1 is provided with a first tubular fixing piece 41 for fixing the free ends of the woven wires, the right disc 2 is provided with a second tubular fixing piece 42 for fixing the free ends of the woven wires, and the first tubular fixing piece 41 of the inner disc surface 11 of the left disc is fixedly connected with the second tubular fixing piece 42 of the inner disc surface 21 of the right disc to form the waist 3. The two tubular fixtures may be secured by nesting with each other or by welding, etc. In other examples, two tubular fasteners may be crimped or welded with the other tubular fasteners.

The braiding wires can be made of metal materials, polymer materials or metal and polymer composite materials.

In the preferred embodiment, the inner, inner or outer disk surfaces of the left disk 1 and/or right disk 2 are fixed with a choke film. The fluid-blocking membrane provides further resistance to blood flow therethrough, or accelerates endothelialization. The choke film can be made of PET material and the like.

In some embodiments of the present invention, the elastic outer protrusions are integrally woven with the inner disk surface.

Further preferably, the elastic outer protrusions are coated with a flexible film material. This may provide a more lubricious or softer interface, reducing damage to the tissue surface.

In other embodiments, the elastic outer protrusions are woven from different woven wire materials and are woven or stitched to the inner disk surface. This is advantageous in providing the elastic outer protrusion with a different elastic capacity than the inner disc surface, e.g. a more loosely woven elastic outer protrusion may be chosen, providing its more flexible properties and thus easier adaptation to the diaphragm, as it does not need to maintain a certain tension like the disc structure of the inner disc surface requiring the maintenance of the left disc 1 or the right disc 2.

In some embodiments, the elastic outer protrusions may be woven from woven filaments of biodegradable or absorbable material, such as polymers PGA, PLA, PLGA. While the left and right discs 1, 2 and the waist 3 may still be selected as alloy wire fabric structures.

In other embodiments of the present invention, the resilient outer protrusions are flexible polymeric housing member members secured to the inner disk surface mesh grid. The resilient outer projections may be non-woven structures, such as having a solid or hollow shell, to provide a contact surface with the diaphragm. It may be particularly advantageous for the resilient outer protrusion to be a hollow shell, providing a greater deformability and a smaller weight. The housing may be formed from a polymeric material by a mold and bonded or stitched to the inner disk surface.

Without being limited to the specific embodiments described above, one skilled in the art may obtain other embodiments of the patent foramen ovale occluder of the present invention based on any practical combination of the embodiments of the occluder configurations mentioned above.

According to the embodiment of the occluder, two overlapped tissues with gaps or holes can be clamped through the elastic outer protruding part or the first narrow cavity 6 arranged near the waist 3, so that the two tissues are clamped between the adjacent waist, gaps or holes among the tissues are avoided, residual shunt is effectively eliminated, and closing is achieved. In addition, the elastic outer protrusion or the first narrow cavity 6 itself also acts as a barrier to fluids such as blood, further reducing residual shunt.

In the embodiment of the PFO plugging device, the primary septum and the secondary septum are clamped near the waist of the plugging device through the elastic outer protruding part or the first narrow cavity gap which is arranged near the waist 3 inside the plugging device, so that the longitudinal flattening of the overlapped part of the primary septum and the secondary septum is tightly attached, the gap is reduced, the residual shunting risk is reduced, and meanwhile, the problem that the prior art that a pressing structure is arranged at the edge of the plugging device can not effectively press the primary septum and the secondary septum to form a gap to generate residual shunting is avoided. In addition, the elastic outer protrusions or first narrow gaps 6 can provide a stronger compressive force, further improving the close packing of the primary and secondary septa near the waist, and acting as a barrier to fluids such as blood, improving the occlusion effect.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.

Claims (22)

1. The utility model provides an occluder, includes left disc, right disc and connects left disc with the waist of right disc, its characterized in that:

the inner disk surface of the left disk is adjacent to the inner disk surface of the right disk and is connected with the waist part;

the inner disc surface of the left disc and the inner disc surface of the right disc are configured to enclose a first annular chamber around the waist, and the first annular chamber is communicated with an external space through a first narrow cavity gap between the inner disc surface of the left disc and the inner disc surface of the right disc.

2. The occluder of claim 1, wherein: the inner disc surface of the left disc and the inner disc surface of the right disc are configured to form a second annular chamber in a combined mode on the periphery of the first annular chamber along the radial direction, the first annular chamber and the second annular chamber are separated by the first narrow cavity gap, and the second annular chamber is communicated with an external space through a second narrow cavity gap between the inner disc surface of the left disc and the inner disc surface of the right disc.

3. The occluder of claim 1 or 2, wherein: the inner disk surface of the left disk and/or the inner disk surface of the right disk are/is provided with an elastic outer protruding part which protrudes out, and the first narrow cavity is formed between one or more elastic outer protruding parts or between the elastic outer protruding part and the inner disk surface of the left disk or the inner disk surface of the right disk.

4. The occluder of claim 3, wherein: the elastic outer protruding portion is annular in whole and surrounds the waist portion.

5. The occluder of claim 4, wherein: the inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with the elastic outer protruding parts, and the elastic outer protruding parts of the left disc and the elastic outer protruding parts of the right disc are oppositely aligned.

6. The occluder of claim 4, wherein: the inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with the elastic outer protruding parts, and the elastic outer protruding parts of the left disc and the elastic outer protruding parts of the right disc are arranged in a staggered manner along the radial direction of the left disc or the right disc.

7. The occluder of claim 3, wherein: the inner disc surface of the left disc and/or the inner disc surface of the right disc are/is provided with a plurality of scattered elastic outer protruding parts, and the plurality of scattered elastic outer protruding parts are arranged on the inner disc surface of the left disc and/or the inner disc surface of the right disc at intervals around the waist.

8. The occluder of claim 7, wherein: the inner disk surface of the left disk is provided with a plurality of dispersed elastic outer protruding parts and the inner disk surface of the right disk is provided with a plurality of dispersed elastic outer protruding parts which are staggered with each other, so that one elastic outer protruding part of the left disk can face the gap between two adjacent elastic outer protruding parts of the right disk.

9. The occluder of claim 7, wherein: the inner disk surface of the left disk is provided with a plurality of dispersed elastic outer protruding parts and the inner disk surface of the right disk is provided with a plurality of dispersed elastic outer protruding parts which are opposite to each other, so that one elastic outer protruding part of the left disk can face one elastic outer protruding part of the right disk.

10. The occluder of claim 3, wherein: the diameter of the left disc and the right disc is 15 mm-40 mm, the maximum diameter of the waist is 1 mm-6 mm, the elastic outer protruding portion is provided with a width along the radial direction of the plugging device, and the width of the elastic outer protruding portion is 1 mm-6 mm.

11. The occluder of claim 10, wherein: the distance between the elastic outer protruding part and the waist part is 1 mm-20 mm.

12. The occluder of claim 10, wherein: the inner disc surface of the left disc and/or the right disc is in an inward concave shape.

13. The occluder of claim 6 or 8, wherein: the elastic outer protruding part of the left disc and the elastic outer protruding part of the right disc are provided with overlapping parts along the axial direction of the plugging device.

14. The occluder of claim 3, wherein: the left disc, the right disc and the waist are of a woven net structure formed by integrally weaving woven wires, and the left disc and/or the right disc is/are provided with tubular fixing pieces for fixing the free ends of the woven wires.

15. The occluder of claim 3, wherein: the left disc and the right disc are respectively of a knitting net structure formed by knitting yarns, the inner disc surface of the left disc and the inner disc surface of the right disc are respectively provided with tubular fixing pieces for fixing the free ends of the knitting yarns, and the tubular fixing pieces of the inner disc surface of the left disc are fixedly connected with the tubular fixing pieces of the inner disc surface of the right disc to form the waist.

16. The occluder of claim 14 or 15, wherein: the braided wire is at least one of a metal material and a polymer material.

17. The occluder of claim 14 or 15, wherein: and a choke film is fixed on the inner part, the inner disk surface or the outer disk surface of the left disk and/or the right disk.

18. The occluder of claim 14 or 15, wherein: the elastic outer protruding part is formed by integrally knitting yarns and an inner disc surface.

19. The occluder of claim 18, wherein: the elastic outer protruding portion is coated with a flexible film material.

20. The occluder of claim 14 or 15, wherein: the elastic outer protruding part is a flexible polymer shell member or a flexible braiding body member fixed on the inner disc surface braided net.

21. The occluder of claim 3, wherein: the waist part is in a conical shape with gradually expanding diameter towards the left disc or the right disc at the joint of the waist part and the left disc or the right disc.

22. An patent foramen ovale occluder, characterized in that it is an occluder according to any one of claims 1-21.