CN219183885U - Patent foramen ovale plugging device - Google Patents

Abstract

The utility model belongs to the field of medical equipment, and discloses an patent foramen ovale plugging device which comprises a first plugging disc, a second plugging disc and a linear connecting piece, wherein the first plugging disc is provided with a first central axis and a first converging element, and the first converging element is positioned at the proximal end of the first plugging disc; the second plugging disc is provided with a second central axis and a second converging element, and the second converging element is positioned at the distal end of the second plugging disc; the distal end of the linear connecting piece is connected with the first converging element, and the proximal end of the linear connecting piece is connected with the second converging element, so that the patent foramen ovale occluder has a preset state and a deformation state; in a preset state, the first central axis is approximately coincident with the second central axis, and the linear connecting piece is in a loose state; in the deformed state, the linear connector is deformed, the first central axis is offset from the second central axis, and the linear connector is in a stretched state. The occluder disclosed by the utility model has good flexibility, can be suitable for various types of patent foramen ovale, and can be prevented from falling off after being implanted.

Description

Patent foramen ovale plugging device

Technical Field

The utility model relates to the technical field of medical appliances, in particular to an patent foramen ovale plugging device.

Background

The secondary orifice on the primary septum at the atrial septum is the normal blood circulation channel in infancy and the secondary septum on the right side of the primary septum forms the fossa ovalis. When the primary septum and the secondary septum fail to be cohesively fused, the formed cleft is the foramen ovale, or is described as patent foramen ovale. Because the patent foramen ovale can enter the left heart system to cause corresponding clinical symptoms, the patent foramen ovale is closely related to cerebral apoplexy patients with unknown reasons or the patent foramen ovale of high-risk groups is closed, and the embolic occurrence rate of the patients is hopefully reduced. In addition, patent foramen ovale has also been found to be associated with the onset of decompression sickness, migraine, and the like, and closure of the foramen ovale may be beneficial to such patients.

The specific structure of the oval hole is shown in fig. 1, the primary septum is positioned on the left atrium side, the secondary septum is positioned on the right atrium side, the secondary hole on the primary septum is a normal blood channel in the period of infants, an unclosed narrow slit is formed between the primary septum and the secondary septum which are not normally adhered and fused, abnormal blood flow possibly passes through the slit from the oval fossa and flows out from the secondary hole, or vice versa. As can be seen in fig. 2, the two end points of the slit are offset from each other, from the right atrium to the left atrium, with the slit extending toward the top of the atrium. Occluders are currently implanted at the open foramen ovale fissures by transvascular intervention techniques to eliminate the fissures. As shown in fig. 3, when the occluder is delivered through a vascular minimally invasive manner, the distal end point of the delivery sheath sequentially passes through the oval fossa and the secondary hole, in the above process, the lower edge end of the secondary hole on the primary septum is always pushed to the left atrium, and the common heart occluder easily deforms the primary septum and the secondary septum greatly to generate stacking, so that the tissue thickness of the occluder to be clamped is increased, thereby affecting the clamping effect after the implantation of the instrument. Ideal patent foramen ovale occluders are expected to have better flexibility, including adaptive slit shape, and effective grip on a wide variety of tissue morphologies.

Disclosure of Invention

The utility model aims to provide an patent foramen ovale plugging device which can be suitable for the fissures of patent foramen ovale and can form effective clamping on primary and secondary tissues with different forms.

The technical scheme provided by the utility model is as follows:

an patent foramen ovale occluder comprising a first occlusion disc, a second occlusion disc and a wire-like connector, the first occlusion disc having a first central axis and a first constriction element, the first constriction element being located at a proximal end of the first occlusion disc;

the second occlusion disk has a second central axis and a second constriction element, the second constriction element being located at a distal end of the second occlusion disk;

the distal end of the linear connecting piece is connected with the first converging element, and the proximal end of the linear connecting piece is connected with the second converging element, so that the patent foramen ovale occluder has a preset state and a deformation state;

in the preset state, the first central axis is approximately coincident with the second central axis, and the linear connecting piece is in a loose state;

in the deformed state, the linear connector is deformed, the first central axis is offset from the second central axis, and the linear connector is in a stretched state.

In some embodiments, the first converging element includes a receiving hole, and the proximal end of the linear connector includes a limiting portion and is receivable in the receiving hole such that the proximal end of the linear connector is rotatable relative to the first converging element; and/or

The second converging element comprises an accommodating hole, and the distal end of the linear connecting piece comprises a limiting part and can be accommodated in the accommodating hole, so that the distal end of the linear connecting piece can rotate relative to the second converging element.

In some embodiments, the portion of the stop adjacent the receiving aperture includes a spherical surface.

In some embodiments, the receiving hole is a counter bore and includes a spherical surface, and the spherical surface of the receiving hole is matched with the spherical surface of the limiting portion.

In some embodiments, the limit portion passes through the receiving hole, the linear connector portion is located in the receiving hole, and the aperture of the receiving hole is larger than the outer diameter of the linear connector and smaller than the maximum width of the limit portion.

In some embodiments, the receiving hole penetrates through the first converging element and/or the second converging element, and the limiting part is located outside the first converging element and/or the second converging element after penetrating through the receiving hole.

In some embodiments, the receiving hole does not penetrate through the first converging element or the second converging element, and the limiting portion is located inside the first converging element or the second converging element after penetrating through the receiving hole.

In some embodiments, the receiving hole is two or more counter bores, the limit portion includes one or more pins, and the pins of the limit portion are nested with the corresponding counter bores and rotate about the pins.

In some embodiments, the first occlusion disk comprises a first frame having a proximal free end, the first constriction element constricting the proximal free end of the first frame;

the second occlusion disk includes a second frame having a proximal free end and a distal free end, the second constriction element constricting the distal free end of the second frame.

In some embodiments, the first constriction element comprises a distal end piece, which constricts the free end of the first frame, and a proximal end piece, in which the receiving hole is arranged.

In some embodiments, the second constriction element comprises a proximal end piece that constricts the distal free end of the second frame and a distal end piece within which the receiving aperture is disposed.

In some embodiments, a third constriction element is further included, constricting the proximal free end of the second frame.

Compared with the prior art, the patent foramen ovale plugging device provided by the utility model has at least one of the following beneficial effects:

1. the linear connecting piece has compliance, freely extends in a set range, and is in a self-adaptive slit shape, so that the plugging device is more attached to tissues, and the implantation effectiveness of the instrument is improved;

2. the linear connecting piece has certain elasticity, and in a deformation state, the linear connecting piece is in a stretching or partial stretching state, so that the tension between the first plugging disc and the second plugging disc can be increased, the clamping force of the plugging device is increased, the plugging device is prevented from falling off after being implanted, the adhesion and the fusion of a primary septum and a secondary septum are facilitated, and the implantation safety and the effectiveness of the instrument are improved.

Drawings

The utility model is described in further detail below with reference to the attached drawings and detailed description:

FIG. 1 is a schematic view of the structure of an foramen ovale;

FIG. 2 is a schematic illustration of abnormal blood flow at the foramen ovale;

FIG. 3 is a schematic illustration of the structure of a delivery sheath delivery occluder;

FIG. 4 is a schematic illustration of a preset state configuration of an patent foramen ovale occluder in accordance with an embodiment of the present application;

FIG. 5 is a schematic view showing a deformed state structure of the patent foramen ovale occluder in accordance with the embodiments of the present application;

FIG. 6 is a schematic structural view of one embodiment of a wire connection of an embodiment of the present application;

FIG. 7 is a schematic view of another embodiment of a wire connector according to an embodiment of the present application;

FIG. 8 is a front view of a first example of a rotational connection of a wire connection to a second converging element in accordance with an embodiment of the present application;

FIG. 9 is a front view of a second example of a rotational connection of a wire connection to a second converging element in accordance with an embodiment of the present application;

FIG. 10 is a front view of a third example of a rotational connection of a wire connection to a second converging element in accordance with an embodiment of the present application;

FIG. 11 is a front view of a fourth example of a rotational connection of a wire connection to a second converging element in accordance with an embodiment of the present application;

FIG. 12 is a side view of one example of a rotational connection of the wire connector of FIG. 11 with a second converging element;

FIG. 13 is a side view of another example of a rotational connection of the wire connector of FIG. 11 with a second converging element;

FIG. 14 is a schematic view of an embodiment of the second frame and third converging element of the present embodiment;

FIG. 15 is a schematic view of another embodiment of the second frame and third converging element of the embodiments of the present application;

FIG. 16 is a schematic view of a further embodiment of the second frame and third converging element of the embodiments of the present application;

FIG. 17 is a schematic view of the configuration of the patent foramen ovale occluder of the present application without access to the delivery sheath;

FIG. 18 is a schematic view of the configuration of a second occluding component of the patent foramen ovale occluder of the present application into a delivery sheath;

FIG. 19 is a schematic view of the structure of a linear connector of the patent foramen ovale occluder of the present application into a delivery sheath;

FIG. 20 is a schematic view of the structure of a fully accessed delivery sheath of the patent foramen ovale occluder of the present application;

FIG. 21 is a schematic view of a first frame of the present application with additional flow blocking elements.

Reference numerals illustrate:

a. a proximal end; b. a distal end; 100. a delivery sheath; 200. a pushing device; 300. primary isolation; 400. secondary isolation;

10. a first plugging disc; 11. a first frame; 111. a first proximal face; 112. a first distal face; 101. a first central axis; 12. a first converging element; 13. a first flow blocking element; 20. a second blocking disc; 21. a second frame; 211. a second proximal face; 212. a second distal face; 201. a second central axis; 22. a second converging element; 221. a proximal member; 222. a distal end member; 223. a hemispherical surface; 224. a through hole; 23. a second flow blocking element; 24. a third converging element; 30. a linear connecting piece; 31. a limit part; 311. a pin; 40. additional flow blocking elements.

Detailed Description

In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the utility model, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

For the sake of simplicity of the drawing, the parts relevant to the present utility model are shown only schematically in the figures, which do not represent the actual structure thereof as a product. Additionally, in order to simplify the drawing for ease of understanding, components having the same structure or function in some of the drawings are shown schematically with only one of them, or only one of them is labeled. Herein, "a" means not only "only this one" but also "more than one" case.

It should be further understood that the term "and/or" as used in this specification and the appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes such combinations.

In this context, it should be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, unless explicitly stated or limited otherwise; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

In addition, in the description of the present application, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

In this application, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not limiting, and "proximal" generally refers to the end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to the end that is distal to the physician, i.e., the end that enters the patient first, in fig. 4, a represents the proximal end of the patent foramen ovale patent occluder of the present utility model, and b represents the distal end of the patent foramen ovale patent occluder of the present utility model.

In one embodiment of the present application, as shown in fig. 4 and 5, an patent foramen ovale occluder comprises a first occlusion disc 10, a second occlusion disc 20 and a wire shaped connector 30, the first occlusion disc 10 having a first central axis 101 and a first constriction element 12, the first constriction element 12 being located at the proximal end of the first occlusion disc 10; the second occlusion disk 20 has a second central axis 201 and a second constriction element 22, the second constriction element 22 being located at the distal end of the second occlusion disk 20; the distal end of the linear connecting piece 30 is connected with the first constriction element 12, and the proximal end of the linear connecting piece 30 is connected with the second constriction element 22, so that the patent foramen ovale occluder has a preset state and a deformed state; in the preset state, the first central axis 101 and the second central axis 201 are approximately coincident, and the linear connector 30 is in a loose state; in the deformed state, the first central axis 101 is offset from the second central axis 201, and the wire-like connection 30 is in a stretched state.

Referring to fig. 4, in the preset state, the first central axis 101 substantially coincides with the second central axis 201; referring to fig. 5, after implantation, the occluder assumes a deformed state, the first occluding disc 10 is positioned in the left atrium, the second occluding disc 20 is positioned in the right atrium, the wire-like connecting member 30 is positioned in the gap between the primary septum 300 and the secondary septum 400, the wire-like connecting member 30 can be elongated and extended, and the extending direction has a degree of freedom within a certain range so as to adapt to the shape of the gap with the patent foramen ovale, and the tissue is not deformed greatly due to the implantation of the occluder, so that the occluder is more attached to the tissue, and the implantation effectiveness of the instrument is improved. At this time, the first central axis 101 deviates from the second central axis 201, and may have an included angle therebetween, or may be parallel to each other, or may be on the same plane or different planes; the linear connecting piece 30 is in a stretching state, so that the tension between the first plugging disc 10 and the second plugging disc 20 can be increased, the plugging device is stable at the implantation position, and the plugging device is prevented from falling off after implantation.

In a preferred embodiment, the wire-shaped connecting member 30 has flexibility and better elasticity, and can be formed by flexible wires or tows composed of a plurality of wires, wherein the wires or tows can be made of medical fibers with good biocompatibility such as polyester, polytetrafluoroethylene, polypropylene, polyurethane, etc., biodegradable fibers such as polyglycolic acid, polylactic acid-glycolic acid, etc., or elastic metals such as nickel-titanium alloy, medical stainless steel, etc.

The elasticity of the wire-shaped connector 30 may be formed of a material itself or may be formed of a shape having elasticity. In some embodiments, the wire-like connection 30 is linear and the material itself is elastic, such as a polyester material such as TPU. In some embodiments, the wire-like connection 30 is shaped to have a resilient shape. As shown in fig. 6, the wire-like connecting member 30 has a tooth-like structure in which a plurality of tooth-like convex portions provide additional axial elasticity. As shown in fig. 7, the wire-like connection 30 is of a helical configuration to provide additional axial resiliency. In some embodiments where the wire-like connector 30 is formed from an elastic wire such as nitinol or medical stainless steel, the tooth-like or spiral-like structure may be formed from a wire having a non-circular cross-section in addition to a circular wire, wherein the structure is formed from a wire having a non-circular cross-section that is more tensile in the same dimension and reduces the radial dimension of the connector 30 in the same tension. In other embodiments, the wire-like connection 30 may also be configured in a wave-like or like manner.

In the deformed state, when the first central axis 101 deviates from the second central axis 201, the linear connecting piece 30 stretches, and the first sealing disc 10 and the second sealing disc 20 can be tensioned under the action of the linear connecting piece 30, so that better tissue fixing performance is provided for the sealing device, and the distance between the first sealing disc 10 and the second sealing disc 20 required by the foramen ovale fissure is adapted. When the wire-like connecting member 30 has an elastic shape, the axial space required for the wire-like connecting member 30 can be reduced.

It should be understood that the material or structure of the wire-like connector 30 should not be construed as limiting the utility model.

In some embodiments, the first converging element 12 is fixedly connected to the distal end of the wire connection 30. In other embodiments, first converging element 12 is rotatably coupled to the distal end of wire link 30, providing additional angular flexibility to wire link 30. After rotational attachment, the angle between linear connector 30 and first central axis 101 may be increased in the range of 10-90, preferably 30-60, to better accommodate the cleft of the foramen ovale with linear connector 30. It will be appreciated that the proximal end of the second converging element 22 and the wire connection 30 may be fixedly or rotatably connected to achieve the above-described effect.

In some embodiments, the proximal end of the first converging element 12 is provided with a receiving hole, and the distal end of the linear connector 30 is provided with a limiting portion 31 and is receivable in the receiving hole, so that the distal end of the linear connector 30 is rotatable relative to the first converging element 12. It will be appreciated that in some embodiments, the distal end of the second converging element 22 may also be provided with an accommodating hole, and the proximal end of the wire-like connector 30 may also be provided with a limiting portion 31 and may be accommodated in the accommodating hole, so that the proximal end of the wire-like connector 30 is rotatable relative to the second converging element 22. In many embodiments, the portion of the stop 31 adjacent the receiving aperture may include a spherical surface to more effectively provide additional angular flexibility to the wire connection 30. The following embodiments take the limiting portion 31 at the proximal end of the second converging element 22 and the linear connecting element 30 as an example, and describe possible arrangements of the limiting portion 31 and the receiving hole.

In the embodiment shown in fig. 8, the distal end of the second converging element 22 is provided with a counterbore in which a hemispherical surface 223 is disposed, and the limiting portion 31 may be hemispherical and adapted to the hemispherical surface 223, so that the limiting portion 31 may rotate relative to the counterbore.

In a preferred embodiment, the second converging element 22 may include a proximal end member 221 and a distal end member 222, where a counterbore is disposed at a distal end of the distal end member 222, and a hemispherical surface 223 is disposed in the counterbore, and the limiting portion 31 may be hemispherical and adapted to the hemispherical surface 223, such that the limiting portion 31 may rotate relative to the receiving hole. The distal member 222 and the proximal member 221 may be connected in sequence in the axial direction, or the proximal portion of the distal member 222 may be nested outside the proximal member 221.

In some embodiments, the receiving hole is a through hole, the limiting portion 31 passes through the receiving hole, the linear connecting member 30 is partially located in the receiving hole, and the aperture of the receiving hole is larger than the outer diameter of the linear connecting member 30 and smaller than the width of the limiting portion 31.

In the embodiment shown in fig. 9, the second converging element 22 is provided with a through hole 224 penetrating the second converging element 22 along the direction of the second central axis 201, the proximal end of the linear connecting element 30 is provided with a limiting portion 31, the linear connecting element 30 penetrates through the through hole 224, the limiting portion 31 is located at the proximal end of the second converging element 22 and can abut against the proximal end of the second converging element 22, the aperture of the through hole 224 is larger than the outer diameter of the linear connecting element 30 and smaller than the width of the limiting portion 31, so that the limiting portion 31 can radially rotate relative to the proximal end of the second converging element 22, and the linear connecting element 30 can axially and relatively move relative to the second converging element 22, thereby adding additional angular flexibility to the linear connecting element 30.

In the embodiment shown in fig. 10, the second converging element 22 is provided with a hole 224, the proximal opening of the hole 224 is located in the second converging element 22, and a spherical surface or a larger space can be provided at the opening position to accommodate the proximal limit portion 31 of the wire-like connecting member 30, that is, the wire-like connecting member 30 is partially located in the hole 224, the proximal limit portion 31 extends out of the hole 224 and is located in the proximal space of the hole 224, and the aperture of the hole 224 is larger than the outer diameter of the wire-like connecting member 30 and smaller than the width of the limit portion 31. In such an embodiment, the limiting portion 31 may be made of a resilient material and may be compressed through the hole 224 to a predetermined shape after being expanded into the space at the proximal end of the hole 224.

In a preferred embodiment, the second converging element 22 comprises a proximal member 221 and a distal member 222 connected in sequence along the second axis 201, wherein a larger space is arranged inside the distal member 222 near the proximal end, the proximal end is closed by the distal end of the proximal member 221, a through hole 224 is arranged near the distal end, the linear connecting member 30 is partially positioned in the through hole 224, the limiting portion 31 extends out of the through hole 224, and the aperture of the through hole 224 is larger than the outer diameter of the linear connecting member 30 and smaller than the width of the limiting portion 31. The proximal member 221 may also be nested within the proximal end of the distal member 222, or partially nested within the proximal end of the distal member 222, and the manner in which the two are connected should not be limiting to the present utility model.

In such an embodiment, the bore 224 may be configured to have a shorter axial length and a greater proximal space, such that greater angular flexibility of the wire connection 30 may be achieved.

In some embodiments, the receiving holes are two or more counter bores, the limit portion 31 includes one or more pins 311, and the pins 311 of the limit portion 31 are nested with the corresponding counter bores and rotate about the pins 311.

In the embodiment shown in fig. 11, the distal end of the second converging element 22 is hollow, the receiving hole is a counter bore arranged on the inner wall of the distal end of the second converging element 22, and the pin 311 of the limiting portion 31 is adapted to the arrangement of the receiving hole. By means of the arrangement, the angular flexibility obtained by the linear connecting piece 30 can enable the first plugging disc 10 and the second plugging disc 20 to obtain a larger dislocation angle range at two ends of a gap with a patent foramen ovale, the tissue clamped by the plugging discs does not deform greatly, and the plugging discs are more attached to the clamped tissue.

Second converging element 22 may also include a proximal member 221 and a distal member 222. The distal end piece 222 is a hollow structure with two open ends, and the proximal end piece 221 closes the proximal end of the distal end piece 222; or the proximal end of the distal member 222 is a closed structure; the proximal member 221 and the distal member 222 may be axially connected or may be nested, the distal side wall of the distal member 222 is provided with a plurality of counter bores, and two ends of the linear connector 30 are respectively provided with one or more pins 311, and the pins 311 are nested with corresponding counter bores.

It will be appreciated that the receiving hole may also be a through hole penetrating the distal wall of the second converging element 22, and the pin 311 of the corresponding limiting portion 31 may be inserted into the receiving hole.

As shown in fig. 12 and 13, the hollow structure inside the distal member 222 may be configured as a circle or a square, the proximal member 221 is disposed at the proximal end of the distal member 222, two ends of the linear connecting member 30 are respectively provided with a pin 311, one end of the pin 311 is connected to the linear connecting member 30, and the other end extends into the receiving hole, so that the linear connecting member 30 rotates relative to the distal member 222. The number of pins 311 is four, four pins 311 are symmetrically arranged with respect to the second central axis 201, and two sets of receiving holes and pins allow angular flexibility in two perpendicular planes of the linear connector 30. The receiving holes and the pins can also be two holes which are symmetrical on both sides of the second central axis 201, and the receiving holes are distributed in the direction that the patent foramen ovale fissures are approximately vertical, so that the adaptability of the plugging device is improved.

The rotational connection manner of the linear connector 30 and the second converging element 22 in the above respective examples is also applicable to the rotational connection of the linear connector 30 and the first converging element 12, and will not be described herein.

In some embodiments, the second occlusion disk 20 further comprises a second frame 21, the second frame 21 being of a double-layered construction and having a proximal free end and a distal free end, the distal free end being fixed within the proximal end of the second constriction element 22. The second frame 21 may be a mesh structure woven from braided filaments, in such embodiments, the proximal and distal free ends of the second frame 21 are strands of braided filaments; the second frame 21 may be a mesh structure formed by carving or etching, or may be a non-mesh structure. The configuration of the second occlusion disk 20 should not be construed as limiting the utility model. The distal free end of the second frame 21 is convergent at the proximal end of the second convergent element 22, in the embodiment where the second convergent element 22 comprises a proximal end piece 221 and a distal end piece 222, i.e. the distal free end of the second frame 21 is convergent within the proximal end piece 221. The second occlusion disk 20 may further comprise a third constriction element 24 constricting the proximal free end of the second frame 21.

It will be appreciated that the first occlusion disk 10 further comprises a first frame 11, the first frame 11 being of a double-layered construction and having a proximal free end, and not having a distal free end, the proximal free end being necked by a first crimping element 12. The first frame 11 may be similar to the second frame 21 in a manner not described herein.

In the embodiment shown in fig. 14, the first sealing disk 10 further comprises a first flow blocking element 13, which is arranged on the first frame 11; the second blocking disk 20 further comprises a second flow blocking element 23, wherein the second flow blocking element 23 is arranged on the second frame 21. The first frame 11 has a substantially flat structure, and the first frame 11 is restored from the restrained state to the unfolded shape of the predetermined state during the delivery process, similar to the process of unfolding an umbrella.

The first frame 11 includes a proximal face and a distal face, respectively a first proximal face 111 and a first distal face 112, the first proximal face 111 and the first distal face 112 being substantially planar, respectively, and approximately conforming. In the embodiment where the first constriction element 12 comprises a proximal end piece and a distal end piece, the free end of the first frame 11 is constricted in the distal end piece of the first constriction element 12, and the receiving hole is arranged in the proximal end piece of the first constriction element 12.

The first choke element 13 may be a choke film, and is disposed inside or outside the first frame 11; when the first choke element 13 is provided outside the first frame 11, it may or may not be located outside the proximal end surface of the first frame 11.

The second frame 21 also includes a proximal face and a distal face. The second choke element 23 may be a choke film, disposed inside or outside the second frame 21; when the second flow blocking member 23 is disposed outside the second frame 21, it may or may not be located outside the distal end surface of the second frame 21.

In the preset state, the first frame 11 and the second frame 21 are axisymmetrically distributed around the respective central axes, and the linear connector 30 is in a relaxed state. In the deformed state, the first frame 11, the linear connector 30 and the second frame 21 adapt to the implantation position structure, the linear connector 30 is in a stretched state, the first central axis 101 and the second central axis 201 deviate, the first converging element 12 and the second converging element 22 after deviation are two endpoints of a line segment, an included angle a is formed between the first converging element and the first central axis 101 or the second central axis 201, and the linear connector 30 deviates from the central axis to be in a configuration adapting to the deformed state. The included angle a ranges from 0 DEG to 60 deg.

In some embodiments, as shown in fig. 14, the second converging element 22 of the second closure disc 20 may not protrude beyond the plane formed by the radial boundary of the second frame 21. The proximal end of the third constriction element 24 does not protrude beyond the proximal end face of the second frame 21 in the axial direction of the second frame 21, and the third constriction element 24 is located inside the second frame 21, the body being covered by the mesh face of the second frame 21, the proximal end face being exposed outside the second frame 21 for setting a connection position for the delivery system connection; the proximal and distal surfaces of the second frame 21 are generally arcuate, but have a smaller arc, and are configured to approximate a plane, such that the second frame 21 has a smaller arc, which is more conducive to endothelialization after implantation of the instrument.

In the embodiment shown in fig. 15, the proximal end surface of the second frame 21 is a second proximal end surface 211, the distal end surface is a second distal end surface 212, the proximal end surface and the distal end surface of the second frame 21 are substantially arc-shaped surfaces, a proximal central area of the second proximal end surface 211 of the second frame 21 has a substantially annular concave area, the third converging element 24 is located in the annular concave area and is located outside the second frame 21, a proximal end of the third converging element 24 does not protrude from the proximal end surface of the second frame 21 in the axial direction of the second frame 21, and a connection position is provided at the proximal end for connection of a conveying system. Other arrangements of these embodiments are similar to other embodiments.

In the embodiment shown in fig. 16, the proximal and distal faces of the second frame 21 are planar, respectively, and the largest radial boundary of the second frame 21 is approximately symmetrically distributed about the second central axis 201, the proximal and distal faces of the second frame 21 approximately fitting. The second frame 21 has a distal end point and a proximal end point, the proximal central region has a substantially annular concave region, the third converging element 24 is disposed in the proximal annular concave region of the second frame 21, the second converging element 22 is disposed at the distal end of the second frame 21, and the proximal end point of the second frame 21 (i.e., the third converging element 24) does not significantly protrude from the proximal end surface of the second frame 21. Other arrangements of these embodiments are similar to other embodiments.

During the insertion of the occluder into the delivery sheath 100, as shown in fig. 17, the pushing device 200 is connected to the proximal end of the second frame 21, the second frame 21 is pulled away from the proximal end and extended into the delivery sheath 100 in a long form, as shown in fig. 18 and 19, when the second frame 21 is moved closer to the distal end, the wire connector 30 is moved into the delivery catheter, and pulls the proximal end of the first frame 11 into the delivery sheath 100, and the edge of the first frame 11 is pulled toward the first central axis 101 and compressed into the delivery sheath 100, unlike the second frame 21. The structure of the stopper completely entering the delivery sheath 100 is shown in fig. 20, in the process of leaving the delivery sheath 100, the edge of the first frame 11 is first restored to the preset shape away from the first central axis 101, the linear connector 30 leaves the delivery sheath 100, and the second frame 21 is restored to the preset shape from the distal end to the proximal end.

In this embodiment, the distal ends of the first frame 11 and the second frame 21 do not have a structure protruding from the occluder, and the proximal ends do not have a structure protruding from the occluder obviously, which is beneficial to shortening the endothelialization time of the occluder after implantation, i.e. the time for the secondary septum 400 and the primary septum 300 to adhere together and fuse together is shortened.

In the embodiment shown in fig. 21, an additional flow blocking element 40 is further included, the additional flow blocking element 40 being provided on the proximal face of the first frame 11 and/or on the distal face of the second frame 21. The shape of the additional flow blocking element 40 may be circular, oval, polygonal, or a vane-type spaced apart, etc. In a preferred embodiment, the additional flow blocking elements 40 are located in a substantially central position of the first frame 11 and/or the second frame 21, distributed around the respective end points, covering the area of the proximal face of the first frame 11 and/or the distal face portion of the second frame 21. The provision of the additional flow blocking element 40 may enhance the effect of blocking blood flow.

The foregoing is merely a preferred embodiment of the present utility model and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present utility model, which are intended to be comprehended within the scope of the present utility model.

Claims (12)

1. An patent foramen ovale occluder comprising a first occlusion disc, a second occlusion disc and a wire-like connector, the first occlusion disc having a first central axis and a first constriction element, the first constriction element being located at a proximal end of the first occlusion disc;

the second occlusion disk has a second central axis and a second constriction element, the second constriction element being located at a distal end of the second occlusion disk;

the distal end of the linear connecting piece is connected with the first converging element, and the proximal end of the linear connecting piece is connected with the second converging element, so that the patent foramen ovale occluder has a preset state and a deformation state;

in the preset state, the first central axis is approximately coincident with the second central axis, and the linear connecting piece is in a loose state;

in the deformed state, the linear connector is deformed, the first central axis is offset from the second central axis, and the linear connector is in a stretched state.

2. The patent foramen ovale occluder of claim 1, wherein,

the first converging element comprises an accommodating hole, the distal end of the linear connecting piece comprises a limiting part and can be accommodated in the accommodating hole, so that the proximal end of the linear connecting piece can rotate relative to the first converging element; and/or

The second converging element comprises an accommodating hole, and the proximal end of the linear connecting piece comprises a limiting part and can be accommodated in the accommodating hole, so that the proximal end of the linear connecting piece can rotate relative to the second converging element.

3. The patent foramen ovale occluder of claim 2, wherein,

the adjacent part of the limiting part and the receiving hole comprises a spherical surface.

4. The patent foramen ovale occluder of claim 3, wherein,

the receiving hole is a counter bore and comprises a spherical surface, and the spherical surface of the receiving hole is matched with the spherical surface of the limiting part.

5. The patent foramen ovale occluder of claim 3, wherein,

the limiting part penetrates through the accommodating hole, the linear connecting piece part is positioned in the accommodating hole, and the aperture of the accommodating hole is larger than the outer diameter of the linear connecting piece and smaller than the maximum width of the limiting part.

6. The patent foramen ovale occluder of claim 5, wherein,

the receiving hole penetrates through the first converging element or the second converging element, and the limiting part penetrates through the receiving hole and is positioned outside the first converging element or the second converging element.

7. The patent foramen ovale occluder of claim 5, wherein,

the receiving hole does not penetrate through the first converging element or the second converging element, and the limiting part penetrates through the receiving hole and is positioned in the first converging element or the second converging element.

8. The patent foramen ovale occluder of claim 3, wherein,

the accommodating hole is formed by two or more counter bores, the limiting part comprises one or more pins, and the pins of the limiting part are connected with the corresponding counter bores in a nested manner and rotate by taking the pins as shafts.

9. An patent foramen ovale occluder according to any one of claims 2-8,

the first plugging disc comprises a first frame, the first frame is provided with a proximal free end, and the first constriction element constricts the proximal free end of the first frame;

the second occlusion disk includes a second frame having a proximal free end and a distal free end, the second constriction element constricting the distal free end of the second frame.

10. The patent foramen ovale occluder of claim 9, wherein,

the first constriction element comprises a proximal end piece and a distal end piece, the distal end piece constricting the free end of the first frame, the proximal end piece having the receiving aperture disposed therein.

11. The patent foramen ovale occluder of claim 9, wherein,

the second constriction element comprises a proximal end piece and a distal end piece, the proximal end piece constricting the distal free end of the second frame, the distal end piece having the receiving aperture disposed therein.

12. The patent foramen ovale occluder of claim 9, wherein,

a third converging element is also included converging the proximal free end of the second frame.

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