CN109833066B - Plugging device - Google Patents

Abstract

The utility model provides an occluder, includes elasticity woven mesh, elasticity woven mesh is woven by the wire and is formed, the wire includes first surface, with the second surface that first surface set up relatively and connect first surface and the side of two relative settings of second surface, the maximum distance between first surface with the second surface is less than first surface or the second surface is in the length of the projection on the plane of perpendicular to wire extending direction. The overlapping area of the metal wires of the near-end disc-shaped structure and the far-end disc-shaped plane of the occluder is larger, the formed mesh has lower density, and the flow-resisting film does not need to be sewed.

Description

Plugging device

Technical Field

The invention relates to the field of medical instruments, in particular to an occluder.

Background

With the continuous development of interventional material instruments and interventional cardiology, minimally invasive treatment of congenital heart diseases such as atrial septal defect (VSD), ventricular septal defect (ASD), Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO) through a catheter interventional occluder becomes an important method. The interventional method for blocking the blood vessel cavity is also a widely accepted treatment method.

The occluder in the current market is generally woven by a plurality of round metal wires, for example, 36 clockwise and 36 counterclockwise metal mesh tubes are woven in a spiral shape in a mutually staggered manner, but after the occluder is shaped, meshes are large, blood shunt at the heart defect part cannot be effectively obstructed, and a flow blocking film made of high polymer materials is usually required to be sewn on two disc surfaces and the waist of the occluder so as to obstruct blood. However, when the occluder is located at the defect part, the flow-blocking membrane separates like a layer of diaphragm to block blood at the defect part, and the blood shunt at the defect part has a certain pressure, for example, the mean pressure of atrial septal defect blood is 18mmHg, and the mean pressure of ventricular septal defect blood shunt is 70mmHg, when blood impacts the flow-blocking membrane, the flow-blocking membrane bears a considerable pressure, and at this time, the flow-blocking membrane fixed at the edge of the disc surface is easily torn, which easily causes the flow-blocking membrane to fall off.

Disclosure of Invention

In view of the above, there is a need for an occluder which can reduce the mesh size without sewing a flow-blocking membrane.

The utility model provides an occluder, includes elasticity woven mesh, elasticity woven mesh is woven by the wire and is formed, the wire includes first surface, with the second surface that first surface set up relatively and connect first surface and the side of two relative settings of second surface, the maximum distance between first surface with the second surface is less than first surface or the second surface is in the length of the projection on the plane of perpendicular to wire extending direction.

In one embodiment, a ratio of a maximum distance of the first surface to the second surface to a length of a projection of the first surface or the second surface on a plane perpendicular to an extending direction of the wire is not more than 0.67 and not less than 0.025.

In one embodiment, the length of the projection of the first surface or the second surface on a plane perpendicular to the extending direction of the metal wire is 0.5-10 mm, and the maximum distance between the first surface and the second surface is 0.025-0.25 mm.

In one embodiment, the connection between the first surface and the side surface and the connection between the second plane and the side surface are provided with chamfers.

In one embodiment, the metal wire is provided with a fiber rope, and a plurality of silk threads are distributed on the fiber rope.

In one embodiment, the first surface is provided with a plurality of through holes penetrating through the second surface, the through holes are distributed along the extending direction of the metal wire, and the fiber rope is fixed on the metal wire through the through holes.

In one embodiment, the fiber rope is wound on the metal wire by passing up and down through the through holes.

In one embodiment, the fiber ropes are a plurality of fiber ropes, each fiber rope is fixed in the through hole in the middle, and two ends of each fiber rope extend out of the first surface and/or the second surface.

In one embodiment, the length of the fiber rope extending out of the first surface or the second surface is 1-5 mm.

In one embodiment, the distance between the adjacent through holes is 5-20 mm.

Compared with the occluder adopting the cylindrical metal wire in the prior art, under the condition that the sectional areas are the same, the occluder provided by the application enables the length of the projection of the first surface or the second surface on the plane perpendicular to the extending direction of the metal wire to be larger by adjusting the ratio of the maximum distance between the first surface and the second surface to the length of the projection of the first surface or the second surface on the plane perpendicular to the extending direction of the metal wire, enables the overlapping areas of the metal wire and the metal wire of the near-end disc-shaped structure and the far-end disc-shaped plane of the occluder to be larger, enables the formed mesh to have smaller density, and can be free from sewing the flow-resisting film.

Drawings

FIG. 1 is a schematic structural view of an occluder in accordance with an embodiment of the present invention;

figure 2 is a schematic cross-sectional view of the wire of the occluding device shown in figure 1;

figure 3 is a top view of the occluding device shown in figure 1;

figure 4 is a schematic cross-sectional view of the wire of an occluding device of another embodiment of the present invention;

figure 5 is a schematic cross-sectional view of a wire of an occluding device of yet another embodiment of the present invention;

figure 6 is a schematic view of a portion of the structure of the elastic mesh grid of the occluding device shown in figure 1;

figure 7 is a schematic plan view of the wire of an occluding device of a further embodiment of the present invention;

figure 8 is a schematic plan view of the wire of an occluding device of yet another embodiment of the present invention.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1, the occluding device 100 of the first embodiment of the present invention comprises a proximal disc-shaped structure 110, a distal disc-shaped structure 120 and a waist portion 130 arranged between the proximal disc-shaped structure 110 and the distal disc-shaped structure 120. A plug head 140 and a closure head 150 may be secured to the proximal and distal ends of the occluding device 100, respectively. The head 140 serves to gather and secure the wires on the proximal disc structure 110 near the proximal end, and the head 140 is provided with a threaded structure for attachment to a delivery system. The seal 150 serves to gather and hold the wires near the distal end of the distal disc structure 120.

The proximal disc structure 110, the distal disc structure 120 and the waist portion 130 are heat set from an elastic knitted mesh woven from wires 101. Specifically, the occluding device 100 can be accommodated in a delivery sheath in a compressed state by using a super-elastic memory alloy material, such as nickel-titanium alloy, and can automatically return to the original shape after being released from the delivery sheath at a defect part, so as to block the heart septal defect or block the blood vessel, maintain sufficient radial supporting force and avoid the displacement of the occluding device 100.

Referring to fig. 2, the wire 101 includes a first surface 1011, a second surface 1013 opposite to the first surface 1011, and two opposite side surfaces 1015 connecting the first surface 1011 and the second surface 1013, and a maximum distance between the first surface 1011 and the second surface 1013 is smaller than a length of a projection of the first surface 1011 or the second surface 1013 on a plane (i.e., a cross section shown in fig. 2) perpendicular to an extending direction of the wire 101. It should be noted that the maximum distance between the first surface 1011 and the second surface 1013 is the maximum length of the first surface 101 along the longitudinal axis. Referring to fig. 3, compared to the occluder using a cylindrical wire in the prior art, in the case of the same cross-sectional area, the present application adjusts the ratio of the distance between the first surface 1011 and the second surface 1013 to the length of the projection of the first surface 1011 or the second surface 1013 on the plane perpendicular to the extending direction of the wire 101, so that the length of the projection of the first surface 1011 or the second surface 1013 on the plane perpendicular to the extending direction of the wire 101 is larger, the overlapping area of the wire and the wire of the proximal disc-shaped structure 110 and the distal disc-shaped plane 120 of the occluder 100 is larger, the mesh density is smaller, and the flow-blocking film does not need to be sewn. It will be appreciated that although increasing the number of wires or increasing the wire diameter of the wires may reduce the mesh opening size under certain conditions, increasing the number of wires or increasing the wire diameter of the wires increases the overall cross-sectional area of the wire, increases the sheathing force, and increases the diameter of the delivery sheath that is matched to the sheathing force, which increases the risk of injury to the patient's blood vessel. This application keeps under the condition that sheath pipe diameter does not increase, can reduce mesh density, increases the choked flow effect of plugging device.

Specifically, the ratio of the maximum distance between the first surface 1011 and the second surface 1013 to the length of the projection of the first surface 1011 or the second surface 1013 onto a plane perpendicular to the extension direction of the wire 101 is not more than 0.67, so as to ensure that the overlapping area of the wire and the wire of the occluder 100 is large and the density of the formed meshes is small. Preferably, the ratio of the distance between the first surface 1011 and the second surface 1013 to the length of the projection of the first surface 1011 or the second surface 1013 on a plane perpendicular to the first surface 1011 is not more than 0.5. Preferably, the ratio of the maximum distance between the first surface 1011 and the second surface 1013 to the length of the projection of the first surface 1011 or the second surface 1013 onto a plane perpendicular to the extension direction of the wire 101 is not less than 0.025, so as to avoid damage to the defective tissue caused by over sharp wires.

Specifically, the length of the projection of the first surface 1011 or the second surface 1013 on a plane perpendicular to the extending direction of the wire 101 is 0.5-10 mm, and the maximum distance between the first surface 1011 and the second surface 1013 is 0.025-0.25 mm, so that the overlapping area of the wire 101 and the wire 101 of the occluder 100 is large and the density of the formed meshes is small in a sheath tube with a proper size for ensuring the occluder 100 to be accommodated.

Furthermore, in order to avoid damage between the wire 101 and the wire 101, the connecting portions of the first surface 1011 and the second surface 1013 and the side surface 1015 are provided with chamfers, so that the edge of the wire 101 is not too sharp, and damage caused by contact between the wire 101 and the wire 101 is avoided.

In the illustrated embodiment, the cross section of the wire 101 is rectangular, and the lengths of projections of the wire 101 on a plane perpendicular to the extending direction of the wire 101 at respective positions along the extending direction are equal. Of course, in other embodiments, the cross-sectional area of the wire 101 may have other shapes. Referring to fig. 4, the cross section of the wire 101 is a parallelogram. Referring to fig. 5, the cross section of the metal wire 101 is trapezoidal, that is, the projection lengths of the first surface 1011 and the second surface 1013 on a plane perpendicular to the extending direction of the metal wire 101 are not equal, so that, under the condition of the same cross section area, the surfaces with larger projection lengths are overlapped with each other, the overlapping area of the metal wire 101 and the metal wire 101 is larger, and the mesh area formed is smaller. It will be appreciated that the cross-section of the wire 101 may also be elliptical, the maximum distance between the first surface 1011 and the second surface 1013 being the length of the minor axis of the ellipse, and the projection of the first surface 1011 or the second surface 1013 onto a plane perpendicular to the direction of extension of the wire 101 being the length of the major axis of the ellipse, the length of the minor axis being less than the length of the major axis.

Further, in order to ensure the better flexibility and elasticity of the occluder 100, please refer to fig. 6, the elastic woven mesh is formed by weaving two sets of wires 101 in opposite directions, i.e. one set of wires 101a1, 101a2 and the woven wires extending in the same direction, and the other set of wires 101b1, 101b2, 101b3, 101b4, 101b5, 101b6 and the woven wires extending in the same direction. In the direction of extension of wire 101a1, the wires intersecting wire 101a1 include co-extending wires 101b1 and 101b2 above wire 101a1, co-extending wires 101b3 and 101b4 below wire 101a1, and co-extending wires 101b5 and 101b6 above wire 101a1, and so on. In the extending direction of the wire 101a2, the wire 101b1 is located below the wire 101a2, the wires 101b2 and 101b3 are located above the wire 101a2, and the wires 101b4 and 101b5 are located below the wire 101a2, thereby repeatedly forming a woven mesh. Through the weaving mode, the constraint force between the metal wires is relatively small, the force required by the deformation of the obtained plugging device 100 is reduced, the sheathing force can be reduced, the sheathing entering of the plugging device 100 is facilitated, and the plugging device is soft, is not easy to wear cardiac tissues, has good elasticity, and can not generate large reaction force along with the beating of the heart. In this embodiment, the elastic mesh grid is woven from 72 wires.

Please refer to fig. 7, in order to further improve the flow-blocking effect of the occluder 100, the metal wire 101 is provided with a fiber cord 160, a plurality of threads 161 are distributed on the fiber cord 160, the fiber cord 160 can be filled in the meshes formed by the metal wire, the mesh size of the occluder is reduced, the flow-blocking effect is improved, and the threads 161 dispersed on the fiber cord 160 can adsorb blood cells, thereby achieving the flow-blocking effect. Specifically, the fiber strand 160 is formed by interweaving a plurality of threads to form a non-unravelable fiber strand, and the naturally unravelable threads 161 are scattered on the surface of the fiber strand 160, i.e., the threads 161 do not participate in the interweaving. In particular, the filaments may be made of a biocompatible polyamide or PET material. In the present embodiment, the threads have a diameter of 0.05 to 0.15mm, and the fiber cord 160 is formed by interlacing 8 to 20 threads.

Specifically, the first surface 1011 defines a plurality of through holes 1012 penetrating through the second surface 1013, the plurality of through holes 1012 are distributed along the extending direction of the wire 101, and the fiber cord 160 is fixed to the wire 101 through the through holes 1012. In the illustrated embodiment, the fiber rope 160 is wound around the metal wire 101 through the up-and-down insertion holes 1012, so that the fiber rope 160 is firmly fixed to the metal wire 101, and the fiber rope 160 is prevented from falling off the metal wire 101.

Further, the distance between adjacent through holes 1012 is 5-20 mm, so that the mesh density of the plugging device 100 can be well reduced, and the flow blocking effect of the plugging device 100 is improved. Preferably, the size of the fiber strands 160 matches the size of the through-holes 1012, i.e., the fiber strands 160 may block the through-holes 1012. Of course, in other embodiments, the diameter of the fiber strand 160 may be less than the inner diameter of the throughbore 1012, e.g., the inner diameter of the throughbore 1012 at the overlap of two wires may be greater than the diameter of the fiber strand 160. Preferably, the fiber string 160 has a bulky structure, and has a tightened profile smaller than that of the through-hole and a natural profile larger than that of the through-hole.

Please refer to fig. 8, which is a schematic structural diagram according to another embodiment of the present application. Unlike fig. 7, the plurality of fiber strands 160 is fixed in the through hole 1012 at the middle of each fiber strand 160, and extends from the first surface 1011 and/or the second surface 1013 at the two ends. Specifically, each fiber strand 160 is threaded through the through-hole 1012 and then tied off and secured within the through-hole 1012 to form two free ends that extend beyond the first surface 1011 and/or the second surface 1013. Of course, in other embodiments, each fiber strand 160 may be knotted at one end and secured within the through-hole, and the other end may be a free end that extends beyond the first surface 1011 and/or the second surface 1013.

Specifically, the length of the fiber cord 160 extending out of the first surface 1011 is 1-5 mm, so that gaps of meshes are filled well, and the flow blocking effect is improved. In the illustrated embodiment, two fiber strands 160 are secured within each throughbore 1012 to form four free ends extending from the first surface 1011 and/or the second surface 1013. Of course, in other embodiments, the number of fiber strands 160 secured within each throughbore 1012 may be selected based on the desired application.

In the illustrated embodiment, the first surface 1011 of each wire 101 has a row of through holes 1012 distributed along its extension. Of course, in other embodiments, the first surface 1011 of each wire 101 may be provided with multiple rows of through holes 1012, and the multiple rows of through holes 1012 are arranged in parallel. In one embodiment, the through holes 1012 in adjacent rows may also be staggered.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (8)

1. An occluder comprises an elastic woven mesh, wherein the elastic woven mesh is formed by weaving metal wires, and is characterized in that the metal wires comprise a first surface, a second surface arranged opposite to the first surface and two oppositely arranged side surfaces connecting the first surface and the second surface, the maximum distance between the first surface and the second surface is smaller than the length of the projection of the first surface or the second surface on a plane perpendicular to the extending direction of the metal wires, the first surface is provided with a plurality of through holes penetrating through the second surface, the through holes are distributed along the extending direction of the metal wires, the metal wires are provided with fiber ropes, a plurality of silk threads are distributed on the fiber ropes, and the fiber ropes are fixed on the metal wires through the through holes.

2. The occluder of claim 1, wherein the ratio of the maximum distance of said first surface to said second surface to the length of the projection of said first surface or said second surface onto a plane perpendicular to the direction of extension of said wires is not more than 0.67 and not less than 0.025.

3. The occluder of claim 2, wherein the first surface or the second surface each has a projection onto a plane perpendicular to the direction of extension of said wires having a length of 0.5 to 10mm, and wherein the maximum distance between said first surface and said second surface is 0.025 to 0.25 mm.

4. The occlusion device of claim 1, wherein a junction of the first and second surfaces and the side surface is chamfered.

5. The occlusion device of claim 1, wherein the fiber strand is wrapped around the wire by passing up and down through the through-holes.

6. The occlusion device of claim 1, wherein the fiber strands are a plurality, each of the fiber strands being secured within the through-hole with ends extending beyond the first surface and/or the second surface.

7. The occlusion device of claim 6, wherein the length of the fiber strand extending beyond the first or second surface is from 1 mm to 5 mm.

8. The occlusion device of claim 1, wherein the distance between adjacent through holes is 5-20 mm.

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