CN104173122A - Plugging device suitable for postoperation perivalvular leakage - Google Patents

Abstract

An occluder suitable for postoperative paravalvular leakage, including a braid and a film, the braid is composed of first and second elliptical areas on both sides and a third elliptical area in the middle; the third elliptical area is the long axis and A hollow elliptical cylinder with a short axis ratio between one-third and two-thirds, the thickness of the third ellipse is based on the mechanical valve sewing ring that is stuck at the place to be blocked; from the third ellipse The outer edge of the outer edge extends 0.2 mm to 1 mm to form the edge of the second elliptical area; at least one expanded film is arranged in the inner cavity of the third elliptical area. When using this occluder for occlusion, the elliptical occluder is arranged along the leak point, and the elliptical occluder has the characteristics of deformation and self-adaptation, and it will deform adaptively after being inserted into the leak point. The leakage point is completely blocked, and the tension is appropriate, which is more suitable for interventional treatment of paravalvular leakage.

Description

An occluder suitable for postoperative paravalvular leakage

technical field

The proposal relates to an occluder commonly used in interventional operations, specifically a special occluder suitable for postoperative paravalvular leakage.

Background technique

A mechanical valve is an artificial valve made of non-biological materials. Its basic structure includes three parts: a valve frame, a valve body, and a sewing ring. The cage ball valve is inlaid with a sphere made of silicon rubber in a cage made of stainless steel. The ball moves up and down in the cage to form closing and opening, and the blood flow at the valve mouth is peripheral. The side tilt disc frame is made of alloy or pyrolytic carbon. The disc is made of pyrolytic carbon material. The disc is suspended and clamped in the circular petal frame by a metal chain. Blood flow was semi-central. The double-leaf petal frame is made of pyrolytic carbon, and two semicircular leaflets made of pyrolytic carbon are embedded in the petal frame. The petals are like two doors, and their switches produce the opening and closing of the petals. The blood flow at the valve is central, and the pressure difference across the valve is small. The mechanical valves of the above three structures are generally sutured on the heart or the aorta by suturing.

Perivalvular leak (PVL) after prosthetic heart valve replacement is a unique complication after valve replacement. According to foreign literature reports, the incidence of paravalvular leakage is about 3 to 12.5%, and the incidence of mitral valve leakage is significantly higher than that of aortic valve. There are many causes of PVL, and generally appear in the early or late operation.

At present, the treatment methods for paravalvular leakage include: surgery and interventional methods. There is no special occluder specifically for this operation. In clinical practice, patent ductus arteriosus occluders or interventricular septum are routinely used. The defect occluder, the main structure of the above-mentioned occluder is cylindrical, it is not suitable to be directly used in the operation of paravalvular leakage, because in the process of using the occluder for occlusion, the occluder and The position and shape of the paravalvular leak do not coincide, and it has poor adaptability, and there may be a bias phenomenon after occlusion. At the same time, in order to adapt to the shape of the paravalvular leak, the deformation of the occluder is relatively large, which causes excessive tension on the suture site and forms a new leak point, so it is not suitable for the treatment of paravalvular leak.

According to the applicant's knowledge, at present, there is no special occluder specially used for occluding paravalvular leaks.

Contents of the invention

In view of the above problems, an occluder suitable for postoperative paravalvular leakage is provided. First, the special occluder developed and designed according to the characteristics of postoperative paravalvular leakage has obvious advantages. Secondly, it has better application Performance, postoperative life and adaptability are better, and third, based on existing molding technology, it is easy to manufacture and produce.

The technical scheme that the present invention solves its technical problem adopts is:

An occluder suitable for postoperative paravalvular leakage, comprising a braided body and a film, the braided body is formed at one time through weaving and shaping processes with thin metal wires, and the film is a medical polymer film, characterized in that ,

The braid is cylindrical as a whole and is composed of the first elliptical area on both sides, the second elliptical area and the third elliptical area in the middle, and the size of the first elliptical area should satisfy that from the third elliptical area The outer edge of the first ellipse extends outwards by 1.5 mm to 2 mm to form the edge of the first ellipse;

The third elliptical area is a hollow elliptical cylinder with a ratio between the major axis and the minor axis of one-third to two-thirds, and is separated from the first and second elliptical areas on both sides. Smooth transition and continuous existence, in the thickness direction, the thickness of the third ellipse is based on the mechanical valve sewing ring that is stuck at the place to be blocked;

The second elliptical area, the size of the second elliptical area should be satisfied, extending outward from the outer edge of the third elliptical area by 0.2 mm to 1 mm to form the edge of the second elliptical area;

The ends of the braided body are respectively located at the center of the first elliptical area or/and the second elliptical area, and a threaded thread is fixed at the end of the second elliptical area by extrusion molding or welding. threaded column;

At least one unfolded film is arranged in the inner cavity of the third elliptical region, and the periphery of each film is stitched and connected with the braided body to form an integral body.

Further, a gold marking point or a platinum marking point is respectively arranged at both ends of the second elliptical region along the major axis direction.

Further, the film is a polyvinyl alcohol polymer film or a polymer silica gel film commonly used in medical treatment.

Further, the closing opening on the second ellipse area is recessed inwardly, and the threaded column is arranged on

inside the depression.

Further, in the thickness direction, the thickness of the third elliptical region is between 3mm and 4mm.

Further, the threaded post is made of the same alloy as the braided body, and the threaded post is sunken inside the entire occluder to ensure a smooth outer surface and reduce the chance of thrombus formation.

Further, the metal wire used in the braid is Nitinol alloy or other alloy filaments that will have a memory function.

The beneficial effects of the present invention are: since the shape of the perivalvular leak is generally an irregular ")" crescent shape, when the occluder is used for occlusion, the elliptical occluder is arranged along the leak point, and the elliptical The unique occluder has the characteristics of deformation and self-adaptation. After being inserted into the leak, it will undergo adaptive deformation to completely seal the leak, and the tension is appropriate, which is more suitable for interventional treatment of paravalvular leak.

Description of drawings

Fig. 1 is a model diagram of the present invention.

Fig. 2 is a front view of Fig. 1 .

Fig. 3 is a bottom view of Fig. 2 .

Fig. 4 is a sectional view A--A in Fig. 2 .

Fig. 5 is a schematic diagram of paravalvular leakage of a mechanical valve.

Fig. 6 is a schematic diagram of the effect of the present invention on paravalvular leak occlusion.

Fig. 7 is a large three-dimensional sample of the present invention.

In the figure: 1 occluder, 1' braided body, 11 first elliptical area, 12 second elliptical area, 13 third elliptical area, 14 threaded post, 2 mechanical flap, 3 chamber wall, 41 first film sheet, 42 The second film sheet, 5 mark points, 6 leak points.

Detailed ways

As shown in Figures 1 to 7, the present invention relates to an occluder suitable for postoperative paravalvular leakage, which is composed of metal filaments, impermeable membranes and fixation elements.

In view of the existing defects, the subject of protection of this patent is as follows:

Developed is a medical device for closure of paravalvular leakage after mechanical valve surgery. The element makes the closure process full of flexibility through minimal damage and minimal intervention. The structure of this element is more in line with the anatomical and physiological structure of the mechanical valve and the suture site, and it is as close as possible to the leak point without reducing the In the case of high bonding strength, the element can reach the blocking site completely and accurately, and the tension is optimized to implement blocking, and the blocking effect and service life are significantly increased.

The overall design idea is to design its shape into an ellipse to reduce the expansion force on the leak. The basic principle is to compress the occluder 1 and guide it to the position of the perivalvular leak that needs to be occluded through the catheter. Make the mark point 5 just facing the junction on both sides of the leak point 6, and then lead the occluder out of the catheter. Since the occluder has a shape memory function, it can be restored to its original shape, and the two sides are respectively stuck on both sides of the leak point , stuck and fixed at the leak point, and finally the catheter and guide wire can be pulled out to complete the fixation, as shown in Figure 6, because the shape of the occluder basically matches the shape of the leak point, and compared with the contour of the leak point Slightly larger, after installation, it can be fixed by its tension.

Based on the above description, when the occluder is fixedly installed, the occluder can close the leakage point as much as possible, and fit it in the correct position as much as possible, so that especially due to the tension and elliptical The shape meets the purpose of both fixed installation and complete sealing.

At the same time, the occluder provided by the present invention is an occluder specially used for treating paravalvular leakage, and is suitable for an occluder guided by a catheter for manipulation.

Since the position to be occluded is located between the mechanical valve 2 and the chamber wall 3 (or tube wall), and the special shape and position determine the requirements of the occluder.

The main body of the occluder 1 is formed by braiding process with thin metal wires, and is braided by 72 metal wires. The special shaping process forms a whole. Here, the above-mentioned metal wire is preferably selected, such as Nitinol alloy or other alloy materials with memory function, which not only have a certain degree of flexibility, but also can automatically return to the original state when the external force is removed. , relying on its own tension to hold it in place. There should be sufficient flexibility to meet operational requirements. Because the alloy used in the occluder has a memory function, the occluder is in a state of compression during the introduction process, and is smoothly introduced, released after reaching the predetermined position, and can return to the predetermined shape in time after the release.

From a structural point of view, the braided part of the occluder includes a first elliptical area 11 on both sides, a second elliptical area 12 and a third elliptical area 13 in the middle. The outer edge of the area extends 2 mm (L) outwards, see illustration 2.

The third ellipse area 13 is a hollow elliptical cylinder with a ratio of major axis to minor axis of one-third to two-thirds, preferably, the ratio of major axis to minor axis is one-half , and there is a smooth transition and continuous existence between the elliptical regions on both sides, and no sharp or discontinuous points can appear. In the thickness direction, the thickness H of the third elliptical region 13 is enough to hold the part to be blocked. The mechanical valve suturing ring shall prevail, and the thickness shall be basically compatible with the thickness of the damaged part of the aortic valve, so as to avoid the phenomenon that the clamping is not tight or too tight. It can be made into a series to meet the needs of leaks of different sizes, and can be selected according to the size of the damaged part that needs to be sealed. In terms of strength performance, this area has its own tension to support the contraction of the leakage point, and it will not deform for a long time. The long-term mentioned here refers to the unit of human age.

The second elliptical area 12, and the size of the second elliptical area should meet the requirement that the outer edge of the third elliptical area extends from 0.2 mm to 1 mm (M) to form the edge of the second elliptical area, preferably is 0.8mm.

The above three parts are formed through a shaping process, and the structure is a woven mesh, and there is no discontinuous, sharp, or uneven shape, and should be a smooth transition.

In the center of the second elliptical area 12 is a closing place, and the closing place is made into a concave shape, and a threaded column 14 with a threaded structure is fixed in the concave place by extrusion molding or welding. The structure is similar to the existing one. The threaded post is similar, and optimally, the threaded post 14 is sunk inside the entire occluder, so as to ensure a smooth outer surface, smoother in appearance, and at the same time, reduce the chance of thrombus formation.

In the process of using metal wires to weave braids, depending on the selection of the process, usually a style with one end closed can be formed; a style with two ends closed can also be used, that is, a braided body is formed at the center of the first ellipse Another closing structure of .

Theoretically, the manufacturing process of the double-closed structure is simpler and easier than the single-closed process. Braids of these two structural forms are within the protection scope of the present invention.

Then use an impermeable sheet-shaped film to block, specifically prepare two circular film sheets with a size equivalent to the area of the third ellipse, marked as the first film sheet 41 and the second film sheet 42, respectively Set in the inner cavity of the third elliptical area and the first elliptical area, the thin film is made of polymer material, for example, polyvinyl alcohol polymer film or polymer silicone film material commonly used in medical treatment. Embed the film into the cavity of the third ellipse, and fully unfold and flatten it without any overlapping or wrinkling, and then use the sewing process to sew the film around the third ellipse to form a partition structure, the suture process should ensure that the joints at the suture are as small and smooth as possible.

A gold marking point 5 or a platinum marking point is respectively welded on both ends of the second elliptical region along the long axis, so that it can be used for position marking during surgery. Through the above method, an occluder is formed.

In the occluder, the braided body forms a flexible skeleton with a certain memory function, and the membrane is a diaphragm for blocking blood. In addition, the specific shape of the braided body meets the need for occlusion of a specific part of the interventricular septum.

The above-mentioned embodiments are only descriptions of preferred implementations of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, those skilled in the art may make various modifications and improvements to the present invention. All should expand in the scope of protection as defined in the claims of the present invention.

Claims (7)

1. be applicable to a stopper for postoperative perivalvular leakage, comprise knitted body and thin film, described knitted body is with thin tinsel through braiding and setting process one-shot forming, and described thin film is medical macromolecule membrane, it is characterized in that,

Whole the 3rd area elliptica for first area elliptica by both sides of column, the second area elliptica and centre of described knitted body forms, and the size aspect of described the first area elliptica should meet, 1.5 millimeters to the 2 millimeters edges that form described the first area elliptica stretch out from the outer of the 3rd area elliptica;

Described the 3rd area elliptica, for the ratio of major axis and minor axis is the oval tubular of a hollow between 1/3rd to 2/3rds, and and seamlessly transit and continued presence between first, second area elliptica of both sides, on thickness direction, the thickness of described the 3rd area elliptica treats that to block the mechanical prosthetic valve suture ring of shutoff place is as the criterion;

The second area elliptica, the size aspect of described the second area elliptica should meet, and 0.2 millimeter to 1 millimeter edge that forms described the second area elliptica stretches out from the outer of the 3rd area elliptica;

Closing in place of described knitted body lays respectively at described the first area elliptica or/and the centre of the second area elliptica, and by the mode of extrusion modling or welding fabrication, fixes a threaded threaded column of tool in described the second area elliptica closing in place;

The thin film of at least one expansion is set in described the 3rd area elliptica internal cavities, and the surrounding of each thin film and knitted body are sewed up and are connected to form one.

2. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, at described the second area elliptica, along the two ends of long axis direction, is respectively arranged with a gold markers point or platinum gauge point.

3. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1 and 2, is characterized in that, described thin film is high-molecular polyvinyl alcohol thin film or macromolecule silica gel thin film conventional in medical treatment.

4. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 2, is characterized in that, the closing in being positioned on described the second area elliptica caves inward, and described threaded column is arranged in depression.

5. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 4, is characterized in that, described threaded column is the alloy body identical with knitted body material, and described threaded column is trapped in the inside of whole stopper in being.

6. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, on thickness direction, the thickness of described the 3rd area elliptica is between 3 millimeters to 4 millimeters.

7. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, the tinsel that described knitted body is used will have the alloy threadlet of memory function for nitinol or other.