CN104000631B - A kind of rupture of aortic sinusal aneurysm plugging device - Google Patents

Abstract

An aortic sinus aneurysm rupture occluder, the braided body includes an arc-shaped area, a cylindrical area and a disc-shaped area, and extends outward from the outer edge of the cylindrical area by 3 to 4 mm to form an arc-shaped area The rim, the cylindrical zone is a hollow cylinder with a diameter between 4 and 20 mm and the thickness is between 2.5 and 4 mm; the discoid zone is a circular flat plate extending 0.5 to 2 mm outward mm; the end of the braid is located in the center of the disc-shaped area and is recessed inward, and a threaded column is fixed in the recess; respectively in the inner cavity of the arc-shaped area, the cylindrical area and the disc-shaped area Sets up an unfolded film. The curvature of the arc-shaped area can fit perfectly with one side of the aortic valve, and it will also form protection during the swinging process of the aortic valve; the convex edge of the disc-shaped area is small, which can realize the function of clamping, At the same time, it minimizes the resistance to the blood when the blood flows through it, making the blood flow smooth.

Description

An aortic sinus aneurysm rupture occluder

technical field

The invention relates to the field of occluders used in aortic sinus aneurysm rupture closure surgery, in particular to an aortic sinus aneurysm rupture occluder.

Background technique

Aortic sinus aneurysm rupture, also known as Valsian sinus aneurysm rupture, is due to the lack of normal elastic tissue and muscle tissue in the aortic sinus wall, which is impacted by high-pressure blood flow and gradually forms a cystic tumor that protrudes outward and eventually ruptures. . This disease is a rare congenital heart disease. The adult incidence rate of this disease is high, and the state of an illness appears suddenly and develops rapidly. The curative effect of the surgery is definite, the mortality rate is low, and the normal heart function can be completely restored after the operation.

During surgery, care should be taken

1. The aorta and sinus aneurysm break into the cardiac chamber through double incision, and the sinus aneurysm rupture is repaired or aortic valvuloplasty is performed at the same time. If the rupture is large, it needs to be repaired with a patch. For larger tumors, part of the tumor wall should be resected.

2. When the aortic sinus aneurysm breaks into the right ventricle, attention should be paid to the exploration and repair of the often coexisting ventricular septal defect.

3. When repairing a ruptured sinus aneurysm, the aortic valve or annulus should be prevented from being pulled, so as not to cause or aggravate aortic insufficiency.

4. Patients with obvious aortic regurgitation or subacute bacterial endocarditis should undergo aortic valve replacement.

5. Pay attention to strengthen myocardial protection.

At present, there is no device specifically used for closure of aortic sinus aneurysm rupture in clinical practice, and a vascular occluder is usually used to perform the occlusion operation. The structure of the existing vascular occluder does not match the shape of the aortic valve. It is easy to cause, and the blockage is not strict, so that there is blood return at the blockage, resulting in cardiac insufficiency. The second is that it affects the closure of the aortic valve, and the third is that at the occlusion site, because the occluder and the aortic valve are not closed tightly, because the aortic valve is composed of three pockets, it is easy to cause thrombosis here. Phenomenon.

Contents of the invention

In order to solve the deficiencies of the prior art, the present invention provides an aortic sinus aneurysm rupture occluder, which is used for occluding the rupture of the aortic sinus aneurysm. It is a special seal designed for the specific shape and structure of the aortic valve. The occluder should solve the phenomenon that thrombus is easily formed at the existing occlusion site, and at the same time, it should be more closely attached to the aortic valve joint.

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

A ruptured aortic sinus aneurysm occluder includes a braid and a film, the braid is mainly formed by a thin metal wire through weaving and shaping processes, and the film is a medical polymer film, characterized in that,

The braid includes an arc-shaped area, a cylindrical area and a disc-shaped area, and the arc of the arc-shaped area coincides with the arc of the aortic valve to be repaired, and the size should meet: from cylindrical The outer edge of the zone extends outward by 3mm to 4mm to form the edge of the arc-shaped zone, and the edge is also continuous and has a certain curvature. Viewed from the outer end face of the arc-shaped zone, the arc-shaped zone should be continuous curved concave ball;

The cylindrical area is a hollow cylinder with a diameter between 4 mm and 20 mm, and there is a smooth transition and continuous existence between the arcuate area and the disc-shaped area. In terms of strength performance, the The cylindrical area has the property of supporting the self-clamping force of the damaged part of the aortic valve and does not deform for a long time; in the thickness direction, the thickness of the cylindrical area is between 2.5 mm and 4 mm;

a disc-shaped region, the disc-shaped region is a circular flat plate, and extends outward from the outer diameter of the cylindrical region by 0.5 mm to 2 mm;

The closing part of the braid is located at the center of the disc-shaped area and is recessed inwardly, and a threaded column with external threads is fixed at the recess by extrusion molding or welding;

An unfolded film is arranged in the inner cavity of the arc-shaped area, the cylindrical area and the disc-shaped area respectively, and the periphery of each film is stitched and connected with the braided body to form a whole.

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

Further, the film should be fully unfolded and flattened, and superimposed and wrinkled phenomena are not allowed.

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.

Further, at the center of the arc-shaped area is another closing structure of a braided body.

Further, the arc-shaped area of the arc-shaped area is a continuous braided structure without a constriction.

Further, the braided body is braided by 72 metal wires.

The beneficial effects of the present invention are:

The structure is reasonable, the arc of the arc-shaped area can fit perfectly with one side of the aortic valve without gap, and it will also form protection during the swinging process of the aortic valve to prevent blood backflow; the convex edge of the disc-shaped area The small size can realize the basic function of being stuck, and at the same time minimize the resistance to the blood when the blood flows through, so that the blood flow is smooth.

It is a special medical component that meets the needs of surgery.

Description of drawings

Fig. 1 is the solid outline of the skeleton of the inventive occluder.

FIG. 2 is a side view of FIG. 1 .

FIG. 3 is a quarter sectional view of FIG. 1 .

Fig. 4 is a solid outline view of an occluder with a membrane structure.

Fig. 5 is a partially enlarged view of A in Fig. 4 .

FIG. 6 is a partially enlarged view of B in FIG. 4 .

Fig. 7 is a perspective view (back side) of the occluder of the present invention.

Fig. 8 is a perspective view (front) of the occluder of the present invention.

Fig. 9 is a developed view of the braided body.

Fig. 10 is a schematic diagram of the occlusion of the occluder during operation.

Fig. 11 is a braided body closed at both ends.

In the figure: 1 occluder, 11 arc-shaped area, 12 cylinder-shaped area, 13 disc-shaped area, 14 threaded column, 2 aortic valve, 31 the first membrane, 32 the second membrane, 33 the third Film sheet, 4 sutures, 5 closing structures.

detailed description

As shown in Figures 1 to 10,

The invention relates to an aortic sinus aneurysm rupture occluder, which is composed of metal filaments, an impermeable membrane and a fixing element.

In the existing patients with aortic sinus aneurysm, the rupture of aortic sinus aneurysm will directly cause the defect of aortic valve, threatening the life of the patient. Prompt revision surgery is required for the patient. The current commonly used repair method is: to use the existing vascular occluder to occlude, and this kind of vascular occluder cannot well meet the needs of aortic valve occlusion.

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

The developed medical device is a medical device for occluding the aortic valve at the rupture of the aortic sinus aneurysm in a manner similar to that of transvenous catheter intervention to occlude the defect of the heart vessel. The element makes the occlusion process full of flexibility through the minimum degree of damage and minimal intervention. The structure of the element is more in line with the anatomical and physiological structure of the valve, and the trauma is minimized, so that the element can completely and accurately reach the occlusion site, blockage.

The basic principle is to compress the occluder 1 and introduce it to the damaged part of the aortic valve to be occluded through the catheter, and then lead the occluder out of the catheter. Since the occluder has a shape memory function, it can be restored to its original state , and the two sides are stuck on both sides of the aortic valve, stuck and fixed at the damaged part, and finally the catheter and guide wire can be pulled out to complete the fixation, as shown in Figure 10.

Based on the above description, when the occluder is fixedly installed, the occluder can achieve the occlusion of the defect as much as possible, and make the side wings on both sides fit on the aortic valve as much as possible, especially During the swinging process of the aortic valve, the impact on the swinging action of the aortic valve should be minimized.

At the same time, the occluder provided by the present invention is a occluder specially used for treating the rupture of an aortic sinus aneurysm, and is suitable for the occluder to be manipulated through catheter guidance.

Since the part to be occluded is located on the aortic valve, and the special shape and position determine the requirements of the occluder.

The main body of the occluder is mainly made of thin metal wires through braiding process. It is braided by 72 metal wires. It is a braided body. It can adopt the structural style of closing both ends (as shown in Figure 11), or one end can be used. Closed style, and a whole formed by a special shaping process. 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. . It should have sufficient flexibility to meet the requirements of belt-through operation. 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 an arc-shaped area 11, a cylindrical area 12 and a disc-shaped area 13, and the arc of the arc-shaped area 11 matches the arc of the aortic valve 2. The curvature should be satisfied with the convenience of the size, extending 3mm to 4mm (L) from the outer edge of the cylindrical area, refer to the figure, and the edge is also a continuous arc area with a certain arc, in the arc area Viewed from the outer end face, the arc-shaped area should be a continuous arc-shaped concave ball shape, and there should be no intermittent or uneven weaving phenomenon. Optimally, the arc radius of the concave ball shape is about 50 mm, which is close to The radian of the existing aortic valve, but not limited thereto, can be made into a series, and can be selected and used according to needs.

The cylindrical zone 12 is a hollow cylinder with a diameter between 4 mm and 20 mm (N), and there is a smooth transition between the arc-shaped zone and the disc-shaped zone and there is no sharp edge. or have sub-continuous points, the size of the cylindrical region 12 can be made into a series, which can be selected according to the size of the required blockage. In terms of strength performance, this region has its own clamp to support the damaged aortic valve The long-term mentioned here refers to the unit of human age. For example, if the patient is 40 years old, the product must meet the design life of at least 30 years. In the thickness direction, the thickness H of the cylindrical region 12 is between 2.5 millimeters and 4 millimeters, and making a series can basically meet the size requirements of the aortic valve. In particular, it should be ensured that the thickness should be basically the same as The thickness of the damaged part of the aortic valve is adapted to avoid the phenomenon that the card is not tight or too tight.

The disc-shaped area 13, which is a circular plate-like shape, and its diameter is slightly larger than that of the cylindrical area, should be controlled to protrude from 0.5 mm to 2 mm (M) on each side. 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.

The central part of the disc-shaped area is a closing part, and the closing part is made into a concave shape, and a threaded column 14 with a threaded structure is fixed in the concave part by extrusion molding or welding. The structure is similar to that of the existing The threaded post is similar to, and optimally, the threaded post is sunken inside the entire occluder, so as to ensure a smooth outer surface and a smoother appearance, and at the same time, reduce the chance of thrombus formation.

Then use an impermeable sheet film to block, specifically prepare a circular film sheet with a size equivalent to the area of the arc-shaped area, marked as the first film sheet 31, which is made of polymer material and For example, polyvinyl alcohol polymer film or polymer silicone film material commonly used in medical treatment. Embed the film in the interlayer of the arc-shaped area, fully unfold and flatten it, and do not allow overlapping or wrinkles, and then use the sewing process to suture the surrounding of the film and the arc-shaped area 4 to form a partition structure, the suture process should ensure that the joints at the suture are as small and smooth as possible.

Then prepare a circular film sheet whose size is equivalent to the cross-sectional effective area of the cylindrical area, denoted as the second film sheet 32, this film sheet is embedded in the middle section of the cylindrical area, and the surroundings of the film are sewn together using a sewing process. Suture with the cylindrical area to form a partition.

Then prepare a circular membrane that is suitable for the cross-sectional effective area of a size and disc-shaped area, denoted as the third membrane 33, this membrane is embedded in the middle section of the disc-shaped area, and the surroundings of the film are embeded using a sewing process. Suture with the disc to form a partition.

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. Moreover, the specific shape of the braided body meets the need for occlusion of the aortic valve, and it swings together with the aortic valve, with a high degree of coincidence and less thrombus.

In the process of using metal wire to weave braids, depending on the selection of the process, it is usually possible to form a style that is closed at one end, as shown in the figure, or a style that is closed at both ends, as shown in Figure 11. , that is, another closing structure 5 of a braided body is at the center of the arc-shaped area. 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.

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 (8)

1. a rupture of aortic sinusal aneurysm plugging device, including knitted body and film, described knitted body main body is one-time formed through braiding and setting process with wire, and described film is medical macromolecule membrane, it is characterised in that

Described knitted body includes arc-shaped district, cylindric district and discoid district, and the described radian in arc-shaped district matches with the radian of aorta petal to be repaired, size aspect should meet: stretching out 3 millimeters to 4 millimeters Zi the outer in cylindric district forms the edge in arc-shaped district, and described edge is also continuous and has certain radian；

Cylindric district, cylindrical shape for a diameter hollow between 4 millimeters to 20 millimeters, and and arc-shaped district and discoid district between seamlessly transit and continued presence, in strength character, described cylindric district has own clamping force and the performance of the shape that remains unchanged for a long period of time supporting aorta petal breakage；In a thickness direction, the thickness in described cylindric district is between 2.5 millimeters to 4 millimeters；

Discoid district, described discoid district is the tabular of a circle, and the outer radius from cylindric district stretches out 0.5 millimeter to 2 millimeters；

It is positioned at the centre in described discoid district at the closing in of described knitted body and caves inward, and by the way of extruded or welding fabrication, fixing one at described recess there is externally threaded threaded post；

One film launched is set respectively in the internal cavities in described arc-shaped district, cylindric district and discoid district, and the surrounding of each film carries out stitching with knitted body and is connected to form one.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that described film is high-molecular polyvinyl alcohol film conventional in medical treatment or macromolecule silica gel thin film.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that described film should sufficiently launch, flatten, and does not allow phenomenon superposition, fold occur.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that described threaded post is the alloy body identical with knitted body material, and described threaded post be in be trapped in the inside of whole plugging device.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that the wire that described knitted body uses be nitinol or other there is the alloy threadlet of memory function.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that at another closing-in structure that the center in described arc-shaped district is described knitted body.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that the arc area in described arc-shaped district is the continuous weaving structure without closing up.

A kind of rupture of aortic sinusal aneurysm plugging device the most according to claim 1, it is characterised in that described knitted body is formed by 72 one metal wire braidings.