CN204971420U - Patent blocking device for arterial duct - Google Patents

Abstract

The utility model provides an occluder for a patent ductus arteriosus, which comprises an occluder body woven from nickel-titanium alloy wires, and is characterized in that the occluder body includes first The disc-shaped covering part, the first supporting waist, the second supporting waist and the opening part, the upper end of the first disc-shaped covering part is ligated by a ligating steel sleeve; or, the occluder body includes the second A disc-shaped covering part, a first supporting waist, a second supporting waist, a third supporting waist and a second disc-shaped covering part, the upper end of the first disc-shaped covering part is ligated by a ligature steel sleeve, and the lower end of the second disc-shaped covering part Ligated by ligature steel sleeve. The utility model is a hollow structure with openings at both ends, through which a guide wire can pass, and can be transported to a lesion position along the guide wire in the sealing treatment of patent ductus arteriosus and paravalvular leakage.

Description

patent ductus arteriosus occluder

technical field

The utility model relates to a patent ductus arteriosus occluder, which is suitable for the patent ductus arteriosus disease in congenital heart disease, and is also suitable for a series of diseases requiring sealing treatment such as vascular fistula and paravalvular leakage.

Background technique

Congenital heart disease is a common congenital malformation of blood vessels/heart septum, resulting in abnormal cardiovascular structure and function. There are nearly 150,000 new cases in my country every year.

The current treatment methods for congenital heart disease mainly include surgery and interventional therapy. Since 2000, interventional therapy has developed rapidly due to its outstanding advantages of small trauma, quick recovery, easy operation, and good safety. Heart defect occluder is a percutaneous, transcatheter implanted non-surgical medical device for the treatment of congenital heart disease. The device is a self-expanding double-disc structure. The two discs are connected by a short waist, roughly forming a dumbbell-shaped structure. The diameter of the short waist matches the size of the defect. The two discs and the waist are sutured with a flow-blocking membrane to prevent blood shunting. And conducive to the growth of endocardial tissue. When the heart defect occluder is delivered to the defect site through the catheter, the heart defect occluder automatically rebounds into a double disc structure, and the two disc structures cover the tissue around the two side walls of the defect site, and at the same time clamp and fix the heart Defect occluder. The waist is stuffed in the heart defect, and the blocking membrane is used to block the blood shunt, so as to seal the defect, improve hemodynamics, and achieve the therapeutic effect.

For the treatment of congenital heart disease, there is a clinical trend of younger treatment, that is, early treatment in early childhood. This is related to the pathogenesis of congenital heart disease. If the treatment is delayed, there is a great risk of "children's easy-to-treat disease, young people's difficult-to-treat disease, and middle-aged and elderly people's incurable disease". However, due to the limitation of the device itself, the conventional design occluder on the market, that is, the occluder with a flow-blocking diaphragm, cannot pass through a thinner sheath tube, and the use of a conventional thick sheath tube will damage the blood vessels and heart of children, so it must not be used. Do not delay treatment, wait for the child to grow up before treatment, which increases the difficulty of the operation and reduces the quality of life of the child.

Contents of the invention

The purpose of the utility model is to provide a patent ductus arteriosus occluder which is convenient for delivery.

In order to achieve the above purpose, the utility model provides a patent ductus arteriosus occluder, which includes an occluder body braided by nickel-titanium alloy wires, and is characterized in that the occluder body includes a top-to-bottom The first disc-shaped covering part, the first supporting waist, the second supporting waist and the opening part are arranged in sequence, and the upper end of the first disc-shaped covering part is ligated by a ligature steel sleeve; or, the occluder body includes from top to bottom The first disc-shaped covering part, the first supporting waist, the second supporting waist, the third supporting waist and the second disc-shaped covering part arranged in sequence, the upper end of the first disc-shaped covering part is ligated by a ligature steel sleeve, and the second disc The lower end of the shaped covering part is ligated by a ligature steel sleeve.

Preferably, the ligating steel sheath is provided with an internal thread, which can be threadedly connected with the head end of the delivery rod.

Preferably, when the occluder body includes the first disc-shaped covering part, the first supporting waist, the second supporting waist and the opening part arranged sequentially from top to bottom, the largest outer diameter of the first supporting waist The diameter is smaller than the maximum outer diameter of the second supporting waist; when the occluder body includes the first disc-shaped covering part, the first supporting waist, the second supporting waist, the third supporting waist and the second supporting waist arranged sequentially from top to bottom For two disc-shaped covering parts, the maximum outer diameter of the first support waist and the maximum outer diameter of the third support waist are smaller than the maximum outer diameter of the second support waist.

Preferably, when the occluder body includes a first disc-shaped covering part, a first support waist, a second support waist and an opening part arranged in sequence from top to bottom, the occluder body is fixedly connected to 2 - 4 polymer blocking films or 2-4 occlusion nets; when the occluder body includes a first disc-shaped covering part, a first support waist, a second support waist, When the third support waist and the second disc-shaped covering part, the occluder body is fixedly connected with 3-5 polymer blocking films or 3-5 occlusion nets.

More preferably, the polymer blocking membrane or the occluding mesh are all arranged inside the occluder body, or at least one polymer blocking membrane or occluding mesh is arranged in the occluder outside of the body.

Preferably, at least a part of the occluder body constitutes an occlusion net, or, the occluder body is fixedly connected to an occlusion net braided by nickel-titanium alloy wires; wherein, the pores of the occlusion net The rate is 20%-50%, and the aperture is 0.02mm-0.20mm.

More preferably, the blocking net is composed of 36-72 heart-shaped units or willow-shaped units.

More preferably, the blocking net is a single-layer or double-layer structure.

More preferably, the diameter of the nickel-titanium alloy wire is 0.03mm-0.16mm.

More preferably, the blocking mesh is supported by a stent composed of 1 or 3-6 thicker nickel-titanium alloy wires, and the diameter of the thicker nickel-titanium alloy wires is 0.10mm-0.80mm.

More preferably, the edge of the occlusion mesh is close to the side wall of the heart defect.

Compared with the prior art, the beneficial effects of the utility model are:

1. Because the inner core of the ligation steel sheath is hollow, the utility model has a hollow structure with openings at both ends, and the guide wire can pass through. In the sealing treatment of patent ductus arteriosus and paravalvular leakage, it can be transported to the lesion along the guide wire Location.

2. The disk surface of the utility model can rotate stably, and the fit is more stable;

3. Due to the specific porosity and pore diameter of the blocking net of the present invention, it has a large surface tension, which can achieve the effect of blocking blood flow, and the blocking effect is good;

4. When the utility model is completely made of nickel-titanium alloy wire, it can pass through a smaller sheath, and at the same time, it is easier to pass the sheath and less damage to blood vessels, so it is suitable for young children;

5. The utility model is easy to operate and can be delivered bidirectionally from arteries and veins.

Description of drawings

Fig. 1 is the structural representation of the patent ductus arteriosus occluder in embodiment 1;

Fig. 2 is the top view of the first NiTi alloy plugging net;

Fig. 3 is the top view of the repeating unit of the first NiTi alloy plugging net;

Fig. 4 is the top view of the second kind of NiTi alloy plugging net;

Fig. 5 is the top view of the repeating unit of the second NiTi alloy plugging net;

Figure 6 is a schematic diagram of the structure of a double-layer NiTi alloy plugging network;

7 is a schematic diagram of the use of the patent ductus arteriosus occluder in Example 1;

Figure 8 is an enlarged view of the ligation steel sleeve in Figure 1;

Figure 9a is a schematic structural view of the patent ductus arteriosus occluder in Example 4;

Figure 9b is a top view of the patent ductus arteriosus occluder in Example 4;

Figure 10a is a schematic structural view of the patent ductus arteriosus occluder in Example 5;

Fig. 10b is a top view of the patent ductus arteriosus occluder in Example 5.

detailed description

Below in conjunction with specific embodiment, further set forth the utility model. It should be understood that these embodiments are only used to illustrate the present utility model and are not intended to limit the scope of the present utility model. In addition, it should be understood that after reading the content taught by the utility model, those skilled in the art can make various changes or modifications to the utility model, and these equivalent forms also fall within the scope defined by the appended claims of the application.

Example 1

As shown in Figure 1 , the patent ductus arteriosus occluder in this embodiment includes an occluder body 1 braided by nickel-titanium alloy wires with a diameter of 16 mm, and the occluder body 1 is composed of top to bottom The first disc-shaped covering part 12 , the first supporting waist part 13 , the second supporting waist part 14 and the opening part 15 are arranged successively. The maximum outer diameter of the first supporting waist portion 13 is smaller than the maximum outer diameter of the second supporting waist portion 14 . The occluder body 1 is sewn and fixedly connected with two occluder meshes 2 woven with 10mm diameter nickel-titanium alloy wires through polyester thread. The occlusion nets 2 are all arranged inside the occluder body 1 . As shown in Figure 2, the blocking net 2 is a single-layer structure composed of a plurality of heart-shaped units as shown in Figure 3, with a porosity of 30% and a pore diameter of 0.05mm-0.09mm. The edge of the occlusion net 2 is close to the side wall of the heart defect, and the blood flow of the defect is blocked by the occlusion net 2 . The ligature steel sleeve 11 is provided with an internal thread, which can be threadedly connected with the head end of the delivery rod.

As shown in FIG. 8 , the ligation steel sheath 11 is fixed to gather the nickel-titanium alloy wire, and the nickel-titanium alloy wire is sandwiched between the inner and outer steel sheaths. The second support waist 14 plays a main supporting role, and it can be stretched and compressed in both axial and radial directions. At the defect position, the second support waist 14 is supported on the defect wall and is compressed in the radial direction. The first disc-shaped covering The part 12 covers the surrounding tissue of the defect, and the first supporting waist 13 is retracted radially to the inside of the second supporting waist 14, and at the same time supports externally, and further radial fixation is achieved by pressing the second supporting waist 14 outward. At the same time, the first supporting waist 13 The supporting waist 13 can ensure that the first disc-shaped covering part 12 can rotate stably within a certain angle, adapting to different tissue shapes around the defect.

When in use, the occluder of the present utility model is sent into the defect position through the delivery sheath, and the product is released, and the occluder is fixed at the defect position. When fully released, as shown in Figure 7, the opening part 15 is everted, and the opening The joint 18 of the part 15 and the second supporting waist 14 is narrowed and closed, and at the same time, the blocking net 2 starts to block the work. Through the large surface tension, the blood shunt is blocked, thereby blocking the defect and improving hemodynamics. So as to achieve the therapeutic effect.

Example 2

Similar to Example 1, the difference is that the structure of the blocking net is as shown in Figure 4, and the blocking net 2 is a single-layer structure composed of a plurality of willow-shaped units as shown in Figure 5, Its porosity is 40%, and the pore diameter is 0.07mm-0.13mm.

Its method of use is the same as in Example 1.

Example 3

Similar to Example 1, the difference is that the structure of the blocking mesh is shown in Figure 6, and the blocking mesh 2 is a double-layer structure with a porosity of 20% and a pore diameter of 0.03mm-0.06mm.

Its method of use is the same as in Example 1.

Example 4

As shown in Figures 9a and 9b, the patent ductus arteriosus occluder in this embodiment includes an occluder body 1 braided by a nickel-titanium alloy wire with a diameter of 12mm, and the occluder body 1 is made of The first disc-shaped covering part 12, the first supporting waist part 13, the second supporting waist part 14, the third supporting waist part 16 and the second disc-shaped covering part 17 arranged in sequence from top to bottom are composed of the upper end of the first disc-shaped covering part 12 The lower end of the second disk-shaped covering portion 17 is ligated by the ligating steel sheath 11 . Both the maximum outer diameter of the first support waist portion 13 and the maximum outer diameter of the third support waist portion 16 are smaller than the maximum outer diameter of the second support waist portion 14 . The occluder body 1 is fixedly connected with three occlusion meshes 2 braided by nickel-titanium alloy wires with a diameter of 8 mm. The occlusion nets 2 are all arranged inside the occluder body 1 . As shown in Figure 2, the blocking net 2 is a single-layer structure composed of a plurality of heart-shaped units as shown in Figure 3, with a porosity of 30% and a pore diameter of 0.05mm-0.09mm. The edge of the occlusion net 2 is close to the side wall of the heart defect, and the blood flow of the defect is blocked by the occlusion net 2 . The ligature steel sleeve 11 is provided with an internal thread, which can be threadedly connected with the head end of the delivery rod.

When in use, the occluder of the present utility model is sent to the defect position through the delivery sheath, the product is released, the occluder is fixed at the defect position, and the occluder net 2 starts to block at the same time, through the larger surface tension, To block the blood shunt, so as to seal the defect, improve the hemodynamics, and achieve the therapeutic effect.

Example 5

As shown in Figure 10b, the patent ductus arteriosus occluder in this embodiment is similar to Embodiment 9, the difference is that the occluder body 1 integrally forms a occlusion net 2, wherein the occluder The porosity of the net 2 is 50%, and the pore diameter is 0.09mm-0.15mm. As shown in Fig. 10a, the blocking mesh 2 is supported by a support 3 composed of a thicker nickel-titanium alloy wire, and the diameter of the thicker nickel-titanium alloy wire is 0.16 mm.

Its use method is the same as that of Embodiment 1, and the support 3 made of the thicker nickel-titanium alloy wire plays the role of support and fixation.

Claims (10)

1. A patent ductus arteriosus occluder, comprising an occluder body (1) braided by nickel-titanium alloy wire, characterized in that, the described occluder body (1) includes sequentially arranged from top to bottom The first disc-shaped covering part (12), the first supporting waist (13), the second supporting waist (14) and the opening part (15), the upper end of the first disc-shaped covering part (12) passes through the ligature steel sleeve (11 ) ligation; or, the occluder body (1) includes a first disc-shaped covering part (12), a first supporting waist (13), a second supporting waist (14), a second supporting waist (14), and Three supports the waist (16) and the second disc-shaped covering part (17), the upper end of the first disc-shaped covering part (12) is ligated by a ligature steel sleeve (11), and the lower end of the second disc-shaped covering part (17) is ligated Steel sleeve (11) is ligated. 2 . The patent ductus arteriosus occluder according to claim 1 , characterized in that, the ligation steel sleeve ( 11 ) is provided with an internal thread, which can be threadedly connected to the head end of the delivery rod. 3 . 3. The patent ductus arteriosus occluder according to claim 1, characterized in that, when the occluder body (1) comprises a first disc-shaped covering part (12), which is sequentially arranged from top to bottom, When the first support waist (13), the second support waist (14) and the opening part (15), the maximum outer diameter of the first support waist (13) is smaller than the maximum outer diameter of the second support waist (14); When the occluder body (1) includes a first disc-shaped covering part (12), a first support waist part (13), a second support waist part (14), and a third support waist part ( 16) and the second disc-shaped covering part (17), the maximum outer diameter of the first support waist (13) and the maximum outer diameter of the third support waist (16) are smaller than the second support waist ( 14) The maximum outer diameter. 4. The patent ductus arteriosus occluder according to claim 1, characterized in that, when the occluder body (1) comprises a first disc-shaped covering part (12) arranged sequentially from top to bottom, When the first support waist (13), the second support waist (14) and the opening part (15), the occluder body (1) is fixedly connected with 2-4 polymer blocking films or 2-4 sealing Blocking the net (2); when the occluder body (1) includes a first disc-shaped covering part (12), a first support waist (13), and a second support waist (14) arranged in sequence from top to bottom 1. When the third support waist (16) and the second disc-shaped covering part (17), the occluder body (1) is fixedly connected with 3-5 polymer blocking films or 3-5 occlusion nets ( 2). 5. The patent ductus arteriosus occluder as claimed in claim 1, characterized in that at least a part of said occluder body constitutes a occluder net (2), or, said occluder body (1 ) is fixedly connected with a plugging net (2) braided by nickel-titanium alloy wires; wherein, the porosity of the plugging net (2) is 20%-50%, and the aperture is 0.02mm-0.20mm. 6. The patent ductus arteriosus occluder according to claim 5, characterized in that, the occlusion net (2) is composed of 36-72 heart-shaped units or willow-shaped units. 7. The patent ductus arteriosus occluder according to claim 5, characterized in that, said occlusion net (2) is a single-layer or double-layer structure. 8. The patent ductus arteriosus occluder according to claim 5, wherein the diameter of the nickel-titanium alloy wire is 0.03mm-0.16mm. 9. The patent ductus arteriosus occluder as claimed in claim 5, wherein the occluder net is supported by a stent (3) composed of 1 or 3-6 thicker nickel-titanium alloy wires, The diameter of the thicker nickel-titanium alloy wire is 0.10mm-0.80mm. 10. The patent ductus arteriosus occluder according to claim 5, characterized in that, the edge of the occluder net (2) is close to the side wall of the heart defect.