KR20010046155A - A Device for Closing the Loss part of Heart and An Operating Method - Google Patents

Abstract

PURPOSE: Disclosed are an apparatus for closing cardiovascular system damage and method for operating heart vascular system damage to residual shunt ratio without damage of heart limbus tissue, to increase transcatheter atresia remedial effect of atrial septal defect(ASD). CONSTITUTION: The apparatus for closing cardiovascular system damage consists of one support part(10) to be formed of numerous support rib(11) with radial shape and have elasticity for other direction; other support part(20) to be formed of numerous support rib(21) with radial shape identical with symmetry direction to be supported on the one support part(10); one film part(30) and other film part(40) to be sticked to the inside of the one support part(10) and other support part(20), to be formed of waterproof thin film.

Description

A device for closing the loss part of heart and an operating method

The present invention can reduce the remaining short-circuit rate after the procedure without damaging the surrounding tissues of the heart and can facilitate the procedure, excellent durability and cardiovascular defect closure mechanisms and procedures that can increase the treatment effect of mild tube closure of atrial septal defect It is about a method.

With the development of medicine, diseases that have been extensively incised and treated through previous surgical procedures are gradually being treated in a simple manner by non-invasive techniques. This has a great response to patients by minimizing post-surgery as well as shortening hospitalization period, reducing blood transfusion, and reducing medical expenses while giving treatment effects comparable to existing methods. This non-invasive mini-incision has been developed because of the development of new medical materials and medical engineering.

Atrial septal defect (ASD) is the third most common congenital heart malformation after ventricular septal defect and arterial patency. This disease should prevent atrial septal defects by surgery if the left and right short-circuit rate of the blood flow is more than 1.5 or paradoxical embolism occurs. Surgical treatment of atrial septal defect is safe in cardiac surgery. Surgical mortality is less than 1%, but the cosmetic and psychological consequences of surgical incisions are large, and the mental burden on patients and their families before and after surgery is very high. Surgical treatment usually requires a hospital stay of 6-8 days, followed by general anesthesia, extracorporeal circulation, and postoperative recovery in isolation from the intensive care unit. These processes are all accompanied by the risk of complications and the cost of treatment.

In order to avoid the above-mentioned problems associated with surgery, King and Raskind of the United States invented the instrument in the early 1970's, placing a catheter in the femoral vein and placing it in the heart, and then atrial septal defect. The method of closing over began. Early instruments had many problems, and the results were not good. Later, King and Raskin improved the instruments. The improved Double-Umbrella Device (Clamshell Device) can be delivered into the heart with a delivery sheath of 11 Fr. (1 Fr ≒ 0.3 mm) thick. However, this is too large to be used in infants and children weighing less than 10Kg, the patient should be selected. The Buttoned Double-Disc Device, developed in the late 1980s by Sideris et al., Has become so small that 8Fr. A thick delivery conduit allows delivery into the heart.

However, when reviewing the treatment result paper by Clamshell Device or Buttoned Device, there are largely the following problems. First, the left and right paragraphs continue after the procedure. Although there are differences among the researchers' reports, there are many left and right short-circuits shortly after the procedure, but gradually closes with time. Is being reported. Second is the mechanical deficiency of the apparatus. In the case of clamshell devices, there are reports of fractures of Umbrella's support, and it increases with time after the procedure. 7-10% of buttoned devices release buttons that combine two discs, some of which may require emergency surgery as the instrument is displaced to another location. Third, the application of the procedure is limited. Longitudinal septal defect closure was considered inadequate when the atrial septal diameter was more than 25 mm or the atrial size was small, the atrial septal defect was inadequate, and the multiple defects were multiple. In addition, there are many problems of existing instruments, such as hemolysis by instruments, difficulty in removing the canal of wrongly positioned instruments.

Accordingly, it is an object of the present invention to provide a cardiovascular defect closure mechanism and procedure that can facilitate the procedure without damaging the surrounding tissues of the heart and can enhance the effect of treating the aluminal septal defect in the mild tube.

Another object of the present invention is to provide a cardiovascular defect closure mechanism and a method for lowering residual short-circuit rate after an operation, having excellent durability, and capable of permanently and safely closing a defect site.

It is still another object of the present invention to provide a cardiovascular defect closure mechanism and a method for positioning the closure mechanism in the exact center of the atrial septal defect site.

1 is a perspective view of a closed state of the closing mechanism according to the present invention

Figure 2 is a perspective view of the expanded state of the closure mechanism according to the invention

Figure 3 is a cross-sectional view of the expanded state of the closure mechanism according to the invention

4 is a perspective view showing a state of use of the closing mechanism according to the present invention

5 is a cross-sectional view of a first use state of the closing mechanism according to the present invention;

6 is a cross-sectional view of a second use state of the closing mechanism according to the present invention;

7a to 7d is an exemplary view showing a heart treatment step in the present invention

8a to 8c is an exemplary view showing a heart treatment step in the present invention

[Explanation of symbols on the main parts of the drawings]

1: closed mechanism 10,20: day, other side support

11,21: support 30, 40: day, other side

50: delivery conduit 51: tube portion

52: expansion and contraction part 53: pusher part

60: heart tissue 61: defect site

Cardiovascular defect closure mechanism of the present invention for achieving the above object is a plurality of support teeth radially and one side support having elasticity in the other direction, and a plurality of support in the direction supported and symmetrical to the one support It is composed of the other side support portion made of the same radial shape and elastic in one direction, and the one side membrane portion and the other side membrane portion formed of the waterproof thin film and respectively attached to the inside of the one side support and the other side support portion It is thought.

Hereinafter, the present invention will be described in more detail with reference to exemplary embodiments shown in the accompanying drawings.

In the embodiment of the present invention, as shown in Figures 1 to 3, a plurality of support teeth (11) made of a radial shape and elastic in the other direction and the one side support portion 10, the one side support portion is supported and symmetrical Attached to the inside of the other side support portion 20 and the one side support portion 10 and the other side support 20 made of the same radial shape and a plurality of elastic in one direction in the direction of being And it is to implement the basic technical idea of the present invention in that it has one side membrane portion 30 and the other side membrane portion 40 made of a thin waterproof film.

When the present invention is produced as a product, as shown in Figure 1, the other side is provided with a high elasticity and the volume is minimized to each other is inserted into the tip of the delivery conduit 50 of the small diameter ( 7a). In use, as shown in FIGS. 3 and 4, the other side support parts 10 and 20 are unfolded in the form of radiation in a direction facing each other by high elasticity and the other side membrane parts 30 and 40 fixed inside the support parts are Spread in a round circle shape to close the defect (61).

Here, one, the other side support (10, 20) is composed of a plurality of supports (11, 21) having a high elasticity to support the function of the tissue 60 of the heart defect site 61 on both sides. do. Such support is bent into a single metal wire extending integrally to make a plurality of support (11, 21) made of a superelastic metal or polymer with biocompatibility. One of the reasons for bending the other side support part into a single metal wire is integrated to prevent side effects of the structural part being separated from the body.

The other side membrane portion 30 and 40 may block blood with a thin film and is made of a synthetic resin material having human compatibility. The other side membrane portions 30 and 40 are respectively fixed to the inside of both support portions 10 and 20 to function to close the defect portions 61 on both sides of the defect portion in the heart. The cells grow easily in the body, and the membrane is secondary fixed by the tissue reaction of the endocardium, so that the defect 61 is permanently closed.

The structure for closing the defective portion 61 with the closure mechanism of the present invention implemented as described above can be largely classified into two types. First, as shown in Figure 5, the other side of the support (11, 21) is bent to some extent in the direction facing each other so that the force is concentrated at the end. This has the advantage that the membranes 30 and 40 are firmly attached to the tissue 60 because the force is concentrated in one place. On the other hand, the support ribs 11, 21 are bent, but the support rods 11, 21 on the other side can be arranged to be staggered with each other and can be arranged to match each other.

Second, as shown in Fig. 6, the other side supporters 11 and 21 are straightened in a straight line with each other so that the force is evenly distributed throughout. This allows the force to be evenly distributed throughout the support, thus preventing local damage to the membrane. On the other hand, as described above, the support teeth (11, 21) is unfolded in a straight straight line, but the support teeth on the other side can be arranged to be staggered with each other and can be arranged to match each other.

For reference, the diameter of the other side membrane portion 30, 40 is preferably made to be 1.6-2.0 times larger than the diameter of the defective portion 61.

Hereinafter, the method of closing the atrial septal defect 61 with the closure mechanism of the present invention will be described in detail.

First, as shown in Figure 7a, the closing mechanism (1) of the present invention is minimized and inserted into the end of the delivery conduit (50). The delivery conduit 50 into which the closure mechanism 1 is inserted reaches the defect 61 of the heart through the patient's femoral vein (see FIG. 8A).

Second, as shown in FIG. 7B, the air is injected through the injection passage of the delivery conduit 50 to expand and contract the expansion and contraction portion 52 so that the delivery conduit 50 is precisely aligned with the center of the missing portion 61 (see FIG. 8B). ). When the expansion and contraction portion 52 is expanded, the outer circumferential surface is in contact with the tissue 60 of the defect site 61, so that the delivery conduit is naturally located at the center. The reason why the delivery conduit 50 is located at the center of the defect site is that the circumferential edge portion is completely supported by the heart tissue 60 when the other side membrane parts 30 and 40 are radially deployed. 61) so that it can be completely closed. At this time, the expansion material of the expansion unit 52 may be filled through the injection passage with a syringe, etc., the expansion material may be selected from the air or liquid medicine.

Third, as shown in Figure 7c, by pushing the rod 53, one side half of the closing mechanism (1) is extruded to the outside of the delivery conduit (50). One side membrane portion 30 of the closure mechanism is then unfolded and supported on one side of cardiac tissue 60 (see FIG. 8C).

Fourth, as shown in Fig. 7d, the delivery conduit 50 is retracted in the state in which the pusher 53 is fixed, thereby completely extruding the other side of the closure mechanism to the outside of the delivery conduit 50. Then, the other side membrane portion 40 of the closure mechanism is unfolded and supported on the other side of the heart tissue 60 to completely close the defective portion 61 (see FIG. 8C). The treatment is completed by completely removing air from the expansion and contraction portion 52 of the delivery conduit 50 and then separating it from the patient's body.

On the other hand, the delivery conduit 50 used in the present invention, as shown in Figure 7a to 7d, a flexible tube having an injection passage and a long, made of a flexible material on the outer peripheral surface of the front end of the tube portion and the injection passage Illustrates that it consists of a thin and stretched portion 52 of the thin film that is connected to and a pusher 53 inserted into the tube portion.

In addition, it is possible to know the size of the missing portion 61 with the amount of expansion material injected into the elastic portion 52. That is, the syringe 52 is provided with a measuring sensor and a measuring means for measuring the amount of the inflation material injected into the elastic portion is detected when the elastic portion 52 is inflated to contact the missing portion 61. Thus, the expansion material is injected into the stretch until the detection sensor is displayed. When the injection amount at the time indicated on the sensor is measured by the measuring means, the expanded size of the stretchable part can be known, and the expanded size is proportional to the size of the defective part. Therefore, knowing the size of the missing part can determine whether or not the size of the closure mechanism is properly used.

As described above, the closure mechanism of the present invention facilitates the procedure without damaging the surrounding tissues of the heart by attaching the other side membrane part between the one side in which the plurality of support teeth are radially unfolded and the other side between the other support parts. It has the effect of increasing the treatment effect of longitudinal tube obstruction of atrial septal defect,

The other side membrane part easily grows the cells in the body, so that the membrane is secondary fixation by the endocardial tissue reaction, the defect site is permanently closed and lowers the remaining short-circuit rate after the procedure and has excellent durability. ,

Inserting the closing mechanism (1) at the distal end of the delivery conduit and installing the expansion and contraction (52) on the outer peripheral surface of the distal end of the delivery conduit to inflate inflation material, the main closure mechanism (1) in the center of the heart defect 61 It has the effect of positioning it correctly.

Claims (5)

The plurality of support arms 11 are formed in the same radial shape with one side support 10 having a radial shape and elastic in the other direction, and a plurality of support arms 21 in a direction that is supported and symmetrical to the one support. One side membrane portion 30 and the other side membrane portion 40, each of which is formed of a waterproof thin film, which is attached to the inside of the other side support portion 20 and the one side support portion 10 and the other side support portion 20, respectively. Cardiovascular defect closure mechanism, characterized in that consisting of. The method of claim 1, wherein the one side support (10) and the other support (20) is a cardiovascular defect closure mechanism, characterized in that made by bending one metal wire extending integrally. According to claim 1, The one side support portion 10 and the other side support portion 20 cardiovascular defect closure mechanism, characterized in that the unfolding in a curved form to some extent in the opposite direction to each other. The method of claim 1, wherein the one side support (10) and the other side support (20) is a cardiovascular defect closure mechanism, characterized in that each of the straight straight. a) minimizing the closing mechanism (1) to the end of the delivery conduit (50) to reach the defect (61) of the heart through the patient's femoral vein; b) expanding the elastic portion 52 through the injection passage of the delivery conduit 50 to accurately position the leading end of the delivery conduit 50 in the center of the defect region 61 of the heart; c) extruding one side membrane portion 30 of the closing mechanism 1 by pushing the pusher 53 of the delivery conduit to the outside of the delivery conduit to support one side of the cardiac tissue 60; d) Cardiovascular defect treatment method characterized in that the step of extruding the other side membrane portion 40 of the closure mechanism to the outside of the delivery conduit to support the other side of the cardiac tissue (60) to completely close the defect (61).