WO2008019590A1

WO2008019590A1 - Cardiac defect occlusion device

Info

Publication number: WO2008019590A1
Application number: PCT/CN2007/002372
Authority: WO
Inventors: Shixian Zang; Yuehui Xie
Original assignee: Lifetech Scientific (Shenzhen) Co., Ltd
Priority date: 2006-08-08
Filing date: 2007-08-08
Publication date: 2008-02-21
Also published as: CN101120893A; CN101120893B

Abstract

A cardiac defect occlusion device includes a metal support mesh (1) formed with a first nosetip and a second nosetip, a first end closure (4), and a second end closure (5). The first end closure (4) encloses the first nosetip of the metal support mesh (1), and forms a first end face (2) with the metal support mesh (1). The second end closure (5) encloses the second nosetip of the metal support mesh (1), and forms a second end face (3) with the metal support mesh (1). The first end closure (4) sinks toward the cavity of the metal support mesh (1) from the first end face (2).

Description

Heart defect occluder

Technical field

The present invention relates to the field of medical devices, and more particularly to a heart defect occluder for treating a heart defect. Background technique

Existing cardiac defect occluders are delivered to the patient's heart through a femoral or jugular vein through a femoral vein or jugular vein.

Figure 1A shows a cross-sectional porch diagram of a heart defect occluder for patent foramen ovale (PFO), and Figure 1B shows a heart defect occluder for patent ductus arteriosus (PDA). Sectional profile of Figure 1, Figure 1C shows a cross-sectional view of the heart defect occluder for ventricular septal defect (VSD.), and Figure 1D shows the heart defect seal for atrial septal defect (ASD) Profile view of the plug. These cardiac defect occluders generally include a metal support mesh 1, a first head 4 and a second head 5 having a predetermined shape; wherein the first head 4 and the metal support mesh 1 form a first end face 2, second The head 5 and the metal support mesh 1 form a second end face 3, and the inside of the metal support mesh 1 is provided with a choke film (not shown).

Figure 1E shows a schematic view of a portion of a prior art cardiac defect occluder that releases a sheath. When working, the orbital vein to the interventricular septum is established in the groin, and the sheath 8 is inserted through the orbit, and the metal support mesh 1 is elongated and placed in the sheath 8 and delivered to the heart defect of the patient through the transport cable 9. . The first end face 2 (not shown) of the cardiac defect occluder is released at one end of the heart defect, and the second end face 3 (not shown) is released at the other end of the defect, and the heart defect is closed. Thereby achieving the function of sealing. This heart defect occluder has the characteristics of easy recycling and self-centering. However, the first head 4 and the second head 5 of the metal support mesh 1 protrude outside the metal support mesh 1, the first end face 2 and the second end face 3, as shown in Fig. 1F. Due to the prominent feature of the existing heart defect occluder releasing the sheath, the first head 4 may touch or damage the surrounding tissue, and at the same time affect the flow of arterial blood, causing serious injury; and, in practice, It was found that the clumping of the body tissues of the first head 4 and the second head was significantly slower than the plane of the heart defect occluder.

Summary of the invention

To this end, the present invention provides a heart defect occluder that addresses at least one of the drawbacks of the prior art.

A heart defect occluder comprising a metal support mesh formed with a first end and a second end; and a first head enclosing the first end of the metal support mesh and the metal support mesh Forming a first end surface; a second head enclosing the second end of the metal support mesh, and the metal The support mesh forms a second end surface; the first head sinks toward the inner cavity of the metal support mesh on the first end face.

Preferably, the outer surface of the first end surface is approximately planar.

In a specific embodiment of the invention, the outer surface of the first end surface may be provided with at least one first flow blocking film.

In a particular embodiment of the invention, the second head can sink into the interior of the metal support mesh on the second end face.

In another embodiment of the invention, at least one pull wire may be disposed between the first and second heads.

Preferably, the outer surface of the second end face is designed to be approximately planar.

According to the invention, the outer surface of the two end faces of the crucible may be provided with at least one second choke film.

Since the first head of the present invention is sunk inside the heart defect occluder, the one end surface of the iliac crest can form a relatively flat approximation plane without the head, which not only removes the damage of the first head touching the surrounding tissue of the heart. It also reduces the impact of the first head on blood flow, reduces the risk of thrombosis, and creates conditions for the outflow of the baffle. In addition, because the first head is sunk inside the metal support net, it does not touch the surrounding tissue, making the doctor safer and more reliable. DRAWINGS

1A is a cross-sectional profile view of a conventional cardiac defect occluder for patent foramen ovale; FIG. 1B is a cross-sectional profile view of a conventional cardiac defect occluder for patent ductus arteriosus; FIG. A cross-sectional profile of a cardiac defect occluder for ventricular septal defect; Figure 1D is a cross-sectional profile of a prior art cardiac occlusion occluder for atrial septal defect; Figure 1E is a prior art portion of a cardiac defect occluder a schematic diagram of releasing the sheath tube;

1F is a schematic view showing the protrusion of the head when the conventional heart defect occluder releases the sheath tube; FIG. 2A is a schematic view of the heart defect occluder for the patent foramen ovale according to the first embodiment of the present invention; A second embodiment of the present invention is a schematic diagram of a cardiac defect occluder for patent ductus arteriosus;

2C is a schematic view of a cardiac defect occluder for a ventricular septal defect according to a third embodiment of the present invention; FIG. 2D is a schematic view of a cardiac defect occluder for atrial septal defect according to a fourth embodiment of the present invention; A schematic view of the position of the first embodiment of the invention when the cardiac defect occluder is retracted into the sheath;

Figure 3B is a schematic view showing the position of the fully-retracted heart defect occluder into the sheath according to the first embodiment of the present invention;

4A is a schematic view showing a heart defect occluder of the third embodiment of the present invention pre-installed in a sheath tube; FIG. 4B is a schematic view showing the heart defect occluder of the third embodiment of the present invention in a left ventricle; 4C is a view showing a position of a first end surface of a heart defect occluder attached to a left ventricular wall according to a third embodiment of the present invention; FIG. 4D is a schematic view showing a position of a metal support mesh of a heart defect occluder embedded in a ventricular septal defect according to a third embodiment of the present invention;

4E is a schematic view showing the position of the heart defect occluder in the third embodiment of the present invention after being completely released and blocked at the ventricular septal defect;

Figure 5 is a schematic view showing the production of a cardiac defect occluder according to a first embodiment of the present invention;

In the following, the invention will be further elucidated with reference to the preferred embodiments shown in the drawings.

Fig. 2A shows a schematic view of a heart defect occluder for the patent foramen ovale in the first embodiment of the present invention. The cardiac defect occluder for the patent foramen ovale includes a metal support mesh 1 formed with a first end (not shown, the same below) and a second end (not shown, the same below), and a first head 4 and a second head 5, wherein the first head 4 closes the first end of the metal support mesh 1 and forms a first end face 2 with the metal support mesh 1; wherein the second head 5, closing the second end of the metal support mesh 1 and forming a second end face 3 with the metal support mesh 1; the first cover 4 on the first end face 2 toward the metal support mesh 1 The inner cavity is subsided. The metal supporting mesh 1 adopts a metal having a memory effect, and can be preset to have various shapes such as a column shape, a tubular shape, etc. according to actual needs; preferably, the metal supporting mesh 1 is made of a nickel-titanium alloy.

Figure 5 is a schematic view showing the production of a heart defect occluder in accordance with a first embodiment of the present invention. In production, the nickel-titanium alloy wire is first woven into a tubular metal support mesh 1, and then a length of a tubular metal support mesh 1 is taken, which is turned from the inside to the outside, so that the inner surface of the tubular metal support mesh 1 is on the eve Bu, the outer surface is included; the first head 4 is welded to one end of the tubular metal support net 1 to close one end of the metal support net 1; based on the welded metal support net 1, then from the inside to the outside Inverted so that the inner surface of the tubular metal support mesh 1 is inside and the outer surface is outside. After the inversion, the second head 5 is made to the other end of the tubular metal support net 1; t is connected early to form the metal support net 1 in a closed state; and the metal support net 1 forming the closed state is placed in a forming mold for heat treatment. It is shaped into the desired shape.

The first head 4 and the second head 5 described above may be formed into a closed state by welding, stamping or the like.

The above description is only a preferred embodiment of the present invention, and the production method of the cardiac defect occluder is not limited to this one method. The first head 4 is collapsed toward the inner cavity of the metal support mesh 1 on the first end face 2, so that the first end face 2 of the cardiac defect occluder and the first head 4 are in a shape of a bar. That is, the first head is reversely wrapped inside the metal support mesh 1 without protruding outside the first end face 2, so that the first end The outer surface of the face 2 forms a relatively flat, flat surface without a protruding head, which not only removes the hazard of the first head 4 touching the surrounding tissue of the heart, but also reduces the way of affecting blood flow and reduces the rate of thrombosis. .

As shown in Fig. 2A, a first baffle film 6 is disposed on the outer surface of the first end face 2; at the same time, at least one pull wire 7 of a corresponding length is connected between the first cap 4 and the second cap 5. 3A and 3B, when the heart defect occluder is pulled back to the sheath 8, the pull wire 7 causes the first end face 2 and the first baffle film 6 to be pulled back to the inner side of the metal support mesh 1, thereby making the outer casing The first flow blocking film 6 does not contact the inner wall of the sheath tube 8, so that the first flow blocking film 6 is not broken by the inner wall of the sheath tube 8.

Preferably, the cardiac defect occluder of the embodiment of the present invention can also use the second head 5 to sink toward the inner cavity of the metal support mesh 1 on the second end face 3, so that the second end face 3 of the cardiac defect occluder Between the second head 5 and the second head 5, the second head 5 is reversely wrapped inside the metal supporting net 1 (not shown), so that the outer surface of the second end surface 3 is approximately planar. At the same time, a second choke film (not shown) is disposed on the outer surface of the second end face 3. Fig. 2B is a view showing a second embodiment of the present invention for a cardiac defect occluder for patent ductus arteriosus. The cardiac defect occluder for patent ductus arteriosus includes a metal support mesh 1 formed with a first end and a second end, and a first head 4 and a second head 5, wherein the first seal The head 4 closes the first end of the metal support mesh 1 and forms a first end face 2 with the metal support mesh 1; wherein the second head 5 closes the second end of the metal support mesh 1, and Forming a second end face 3 with the metal support mesh 1; the first head 4 sinks onto the inner cavity of the metal support mesh 1 on the first end face 2.

Since the first head 4 is sunk inside the metal support mesh 1, the outer surface of the first end face 2 forms a relatively flat approximation plane without the protruding head, thereby removing the first head 4 from touching the inner periphery of the heart. The hazards of the tissue reduce the way in which blood flows, P > the rate of thrombosis.

Similarly, the second head 5 can also be sunk inside the metal support mesh 1 such that the outer surface of the second end face 3 forms a relatively flat, flat surface without a protruding head, thereby removing the second head 5 and touching the heart. The harm of the surrounding tissues reduces the way of affecting blood flow and reduces the rate of thrombosis formation.

In the cardiac defect occluder of the embodiment, the first end surface 2 has a first blocking film 6 disposed on the outer surface thereof; and at the same time, at least one wire of the corresponding length is connected between the first head 4 and the second head 5. 7. 3A and 3B, when the heart defect occluder is pulled back to the sheath 8, the pull wire 7 causes the first end face 2 and the first baffle film 6 to be pulled back to the inner side of the metal support mesh 1, thereby making the outer casing The first flow blocking film 6 does not contact the inner wall of the sheath tube 8, so that the first flow blocking film 6 is not broken by the inner wall of the sheath tube 8. 2C shows a cardiac defect occluder display for a ventricular septal defect according to a third embodiment of the present invention. Intention. The heart defect occluder for use in a ventricular septal defect includes a metal support mesh 1 formed with a first end and a second end, and a first head 4 and a second head 5, wherein the first head 4 Closing the first end of the metal support mesh 1 and forming a first end face 2 with the metal support mesh 1; wherein the second cover 5 closes the second end of the metal support mesh 1, and The metal support mesh 1 forms a second end face 3; the first head 4 sinks onto the inner cavity of the metal support mesh 1 on the first end face 2.

Since the first head 4 is sunk inside the metal support mesh 1, the outer surface of the first end face 2 forms a relatively flat approximation plane without the protruding head, thereby removing the first head 4 from touching the inner periphery of the heart. The hazards of the organization reduce the way in which blood flows and reduce the rate of blood test formation.

In the cardiac defect occluder of the present embodiment, the first end surface 2 is provided with a first blocking film 6 on the outer surface thereof; and at the same time, at least one pulling line 7 of a corresponding length is connected between the first head 4 and the second head 5. . 3A and 3B, when the heart defect occluder is pulled back to the sheath 8, the pull wire 7 causes the first end face 2 and the first baffle film 6 to be pulled back to the inner side of the metal support mesh 1, thereby making the outer casing The first flow blocking film 6 does not contact the inner wall of the sheath tube 8, so that the first flow blocking film 6 is not broken by the inner wall of the sheath tube 8. Fig. 2D shows a schematic view of a heart defect occluder for atrial septal defect in accordance with a fourth embodiment of the present invention. The cardiac defect occluder for atrial septal defect includes a metal support mesh 1 formed with a first end and a second end, and a first head 4 and a second head 5, wherein the first head 4 Closing the first end of the metal support mesh 1 and forming a first end face 2 with the metal support mesh 1; wherein the second cover 5 closes the second end of the metal support mesh 1, and The metal support mesh 1 forms a second end face 3; the first head 4 sinks onto the inner cavity of the metal support mesh 1 on the first end face 2.

Since the first head 4 is sunk inside the metal support mesh 1, the outer surface of the first end face 2 forms a relatively flat approximation plane without the protruding head, thereby removing the first head 4 from touching the inner periphery of the heart. Tissue hazards reduce the way blood flow is affected and reduce the rate of thrombosis.

In the cardiac defect occluder of the present embodiment, the first end surface 2 is provided with a first blocking film 6 on the outer surface thereof; and at the same time, at least one pulling line 7 of a corresponding length is connected between the first head 4 and the second head 5. . 3A and 3B, when the heart defect occluder is pulled back to the sheath 8, the pull wire 7 causes the first end face 2 and the first baffle film 6 to be pulled back to the inner side of the metal support mesh 1, thereby making the outer casing The first choke film 6 is not The inner wall of the sheath 8 is brought into contact so that the first baffle film 6 is not broken by the inner wall of the sheath 8. Since the first flow blocking film 6 of the technical solution of the above embodiment encloses the outer surface of the first end surface 2, it not only promotes the growth of the endothelium, reduces the formation rate of the thrombus, but also reduces the metal elements harmful to the human body. Translation. At the same time, the first head 4 is sunk inside the metal support mesh 1 so that the heart defect occluder does not touch the surrounding tissue, making the doctor more reliable to operate. In addition, since the second end face 3 is placed in the environment of venous blood, the second head 5 that has subsided inside the metal support mesh 1 can also reduce the influence on the venous blood flow, thereby reducing the thrombus formation rate; The second baffle film on the outer surface of the end face 3 is also beneficial for promoting the growth of the endothelium, reducing the rate of thrombus formation, and reducing the release of harmful metal elements. In order to further better illustrate the working principle of the above embodiment of the present invention, the specific use of the heart defect occluder of the above embodiment will be briefly described below.

Figures 4A, 4B, 4C and 4D are examples of cardiac defect occluders for ventricular septal defects. First, a femoral vein to the interventricular septum is established in the groin, the sheath 8 is inserted through the orbit, and then the cardiac defect occluder connected with the transport cable 9 is pushed into the sheath 8 to seal the heart defect by transporting the cable 9. The device is delivered to the left ventricle as shown in Figure 4A.

Under the supervision of a dedicated contrast instrument and apparatus, the heart defect occluder is pushed out of the sheath 8 by the delivery cable 9 to open the first end face 2 of the heart defect occluder, as shown in Figure 4B.

The delivery cable 9 and the sheath 8 are withdrawn to fully open the first end face 2 and conform to the left ventricular wall, as shown in Figure 4C.

After the position of the left ventricular wall is determined to be good, the heart defect occluder is pushed out of the sheath 8 to open the second end face 3 of the heart defect occluder, as shown in Fig. 4D.

The second end face 3 is released, and the heart defect occluder is inserted into the ventricular septal defect, thereby closing the defect, as shown in Fig. 4E.

Claims

Claim

A heart defect occluder comprising a metal support mesh formed with a first end and a second end; and a first head enclosing a tip end of the metal support mesh and with the metal support Forming a first end surface; a second head closing the second end of the metal support net and forming a second end surface with the metal support net; wherein: the first head is on one end surface of the crucible Falling into the inner cavity of the metal support mesh.

2. A heart defect occluder according to claim 1 wherein: the outer surface of the one end face is approximately planar.

The cardiac defect occluder according to claim 2, wherein at least one first baffle film is disposed on an outer surface of the first end surface.

The heart defect occluder according to any one of claims 1 to 3, wherein the second head sinks toward the inner cavity of the metal support mesh on the second end face.

The cardiac defect occluder according to any one of claims 1 to 3, characterized in that at least one pull wire is disposed between the first head and the second head.

The cardiac defect occluder according to claim 4, wherein at least one pull wire is disposed between the first head and the second head.

The cardiac defect occluder according to claim 4, wherein the outer surface of the second end surface is approximately planar.

The cardiac defect occluder according to claim 6, wherein the outer surface of the second end surface is approximately planar.

The cardiac defect occluder according to claim 7, wherein: the outer surface of the second end surface is provided with at least one second blocking film.

The cardiac defect occluder according to claim 8, wherein the outer surface of the second end surface is provided with at least one second blocking film.