CN101081181A - Device for treating congenital herat disease and using method thereof - Google Patents

Abstract

A new type of treatment device for congenital heart disease includes an expandable stent lined with a medical one-way shunt valve. The expandable stent is a dumbbell-shaped structure, which may be a self-expanding stent made of nickel-titanium memory alloy steel wire or a titanium-steel alloy stent, and the valve is a biological valve or a polymer valve. The above method of using the treatment device includes: delivering the treatment device to the shunt site by means of an interventional method, and expanding into a dumbbell-shaped elastic structure after release, and fixing it at the shunt site. It self-expands above 33°C to form a dumbbell-shaped structure, or the titanium-steel alloy stent expands after balloon expansion. A valve lined with a medical one-way shunt only allows blood flow from right to left through the stent, not left to right. The advantages of the present invention include: less trauma, easy to be accepted by patients, relatively mature technology, easy to master, and less demanding operation conditions.

Description

A therapeutic device applicable to congenital heart disease and its application method

technical field

The invention belongs to the field of medical devices, and relates to a treatment device for congenital heart disease, in particular to a treatment device for patients with severe pulmonary hypertension caused by blood shunting from left to right in congenital heart disease.

Background technique

Congenital heart disease such as ventricular septal defect, patent ductus arteriosus, atrial septal defect, etc., due to continuous abnormal shunt (left to right shunt) from the high pressure aortic system to the low pressure pulmonary artery system, resulting in increased pulmonary blood volume and increased pulmonary vascular resistance. lead to pulmonary hypertension. Under the continuous effect of increased blood flow and pressure, the function of pulmonary vascular endothelial cells changes, pulmonary vascular resistance gradually increases, and pulmonary hypertension develops progressively until right-to-left shunt occurs, that is, Eisenmenger syndrome. With cyanosis, the patient has lost the chance of surgery at this time, and the only treatment is combined heart and lung transplantation. When the pressure of the pulmonary circulation is close to that of the systemic circulation, there will be two-way shunt (that is, left-to-right shunt during rest or systole, and right-to-left shunt during exercise or diastole). At this time, the body still has a certain compensatory mechanism. Means to reduce the afterload of the right ventricle and increase the cardiac output are effective means to treat pulmonary hypertension. For severe pulmonary hypertension with bidirectional shunt, drug therapy is less effective. Surgical closure of the channel between the systemic pulmonary circulation will seriously increase the burden on the right heart, coupled with the impact of extracorporeal circulation, protamine and general anesthesia, and the application of artificial respiration, etc., it is very easy to cause acute pulmonary artery pressure to rise and cause pulmonary hypertension crisis and death after surgery . Right ventricular assist device or artificial heart is applied to pulmonary hypertension secondary to congenital heart disease, which improves the symptoms of patients and improves the survival rate of patients. However, this device is easy to cause complications such as bleeding, infection and thromboembolism, which is expensive and permanent. The placement of the device awaits further study. Some scholars use artificial atrial septal defect to treat pulmonary hypertension, and relieve the symptoms of pulmonary hypertension by reducing the right ventricular afterload. This method relieves the symptoms of patients to a certain extent, but the effect is not certain. Some scholars have successfully repaired the ventricular septal defect with severe pulmonary hypertension by using a one-way valve patch, which significantly improved the patient's symptoms. However, this is an extracorporeal operation under general anesthesia. Surgical techniques are difficult and difficult to popularize. So far, there is still a lack of effective, minimally invasive, and easy-to-promote treatment methods for this disease.

Contents of the invention

The purpose of the present invention is to provide a novel treatment device for congenital heart disease, which can assist in efficient, minimally invasive and easy-to-promote treatment.

The object of the present invention is achieved in that a novel treatment device for congenital heart disease comprises an expandable stent, and the stent is lined with a medical one-way shunt valve.

Further, the expandable stent is a dumbbell-shaped structure, which may be a self-expanding stent made of nickel-titanium memory alloy steel wire or a titanium-steel alloy stent, and the valve is a biological valve or a polymer valve.

The dumbbell-shaped structure is a self-expanding stent or a titanium-steel alloy stent made of nickel-titanium memory alloy steel wire.

The above-mentioned method of using the treatment device includes: delivering the treatment device to the shunt site by means of an interventional device, and then releasing it, and expanding into a dumbbell-shaped elastic structure and fixing it at the shunt site after release.

Furthermore, it self-expands above 33°C to form a dumbbell-shaped structure, or the titanium-steel alloy stent expands after balloon expansion.

A valve lined with a medical one-way shunt only allows blood flow from right to left through the stent, not left to right.

Owing to adopting said scheme, the present invention has the following advantages:

1. Minimally invasive; the device is placed using local anesthesia and interventional methods, avoiding general anesthesia and thoracotomy, reducing surgical complications and surgical risks, no need for blood transfusion, fast postoperative recovery, and short hospital stay. An effective treatment is provided for patients with severe pulmonary hypertension who cannot tolerate general anesthesia and major surgery.

2. Low cost; because the various materials and conveying devices for making the device are all domestic materials and produced by domestic manufacturers, the cost is reduced, and it is not only suitable for developed countries, but also suitable for the national conditions of developing countries.

It is easy to popularize; this method has less trauma, is easy to be accepted by patients, is a relatively mature technique, is easy to master, and does not require high surgical conditions.

Description of drawings

Fig. 1 is a schematic side view of an embodiment of the present invention.

FIG. 2 is a schematic front view of the embodiment illustrated in FIG. 1 .

Detailed ways

A new type of treatment device that can be used for patients with severe pulmonary hypertension caused by left-to-right shunt of congenital heart disease. Lined medical one-way shunt biological valve (or polymer valve). The device of the present invention is transported to the shunt site by means of an interventional device, and then released. After release, it expands into a dumbbell-shaped elastic structure and is firmly fixed on the shunt site. After expansion, the inner diameter is greater than 2mm, which is suitable for shunts of different sizes.

Specifically, please refer to Figure 1-2, the dumbbell-shaped structure can be a self-expanding stent made of nickel-titanium memory alloy steel wire, which expands by itself to form a dumbbell-shaped network structure 1 above 33°C, and No balloon dilatation is required, or the titanium steel alloy stent is expanded after balloon dilation.

The valve lined with medical one-way shunt can use the type of trilobate valve 2, the elastic effect of the valve facilitates the withdrawal of the conveyor, simplifies the blocking device, and the operation is simpler; while the valve only allows blood flow from right to left through the stent without allowing blood flow left to right through the stent.

A dumbbell-shaped self-expanding stent or a titanium-steel alloy stent is woven into a nickel-titanium memory alloy steel wire, and a biological valve or a polymer valve that functions as a one-way shunt is built in. The device uses a delivery device to be delivered to the shunt site under DSA. After the device is released, it can self-expand to form a dumbbell-shaped structure (or a titanium-steel alloy stent expands after balloon expansion). It self-expands above 33°C to form a dumbbell-shaped structure without balloon expansion. After expansion, it can be firmly fixed at the shunt. The built-in valve can only shunt the blood flow from right to left, but not from left to right. shunt.

For pulmonary hypertension patients with congenital heart disease combined with two-way shunt, design a occlusion device with a one-way shunt valve, and use interventional methods to fix the device in the shunt site. The valve can only shunt the blood flow from right to left , instead of shunting from left to right, which effectively prevents the further development of pulmonary hypertension, reduces the afterload of the right ventricle and pulmonary circulation pressure, promotes the opening of the partially spasmodic pulmonary artery, improves the symptoms of patients, and prolongs the life of patients.

The above description of the embodiments is for those of ordinary skill in the art to understand and apply the present invention. It is obvious that those skilled in the art can easily make various modifications to these embodiments, and apply the general principles described here to other embodiments without creative efforts. Therefore, the present invention is not limited to the embodiments herein, and improvements and modifications made by those skilled in the art according to the disclosure of the present invention should fall within the protection scope of the present invention.

Claims (6)

1. A treatment device for congenital heart disease, characterized in that it includes an expandable stent lined with a medical one-way shunt valve. 2. The treatment device for congenital heart disease according to claim 1, characterized in that: the expandable stent is a dumbbell-shaped structure, a self-expanding stent made of nickel-titanium memory alloy steel wire or titanium steel An alloy stent, the valve is a biological valve or a polymer valve. 3. The treatment device for congenital heart disease according to claim 2, characterized in that: the dumbbell-shaped structure is a self-expandable stent or a titanium-steel alloy stent braided by nickel-titanium memory alloy steel wire. 4. The method of using the therapeutic device according to any one of claims 1-3, characterized in that: the therapeutic device is transported to the shunt site by means of an interventional device, and then released, and then expands into a dumbbell-shaped elastic The structure is fixed at the shunt site. 5. The method of using the treatment device according to claim 4, characterized in that: it expands itself to form a dumbbell-shaped structure above 33°C, or the titanium-steel alloy stent expands after balloon expansion. 6. The method of using the treatment device according to claim 4, characterized in that: the valve lined with medical one-way shunt only allows the blood flow to pass through the stent from right to left, and does not allow blood flow to pass from left to right stand.

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