Device for performing minimally invasive closure of defects of the heart

Description of occlusion device

A device for performing minimally invasive closure of defects in the heart consists of an occluder and a delivery system.

The occluder is a device introduced by intravascular access to eliminate secondary defects of the atrial septum (pathological blood flow from the left atrium to the right).
The occluder is a self-expanding wicker product made of nitinol and is intended for implantation in the atrial septal defect of the heart. A properly implanted occluder does not interfere with valve function and intracardiac hemodynamics.

The occluder in a straightened state

The device consists of two discs (left atrial – A, right atrial – C), interconnected by a short neck (B), corresponding in diameter to the size of the defect to be closed. To ensure optimal closing ability, the device is filled with a special polyester fabric. The device has x-ray contrast, which allows for visual fluoroscopic control during positioning.

The procedure for closing the atrial septum is prescribed for patients with echocardiographic confirmation of the presence of a secondary atrial defect and clinical confirmation of the overload of the right ventricle in volume (i.e., a shunt of blood from the left ventricle to the right in a ratio of 1.5: 1 or an increase in the size of the right ventricle). The occluder is installed in the defect and fixed in it by deployment from a folded state due to the elastic forces of the structure.

Occluder Delivery System with its components

The delivery system consists of a device for loading the occluder (A), a hemostatic valve (B) with a side port, a disposable disposable delivery catheter (C), a delivery pusher catheter (D) with a plastic clip (E). A bundle of bougie (G) is supplied with the supplying catheter, which provides a smooth diametrical transition from the wire guide to the outer sheath of the delivering catheter, which is important in the process of conducting the delivery system to the target zone. At the distal end of the pusher is a thread through which the pusher is connected to the caudal edge of the occluder. The diameter of the delivering catheter is selected based on the size of the implantable occluder.

Окклюдеры и системы доставки поставляются в отдельных стерильных упаковкахOccluders and delivery systems are delivered in separate sterile packaging.

Precautionary measures

Occluder implantation can only be performed by the doctors who are familiar with the methods of performing endovascular interventions (including the use of this device), and if they are aware of possible complications, and only in medical institutions that are specially equipped to perform the necessary operations in case of complications. All manipulations should be carried out under fluoroscopic and echocardiographic control.

All components of the kit for installing the occluder are disposable, their re-sterilization and reuse are not allowed. They are not maintainable.

Имплантация окклюдера противопоказана:Occluder implantation is contraindicated:

  • To patients with extensive congenital heart disease, for whom the only adequate treatment is heart surgery.
  • To patients who have undergone sepsis within one month before implantation or suffering from a systemic infectious disease that cannot be completely cured before implantation of the device.
  • To patients with blood clotting disorders that have not been cured by an ulcer or other contraindication to the use of aspirin, except when it is possible to prescribe another antiplatelet drug for a period of up to 6 months after implantation of the device.
  • To patients who are contraindicated in taking antiplatelet or anticoagulant drugs. Patients with an intracardiac thrombus detected by echocardiography (especially in the left atrium or in the appendage of the left atrium). Patients whose anatomical features or condition make cardiac catheterization practically impossible.
  • To patients with defect boundaries less than 5 mm of the sparous sinus, atrioventricular valve, or right superior pulmonary vein.