RU236826U1 - Device for endovascular treatment of atrial septal defect - Google Patents

Abstract

The utility model relates to medicine, namely to cardiovascular surgery, and can be used in endovascular treatment of diseases. The technical result of the claimed utility model is the treatment of small slit-like congenital ASDs and artificial ASDs, as well as cardiac arrhythmias with the launch of reparative regeneration processes leading to spontaneous adhesion and restoration of the integrity of the interatrial septum.

Description

The utility model relates to medicine, namely to cardiovascular surgery, and can be used in endovascular treatment of diseases.

Atrial septal defects (ASD) represent a large proportion of congenital heart defects, about 7% of all defects, and require surgical intervention.

O.O.O. – open oval window, which affects up to 20% of the world's population, is not a defect and is considered a minor anomaly in the development of the heart. No treatment is required, but many cardiologists are convinced of the opposite and recommend its closure.

In clinical practice, these patients represent a large, endless stream of patients. Differential diagnostics between these diagnoses is based on:

1 - under dynamic observation, sometimes lasting for several years;

2 - on measuring the ratio of pulmonary and systemic blood flow (Q/P: Q/S).

O.O. is a minor anomaly of the heart development that does not require observation and treatment. However, there is a certain group of cardiac surgeons and endovascular specialists who recommend and close oval windows with Amplantzer devices, citing rather vague and fuzzy indications for this procedure.

ASD is a heart defect and requires closure in one way or another. Among these defects, there are borderline forms with oval windows. They are distinguished by a small drop and a slit-like shape, but in most cases they must be closed.

In the era before the widespread introduction of ultrasound devices into practice, up until the 90s of the 20th century, the gold standard for diagnosing ASD and differential diagnosis with ASD was cardiac catheterization. This study measured the pressure in all accessible cavities of the heart, as well as blood oxygen saturation. The difference in pressure and blood oxygen saturation in the right and left atriums was an essential diagnostic criterion. Sometimes, contrast was used with video recording, which was an addition to making a topical diagnosis. Nowadays, the frequency of cardiac catheterization has decreased due to the widespread use of echocardiography.

For the treatment of small ASDs, the Amplanzer device (Fig. 1) is currently used, which is a product made of surgical metal with memory, packed in an intracardiac catheter. Delivered through the venous vessels to the atrial septal defect, the device, pushed out of the catheter, takes the form of "umbrella pancakes" and closes the defect from both the left and right atrium. The delivery device is "unfastened" and removed from the vein.

It is known that the mesothelial, endothelial and endocardial layers of the internal membranes protect the contacting parts of the internal organs, vessels and heart from adhesion, adhesions, scarring, etc.

Mechanical damage to the mesothelium of the serous membrane during operations on abdominal organs leads to an adhesion process, which is well known to all surgeons.

Scarification of the edges of the atrial septal defect also leads to spontaneous adhesion and fusion of the edges of the defect, i.e. healing.

Some endovascular surgical procedures for the treatment of complex forms of cardiac arrhythmias require dissection of the interatrial septum for direct access to the pulmonary vein orifices, where trigger points are located that disrupt the harmony of cardiac contractions. These points are subjected to radiofrequency or cryotherapy to restore normal cardiac rhythm. After these endovascular procedures, the artificially created interatrial anastomosis, in some cases, does not close spontaneously. An unclosed opening in the interatrial septum negatively affects the hemodynamics of the pulmonary circulation, causing pulmonary hypervolemia and hypertension.

The objective of the claimed utility model is to develop a device for scarification of the edges of an interatrial congenital or artificial defect.

The technical result of the claimed utility model is the treatment of small slit-like congenital ASDs and artificial ASDs, as well as cardiac arrhythmias with the initiation of reparative regeneration processes leading to spontaneous adhesion and restoration of the integrity of the interatrial septum.

The technical result of the claimed invention is achieved due to the fact that a device for endovascular treatment of an atrial septal defect is used, including an intracardiac catheter, the peculiarity of which is that the conductor of the intracardiac catheter at a distance of 20 mm from the end of the conductor has a special working surface 40 mm long made by tightly winding a wire in the form of a spiral made of thin surgical steel onto the conductor and strengthening it with circular silver couplings, and the pitch of the spiral is 3-4 mm.

The details, features, and advantages of the present utility model follow from the following description of the implementation of the claimed technical solution using drawings showing:

Fig. 1 - stages of installation of the Amplanzer device;

Fig.2 - general view of the modified conductor.

A device has been developed that consists of a standard intracardiac catheter and a modified conductor.

The following positions are indicated by numbers on the drawing:

1 - intracardiac catheter conductor, 2 - working surface, 3 - spiral.

Implementation of a utility model.

The device (Fig. 2) consists of an intracardiac catheter and a modified conductor 1.

The intracardiac catheter 1 conductor has a special working surface 2 40 mm long at a distance of 20 mm from the end of the conductor, which is capable of scarifying the endocardium of the defect edges. The standard curved end of the conductor allows controlling the position of the conductor in the defect so that it does not fall out of the defect opening during manipulations, and performing longitudinal scarifying tractions in order to activate the adhesive process.

The working surface 2 is made by tightly winding the wire in the form of a spiral 3 made of thin surgical steel on the conductor 1 and strengthening it with circular silver couplings. The pitch of the spiral 3 is 3-4 mm, which is the scarifying element of the modified conductor.

Access to the venous bed is achieved by puncturing the femoral vein below the inguinal ligament. We insert an introducer, through which we pass a catheter into the heart. Then, under visual control, we pass the catheter into the septal defect. Next, we remove the standard guidewire from the catheter. We insert the proposed device instead. Pulling the catheter back, we push out the device, with the working part of which we scarify the edges of the defect. We pack the device into the catheter and remove it.

A follow-up examination with ECHOKS after 1.5-2 months confirms spontaneous fusion of the defect.

Clinical example 1.

Patient H., 15 years old. Admitted to the cardiac surgery department of the Republican Children's Clinical Hospital of the Ministry of Health of the Republic of Tatarstan with the diagnosis: ASD with minor shunt.

The purpose of hospitalization was to clarify the diagnosis by performing cardiac catheterization with measurement of pressure, oxygenation and other parameters. According to the echocardiography data, there is a small 2×6 mm slit-shaped atrial septal defect with left-right shunt. QP/QS=1.2:1. The diagnosis was made at the age of 1 year, since then the patient has been observed by a pediatrician and a pediatric cardiologist. Recently, the patient's family has been actively discussing the need to close the defect due to her age, which requires active physical education, as well as, in the near future, starting a family and having children, which, from the parents' point of view, can be negatively affected by the presence of a defect in the cardiac septum. Indications for endovascular surgery are relative.

Sounding of the heart cavities was performed using the standard method with measurement of pressure and blood oxygenation in the right and left cavities. At the end of the sounding process, a procedure with a "brush" was performed. The cardiac catheter guide was removed. A modified guide was inserted. The probe was inserted into the ASD, longitudinal traction was performed 5-6 times under visual control.

The next day the patient was discharged in satisfactory condition.

A follow-up examination after 45 days using echocardiography revealed "spontaneous" healing of the defect. No discharge was detected.

Clinical example 2.

Patient A., 64 years old. Admitted to the cardiac arrhythmia department of the Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan with a diagnosis of atrial flutter. Drug therapy is currently ineffective, a procedure for ablation of the pulmonary veins has been prescribed.

After performing the necessary manipulations, a modified conductor was inserted into the probe through the artificial ASD, and longitudinal tractions were performed under visual control to scarify the edges of the defect.

The patient was examined after 30 days: the heart rhythm remains normal, there is no arrhythmia. On echocardiography, the septum between the atria is without leaks.

Thus, the proposed method of treating ASD significantly facilitates, simplifies and reduces the cost of existing treatment methods.

A very important point is that the patient does not carry a metal object in his heart, as in the case of the Amplantzer device. By scarifying the edges of the defect, we stimulate the healing processes within the framework of reparative regeneration.

Claims (1)

A device for endovascular treatment of an atrial septal defect, including an intracardiac catheter conductor made with a bent end for monitoring the position of the conductor in the defect, wherein the intracardiac catheter conductor at a distance of 20 mm from the bent end has a working surface for scarification of the endocardium of the edges of the atrial septal defect, the length of the working surface is 40 mm, the working surface is made by winding a wire in the form of a spiral made of surgical steel onto the conductor, the wire is secured to the conductor with couplings made of silver, and the pitch of the spiral is 3 mm.