RU2797187C1 - Method for fixing a temporary epicardial electrode and a device for its implementation - Google Patents

Abstract

FIELD: cardiovascular surgery.

SUBSTANCE: method used for implanting epicardial electrodes in cardiac electrotherapy. In the method of fixing a temporary epicardial electrode after open heart surgery for conducting pacing in the postoperative period, a temporary electrode is fixed in the operated organ after the atraumatic needle of the electrode is passed through the myocardium with its subsequent cutting off from the electrode. After the implantation of the electrode, its uninsulated part is crimped with a device to form a shape that allows to keep the uninsulated part of the electrode in the place of fixation, while not preventing free and atraumatic removal. The device for forming the shape of the implantable uninsulated part of the temporary epicardial electrode after open heart surgery for pacing in the postoperative period is a single part, consisting of the upper and lower branches separated from each other by an angleα. The surfaces of the branches facing each other are equipped with teeth. The device is made of a flexible material approved for use in medicine in the form of an alligator clip and is equipped with a cut to accommodate the uninsulated part of the electrode.

EFFECT: reliable fixation of the temporary electrode to the surface of the heart, which does not cause excessive traumatization of tissues for the implementation of stable temporary pacing followed by atraumatic removal of this electrode by ordinary traction.

2 cl, 9 dwg

Description

The invention relates to medicine, namely to cardiovascular surgery, and can be used for implanting epicardial electrodes in cardiac electrotherapy.

An electrode for temporary pacing is known (US 4444207, publ. 27.07.1982, IPC A61N 1/05), equipped with a stranded flexible conductor, having an insulating coating for most of the length, the non-insulating part of the conductor is connected to an atraumatic curved needle, with the second end of the insulating conductor connected by a straight needle. A curved needle is passed through the surface of the heart wall and pulled back through the same surface of the heart wall, thus the uninsulated part of the conductor is embedded in the wall of the heart. The curved needle is then passed through the disc. The disk moves along the non-insulated part of the conductor until it touches the surface of the heart wall, the excess part of the non-insulated conductor with a curved needle is cut off after the button. The disk serves to hold the guidewire in a fixed position relative to the wall of the heart during cardiac stimulation.

The disadvantage of this electrode is its fixation with an external stopper in the form of a disc to the heart tissues. When the electrode is removed from the heart by pulling, the fixing disk may remain in the pericardial cavity.

An electrode is known (US 4341226 A, publ. 27.07.1982, IPC A61N 1/05) for temporary pacing, containing a working sleeve with a first end in the form of a truncated cone connected to a ligature conductor, including an atraumatic curved needle and a spiral locking section, the second end of the working The bushing is connected to a flexible stranded wire in an insulating coating and a plug in the form of a straight needle that can be broken off. The working sleeve of the electrode is fixed in the tissues by means of a spiral locking section.

The disadvantage of this electrode is its spiral part, which serves as a stopper and is located in the myocardium. When traction may cause an increased risk of injury to the epicardium and myocardium.

Closest to the proposed invention (prototype) should be considered an electrode for temporary pacing, containing a working sleeve, a ligature conductor and a flexible stranded wire made of annealed steel of vacuum induction remelting. The first end of the working sleeve in the form of a truncated cone is connected by a smaller base to the ligature conductor. The second cylindrical end of the sleeve is connected to a flexible stranded wire. The ligature conductor includes an atraumatic curved needle and a spiral locking section. The stranded wire is equipped with a polyethylene electrical insulating coating and a straight needle plug. The working bushing has a polished surface and is connected flush with the polyethylene insulating coating. The plug is made in the form of a surgical needle with a circular groove for breaking, which is located at a distance of 21-24 mm from its end with a stranded wire (patent RU No. 2641062, publ. 15.01.2018, IPC A61N 1/05).

The disadvantage of this device is the presence of a spiral locking area, which is rigidly fixed and does not allow you to vary the possibility of fixing the electrode to the myocardium and epicardium. In addition, the presence of a spiral section on the electrode makes it difficult to fix it to areas of the heart with a thin wall, such as the atrial myocardium.

The purpose of the invention is to ensure reliable fixation of a temporary electrode to the surface of the heart, which does not cause excessive tissue trauma, for the implementation of stable temporary pacing followed by atraumatic removal of this electrode by simple traction.

The goal is achieved as follows: a method for fixing a temporary epicardial electrode, including fixing a temporary electrode in the operated organ, after passing the atraumatic needle of the electrode through the myocardium and then cutting it off from the electrode, the non-insulated part of the electrode is crimped by a device in the form of a crocodile clip, for form formation. This allows you to securely hold the uninsulated part of the electrode in place of fixation, providing a good contact area of the electrode and does not prevent its removal by traction at the moment when the need for temporary pacing disappears.

The essence of the invention is illustrated by drawings:

Fig. 1 - Electrode.

Fig. 2 - Electrode with a device (shaper).

Fig. 3 - Device (former).

Fig. 4 - Sinusoidal shape of the non-insulated part of the electrode after being crimped by the device.

Fig. 5 - Dimensions of the device (former).

Fig. 6 - The shape of the teeth of the upper and lower branches of the device (former).

Fig. 7 - Scheme of hemming and fixing the electrode with the device.

Fig. 8 - Scheme of removing the electrode by traction.

Fig. 9 - Scheme of the location of the programmed deformed electrode section on the epicardium with and without additional fixation.

Thus, when implementing the method of fixing a temporary epicardial electrode (Fig. 1) after operations on the "open" heart, a device (former) created by us is used to conduct pacing in the postoperative period, which forms the shape of the non-insulated part of the electrode.

The figure 2 shows an electrode for temporary pacing, including a Keith needle 1, an atraumatic curved needle 2 and a conductive wire with an insulated part 3 and an uninsulated part 4 with a device (shaper) 5.

The device (shaper) (Fig. 3) is made of a flexible material approved for use in medicine and is a single part made in the form of a crocodile clip without a spring and a sleeve, designed to form the shape of the implantable non-insulated part of the electrode, consisting of the upper branches 6 and lower branches 7 divorced from each other at an angle α. For ease of use, the optimal angle α=15-20°. The faces of the jaws facing each other are provided with teeth in the form of a sinusoid, and, when the jaws are closed, the teeth on the upper jaw precisely engage with the teeth on the lower jaw, so that the jaws will completely close along the entire length of their teeth. The device (shaper) has a cut 8 designed to accommodate the non-insulated part of the electrode (Fig. 3). The figure 4 shows the shape of the uninsulated part of the electrode, in the form of a sinusoid, after being compressed by the device (former).

In figure 5, the indicated quantitative values of the structural elements of the device (shaper) are optimal. Also, depending on obtaining the required form factor of the shape of the uninsulated part of the electrode after crimping, these dimensions can vary without changing the result achieved. The shape of the teeth of the upper and lower branches to form the shape of the bare part of the electrode can also vary (FIG. 6).

Thus, the use of the device (shaper) created by us, for the formation of a sinusoidal shape, allows you to securely fix the non-insulated part of the electrode and does not prevent its free and atraumatic removal.

The method is carried out as follows.

The patient is taken to the operating room. They give induction anesthesia, intubate, cannulate the central veins and the radial artery on the left. Under conditions of neuroleptanalgesia, the surgical field is treated with an antiseptic solution, delimited with sterile linen. Cut the skin, subcutaneous tissue, perform median sternotomy, longitudinal T-shaped pericardiotomy. Carry out heparinization. The heart-lung machine is connected according to the "vena cava - aorta" scheme. After performing the main stage of the operation and restoring cardiac activity, the required number of electrodes is fixed to the heart by passing an atraumatic electrode needle through the myocardium with access to the epicardium. Subsequently, the needle is cut off, and the free end of the electrode is crimped by a device (former), thus ensuring reliable fixation of the electrode and the possibility of conducting stable stimulation (Fig. 7). Then, the chest is closed, the wound is sutured in layers. After the need for temporary pacing (ECS) ceases, the electrodes are removed by simple traction (Fig. 8), and the shape of the electrode compression makes it easy and atraumatic.

The application of the proposed method allows:

- securely fix temporary electrodes for pacing to the surface of the heart;

- provide a large area of contact of the electrode with the surface (Fig. 9);

- provide atraumatic and easy removal of electrodes by simple traction.

The present invention was used in 10 patients (including 5 men and 5 women, aged from 36 to 72 years) and made it possible to ensure reliable fixation of the electrodes and their atraumatic removal on the 10th day after the operation. Before the removal of the electrodes, a low stimulation threshold (not higher than 5 mA) and stable rhythm control were recorded, and after the removal of the electrodes, not a single case of dangerous complications (hemopericardium, trauma to the heart walls) was recorded, which allows us to talk about the fact that the proposed invention is effective and safe.

Claims (2)

1. A method for fixing a temporary epicardial electrode after operations on an "open" heart for conducting pacing in the postoperative period, including fixing a temporary electrode in the operated organ after passing an atraumatic needle of the electrode through the myocardium with its subsequent cutting off from the electrode, characterized in that after implantation of the electrode it the uninsulated part is crimped with the device according to claim 2 to form a shape that allows you to keep the uninsulated part of the electrode in place of fixation, while not preventing free and atraumatic removal. 2. A device for shaping the shape of the implantable non-insulated part of the temporary epicardial electrode after operations on the "open" heart for pacing in the postoperative period, which is a single part consisting of the upper and lower jaws separated from each other by an angle α, while facing each other To each other, the surfaces of the branches are provided with teeth, and the device is made of a flexible material approved for use in medicine, in the form of a crocodile clip and equipped with a cut to accommodate the non-insulated part of the electrode.

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