RU172757U1 - Device for temporary occlusion of the great vessels and aorta - Google Patents

Abstract

The proposed utility model relates to medical equipment, namely to medical and surgical instruments, in particular to a device for temporary occlusion of the great vessels and the aorta. The proposed device for the temporary occlusion of the main vessels and the aorta allows to reduce the time of installation and insertion into the vessels. The proposed device is ready for application without preliminary manipulations (introduction of the conductor), which is especially important in the field, is already put into operation without additional operations.

Description

The proposed utility model relates to medical equipment, namely to medical and surgical instruments, in particular to a device for temporary occlusion of the great vessels and the aorta.

Known catheter "over-the-wire" - a double-lumen balloon catheter with a lumen for the guide along the entire length (http://medbook.me/kardiologiya _730 / ballonyi-kateteryi-46139.html).

In this system, the intracoronary conductor and the catheter balloon move independently of each other, which allows the conductor to leave behind the site of damage to the coronary artery, while the catheter balloon is removed from the artery into the lumen of the guide catheter.

This system also allows you to change the conductors, both outside the guide catheters, and in cases where the balloon catheter is in the lumen of the guide catheter.

The disadvantage of the over-the-wire catheter balloon is their relatively large profile, which does not allow their use with small-diameter guide catheters.

The known balloon requires significant support from the guide catheter when they are passed through the damaged section of the main vessels.

To change the balloon catheter of this type while maintaining the position of the apex of the conductor behind the damaged portion of the coronary artery, conductors having a double length (> 3 m) are necessary. Two doctors are required for management.

The closest in technical essence to the proposed technical solution is a device for temporary occlusion of the great vessels and the aorta, including a catheter, at the distal end of which there is an inflatable balloon, a J-type conductor, and a connector and a fluid balloon inflation mechanism connected to it at the proximal end of the catheter e.g. a syringe (see WO2014134215 according to class A61M 25/10, 2015).

The known device can be used in the field.

However, it has several disadvantages, namely:

- the complexity of the design associated with the presence of an additional centering element and the use of a double-lumen catheter (one lumen for installation of the conductor, and the second lumen for inflating the balloon);

- the possibility of mixing the balloon with pulse tremors in view of the insufficient rigidity of the catheter;

- the difficulty of positioning the balloon inside the vessel;

- the lack of reliable fixation of the catheter on the skin leads to displacement of the balloon in the vessel.

The technical result solved by the proposed utility model is to simplify the design of the device for temporary occlusion of the great vessels and the aorta, providing accurate and reliable occlusion of the aorta and the great vessels, both in the field and in the hospital.

The technical result in the proposed utility model is achieved by the creation of a device for temporary occlusion of the great vessels and the aorta, including a catheter at the distal end, which has an inflatable balloon, a J-type conductor, and a connector and a fluid balloon inflation mechanism connected to it at the proximal end of the catheter, which , according to the utility model, it is equipped with a movable catheter depth limiter inserted on the catheter into the vessel and the device retainer to the skin located on the proxy the small part of the catheter, while the latch is located proximal to the depth gauge, and the conductor consists of a super-rigid part and a flexible part with a J-end, the catheter being single-lumen, in the lumen, which is placed and hermetically fixed at both ends of the catheter, and the flexible part located outside the distal end of the catheter.

The proposed device for temporary occlusion of the great vessels and the aorta has a simplified design due to the execution of a single-lumen catheter, which reduces the cost of production.

The proposed utility model provides the ability to pre-determine the depth of introduction of the device into the main vessels by moving and installing the limiter of the depth of introduction of the catheter into the vessel.

The proposed device for temporary occlusion of the great vessels and the aorta can reduce the time of installation and its introduction into the vessels,

The proposed device is ready for use without preliminary manipulations (introduction of the conductor), which is especially important in the field, is already put into operation without additional operations.

The proposed utility model allows to exclude the movement of the catheter (due to the impact of pulse blood jerks on the balloon) due to the fixation of the device to the skin with the help of a retainer and the presence of an extra-rigid part inside the catheter

The essence of the proposed utility model is illustrated by the following description and drawing, which shows a General view of the device for temporary occlusion of the great vessels and the aorta.

A device for temporary occlusion of the great vessels and the aorta includes a catheter 1 at the distal end, which is inflated balloon 2, a J-type conductor, and a connector 3 installed on the proximal end of the catheter, and a fluid balloon inflating mechanism 4 connected to it, a movable depth gauge 5 catheter into the vessel and the device retainer to the skin 6 located on the proximal part of the catheter,

The latch 6 is located proximal to the depth gauge 5.

The J-type conductor consists of a super-rigid part 7 and a flexible part 8 with a J-end.

The catheter 1 is single-lumened, and in the lumen (to hell, not showing) is placed and tightly fixed at both ends of the catheter super-rigid part 7, and the flexible part 8 is located outside the distal end of the catheter 1.

The mechanism for inflating 4 cylinders with liquid, depending on technical capabilities, can be either in the form of a syringe or any mechanism for supplying liquid to the cylinder.

The operation of the device for temporary occlusion of the great vessels and the aorta is as follows:

Before the introduction of the catheter 1 with balloon 2 into the aorta or the main vessel, the optimal depth of injection is determined by applying the catheter 1 to the surface of the patient's body.

The point corresponding to the entry site of the catheter 1 with the balloon 2 into the aorta is fixed using a movable limiter 5 for the depth of insertion of the catheter into the vessel.

Using the rectifier of the flexible part 8 with the J-end (to hell. Not showing.), A catheter 1 with a balloon 2 is introduced into a pre-installed introducer sheath (to hell not showing).

Then the rectifier 9 is removed, and the catheter 1 with the balloon 2 is inserted into the aorta or the main vessel under fluoroscopic control.

In the absence of fluoroscopy to inflate balloon 2, for example, in the 1 zone of the aorta, you should focus on the xiphoid process of the patient, and for zone II - the navel area.

After the introduction of the balloon 2 to the indicated mark, the device retainer to the skin 6 is fixed on the patient, which prevents the possible displacement of the first. The correct positioning of the cylinder is checked by x-ray control.

After confirming the correct position of the balloon, a mixture of contrast medium and physiological saline is introduced into the catheter in a 1: 1 ratio, diluted into a balloon inflating mechanism of 4 cylinders with a liquid, for example, a 20 ml syringe, under fluoroscopy or subsequent radiography.

The volume of injected fluid is determined by the attached nomogram. An x-ray sign of complete vessel occlusion is the elongated (close to rectangular) shape of the balloon 1 along the length of the vessel, which is formed due to moderate over-inflation of the balloon and its creep along the vascular wall.

In the absence of an X-ray machine, they are guided by the sensation of light resistance that occurs when a sufficient amount of solution is introduced, and the piston recoils in the syringe, after which the introduction is stopped.

Balloon 1 is inflated slowly and only after coordination with the anesthetist, and the severity of hemodynamic changes depends on the type of vessel being occluded and the level of occlusion.

If necessary, ischemia time can be minimized using intermittent balloon occlusion (periodic deflation).

After balloon 1 is inflated, emergency interventions are performed depending on the clinical situation.

With sufficient stabilization of the patient's condition, computed tomography is possible.

If angiocontrasting is required to topically visualize the damage zone, balloon 1 is deflated slightly.

Balloon blowing is performed only by agreement with the anesthetist after the final or temporary stop of bleeding surgically or endovascularly.

Rapid deflation of the balloon will inevitably lead to circulatory collapse; therefore, the inflation rate of the balloon is chosen 3-5 ml every 30 sec.

The extraction of the last few milliliters of fluid is the most important, since it is at this moment that the blood flow is completely restored through the occluded vessel.

At the moment when the cylinder is no longer necessary, it is removed (after full blowing off).

The proposed utility model was clinically tested at the Department of Military Field Surgery of the Military Medical Academy. CM. Kirov MORF in St. Petersburg and the results confirmed the reliability, ease of installation of the device for temporary occlusion of the great vessels and the aorta, a significant reduction in the risk of thrombosis, as well as a significant reduction in the time spent on surgical intervention in the patient's body (installation, removal, etc. )

Claims (1)

A device for temporary occlusion of the great vessels and the aorta, including a catheter, at the distal end of which a balloon is installed, a J-type conductor, a connector installed on the proximal end of the catheter and a fluid balloon inflation mechanism connected to it, characterized in that it is equipped with a mobile balloon placed on the catheter a depth limiter for introducing the catheter into the vessel and a device retainer to the skin located on the proximal part of the catheter, while the retainer is located proximal to the depth gauge They are, and the J-type conductor consists of a super-rigid part and a flexible part with a J-end, and the catheter is single-lumen, in the lumen of which the super-rigid part of the conductor is placed and hermetically fixed at both ends, and the flexible part is located outside the distal end of the catheter.

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