阅读说明：本技术 一种用于治疗Fontan循环衰竭的新型辅助装置 (Novel auxiliary device for treating Fontan circulatory failure ) 是由 周诚 夏家红 于 2019-09-25 设计创作，主要内容包括：本发明涉及Fontan术后辅助治疗器具技术领域,特别涉及一种用于治疗Fontan循环衰竭的新型辅助装置,包括球囊,球囊置于Fontan手术后的肺动脉、上腔静脉及下腔静脉的交汇处；且球囊的两端分别位于上腔静脉和下腔静脉中；随球囊充放气,使上腔静脉及下腔静脉的内的血液挤压进入肺动脉中。通过上述方式,将球囊置入至肺动脉、上腔静脉及下腔静脉的交汇处,通过球囊的充放气,使得球囊膨胀收缩,进而将所述上腔静脉及所述下腔静脉的内的血液挤压进入肺动脉中。与球囊相偶联的瓣膜同步开放与关闭,防止血液向上、下腔静脉逆流。从而使得血液搏动性进入到肺动脉,起到部分右心室的作用,从而治疗Fontan循环衰竭的患者,为后期心脏移植手术提供有力条件。(The invention relates to the technical field of auxiliary treatment appliances after Fontan operations, in particular to a novel auxiliary device for treating Fontan circulatory failure, which comprises a balloon, wherein the balloon is arranged at the junction of a pulmonary artery, a superior vena cava and an inferior vena cava after the Fontan operations; and both ends of the balloon are respectively positioned in the superior vena cava and the inferior vena cava; the balloon is inflated and deflated, so that blood in the superior vena cava and the inferior vena cava is squeezed into the pulmonary artery. By the mode, the saccule is placed at the intersection of the pulmonary artery, the superior vena cava and the inferior vena cava, and is inflated and deflated through inflation and deflation of the saccule, so that blood in the superior vena cava and the inferior vena cava is squeezed into the pulmonary artery. The valve coupled with the saccule is opened and closed synchronously to prevent the blood from flowing back to the superior and inferior vena cava. So that blood pulsates to enter the pulmonary artery to play a part of right ventricle, thereby treating patients with Fontan circulatory failure and providing powerful conditions for later heart transplantation operations.)

1. A novel auxiliary device for treating Fontan circulatory failure, comprising a balloon, wherein the balloon is placed at the junction of a pulmonary artery, a superior vena cava, and an inferior vena cava after Fontan surgery; and both ends of the balloon are respectively positioned in the superior vena cava and the inferior vena cava; and with the inflation and deflation of the balloon, the blood in the superior vena cava and the inferior vena cava is extruded into the pulmonary artery.

2. The novel auxiliary device for treating Fontan circulatory failure of claim 1, further comprising an umbrella valve; umbrella-shaped valves are arranged at the upper end and the lower end of the saccule; the opening and closing of the umbrella-shaped valve are synchronous with the inflation and deflation of the saccule.

3. The novel auxiliary device for treating Fontan circulatory failure of claim 2, further comprising valve chordae tendineae; one end of the valve chordae tendineae is connected with the umbrella-shaped valve, and the other end is connected with the saccule; when the balloon is deflated, the balloon pulls the umbrella valve through the valve chordae tendineae, closing the umbrella valve.

4. The novel auxiliary device for treating Fontan circulatory failure as claimed in claim 3, wherein the valve chordae tendineae are in a group of 3-8.

5. The novel auxiliary device for treating Fontan circulatory failure as claimed in claim 4, wherein the diameter of the balloon is gradually reduced at both ends.

6. The novel auxiliary device for treating Fontan circulatory failure as in claim 5, further comprising an air pump; the air pump is positioned outside the body and is connected with the saccule through a catheter.

7. The novel auxiliary device for treating Fontan circulatory failure of claim 6, wherein the valve chordae tendineae are selected from gore-tex sutures.

8. The novel accessory device for treating Fontan circulatory failure of claim 7, wherein the balloon of the device is placed by the internal jugular vein or the femoral vein.

9. the novel auxiliary device for treating Fontan circulatory failure as recited in claim 8, wherein the diameter of the balloon after inflation is less than or equal to the diameter of the superior vena cava and inferior vena cava.

Technical Field

The invention relates to the technical field of Fontan postoperative auxiliary treatment appliances, in particular to a novel auxiliary device for treating Fontan circulatory failure.

Background

Since 1971 when Francis Fontan physicians performed the first Fontan surgery, Fontan surgery has become the "gold standard" for complex, first-heart, single-ventricle patient surgery. The surgical procedure has undergone improvement, and the most commonly used Fontan procedure at present is the external tube TCPC (vena cava-pulmonary artery junction) procedure. The basic idea is to connect the superior and inferior vena cava with the right pulmonary artery directly, open the right ventricle and use the only ventricle to undertake the systemic circulation. This procedure separates the systemic circulation from the pulmonary circulation, significantly improving hypoxia and quality of life in single ventricular patients, and has become a milestone for single ventricular therapy.

However, in the long-term follow-up after the Fontan surgery, it was found that a large number of patients in the long term had vena cava blood that could not effectively enter the pulmonary arteries due to the lack of right ventricle in the pulmonary circulation, and thus Fontan circulatory failure occurred. The symptoms of persistent heart failure, edema, low cardiac output, impaired exercise tolerance, stubborn tachyarrhythmia, protein loss enteropathy, plastic bronchitis and the like, the lethality rate is extremely high, and heart transplantation is always the only choice for patients of the type. Treatment efficacy is severely compromised by lack of supply to the heart and frequent accumulation of multiple organ damage in patients with Fontan circulatory failure. The heart assistance for the patients and the improvement of the treatment effect become research hotspots.

There are currently a number of difficulties with Fontan cycle assistance: the VA-ECMO effect is poor; limited indications using LVAD; the elimination of Fontan cycle + RVAD requires complicated extracorporeal circulation surgery, has large trauma and is not suitable for emergency assistance; the pump design directly used for the Fontan cycle assist is quite complex and still in the laboratory phase. Therefore, in order to solve the problem of Fontan circulatory failure from after-Fontan surgery to during heart transplantation, the applicant developed for this.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, the main object of the present invention is to provide a novel auxiliary device for treating Fontan circulatory failure, which is realized to solve the problem of Fontan circulatory failure from the time of Fontan operation to the time of heart transplantation.

In order to solve the technical problems, the embodiment of the invention provides a novel auxiliary device for treating Fontan circulatory failure, which comprises a balloon, wherein the balloon is arranged at the junction of a pulmonary artery, a superior vena cava and an inferior vena cava after Fontan surgery; and both ends of the balloon are respectively positioned in the superior vena cava and the inferior vena cava; and with the inflation and deflation of the balloon, the blood in the superior vena cava and the inferior vena cava is extruded into the pulmonary artery.

Wherein, also comprises an umbrella valve; umbrella-shaped valves are arranged at the upper end and the lower end of the saccule; the opening and closing of the umbrella-shaped valve are synchronous with the inflation and deflation of the saccule.

Wherein, also comprises valve chordae tendineae; one end of the valve chordae tendineae is connected with the umbrella-shaped valve, and the other end is connected with the saccule; when the balloon is deflated, the balloon pulls the umbrella valve through the valve chordae tendineae, closing the umbrella valve.

Wherein, the valve chordae tendineae are 3-8 in one group.

Wherein, the diameters of the two ends of the saccule are gradually reduced.

Wherein, also include, the air pump; the air pump is positioned outside the body and is connected with the saccule through a catheter.

Wherein the valve chordae tendineae are selected as gore-tex sutures.

Wherein the balloon of the device is placed by the internal jugular vein or the femoral vein.

Wherein the diameter of the balloon after inflation is smaller than or equal to the diameter of the superior vena cava and the inferior vena cava.

In the embodiment of the invention, the saccule is arranged at the intersection of the pulmonary artery, the superior vena cava and the inferior vena cava, and is inflated and deflated through inflation and deflation of the saccule, so that blood in the superior vena cava and the inferior vena cava is squeezed into the pulmonary artery. The valve is opened and closed synchronously, and the blood is prevented from flowing backwards to the superior vena cava and the inferior vena cava. The blood pulsates to enter the pulmonary artery, and the function of partial right ventricle is achieved, so that the Fontan circulatory failure treatment device can treat patients with Fontan circulatory failure and provide powerful conditions for later heart transplantation operations.

Drawings

In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.

FIG. 1 is a schematic view of the balloon inflation operation of the present invention;

FIG. 2 is a schematic view of the balloon deflation operation of the present invention;

Fig. 3 is a schematic representation of a post-Fontan operative angiogram.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.

Referring to fig. 3, fig. 3 is a photograph of a post-Fontan operative blood vessel showing the junction between the superior vena cava, inferior vena cava, and pulmonary artery. When the blood flows into the pulmonary artery from the superior vena cava and the inferior vena cava and the flow is not smooth, the Fontan circulation failure phenomenon occurs. The invention discloses a novel auxiliary device for treating Fontan circulatory failure, which comprises a balloon 6 and an air pump. The air pump is positioned outside the body, not shown, and is connected with the balloon 6 through a catheter. The air pump is used for inflating and deflating the balloon 6, and the selection of the air pump, the connection mode with the balloon and the like can be obtained by the existing basic knowledge of the technicians in the field, and are not described in detail herein. The saccule 6 is placed from the internal jugular vein or the femoral vein through a minimally invasive operation, and the saccule 6 is sent to the junction of the pulmonary artery 3, the superior vena cava 1 and the inferior vena cava 2 after the Fontan operation; the balloon 6 is now positioned at both ends in the superior vena cava 1 and inferior vena cava 2, respectively. When the balloon 6 is inflated, the balloon 6 is inflated to press the blood flowing into the superior vena cava 1 and the inferior vena cava 2 into the pulmonary artery 3, and the right ventricle functions as a part of the right ventricle, so that the blood flow can pulsate into the pulmonary artery. Alleviating the problem of Fontan circulatory failure.

In order to further increase the blood inflow volume of the pulmonary artery 3 and increase the blood inflow pressure during the use process, the invention is also provided with an umbrella valve 4 and valve chordae tendineae 5. Umbrella-shaped valves 4 are arranged at the upper end and the lower end of the saccule 6. One end of the valve chordae tendineae 5 is connected with the umbrella-shaped valve 4, and the other end is connected with the saccule 6; the connection mode can be the existing connection modes such as sewing, coupling and the like. The opening and closing of the umbrella-shaped valve 4 are synchronous with the inflation and deflation actions of the saccule 6. When the balloon is deflated, as shown in fig. 2, the balloon 6 pulls the umbrella valve 4 through the valve chordae 5, closing the umbrella valve 4 and allowing blood to exit the superior and inferior vena cava 1, 2. When the balloon 6 is inflated, as shown in fig. 1, the balloon 6 is expanded, the umbrella-shaped valve 4 automatically returns to the original shape, the superior vena cava 1 and the inferior vena cava 2 are sealed, and then blood is squeezed into the pulmonary artery 3. The umbrella-shaped valve 4 is used for plugging the superior vena cava 1 and the inferior vena cava 2, and has the function similar to a one-way valve, so that the blood volume entering the pulmonary artery is increased, and the blood pressure entering the pulmonary artery can also be increased. Meanwhile, the valve chordae tendineae 5 help the umbrella-shaped valve 4 to close in time when the saccule 6 is deflated, so that the pulmonary artery blood backflow phenomenon caused by saccule contraction is reduced as much as possible.

In an alternative embodiment, the set of valve chordae 5 consists of 3-8 chordae. There are two sets of valve chordae 5, one of which cooperates to connect the balloon to the umbrella valve located in the superior vena cava. The other set is used in conjunction with the balloon to connect the umbrella valve located in the inferior vena cava.

In an alternative embodiment, the balloon 6 is tapered at both ends.

In an alternative embodiment, the valve chordae 5 are chosen as gore-tex sutures.

In an alternative embodiment, the diameter of the balloon 6 after inflation is less than or equal to the diameter of the superior vena cava, inferior vena cava. The diameter of the balloon after being inflated can be the part S1 with the diameter not gradually reduced at the two ends of the balloon or the diameter of the balloon at the position S2 near the pulmonary artery after being inflated. Or the diameters of all parts of the balloon are smaller than or equal to the diameters of the superior vena cava and the inferior vena cava.

In an alternative embodiment, the diameter d of the umbrella valve 4 after opening is equal to the diameter of the superior vena cava and inferior vena cava.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention, and the technical solutions are all covered in the scope of the present specification. In particular, the technical features mentioned in the embodiments can be combined in any way as long as there is no structural conflict.