CN115957044A

CN115957044A - Percutaneous implanted diastole auxiliary system

Info

Publication number: CN115957044A
Application number: CN202111184727.6A
Authority: CN
Inventors: 柳光茂; 胡盛寿
Original assignee: Yuanshen Shenzhen Medical Instrument Co ltd
Current assignee: Yuanshen Shenzhen Medical Instrument Co ltd
Priority date: 2021-10-11
Filing date: 2021-10-11
Publication date: 2023-04-14

Abstract

The invention discloses a percutaneous implanted diastole auxiliary system which is used for treating diastole insufficiency. The system comprises a conveying conduit device and a bracket type elastic spring, wherein the conveying conduit device comprises a conveying sleeve, an ejector plate and a hard flexible ejector rod, wherein the ejector plate and the hard flexible ejector rod are arranged in the conveying sleeve; the bracket type elastic spring is a closed loop structure consisting of a plurality of upper fixed rings, a plurality of lower fixed rings and spring wires which are respectively arranged between the corresponding upper fixed rings and the corresponding lower fixed rings; the bracket type elastic spring is accommodated in the position close to the end part in the conveying sleeve after being compressed and folded, and one end of the bracket type elastic spring, which is close to the upper fixing ring, is in contact with an ejector plate arranged in the conveying sleeve; the foldable bracket type elastic spring is ejected out of the conveying sleeve by controlling the ejection rod to move forwards in the conveying sleeve, and the bracket type elastic spring is in a spreading state under the condition of not being restricted by the conveying sleeve.

Description

Percutaneous implanted diastole auxiliary system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a percutaneous implanted diastole auxiliary system which is used for treating diastole insufficiency.

Background

Diastolic heart failure is the dysfunction of ventricular diastolic function under the condition that ventricular systolic function is normal or mild failure, which results in the reduction of blood filling amount in ventricles and the increase of ventricular end diastolic pressure, and the left ventricular ejection fraction of patients with diastolic heart failure is generally reserved, so the patients with diastolic heart failure cannot be treated by the traditional ventricular assist device for increasing cardiac output.

Diastolic heart failure is caused by a decrease in ventricular filling due to abnormal, impaired ventricular diastolic function that slows or weakens ventricular filling or poor ventricular compliance that is restricted to diastolic function resulting in ventricular filling failure. The body must obtain normal ventricular filling and stroke volume by a method of increasing left ventricular filling pressure, so that the pressure of venous return is increased, the pulmonary venous pressure is increased, and then a series of symptoms such as dyspnea, abdominal or leg edema, cardiogenic shock and the like of a patient can be caused. Diastolic heart failure is mainly manifested by dyspnea and impaired exercise tolerance, the current treatment means mainly include etiology treatment and drug treatment, the prognosis difference is large, the basic diseases are complicated, and the prognosis of different patients is different.

Therefore, the minimally invasive implanted heart assist device suitable for diastolic heart failure treatment is of great significance, can solve the problem of poor prognosis of drug treatment, replace drug treatment, and can restore the diastolic function of the ventricles to be normal by enhancing the diastolic function and filling performance of the ventricles for a long time.

Disclosure of Invention

The invention aims to provide a percutaneous implanted diastole auxiliary system which is suitable for assisting and recovering the diastole function of the diastolic heart failure heart and is designed for enhancing the cardiac output of a diastolic heart failure patient and reducing the left ventricular diastolic pressure, aiming at the physiological defects of a circulatory system, such as the reduction of ventricular filling, the reduction of stroke volume and the increase of end diastolic pressure of the diastolic heart failure, and aiming at the problem that the effect difference of the drug treatment on the diastolic heart failure is large.

In order to achieve the purpose, the invention adopts the following technical scheme:

a percutaneous implanted diastole auxiliary system comprises a conveying conduit device and a bracket type elastic spring, wherein the conveying conduit device comprises a conveying sleeve, an ejector plate and a hard flexible ejector rod, wherein the ejector plate and the hard flexible ejector rod are arranged in the conveying sleeve;

the bracket type elastic spring is a closed loop structure consisting of a plurality of upper fixing rings, a plurality of lower fixing rings and spring wires which are respectively arranged between the corresponding upper fixing rings and the corresponding lower fixing rings; the bracket type elastic spring is accommodated in the position close to the end part in the conveying sleeve after being compressed and folded, and one end of the bracket type elastic spring, which is close to the upper fixing ring, is in contact with an ejector plate arranged in the conveying sleeve; the foldable bracket type elastic spring is ejected out of the conveying sleeve by controlling the ejection rod to move forwards in the conveying sleeve, and the bracket type elastic spring is in a spreading state under the condition of not being restricted by the conveying sleeve.

Preferably, the opening diameter of the bracket-type spring surrounded by the plurality of upper fixing rings is larger than the opening diameter surrounded by the plurality of lower fixing rings.

Preferably, the plurality of upper fixing rings and the plurality of lower fixing rings are equal in number and are uniformly arranged.

Preferably, the number of the plurality of upper fixing rings and the number of the plurality of lower fixing rings are respectively 3 to 6.

Preferably, the diameter of the spring wire is 0.5mm-1mm.

Preferably, the upper fixing ring and the lower fixing ring of the bracket type elastic spring are integrally formed with the spring wire.

Preferably, the stent type elastic spring has a folding and self-expanding function, the expanded shape in the expanded state is matched with the shape of the inner wall of the ventricle, and the outer diameter determined by the spring wire in the shape is slightly larger than the maximum inner diameter of the corresponding position of the inner wall of the ventricle at the end diastole.

The invention has the beneficial effects that:

the diastole auxiliary system adopts the flexible tubular hollow conveying catheter device as a passage, and conveys the compressed elastic spring into the ventricle through the femoral artery in a minimally invasive way, and has the advantages of quick implantation, small wound and simple and convenient operation; the elastic spring can be compressed so as to be implanted in a minimally invasive way through the conveying catheter device, works on the inner wall of the ventricle in the diastole of the ventricle by virtue of the self-expansion function of the elastic spring, enhances the diastole function of the ventricle without an external power source, and has the beneficial effects that no internal and external connecting wires are needed when the elastic spring is passive, and the infection caused by the internal and external connecting wires is avoided. The whole system has small operation trauma, reduces operation risk, can effectively treat diastolic heart failure and relieve or reverse the heart failure.

The diastole auxiliary system has the elastic spring with the structural characteristics of wide top and narrow bottom, is similar to the structure in the ventricle, and the outer diameter of each position of the elastic spring in a natural state from top to bottom is larger than the inner diameter of the ventricle at the corresponding position of the inner wall of the ventricle at the end diastole, so the elastic spring can be well attached to the inner wall of the ventricle.

Drawings

FIG. 1 is a schematic representation of the diastolic assist system of the present invention showing the delivery catheter device releasing the stent-type resilient spring into the left ventricle through the transthoracic aortic trans-valve.

Fig. 2 is a schematic structural diagram of the stent-type elastic spring in the diastolic auxiliary system of the present invention in an expanded state (natural state).

Fig. 3 is a schematic structural diagram of the stent-type elastic spring in the diastolic auxiliary system according to the present invention in a folded state.

Fig. 4 is a schematic diagram illustrating a state of the stent type elastic spring in the ventricular diastolic assist system of the present invention after being implanted into the left ventricle.

Detailed Description

The following describes embodiments of the present invention in further detail with reference to the accompanying drawings.

The diastolic assist system of the present invention includes a delivery catheter device 1 and a stent type spring 2. As shown in fig. 1, the delivery catheter device 1 includes a flexible tubular hollow delivery cannula 11, and an ejector plate 12 and a rigid flexible ejector rod 13 which are installed in the delivery cannula 11, wherein one end of the ejector rod 13 is connected to the ejector plate 12 and can drive the ejector plate 12 to move back and forth along the inner wall of the delivery cannula 11. A folded bracket type elastic spring 2 described later is accommodated in a position of a front end portion (head portion) of the delivery casing 11. The inner diameter of the delivery sleeve 11 matches the outer contour of the folded stent spring 2, preferably enabling an unobstructed forward and backward movement of the folded stent spring in the delivery sleeve. From the viewpoint of percutaneous implantation by minimally invasive surgery, the inner diameter of the delivery cannula 11 is preferably controlled to be about 6 mm.

As shown in fig. 2, the bracket-type elastic spring 2 is a closed loop structure composed of a plurality of upper fixing rings 21, a plurality of lower fixing rings 22, and spring wires 23 respectively disposed between the corresponding upper fixing rings 21 and lower fixing rings 22. As a connection manner among the upper fixing rings 21, the lower fixing rings 22, and the spring wires 23, for example, each upper fixing ring 21 may be connected to two adjacent lower fixing rings 22 by the spring wires 23, respectively, and each lower fixing ring 22 may be connected to two adjacent upper fixing rings 21 by the spring wires 23, respectively. The number of the plurality of upper fixing rings 21 is equal to that of the plurality of lower fixing rings 22, and the upper fixing rings and the lower fixing rings are uniformly arranged. Although the number of the upper fixing rings 21 and the number of the lower fixing rings 22 shown in fig. 2 are 4, the specific number of the upper fixing rings 21 and the lower fixing rings 22 is not particularly limited in the present invention, and may be, for example, 3 to 6, or 6 or more. The direction along the space between the upper fixing ring 21 and the lower fixing ring 22 is referred to as the axial direction, and the outer contour surrounded by the plurality of upper fixing rings 22 or the plurality of lower fixing rings 23 is referred to as the radial direction. The opening diameter R1 of the bracket-type spring 2 surrounded by the plurality of upper fixing rings 21 is larger than the opening diameter R2 surrounded by the plurality of lower fixing rings 22. The bracket type elastic spring 2 has the functions of folding and self-expanding, and the folded shape is as shown in fig. 3, at this time, the maximum distance between the upper fixing ring 21 and the lower fixing ring 22 determines the length of the folded bracket type elastic spring 2 in the inner sleeve 12; the expanded shape of the expanded state is matched with the shape of the inner wall of the ventricle, and the outer diameter determined by the spring wire in each part is slightly larger than the maximum inner diameter of the inner wall of the ventricle of the part at the end diastole. By "slightly larger" is meant that the spring is minimally assured of conforming to the inner wall of the ventricle throughout the cardiac cycle. The bracket-type elastic spring 2 can be formed by integrally forming the upper fixing ring 21, the lower fixing ring 22 and the spring wire 23, for example, the whole body is made of a complete spring wire by a spring processing and rolling process. The diameter of the spring wire 23 is preferably 0.5mm to 1mm. The material of the bracket-type elastic spring includes, but is not limited to, titanium alloy, 316L stainless steel, elastic alloy with good biocompatibility, and the like.

The assembly process of the diastolic assist system of the present invention will be described below. The spring wire of the bracket type elastic spring 2 in an expanded state (natural state) is accommodated in the position close to the end part in the conveying sleeve 11 after being compressed and folded along the radial direction, and one end of the bracket type elastic spring 2 close to the upper fixing ring 21 is in contact with an ejector plate 12 arranged in the conveying sleeve 11; the folded bracket-type elastic spring 2 is ejected from the delivery casing 11 by controlling the ejection rod 13 to move forward in the delivery casing, and the bracket-type elastic spring 2 is in an expanded state without being constrained by the delivery casing 11.

As shown in fig. 1, after the structural assembly of the ventricular diastole auxiliary system of the present invention is completed, the delivery cannula 11 is implanted percutaneously, the stent-type elastic spring 2 is delivered to the left ventricle 3 close to the aortic valve through the femoral artery 4 by transthoracic aortic valve-crossing, the ejector plate 12 is driven by the control ejector rod 13 to move forward, and the stent-type elastic spring is ejected from the delivery cannula 11 and released into the left ventricle 3, so as to be in a stretched state and supported on the inner wall of the ventricle. At this point, the delivery cannula 11 is removed. As shown in fig. 4, the positions of the left ventricle 3, the right ventricle 5, the right atrium 6, and the left atrium 7 in the heart are simply marked, and the stent-type elastic spring 2 located in the left ventricle 3 is in an expanded state. Under the state, the bracket type elastic spring 2 contracts under the action of inward extrusion force of the inner wall of the ventricle when the heart contracts, the elastic spring 2 with elastic expansion force expands outwards to assist the diastole of the ventricle when the heart relaxes, so that the cardiac output is improved, and the diastolic pressure of the left ventricle is reduced.

Specifically, since the size of the outer contour of the stent-type elastic spring 2 in the expanded state is larger than the maximum size of the end-diastole ventricular inner wall, the upper fixing rings 21 and the lower fixing rings 22 which are uniformly arranged on the stent-type elastic spring 2 are attached to the left ventricular inner wall, the lower fixing rings 22 are attached to the position close to the apex of the heart in the left ventricular inner wall, the upper fixing rings 21 are attached to the position close to the aortic valve in the left ventricular inner wall, and the outward-protruding elastic spring wire 23 is attached to the left ventricular inner wall in the whole cardiac cycle. The size of the outer contour of the bracket type elastic spring in a natural state is larger than the maximum size of the inner wall of the ventricle in the end diastole, so that the bracket type elastic spring is always in a contraction state of bearing the extrusion of the inner wall of the ventricle in the left ventricle, the bracket type elastic spring is further compressed to store elastic energy when the ventricle contracts, and the bracket type elastic spring releases the elastic energy when the ventricle relaxes, so that the diastole of the ventricle is assisted.

Finally, it should be understood that the above-mentioned embodiments are not intended to limit the present invention, and any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A percutaneous implanted diastole auxiliary system is characterized by comprising a conveying conduit device and a bracket type elastic spring, wherein the conveying conduit device comprises a conveying sleeve, an ejector plate and a hard flexible ejector rod, wherein the ejector plate and the hard flexible ejector rod are arranged in the conveying sleeve;

the bracket type elastic spring is a closed loop structure consisting of a plurality of upper fixed rings, a plurality of lower fixed rings and spring wires which are respectively arranged between the corresponding upper fixed rings and the corresponding lower fixed rings; the bracket type elastic spring is accommodated in the position close to the end part in the conveying sleeve after being compressed and folded, and one end of the bracket type elastic spring, which is close to the upper fixing ring, is in contact with an ejector plate arranged in the conveying sleeve; the foldable bracket type elastic spring is ejected out of the conveying sleeve by controlling the ejection rod to move forwards in the conveying sleeve, and the bracket type elastic spring is in a spreading state under the condition of not being restricted by the conveying sleeve.

2. The percutaneously implantable diastolic assist system of claim 1, wherein the stent spring has an opening surrounded by a plurality of upper retaining rings having a diameter greater than an opening surrounded by a plurality of lower retaining rings.

3. The percutaneously implanted diastolic assist system of claim 1 or 2, wherein the plurality of upper fixation rings is equal in number and evenly arranged with the plurality of lower fixation rings.

4. The percutaneously implantable diastolic assist system of claim 3, wherein the number of the plurality of upper fixation rings and the plurality of lower fixation rings is 3 to 6, respectively.

5. The percutaneously implanted diastolic assist system of claim 1 or 2, wherein the spring wire has a diameter of 0.5mm to 1mm.

6. The percutaneously implanted diastolic assist system of claim 1 or 2, wherein the upper and lower retainer rings of the stented spring are integrally formed with the wire.

7. The percutaneously implantable diastolic assist system according to claim 1 or 2, wherein the stent type elastic spring has a foldable and self-expandable function, and a shape in an expanded, expanded state matches a shape of an inner wall of a ventricle, and an outer diameter determined by the spring wire in the shape is slightly larger than a maximum inner diameter of a corresponding position of the inner wall of the ventricle at the end diastole.