CN113827374A - A new type of special cutting balloon for transcatheter artificial heart valve replacement - Google Patents

Abstract

The invention discloses a novel special cutting balloon for transcatheter artificial intervention heart valve replacement, which is particularly suitable for patients who need TAVR treatment after surgical biological valve replacement, and relates to the technical field of medical instruments. When TAVR operation is performed, the cutting saccule needs to be expanded by using higher pressure, so that the cutting saccule can linearly cut the aortic root, and the artificial intervention heart valve stent can be smoothly released and is fully attached to the wall. Better attached can effectively reduce TAVR postoperative valve week and leak, adopts novel through the special cutting sacculus of pipe artificial intervention heart valve replacement art's cutting effect, can improve TAVR operation success rate, reduces the emergence probability of operative complications such as artificial intervention heart valve aversion or postoperative valve week and leaks.

Description

Novel special cutting sacculus of artifical intervention heart valve replacement art through pipe

Technical Field

The invention relates to the technical field of medical instruments, in particular to a novel special cutting balloon for transcatheter artificial intervention heart valve replacement.

Background

Aortic Stenosis (AS) is a common valvular heart disease in the elderly, with increasing incidence AS the age increases. The incidence of AS is about 2% in people aged 65 and above, and about 4% in people aged 85 and above. Transcatheter Aortic Valve Replacement (TAVR) is an emerging minimally invasive Valve Replacement technology in the last decade, adopts transcatheter minimally invasive intervention technology and pedestrian artificial Aortic Valve Replacement, has the advantages of no chest opening, low risk, simplicity and convenience in operation, small wound, quick recovery, few complications and the like, and is particularly suitable for patients with surgical contraindications or high-risk surgical operations.

At present, TAVR operations are carried out in heart departments of major provincial hospitals in China, but the TAVR operations have higher requirements on the operation of an operator in the operation, the anatomical characteristics of the aortic root need to be mastered, and the operation is carried out according to the disease condition characteristics of a patient. Before the release of the artificial intervention heart valve stent, the balloon pre-expansion is needed to provide a base for the release of the stent, so as to achieve a better release effect of the valve stent. The valve stent has good release form and good fit with the aortic root, thereby not only effectively reducing the incidence rate of leakage around the TAVR postoperative valve, but also prolonging the service life of the artificial heart valve. In the elderly AS patients in China, due to factors such AS severe calcification of aortic valves, stenosis, adhesion of rheumatic lesions and the like, the shape and the texture of local tissues of the valves are hard, balloon pre-expansion is seriously affected, and the valve stent cannot be effectively released. When the existing balloon TAVR is pre-expanded in the operation, the balloon can slide or cannot be effectively expanded due to serious calcification, so that ideal balloon pre-expansion cannot be achieved. The research and development of the novel cutting sacculus special for the heart valve replacement operation through the manual intervention of the catheter can be the key of the success of the TAVR operation, the newly researched and developed cutting sacculus can assist an operator in the TAVR operation to better and more effectively pre-expand the sacculus before the TAVR operation, the development and the popularization of the TAVR technology in China can be facilitated, and the important clinical practical significance is achieved. At present, a related similar TAVR surgical special cutting sacculus is not seen at home and abroad.

Disclosure of Invention

Technical problem to be solved

Aiming at the defects of the prior art, the invention provides a novel special cutting balloon for transcatheter artificial intervention heart valve replacement, which solves the problems that the aortic valve is narrowed again after surgical biological valve operation, or the aortic root part has abnormal anatomical structure characteristics in TAVR operation, part of aortic root tissues of patients are calcified, the texture is hard (the earlier clinical research proves that the calcification degree of AS patients in China is higher), when the balloon is pre-expanded, the balloon can slide, the balloon expansion is not ideal, or the balloon can not be effectively expanded, and the release of a TAVR valve stent in the TAVR operation, especially the self-expansion artificial intervention heart valve, can possibly cause operation failure. Severe aortic valve or surrounding tissue calcification can lead to inefficient attachment of TAVR postoperative valve stents to the aortic wall, with perivalvular leakage. The artificial intervention valve stent can not be effectively expanded, so that the irregular shape of the valve stent is released by self expansion, thereby influencing the shape and the working state of the artificial valve leaflet, increasing the fatigue of the artificial valve leaflet and greatly reducing the service life of the artificial heart valve.

(II) technical scheme

In order to achieve the above purposes, the technical scheme adopted by the invention is as follows: the utility model provides a novel special cutting sacculus of heart valve replacement art is intervene to pipe manual work, includes the sacculus, the right-hand member of sacculus and the left end fixed connection of sacculus pipe, the right-hand member of sacculus pipe and the left end fixed connection of sacculus connecting piece, the surface mosaic of sacculus has five groups of little blades, and the quantity of every group little blade is 1-2.

Preferably, the balloon part is a non-compliant balloon made of nylon, polyester or polyolefin.

Preferably, the height of the microblade is 0.25-0.30 mm and the length is 15 mm.

(III) advantageous effects

The invention has the beneficial effects that:

1. when TAVR operation is performed, the cutting saccule needs to be expanded by using higher pressure, so that the cutting saccule can linearly cut the aortic root, and the artificial intervention heart valve stent can be smoothly released and is fully attached to the wall. Better is attached, can effectively reduce TAVR postoperative valve week and leak, adopts novel through the special cutting sacculus of pipe artificial intervention heart valve replacement art's cutting effect, can improve TAVR operation success rate, reduces the emergence probability of operative complications such as artificial intervention heart valve aversion or postoperative valve week and leaks, and the release of heart valve support is intervened in the manual work of better form can be so that the better work of artificial valve leaf and can prolong the life of artificial intervention heart valve.

2. According to the novel cutting balloon special for transcatheter artificial intervention heart valve replacement, the balloon blades are designed in a split arrangement mode, so that the conveying performance of the balloon is greatly improved, and the cutting balloon can also better adapt to a special anatomical structure of the root of an aorta when the balloon is inflated and expanded; secondly, because the root of the aorta is of a three-dimensional structure which is different from a tubular structure of a coronary artery, when the split blades are designed, an annular combination mode is adopted, 5 micro blades are uniformly arranged outside the balloon in an annular mode, and the cutting balloon can be fully attached to the root tissue of the aorta after being inflated so as to achieve an effective linear cutting effect.

Drawings

FIG. 1 is a front view of two sets of blades according to the present invention;

FIG. 2 is a left side view schematic of the balloon of the present invention;

FIG. 3 is a front view of two micro-blades of the same cutting line according to the present invention;

FIG. 4 is a schematic view of the cutting balloon of the present invention reaching the root of the aorta;

FIG. 5 is a schematic view of the cutting balloon of the present invention in an operative position;

FIG. 6 is a front view of a set of blades of the present invention;

FIG. 7 is a front view of a set of micro-blades with the same cutting line.

In the figure: 1 sacculus, 2 microblades, 3 sacculus connecting pieces, 4 sacculus pipes.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

As shown in fig. 1 to 7, the present invention provides a technical solution: a novel special cutting sacculus for transcatheter artificial intervention heart valve replacement comprises asacculus 1, wherein the head end of thesacculus 1 is soft enough to ensure that peripheral blood vessels and heart valve tissues cannot be damaged, the main body diameter of thesacculus 1 is 18 mm, 20 mm, 22 mm, 24 mm and 26mm, the length is 40mm, the right end of thesacculus 1 is fixedly connected with the left end of asacculus conduit 4, the outer layer of thesacculus conduit 4 is coated with a hydrophilic coating to increase the pushing function of the conduit and reduce the damage to blood vessels, a guide wire channel and a contrast agent channel are arranged in thesacculus conduit 4 to meet different requirements, the pushing rod part of thesacculus conduit 4 is made of metal materials, common materials comprise stainless steel, nickel-titanium alloy and other metal materials, the pushing rod is specially designed at the same time to meet the condition that the pushing rod can be flexibly bent according to the bending condition of the blood vessels so as to smoothly push the sacculus to the aortic annulus part and avoid the damage to the blood vessels, the right-hand member ofsacculus pipe 4 and the left end fixed connection ofsacculus connecting piece 3,sacculus connecting part 3 is used for injecting gas or liquid intosacculus 1 respectively, another connecting part is sacculus seal wire passageway, suitable position can be carried along the track of seal wire tosacculus pipe 4 like this, the surface ofsacculus 1 is inlayed and is had five groups ofmicroblades 2, the quantity of everygroup microblade 2 is 1-2, themicroblade 2 ofsacculus 1 outside, total 5-10 blades, inlay aroundsacculus 1 external diameter,encircle sacculus 1 respectively, every twomicroblades 2 are in same cutting line, its effect lies in: because this kind of sacculus is TAVR operation special use, is big sacculus, if blade length overlength, can lead to the trafficability characteristic ofsacculus 1 poor, and inlay 2short microblades 2 on same cutting line and can improve trafficability characteristic, still help to deal with the complicated spatial structure in aorta root simultaneously.

Theballoon 1 is a non-compliant balloon made of nylon, polyester or polyolefin, and themicro-blade 2 has a height of 0.25-0.30 mm and a length of 15 mm.

FIG. 4 shows the cutting balloon reaching the root of the aorta with the cutting balloon in place;

fig. 5 shows the cutting balloon working part, theballoon 1 is inflated and expanded to cut the aortic root tissue, so as to smoothly release the artificial intervention heart valve stent, provide a better release substrate, improve the success rate of the operation and prolong the service time of the artificial intervention heart valve.

The method comprises the following operation steps:

s1, when the balloon needs to be used, firstly, theballoon 1 is in a contraction state, and themicro-blade 2 is wrapped;

s2, enabling the cutting balloon to reach the root of the aorta, and placing the cutting balloon at a proper position;

and S3, finally, inflating and expanding theballoon 1, wherein themicro-blade 2 can be fully contacted with the aortic root tissue or the valve leaflet tissue for cutting, when the cutting is completed, theballoon 1 can be gradually decompressed, and themicro-blade 2 can be rewrapped by theballoon 1 and is withdrawn out of the body.

The above-mentioned embodiments, objects, technical solutions and advantages of the present invention are further described in detail, it should be understood that the above-mentioned embodiments are only illustrative of the present invention and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (3)

Translated fromChinese

1.一种新型经导管人工介入心脏瓣膜置换术专用切割球囊，包括球囊（1），其特征在于：所述球囊（1）的右端与球囊导管（4）的左端固定连接，所述球囊导管（4）的右端与球囊连接件（3）的左端固定连接，所述球囊（1）的外表面镶嵌有五组微刀片（2），每组微刀片（2）的数量为1-2个，且每两个微刀片（2）处于同一切割线上。1. A novel transcatheter artificial interventional heart valve replacement special cutting balloon, comprising a balloon (1), characterized in that: the right end of the balloon (1) is fixedly connected to the left end of the balloon catheter (4), The right end of the balloon catheter (4) is fixedly connected with the left end of the balloon connector (3), and the outer surface of the balloon (1) is inlaid with five groups of microblades (2), each group of microblades (2) The number is 1-2, and every two microblades (2) are on the same cutting line.2.根据权利要求1所述的一种新型经导管人工介入心脏瓣膜置换术专用切割球囊，其特征在于：所述球囊（1）部分为非顺应性球囊，材质为尼龙、聚酯或是聚烯烃制成。2. A new type of special cutting balloon for transcatheter artificial heart valve replacement according to claim 1, characterized in that: the balloon (1) part is a non-compliant balloon, and the material is nylon, polyester or polyolefin.3.根据权利要求1所述的一种新型经导管人工介入心脏瓣膜置换术专用切割球囊，其特征在于：所述微刀片（2）的高度为0.25-0.30毫米，长度为15毫米。3 . The new type of special cutting balloon for transcatheter artificial heart valve replacement according to claim 1 , wherein the height of the micro blade ( 2 ) is 0.25-0.30 mm, and the length is 15 mm. 4 .

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