Balloon of transcatheter aortic valve delivery system

By designing a balloon with a transcatheter aortic valve delivery system with a bee-waist-like structure after filling, the problem of perival leakage in the prior art was solved, and better valve stent positioning and fitting were achieved, which significantly reduced the perival leakage phenomenon after surgery.

CN223009320UActive Publication Date: 2025-06-24ORBUSNEICH MEDICAL SHENZHEN CO LTD
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Patent Information

Application Number
CN202420619767.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-03-27
Publication Date
2025-06-24
Estimated Expiration
2034-03-27

AI Technical Summary

Technical Problem

In the prior art, during cardiac interventional treatment, the balloon dilated valve of the transcatheter aortic valve delivery system has a problem of perival leakage, resulting in symptoms such as chest tightness, chest pain, fatigue, dizziness, etc., and may even experience heart failure and sudden death.

Method used

A balloon of a catheter aortic valve delivery system is designed. After filling, it has a bee waist-shaped structure, with both ends being symmetrically arranged conical structures. The bee waist-shaped structure is coaxially arranged with the conical structure to form a shoulder, and the transition part is arc-shaped. The maximum diameter of the bee waist-shaped structure is connected to the large end of the conical structure, with the small end of the conical structure facing outward, and a cylindrical cylinder is connected to the small end of the conical structure.

Benefits of technology

Through the design of the bee waist-like structure, the balloon can better cover the edges of the valve stent and calcified valve, reduce the periphery leakage phenomenon, and enable the valve stent to be better positioned at the natural valve, reduce the risk of shedding, and significantly improve the periphery leakage problem after surgery.

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Abstract

The utility model discloses a balloon of a transcatheter aortic valve conveying system, which comprises a balloon, and after the balloon is filled, the middle of the balloon is of a bee waist-shaped structure. Compared with the prior art, the middle of the balloon is arranged to be of the wasp-waist-shaped structure, the periphery of the wasp-waist-shaped structure covers the edges of the valve support and the calcified valve, and on one hand, the phenomenon of perivalvular leakage is reduced; and on the other hand, the balloon can be better positioned at a natural valve through the bee waist-shaped structure, and is not easy to fall off from an aortic stenosis part.
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Description

Technical Field

[0001] The utility model relates to a medical device, in particular to a balloon of a transcatheter aortic valve delivery system for cardiac interventional therapy. Background Art

[0002] Aortic valve stenosis may be caused by senile aortic valve calcification. Patients may be asymptomatic during the compensatory period. Most patients with severe stenosis of the valve orifice have lassitude, dyspnea (exertional or paroxysmal), angina pectoris, dizziness or syncope, and even sudden death. The existing treatment methods from the cardiology department are mainly aortic valve replacement, using an inflated valve for replacement. Classified by the valve inflation method, the valves used in aortic valve replacement are divided into two types, one is a balloon-expandable valve, and the other is a self-expandable valve.

[0003] The balloon used in the existing balloon-expandable valve has a straight cylindrical structure. The balloon is connected to the distal end of the catheter to form a balloon catheter. The valve, which is also straight cylindrical, is evenly pressed circumferentially by a crimper and pressed at the middle position of the folded balloon. The valve, valve stent and balloon are pushed through a delivery device and a cannula into the cardiac valve annulus to be replaced. When interventional therapy is used to replace the aortic valve, the balloon is inflated by the pressurization of the liquid in the catheter, so that the valve and stent pressed on its surface can be expanded and attached to the aortic valve. In this process, usually the valve and stent are expanded into a regular straight cylindrical shape like the balloon. However, due to the irregular annular shape of the calcified lesion position of the aortic valve, there will be a gap between the stent and the calcified lesion position, resulting in a leak between the native valve and the implanted valve after surgery. This phenomenon is called paravalvular leak. Severe paravalvular leak ultimately leads to symptoms such as chest tightness, chest pain, fatigue, dizziness, etc. in the postoperative patients, and is prone to heart failure and sudden death in severe cases.

[0004] In response to this, a method of increasing the extended skirt at the bottom of the balloon-expandable valve is adopted, so that the structure at the aortic root of the valve is thickened, squeezing the irregular calcified lesion position and reducing the paravalvular leak. However, the skirt only increases the area of the valve base, increasing the friction between the calcified lesion position and the valve stent, preventing the stent from falling off. The gap between the balloon-expandable valve and the irregular calcified lesion position still exists, and the effect of reducing the paravalvular leak is still not obvious enough. Content of the Utility Model

[0005] The purpose of the utility model is to provide a balloon of a transcatheter aortic valve delivery system, and the technical problem to be solved is to reduce paravalvular leak.

[0006] To solve the above problems, the utility model is implemented by adopting the following technical solutions: A balloon of a transcatheter aortic valve delivery system includes a balloon. After being filled, the middle part of the balloon has a wasp-waist structure.

[0007] Furthermore, both ends of the balloon are symmetrically arranged conical structures, the hourglass-shaped structure is coaxially arranged with the conical structure, and a transition part is arranged between the hourglass-shaped structure and the conical structure to form a shoulder.

[0008] Furthermore, the transition part is arc-shaped.

[0009] Furthermore, the hourglass-shaped structure is an arc-shaped convex towards the axis of the balloon.

[0010] Furthermore, the maximum diameter of the hourglass-shaped structure is connected to the large end of the conical structure, and the small end of the conical structure faces outward.

[0011] Furthermore, a cylindrical cylinder is connected to the small end of the conical structure.

[0012] Compared with the prior art, in the present utility model, the middle part of the balloon is set as an hourglass-shaped structure, so that the outer periphery of the hourglass-shaped structure covers the edge of the valve stent and the calcified valve. On the one hand, the phenomenon of paravalvular leakage is reduced; on the other hand, the hourglass-shaped structure enables the balloon to be better positioned at the natural valve and is not easily detached from the aortic stenosis. Description of the Drawings

[0013] Figure 1 is a schematic structural diagram of the balloon of the present utility model.

[0014] Figure 2 is a schematic diagram of the balloon contraction of the present utility model.

[0015] Figure 3 is Figure 2 a schematic diagram after inflation.

[0016] Figure 4 is a schematic structural diagram when the stent is expanded after the balloon of the present utility model is inflated. Detailed Embodiments

[0017] The present utility model will be further described in detail below with reference to the drawings and embodiments.

[0018] As Figure 1 shown, the present utility model discloses a balloon (balloon) of a transcatheter aortic valve delivery system. After the balloon is inflated, the middle part of the balloon presents an hourglass-shaped structure 1, both ends of the balloon are symmetrically arranged conical structures 2, the hourglass-shaped structure 1 is coaxially arranged with the conical structure 2, an arc-shaped transition part is arranged between the hourglass-shaped structure 1 and the conical structure 2 to form a shoulder 3, the maximum diameter of the hourglass-shaped structure 1 is connected to the large end of the conical structure 2, the hourglass-shaped structure is an arc-shaped convex towards the axis of the balloon, the small end of the conical structure 2 faces outward, and a cylindrical cylinder 4 is connected to the small end of the conical structure 2.

[0019] As shown Figure 4 In the figure, the middle part of the balloon of the present utility model is in a wasp-waist structure 1, which will expand the balloon-expandable valve into the same wasp-waist shape. The balloon-expandable valve in the wasp-waist shape can better fit the stenosis and calcification at the irregular aortic valve to avoid paravalvular leakage.

[0020] As shown Figure 2 In the figure, in the folded and contracted state, the balloon is in a cylindrical shape as a whole. As shown Figure 3 In the figure, in the fully inflated state, the wasp-waist structure 1 of the balloon expands as a whole, and a height difference is formed between the middle position and the shoulders of the balloon. The middle wasp-waist structure 1 will be formed into an inner arc. The shoulders 3 of the balloon are stuck on the aortic valve, so that the entire aortic valve annulus is blocked. After the balloon expands as a whole, it can be continuously pressurized and inflated. At this time, the middle part of the wasp-waist structure will continue to expand with the pressure, while the two shoulders will not have excessive deformation. This design enables the balloon to hold the aortic valve as a whole in the circumferential direction, thereby reducing paravalvular leakage.

[0021] After applying the balloon of the transcatheter aortic valve delivery system of the present utility model to the transcatheter aortic valve delivery system, during the operation, when the balloon and the valve stent are sent to the area of the aortic valve through the transcatheter aortic valve delivery system, the balloon is pressurized and inflated by perfusing liquid to expand the valve stent. The two ends of the wasp-waist structure 1 expand first and expand the two ends of the valve stent, and then the middle expands, so as to ensure that the center point of the valve stent coincides with the center point of the balloon. When the balloon expands to the working pressure, the valve stent will be shaped into the same shape as the balloon and stuck at the natural valve ( Figure 4 as shown in the figure), with better conformity to the natural valve, so that the wasp-waist structure 1 of the balloon will cover the edges of the valve stent and the calcified valve, which can reduce the phenomenon of paravalvular leakage. On the other hand, the wasp-waist structure enables the valve stent to be better positioned at the natural valve and is not easily detached from the aortic stenosis.

[0022] The balloon of the present utility model can expand the valve stent into a whole wasp-waist structure. The wasp-waist-shaped valve stent will cover the irregular calcified positions with the large end parts at both ends. With its inner arc shape that fits the aortic wall better, it can greatly improve the problem of paravalvular leakage, which is safe and reliable.

Claims

1. A balloon for a transcatheter aortic valve delivery system, comprising a balloon, characterized in that: When the balloon is inflated, the middle of the balloon presents a wasp waist-shaped structure (1); the two ends of the balloon are symmetrically arranged conical structures (2); the wasp waist-shaped structure (1) and the conical structure (2) are arranged coaxially; a transition portion is provided between the wasp waist-shaped structure (1) and the conical structure (2) to form a shoulder (3).

2. The balloon of the transcatheter aortic valve delivery system according to claim 1, characterized in that: The transition portion is arc-shaped.

3. The balloon of the transcatheter aortic valve delivery system according to claim 1 or 2, characterized in that: The wasp waist structure (1) is an arc-shaped structure convex inwardly toward the axis of the balloon.

4. The balloon of the transcatheter aortic valve delivery system according to claim 3, characterized in that: The largest diameter of the wasp waist-shaped structure (1) is connected to the large end of the conical structure (2), and the small end of the conical structure (2) faces outwards.

5. The balloon of the transcatheter aortic valve delivery system according to claim 4, characterized in that: A cylindrical barrel (4) is connected to the small end of the conical structure (2).