Aortic valve balloon dilatation device

Abstract

The invention provides an aortic valve balloon dilatation device, the aortic valve balloon dilatation device comprises a balloon catheter and an adjustable structure, and the adjustable structure can penetrate through the balloon catheter; the adjustable structure comprises a variable catheter, an adjustable guide pipe and an elastic part, wherein the variable catheter is provided with a protruding part; the protruding part comprises an outer protruding side and an inner protruding side, and the protruding height of the outer protruding side is larger than the protruding height of the inner protruding side. The adjusting tube and the variable catheter provided by the invention not only have certain supporting force, but also have certain tube diameter, so that the pigtail catheter can be sleeved in the adjusting tube in advance, the pigtail catheter does not need to be independently conveyed in the prior art, and the operation time is shortened by more than 40%.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to an aortic valve balloon dilatation device. BACKGROUND

[0002] Aortic valve balloon dilatation is an interventional treatment method for treating aortic stenosis (AS). It is used by inserting a catheter with an inflatable balloon through the femoral artery into the aorta and aortic valve site to dilate the stenotic aortic valve to improve blood flow and relieve related symptoms.

[0003] The prior art surgical method is to first pass the distal end of the soft guide wire through the aortic valve (cross valve) into the left ventricle as a guide, then the pigtail catheter enters the left ventricle along the soft guide wire, and then the soft guide wire is withdrawn and replaced with a hard guide wire. After the hard guide wire is arranged, the pigtail catheter is withdrawn, and the distal end of the balloon catheter is passed through the aortic valve along the hard guide wire to pre-dilate the valve. Such a surgical method requires multiple changes of guide wires and catheters, and then the balloon catheter can be delivered to the patient along the hard guide wire, so the operation time is long, the patient's pain is increased, and the surgical risk is also increased.

[0004] In addition, in order to avoid damage to the patient's tissue by the guide wire, the straight guide wire is generally made of a material that is easy to bend, so even if it should maintain a straight line through the defective valve, it is easy to bend.

[0005] One difficulty associated with this procedure is that it requires a high degree of skill from the surgical medical staff, which is not conducive to the promotion of the surgery.

[0006] The imaging equipment currently used in the operating room generally displays a two-dimensional view. Therefore, the position of the aortic valve orifice cannot be accurately determined from the two-dimensional image alone, and the medical staff may misjudge, such as mistakenly considering the tip of the guide wire close to the aortic wall as the aortic valve orifice, which may lead to a failed surgery in severe cases.

[0007] In view of the above problems, a balloon catheter device is designed, which can quickly and safely pass through the stenotic aortic valve and complete the valve pre-expansion in one step, reducing the surgical operation steps. SUMMARY

[0008] The present application provides an aortic valve balloon dilatation device, which comprises a balloon catheter and an adjustable structure, the adjustable structure can pass through the balloon catheter; the adjustable structure comprises:

[0009] A variable catheter provided with a protrudable part;

[0010] The protrudable part comprises an outer protruding side and an inner protruding side, the protrudable height of the outer protruding side is greater than that of the inner protruding side.

[0011] In other embodiments, the adjustable structure further comprises an adjusting tube, the adjusting tube is sleeved in the variable catheter, and a distal end of the adjusting tube is fixedly connected with the distal end of the variable catheter, and other parts of the adjusting tube can move relative to the variable catheter to change the protruding height of the protrudable part, so that the protrudable part is in an expanded state or a collapsed state.

[0012] In other embodiments, in the expanded state, along the cross section of the protrudable part, the outer peripheral length of the outer protruding side is greater than that of the inner protruding side.

[0013] In other embodiments, the protrudable part is one of a balloon, a braided mesh and a basket.

[0014] In other embodiments, the protrudable part is a balloon, and the balloon is in communication with the outside at a proximal end.

[0015] In other embodiments, the protrudable part is a basket, and the basket comprises 3-5 basket strips in the axial direction of the variable catheter.

[0016] In other embodiments, in the expanded state, along the maximum cross section of the protrudable part, the central angle α of the circular arc surrounded by the basket strips is 60°-270°, preferably 80°-220°, and more preferably 90°-180°.

[0017] In other embodiments, the protrudable height of the protrudable part is 3mm-45mm, preferably 4mm-35mm, and more preferably 5mm-30mm.

[0018] In other embodiments, the inner diameter of the adjusting tube is greater than the outer diameter of the pigtail catheter, the variable catheter has a hardness that allows the pigtail catheter to pass through and provides a support force.

[0019] In other embodiments, the balloon catheter comprises an inflatable balloon made of a high polymer material.

[0020] Compared with the prior art, the present application has the following beneficial effects:

[0021] 1. The adjusting tube and the variable catheter provided by the present application have a certain support force and a certain pipe diameter, so that the pigtail catheter can be sleeved in the adjusting tube in advance, and it is not necessary to separately transport the pigtail catheter as in the prior art.

[0022] 2. Balloon catheters, pigtail catheters, and adjustable structures can be simultaneously delivered to the target location along the soft guidewire, reducing surgical time by more than 40%. Furthermore, the reduction in surgical steps lowers the probability of errors by medical staff and lowers the skill requirements, thus facilitating the widespread adoption of the procedure.

[0023] 3. By adjusting the height of the protrusion of the protruding part, the distal end of the adjustment tube can be directed toward the aortic valve orifice, so that the guidewire can pass smoothly through the aortic valve orifice and reach the left ventricle, in preparation for subsequent surgery.

[0024] 4. Because the cross-sectional shape of the protruding portion is not a regular circle, but rather the protruding height of the outer protruding side is greater than that of the inner protruding side, and there is even no basket or other protruding object on the inner protruding side, for patients with a large aorta, the protruding portion will not bulge too much, causing the adjusting tube to cross the aortic midline, thus preventing the inner protruding portion from compressing the inner aortic side to prevent the outer protruding side from continuing to bulge. In other words, the adjustable structure provided by this invention can not only accommodate more patients with aortic valve disease for use in aortic valve replacement surgery to assist in guidewire crossing the valve and aortic valve pre-dilation, but can also be used in atrial septal puncture surgery.

[0025] 5. The adjustable structure and guidewire-assisted transvalvular device provided by the present invention have a simple structure and low production cost, which can reduce the cost of use for patients. Attached Figure Description

[0026] The invention will be more fully understood and appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 This is a schematic diagram of an aortic valve balloon dilation device provided by the present invention;

[0028] Figure 2 This is a schematic diagram of the contraction and expansion states of the adjustable structure 10.

[0029] Figure 3A A schematic diagram of the adjustable structure formed by the net basket;

[0030] Figure 3B for Figure 3A A cross-sectional view of the center net basket at point C-C'.

[0031] Figure 4 A schematic diagram of an adjustable structure formed by woven mesh;

[0032] Figure 5 A schematic diagram of the adjustable structure formed by the balloon;

[0033] Figure 6 This is a schematic diagram of an adjustable structure, specifically a pig tail cannula.

[0034] Figure 7 is a cross-sectional view of the balloon dilatation device shown in Figure 6

[0035] Figure 8 is a schematic view of the balloon dilatation device shown in

[0036] Figure 9 is a schematic view of the aortic valve balloon dilatation device provided by the present application in a delivery state;

[0037] Figure 10 is a cross-sectional view of the balloon dilatation device shown in Figure 9

[0038] Figure 11 is a schematic view of the balloon dilatation device shown in Figure 9

[0039] Figure 12 is a schematic view of the balloon dilatation device shown in Figure 9

[0040] Figure 13 Figure 14 are two other embodiments of the aortic valve balloon dilatation device provided by the present application.

[0041] wherein 100, aortic valve balloon dilatation device, 10, adjustable structure, 101, variable catheter, 102, protruding part, 103, adjusting tube, 104, pigtail catheter, 105, fixing seat, 106, balloon catheter, 1061, balloon, 1062, liquid filling tube, 1063, Y valve, 107, soft guide wire DETAILED DESCRIPTION

[0042] In order to more clearly illustrate the embodiments of the present application, the specific embodiments of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only part of the embodiments of the present application, and other similar embodiments can be extended according to the embodiments provided by the present application, which should also be covered within the protection scope of the present patent.

[0043] Reference will now be made to the drawings, wherein: Figure 1 ​​​​​Figure 1 is a schematic diagram of an aortic valve balloon dilatation device provided by the present application. The balloon dilatation device 100 comprises an adjustable structure 10 and a balloon catheter 106, the adjustable structure 10 can pass through the hollow pipe of the balloon catheter 106, and the distal end of the adjustable structure 10 can pass through the balloon 1061 located at the distal end of the balloon catheter 106. Generally, the balloon dilatation device 100 can also comprise a pigtail catheter 104, which can pass through the hollow pipe of the adjustable structure 10. Of course, the pigtail catheter 104 can not be included in the system of the balloon dilatation device 100, but can be configured by a hospital or other institution. The pigtail catheter 104 is a prior art, which mainly provides a channel for subsequent replacement of a hard guide wire. In other embodiments, the pigtail catheter 104 can be replaced by a guide catheter without changing the use of the patent.

[0044] Reference is now made to Figure 2 Figure 2 is a schematic diagram of the adjustable structure 10 in the collapsed state and the expanded state. Here, the collapsed state diagram is taken as an example. The adjustable structure comprises a variable catheter 101 and an adjusting tube 103, the adjusting tube 103 is sleeved in the variable catheter 101, and the distal end of the adjusting tube 103 is fixedly connected with the distal end of the variable catheter. Among them Figure 2 In which the lower end is the distal end, and the upper end is the proximal end, which is the end close to the medical staff during the operation.

[0045] The variable catheter 101 comprises a delivery section 1011, a protrudable part 102, and preferably the distal end of the variable catheter 101 can also be provided with a collapsed end 1012, and the two ends of the protrudable part 102 are connected to the delivery section 1011 and the collapsed end 1012 respectively. The distal end of the variable catheter 103 is fixedly connected with the collapsed end 1012. The other part of the adjusting tube 103 can move relative to the variable catheter 101, and the proximal end of the adjusting tube 103 passes out of the variable catheter 101, fixing the position of the proximal end of the variable catheter 101. Pulling the adjusting tube 103 towards the proximal end, the protrudable part 102 is subjected to a squeezing force, and moves in a direction perpendicular to the center line of the adjustable structure, i.e. laterally, i.e. the protrudable part 102 bulges outward, so as to change its protruding height, so that the protrudable part 102 is in the expanded state.

[0046] In order to adapt to more patients, continue as Figure 2As shown, the protrudable portion 102 comprises an outer protruding side 1023 and an inner protruding side 1024, the protrudable height H1 of the outer protruding side 1023 is greater than the protrudable height H2 of the inner protruding side. Wherein, the protrudable height refers to the vertical distance from the farthest end of the outer protruding side 1023 and the inner protruding side 1024 to the central axis of the adjusting tube 103. In a preferred embodiment, the protrudable height of the protrudable portion 102 is 3mm-45mm, preferably 4mm-35mm, more preferably 5mm-30mm. Such as 8mm, 10mm, 15mm, 18mm, 20mm, 24mm, 26mm, 28mm, 32mm, 38mm, 42mm, 44mm, etc., which can meet the needs of most patients.

[0047] That is, in the inflated state, Figure 2 The cross section (not shown) of the protrudable portion 102 at points A, O, B, the outer peripheral length of the outer protruding side 1023 is greater than the outer peripheral length of the inner protruding side 1024.

[0048] The protrudable portion 102 functions to extend to its surroundings, especially to the outside, when pulling back the adjusting tube 103, and can provide a certain supporting force, so the protrudable portion 102 needs to have both flexibility and strength, which can be a balloon, a woven mesh, or a basket.

[0049] As Figure 3A The variable catheter 101 shown has a protrudable portion 102 in the shape of a basket, which is surrounded by a plurality of basket bars 1021 extending in the axial direction of the variable catheter 101. Further, the number of basket bars 1021 is 3-5. When the protrudable portion 102 is in the inflated state, along the cross section at AOB, as Figure 3B As shown, the central angle α of the arc surrounded by the basket bars 1021 is 60°-270°, preferably 80°-220°, more preferably 90°-180°.

[0050] In Figure 3A , Figure 3B the embodiment shown, Figure 3B In the cross-sectional view, the cross sections of the plurality of basket bars 1021 are drawn as continuous lines, only for the convenience of understanding. The structure of the protrudable portion 102 is mainly composed of the basket bars 1021. The shape of the basket bars 1021 can be rectangular, S-shaped, or other irregular shapes, as long as it can meet the requirements of being inflatable and supportable.

[0051] In Figure 3A , Figure 3BIn the illustrated embodiment, the protruding portion 102 can be formed by cutting a polymer tube. It can be created at the distal end of the variable conduit 101 by axially cutting the variable conduit 101 and removing several baskets to form a partial slot. Alternatively, it can be made using a single polymer tube. Multiple basket strips are cut along the axial direction of the polymer tube to form the protruding portion 102, which is then welded or bonded to the delivery section 1011 and the receiving section 1012 of the variable conduit 101. The material used to make the basket strips 1021 can be a polymer material, such as PEBAX, PA, PTFE, HDPE, TPU, PEEK, etc. It can also be made using silicone material through injection molding, or multiple basket strips can be formed by weaving.

[0052] like Figure 4 The variable conduit 101 or adjustable structure shown has a protruding part 102 that is a semi-circular structure formed by a braided mesh. The protruding part 102 can bulge out to one side of the adjusting tube 103 or the variable conduit 101. The braided mesh can be made of polymer material or metal material, and the two ends of the braided mesh are respectively fixed to the distal end of the conveying section 1011 and the proximal end of the receiving end 1012.

[0053] like Figure 5 The variable catheter 101 or adjustable structure 10 shown has a protruding portion 102 that is a balloon body communicating proximally with the outside. The balloon body has a semi-circular structure. By injecting liquid into the balloon body, it protrudes outward, thereby changing the relative position of the adjusting tube 103 and the blood vessel. When the protruding portion 102 is a balloon body or balloon, the adjustable structure may also omit the adjusting tube. Instead, water or other liquid is injected into the balloon body or balloon using an external syringe, causing the balloon body or balloon to inflate and protrude. This also changes the lateral position of the central axis of the distal end of the variable catheter 101.

[0054] Still with Figure 2 , Figure 3A , Figure 3BThe shown embodiment illustrates the innovation of the present application. The inner diameter of the adjusting tube 103 is larger than the outer diameter of the pigtail catheter 104, and in order to facilitate the surgical process, the pigtail catheter 104 can directly pass through the adjustable structure, the adjusting tube 103 and the variable catheter 102 can be made of higher hardness material, so that when the pigtail catheter 104 passes through the adjusting tube 103, the adjusting tube 103 can provide sufficient support and avoid the accumulation of the curled part at the distal end of the pigtail catheter 104 in the hollow channel of the adjusting tube 103. It should be noted that the existing catheter devices for treating structural heart valve diseases do not have the function of allowing the pigtail catheter 104 to pass through, generally, after the pigtail catheter 104 crosses the aortic valve along the soft guide wire, the soft guide wire is replaced with a hard guide wire, and the pigtail catheter 104 is withdrawn, and then the balloon catheter 106 is delivered along the hard guide wire to prepare for subsequent expansion of the stenotic aortic valve. This is because, on the one hand, due to the larger hardness of the hard guide wire, it may pierce the patient's tissue during delivery, so generally a soft guide wire is used first, and then replaced with a hard guide wire after crossing the aortic valve with the help of the pigtail catheter. On the other hand, the hard guide wire with larger hardness has certain difficulty in passing through the aortic arch, and even if it can pass through the aortic arch, it will move along the outside of the aorta to the aortic root, thus causing subsequent difficulty in crossing the valve. The adjustable structure 10 provided by the present application is provided with the protrudable part 102 at the distal end, so even if the hardness of the adjusting tube 103 and / or the variable catheter 101 is larger, when reaching the aortic root, the guide wire and the pigtail catheter 104 can cross the valve by inflating the protrudable part 102, therefore, the adjustable structure 10 provided by the present application, which is provided with the protrudable part 102 at the distal end, is an increased design, rather than the ordinary catheter in the prior art which can increase the hardness of the catheter at will to achieve the simultaneous delivery of the pigtail catheter 104.

[0055] As shown in Figure 6 , Figure 7 , the adjustable structure 10 provided by the present application and the pigtail catheter 104 cooperate with each other, the variable catheter 101 of the adjustable structure 10 and the proximal end of the adjusting tube 103 are respectively provided with the fixed seat 105 and 1031, the fixed seat 105 is used to lock the variable catheter 101 and the adjusting tube 103 during the operation to fix the protrusion height of the protrudable part 102, and to seal the gap between the two. The fixed seat 1031 is used to lock the adjusting tube 103 and the pigtail catheter 104 during the operation and to seal the gap between the two. The proximal end of the adjusting tube 103 passes out of the proximal end of the variable catheter 101, the medical staff changes the protrusion height of the protrudable part 102 by pulling the adjusting tube 103 towards the proximal end, and fixes the protrusion height of the protrudable part 102 by locking the fixed seat 105, which facilitates the subsequent crossing of the valve by the soft guide wire and the pigtail catheter 104.

[0056] In Figure 6In the shown embodiment, the inner part of the fixing seat 105 is provided with a silica gel sealing device to seal the gap between the adjusting tube 103 and the variable catheter 101, and the fixing seat 105 is provided with a locking function, which can fix the adjusting tube by rotating or pressing in a squeezing manner.

[0057] As shown in Figure 8 the structure schematic diagram of the balloon catheter 106 and the balloon 1061 in the inflated state provided by the present application. The balloon catheter 106 comprises a liquid filling tube 1062, and the balloon 1061 located at the distal end of the liquid filling tube 1062 and in communication with the liquid filling tube 1062, and a Y valve 1063 provided on the proximal end side wall of the liquid filling tube 1062 and in communication with the liquid filling tube 1062. In order to facilitate the protruding part 102 to pass through the balloon 1061, the inner part of the balloon 1061 is provided with a hollow passage which is not less than the inner diameter of the liquid filling tube 1062. During the operation, the Y valve 1063 can be used to fill the liquid filling tube 1062 with high-pressure liquid, such as normal saline or normal saline containing contrast agent, so that the balloon 1061 is inflated and expanded to dilate the aortic valve. Of course, in order to facilitate transportation, the balloon catheter 106 is in a folded and contracted state during transportation. After the balloon 1061 completes the expansion of the aortic valve, the high-pressure liquid in the balloon 1061 is extracted through the Y valve 1063, and the balloon 1061 returns to the contracted state. The practical balloon catheter 106 of the present application can also be the prior art.

[0058] Because the shape of the blood vessel is twisted, the variable catheter 101 and the adjusting tube 102 need to have a certain flexibility and bending resistance. Preferably, high molecular materials such as PEBAX, PA, PTFE, HDPE, TPU, PEEK, etc. can be used, and the catheter can also be made of the above-mentioned materials and woven metal wires.

[0059] In order to illustrate the beneficial effects of the aortic valve balloon dilatation device provided by the present application, the pigtail catheter 104 is still introduced in the balloon dilatation device to describe the operation process. As shown in Figure 9- Figure 11 During the operation, first, the soft guide wire 107 is transported to the aortic root (without crossing the valve), and then the aortic valve balloon dilatation device provided by the present application, which comprises the balloon catheter 601, the adjustable structure 10 and the pigtail catheter 104 from outside to inside, is crossed over the aortic arch along the soft guide wire 107 and reaches the ascending aorta. Due to the centrifugal effect of the guide wire and the balloon dilatation device, the distal end thereof will adhere to the outer aortic wall after reaching the ascending aorta, as shown in Figure 9 At this time, the protruding part 102 and the balloon 1061 are in the contracted state.

[0060] The medical staff pulls the adjusting tube 103 to the proximal end, changes the protruding height of the protruding part 102, and makes the outer protruding side 1023 of the protruding part 102 abut against the outer aortic wall. As the protruding height H1 of the protruding part 102 gradually increases, the protruding part 102 is gradually pushed into the left ventricle, as shown in Figure 10 The protruding height of the protruding part 102 is preferably in the range of 3mm-45mm. After the central axis of the pigtail catheter 104 is aligned with the aortic valve, the soft guide wire 107 is pushed to the distal end, so that the soft guide wire 107 crosses the aortic valve along the pigtail catheter 104. The distal end of the soft guide wire 107 enters the left ventricle from the aorta. Then the distal end of the pigtail catheter 104 is sent into the left ventricle along the soft guide wire 107, the soft guide wire 107 is withdrawn, and the hard guide wire is sent into the left ventricle along the pigtail catheter 104.

[0061] After the hard guide wire (not shown) enters the left ventricle, the adjusting tube 103 is pushed to the distal end, so that the protruding part 102 is in a retracted state. The adjustable structure 10 in the retracted state and the balloon catheter 106 are sequentially pushed to the distal end, so that the balloon 1061 and the protruding part 102 are located between the aortic valve, as shown in Figure 11 The purpose of this step is to deliver the balloon 1061 into the diseased aortic valve. Of course, in other cases, the protruding part 102 can be pushed into the left ventricle or pulled back into the hollow lumen of the liquid-filled tube 1062.

[0062] Then, high-pressure liquid such as normal saline is injected into the balloon 1062 through the Y valve, so that the balloon 1062 expands, as shown in Figure 12 so as to dilate the diseased aortic valve and prepare for subsequent aortic valve implantation.

[0063] For the convenience of description, the locking or loosening of the fixed seat 105, 1031 during use is not described in detail, but this part is only used to relatively lock the relative positions of the variable catheter 101, the adjusting tube 103, and the pigtail catheter 104, and to avoid blood overflow. During the operation, as long as the relative movement between two or three components is not required, the fixed seat is locked, and when the relative position needs to be adjusted, the fixed seat is loosened.

[0064] As shown in Figure 10 The protruding part 102 of the aortic valve balloon dilatation device provided by the application is not uniform in size when it is in the expanded state, which is not only suitable for patients whose aortic valve orifice opens towards the outer aorta and the center of the aorta, but also suitable for patients whose aortic valve orifice is more inward, so the application range of the patients is wider.

[0065] Figure 13 、 Figure 14The other two embodiments of the aortic valve balloon dilatation device provided by the present application do not show the balloon catheter here for simplicity. Figure 13 In the shown embodiment, the outer side 1021 of the protrudable part 102 is larger than the inner side 1022 of the protrudable part 102, and when the protrudable part 102 is transformed from the contracted state to the expanded state, the central axis of the adjusting tube 103 moves from the outer side of the aorta to the aortic valve orifice side, and since the protrudable height of the inner side 1022 is smaller than the protrudable height of the outer side 1021, the adjusting tube 103 can move further to the inner side of the aorta. Figure 14 In the shown embodiment, the inner side of the protrudable part 102 is not provided with the basket, and thus the protrudable part 102 is subjected to smaller inner side resistance during the expansion process, and the central axis of the adjusting tube 103 can move radially to the inner side of the aorta by a larger distance. That is, the aortic valve balloon dilatation device provided by the present application not only can be applied to patients whose aortic valve orifices are located in the middle and outer side of the aorta, but also can be applied to patients whose aortic valve orifices are located in the inner side of the aorta, and thus the applicability is stronger.

[0066] The above only describes the preferred embodiments of the present application, and it should be noted that those skilled in the art can make several improvements and refinements without departing from the principles of the present application, and these improvements and refinements should also be considered to fall within the protection scope of the present application.

Claims

1. An aortic valve balloon dilatation device, characterized by, The aortic valve balloon dilation device comprises a balloon catheter and an adjustable structure which can pass through the balloon catheter. The adjustable structure comprises: a variable catheter provided with a protrudable part; the protrudable part comprises an outer protruding side and an inner protruding side, the protruding height of the outer protruding side is greater than that of the inner protruding side.

2. The balloon-expandable aortic valve device of claim 1, wherein, The adjustable structure further comprises an adjusting tube which is sleeved in the variable catheter, and the distal end of the adjusting tube is fixedly connected with the distal end of the variable catheter, and the other part of the adjusting tube can move relative to the variable catheter to change the protruding height of the protrudable part, so that the protrudable part is in an expanded state or a retracted state.

3. The balloon-expandable aortic valve device of claim 1, wherein, In the expanded state, along the cross section of the protrudable part, the outer peripheral length of the outer protruding side is greater than that of the inner protruding side.

4. The balloon-expandable aortic valve device of claim 1, wherein, The protrudable part is one of a balloon, a braided mesh and a basket.

5. The balloon-expandable aortic valve device of claim 4, wherein, The protrudable part is a balloon, and the balloon is in communication with the outside at the proximal end.

6. The balloon-expandable aortic valve device of claim 4, wherein, The protrudable part is a basket, and the basket comprises 3-5 basket bars which are axially arranged along the variable catheter.

7. The balloon-expandable aortic valve device of claim 5, wherein, In the expanded state, along the maximum cross section of the protrudable part, the central angle α of the circular arc surrounded by the basket bars is 60°-270°, preferably 80°-220°, and more preferably 90°-180°.

8. The balloon-expandable aortic valve device of claim 1, wherein, The protruding height of the protrudable part is 3mm-45mm, preferably 4mm-35mm, and more preferably 5mm-30mm.

9. The balloon-expandable aortic valve device of claim 1, wherein, The inner diameter of the adjusting tube is greater than the outer diameter of the pigtail catheter, the variable catheter has a hardness and provides a supporting force for the pigtail catheter.

10. The balloon-expandable aortic valve device of claim 1, wherein, The balloon catheter comprises an inflatable balloon which is made of a high polymer material.

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