Auxiliary heart valve fixing device

Abstract

The invention discloses an auxiliary heart valve fixing device, belongs to the technical field of medical instruments, and solves the problems that an existing valve support is used for pure reflux of an aortic valve and a low-calcification valve cannot be reliably fixed, the auxiliary heart valve fixing device comprises a device conveying mechanism and a device body, and the device conveying mechanism comprises an auxiliary guide part and an auxiliary conveying part; the auxiliary conveying part comprises a conveying sleeve, an auxiliary adjusting part and a balloon catheter part; the device main body is used for supporting various specifications of existing heart valves implanted through catheters; the device main body is arranged, the valve supporting part is higher in compactness relative to the adjustable fixed crown and the auxiliary extension part, so that the heart valve can be stably supported, the auxiliary extension part and the auxiliary connecting seat cooperate to ensure the flexibility of the device main body, various existing valves implanted through a catheter can be matched and fixed, the surgical risk is reduced, and the surgical efficiency is improved. Meanwhile, the surgical success rate and the clinical application range of the existing valve are increased.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a heart valve auxiliary fixation device. Background Art

[0002] Heart valves are tissues within the heart, located between the atria and ventricles, that control the direction of blood flow. The heart has four valves: the tricuspid, mitral, aortic, and pulmonary valves. The function of these valves is crucial. Valvular problems, such as stenosis or regurgitation, can increase the burden on the heart and even lead to serious consequences such as heart failure. A heart valve assist device is a medical device used to treat heart valve disease. It is typically made of metal or biomaterials and can be placed on the heart valve to help maintain normal valve function.

[0003] Chinese patent CN112089506A discloses a valve stent and a heart valve having the same. The valve stent has an inflow end and an outflow end. A waist is formed inwardly near the inflow end to determine and limit the position of the valve stent. A connection portion is provided at the outflow end for connecting to a delivery system. The heart valve comprises a valve body, a skirt, and the valve stent. The valve body is disposed inside the valve stent. The skirt is an elastic body connected to the valve body and disposed on the circumferential wall of the valve stent. However, existing valve stents cannot be reliably fixed for pure aortic regurgitation and low-calcification valves. To address the above problems, we propose a heart valve auxiliary fixation device. Summary of the Invention

[0004] The purpose of the present invention is to address the deficiencies of the existing technology and provide a heart valve auxiliary fixation device to solve the problem that the existing valve stent cannot be reliably fixed for aortic valve pure regurgitation and low calcification valves.

[0005] The present invention is achieved by providing a heart valve auxiliary fixation device, the heart valve auxiliary fixation device comprising:

[0006] A device conveying mechanism, the device conveying mechanism comprising an auxiliary guide portion and an auxiliary conveying portion sleeved outside the auxiliary guide portion;

[0007] Wherein, the auxiliary transmission unit includes:

[0008] A delivery sleeve, wherein the delivery sleeve is slidably sleeved on the auxiliary guide portion;

[0009] An auxiliary adjustment portion connected to the delivery cannula, the auxiliary adjustment portion being used to adjust the position of the device body to ensure that the device body fits snugly and properly with the heart valve;

[0010] a balloon catheter portion, the balloon catheter portion being slidably sleeved on the auxiliary guide portion and connected to the auxiliary adjustment portion, and being used to support the device body and assist in fixing the device body;

[0011] A device body, the device body being used to support various sizes of existing transcatheter implanted heart valves;

[0012] Wherein, the device body includes:

[0013] An adjustable fixing crown, which is used to assist in supporting the heart valve and to fix the device body;

[0014] A valve support portion fixedly connected to the adjustable fixing crown, the valve support portion being used to support various specifications of existing transcatheter implanted heart valves;

[0015] an auxiliary extension portion, the auxiliary extension portion being connected to the valve support portion and being used to guide the valve support portion and assist in the recovery of the valve support portion;

[0016] An auxiliary connecting base is installed at one end of the auxiliary extension.

[0017] Preferably, the adjustable fixed crown comprises:

[0018] At least one set of skirt fixing frames, the skirt fixing frames are used to fix the device body, and the skirt fixing frames are fixedly connected to each other;

[0019] At least one set of skirt bending arms, wherein the skirt bending arms are arranged on one side of the skirt fixing frame and are fixedly connected to the end of the skirt fixing frame;

[0020] An inner skirt arm, the inner skirt arm being arranged on one side of the skirt fixing frame and being used to support the skirt fixing frame;

[0021] At least one set of crown connecting rods, wherein the crown connecting rods are arranged on one side of the inner skirt arm, one end of the crown connecting rods is fixedly connected to the inner skirt arm, and the crown connecting rods are used to support the inner skirt arm.

[0022] Preferably, the adjustable fixed crown further comprises:

[0023] at least one set of crown bending arms, each of which is connected to the tube connecting rod and the valve support portion;

[0024] The crown cross bar is arranged between the adjacent crown bending arms, and is used to support and connect the adjacent crown bending arms.

[0025] Preferably, the valve support portion comprises:

[0026] At least one group of dense support frames, the dense support frames are used to support the heart valve, the dense support frames are slidably sleeved on the outer wall of the balloon catheter part, and adjacent dense support frames surround and form a valve support cavity;

[0027] At least one group of supporting cross bars, wherein the supporting cross bars are circumferentially arranged between adjacent dense support frames, and both ends of the supporting cross bars are respectively fixedly connected to the dense support frames.

[0028] Preferably, the auxiliary extension portion comprises:

[0029] At least one set of arc-shaped extension arms, one end of each of the arc-shaped extension arms being fixedly connected to the auxiliary connection seat;

[0030] An extended bending arm, wherein the extended bending arm is fixedly mounted on the end of the arc-shaped extending arm, and one end of the extended bending arm away from the arc-shaped extending arm is fixedly connected to the dense support frame;

[0031] At least one group of auxiliary extension arms is cross-fixedly connected, and ends of the auxiliary extension arms are fixedly connected to the arc-shaped extension arms, and the auxiliary extension arms surround and form an auxiliary extension cavity.

[0032] Preferably, the auxiliary guide portion includes:

[0033] An auxiliary guide wire, which passes through the delivery sheath, the auxiliary adjustment portion, and the balloon catheter portion, and is used to guide and limit the delivery sheath, the auxiliary adjustment portion, and the balloon catheter portion;

[0034] The guidewire limiting post is fixedly installed on the end of the auxiliary guidewire, and is used to limit the delivery sleeve, the auxiliary adjustment part, and the balloon catheter part.

[0035] Preferably, the balloon catheter portion comprises:

[0036] A collapsible balloon, wherein the interior of the collapsible balloon is provided with an inner hollow cavity, the sliding sleeve of the collapsible balloon is provided on the exterior of the auxiliary guide wire, and the exterior of the collapsible balloon is provided with a balloon expansion sleeve;

[0037] A catheter sheath, wherein the catheter sheath is fixedly mounted on the end of the collapsible balloon, and an end of the catheter sheath away from the collapsible balloon is connected to the auxiliary adjustment portion;

[0038] A catheter tip, which is sleeved on the outside of the auxiliary guide wire and is detachably connected to the collapsible balloon;

[0039] At least one auxiliary dressing portion, the auxiliary dressing portion being sleeved on the outer wall of the balloon expansion sleeve and used for performing auxiliary dressing treatment on the heart valve, wherein the auxiliary dressing portion comprises an auxiliary dressing layer, and a plurality of drug filling grooves are provided on the surface of the auxiliary dressing layer;

[0040] an auxiliary inflation portion, the auxiliary inflation portion being arranged at one end of the collapsible balloon;

[0041] The auxiliary inflation unit includes:

[0042] An auxiliary inflation valve, the auxiliary inflation valve being fixedly mounted on the end of the collapsible balloon and connected to the air pump via an inflation tube, and one end of the auxiliary inflation valve being connected to the inner hollow cavity of the collapsible balloon;

[0043] The expansion balloon, the expansion balloon fixing sleeve is arranged at the end of the balloon expansion sleeve, and the expansion balloon is connected to the auxiliary inflation valve through the air guide branch tube. The expansion balloon is used to adjust the expansion range of the adjustable fixed crown.

[0044] Preferably, the auxiliary adjustment unit includes:

[0045] A supporting catheter, the supporting catheter being slidably mounted on the outside of the delivery cannula;

[0046] An adjusting sleeve, wherein the adjusting sleeve is slidably mounted on the outer surface of the supporting conduit, and one end of the adjusting sleeve is fixedly connected to a grabbing and pushing seat;

[0047] An auxiliary grasping portion is installed at one end of the adjusting sleeve and is used to grasp and adjust the position of the auxiliary connecting seat.

[0048] Preferably, the auxiliary grasping portion comprises:

[0049] At least one set of claw limiting grooves, the claw limiting grooves being provided at the end of the supporting conduit;

[0050] An auxiliary grasping claw rotatably mounted in the claw limiting groove, wherein the auxiliary grasping claw is used to grasp the auxiliary connecting seat and the catheter sheath;

[0051] At least one set of reset torsion springs, the reset torsion springs are fixedly installed in the claw limit groove, and one end of the reset torsion springs is fixedly connected to the auxiliary grabbing claw

[0052] at least one set of meshing teeth, wherein the meshing teeth are fixedly mounted on the end of the auxiliary grasping claw;

[0053] An inner gear ring is mounted on the inner wall of the adjusting sleeve, and the inner gear ring is meshed with the meshing teeth.

[0054] Compared with the prior art, the embodiments of the present application have the following beneficial effects:

[0055] In an embodiment of the present invention, a device main body is provided, which is composed of an adjustable fixing crown, a valve support part, an auxiliary extension part, and an auxiliary connecting seat. The valve support part has a higher density than the adjustable fixing crown and the auxiliary extension part, so that it can firmly support the heart valve, and the expansion range of the adjustable fixing crown can be adjusted by the balloon catheter part, so that the adjustable fixing crown firmly covers the heart valve. At the same time, the auxiliary extension part and the auxiliary connecting seat cooperate to ensure the flexibility of the device main body, and can match and fix various existing transcatheter implanted valves. Compared with the existing technology, it is easier to recover and install, and it is also convenient to adjust the position of the device main body when the device main body is installed.

[0056] In an embodiment of the present invention, an adjustable fixed crown is provided, and the adjustable fixed crown is composed of a skirt fixing frame, a skirt bending arm, an inner skirt arm, a crown connecting rod, a crown bending arm and a crown cross bar. The skirt fixing frame, the skirt bending arm, the inner skirt arm, the crown connecting rod and the crown bending arm cooperate with each other to achieve stable covering of the heart valve, and the mesh frame structure composed of the adjustable fixed crown effectively forms support inside the heart valve, helping to alleviate the stenosis or occlusion of the heart valve.

[0057] In an embodiment of the present invention, an auxiliary extension part is provided, which is composed of an arc-shaped extension arm, an extended bending arm and an auxiliary extension arm. The arc-shaped extension arm, the extended bending arm and the auxiliary extension arm are connected to form an arc-shaped cross elastic mesh frame structure. The auxiliary extension part can better guide and limit the device body, and will not cause damage to the heart valve, which is conducive to the recovery and adjustment of the position of the device body.

[0058] In an embodiment of the present invention, a balloon catheter portion is provided, which is composed of a collapsible balloon, an auxiliary dressing portion, an auxiliary inflation portion, and an expansion balloon. The collapsible balloon, the auxiliary dressing portion, the auxiliary inflation portion, and the expansion balloon cooperate with each other to achieve stable expansion of the device body, and can also ensure that the agent is evenly adhered to the surface of the auxiliary dressing layer and released to the inner surface of the target area during the expansion process, and realize flexible adjustment of the expansion range of the adjustable fixed crown, thereby meeting the support requirements of the heart valve.

[0059] In an embodiment of the present invention, an auxiliary adjustment part is provided, which is composed of an adjustment sleeve, a supporting catheter, and an auxiliary grasping part. The setting of the auxiliary adjustment part can solve the problem of inconvenient angle adjustment of the device body when the device body is installed, thereby facilitating the precise installation and release of the device body and ensuring that the device body firmly supports the heart valve.

[0060] In an embodiment of the present invention, an auxiliary grasping portion is provided, which is composed of an inner gear ring, an auxiliary grasping claw, a reset torsion spring and meshing teeth. The setting of the reset torsion spring facilitates the auxiliary grasping claw to fix and clamp the catheter sheath when the device body is transported, thereby avoiding the falling off of the device body. The setting of the inner gear ring and the meshing teeth can engage and transmit after the device body is expanded and fixed, thereby adjusting the grasping range of the auxiliary grasping claw, so that the auxiliary grasping claw can flexibly grasp the auxiliary connecting seat, thereby realizing flexible adjustment of the angle and position posture of the device body. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 It is a structural schematic diagram of a heart valve auxiliary fixation device provided by the present invention.

[0062] Figure 2 It is a structural schematic diagram of the device main body provided by the present invention.

[0063] Figure 3 It is an axonometric view of the device body provided by the present invention.

[0064] Figure 4 It is a front view of the device body provided by the present invention.

[0065] Figure 5 It is a schematic structural diagram of the balloon catheter portion provided by the present invention.

[0066] Figure 6 It is a schematic diagram of the three-dimensional structure of the balloon catheter part provided by the present invention.

[0067] Figure 7 It is a front view of the balloon catheter portion provided by the present invention.

[0068] Figure 8 yes Figure 7 AA section view.

[0069] Figure 9 It is a structural schematic diagram of the auxiliary adjustment part provided by the present invention.

[0070] Figure 10 It is an axonometric view of the auxiliary adjustment part provided by the present invention.

[0071] In the figure: 1- auxiliary guide part, 11- auxiliary guide wire, 12- guide wire limiting column, 2- auxiliary transmission part, 21- delivery sleeve, 22- catheter sheath, 23- catheter tip, 24- auxiliary inflation part, 241- auxiliary inflation valve, 242- expansion balloon, 243- airway branch, 25- auxiliary dressing part, 251- auxiliary dressing layer, 252- drug filling groove, 26- collapsible balloon, 261- balloon expansion sleeve, 262- inner hollow cavity, 3- device body, 31- adjustable fixing crown, 311- skirt fixing frame, 312- skirt bending arm, 313- inner skirt arm, 314- Crown connecting rod, 315-crown bending arm, 316-crown cross bar, 32-valve support part, 321-dense support frame, 322-support cross bar, 323-valve support cavity, 33-auxiliary extension part, 331-arc extension arm, 332-auxiliary extension arm, 333-auxiliary extension cavity, 334-extension bending arm, 34-auxiliary connecting seat, 4-auxiliary adjustment part, 41-adjusting sleeve, 42-supporting catheter, 43-grabbing push seat, 44-auxiliary grasping part, 441-inner gear ring, 442-auxiliary grasping claw, 443-claw limiting groove, 444-reset torsion spring, 445-engaging teeth. DETAILED DESCRIPTION

[0072] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this application belongs. The terms used in the specification of the application are only for the purpose of describing specific embodiments and are not intended to limit this application. The terms "including" and "having" and any variations thereof in the specification and claims of this application and the above-mentioned drawings are intended to cover non-exclusive inclusions. The terms "first", "second", etc. in the specification and claims of this application or the above-mentioned drawings are used to distinguish different objects, not to describe a specific order.

[0073] The existing valve stents cannot be reliably fixed for pure aortic valve regurgitation and low calcification valves. To solve the above problems, we have proposed a heart valve auxiliary fixation device. In short, the heart valve auxiliary fixation device consists of a device delivery mechanism and a device body 3. The device delivery mechanism consists of an auxiliary guide part 1 and an auxiliary transmission part 2 sleeved on the outside of the auxiliary guide part 1. The auxiliary transmission part 2 includes a delivery sheath 21, an auxiliary adjustment part 4 connected to the delivery sheath 21, and a balloon catheter part. The device body 3 includes an adjustable fixing crown 31, a valve support part 32 fixedly connected to the adjustable fixing crown 31, an auxiliary extension part 33, and an auxiliary connecting seat 34 installed at one end of the auxiliary extension part 33. During operation, the auxiliary guide part 1 is first pushed to the heart valve target area, and then the device main body 3 is put on the outside of the balloon catheter part, and the balloon catheter part is connected with the auxiliary adjustment part 4 and the delivery sheath 21 in turn. Then the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are passed through one end of the auxiliary guide part 1, and the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are pushed into the heart valve target area, and then the balloon catheter part is started, and the balloon catheter part drives the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 to expand, so that the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 firmly support the heart valve. According to the installation requirements of the device main body 3, the auxiliary adjustment part 4 is operated, and the auxiliary adjustment part 4 drives the balloon catheter part and the device main body 3 to move, ensuring that the device main body 3 fits the heart valve. In an embodiment of the present invention, a device body 3 is provided. The device body 3 is composed of an adjustable retaining crown 31, a valve support portion 32, an auxiliary extension portion 33, and an auxiliary connector 34. The valve support portion 32 is denser than the adjustable retaining crown 31 and the auxiliary extension portion 33, thereby providing stable support for the heart valve. The expansion range of the adjustable retaining crown 31 can be adjusted by the balloon catheter portion, allowing the adjustable retaining crown 31 to firmly enclose the heart valve. The auxiliary extension portion 33 and the auxiliary connector 34 cooperate to ensure the flexibility of the device body 3, allowing it to match and secure various existing transcatheter implanted valves. Compared with existing technologies, it is easier to recover and install, and also facilitates the adjustment of the position of the device body 3 during installation. Existing integrated valves with anchoring devices for treating pure aortic regurgitation require larger access arteries and more stringent vascular conditions due to the large outer diameter of the implanted device. This device specifically addresses this problem, reducing surgical risks while increasing surgical success rates and the clinical applicability of existing valves.

[0074] The embodiment of the present invention provides a heart valve auxiliary fixation device, such as Figure 1 As shown, the heart valve auxiliary fixation device includes:

[0075] The device conveying mechanism includes an auxiliary guide portion 1 and an auxiliary conveying portion 2 sleeved outside the auxiliary guide portion 1;

[0076] Wherein, the auxiliary transmission unit 2 includes:

[0077] A delivery sleeve 21, wherein the delivery sleeve 21 is slidably sleeved on the auxiliary guide portion 1;

[0078] In this embodiment, the delivery sleeve 21 is a metal, plastic or alloy sleeve with a hollow interior. One end of the delivery sleeve 21 can be fixedly connected to an auxiliary push handle. During work, medical personnel can hold the auxiliary push handle so that the delivery sleeve 21 pushes the auxiliary adjustment part 4, the balloon catheter part and the device body 3 to move to the designated target area.

[0079] An auxiliary adjustment portion 4 connected to the delivery cannula 21, the auxiliary adjustment portion 4 is used to adjust the position of the device body 3 to ensure that the device body 3 fits snugly with the heart valve;

[0080] The balloon catheter part is slidably sleeved on the auxiliary guide part 1 and connected to the auxiliary adjustment part 4. The balloon catheter part is used to support the device body 3 and assist in fixing the device body 3.

[0081] The device body 3 is used to support existing transcatheter implanted heart valves of various specifications.

[0082] Among them, such as Figure 2-Figure 4 As shown, the device body 3 includes:

[0083] An adjustable fixing crown 31, which is used to assist in supporting the heart valve and to fix the device body 3;

[0084] A valve support portion 32 fixedly connected to the adjustable fixing crown 31, wherein the valve support portion 32 is used to support various specifications of existing transcatheter implanted heart valves;

[0085] An auxiliary extension portion 33 , which is connected to the valve support portion 32 and is used to guide the valve support portion 32 and assist in retrieving the valve support portion 32 ;

[0086] An auxiliary connecting seat 34 is mounted on one end of the auxiliary extension portion 33 .

[0087] In this embodiment, the auxiliary connecting seat 34 can be a round seat or a spherical seat with a hollow interior. The auxiliary connecting seat 34 can be connected to the auxiliary adjustment part 4. This facilitates adjustment of the position and angle of the device body 3. At the same time, the adjustable fixing crown 31, the valve support part 32, and the auxiliary extension part 33 are all mesh frame structures. The frame density of the valve support part 32 is greater than that of the adjustable fixing crown 31 and the auxiliary extension part 33. The supporting force of the valve support part 32 is stronger than that of the adjustable fixing crown 31 and the auxiliary extension part 33 on both sides. The adjustable fixing crown 31 can fix the device body 3. The side opening area of the adjustable fixing crown 31 is adjustable (passage diameter>6mm), which will not block the passage of the auxiliary guide part 1, thereby reducing paravalvular leakage of the device body 3.

[0088] During operation, the auxiliary guide part 1 is first pushed to the heart valve target area, and then the device main body 3 is put on the outside of the balloon catheter part, and the balloon catheter part is connected with the auxiliary adjustment part 4 and the delivery sheath 21 in turn. Then the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are passed through one end of the auxiliary guide part 1, and the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are pushed into the heart valve target area, and then the balloon catheter part is started, and the balloon catheter part drives the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 to expand, so that the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 firmly support the heart valve. According to the installation requirements of the device main body 3, the auxiliary adjustment part 4 is operated, and the auxiliary adjustment part 4 drives the balloon catheter part and the device main body 3 to move, ensuring that the device main body 3 fits the heart valve.

[0089] In an embodiment of the present invention, a device main body 3 is provided, and the device main body 3 is composed of an adjustable fixing crown 31, a valve support part 32, an auxiliary extension part 33, and an auxiliary connecting seat 34. The valve support part 32 is denser than the adjustable fixing crown 31 and the auxiliary extension part 33, so that it can firmly support the heart valve, and the expansion range of the adjustable fixing crown 31 can be adjusted by the balloon catheter part, so that the adjustable fixing crown 31 firmly covers the heart valve. At the same time, the auxiliary extension part 33 and the auxiliary connecting seat 34 cooperate to ensure the flexibility of the device main body 3, which is easier to recycle and install than the existing technology, and is also convenient for adjusting the position of the device main body 3 when the device main body 3 is installed.

[0090] In a further preferred embodiment of the present invention, Figure 2-Figure 4 As shown, the adjustable fixing crown 31 includes:

[0091] At least one set of skirt fixing frames 311, wherein the skirt fixing frames 311 are used to fix the device body 3, and the skirt fixing frames 311 are fixedly connected to each other;

[0092] In this embodiment, the skirt fixing frames 311 are evenly distributed circumferentially, and the number of the skirt fixing frames 311 can be 3-6 groups. The skirt fixing frames 311 can be an arc-shaped round rod or an arc-shaped square rod structure. The material of the skirt fixing frames 311 can be stainless steel, nickel-titanium alloy or cobalt-chromium alloy. At the same time, in order to avoid damage to the heart valve and immune rejection caused by metal materials, the outer wall of the skirt fixing frames 311 can be coated with biodegradable materials (such as polylactic acid, polyhydroxybutyric acid, etc.) or biological materials (such as pig valves, bovine pericardium, etc.), and the skirt fixing frames 311 are fixedly connected by integrated connection or welding.

[0093] At least one set of skirt bending arms 312, wherein the skirt bending arms 312 are disposed on one side of the skirt fixing frame 311 and are fixedly connected to an end of the skirt fixing frame 311;

[0094] In this embodiment, the skirt bending arm 312 is arranged on the inner side of the skirt fixing frame 311. The shape of the skirt bending arm 312 can be a "U" shape, a "V" shape or an "L" shape structure, and the material of the skirt bending arm 312 is consistent with the material of the skirt fixing frame 311.

[0095] An inner skirt arm 313 , which is disposed on one side of the skirt fixing frame 311 and is used to support the skirt fixing frame 311 ;

[0096] At least one set of crown connecting rods 314 is provided on one side of the inner skirt arm 313 , one end of the crown connecting rod 314 is fixedly connected to the inner skirt arm 313 , and the crown connecting rod 314 is used to support the inner skirt arm 313 .

[0097] It should be noted that the inner skirt arm 313 can also be U-shaped, V-shaped, or L-shaped, and can be plugged or welded to the sidewall of the skirt fixing frame 311. The inner skirt arm 313 can have a bending angle of 30-120°. The crown connecting rod 314 can be a rectangular rod or a round rod. The crown connecting rod 314, the crown bending arm 315, and the crown crossbar 316 are made of the same material. The length of the skirt bending arm 312 and the inner skirt arm 313 can be half or one-third of the length of the skirt fixing frame 311.

[0098] At least one set of crown bending arms 315, each of which is connected to the tube connecting rod and the valve support portion 32;

[0099] The crown cross bar 316 is disposed between adjacent crown bending arms 315 , and is used to support and connect adjacent crown bending arms 315 .

[0100] In this embodiment, the crown bending arm 315 can be a ring-shaped "U"-shaped, "V"-shaped or "L"-shaped structure, and the two ends of the crown cross bar 316 are fixedly connected to the crown bending arms 315 on both sides by riveting or plugging. The number of crown cross bars 316 can be 3-6 groups, and the crown cross bars 316 are evenly arranged in the circumferential direction.

[0101] In an embodiment of the present invention, an adjustable fixing crown 31 is provided. The adjustable fixing crown 31 is composed of a skirt fixing frame 311, a skirt bending arm 312, an inner skirt arm 313, a crown connecting rod 314, a crown bending arm 315 and a crown cross bar 316. The skirt fixing frame 311, the skirt bending arm 312, the inner skirt arm 313, the crown connecting rod 314 and the crown bending arm 315 cooperate to achieve a stable covering of the heart valve, and the mesh frame structure composed of the adjustable fixing crown 31 effectively forms a support inside the heart valve, helping to alleviate the stenosis or occlusion of the heart valve.

[0102] In this embodiment, the valve support portion 32 includes:

[0103] At least one group of dense support frames 321, the dense support frames 321 are used to support the heart valve, the dense support frames 321 are slidably sleeved on the outer wall of the balloon catheter part, and adjacent dense support frames 321 surround and form a valve support cavity 323;

[0104] At least one set of support crossbars 322 is circumferentially arranged between adjacent dense support frames 321, with both ends of the support crossbars 322 fixedly connected to the dense support frames 321. In this embodiment of the present invention, the valve support portion 32 has a strong support force for the heart valve, and the support cross-frame structure formed by the valve support portion 32 can provide sufficient support force and corrosion resistance for the heart valve, ensuring the long-term effective operation of the stent within the heart valve.

[0105] It should be noted that the shape of the valve support cavity 323 formed by the adjacent dense support frames 321 can be a circular, diamond-shaped, pentagonal or hexagonal structure, and the dense support frame 321 is formed by welding or plugging multiple groups of "V"-shaped or bent arms. The cross-sectional shape of the dense support frame 321 can be a circular, rectangular or diamond-shaped structure. The dense support frame 321 and the supporting cross bar 322 are fixedly connected by plugging or welding. The distribution density of the valve support cavity 323 is greater than the distribution density of the adjustable fixed crown 31 and the auxiliary extension cavity 333.

[0106] In a further preferred embodiment of the present invention, Figure 2 As shown, the auxiliary extension portion 33 includes:

[0107] At least one set of arc-shaped extension arms 331, one end of each of the arc-shaped extension arms 331 being fixedly connected to the auxiliary connection base 34;

[0108] An extended bending arm 334, wherein the extended bending arm 334 is fixedly mounted on the end of the arc-shaped extension arm 331, and an end of the extended bending arm 334 away from the arc-shaped extension arm 331 is fixedly connected to the dense support frame 321;

[0109] At least one set of auxiliary extension arms 332 is cross-fixedly connected, and ends of the auxiliary extension arms 332 are fixedly connected to the arc-shaped extension arms 331 , and the auxiliary extension arms 332 surround and form an auxiliary extension cavity 333 .

[0110] In this embodiment, the arc-shaped extension arm 331 is symmetrically arranged in two groups, and the arc-shaped extension arm 331, the extended bending arm 334 and the auxiliary extension arm 332 can be in the shape of a flat bar or a round rod structure, and the ends of the arc-shaped extension arms 331 close to each other are welded or riveted to the auxiliary connecting seat 34, the extended bending arm 334 can be a "V"-shaped or "L"-shaped arm structure, and the auxiliary extension arm 332 can also be a straight, arc-shaped "V" or "L" arm structure, one end of the auxiliary extension arm 332 is welded or mortised to the dense support frame 321, and the other end of the auxiliary extension swing arm is riveted or welded to the end of the arc-shaped extension arm 331. In this embodiment, the auxiliary extension cavity 333 can be in the shape of a circular, diamond, pentagonal or hexagonal structure, and the internal area of the auxiliary extension cavity 333 is larger than the valve support cavity 323, and the distribution density is less than the valve support cavity 323, thereby ensuring the flexibility of the auxiliary extension part 33.

[0111] In an embodiment of the present invention, an auxiliary extension portion 33 is provided, and the auxiliary extension portion 33 is composed of an arc-shaped extension arm 331, an extension bending arm 334 and an auxiliary extension arm 332. The arc-shaped extension arm 331, the extension bending arm 334 and the auxiliary extension arm 332 are connected to form an arc-shaped cross elastic mesh frame structure. The auxiliary extension portion 33 can better guide and limit the device body 3, and will not cause damage to the heart valve, which is beneficial to the recovery and adjustment of the position of the device body 3.

[0112] In a further preferred embodiment of the present invention, Figure 1 and Figure 5 As shown, the auxiliary guide portion 1 includes:

[0113] An auxiliary guide wire 11, which passes through the delivery sheath 21, the auxiliary adjustment portion 4, and the balloon catheter portion, and is used to guide and limit the delivery sheath 21, the auxiliary adjustment portion 4, and the balloon catheter portion;

[0114] The guidewire limiting post 12 is fixedly mounted on the end of the auxiliary guidewire 11 and is used to limit the delivery sleeve 21 , the auxiliary adjustment part 4 , and the balloon catheter part.

[0115] In this embodiment, the auxiliary guide wire 11 is a stainless steel, nickel-titanium alloy, or platinum soft-head wire structure with a polished surface. At the same time, a long hydrophilic coating can be coated on the outer wall of the auxiliary guide wire 11, and the guide wire limiting column 12 can be a pointed cone, column, or "J"-shaped limiting column structure.

[0116] In a further preferred embodiment of the present invention, Figure 5-Figure 8 As shown, the balloon catheter portion includes:

[0117] A collapsible balloon 26 , wherein an inner hollow cavity 262 is provided inside the collapsible balloon 26 , the collapsible balloon 26 is slidably sleeved on the outside of the auxiliary guide wire 11 , and a balloon expansion sleeve 261 is provided on the outside of the collapsible balloon 26 ;

[0118] In this embodiment, the shrinkable balloon 26 is a double-layer hollow balloon, which is provided with an inner hollow cavity 262, and the outer wall of the shrinkable balloon 26 is provided with a balloon expansion sleeve 261. The balloon expansion sleeve 261 is made of a flexible polymer material, and in the embodiment of the present invention, a material such as polyimide or polyurethane can be used. These materials have good flexibility and elasticity, and can ensure that the balloon expansion sleeve 261 can withstand high pressure when expanded. The surface of the balloon expansion sleeve 261 is coated with a hydrophobic or hydrophilic coating. At the same time, the outer wall of the balloon expansion sleeve 261 can also be coated with a biodegradable polymer, such as polylactic acid (PLLA) and polyhydroxybutyric acid (PHBA). These materials can gradually degrade after implantation and are eventually absorbed by the human body, effectively avoiding the risk of long-term foreign body reaction.

[0119] The catheter sheath 22 is fixedly mounted on the end of the collapsible balloon 26, and one end of the catheter sheath 22 away from the collapsible balloon 26 is locked by the auxiliary adjustment part 4;

[0120] The catheter tip 23 is sleeved on the outside of the auxiliary guide wire 11 and is detachably connected to the collapsible balloon 26;

[0121] In this embodiment, the catheter sheath 22 and the catheter tip 23 are symmetrically disposed at both ends of the collapsible balloon 26. The catheter sheath 22 and the catheter tip 23 can be connected to the ends of the collapsible balloon 26 by plugging or threading. The provision of the catheter tip 23 guides the collapsible balloon 26 while also reducing tissue damage. The catheter sheath 22 can be made of polytetrafluoroethylene (PTFE) or polyethylene (PE). The function of the catheter sheath 22 is to protect the internal structure of the collapsible balloon 26 and guide the collapsible balloon 26 into the target area.

[0122] At least one auxiliary dressing portion 25, which is sleeved on the outer wall of the balloon expansion sleeve 261 and is used for auxiliary dressing treatment of the heart valve, wherein the auxiliary dressing portion 25 includes an auxiliary dressing layer 251, and a plurality of drug filling grooves 252 are formed on the surface of the auxiliary dressing layer 251;

[0123] The auxiliary inflation portion 24 is provided at one end of the collapsible balloon 26 .

[0124] In this embodiment, the auxiliary dressing portion 25 can assist in dressing the heart valve target area, thereby facilitating the application of drugs to the target area during operation. The coated drugs may be paclitaxel or sirolimus, which are used to inhibit restenosis of blood vessels or heart valves.

[0125] It should be noted that the auxiliary medicine applying layer 251 is fixedly mounted on the outer wall of the balloon expansion sleeve 261 by suturing or bonding, and the drug filling groove 252 can be a dovetail groove structure. The setting of the drug filling groove 252 can ensure that the drug is evenly adhered to the surface of the auxiliary medicine applying layer 251 and released to the inner surface of the target area during the expansion process.

[0126] The auxiliary inflation portion 24 includes:

[0127] An auxiliary inflation valve 241 is fixedly mounted on the end of the collapsible balloon 26 , and the auxiliary inflation valve 241 is connected to the air pump via an inflation tube, and one end of the auxiliary inflation valve 241 is connected to the inner hollow cavity 262 of the collapsible balloon 26 ;

[0128] The expansion balloon 242 is fixedly mounted on the end of the balloon expansion sleeve 261 , and the expansion balloon 242 is connected to the auxiliary inflation valve 241 through the air guide tube 243 . The expansion balloon 242 is used to adjust the expansion range of the adjustable fixing crown 31 .

[0129] In this embodiment, the auxiliary inflation valve 241 can be a three-way valve, and the way in which the auxiliary inflation valve 241 is connected to the air pump through the inflation tube and the working principle are all existing technologies and will not be elaborated here. The auxiliary inflation valve 241 is fixed to the end of the collapsible balloon 26 by snapping or welding, and the air pump is externally arranged on one side of the auxiliary push handle. The structure of the expansion balloon 242 is the same as that of the collapsible balloon 26. The setting of the expansion balloon 242 can realize flexible adjustment of the expansion range of the adjustable fixing crown 31, thereby meeting the support requirements of the heart valve.

[0130] In an embodiment of the present invention, a balloon catheter portion is provided, which is composed of a collapsible balloon 26, an auxiliary dressing portion 25, an auxiliary inflation portion 24, and an expansion balloon 242. The collapsible balloon 26, the auxiliary dressing portion 25, the auxiliary inflation portion 24, and the expansion balloon 242 cooperate with each other to achieve stable expansion of the device body 3, and can also ensure that the agent is evenly adhered to the surface of the auxiliary dressing layer 251 and released to the inner surface of the target area during the expansion process, and realize flexible adjustment of the expansion range of the adjustable fixing crown 31, thereby meeting the support requirements of the heart valve.

[0131] During operation, after the position of the device main body 3 is adjusted, the air pump and the auxiliary inflation valve 241 are turned on, and then the auxiliary inflation valve 241 blows gas into the shrinkable balloon 26, so that the shrinkable balloon 26 drives the balloon expansion sleeve 261, the auxiliary medicine layer 251 and the expansion balloon 242 to expand, and then the balloon expansion sleeve 261, the auxiliary medicine layer 251 and the expansion balloon 242 drive the valve support part 32 to expand to the designated target area of the heart valve. At the same time, during the expansion process, the drug filling groove 252 is opened to ensure that the drug is released to the inner surface of the target area during the expansion process, and then the auxiliary inflation valve 241 is opened, and the auxiliary inflation valve 241 blows gas into the expansion balloon 242 through the air guide branch 243, so that the expansion balloon 242 drives the device to expand, ensuring the flexible adjustment of the expansion range of the adjustable fixed crown 31, thereby meeting the support requirements of the heart valve.

[0132] In a further preferred embodiment of the present invention, Figure 9-10 As shown, the auxiliary regulating part 4 includes:

[0133] A supporting catheter 42 slidably mounted on the outside of the delivery sleeve 21 ;

[0134] An adjusting sleeve 41 is slidably mounted on the outer surface of the supporting guide tube 42 , and one end of the adjusting sleeve 41 is fixedly connected to a grabbing and pushing seat 43 ;

[0135] The auxiliary grasping portion 44 is installed at one end of the adjusting sleeve 41 , and is used to grasp and adjust the position of the auxiliary connecting seat 34 .

[0136] It should be noted that the supporting tube 42 is hollow inside, and the material of the adjusting sleeve 41 and the supporting tube 42 is the same as that of the conveying sleeve 21, and the grabbing and pushing seat 43 can be a rectangular seat or a round seat with a hollow interior. In order to facilitate the adjustment of the auxiliary grabbing part 44, the outer wall of the grabbing and pushing seat 43 is provided with an anti-slip groove.

[0137] In an embodiment of the present invention, an auxiliary adjustment part 4 is provided, which is composed of an adjustment sleeve 41, a supporting catheter 42, and an auxiliary grasping part 44. The setting of the auxiliary adjustment part 4 can solve the problem of inconvenient angle adjustment of the device main body 3 when the device main body 3 is installed, thereby facilitating the precise installation and release of the device main body 3, and ensuring that the device main body 3 firmly supports the heart valve.

[0138] Alternatively, the auxiliary adjustment part 4 may also be a sampler or sampling clamp in the prior art.

[0139] In a further preferred embodiment of the present invention, Figure 9 As shown, the auxiliary grasping portion 44 includes:

[0140] At least one set of claw limiting grooves 443, each of which is provided at the end of the supporting conduit 42. The claw limiting grooves 443 are circumferentially provided at the end of the supporting conduit 42. The claw limiting grooves 443 may be circular, square, or rectangular, and the number of claw limiting grooves 443 may be 3-6 sets.

[0141] The auxiliary grabbing claw 442 is rotatably mounted in the claw limiting groove 443 , and the auxiliary grabbing claw 442 is used to grab the auxiliary connecting seat 34 and the catheter sheath 22 ;

[0142] In the embodiment of the present invention, the auxiliary grabbing claw 442 may be an L-shaped clamping arm or a bent arm structure, and one end of the auxiliary grabbing claw 442 is rotatably connected to the inner wall of the claw limiting groove 443 through a bearing.

[0143] At least one set of return torsion springs 444 is fixedly installed in the claw limiting groove 443 , and one end of the return torsion spring 444 is fixedly connected to the auxiliary grabbing claw 442 .

[0144] In an embodiment of the present invention, one end of the reset torsion spring 444 is fixed in the claw limiting groove 443 by spot welding or riveting, and the other end of the reset torsion spring 444 is fixedly connected to the end of the auxiliary grasping claw 442 by mortise and tenon joints or rivets. The setting of the reset torsion spring 444 facilitates the auxiliary grasping claw 442 to fix and clamp the catheter sheath 22 during the transportation of the device main body 3, thereby avoiding the falling off of the device main body 3.

[0145] At least one set of meshing teeth 445, wherein the meshing teeth 445 are fixedly mounted on the end of the auxiliary grasping claw 442, and the meshing teeth 445 are provided in multiple sets and are circumferentially or arcuately arranged on the end of the auxiliary grasping claw 442;

[0146] An inner gear ring 441 is mounted on the inner wall of the adjusting sleeve 41 , and the inner gear ring 441 is meshed with the meshing teeth 445 .

[0147] In an embodiment of the present invention, an auxiliary grasping portion 44 is provided, and the auxiliary grasping portion 44 is composed of an inner gear ring 441, an auxiliary grasping claw 442, a reset torsion spring 444 and meshing teeth 445. The setting of the reset torsion spring 444 facilitates the auxiliary grasping claw 442 to fix and clamp the catheter sheath 22 when the device main body 3 is transported, thereby avoiding the falling off of the device main body 3. The setting of the inner gear ring 441 and the meshing teeth 445 can engage and transmit after the device main body 3 is expanded and fixed, thereby adjusting the grasping range of the auxiliary grasping claw 442, so that the auxiliary grasping claw 442 can flexibly grasp the auxiliary connecting seat 34, thereby realizing flexible adjustment of the angle and position posture of the device main body 3.

[0148] When the balloon catheter part drives the adjustable fixing crown 31, the valve support part 32, and the auxiliary extension part 33 to expand, the adjustable fixing crown 31, the valve support part 32, and the auxiliary extension part 33 provide firm support for the heart valve, and the auxiliary adjustment part 4 adjusts it according to the posture and position of the device body 3. During operation, the delivery sleeve 21, the catheter sheath 22, and the collapsible balloon 26 are pulled into the supporting catheter 42, and then the grabbing push seat 43 is manually pushed so that the grabbing push seat 43 drives the adjusting sleeve 41 to slide along the supporting catheter 42, so that the adjusting sleeve 41 drives the inner gear ring 441 to engage with the meshing teeth 445 on the auxiliary grabbing claw 442, and then drives the auxiliary grabbing claw 442 to swing, thereby adjusting the grabbing range of the auxiliary grabbing claw 442, and then making multiple groups of the auxiliary grabbing claws 442 grab the auxiliary connecting seat 34, thereby facilitating the flexible adjustment of the posture and position of the adjusting stent crown 31, the valve support part 32, and the auxiliary extension part 33.

[0149] In summary, the present invention provides a heart valve auxiliary fixation device. When working, the auxiliary guide part 1 is first pushed to the heart valve target area, and then the device body 3 is put on the outside of the balloon catheter part, and the balloon catheter part is connected with the auxiliary adjustment part 4 and the delivery sheath 21 in turn. Then the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are passed through one end of the auxiliary guide part 1, and the balloon catheter part, the auxiliary adjustment part 4 and the delivery sheath 21 are pushed into the heart valve target area. Then the balloon catheter part is started, and the balloon catheter part drives the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 to expand, so that the adjustable fixing crown 31, the valve support part 32 and the auxiliary extension part 33 firmly support the heart valve. According to the installation requirements of the device body 3, the auxiliary adjustment part 4 is operated, and the auxiliary adjustment part 4 drives the balloon catheter part and the device body 3 to move, ensuring that the device body 3 fits the heart valve.

[0150] In an embodiment of the present invention, a device body 3 is provided. The device body 3 is composed of an adjustable retaining crown 31, a valve support portion 32, an auxiliary extension portion 33, and an auxiliary connector 34. The valve support portion 32 is denser than the adjustable retaining crown 31 and the auxiliary extension portion 33, thereby providing stable support for the heart valve. The expansion range of the adjustable retaining crown 31 can be adjusted by the balloon catheter portion, allowing the adjustable retaining crown 31 to firmly enclose the heart valve. The auxiliary extension portion 33 and the auxiliary connector 34 cooperate to ensure the flexibility of the device body 3, allowing it to match and secure various existing transcatheter implanted valves. Compared with existing technologies, it is easier to recover and install, and also facilitates the adjustment of the position of the device body 3 during installation. Existing integrated valves with anchoring devices for treating pure aortic regurgitation require larger access arteries and more stringent vascular conditions due to the large outer diameter of the implanted device. This device specifically addresses this problem, reducing surgical risks while increasing surgical success rates and the clinical applicability of existing valves.

[0151] It should be noted that for the aforementioned embodiments, for simplicity of description, they are all expressed as a series of action combinations. However, those skilled in the art should be aware that the present invention is not limited by the order of the actions described, because according to the present invention, certain steps may be performed in other orders or simultaneously. Secondly, those skilled in the art should also be aware that the embodiments described in this specification are all preferred embodiments, and the actions and modules involved are not necessarily required by the present invention.

[0152] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the scope of protection of the invention. Obviously, the embodiments described are only some embodiments of the present invention, rather than all embodiments. Based on these embodiments, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above embodiments, ordinary technicians in this field can still combine, add, delete or make other adjustments to the features in the various embodiments of the present invention according to the circumstances without conflict, without making creative work, so as to obtain different other technical solutions that do not deviate from the concept of the present invention in essence, and these technical solutions also fall within the scope of protection of the present invention.

Claims

1. A heart valve auxiliary fixation device, comprising: A device conveying mechanism, comprising an auxiliary guide portion (1) and an auxiliary conveying portion (2) sleeved outside the auxiliary guide portion (1); Wherein, the auxiliary transmission part (2) comprises: A conveying sleeve (21), wherein the conveying sleeve (21) is slidably sleeved on the auxiliary guide portion (1); An auxiliary adjustment portion (4) connected to the delivery sleeve (21), characterized in that the auxiliary adjustment portion (4) is used to adjust the position of the device body (3) to ensure that the device body (3) fits snugly with the heart valve; A balloon catheter portion, the balloon catheter portion is slidably sleeved on the auxiliary guide portion (1), and the balloon catheter portion is connected to the auxiliary adjustment portion (4), and the balloon catheter portion is used to support the device body (3) and assist in fixing the device body (3); A device body (3), the device body (3) is used to support various specifications of existing transcatheter implanted heart valves; Wherein, the device body (3) comprises: An adjustable fixing crown (31), the adjustable fixing crown (31) is used to assist in supporting the heart valve and to fix the device body (3); A valve support portion (32) fixedly connected to the adjustable fixing crown (31), wherein the valve support portion (32) is used to support various specifications of existing transcatheter implanted heart valves; An auxiliary extension portion (33), the auxiliary extension portion (33) is connected to the valve support portion (32), and the auxiliary extension portion (33) is used to guide the valve support portion (32) and assist in the recovery of the valve support portion (32); An auxiliary connecting seat (34) is installed at one end of the auxiliary extension portion (33).

2. The heart valve auxiliary fixation device according to claim 1, characterized in that: The adjustable fixed crown (31) comprises: At least one set of skirt fixing frames (311), the skirt fixing frames (311) being used to fix the device body (3), and the skirt fixing frames (311) being fixedly connected to each other; At least one set of skirt bending arms (312), wherein the skirt bending arms (312) are arranged on one side of the skirt fixing frame (311), and the skirt bending arms (312) are fixedly connected to the ends of the skirt fixing frame (311); An inner skirt arm (313), the inner skirt arm (313) being arranged on one side of the skirt fixing frame (311), and the inner skirt arm (313) being used to support the skirt fixing frame (311); At least one set of crown connecting rods (314), the crown connecting rods (314) are arranged on one side of the inner skirt arm (313), one end of the crown connecting rod (314) is fixedly connected to the inner skirt arm (313), the crown connecting rod (314) is used to support the inner skirt arm (313), and the length of the skirt bending arm (312) and the inner skirt arm (313) is one half or one third of the length of the skirt fixing frame (311).

3. The heart valve auxiliary fixation device according to claim 2, wherein: The adjustable fixed crown (31) further comprises: At least one set of crown bending arms (315), wherein the crown bending arms (315) are respectively connected to the tube connecting rod and the valve support portion (32); A crown cross bar (316), wherein the crown cross bar (316) is arranged between adjacent crown bending arms (315), and the crown cross bar (316) is used to support and connect adjacent crown bending arms (315).

4. The heart valve auxiliary fixation device according to claim 3, wherein: The valve support portion (32) comprises: At least one group of dense support frames (321), the dense support frames (321) are used to support the heart valve, the dense support frames (321) are slidably sleeved on the outer wall of the balloon catheter portion, and adjacent dense support frames (321) surround and form a valve support cavity (323); At least one group of supporting cross bars (322), wherein the supporting cross bars (322) are circumferentially arranged between adjacent dense support frames (321), and both ends of the supporting cross bars (322) are respectively fixedly connected to the dense support frames (321).

5. The heart valve auxiliary fixation device according to claim 4, characterized in that: The auxiliary extension portion (33) comprises: At least one set of arc-shaped extension arms (331), one end of each of the arc-shaped extension arms (331) being fixedly connected to the auxiliary connection seat (34); An extended bending arm (334), wherein the extended bending arm (334) is fixedly mounted on the end of the arc-shaped extension arm (331), and an end of the extended bending arm (334) away from the arc-shaped extension arm (331) is fixedly connected to the dense support frame (321); At least one group of auxiliary extension arms (332), the auxiliary extension arms (332) are cross-fixedly connected, and the ends of the auxiliary extension arms (332) are fixedly connected to the arc-shaped extension arms (331), and the auxiliary extension arms (332) surround to form an auxiliary extension cavity (333).

6. The heart valve auxiliary fixation device according to any one of claims 3 to 5, characterized in that: The auxiliary guide portion (1) comprises: An auxiliary guide wire (11), the auxiliary guide wire (11) passes through the delivery sleeve (21), the auxiliary adjustment portion (4), and the balloon catheter portion, and the auxiliary guide wire (11) is used to guide and limit the delivery sleeve (21), the auxiliary adjustment portion (4), and the balloon catheter portion; A guide wire limiting column (12) is fixedly mounted on the end of the auxiliary guide wire (11), and the guide wire limiting column (12) is used to limit the transport sleeve (21), the auxiliary adjustment part (4), and the balloon catheter part.

7. The heart valve auxiliary fixation device according to claim 6, characterized in that: The balloon catheter portion comprises: A collapsible balloon (26), wherein an inner hollow cavity (262) is provided inside the collapsible balloon (26), the collapsible balloon (26) is slidably sleeved on the outside of the auxiliary guide wire (11), and a balloon expansion sleeve (261) is provided on the outside of the collapsible balloon (26); A catheter sheath (22), the catheter sheath (22) is fixedly mounted on the end of the collapsible balloon (26), and one end of the catheter sheath (22) away from the collapsible balloon (26) is connected to the auxiliary regulating portion (4); A catheter tip (23), wherein the catheter tip (23) is sleeved on the outside of the auxiliary guide wire (11), and the catheter tip (23) is detachably connected to the collapsible balloon (26); At least one set of auxiliary medicine application parts (25), the auxiliary medicine application parts (25) are sleeved on the outer wall of the balloon expansion sleeve (261), and the auxiliary medicine application parts (25) are used for auxiliary medicine application treatment of the heart valve, wherein the auxiliary medicine application part (25) includes an auxiliary medicine application layer (251), and a plurality of groups of medicine filling grooves (252) are provided on the surface of the auxiliary medicine application layer (251); an auxiliary inflation portion (24), the auxiliary inflation portion (24) being arranged at one end of the collapsible balloon (26); Wherein, the auxiliary inflation portion (24) comprises: An auxiliary inflation valve (241), the auxiliary inflation valve (241) is fixedly mounted on the end of the collapsible balloon (26), and the auxiliary inflation valve (241) is connected to the air pump through an inflation tube, and one end of the auxiliary inflation valve (241) is connected to the inner hollow cavity (262) of the collapsible balloon (26); The expansion balloon (242) is fixedly mounted on the end of the balloon expansion sleeve (261), and the expansion balloon (242) is connected to the auxiliary inflation valve (241) through the air guide tube (243). The expansion balloon (242) is used to adjust the expansion range of the adjustable fixed crown (31).

8. The heart valve auxiliary fixation device according to claim 7, characterized in that: The auxiliary regulating part (4) comprises: A supporting catheter (42) is slidably mounted on the outside of the delivery sleeve (21); An adjusting sleeve (41), wherein the adjusting sleeve (41) is slidably mounted on the outer surface of the supporting conduit (42), and one end of the adjusting sleeve (41) is fixedly connected to a grabbing and pushing seat (43); An auxiliary grasping portion (44) is installed at one end of the adjusting sleeve (41), and the auxiliary grasping portion (44) is used to grasp and adjust the position of the auxiliary connecting seat (34).

9. The heart valve auxiliary fixation device according to claim 8, characterized in that: The auxiliary grasping portion (44) comprises: At least one set of claw limiting grooves (443), wherein the claw limiting grooves (443) are provided at the end of the supporting conduit (42); An auxiliary grabbing claw (442) is rotatably mounted in the claw limiting groove (443), wherein the auxiliary grabbing claw (442) is used to grab the auxiliary connecting seat (34) and the catheter sheath (22); At least one set of reset torsion springs (444), wherein the reset torsion springs (444) are fixedly installed in the claw limiting groove (443), and one end of the reset torsion springs (444) is fixedly connected to the auxiliary grabbing claw (442).

10. The heart valve auxiliary fixation device according to claim 8, characterized in that: The auxiliary grasping portion (44) further comprises: at least one set of meshing teeth (445), wherein the meshing teeth (445) are fixedly mounted on the end of the auxiliary grasping claw (442); An inner gear ring (441) is mounted on the inner wall of the adjusting sleeve (41), and the inner gear ring (441) is meshedly connected with the meshing teeth (445).

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