Heart valve repair components and repair systems

Abstract

The present application provides a heart valve repair component, which belongs to the field of medical device technology. The repair component includes: a stable stent, a balloon body and an auxiliary frame. The stable stent includes a plurality of support rods distributed circumferentially, and each support rod is interconnected to form a deformable stable stent, and in the expanded state, each support rod at the inflow end of the stable stent is gathered along an annular surface to a first center. The balloon body is arranged at the outflow end of the stable stent. The auxiliary frame is used to fix the balloon body to the native leaflet, so as to achieve the cooperation between the balloon body and the native leaflets. In the expanded state, the stable stent of the heart valve repair component of the present application, each support rod at the inflow end of the stable stent is gathered along an annular surface to a first center, the local bending strain of the stable stent of this structure is small, the difficulty of pressing and gripping is small, the stable stent is not easy to be damaged, and the stable stent is better fitted to the atrial wall after expansion, so that the posture of the repair component is more stable after the component is implanted.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices for heart valve repair, and in particular to a heart valve repair component and repair system. Background Art

[0002] The heart is divided into two parts, each containing a ventricle and atrium. The ventricles and atria are separated by the ventricular septum and the atrial septum. Valves prevent blood from flowing backward between the atria and ventricles. Normal valves only allow blood to flow in one direction within the heart. Mitral regurgitation, among other conditions, is caused by valvular insufficiency. When the left ventricle contracts, blood flows from the left ventricle into the aorta and the left atrium, where there is less resistance. The left atrium receives blood from the pulmonary veins as well as blood flowing back from the left ventricle. Therefore, increased left atrial pressure increases pulmonary vein and capillary pressure, leading to dilation and congestion. Simultaneously, the left ventricle experiences an increased volume load during diastole, causing left ventricular enlargement. In acute mitral regurgitation, a sudden increase in the amount of blood flowing backward from the left atrium can cause a sharp rise in left atrial and pulmonary venous pressure, leading to acute pulmonary edema. Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilatation. After tricuspid regurgitation occurs, symptoms of right heart failure such as fatigue, ascites, edema, pain in the liver area, indigestion, and poor appetite worsen, and may even directly lead to death.

[0003] Generally, the mitral / tricuspid valve repair edge-to-edge repair or mitral / tricuspid valve replacement is currently used. The edge-to-edge repair is to clamp the edges of the regurgitant leaflets with a clip, for example, the large blood channel originally formed by the leaflets is changed into two small blood channels, that is, the two leaflets are clamped in the middle. The edge-to-edge repair has the following disadvantages, for example: it may cause valve stenosis: it can be seen by inserting multiple clips or using clips with wider clamping walls. If the disease recurs after surgery, it will be difficult to intervene with the clip again, which may cause further stenosis and other defects. Mitral / tricuspid valve replacement completely replaces the corresponding heart valve, but it is also prone to thrombosis, product decay and poor durability.

[0004] In response to the above problems, it is hoped that a heart valve repair component and repair system can be provided, which, with the cooperation of various components, can complete the compression delivery, support release, and stabilization of the repair component in the atrial tissue, so that the balloon body can partially replace the heart valve, retaining most of the original leaflet function, thereby promoting the treatment of heart valve regurgitation.

[0005] Application Contents

[0006] In view of the above-mentioned problems of the prior art, the technical problem solved by the present application is to provide a heart valve repair component, including a stabilizing stent, a balloon body and an auxiliary frame, wherein in the expanded state, the support rods at the inflow end of the stabilizing stent converge along a circular surface toward a first center, and the first center is located at the inflow end of the stabilizing stent, that is, when the stabilizing stent of this structure is expanded, its support rods each extend in one direction and extend to the same point, so the local bending strain of the stabilizing stent is small, the difficulty of pressing and gripping is small, the stabilizing stent is not easy to be damaged, and after expansion, the stabilizing stent fits better with the atrial wall, making the posture of the component more stable after implantation.

[0007] To achieve the above-mentioned and other related objectives, the present application provides, in a first aspect, a heart valve repair assembly, comprising: a stabilizing stent, comprising a plurality of circumferentially distributed support rods, wherein the support rods are interconnected to form a deformable stabilizing stent, and in an expanded state, the support rods at the inflow end of the stabilizing stent converge toward a first center along an annular surface;

[0008] a balloon body, arranged at the outflow end of the stable stent;

[0009] The auxiliary frame is used to fix the balloon body to the native valve leaflets to achieve the coordinated work between the balloon body and the native valve leaflets.

[0010] In one possible implementation of the first aspect, the stabilizing bracket includes a folding portion and a supporting portion;

[0011] One end of each support rod extends from the interface as a starting point to the first center and gathers to form the gathered portion, and the other end of each support rod extends from the interface as a starting point to the second center and gathers to form the support portion.

[0012] In one possible implementation of the first aspect, the first center is located at the inlet of the stabilizing bracket; and the second center is located at the outlet of the stabilizing bracket.

[0013] In one possible implementation of the first aspect, the first center is located at the center of the stabilizing bracket inlet; and the second center is located at the center of the stabilizing bracket outflow outlet.

[0014] In an implementable embodiment of the first aspect, the line connecting the first center and the second center is perpendicular to the interface.

[0015] In one possible implementation of the first aspect, in the expanded state, the stabilizing bracket is hemispherical in shape.

[0016] In an implementation manner of the first aspect, the support rods are interconnected to form a stable bracket having a plurality of openable portions; and in an unfolded state, the openable portions form an opening.

[0017] In one possible implementation of the first aspect, the opening is a diamond-shaped opening or a diamond-like opening.

[0018] In one possible implementation of the first aspect, bone nodes are provided at the connection points of the support rods of adjacent openings.

[0019] In one possible implementation of the first aspect, the support rods are distributed in at least one row.

[0020] In one possible implementation of the first aspect, the support rods are arranged in a single row or in an upper and lower double row.

[0021] In one possible implementation of the first aspect, when the support rods are arranged in two rows, the upper openings in the upper row and the lower openings in the lower row are staggered.

[0022] In one possible implementation of the first aspect, the support rod located at the outflow end of the stabilizing stent and close to the auxiliary stent is arranged to be in a non-interference state with the balloon body.

[0023] In an implementable embodiment of the first aspect, the support rod located at the outflow end of the stabilizing bracket and close to the auxiliary bracket is bent toward the inside of the stabilizing bracket.

[0024] In an implementable embodiment of the first aspect, a support rod located at the outflow end of the stabilizing support and close to the auxiliary support is shorter than an adjacent support rod.

[0025] In one possible embodiment of the first aspect, all or part of the stable stent is provided with a membrane capable of promoting endothelialization of the stable stent or is wrapped with a suture capable of promoting endothelialization of the stable stent.

[0026] In one embodiment of the first aspect, the membrane promoting endothelialization of the stable stent is disposed on a portion of the stable stent away from the auxiliary stent, and / or the membrane promoting endothelialization of the stable stent is disposed on a portion of the stable stent close to the auxiliary stent.

[0027] In one possible embodiment of the first aspect, the membrane that promotes stable stent endothelialization or the suture that promotes stable stent endothelialization is made of PET or PTFE.

[0028] In one possible implementation of the first aspect, at least some of the support rods are provided with anchoring portions.

[0029] In one possible embodiment of the first aspect, the anchoring portion is selected from teeth, thorns or hooks.

[0030] In an implementable embodiment of the first aspect, the anchoring portion includes an upper anchoring portion and a lower anchoring portion, the anchoring end of the upper anchoring portion points to the inflow end, and the anchoring end of the lower anchoring portion points to the outflow end.

[0031] In one possible implementation of the first aspect, the upper anchoring portion is arranged on a side away from the balloon body, and the lower anchoring portion is arranged on a side close to the balloon body.

[0032] In an implementable embodiment of the first aspect, at least two hanging ears are provided at the inlet of the stabilizing bracket.

[0033] In one possible implementation of the first aspect, the lengths of the hanging ears are consistent or inconsistent.

[0034] In one possible implementation of the first aspect, a threading hole is provided at the inflow end of each of the lugs for externally connecting a component for delivering the heart valve repair component or for threading a pull wire to manipulate the control or recovery of the heart valve repair component.

[0035] In an implementable embodiment of the first aspect, each of the hanging ears converges toward the first center.

[0036] In an implementable embodiment of the first aspect, each of the hanging ears converges toward the first center along an arc-shaped annular surface.

[0037] In an implementable embodiment of the first aspect, three hanging ears are provided at the inlet of the stabilizing bracket.

[0038] In one possible implementation of the first aspect, the auxiliary frame is a U-shaped structure formed by bending a plurality of connecting rods.

[0039] In one possible implementation manner of the first aspect, the balloon body includes at least two layers of grid skeletons arranged inside and outside, and the single grids of adjacent layers of grid skeletons are arranged in an interlaced manner.

[0040] In one possible implementation of the first aspect, the balloon body is provided with at least one fixing position, and the fixing position is used for connecting to the auxiliary frame or for externally connecting a delivery member.

[0041] In one possible embodiment of the first aspect, at least one fixing port is provided at the proximal end or the distal end of the balloon body to form the fixing site.

[0042] In one possible implementation of the first aspect, an upper fixing port is provided at the proximal end of the balloon body, and a lower fixing port is provided at the distal end of the balloon body.

[0043] In one possible implementation manner of the first aspect, the upper fixing opening is sealed by laminating.

[0044] In one possible implementation manner of the first aspect, the covering film is made of a biocompatible material; or the covering film is made of a polymer material.

[0045] In one possible implementation manner of the first aspect, the upper fixing port or the lower fixing port is sutured with medical suture or sutured with a thread made of the same material as the balloon body.

[0046] In one possible implementation manner of the first aspect, the lower fixing opening is constricted by a locking ring.

[0047] In one possible implementation of the first aspect, the locking ring is made of a medical imaging material.

[0048] In one possible embodiment of the first aspect, the balloon body further includes a covering membrane, and the covering membrane covers at least a portion of the lattice skeleton.

[0049] In one possible implementation manner of the first aspect, the covering film is made of a biocompatible material; or the covering film is made of a polymer material.

[0050] In one possible implementation of the first aspect, in a working state and in the direction of leaflet closure, the balloon body is a crescent-shaped arc.

[0051] In one possible implementation of the first aspect, in a working state and in the direction of blood flow, the balloon body is conical or streamlined.

[0052] In one embodiment of the first aspect, in the working state and when the native valve is closed, the rear portion of the balloon body is in contact with at least one leaflet of the native valve, and the front portion of the balloon body is in contact with another leaflet of the native valve.

[0053] In one possible implementation of the first aspect, the grid skeleton is made of medical shape memory alloy.

[0054] A second aspect of the present application provides a heart valve repair system, comprising the heart valve repair assembly as described in the first aspect;

[0055] The delivery catheter is used to deliver the repair component in a compressed delivery state to the mitral valve or tricuspid valve, and adjust the appropriate position to deploy the heart valve repair component.

[0056] The heart valve repair assembly and repair system provided in this application have, but are not limited to, the following beneficial effects:

[0057] 1) The heart valve repair assembly of the present application comprises a stabilizing stent, a balloon body, and an auxiliary stent. When the stabilizing stent is deployed, the support rods at the inflow end of the stabilizing stent converge toward a first center along a circular surface. This structure minimizes local bending strain in the stabilizing stent, reduces compression and gripping difficulty, and reduces damage to the stabilizing stent. Furthermore, after deployment, the stabilizing stent adheres better to the atrial wall, ensuring a more stable posture of the repair assembly after implantation.

[0058] 2) The balloon of the present application adopts the setting of at least two layers of grid skeleton to provide good support force, and the single grids of adjacent layers of grid skeleton are staggered with each other, and the uncertainty between the grids is compensated by staggering. For example, when the balloon is prepared by heat setting, because the balloon has an irregular curved surface, the staggered setting of the grids can easily control the density between the grids; for example, by staggering adjacent layers of grids, the risk of elastic failure of the balloon due to the breakage of a grid line can be reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1 Shown is a partial structural schematic diagram of the side view of the repair component described in Example 1 of the present application.

[0060] Figure 2 Display as Figure 1 Enlarged view of the middle gather part.

[0061] Figure 3 It shows a schematic diagram of the partial structure from a frontal perspective of the repair component described in Example 1 of the present application after the balloon body is removed.

[0062] Figure 4 Shown is a cutting diagram of the repair component described in Example 1 of the present application after the balloon body is removed.

[0063] Figure 5 Shown is a schematic diagram of the overall structure from a top view of the repair component described in an embodiment of the present application after the balloon body is removed.

[0064] Figure 6 Shown is a partial structural schematic diagram of the side view of the repair component described in Example 2 of the present application.

[0065] Figure 7 Shown is a schematic diagram of the overall structure of the repair component described in Example 2 of the present application.

[0066] Figure 8 Shown is a schematic diagram of the overall structure of the repair component described in Example 2 of the present application from a frontal perspective.

[0067] Figure 9 Shown is a schematic diagram of the overall structure of the repair component described in Example 2 of the present application after the balloon body is removed.

[0068] Figure 10 It shows a schematic diagram of the structure from a frontal perspective of the repair component described in Example 2 of the present application after the balloon body is removed.

[0069] Figure 11 Display as Figure 10 Enlarged view of part A in .

[0070] Figure 12Shown is a cutting diagram of the repair component described in Example 2 of the present application after the balloon body is removed.

[0071] Figure 13 It shows a schematic diagram of the overall structure of the repair component described in Example 3 of the present application after the balloon body is removed.

[0072] Figure 14 It shows a schematic diagram of the structure from a frontal perspective of the repair component described in Example 3 of the present application after the balloon body is removed.

[0073] Figure 15 Shown is a cutting diagram of the repair component described in Example 3 of the present application after the balloon body is removed.

[0074] Figure 16 Shown is a schematic diagram of part of the structure of the repair component described in Example 3 of the present application after the balloon body is removed.

[0075] Figure 17 Display as Figure 16 Enlarged view of part B in .

[0076] Figure 18 Display as Figure 16 Enlarged view of part C in .

[0077] Figure 19 Shown is a schematic diagram of the structure of a single-layer skeleton balloon.

[0078] Figure 20 It shows the first state diagram of the interlaced double-layer skeleton of the balloon body described in Example 4 of the present application.

[0079] Figure 21 It shows the second state diagram of the interlaced double-layer skeleton of the balloon body described in Example 4 of the present application.

[0080] Figure 22 Shown is a schematic diagram of the overall structure of the balloon described in Example 4 of the present application.

[0081] Figure 23 Shown is a schematic diagram of the heart valve repair balloon described in an embodiment of the present application being implanted into the mitral valve.

[0082] Figure 24 Shown is a schematic diagram of the balloon coating for heart valve repair described in Example 5 of the present application.

[0083] Figure 25 Shown is a schematic diagram of the heart valve repair component described in Example 7 of the present application being implanted in the mitral valve of the heart.

[0084] Description of Reference Numerals

[0085] 1. Secure the bracket

[0086] 11. Gathering

[0087] 12 Support

[0088] 100 support rods

[0089] 1001 Support rod near auxiliary frame

[0090] 1002 Enhancement Block

[0091] 101 Opening

[0092] 1011 front opening

[0093] 1012 rear opening

[0094] 1013 Upper opening

[0095] 1014 Lower opening

[0096] 1021 Upper anchor

[0097] 1022 Lower anchor

[0098] 103 Bone Joint

[0099] 13 mounting ears

[0100] 130 threading holes

[0101] 131 First mounting ear

[0102] 132 Second mounting ear

[0103] 133 Third mounting ear

[0104] 2 Balloon

[0105] 211 inner grid skeleton

[0106] 212 outer mesh bone

[0107] 201 Posterior part of the balloon

[0108] 202 Anterior part of the balloon

[0109] 221 upper fixing port

[0110] 222 lower fixing port

[0111] 223 Locking Ring

[0112] 23 Lamination

[0113] 231 First Lamination

[0114] 232 Second coating

[0115] 233 Third coating

[0116] 234 Fourth coating

[0117] 3 Auxiliary frame

[0118] 31 reinforcement

[0119] 32 First auxiliary pole

[0120] 33 Second auxiliary pole

[0121] 34 Upper accessories

[0122] 341 upper suture hole

[0123] 342 First auxiliary pole

[0124] 343 Second auxiliary pole

[0125] 35 lower accessories

[0126] 351 upper suture hole

[0127] 352 First auxiliary pole

[0128] 353 Second auxiliary pole

[0129] 300 storage space

[0130] 301 First support surface

[0131] 302 Second supporting surface

[0132] L1 interface

[0133] L2 The line connecting the first and second centers

[0134] PL posterior leaflet

[0135] AL anterior leaflet DETAILED DESCRIPTION Detailed Description of the Invention

[0137] The heart valve repair component described in the present invention is mainly used to assist the functionally impaired native valve leaflet group to achieve its normal physiological switching function, such as the mitral valve / tricuspid valve, or the pulmonary valve, or the aortic valve, etc. Taking the mitral valve as an example, after the repair component of the present application is implanted at the desired site, the auxiliary frame is released in sequence to allow the auxiliary frame to capture the native valve leaflet, and then the balloon body and the stabilizing stent are released, and the angle is adjusted to make the balloon body close to the other native valve leaflet, and the stabilizing stent is continued to be released and the precise position of the balloon body is adjusted, and finally the stabilizing stent is adhered to the atrial wall and the balloon body is aligned with the other native valve leaflet. During the development and research process, the applicant found that the shape of the stabilizing stent plays a vital role in the compression delivery, self-expansion, deployment posture, stability on the atrial wall, or adjustment of the precise position of the balloon body. Based on this primary demand, the applicant completed the present invention.

[0138] Regarding terminology used in this application: The term "switching function" generally refers to the closing of the native valve leaflets during ventricular contraction to prevent blood backflow and the opening of the native valve leaflets during ventricular expansion to allow blood to flow through. "Operating state" generally refers to the process of the balloon performing its switching function. "Inflow end" and "outflow end" generally refer to the components placed in the appropriate position in the heart, defined by the direction of blood flow. For example, the upstream portion of the blood flow is called the inflow end, and the downstream portion is called the outflow end. "Inflow port" and "outflow port" generally refer to the inlet of the stent's inflow end, and the outlet of the stent's outflow end, respectively. "Proximal end" and "distal end" generally refer to the end closer to the operator, and the distal end to the end farther from the operator, respectively. "Anterior" and "posterior" are generally defined in common anatomical terms unless otherwise specified. For example, in the mitral valve, the portion closer to the posterior leaflet is called the posterior portion, and the portion closer to the anterior leaflet is called the anterior portion. "Inner side" and "outer side" generally refer to the portion that can form a certain amount of accommodation or support space, and the portion that cannot form a certain amount of space, referred to as the inner side, and the portion that cannot form a certain amount of space, referred to as the outer side. In this application, a “connection end” generally refers to the connection point where one component is connected to another component, and a “free end” in this application generally refers to an end of a component that is free and not connected to other components.

[0139] The term "deformable" as used in this application refers to a conventional self-expanding stent, meaning that the stent has at least two states: an initial state of compressed delivery and a final state of deployed or self-expanded state. In this application, an "annular surface" refers to, for example, an arcuate surface. A "non-interference state" means that the support rods on the stent do not interfere with the normal swinging of the balloon. A "quasi-hemispherical shape" refers to the overall shape of the stent (which may include lugs), which minimizes the bending strain of the stent and provides excellent support. A "delivery member" can be a delivery device such as a delivery catheter.

[0140] Regarding the "member for securing the balloon to the cardiac tissue at the native valve annulus" in this application, at least one of the following can be selected: a clamping member provided on the balloon, for clamping the balloon to the cardiac tissue near the native valve leaflets or the annulus; a member connected to the balloon (such as the accessory described in this application), for connecting the balloon and cooperating in clamping the balloon to the native valve leaflets; a member indirectly connected to the balloon (such as the support frame described in this application), for pressing against the cardiac tissue to assist in supporting the balloon and maintaining a stable position. The "balloon mold" can be manufactured in various shapes based on the physiological structure of the heart valve or customized based on the imaging structure of the patient's heart valve. "Wire," "braided wire," "lattice skeleton," etc., as used in this application, refer to medical metal, wire, or metal alloy wire with a memory property. Nickel-titanium wire is commonly used. Nickel-titanium alloy is a shape memory alloy, a specialized alloy that automatically returns to its original shape after plastic deformation at a specific temperature. Its expansion and contraction rate is over 20% and it has excellent corrosion resistance. In addition, the well-known technologies generally associated with heart valve repair are not described in detail, and those skilled in the art can understand them in a conventional manner in the prior art.

[0141] The following describes the implementation of the present application through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0142] Please see the attached Figure 1-25 It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions for the implementation of this application. Therefore, they have no substantive technical significance. Any structural modification, change in proportion or adjustment of size, without affecting the efficacy and purpose of this application, should still fall within the scope of the technical content disclosed in this application.

[0143] Example 1

[0144] Taking the mitral valve as an example, see Figure 1-Figure 5, a heart valve repair component is provided, comprising: a stabilizing stent 1, a balloon body 2 and an auxiliary frame 3. The balloon body 2 is arranged at the outflow end of the stabilizing stent 1, and is configured to cooperate with the leaflets of the native valve to assist the native valve in restoring its switching function. The auxiliary frame 3 is used to fix the balloon body 2 to the native leaflets to achieve the cooperation between the balloon body 2 and the native leaflets. It is worth noting that similar to the prior art, the auxiliary frame of the present application is made of a biocompatible elastic material, preferably a memory alloy, and more specifically, nickel-titanium alloy. During the actual implantation process, the repair component is combined with a delivery catheter to enter the body, and the auxiliary frame 3 is first released from the delivery catheter. Wait until the auxiliary frame 3 and the delivery catheter form a certain angle (40° to 90°) to stop releasing, use imaging equipment to view the relative position of the auxiliary frame 3 and the native leaflets, and through the pulling action, the auxiliary frame 3 is used to capture the native leaflets.

[0145] The stabilizing stent 1 is a self-expanding mesh structure. After being implanted in the body in a compressed delivery state, the stabilizing stent 1 expands to form a preset shape, which serves to connect the delivery balloon 2. The stabilizing stent 1 is delivered and implanted in the corresponding part of the body, such as the heart tissue near the atrial valve ring, which allows blood to flow normally from the atrium to the ventricle. The important purpose of the stabilizing stent 1 is to be firmly fixed in the atrium and almost not affect the normal blood flow, and to withstand the load caused by the impact of the blood flow on the balloon 2, thereby ensuring the normal operation of the balloon 2. The stabilizing stent 1 needs to go from a compressed delivery state to an expanded state. During this deformation process, the strain force at various parts of the stabilizing stent 1 and the difficulty of pressing and gripping will have a crucial impact on whether the stabilizing stent 1 can be smoothly deployed or whether it can be deployed to the preset state or whether it can be stably fixed to the atrial wall.

[0146] For details, see Figure 1-3 The stable stent 1 includes a plurality of support rods 100 distributed circumferentially. The support rods 100 are interconnected to form a deformable stable stent 1. In the deployed state, the support rods 100 at the inflow end of the stable stent 1 converge toward the first center C1 along an annular surface. The first center is located at the inflow end of the stable stent 1. The annular surface can be an arcuate annular surface. The first center C1 refers to the inflow port of the stable stent 1, preferably the center of the inflow port of the stable stent 1. The support rods 100 near the inflow end of the stable stent 1 converge toward the first center C1 along the above-mentioned annular surface, similar to the gathering structure of a bun or a gathering structure of a garlic. The local bending strain of the stable stent 1 with this structure is small, and the compression and gripping difficulty is small. The stable stent 1 is not easily damaged during the deformation process from compression to delivery to deployment. It is easier to deploy to a preset shape. After deployment, the stable stent 1 fits better with the atrial wall, making the posture of the entire component more stable after implantation in the heart.

[0147] In one embodiment, see Figure 1 and Figure 3 The stable support 1 includes a gathering portion 11 and a support portion 12. One end of each support rod 100 extends from the interface L1 to the first center C1 and gathers to form the gathering portion 11, and the other end of each support rod 100 extends from the interface L1 to the second center C2 and gathers to form the support portion 12. In order to meet the advantageous functions of the stable support 1 described above, the stable support 1 is preferably configured as a hemispherical shape, that is, the first center C1 is located at the center of the inlet of the stable support, the second center C2 is located at the center of the outlet of the stable support, and the line L2 connecting the first center C1 and the second center C2 is perpendicular to the interface L1.

[0148] For more details, see Figure 1-3 The stable stent 1 is a self-expanding mesh structure. In this example, each support rod 100 is connected to form a stable stent 1 with multiple openable parts. In the expanded state, the openable parts form openings 101. Preferably, the openings 101 are diamond-shaped or diamond-like openings, which facilitate the deformation process from the compressed delivery state to the expanded state. Figure 3 In the unfolded state, the multiple diamond-shaped openings of the stable bracket 1 have the same shape, and one end gradually extends and gathers toward the first center C1 with the interface L1 as the starting point, and the other end gradually extends and gathers toward the second center C2 with the interface L1 as the starting point, thereby forming a hemispherical stable bracket 1.

[0149] In one embodiment, see Figure 3 Each support rod 100, or rather, each opening formed by the connection of the support rods, is distributed in at least one row. After being implanted in the body in a compressed state, the stable stent 1 self-expands to form a stable stent of a predetermined shape, serving to connect the delivery balloon 2. After being delivered and implanted in the corresponding part of the body, such as the cardiac tissue near the atrial valve ring, it is anchored to the cardiac tissue through corresponding anchoring means to provide stable support. The overall area and structural stability of the stable stent 2 will affect the blood flow performance or support capacity after implantation. The appropriate stable stent 1 is selected according to actual needs. In this embodiment, the support rods 100 are selected to be arranged in a double row, i.e., the diamond-shaped openings are arranged in a double row, i.e., the upper openings 1013 in the upper row and the lower openings 1014 in the lower row are preferably staggered, reducing the amount of material used for the stable stent, i.e., reducing the implantation of foreign objects. In addition, the staggered upper openings 1013 and lower openings 1014 facilitate the deformation of the stent from compression to expansion and the stability of the posture after expansion.

[0150] In one embodiment, see Figure 3The aforementioned anchoring means is to provide an anchoring portion on the support rod 100. Preferably, at least a portion of the support rod 100 is provided with an anchoring portion, such as teeth, thorns, hooks, etc. Specifically, the anchoring portion includes an upper anchoring portion 1021 and a lower anchoring portion 1022. The anchoring end of the upper anchoring portion 1021 points to the inflow end of the stable stent 1, and the anchoring end of the lower anchoring portion 1022 points to the outflow end of the stable stent 1. The anchoring end refers to the end of the anchoring portion that is anchored to the heart tissue. More preferably, the upper anchoring portion 1021 is located on the side of the stabilizing stent 1 away from the balloon body 2, while the lower anchoring portion 1022 is located on the side of the stabilizing stent 1 close to the balloon body 2. Due to the presence of the balloon body 2, the repair assembly is not in a well-balanced state. This is because when blood flows from the atrium to the ventricle, the front portion 202 of the balloon body is impacted by the blood, and when the leaflets close, the rear portion 201 of the balloon body will bear the impact of blocking the blood. Therefore, the repair assembly has a tendency to flip. The design of the anchoring portion can maintain the stability of the assembly. In addition, the above preferred anchoring portion arrangement does not require an excessive number of anchoring portions and can prevent the repair assembly from flipping by cooperating with the upper and lower anchoring portions in special locations. Furthermore, the corresponding number of anchoring portions can be set as needed, for example, according to the number of layers of the stabilizing stent 1. In this embodiment, the anchoring portion adopts a barb, and the barb is in the form of a barb connecting portion connected to the stabilizing stent 1 and extending in the direction away from the stabilizing stent 1 in accordance with the shape of the stabilizing stent 1 until the free end of the barb.

[0151] In one specific embodiment, in addition to the above, it is also necessary to rapidly endothelialize the stabilizing stent 1, that is, to stably position the stabilizing stent 1 in the atrial wall. Therefore, in this example, the stabilizing stent 1 is entirely or partially provided with a membrane capable of promoting endothelialization of the stabilizing stent 1, or is wrapped with sutures capable of promoting endothelialization of the stabilizing stent 1. The membrane or sutures capable of promoting endothelialization of the stabilizing stent 1 are made of PET or PTFE. Preferably, 1) the stabilizing stent 1 is partially provided with a PET membrane, for example, by gluing or suturing. The specific placement of the PET membrane can be on the stabilizing stent 1 away from the side of the balloon body 2 or on the stabilizing stent 1 near the side of the balloon body 2. Because the balloon body 2 tends to flip the stabilizing stent 1 when impacted by blood flow, these two locations facilitate rapid endothelialization, facilitating rapid endothelialization of the stabilizing stent 1 within the atrial wall, thereby stably securing it within the atrial wall. Preferably, the PET membrane is placed on the stabilizing stent 1 away from the side of the balloon body 2 and on the stabilizing stent 1 near the balloon body 2. 2) Sutures capable of promoting endothelialization are wrapped around each support rod 100 of the entire stabilization stent 1. The sutures are wrapped around each support rod 100 so as not to interfere with blood flow, or the sutures are wrapped at the same location as the PET film. Wrapping the sutures around the stabilization stent 1 increases the contact friction between the stabilization stent 1 and the atrial wall and facilitates cardiac tissue adhesion. When the sutures are made of a material that promotes endothelialization, such as PET, they can also promote rapid endothelialization of the stabilization stent 1.

[0152] In a specific embodiment, as described above, the stabilizing stent 1, in addition to being connected to the supporting auxiliary frame 3 and thus supporting the balloon body 2, also needs to bear the load brought by the impact of blood flow on the balloon body 2 to ensure the normal operation of the balloon body 2. Therefore, it is necessary to ensure that the support rod 100 on the stabilizing stent 1 does not interfere with the balloon body 2. The support rod 1001 located at the outflow end of the stabilizing stent 1 and close to the auxiliary frame is set to a non-interference state with the balloon body 2. Figure 1 and Figure 4 The non-interference settings are listed as follows: 1) The support rod 1001 located at the outflow end of the stable bracket 1 and close to the auxiliary bracket 3 is bent toward the inner side of the stable bracket 1, that is, the two diamond-shaped openings on both sides of the auxiliary bracket 3 are bent inward, which can avoid interference with the balloon body 2, facilitate the free movement of the balloon body 2, and improve the hemodynamic performance of the balloon body; 2) The length of the support rod 1001 located at the outflow end of the stable bracket 1 and close to the auxiliary bracket is shorter than the adjacent support rod, that is, the outflow end length of the diamond-shaped openings on both sides of the auxiliary bracket 3 is shortened to prevent it from interfering with the balloon body 2.

[0153] In some embodiments, see Figure 1-3At least two hooks 13 are provided at the inlet of the stable stent 1 for externally delivering the components of the heart valve repair assembly. Each hook 13 is circumferentially arranged along the inlet (inflow end) of the stable stent 1, and a threading hole 130 is provided at the inflow end of each hook 13 for externally delivering the components of the heart valve repair assembly or for threading a pull wire to manipulate the control or recovery of the heart valve repair assembly. The lengths of each hook 13 can be selected to be consistent or inconsistent. The preferred embodiment of each hook 13 is that the lengths are inconsistent, the purpose of which is to make the stable stent 1 on the side of the short hook be released and self-expanded into place first, which can prevent the stable stent 1 from instantly collapsing from the delivery device and causing the fixed position of the balloon body 2 to shift. After the anchoring portion on the stable stent 1 is securely attached to the appropriate atrial position, the remaining longer hooks are released to enhance the stability of the release process of the stable stent 1. The preferred embodiment of the present invention is that each hook is evenly distributed at the inflow end of the stable stent 1.

[0154] For more details, see Figure 4 and Figure 5 The preferred embodiment further illustrates three hanging ears, wherein the first hanging ear 131 is a short hanging ear, and the second hanging ear 132 and the third hanging ear 133 are long hanging ears. The first hanging ear 131 is located on the side of the stabilizing stent 1 away from the auxiliary frame 3. Since the position of the balloon body 2 is the most critical, the stabilizing stent 1 away from the balloon body 2 is released first, while the stabilizing stent 1 close to the balloon body 2 is not released. This allows for further adjustment of the position of the balloon body 2, improves the accuracy of the valve or balloon body 2 implantation, and increases the stability of the release of the stabilizing stent 1.

[0155] For more details, see Figure 1-3 Each of the lugs 13 converges toward the first center C1. Preferably, each of the lugs 13 converges toward the first center C1 along an arc-shaped annular surface. That is, the lugs are also configured to converge in an arc shape from the periphery toward the first center C1, so that the entire stabilizing stent is more hemispherical. This shape allows the entire stabilizing stent to better fit the atrial wall without causing the lugs to protrude too much and damage the atrial wall tissue.

[0156] Example 2

[0157] The auxiliary frame of the present application is made of biocompatible elastic material, preferably memory alloy, and more specifically nickel-titanium alloy. During the actual implantation process, the repair component cooperates with the delivery catheter to enter the body, and the auxiliary frame 3 is first released from the delivery catheter. The release is stopped when the auxiliary frame 3 and the delivery catheter form a certain angle (40°~90°). The relative position of the auxiliary frame 3 and the native leaflet is viewed with the help of imaging equipment, and the auxiliary frame 3 captures the native leaflet through the pulling action.

[0158] In one embodiment, see Figure 6-Figure 12The auxiliary frame 3 is arranged at the outflow end of the stable stent 1. The auxiliary frame 3 includes a loading portion close to the stable stent 1 and a clamping portion away from the stable stent 1. A holding space 300 is formed between the loading portion and the clamping portion. The holding space 300 is used to load the balloon body 2 and capture and accommodate the native leaflets. The abutting surface of the clamping portion abuts the native leaflets, and a reinforcement member 31 is provided on the abutting surface. For example, see Figure 11 A reinforcement member 31 is provided on the upper portion of the clamping portion, and one side of the reinforcement member 31 is used to support the native valve leaflets. In this example, the loading portion is the portion of the auxiliary frame 3 close to the stabilizing stent 1, and the clamping portion is the portion of the auxiliary frame 3 away from the stabilizing stent 1. A holding space 300 is formed between the clamping portion and the loading portion. The loading portion can be used to install the balloon body 2, and the balloon body 2 is positioned within the holding space 300, thereby forming a space for capturing and accommodating the native valve leaflets within the holding space 300 and between the balloon body 2 and the clamping portion.

[0159] In one embodiment, see 9 Figure 12 , the loading part and the clamping part are integrally formed. For more details, refer to Figure 9 The auxiliary frame 3 includes a first auxiliary rod 32 and a second auxiliary rod 33. One end of each of the first and second auxiliary rods 32 and 33 is joined to the stabilizing frame 1, while the other ends extend toward the outflow end of the stabilizing frame 1 to form the loading portion. These rods then bend away from the stabilizing frame 1 and then extend toward the inflow end of the stabilizing frame 1 to form the clamping portion, thereby forming a loading space 300 between the clamping portion and the loading portion. More specifically, the first and second auxiliary rods 32 and 33 can be joined to the stabilizing frame 1 by means of connectors, welding, or direct, integral molding.

[0160] For details, see Figure 9 The first auxiliary rod 32 and the second auxiliary rod 33 are arranged opposite to each other, and form a U-shaped structure after the above extension and bending, that is, the loading part and the clamping part are integrally formed into a U-shaped structure.

[0161] For more details, see Figure 6 and Figure 7 The free end of the clamping part forms a first abutting surface 301, and the connecting end of the clamping part forms a second abutting surface 302, and the first abutting surface 301 and the second abutting surface 302 are smoothly connected to achieve the effect of stably fitting the native leaflet. In addition, a reinforcement member 31 is arranged on the first abutting surface 301. This position bears more load during use of the repair component. The reinforcement member 31 is arranged to increase the clamping area with the native leaflet, which is conducive to improving the clamping stability and reducing damage to the native leaflet.

[0162] For more details, see Figure 9Along the direction from the outflow end to the inflow end of the stable stent 1, the first auxiliary rod 32 and the second auxiliary rod 33 forming the clamping part gradually approach the holding space 300, that is, the lower side space of the holding space 300 is larger, so as to better accommodate the balloon body 2 and not interfere with the movement of the balloon body 2; the upper side space of the holding space 300 is smaller, so that the clamping part can better fit the native leaflet to ensure the stability of the fixation of the balloon body 2.

[0163] For more details, see Figures 9-11 , along the direction from the outflow end to the inflow end of the stabilizing stent 1, the first auxiliary rod 32 and the second auxiliary rod 33 forming the clamping portion gradually move away from each other, that is, the distance between the free end of the first auxiliary rod 32 and the free end of the second auxiliary rod 33 is widened, thereby facilitating the clamping portion to form a larger contact area with the native leaflet. More specifically, the two ends of the reinforcement member 31 are respectively connected to the free end of the first auxiliary rod 32 and the free end of the second auxiliary rod 33. As described above, the reinforcement member is provided on the abutting surface of the clamping portion (specifically, the first abutting surface 301, which can be understood as a surface of the reinforcement member 31 forming the first abutting surface 301). The widening distance between the free end of the first auxiliary rod 32 and the free end of the second auxiliary rod 33 increases the contact area between the reinforcement member 31 and the native leaflet, thereby facilitating reducing damage to the leaflet. More specifically, the reinforcement 31 is a multi-zigzag connecting rod structure. Compared with the ordinary single-loop structure, the overall size is widened, and the clamping area with the native leaflet is increased. As mentioned above, along the direction from the outflow end to the inflow end of the stable stent 1, the first auxiliary rod 32 and the second auxiliary rod 33 forming the clamping portion are gradually approached to the holding space 300. Therefore, the reinforcement 31 connected between the free end of the first auxiliary rod 32 and the free end of the second auxiliary rod 33 is slightly inwardly buckled. Specifically, for example, Figure 9 The lower side of the reinforcement 31 is inclined toward the mounting space 300 , which can also improve the clamping stability, and the increase in area helps to reduce damage to the leaflet.

[0164] In one embodiment, see Figure 10 and Figure 11 The auxiliary frame 3 further includes an upper auxiliary member 34 and a lower auxiliary member 35 for connecting to the balloon body 2. Specifically, one end of the upper auxiliary member 34 is connected to the stable support 1 or the loading portion, and the other end extends toward the inflow end of the stable support 1 and toward the outside of the stable support 1 to form the upper auxiliary member free end. One end of the lower auxiliary member 35 is connected to the stable support 1 or the loading portion, and the other end extends toward the outflow end of the stable support 1 to form the lower auxiliary member free end.

[0165] For details, see Figures 9-11The upper auxiliary part 34 and the lower auxiliary part 35 are both rod structures. The upper auxiliary part 34 is used to fix the upper part of the balloon body 2, and the lower auxiliary part 35 is used to fix the lower part of the balloon body 2. The balloon body 2 can be made of a mesh frame made of medical metal cutting or metal wire weaving, and a coating is coated on the outside of the mesh frame. The balloon body 2 can be fixed to the auxiliary frame 3 in such a way that the upper part of the balloon body 2 is inserted into the upper auxiliary part 34, and the lower part of the balloon body 2 is inserted into the lower auxiliary part 35, and the free end of the lower auxiliary part 35 is located in the holding space 300 to ensure that the lower auxiliary part 35 does not extend out of the outer surface of the balloon body 2, so as to prevent it from affecting the closure of the native leaflets that are not clamped and the balloon body 2. More specifically, an upper suture hole 341 is provided at the free end of the upper auxiliary part 34, and a lower suture hole 351 is provided at the free end of the lower auxiliary part 35. The purpose of the suture holes is to use sutures to suture and fix the upper and lower auxiliary parts 34 and 35 to the balloon body 2.

[0166] For more details, see Figure 11 The upper auxiliary component 34 includes a first upper auxiliary rod 342 and a second upper auxiliary rod 343 that are arranged opposite to each other. The free ends of the first upper auxiliary rod 342 and the second upper auxiliary rod 343 are both provided with upper suture holes 341. The relative arrangement here specifically means that the first upper auxiliary rod 342 and the second upper auxiliary rod 343 are respectively arranged at the two ends of the spatial opening of the holding space 300, that is, a certain distance is maintained to better fix the upper part of the balloon body 2 and maintain the stability of the fixation. The lower auxiliary component 35 includes a first lower auxiliary rod 352 and a second lower auxiliary rod 353, and the free ends of the first lower auxiliary rod 352 and the second lower auxiliary rod 353 merge to form the free end of the lower auxiliary component. The contact amount between the lower auxiliary component 35 and the balloon body 2 is small, so the lower auxiliary component 35 is directly inserted into the balloon body 2 by adopting an integrated arrangement, so as to better select the fixing angle of the balloon body 2.

[0167] In one embodiment, see Figure 13 and Figure 14 One end of the first auxiliary rod 32 and the second auxiliary rod 33 are respectively connected to the stabilizing bracket 1 to form an auxiliary rod joint. This auxiliary rod joint is provided with a reinforcement block 1002. The provision of the reinforcement block 1002 helps to increase the strength and stability of the connection. Specifically, the connecting ends of the first upper auxiliary rod 342 and the second upper auxiliary rod 343 are respectively connected to the reinforcement block 1002. More specifically, the connecting ends of the first lower auxiliary rod 352 and the second lower auxiliary rod 353 are connected to the reinforcement block 1002. In other words, the reinforcement block 1002 provides a connection point for the above components, which improves the connection stability.

[0168] Example 3

[0169] The difference from Example 1 and Example 2 is that, see Figure 13-18Each support rod 100 is circumferentially connected to form a mesh-like, self-expandable stent 1, and each support rod 100 is arranged in a single row. This has the following advantages: 1) The surface area of ​​the stent 1 is small, reducing the amount of metal implanted and making the repair assembly patient-friendly; 2) The single-row arrangement of the stent 1 has a low shortening rate (i.e., the length of the compressed stent shortens during expansion; the smaller the shortening rate, the smaller the change in the stent 1), facilitating release and positioning after in vivo delivery; 3) The single-row arrangement of the stent 1 is short overall, reducing the length of the distal portion of the delivery catheter and the bending radius of the distal portion of the delivery catheter that wraps around the stent, thus reducing the difficulty of bending during implantation; 4) The single-row arrangement of the stent 1 reduces the stent area, reduces blood flow obstruction at the valve orifice, and thus reduces turbulence, which is more conducive to blood circulation; 5) The atrial structure of the mitral / tricuspid valve inflow end is irregular, difficult to predict, and cannot withstand large support forces. The single-row grid can effectively increase the adaptability of the stent to the atrial morphology, minimizing myocardial damage.

[0170] Specifically, to maintain the stability of the support frame, refer to Figure 14 , from the front view, the front openings 1011 located in the front row and the rear openings 1012 located in the rear row are arranged alternately.

[0171] For more details, see 13- Figure 15 The auxiliary frame 3 includes a first auxiliary rod 32 and a second auxiliary rod 33, and is arranged similarly to that in Example 4 to form a holding space 300 between the clamping portion and the loading portion. Preferably, the first auxiliary rod 32 and the second auxiliary rod 33 are arranged opposite to each other, and after being extended and bent in a manner similar to that in Example 4, a U-shaped structure is formed, that is, the loading portion and the clamping portion are integrally formed into a U-shaped structure. More specifically, along the direction from the outflow end to the inflow end of the stable stent 1, the first auxiliary rod 32 and the second auxiliary rod 33 forming the clamping portion are successively approached to the holding space 300, that is, the lower side space of the holding space 300 is larger so as to better accommodate the balloon body 2 and not interfere with the movement of the balloon body 2; the upper side space of the holding space 300 is smaller, so that the clamping portion can better fit the native valve leaflet, thereby ensuring the stability of the balloon body 2 fixation.

[0172] For more details, see 22 and Figure 23 The support rods 100 are interconnected to form a stable bracket 1 with multiple openings, and the support rods 100 with adjacent openings form bone nodes 103. The bone node structure improves torsional resistance and rigidity.

[0173] Example 4

[0174] The balloon body 2 is configured to cooperate with the leaflets of the native valve to assist in restoring its opening and closing function. The balloon body 2 comprises at least two layers of mesh frames, one inside the other, with the individual meshes of adjacent layers interlaced. After implantation into the heart in a compressed delivery state, the balloon body 2 expands and partially clamps onto the native leaflets, while the remaining meshes cooperate with the other leaflets to assist in the normal opening and closing function of the native valve. If the mesh frame is at risk of failure, this can lead to balloon failure. The arrangement of staggered meshes in adjacent layers can reduce this risk. For example, partially staggered meshes refer to staggered meshes located in areas of the balloon body 2 most susceptible to failure. The mesh frame is made of cut medical metal or braided wire. In the final operating state of the balloon body 2 of this embodiment, it is a relatively closed structure, making it unsuitable for secondary expansion. The balloon body 2 needs to be compressed and gripped externally before it can automatically recover after being delivered into the body. Therefore, the mesh frame is preferably made of a medical shape memory alloy, specifically nickel-titanium shape memory alloy. In addition, the number of layers of the two inner and outer grid skeletons is selected according to the functional requirements of the balloon body 2.

[0175] Provide a specific embodiment, see Figure 20-22 The balloon body 2 is made of woven metal wire. Specifically, the balloon body 2 includes an inner grid frame 211 and an outer grid frame 212. The inner grid frame 211 and the outer grid frame 212 are not fixed, forming an elastic contact support effect. Figure 22 The outer covering 23 of the balloon body 2 serves to seal the lattice frame of the balloon body 2 and to mimic the original valve leaflet. The covering 23 is generally made of a smooth polymer film and is bonded to the lattice frame by an adhesive. For example, the adhesive is FEP (Fluorinated ethylene propylene), which can be treated at about 300°C for a few minutes to form a good adhesion with the covering 23, so that the covering 23 is firmly attached to the balloon body 2. Figure 19 For a balloon with a single-layer mesh skeleton, if the metal wire in one of the meshes is broken, there will be an area in the entire balloon that lacks the coating 23 on the metal wire support surface. However, the two layers of mesh in the present application are staggered and not fixed to each other, forming an elastic contact support effect. If a nickel-titanium wire in a certain layer is broken, the crossed metal wires in the other layer can still provide a certain support force. And the appropriate mesh density is selected through fatigue verification. The mesh density of each layer of mesh skeleton is about 10 to 12 ppi, and then the mesh skeletons of adjacent layers are staggered to form a multi-layer mesh skeleton with appropriate mesh density. Furthermore, the two layers of mesh are not fixed to each other, which is conducive to the compression and recovery of the balloon.

[0176] In the working state and the native heart valve is closed, the rear portion 201 of the balloon body is in contact with a portion of one of the leaflets of the native heart valve, and the front portion 202 of the balloon body is in contact with a portion or multiple portions of another leaflet of the native heart valve instead of a portion of the leaflet. Therefore, the surface shape of the balloon body 2 needs to be similar to the closed shape of the leaflet of the native heart valve. Figure 23 Taking mitral valve repair as an example, the rear portion 201 of the balloon body cooperates with the auxiliary frame 3 to clamp a portion of the posterior leaflet PL against the balloon body 2, so that the front portion 202 of the balloon body contacts and fits with a portion or multiple portions of the anterior leaflet AL in the native heart valve. The balloon body 2 is also configured to be a crescent-shaped arc in the working state and in the direction of leaflet closure, with the aim of infinitely approaching the anatomical morphology of the native leaflet, so that the balloon body 2 can assist the native leaflet in forming a good sealing surface to prevent mitral valve regurgitation. More specifically, in the working state and in the direction of blood flow (the direction in which blood flows from the atrium to the ventricle), the front portion 202 of the balloon body is configured to be conical or streamlined, which minimizes the impact on blood flow while increasing the contact area between the balloon body and the anterior leaflet AL in the native heart valve as much as possible, thereby better forming a good sealing surface to prevent mitral valve regurgitation.

[0177] In a specific embodiment, the balloon body 2 is provided with at least one fixing position, which is used to connect the auxiliary frame or to connect an external delivery member. The external delivery member can be a delivery tube type compression delivery device. Figure 1 、 Figure 6 Figure 23 In the present application, the auxiliary frame 3 connected to the balloon body 2 plays the role of connecting the balloon body 2 and cooperating with the balloon body 2 to clamp onto the native leaflet to assist the native leaflet in achieving the switching function.

[0178] In a specific embodiment, the connection method between the fixed position of the balloon body 2 and its external component can be selected from suture suturing or film connection, or other common methods and their combinations. For example, at least one fixing port is provided at the proximal or distal end of the balloon body 2 to form the fixed position, which is used to externally fix the balloon body 2 to the component on the heart tissue at the native valve ring. In this embodiment, a preferred connection method is provided, see Figure 20 and- Figure 22An upper fixing port 221 is provided at the inflow end of the balloon body 2, and the balloon body 2 is inserted into the auxiliary frame 3 through the upper fixing port 221. After the balloon body 2 is set on the auxiliary frame 3 through the upper fixing port 221, sutures (medical sutures or materials of the same material as the grid frame) can be used in combination with a coating 23 to seal the upper fixing port 221 and further fix it to the auxiliary frame 3, wherein the coating 23 is made of a polymer material, or the coating 23 is made of PET (Polyethylene terephthalate, polyethylene terephthalate plastic) or E-PTFE (Expanded PTFE, expanded polytetrafluoroethylene). The outflow end of the balloon body 2 has relatively little contact with the auxiliary frame 3, so the auxiliary frame 3 can be directly inserted through the gap of the grid skeleton of the balloon body 2. This installation method is conducive to selecting a fixed angle of the balloon body 2, that is, space can be reserved for the auxiliary frame 3 and the balloon body 2 to clamp the native valve leaflet, and it can also ensure that the balloon body 2 maintains a certain conical or streamlined shape in the direction of blood flow.

[0179] In another embodiment, see Figure 7 or Figure 19 The auxiliary frame 3 extends through the lower fixing opening 222 of the balloon body 2. The balloon body 2 at the lower fixing opening 222 is secured by a locking ring 223 and then positioned within the balloon body 2. The locking ring 223 is preferably made of a material suitable for medical imaging, such as an X-ray opaque material, a high-density metal, or a special shape that facilitates imaging and identification, more specifically, a platinum-iridium alloy. This locking ring 223 not only locks the balloon body 2 into a closed configuration but also serves as a marker.

[0180] Example 5

[0181] Provided is a method for preparing a balloon for heart valve repair, comprising the following steps: S1, weaving a balloon comprising at least two layers of a lattice skeleton, wherein the balloon comprises a balloon wall and an adjustable cavity located inside the balloon wall;

[0182] Specifically, the inner and outer two-layer grid is used as an example for specific description:

[0183] S11. Separately weave the inner mesh skeleton and the outer mesh skeleton and combine them into a balloon body or use a layer of mesh skeleton to realize a balloon body with an inner and outer double-layer skeleton by overlapping. Specifically, an optional preparation method is provided: 1) Weave an inner mesh with a certain opening or fully surrounded mesh density of 10-12ppi, and then continue to weave a layer of outer mesh skeleton corresponding to the inner mesh skeleton on the outside of the inner mesh skeleton. The outer mesh density is 10-12ppi and the outer mesh of at least part of the outer mesh is staggered with the inner mesh of the inner mesh. 2) Weave a layer of mesh skeleton and fold the layer of mesh to form a balloon body with an inner mesh skeleton and an outer mesh skeleton. Be sure to make sure that the outer mesh of at least part of the outer mesh skeleton is staggered with the inner mesh of the inner mesh skeleton. The two layers of mesh are interlaced and not fixed, forming an elastic contact support with good support force and good elastic maintenance ability, and is conducive to balloon compression.

[0184] S12. Provide a capsule mold. The shape of the mold can be manufactured in multiple models according to the physiological structure of the heart valve, or customized according to the imaging structure of the patient's heart valve. The capsule mold can be customized or 3D printed according to the required capsule shape. The material of the capsule mold needs to be able to withstand a high temperature of about 600°C.

[0185] S2. Shape the balloon body of step S1 so that the balloon body is configured to cooperate with the leaflets of the native valve. Specifically, S21. Place the balloon body prepared in step S11 on the balloon body mold for shaping. The specific shaping method is heat setting. Preferably, the balloon body and the balloon body mold are heated at 480-550°C for 10-30 minutes. Of course, the optional temperature is 480-490°C, 490-500°C, 500-510°C, 510-520°C, 520-530°C, 530-540°C, or 540-550°C. The optional heating time is 10-15 minutes, 15-20 minutes, 20-25 minutes, or 25-30 minutes. The specific temperature or heating time can be selected according to the material and thickness of the skeleton or the functional verification of the balloon body after shaping. More specifically, the prepared balloon body is placed on a balloon mold for simple shaping and then placed in a boiling furnace. After being placed at a temperature of 510° C. for 15 minutes, it is cooled to shape and demolded.

[0186] Furthermore, the preparation method also includes S3, coating the balloon body, wherein the coating layer formed by the coating is made of a biocompatible material, or the coating layer is made of a polymer material, or the coating layer is made of PET or E-PTFE. Specifically, the optional coating method is: 1) an adhesive layer with an adhesive function is placed on the balloon body obtained in step S2, and then coated with a coating layer, and finally heat-adhesion processing is performed to fix the shape. The adhesive layer is made of a polymer material, that is, a polymer film, which can form an adhesive effect when melted. For example, the adhesive layer is made of FEP film. FEP film is selected because it can be heated at 280-320°C for 5-20 minutes. After the FEP film melts, it can be firmly bonded to the coating layer. Of course, the temperature can be selected from 280-290°C, 290-300°C, 300-310°C, or 310-320°C. The optional heating time is 5 to 10 minutes, 10 to 15 minutes, or 15 to 20 minutes. The specific temperature is selected according to the properties and thickness of the material and the functional state after processing.

[0187] More specifically, before step S3, the following step is also included: trimming the balloon body formed in step S2 so that it has at least one opening to form a mounting position.

[0188] In one embodiment, see Figure 24 The coating 23 is a single integral film. Specifically, the coating 23 includes a first coating 231, a second coating 232, a third coating 233 and a fourth coating 234. The coating 23 is made of E-PTFE film, and an FEP film is provided at the overlapping portion formed by the first coating 231, the second coating 232 and the third coating 233. The thickness of the above films is selected according to actual needs. The specific coating process of the balloon lattice skeleton with the overall membrane can be as follows: the lattice skeleton of the balloon is placed at the central placement site of the overall membrane (preferably, the front part of the balloon is placed close to the central placement site), the first covering membrane 231 is folded to the right and placed on the balloon body, and then the FEP membrane is placed at the overlapping position of the first covering membrane 231; the second covering membrane 232 is folded to the left so that a part of the second covering membrane 232 overlaps with the above-mentioned FEP membrane, and then the FEP membrane is placed at the overlapping position of the second covering membrane 232; the third covering membrane 233 is folded upward to wrap the balloon body (if there is a part that protrudes above the balloon body, the protruding part is folded downward, and the protruding part can be understood as a redundant part); finally, the fourth covering membrane 234 is folded downward to wrap the upper fixing port 24 of the balloon body, and heat treatment is used to fix it after the coating is completed.

[0189] Example 6

[0190] The preparation method of Example 5 was used to prepare the balloon for heart valve repair described in Example 5. Specifically:

[0191] S11. Weave a mesh skeleton and fold the mesh skeleton over and over to form a balloon body having an inner mesh skeleton and an outer mesh skeleton. The mesh skeleton is made of nickel-titanium wire. Basic parameters: nickel-titanium wire diameter: 0.1-0.13 mm, elongation: 25-50%, nickel-titanium alloy memory wire chemical composition (mass percentage): Ni: 55.4%-57.0%, C ≤ 0.040%, H ≤ 0.005%, O ≤ 0.040%, N ≤ 0.005%, Co ≤ 0.050%, Cu ≤ 0.010%, Cr ≤ 0.010%, Fe ≤ 0.050%, Nb ≤ 0.025%, balance Ti. The inner mesh density is 10 ppi, and the outer mesh density is 10 ppi.

[0192] S12. Provide a suitable capsule mold.

[0193] S13, putting the balloon body on the balloon body mold so that the balloon body fits the balloon body mold, and adjusting the positions of the inner layer grid skeleton and the outer layer grid skeleton so that the single grids of the adjacent layers of grid skeleton are staggered.

[0194] S2. The balloon body treated in step S13 is heat-set, specifically: the balloon body treated in step S13 and the balloon body mold used therein are placed in a furnace, placed at a temperature of 510° C. for 15 minutes, cooled to set the shape, and demolded. After demolding, the size of the balloon body is 16 mm in height, 21 mm in width, and 11 mm in thickness.

[0195] S3. Balloon coating. Specifically, 1) first remove all the nickel-titanium alloy wire or stainless steel wire at the opening of the balloon (here, the nickel-titanium alloy wire or stainless steel wire refers to the braided wire used to fix the balloon to the mold), for example, by using diagonal pliers to trim it; 2) wrap the balloon with FEP film, the FEP film is about 4 mm wide and about 85 mm long, so that the front, back, left and right surfaces of the balloon contain FEP film. The FEP film mainly serves to fix the E-PTFE coating layer to the balloon skeleton; 3) provide a tool that matches the overall film shape of the coating, use the coating method described in Example 2, and coat the balloon with E-PTFE film, and place FEP film between the overlapping films; 4) place the balloon in a hot oven, heat it to 300°C for 10 minutes, and obtain a balloon after cooling.

[0196] Example 7

[0197] A heart valve repair system is provided, comprising the heart valve repair component as described in the above embodiments.

[0198] and a delivery catheter for delivering the repair component in a compressed delivery state to the mitral valve or tricuspid valve, adjusting the appropriate position to unfold the heart valve repair component, and placing the balloon body in an appropriate position.

[0199] Briefly describe the method of using the above repair system: the heart valve repair component is compressed in the delivery catheter, and after the delivery catheter is delivered into the body, refer to Figure 25 , the first thing released is the auxiliary frame 3, wait until the auxiliary frame and the delivery catheter are at a certain angle (40°~90°) and stop releasing, use the imaging equipment to watch the relative position of the auxiliary frame 3 and the posterior leaflet PL, and capture the posterior leaflet PL by pulling. When the capture is successful, keep the overall position of the heart valve repair component unchanged, and continue to release. At this time, the auxiliary frame 3 will completely clamp the posterior leaflet PL, and then the balloon body 2 will be completely released and will mate with the anterior leaflet AL. Then the stabilizing stent 1 is completely released and forms a good contact with the atrial wall. Finally, release the connection parts of the ear and the delivery catheter in sequence, and the release of the entire repair component is completed.

[0200] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. A heart valve repair assembly comprising: A stabilizing bracket (1) comprising a plurality of circumferentially distributed support rods (100), wherein the support rods (100) are interconnected to form a deformable stabilizing bracket (1), and in an expanded state, the support rods at the inflow end of the stabilizing bracket (1) converge toward a first center along an annular surface; A balloon body (2) is arranged at the outflow end of the stable stent (1); The auxiliary frame (3) is used to fix the balloon body (2) to the native leaflets, so as to achieve the cooperation between the balloon body (2) and the native leaflets. At least two hanging ears (13) are provided at the inlet of the stabilizing bracket (1); the lengths of the hanging ears (13) are different, and the length of the hanging ears close to the auxiliary bracket (3) is longer than the length of the hanging ears away from the auxiliary bracket (3).

2. The heart valve repair assembly according to claim 1, characterized in that: The stabilizing bracket (1) comprises a folding portion (11) and a supporting portion (12); One end of each support rod (100) extends from the interface as a starting point toward a first center and gathers to form the gathered portion (11), and the other end of each support rod (100) extends from the interface as a starting point toward a second center and gathers to form the support portion (12).

3. The heart valve repair assembly according to claim 2, characterized in that: The first center is located at the inlet of the stabilizing bracket (1); and the second center is located at the outlet of the stabilizing bracket (1).

4. The heart valve repair assembly according to claim 3, characterized in that: The first center is located at the center of the inlet of the stable support (1); the second center is located at the center of the outlet of the stable support (1); And / or, the line connecting the first center and the second center is perpendicular to the interface.

5. The heart valve repair assembly according to claim 1, characterized in that: Also includes at least one of the following technical features: a1. In the unfolded state, the stabilizing bracket (1) is in a hemispherical shape; a2. The support rods (100) are connected to each other to form a stable bracket having a plurality of openable portions; and in the unfolded state, the openable portions form openings (101); a3. The support rods (100) are distributed in at least one row; a4. The support rod located at the outflow end of the stable support (1) and close to the auxiliary frame (3) is arranged to be in a non-interfering state with the balloon body (2); a5. The whole or part of the stable stent (1) is provided with a membrane capable of promoting endothelialization of the stable stent (1) or is wrapped with sutures capable of promoting endothelialization of the stable stent (1); a6. An anchoring portion is provided on at least part of the support rod (100); a8. The auxiliary frame (3) is a U-shaped structure formed by bending a plurality of connecting rods.

6. The heart valve repair assembly according to claim 5, characterized in that: Also includes at least one of the following technical features: a21, the opening (101) is a diamond-shaped opening or a diamond-like opening; a22, providing a bone node (103) at the connection of the support rod adjacent to the opening (101); a31, each of the support rods (100) is arranged in a single row or in an upper and lower double row; a41, the support rod located at the outflow end of the stabilizing bracket (1) and close to the auxiliary bracket (3) is bent toward the inner side of the stabilizing bracket (1); a42, the length of the support rod located at the outflow end of the stable support (1) and close to the auxiliary frame (3) is shorter than the adjacent support rods; a51. The membrane promoting endothelialization of the stable stent (1) is arranged on a portion of the stable stent away from the auxiliary stent (3), and / or the membrane promoting endothelialization of the stable stent is arranged on a portion of the stable stent close to the auxiliary stent (3); a52. The membrane that promotes the endothelialization of the stent (1) or the suture that promotes the endothelialization of the stent (1) is made of PET or PTFE; a61, the anchoring portion is selected from teeth, thorns or hooks; a62, the anchoring portion comprises an upper anchoring portion (1021) and a lower anchoring portion (1022), the anchoring end of the upper anchoring portion (1021) points to the inflow end, and the anchoring end of the lower anchoring portion (1022) points to the outflow end; a72. A threading hole (130) is provided at the inflow end of each of the hanging ears (13), for externally connecting a component for delivering the heart valve repair component or for threading a pull wire to control or recover the heart valve repair component; a73, each of the hanging ears (13) gathers toward the first center; a74. Three hanging ears (13) are provided at the inlet of the stabilizing bracket (1).

7. The heart valve repair assembly according to claim 1, characterized in that: Also includes at least one of the following technical features: a71. A threading hole (130) is provided at the inflow end of each of the hanging ears (13), for externally connecting a component for delivering the heart valve repair component or for threading a pull wire to control or recover the heart valve repair component; a72, each of the hanging ears (13) gathers toward the first center; a73. Three hanging ears (13) are provided at the inlet of the stabilizing bracket (1).

8. The heart valve repair assembly according to claim 7, characterized in that: Technical feature a73) also includes: each of the hanging ears (13) is gathered toward the first center along an arc-shaped annular surface.

9. The heart valve repair assembly according to claim 6, characterized in that: Also includes at least one of the following technical features: a311, when the support rods (100) are arranged in two rows, the upper openings (1013) in the upper row and the lower openings (1014) in the lower row are arranged in a staggered manner; a621, the upper anchoring portion (1021) is arranged on a side away from the balloon body (2), and the lower anchoring portion (1022) is arranged on a side close to the balloon body (2).

10. The heart valve repair assembly according to claim 1, characterized in that: Include at least one of the following technical features: b1. The balloon body (2) comprises at least two layers of grid skeletons arranged inside and outside, and the single grids of the grid skeletons of adjacent layers are arranged in an interlaced manner; b2. The balloon body (2) is provided with at least one fixing position, and the fixing position is used to connect the auxiliary frame or to connect an external conveying member; b3. The balloon body (2) further includes a covering film (23), wherein the covering film (23) covers at least a portion of the lattice skeleton; b4. In the working state and in the direction of leaflet closing, the balloon body (2) is in a crescent-shaped arc shape; b5. In the working state and in the direction of blood flow, the balloon body (2) is conical or streamlined; b6. In the working state and the native valve is closed, the rear portion (201) of the balloon body is in contact with at least one leaflet of the native valve, and the front portion (202) of the balloon body is in contact with another leaflet of the native valve; b7. The material of the grid skeleton is medical memory alloy.

11. The heart valve repair assembly according to claim 10, characterized in that: In technical feature b2, at least one fixing opening is provided at the proximal end or the distal end of the balloon body (2) to form the fixing position.

12. The heart valve repair assembly according to claim 11, characterized in that: An upper fixing opening (221) is provided at the proximal end of the balloon body (2), and a lower fixing opening (222) is provided at the distal end of the balloon body (2).

13. The heart valve repair assembly according to claim 12, wherein: Also includes at least one of the following technical features: b21, the upper fixed opening (221) is sealed by a covering film (23); b22, the upper fixing port (221) or the lower fixing port (222) is sutured with medical sutures or sutured with a thread of the same material as the balloon body (2); b23, the lower fixing opening (222) is tightened by a locking ring (223).

14. The heart valve repair assembly according to claim 13, characterized in that: In feature b3 or b21, the covering film (23) is made of a biocompatible material; or the covering film (23) is made of a polymer material; And / or, in feature b23, the material of the locking ring (223) is a medical imaging material.

15. A heart valve repair system comprising: The heart valve repair assembly according to any one of claims 1 to 14; The delivery catheter is used to deliver the repair component in a compressed delivery state to the mitral valve or tricuspid valve, and adjust the appropriate position to deploy the heart valve repair component.

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