Heart valve repair balloon and heart valve repair component

Abstract

The present application provides a balloon body for heart valve repair, which belongs to the field of medical device technology. The balloon body includes a balloon wall and an adjustable cavity located inside the balloon wall, and the balloon wall includes at least two layers of grid skeletons, and at least part of the grids of adjacent layers of grid skeletons are staggered. The balloon body is configured to cooperate with each leaflet of the native valve to assist the native valve in restoring its switching function compared to a balloon body with a single layer of grid skeleton. The setting of at least two layers of grid skeletons in the present application can provide good supporting force, and at least part of the grids of adjacent layers of grid skeletons are staggered, and the uncertainty between the grids is compensated by the staggering. For example, if heat setting is adopted, because the balloon body is an irregular curved surface, the staggered setting of the grids can easily control the density between the grids; for another example, by staggering the adjacent layers of grids, the risk of elastic failure of the balloon body due to the breakage of a certain grid line can be reduced.

Description

Technical Field

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

[0002] Mitral regurgitation is caused by valvular insufficiency. During left ventricular contraction, blood flows from the left ventricle into the aorta and the left atrium, where resistance is lower. The left atrium receives blood from the pulmonary veins as well as blood from the left ventricle. Consequently, increased left atrial pressure leads to increased pressure in the pulmonary veins and pulmonary capillaries, leading to dilation and congestion. Simultaneously, the left ventricular volume load increases during diastole, causing left ventricular enlargement. In acute mitral regurgitation, a sudden surge of blood backflow from the left atrium can cause a sharp increase 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 dilation. When tricuspid regurgitation occurs, symptoms of right heart failure, such as fatigue, ascites, edema, liver pain, indigestion, and poor appetite, worsen, and can even 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 order to solve the above problems, it is hoped to provide a heart valve repair balloon and a heart valve repair system, so that the balloon can partially replace the heart valve and retain most of the original leaflet function, thereby promoting the treatment of heart valve regurgitation. Summary of the Invention

[0005] In view of the above-mentioned problems of the prior art, the technical problem solved by the present application is to provide a balloon body for heart valve repair and a heart valve repair system, wherein the balloon wall includes at least two layers of grid skeletons, and at least part of the grids of adjacent layers of grid skeletons are staggered. The staggered grids can compensate for the uncertainty between the grids, and the complementary grid design can reduce the risk of elastic failure of the balloon body.

[0006] To achieve the above-mentioned objectives and other related objectives, the first aspect of the present application provides a balloon body for heart valve repair, the balloon body comprising a balloon wall and an adjustable cavity located inside the balloon wall, the balloon wall comprising at least two layers of grid skeletons, and at least part of the grids of adjacent layers of grid skeletons are staggered; the balloon body is configured to cooperate with the leaflets of the native valve to assist the native valve in restoring its switching function.

[0007] In one possible implementation of the first aspect, the capsule wall includes an inner grid skeleton and an outer grid skeleton, and the inner grid skeleton and the outer grid skeleton are relatively fixedly arranged.

[0008] In one possible implementation of the first aspect, the inner single grids of the inner grid skeleton are staggered with the outer single grids of the outer grid skeleton.

[0009] In one possible implementation of the first aspect, an adhesive layer is provided on the surface of each layer of the grid skeleton and / or between adjacent layers of the grid skeleton.

[0010] In one possible implementation manner of the first aspect, the bonding layer is an adhesive; or the bonding layer is made of a polymer film; or the bonding layer is made of FEP.

[0011] In one embodiment of the first aspect, the balloon body is provided with at least one mounting site, and the mounting site is used for externally connecting a component for delivering the balloon body or for externally fixing the balloon body to the heart tissue at the native valve annulus.

[0012] In one embodiment of the first aspect, at least one opening is provided at the proximal end or the distal end of the balloon body to form the mounting site for externally fixing the balloon body to the component on the heart tissue at the native valve annulus.

[0013] In one possible implementation of the first aspect, an upper opening is provided at the proximal end of the balloon body; and / or a lower opening is provided at the distal end of the balloon body.

[0014] In one possible implementation manner of the first aspect, the opening is sealed by a covering film.

[0015] In one possible implementation of the first aspect, the coating is made of a biocompatible material, or the coating is made of a polymer material, or the coating is made of PET (Polyethylene terephthalate) or PTFE or E-PTFE (Expanded PTFE).

[0016] In one possible implementation manner of the first aspect, the opening is sutured using medical sutures or the same material as the mesh skeleton.

[0017] In one possible implementation of the first aspect, the opening is confined by a locking ring.

[0018] In one possible implementation of the first aspect, the locking ring is made of a medical imaging material, such as a platinum-iridium alloy.

[0019] In one possible implementation of the first aspect, the balloon at the opening is set inside the balloon after being tightened by the locking ring.

[0020] In one possible implementation of the first aspect, the balloon body further includes a coating layer, and the coating layer covers at least a portion of the lattice skeleton.

[0021] In one possible implementation manner of the first aspect, the covering layer is made of a biocompatible material; or, the covering layer is made of a polymer material; or, the covering layer is made of PET, PTFE, or E-PTFE.

[0022] In one possible implementation of the first aspect, in a working state and in the direction of leaflet closure, the balloon body is configured to be a crescent-shaped arc.

[0023] In one possible implementation of the first aspect, in a working state and in the direction of blood flow, the balloon body is configured to be conical or streamlined.

[0024] 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.

[0025] In one possible implementation of the first aspect, the lattice skeleton is made of a medical memory alloy, preferably a nickel-titanium alloy.

[0026] A second aspect of the present application provides 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, the balloon comprising a balloon wall and an adjustable cavity located inside the balloon wall;

[0027] S2. Shape the balloon body of step S1 so that the balloon body is configured to cooperate with each leaflet of the native valve.

[0028] In one embodiment of the second aspect, the balloon body has an inner lattice skeleton and an outer lattice skeleton, and step S1 specifically includes the following steps:

[0029] S11, weaving an inner mesh frame and an outer mesh frame separately and combining them into a balloon body; or weaving a layer of mesh frame and folding and sleeved it to form a balloon body having an inner mesh frame and an outer mesh frame;

[0030] S12. Providing a capsule mold, wherein the shape of the capsule mold is designed according to the imaging structure of the heart valve;

[0031] S13, placing the balloon prepared in step S11 on the balloon mold for shaping.

[0032] In an embodiment of the second aspect, in step S13, the balloon is placed on the balloon mold and the positions of the inner grid skeleton and the outer grid skeleton are adjusted so that at least part of the grids of adjacent grid skeletons are staggered.

[0033] In one possible implementation of the second aspect, the balloon is placed on the balloon mold and the positions of the inner grid skeleton and the outer grid skeleton are adjusted so that the single grids of adjacent grid skeletons are staggered.

[0034] In one embodiment of the second aspect, in step S2, the balloon is shaped by heat setting; preferably, the balloon is heated at 480-550° C. for 10-30 minutes.

[0035] In an embodiment of the second aspect, the preparation method further includes: S3, coating the balloon.

[0036] In one possible implementation of the second aspect, an adhesive layer having an adhesive function is disposed on the outside of the balloon obtained in step S2, and then coated with a coating layer, and finally shaped by thermal adhesion processing.

[0037] In one possible implementation manner of the second aspect, the bonding layer is made of a polymer material; or the bonding layer is made of FEP.

[0038] In one possible implementation of the second aspect, the covering layer is made of a biocompatible material; or, the covering layer is made of a polymer material; or, the covering layer is made of PET or E-PTFE.

[0039] In one possible implementation of the second aspect, the heat adhesion processing and shaping is: heating the coated balloon body at 280-320° C. for 5-20 minutes.

[0040] In one embodiment of the second aspect, the coating layer is adhered to the outer surface of the balloon by an adhesive. Preferably, the adhesive is an FEP film.

[0041] In one possible implementation of the second aspect, step S3 further includes the following step: trimming the balloon body formed in step S2 so that it has at least one opening to form a mounting site.

[0042] A third aspect of the present application provides a balloon prepared by the method for preparing a balloon for heart valve repair as described in the second aspect.

[0043] A fourth aspect of the present application provides a heart valve repair assembly, comprising: a stabilizing frame configured to press against heart tissue; a balloon as described in the first or third aspect above, the balloon being disposed at an outflow end of the stabilizing frame;

[0044] The auxiliary frame is used to fix the balloon body to the native valve leaflets to achieve the coordination between the balloon body and the leaflets of the native valve.

[0045] In an embodiment of the fourth aspect, the stabilizing frame includes a plurality of mutually connected support columns, and the support columns are circumferentially connected to form a mesh-shaped stabilizing frame.

[0046] In one possible implementation of the fourth aspect, the support columns are distributed in at least one row.

[0047] In one possible implementation of the fourth aspect, the support columns are arranged in a single row, in an upper and lower double row, or in an inner and outer double row.

[0048] In one possible implementation of the fourth aspect, each of the support columns is circumferentially connected to form a stable support frame having a plurality of diamond-shaped openings.

[0049] In one possible implementation of the fourth aspect, at least some of the support columns are provided with anchors.

[0050] In one possible embodiment of the fourth aspect, the anchoring element is selected from teeth, thorns or hooks.

[0051] In an embodiment of the fourth aspect, the anchoring member includes an upper anchoring member and a lower anchoring member, the anchoring end of the upper anchoring member points to the inflow end, and the anchoring end of the lower anchoring member points to the outflow end.

[0052] In one possible implementation of the fourth aspect, the stabilizing bracket is in a semi-spherical shape.

[0053] In one possible implementation of the fourth aspect, at least three lugs are provided on the inflow end of the stabilizing support for externally connecting components for delivering the heart valve repair assembly.

[0054] In one embodiment of the fourth aspect, a portion of the stabilizing stent is sutured with a membrane capable of promoting endothelialization of the stent, or sutures of a material capable of promoting endothelialization of the stent are wrapped around the stabilizing stent.

[0055] The fifth aspect of the present application provides a heart valve repair system, comprising the heart valve repair component as described in the fourth aspect; a delivery catheter for delivering the repair component in a compressed delivery state to the mitral valve or tricuspid valve, and adjusting the appropriate position to expand the heart valve repair component.

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

[0057] 1) Compared with the balloon body with a single-layer grid skeleton, the setting of at least two layers of grid skeleton in the present application can provide good support force, and at least part of the grids of adjacent layers of grid skeleton are staggered, and the uncertainty between the grids is compensated by the staggered setting. For example, if heat setting is adopted, because the balloon body 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 body due to the breakage of a certain grid line can be reduced.

[0058] 2) The present application also provides some optional connection methods between the balloon body and the component that externally fixes the balloon body to the heart tissue at the native valve ring, for example, by setting an upper opening on the upper part of the balloon body, inserting the balloon body onto the component from the opening, and directly passing the component out from the lower part of the balloon body / setting a lower opening on the lower part of the balloon body, wherein the opening can be selectively sealed, or closed by a locking ring with a developing function.

[0059] 3) The support frame of the present application is spherical in the expanded state, that is, the support rods at the inflow end or outflow end of the support frame are gathered toward the center of the inflow inlet or outflow outlet of the support frame to form a spherical support frame. Therefore, the local bending strain of the support frame is small, the compression and gripping difficulty is small, the support frame is not easy to be damaged, and after expansion, the support frame fits better with the atrial wall, so that the posture of the repair component is more stable after the component is implanted. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 Shown is a first state diagram of the balloon skeleton for heart valve repair described in Example 1 of the present application.

[0061] Figure 2 Shown is a second state diagram of the balloon skeleton for heart valve repair described in Example 1 of the present application.

[0062] Figure 3 Shown is a schematic structural diagram of the balloon for heart valve repair described in Example 1 of the present application.

[0063] Figure 4 It shows a schematic diagram of the balloon for heart valve repair described in Example 1 of the present application being implanted into the mitral valve.

[0064] Figure 5 Shown is a flow chart of the method for preparing the balloon for heart valve repair described in Example 2 of the present application.

[0065] Figure 6 Shown is a schematic diagram of the balloon coating for heart valve repair described in Example 2 of the present application.

[0066] Figure 7 Shown is a partial structural schematic diagram of the side view of the repair component described in Example 4 of the present application.

[0067] Figure 8 Shown is a schematic diagram of the overall structure of the repair component described in Example 4 of the present application.

[0068] Figure 9 Shown is a schematic diagram of the overall structure of the repair component described in Example 4 of the present application from a top view.

[0069] Figure 10 Shown is a partial structural schematic diagram of the repair component described in Example 4 of the present application after the balloon body is removed from the side view.

[0070] Figure 11 Display as Figure 10 Enlarged view of part A in .

[0071] Figure 12 Shown is a schematic diagram of the overall structure of the repair component described in Example 4 of the present application from a frontal perspective.

[0072] Figure 13 It shows a schematic diagram of the structure of the repair component described in Example 4 of the present application after the balloon body is removed.

[0073] Figure 14 Shown is a schematic diagram of the structure from a frontal perspective of the repair component described in Example 4 of the present application after the balloon body is removed.

[0074] Figure 15 Display as Figure 14 Enlarged view of part B in .

[0075] Figure 16 Shown is a cutting diagram of the repair component described in Example 4 of the present application after the balloon body is removed.

[0076] Figure 17 Shown is a partial structural schematic diagram of the side view of the repair component described in Example 5 of the present application.

[0077] Figure 18 Shown is a schematic diagram of the structure of the repair component described in Example 5 of the present application after the balloon body is removed.

[0078] Figure 19It shows a schematic diagram of the overall structure of the repair component described in Example 5 of the present application after the balloon body is removed.

[0079] Figure 20 Shown is a schematic diagram of the structure from a frontal perspective of the repair component described in Example 5 of the present application after the balloon body is removed.

[0080] Figure 21 Shown is a cutting diagram of the repair component described in Example 5 of the present application after the balloon body is removed.

[0081] Figure 22 It shows a partial structural schematic diagram of the repair component described in Example 6 of the present application after the balloon body is removed.

[0082] Figure 23 Display as Figure 22 Enlarged view of part C in .

[0083] Figure 24 Display as Figure 22 Enlarged view of part D in .

[0084] Figure 25 Shown is a schematic diagram of the heart valve repair assembly according to an embodiment of the present application being implanted into the mitral valve of the heart.

[0085] Description of Reference Numerals

[0086] 1. Balloon

[0087] 101 Posterior part of the saccule

[0088] 102 Anterior part of the balloon

[0089] 11 Cyst wall

[0090] 111 Inner mesh skeleton

[0091] 112 outer mesh skeleton

[0092] 12 adjustable cavities

[0093] 13 Upper opening

[0094] 14 bottom opening

[0095] 141 Lamination

[0096] 142 coating layer

[0097] 1421 First coating layer

[0098] 1422 Second coating layer

[0099] 1423 Third coating layer

[0100] 151 Locking Ring

[0101] 2 Stable support

[0102] 201 Enhancement Block

[0103] 21 Support Column

[0104] 211 connection block

[0105] 212 First Support Pillar

[0106] 22 mounting ears

[0107] 221 First mounting ear

[0108] 222 Second mounting ear

[0109] 223 Third mounting ear

[0110] 231 Upper rhombus mouth

[0111] 232 lower rhombus mouth

[0112] 233 front opening

[0113] 234 rear opening

[0114] 24 Upper Barb

[0115] 25 barbs

[0116] 3 Auxiliary frame

[0117] 300 storage space

[0118] 301 First support surface

[0119] 302 Second supporting surface

[0120] 31 reinforcement

[0121] 32 First auxiliary pole

[0122] 33 Second auxiliary pole

[0123] 34 Upper accessories

[0124] 341 upper suture hole

[0125] 342 First auxiliary pole

[0126] 343 Second auxiliary pole

[0127] 35 lower accessories

[0128] 351 upper suture hole

[0129] 352 First auxiliary pole

[0130] 353 Second auxiliary pole

[0131] PL posterior leaflet

[0132] AL anterior leaflet

[0133] C1 First Center

[0134] C2 Second Center

[0135] L1 interface DETAILED DESCRIPTION Detailed Description of the Invention

[0137] The heart valve repair balloon described in the present invention functions to at least partially replace some of the native leaflets of a heart valve, thereby assisting the native leaflet group (e.g., the mitral / tricuspid valve, or the pulmonary valve, or the aortic valve) in achieving its normal opening and closing function, such as preventing ventricular blood from flowing back into the ventricular ventricle, thereby treating mitral / tricuspid regurgitation. During the development and research process, the applicant discovered that both laser-cut balloons and single-layer braided balloons had insufficient support force or unpredictable elastic failure risks during the verification process. Therefore, the applicant's primary goal is to develop a balloon suitable for heart valve repair that overcomes these deficiencies.

[0138] Explanation of terms in this application: The term "switching function" in this application generally refers to the closing of the native valve leaflet group to prevent blood backflow when the ventricle contracts, and the opening of the native valve leaflet group to allow blood to flow through when the ventricle expands. "Working state" in this application generally refers to the process of the balloon body realizing its switching function. "Inflow end" and "outflow end" in this application generally refer to the direction of blood flow after the components are placed in the appropriate position of the heart, that is, the part located upstream of the blood flow is called the inflow end, and the part located downstream of the blood flow is called the outflow end. "Inflow port" and "outflow port" in this application generally refer to the inlet of the inflow end of the support frame as the inflow port, and the outlet of the outflow end of the support frame as the outflow port. "Proximal end" and "distal end" in this application generally refer to the end closer to the operator and the distal end as the end farther away from the operator. "Front" and "posterior" are defined in common anatomy in terms of front and back unless otherwise directly defined. For example, in the mitral valve, the part close to the posterior leaflet is called the posterior part, and the part close to the calyx leaflet is called the anterior part. In this application, the terms "inside" and "outside" generally refer to areas that can form a certain amount of space for storage or carrying, while those that cannot are referred to as the outside. In this application, the term "connection end" generally refers to the point where one component connects to another, and the term "free end" generally refers to an end of a component that is free and not connected to another component.

[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 struts on the stent do not interfere with the normal swinging of the balloon. A "quasi-hemispherical" shape refers to the stent (optionally with lugs) being a semi-spherical stent as a whole, minimizing the bending strains of the stent while providing excellent, stable support. A "delivery member" can be a delivery device such as a delivery catheter.

[0140] As used herein, the term "means for delivering the balloon" can be a delivery device such as a delivery catheter. The term "means for securing the balloon to cardiac tissue at the native valve annulus" can include at least one of the following: a clamping member provided on the balloon, for clamping the balloon to the native valve leaflets or cardiac tissue near the annulus; a member connected to the balloon (such as the accessory described herein), for connecting the balloon and cooperating with the balloon to clamp the balloon to the native valve leaflets; and a member indirectly connected to the balloon (such as the stabilizing support described herein), for pressing against the cardiac tissue to assist in supporting the balloon and maintaining a stable state. The term "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 herein, refers to medical memory metal, wire, or metal alloy wire, typically nickel-titanium wire. Nickel-titanium alloy is a shape memory alloy, a specialized alloy that can automatically return to its original shape after plastic deformation at a specific temperature. Its expansion rate is above 20%, and it has excellent corrosion resistance. In addition, the known technologies usually associated with heart valve repair are not described in detail, and those skilled in the art can understand the conventional methods 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] See Figures 1-4 , a balloon for heart valve repair is provided, wherein the balloon 1 is configured to cooperate with each leaflet of the native valve to assist the native valve in restoring its switching function. The balloon 1 comprises a balloon wall 11 and an adjustable cavity 12 located inside the balloon wall 11. The balloon wall 11 comprises at least two layers of mesh skeletons, and at least part of the meshes of adjacent layers of mesh skeletons are staggered. After being implanted into the heart in a compressed delivery state, the balloon 1 will expand and be partially clamped on the native leaflets, while the remaining part cooperates with other native leaflets to assist the native valve in performing normal switching functions. If the mesh skeleton has a risk of failure, it may lead to recurrence of the disease. The setting of the staggered meshes of adjacent layers can reduce the risk of failure. For example, the partially staggered meshes refer to the staggered setting of meshes at the parts of the balloon 1 that are prone to failure risks. The mesh skeleton is made of medical metal cutting or woven metal wire. In the final working state of the balloon body 1 of this embodiment, it is a relatively closed structure and is therefore not suitable for secondary expansion. The balloon body 1 needs to be compressed and gripped in vitro so that it can automatically recover after entering the body through the delivery device. Therefore, the lattice skeleton is preferably made of medical memory alloy, specifically nickel-titanium memory alloy. In addition, the number of layers of the balloon wall 11 is selected according to the functional requirements of the balloon body 1. A specific embodiment is provided below:

[0145] See Figure 2 The balloon body is made of woven metal wire. Specifically, the balloon wall 11 includes an inner grid frame 111 and an outer grid frame 112, and the inner grid frame 111 and the outer grid frame 112 are preferably not fixed, forming an elastic contact support effect. Of course, it is also possible to maintain a partial / local relatively fixed setting without affecting its elastic support effect. The relative fixing method can be selected: 1) maintaining a certain friction between the metal wires of the inner and outer grids so that the positions of the inner and outer grid frames after the inner and outer weaving are relatively fixed; 2) providing an adhesive layer on the surface of the grid frame and / or between adjacent layers of the grid frame, wherein the adhesive layer is formed by a polymer film, and the polymer film is wrapped around the grid frame and melted at a high temperature to achieve a strong bonding effect, which is convenient to use.

[0146] Furthermore, see Figure 3 Some balloons require a coating layer 142 to enclose the balloon's lattice framework and mimic native valve leaflets. This coating layer 142 is typically made of a smooth polymer film, while the adhesive layer is also made of a polymer film. At a certain temperature, the polymer film in the adhesive layer melts, effectively bonding the coating layer. More specifically, the adhesive layer is preferably made of FEP (Fluorinated ethylene propylene), which can form good adhesion to the coating layer 142 by treating it at approximately 300°C for a few minutes.

[0147] Preferably, each inner single grid of the inner grid skeleton 111 is staggered with each outer single grid of the outer grid skeleton 112, that is, each grid contains the grid lines of its adjacent layer. Compared with a single-layer skeleton, if the metal wire in one of the grids is broken, there will be an area in the entire balloon body that lacks a coating layer on the surface supporting the metal wire. The multi-layer grid skeleton is staggered, and the two layers of grids are staggered and not fixed, forming an elastic contact support effect. If a nickel-titanium wire in a certain layer is broken, the crossed wires in the other layer can still provide a certain support force. The appropriate grid density is selected through fatigue verification, and the grid density of each layer of grid skeleton is about 10 to 12 ppi. Then the grid skeletons of adjacent layers are staggered to form a multi-layer grid skeleton with appropriate grid density. Furthermore, the two layers of grids are not fixed, which is conducive to the compression and recovery of the balloon body.

[0148] In the working state and with the native heart valve closed, the rear part of the balloon body fits in contact with a portion of one of the leaflets of the native heart valve, replacing a portion of the leaflet, and the front part of the balloon body fits in contact with a portion or multiple portions of another leaflet of the native heart valve. Therefore, the surface shape of the balloon body needs to be somewhat similar to the closed shape of the leaflet of the native heart valve. Figure 4 Taking mitral valve repair as an example, the rear part 101 of the balloon body cooperates with the auxiliary frame 3 to clamp a part of the posterior leaflet PL against the balloon body 1, so that the front part 102 of the balloon body contacts and fits with a part or multiple parts of the anterior leaflet AL in the native heart valve. And the balloon body 1 is set to a crescent-shaped arc in the working state (expanded state) and in the direction of leaflet closure, with the purpose of infinitely approaching the anatomical morphology of the native leaflet, so that the balloon body 1 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 of blood flowing from the atrium to the ventricle), the front part of the balloon body is set to a conical or streamlined shape, which can minimize 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. The physiological morphology of the mitral valves of different individuals is similar, and different specifications and models can be produced to meet different needs, or the balloon body 1 can be customized according to the imaging information of different individuals.

[0149] In a specific embodiment, the balloon body 1 is provided with at least one mounting position, and the mounting position is used for externally connecting a component for delivering the balloon body or for externally connecting a component for fixing the balloon body to the heart tissue at the native valve annulus. For example, 1) a component for externally delivering the balloon body 1, such as a delivery tube-type compression delivery device. 2-1) a component for fixing the balloon body 1 to the heart tissue at the native valve annulus, such as providing a clamp somewhere on the balloon body 1, the clamp being used to clamp the balloon body 1 to the heart tissue near the native valve leaflet or the valve annulus, and to keep the balloon body 1 stably in a suitable position to assist the diseased native valve leaflet group to complete the physiological switching function. See Figure 4 and Figure 7 The auxiliary frame 3 connected to the balloon body 1 in this application plays the role of connecting the balloon body 1 and cooperating with the balloon body 1 to clamp onto the native valve leaflet to assist the native valve leaflet in achieving the opening and closing function; 2-2) See Figure 7 , there may also be a stabilizing frame 2 indirectly connected to the balloon body 1, and the stabilizing frame 2 presses against the heart tissue to further assist in supporting the balloon body 1 to maintain the balloon body 1 in a stable state.

[0150] In a specific embodiment, the mounting position on the balloon body 1 can be any part of the balloon body, and the connection method of the balloon body 1 and its external components can be selected from suture suturing or film connection, or other common methods and their combinations. For example, at least one opening is provided at the proximal end or distal end of the balloon body to form the mounting position for externally fixing the balloon body to the components on the heart tissue at the native valve annulus. In this embodiment, a preferred connection method is provided, see Figure 1 、 Figure 2 The inflow end of the balloon 1 is provided with an upper opening 13, through which the balloon is inserted into the auxiliary frame 3. After the balloon 1 is inserted through the upper opening 13, sutures (medical sutures or a material similar to the lattice frame) and a coating 141 are used to seal the upper opening 13 and further secure it to the auxiliary frame 3. The coating 141 is made of a polymer material, such as PET (Polyethylene terephthalate) or E-PTFE (Expanded Polytetrafluoroethylene). The outflow end of the balloon 1 has relatively little contact with the auxiliary frame 3, so the auxiliary frame 3 can be inserted directly through the gaps in the lattice frame of the balloon 1. This installation method facilitates the selection of the fixed angle of the balloon 1, reserving space for the auxiliary frame 3 and the balloon 1 to clamp the native valve leaflets, while ensuring that the balloon 1 maintains a certain conical or streamlined shape in the direction of blood flow.

[0151] In another specific embodiment, the balloon body 1 has a closed lower opening 14. Specifically, the balloon body 1 is secured at the lower opening 14 by a locking ring 151 and then positioned within the balloon body 1. The locking ring 151 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. In other words, the locking ring 151 not only locks the balloon body 1 into a closed configuration, but also serves as a marker.

[0152] In a specific embodiment, the balloon body 1 further includes a coating layer 142, which covers at least a portion of the lattice frame. The material of the coating layer 142 imitates the physical properties of the native leaflet to assist in completing the opening and closing function of the native valve. Figure 3 and Figure 4 A coating layer 142 is provided outside the grid skeleton. The coating layer 142 is made of a biocompatible material, or a polymer material, or PET or E-PTFE.

[0153] Example 2

[0154] See Figure 5 , provides 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;

[0155] Specifically, the inner and outer two-layer grid is used as an example for specific description:

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] In one embodiment, see Figure 3 and Figure 6The coating 141 and the coating layer 142 are the same integral film, and the shape of the integral film is as follows: Figure 6 As shown, specifically, the coating layer 142 includes a first coating layer 1421, a second coating layer 1422 and a third coating layer 1423. The coating 141 and the coating layer 142 are both made of E-PTFE film, and an FEP film is set at the overlapping part formed by the first coating layer 1421, the second coating layer 1422 and the third coating layer 1423. The thickness of the above-mentioned films is selected according to actual needs. The specific coating process of the balloon lattice skeleton coated 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 coating layer 1421 is folded to the right and placed on the balloon body, and then the FEP film is placed at the overlapping position of the first coating layer 1421; the second coating layer 1422 is folded to the left so that a part of the second coating layer 1422 overlaps with the above-mentioned FEP film, and then the FEP film is placed at the overlapping position of the second coating layer 1422; the third coating layer 1423 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 coating 141 is folded downward to wrap the upper opening 13 of the balloon body, and after the coating is completed, it is fixed by heat treatment.

[0162] Example 3

[0163] The preparation method of Example 2 was used to prepare the balloon for heart valve repair described in Example 1. Specifically:

[0164] 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.

[0165] S12. Provide a suitable capsule mold.

[0166] 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.

[0167] 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.

[0168] 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, and use the coating method described in Example 2 to coat the balloon with E-PTFE film, with FEP film placed between the overlapping films; 4) place the balloon in a hot oven, heat it to 300°C for 10 minutes, and after cooling, obtain the balloon described in Example 1.

[0169] Example 4

[0170] See Figures 7-16 A heart valve repair assembly is provided, comprising: a stabilizing support 2 configured to press against cardiac tissue and having a mesh structure to enable normal blood flow from the atria to the ventricles. The balloon 1 described in Example 1 or Example 3 is disposed at the outflow end of the stabilizing support 2. The repair assembly further comprises at least one auxiliary frame 3 for securing the balloon 1 to the native valve leaflets to achieve physiological functions of the balloon and the leaflets of the native valve. Specifically, the stabilizing support 2, in a compressed state, self-expands into a predetermined configuration after implantation within the body, serving to connect the delivery balloon 1. After delivery and implantation within the body, the support provides stable support, such as cardiac tissue near the atrial annulus. The support is anchored to the cardiac tissue via appropriate anchoring means to provide stable support. The overall contact area of ​​the stabilizing support 2 with the cardiac tissue and its structural stability can affect blood flow performance or support capacity after implantation. Therefore, an appropriate stabilizing support 2 should be selected based on actual needs.

[0171] See Figure 7-Figure 8The stabilizing frame 2 includes a plurality of supporting columns 21 connected to each other, and each supporting column 21 is circumferentially connected to form a mesh-like stabilizing frame 2, and the openings formed by each supporting column are distributed in two rows, upper and lower. Both rows of grids are rhombus-like, which is conducive to the deformation process from the compressed delivery state to the expanded state, and the upper rhombus opening 231 of the upper row of rhombuses near the inflow end is smaller than the lower rhombus opening 232 of the lower row of rhombuses near the outflow end. This form of stabilizing frame 2 has a better fit with the atrial wall, so that the posture after implantation is more stable.

[0172] It should be noted that the important purpose of the stabilizing stent 2 is to be firmly fixed in the atrium with little impact on normal blood flow, and to withstand the load caused by the impact of blood flow on the balloon body 1, thereby ensuring the normal operation of the balloon body 1. The stabilizing stent 2 needs to be deformed from a compressed delivery state to an expanded state. During this deformation process, the strain force at each part of the stabilizing stent 2 and the difficulty of pressing and gripping will have a crucial impact on whether the stabilizing stent 2 can be smoothly deployed, whether it can be deployed to a preset state, or whether it can be stably fixed to the atrial wall. Preferably, in the expanded state, the stabilizing stent 2 forms a semi-spherical shape. The local bending strain of the stabilizing stent 2 of this structure is small, the difficulty of pressing and gripping is small, the stabilizing stent 2 is not easily damaged during the deformation process from compression, delivery to expansion, and is easier to deploy to the preset shape. After deployment, the stabilizing stent 2 fits better with the atrial wall, making the posture of the entire assembly more stable after implantation in the heart.

[0173] In one embodiment, see Figure 7 The connection between the adjacent support columns constituting the lower diamond-shaped opening 232 forms a connection block 211 of a bone-like joint structure, which can enhance the torsional resistance of the mesh-like stable support frame 2 and improve the rigidity of the stable support frame 2.

[0174] In a specific embodiment, anchoring members, such as teeth, thorns, hooks, etc., are provided along the circumference of the stabilizing support 2. Specifically, the anchoring members include an upper anchoring member and a lower anchoring member. The anchoring end of the upper anchoring member points to the inflow end, and the anchoring end of the lower anchoring member points to the outflow end. The anchoring end refers to the end of the anchoring member anchored to the heart tissue. Figure 7 and Figure 10The anchors are barbs, the upper anchor is the upper barb 24, and the lower anchor is the lower barb 25. The upper barb 24 points to the inflow end, and the lower barb 25 points to the outflow end. The upper barb 24 is located on the side of the stabilizing frame 2 away from the balloon body 1, while the lower barb 25 is located on the side of the stabilizing frame 2 close to the balloon body 1, playing the role of stabilizing the stabilizing frame 2 to the atrial wall, thereby preventing the stabilizing frame 2 from flipping. This is because the existence of the balloon body 1 makes the repair component not in a very good state of balance. This is because when blood flows from the atrium to the ventricle, the front part 102 of the balloon body is impacted by the blood, and when the leaflet is closed, the rear part 101 of the balloon body will bear the impact of blocking the blood, so the repair component will have a tendency to flip. The design of the anchor can maintain the stability of the component, and the preferred anchor setting method as above does not require the introduction of too many anchors, and the cooperation of the upper and lower anchors in special parts can prevent the repair component from flipping. Furthermore, a corresponding number of anchoring members can be provided as needed, for example, according to the number of layers of the stabilizing support 2. In this embodiment, the barbs are in the form of a connecting portion of the barb connected to the stabilizing support 2 and extending in a direction away from the stabilizing support 2 to the free end of the barb.

[0175] In one specific embodiment, in addition to the above, it is also necessary to rapidly endothelialize the stabilizing strut 2 so that it is stably positioned in the atrial wall. Therefore, in this embodiment, the stabilizing strut 2 is entirely or partially provided with a membrane or suture that promotes endothelialization of the stabilizing strut 2. The membrane or suture that promotes endothelialization of the stabilizing strut 2 is made of PET or PTFE. Preferably, 1) the stabilizing strut 2 is partially provided with a PET membrane, for example, by gluing or suturing. The PET membrane can be provided at the stabilizing strut 2 on the side away from the balloon body 1 or at the side close to the balloon body 1. Because the balloon body 1 tends to flip over when impacted by blood flow, these two locations facilitate rapid endothelialization, facilitating rapid endothelialization of the stabilizing strut 2 within the atrial wall, thereby stably securing it there. Preferably, the PET membrane is provided at the stabilizing strut 2 on the side away from the balloon body 1 and at the side close to the balloon body 1. 2) Sutures capable of promoting endothelialization are wrapped around each support column 21 of the entire stabilization stent 2. The sutures are wrapped around each support column 21 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 2 increases the contact friction between the stabilization stent 2 and the atrial wall, facilitating adhesion of cardiac tissue. When the sutures are made of a material that promotes endothelialization, such as PET, they can also promote rapid endothelialization of the stabilization stent 2.

[0176] In one embodiment, see Figure 7 、 Figure 13 and Figure 16 As mentioned above, in addition to connecting the supporting auxiliary frame 3 and thus supporting the balloon body 1, the stabilizing frame 2 also needs to bear the load brought by the impact of blood flow on the balloon body 1 to ensure the normal operation of the balloon body 1. Therefore, it is necessary to ensure that the support column 21 on the stabilizing frame 2 does not interfere with the balloon body 1. The first support column 212 located at the outflow end of the stabilizing frame 2 and close to the auxiliary frame is set to a non-interference state with the balloon body 1. The non-interference setting methods are listed as follows: 1) The first support column 212 located at the outflow end of the stabilizing frame 2 and close to the auxiliary frame is bent toward the inner side of the stabilizing frame 2, that is, the two openings on both sides of the auxiliary frame 3 are bent inward, which can avoid interference with the balloon body 1, facilitate the free movement of the balloon body 1, and improve the hemodynamic performance of the balloon body; 2) The first support column 212 located at the outflow end of the stabilizing frame 2 and close to the auxiliary frame is shorter than the adjacent support column, that is, the outflow end length of the lower diamond-shaped openings on both sides of the auxiliary frame 3 is shortened to prevent them from interfering with the balloon body 1.

[0177] In one embodiment, see Figure 7-Figure 9 At least three lugs 22 are provided at the inflow end of the stabilizing stent 2. The three lugs 22 are circumferentially arranged along the inflow end of the stabilizing stent 2, and a threading hole is provided at the inflow end of each lug 22 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. The lengths of the lugs 22 can be selected to be consistent or inconsistent. The preferred embodiment of the lugs 22 is that the lengths are inconsistent, with the purpose of allowing the stabilizing stent 2 on the side of the short lug to be released and self-expanded into place first, thereby preventing the stabilizing stent 2 from instantly collapsing from the delivery device and causing the fixed position of the balloon body 1 to shift. After the anchor on the stabilizing stent 2 is securely attached to the appropriate atrial position, the remaining longer lugs are released to enhance the stability of the release process of the stabilizing stent 2. The preferred embodiment of the present invention is that the lugs are evenly distributed at the inflow end of the stabilizing stent 2.

[0178] For details, see Figure 9 The preferred embodiment further illustrates three lugs, wherein the first lug 221 is a short lug, and the second and third lugs 222 and 223 are long lugs. The first lug 221 is located on the side of the stabilizing strut 2 away from the auxiliary frame 3. Since the position of the balloon body 1 is the most critical, the stabilizing strut 2 away from the balloon body 1 is released first, while the stabilizing strut 2 close to the balloon body 1 is not released. This allows for further adjustment of the balloon body 1's position, improves the accuracy of the valve or balloon body 1 implantation, and increases the stability of the release of the stabilizing strut 2.

[0179] For more details, see Figure 12 When the stabilizing bracket 2 is in the unfolded state, the front diamond-shaped openings 233 in the front row and the rear diamond-shaped openings 234 in the rear row are cross-arranged.

[0180] In a specific embodiment, the auxiliary frame of the present application is made of a biocompatible elastic material, preferably a memory alloy, and more specifically a nickel-titanium alloy. During the actual implantation process, the repair component is inserted into the body with the delivery catheter. 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° to 90°). The relative position of the auxiliary frame 3 and the native leaflet is observed with the help of imaging equipment, and the auxiliary frame 3 is pulled to capture the native leaflet. Figure 7-16 As shown, the auxiliary frame 3 is arranged at the outflow end of the stabilizing frame 2. The auxiliary frame 3 includes a loading portion close to the stabilizing frame 2 and a clamping portion away from the stabilizing frame 2. 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 1 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 13 A reinforcement 31 is provided on the upper portion of the clamping portion, and one side of the reinforcement 31 is used to support the native leaflets. The loading portion described in this example is the portion of the auxiliary frame 3 close to the stabilizing frame 2, and the clamping portion is the portion of the auxiliary frame 3 away from the stabilizing frame 2. 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 1, and the balloon body 1 is located in the holding space 300, thereby forming a space for capturing and accommodating the native leaflets in the holding space 300 and between the balloon body 1 and the clamping portion. It is worth noting that similar to the prior art, the auxiliary frame of this application is made of a biocompatible elastic material, preferably a memory alloy, and more specifically, a nickel-titanium alloy. During the actual implantation process, the repair component is inserted into the body with the delivery catheter. 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° to 90°). The relative position of the auxiliary frame 3 and the native leaflets is observed with the help of an imaging device, and the auxiliary frame 3 is used to capture the native leaflets by pulling.

[0181] In one embodiment, see 12- Figure 15 , the loading part and the clamping part are integrally formed. For more details, refer to Figure 13 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 2, while the other ends extend toward the outflow end of the stabilizing frame 2 to form the loading portion. These rods then bend away from the stabilizing frame 2 and then bend toward the inflow end of the stabilizing frame 2 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 2 by connectors, welding, or direct, integral molding.

[0182] For details, see Figure 13The 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.

[0183] For more details, see Figure 8 and Figure 9 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.

[0184] For more details, see Figure 11 and Figure 13 Along the outflow end to the inflow end of the stabilizing support 2, 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 1 and not interfere with the movement of the balloon body 1; 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 1.

[0185] For more details, see Figure 1 and Figure 15 Along the outflow end to the inflow end of the stabilizing support 2, 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 ends of the first auxiliary rod 32 and the second auxiliary rod 33 is widened, thereby facilitating a larger contact area between the clamping portion and the native leaflet. More specifically, the two ends of the reinforcement member 31 are respectively connected to the free ends of the first auxiliary rod 32 and 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). The widening distance between the free ends of the first auxiliary rod 32 and the second auxiliary rod 33 increases the contact area between the reinforcement member 31 and the native leaflet, thereby reducing damage to the leaflet. More specifically, the reinforcement member 31 is a multi-bend 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 stabilizing support 2, 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 member 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, the slightly inward buckling is as follows: Figure 13 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.

[0186] In one embodiment, see Figure 14 and Figure 15 The auxiliary frame 3 further includes an upper auxiliary member 34 and a lower auxiliary member 35 for connecting to the balloon body 1. Specifically, one end of the upper auxiliary member 34 is connected to the stabilizing frame 2 or the loading portion, and the other end extends toward the inflow end of the stabilizing frame 2 and toward the outside of the stabilizing frame 2 to form an upper auxiliary member free end. One end of the lower auxiliary member 35 is connected to the stabilizing frame 2 or the loading portion, and the other end extends toward the outflow end of the stabilizing frame 2 to form a lower auxiliary member free end.

[0187] For details, see Figure 8 and Figure 14 The 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 1, and the lower auxiliary part 35 is used to fix the lower part of the balloon body 1. The balloon body 1 can be made of a mesh skeleton made of medical metal cutting or metal wire weaving, and a coating is coated on the outside of the mesh skeleton. The balloon body 1 can be fixed to the auxiliary frame 3 in such a way that the upper part of the balloon body 1 is inserted into the upper auxiliary part 34, and the lower part of the balloon body 1 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 1, so as to prevent it from affecting the closure of the native leaflets that are not clamped and the balloon body 1. 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 1.

[0188] For more details, see Figure 15 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 1 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 1 is small, so the lower auxiliary component 35 is directly inserted into the balloon body 1 by adopting an integrated arrangement, so as to better select the fixing angle of the balloon body 1.

[0189] In one embodiment, see Figure 13 and Figure 14One end of the first auxiliary rod 32 and the second auxiliary rod 33 are respectively connected to the stabilizing bracket 2 to form an auxiliary rod joint. This auxiliary rod joint is provided with a reinforcement block 201. The provision of the reinforcement block 201 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 201. 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 201. In other words, the reinforcement block 201 provides a connection point for the above components, which improves the connection stability.

[0190] Example 5

[0191] See Figure 17-18 , which is different from the specific embodiments in Example 4 in that, when the stabilizing support 2 is deployed, the stabilizing support 2 is more like a semi-spherical shape. The local bending strain of the stabilizing support 2 of this structure is small, and the compression and gripping difficulty is small. The stabilizing support 2 is not easily damaged during the deformation process from compression to delivery to deployment, and is easier to deploy to the preset shape. After deployment, the stabilizing support 2 fits better with the atrial wall, making the posture of the entire assembly more stable after implantation in the heart. For details, see Figure 18 The support columns 21 at the inflow end of the stabilizing stent 2 converge toward a first center C1 along an annular surface, with the first center located at the inflow end of the stabilizing stent 2. The annular surface may be an arcuate annular surface, with the first center C1 located at the inflow port of the stabilizing stent 2, preferably located at the center of the inflow port of the stabilizing stent 2. The support columns 21 near the inflow end of the stabilizing stent 2 converge toward the first center C1 along the annular surface, similar to the convergence structure of a bun or a garlic clove. This structure reduces the local bending strain of the stabilizing stent 2 and makes it easier to compress and grip. The stabilizing stent 2 is less susceptible to damage during the deformation process from compression, delivery, to deployment, making it easier to deploy to a preset configuration. After deployment, the stabilizing stent 2 better adheres to the atrial wall, making the entire assembly more stable after implantation in the heart.

[0192] More specifically, one end of each support column 21 extends from the interface L1 toward the first center C1 and converges to form the gathered portion of the stable support frame 2. The other end of each support column 21 extends from the interface L1 toward the second center C2 and converges to form the supporting portion of the stable support frame 2. To achieve the advantages of the stable support frame 2 described above, the stable support frame 2 is preferably configured as a semi-spherical shape, with the first center C1 located at the center of the support frame's inlet, the second center C2 located at the center of the support frame's outlet, and the line L2 connecting the first center C1 and the second center C2 is perpendicular to the interface L1.

[0193] For more details, see Figure 18The stabilizing frame 2 is a self-expanding mesh structure. When the stabilizing frame 2 is expanded, the upper diamond-shaped openings 231 of the upper row of diamonds near the inflow end and the lower diamond-shaped openings 232 of the lower row of diamonds near the outflow end are connected to form a mesh stabilizing frame. One end of the mesh stabilizing frame gradually extends and converges toward the first center C1 with the interface L1 as the starting point, and the other end gradually extends and converges toward the second center C2 with the interface L1 as the starting point, thereby forming a hemispherical stabilizing frame 2.

[0194] For more details, see Figure 18 Each of the lugs 22 converges toward the first center C1. Preferably, each of the lugs 22 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, making the entire stent more hemispherical. This shape allows the entire stent to better fit the atrial wall without causing the lugs to protrude excessively and damage the atrial wall tissue.

[0195] Example 6

[0196] The difference from Example 4 is that, see Figure 19-24 Each support column 21 is circumferentially connected to form a mesh-like, self-expandable stent 1, and each support column 21 is arranged in a single row. This has the following advantages: 1) The surface area of ​​the stent 2 is reduced, which reduces the amount of metal implanted and makes the repair assembly more patient-friendly. 2) The single-row stent 2 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 2), which facilitates release and positioning after in vivo delivery. 3) The single-row stent 2 has a short overall length, which reduces the length of the distal portion of the delivery catheter and the bending radius of the stent-wrapped portion of the delivery catheter, thus reducing the difficulty of bending during implantation. 4) The single-row stent 2 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, unpredictable, and cannot withstand large supporting forces. The single-row grid effectively increases the adaptability of the stent to the atrial morphology, minimizing myocardial damage.

[0197] Specifically, to maintain the stability of the support frame, refer to Figure 20 From the front view, the front openings 233 in the front row and the rear openings 234 in the rear row are arranged alternately.

[0198] For more details, see 19- Figure 22The 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 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 stabilizing support frame 2, 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 of the holding space 300 has a larger space to better accommodate the balloon body 1 and does not interfere with the movement of the balloon body 1; the upper side of the holding space 300 has a smaller space, so that the clamping portion can better fit the native valve leaflet, thereby ensuring the stability of the balloon body 1.

[0199] For more details, see 22 and Figure 23 The support columns 21 are connected to each other to form a stable support frame 2 with multiple openings, and the support columns 21 of adjacent openings form a connecting block 211. Preferably, the connecting block 211 is a bone joint structure to improve torsional resistance and rigidity.

[0200] Example 7

[0201] A heart valve repair system is provided, comprising the heart valve repair component as described in any one of Examples 4-6.

[0202] 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.

[0203] 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°) to 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 1 will be completely released and will mate with the anterior leaflet AL. Then the stabilizing frame 2 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 turn, and the release of the entire repair component is completed.

Claims

1. A balloon for repairing a heart valve, the balloon (1) comprising a balloon wall (11) and an adjustable cavity (12) located inside the balloon wall, the balloon wall (11) comprising at least two layers of lattice skeletons, and at least part of the grids of adjacent layers of lattice skeletons being staggered; The balloon body (1) is configured to cooperate with each leaflet of the native valve to assist the native valve in restoring its opening and closing function; The capsule wall (11) comprises an inner grid frame (111) and an outer grid frame (112), and the inner grid frame (111) and the outer grid frame (112) are not fixedly arranged, and each inner single grid of the inner grid frame (111) is staggered with each outer single grid of the outer grid frame (112), that is, each grid contains grid lines of its adjacent layer; The balloon body (1) further includes a covering layer (142), and the covering layer (142) covers at least a portion of the grid skeleton; in a working state and when the native valve is closed, the rear portion (101) of the balloon body is in contact with at least one leaflet of the native valve, and the front portion (102) of the balloon body is in contact with another leaflet of the native valve.

2. The balloon for heart valve repair according to claim 1, characterized in that: The balloon body (1) is provided with at least one mounting position, and the mounting position is used for externally connecting a component for delivering the balloon body or for externally connecting a component for fixing the balloon body to the heart tissue at the native valve ring.

3. The balloon for heart valve repair according to claim 2, characterized in that: At least one opening is provided at the proximal or distal end of the balloon body (1) to form the mounting position for externally fixing the balloon body (1) to the component on the heart tissue at the native valve ring, and an upper opening (13) is provided at the proximal end of the balloon body (1); and / or a lower opening is provided at the distal end of the balloon body (1).

4. The balloon for heart valve repair according to claim 3, characterized in that: Include at least one of the following technical features: a1, the opening is sealed by a covering film (141); a2. The opening is sutured with medical sutures or the same material as the mesh frame; a3. The opening is closed by a locking ring (151).

5. The balloon for heart valve repair according to claim 4, characterized in that: Include at least one of the following technical features: 1) In technical feature a1, the covering film (141) is made of a biocompatible material, or the covering film (141) is made of a polymer material, or the covering film (141) is made of PET or E-PTFE; 2) In technical feature a3, the material of the locking ring (151) is a medical imaging material; 3) In technical feature a3, the balloon body (1) at the opening is tightened by the locking ring (151) and then arranged inside the balloon body (1).

6. The balloon for heart valve repair according to any one of claims 1 to 5, characterized in that: Also includes at least one of the following technical features: b2. In the working state and in the direction of leaflet closing, the balloon body (1) is configured to be a crescent-shaped arc; b3. In the working state and in the direction of blood flow, the balloon body (1) is configured to be conical or streamlined.

7. A method for preparing a heart valve repair balloon, using the heart valve repair balloon according to any one of claims 1 to 6, comprising the following steps: S1. Weaving a balloon body comprising at least two layers of lattice skeletons, wherein the balloon body comprises a balloon wall and an adjustable cavity located inside the balloon wall; S2. Shape the balloon body of step S1 so that the balloon body is configured to cooperate with each leaflet of the native valve.

8. The method for preparing a balloon for heart valve repair according to claim 7, characterized in that: The balloon body has an inner grid skeleton and an outer grid skeleton, and step S1 specifically includes the following steps: S11, weaving an inner mesh frame and an outer mesh frame separately and combining them into a balloon body; or weaving a layer of mesh frame and folding and sleeved it to form a balloon body having an inner mesh frame and an outer mesh frame; S12. Providing a capsule mold, wherein the shape of the capsule mold is designed according to the imaging structure of the heart valve; S13, placing the balloon prepared in step S11 on the balloon mold, and proceeding to step S2.

9. The method for preparing a balloon for heart valve repair according to claim 8, characterized in that: In step S13, the balloon is placed on the balloon mold and the positions of the inner grid skeleton and the outer grid skeleton are adjusted so that at least part of the grids of adjacent grid skeletons are staggered.

10. The method for preparing a balloon for heart valve repair according to claim 9, characterized in that: The balloon body is arranged on the balloon body mold and the positions of the inner layer grid skeleton and the outer layer grid skeleton are adjusted so that each single grid of the adjacent layer grid skeleton is staggered.

11. The method for preparing a balloon for heart valve repair according to claim 7, characterized in that: In step S2, the balloon is shaped by heat setting.

12. The method for preparing a balloon for heart valve repair according to claim 11, characterized in that: Heat the balloon at 480-550°C for 10-30 minutes.

13. The method for preparing a balloon for heart valve repair according to claim 7, characterized in that: The preparation method further comprises: S3, coating the balloon.

14. The method for preparing a balloon for heart valve repair according to claim 13, characterized in that: One of the following technical features: c1. Arranging an adhesive layer having an adhesive function on the balloon obtained in step S2, then coating it with a coating layer, and finally shaping it by thermal bonding; c2. adhering the coating layer to the outside of the balloon body by an adhesive; c3. Before step S3, the method further includes the following step: trimming the balloon body formed in step S2 so that it has at least one opening to form a mounting position.

15. The method for preparing a balloon for heart valve repair according to claim 14, characterized in that: Technical features c1 or c2 include at least one of the following technical features: c11. The bonding layer is made of a polymer material; or the bonding layer is made of FEP; c12. The coating layer is made of a biocompatible material; or, the coating is made of a polymer material; or, the coating is made of PET or PTFE; c13. Thermal adhesion processing and shaping: heating the coated balloon at 280-320°C for 5-20 minutes; c21. The adhesive is FEP film.

16. A heart valve repair assembly comprising: A stabilizing support (2) configured to press against cardiac tissue; The balloon (1) according to any one of claims 1 to 6, wherein the balloon (1) is arranged at the outflow end of the stabilizing support (2); The auxiliary frame (3) is used to fix the balloon body (1) to the native valve leaflets, so as to achieve the coordination between the balloon body (1) and each leaflet of the native valve.

17. The heart valve repair assembly according to claim 16, wherein: The stabilizing support frame (2) comprises a plurality of mutually connected support columns (21), and the support columns (21) are circumferentially connected to form a mesh-shaped stabilizing support frame (2).

18. The heart valve repair assembly according to claim 17, wherein: Also includes at least one of the following technical features: d1, the support columns (21) are distributed in at least one row; d2. Anchoring members are provided on at least part of the support columns (21); d3. The shape of the stable support frame (2) is semi-spherical; d4. The inflow end of the stabilizing support (2) is provided with at least three hanging ears (22) for externally connecting components for delivering the heart valve repair assembly; d5. Suturing part of the stabilizing stent (2) with a membrane that can promote the endothelialization of the stent, or wrapping sutures of a material that can promote the endothelialization of the stabilizing stent (2) around the stabilizing stent (2).

19. The heart valve repair assembly according to claim 18, wherein: Also includes at least one of the following technical features: d11, each support column (21) is arranged in a single row, an upper and lower double row, or an inner and outer double row; d12, each of the support columns (21) is circumferentially connected to form a stable support frame (2) having a plurality of diamond-shaped openings; d21. The anchoring member is selected from teeth, thorns or hooks; d22. The anchoring member includes an upper anchoring member and a lower anchoring member, wherein the anchoring end of the upper anchoring member points to the inflow end, and the anchoring end of the lower anchoring member points to the outflow end.

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