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. Specifically, it includes a support frame for pressing against cardiac tissue, a balloon body for cooperating with each native leaflet, and an auxiliary frame. The auxiliary frame is arranged at the outflow end of the support frame. The auxiliary frame includes a loading portion close to the support frame and a clamping portion away from the support frame. A holding space for loading the balloon body and capturing and accommodating the native leaflets is formed between the loading portion and the clamping portion. Among them, the abutting surface of the clamping portion abuts against the native leaflets and a reinforcement is provided on the abutting surface. After the repair component of the present application is compressed and delivered and implanted into the body, the clamping portion captures the native leaflets. Finally, the auxiliary frame and the balloon body loaded on the auxiliary frame cooperate to clamp the native leaflets and make the abutting surface of the clamping portion abut against the native leaflets, and make the balloon body cooperate with other native leaflets. Finally, the support frame is completely released and pressed against the cardiac tissue. The present application sets a reinforcement on the abutting surface to increase the clamping area with the native leaflets and help reduce damage to the native leaflets.

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. Summary of the Invention

[0005] In view of the deficiencies of the prior art described above, the technical problem solved by the present application is to provide a heart valve repair component, comprising: a support frame, a balloon body and an auxiliary frame. After being compressed and delivered and implanted in the body, the clamping portion of the auxiliary frame captures the native leaflets, and as it is gradually released, the auxiliary frame and the balloon body loaded on the auxiliary frame cooperate to clamp the native leaflets and make the abutting surface of the clamping portion abut against the native leaflets, and make the balloon body cooperate with other native leaflets, and finally the support frame is completely released and pressed against the heart tissue. The clamping ability of the auxiliary frame plays a very important role in the stability of the repair component. Therefore, the present application sets a reinforcement on the abutting surface to increase the clamping area with the native leaflets and help reduce damage to the native leaflets.

[0006] To achieve the above-mentioned and other related objectives, the present application provides, in a first aspect, a heart valve repair assembly, comprising:

[0007] a support frame configured to press against heart tissue;

[0008] The balloon body is configured to cooperate with each native valve leaflet;

[0009] An auxiliary frame is provided at the outflow end of the support frame, the auxiliary frame comprising a loading portion close to the support frame and a clamping portion away from the support frame, wherein a holding space is formed between the loading portion and the clamping portion; the holding space is used to load the balloon body and capture and accommodate the native valve leaflets;

[0010] Wherein, the abutting surface of the clamping portion abuts against the native leaflet, and a reinforcement piece is provided on the abutting surface.

[0011] In an implementable embodiment of the first aspect, the loading portion and the clamping portion are integrally formed.

[0012] In one embodiment of the first aspect, the auxiliary frame includes a first auxiliary rod and a second auxiliary rod; one end of the first auxiliary rod and the second auxiliary rod are respectively engaged with the support frame, and the other ends extend toward the outflow end of the support frame to form the loading portion, and then extend toward the inflow end of the support frame after bending to form the clamping portion.

[0013] In an implementable embodiment of the first aspect, the first auxiliary rod and the second auxiliary rod are arranged opposite to each other.

[0014] In an implementable embodiment of the first aspect, along the direction from the outflow end to the inflow end of the support frame, the first auxiliary rod and the second auxiliary rod forming the clamping portion gradually approach the holding space.

[0015] In an implementable embodiment of the first aspect, the first auxiliary rod and the second auxiliary rod forming the clamping portion gradually move away from each other along a direction from an outflow end to an inflow end of the support frame.

[0016] In an implementable embodiment of the first aspect, both ends of the reinforcement member are connected to the free end of the first auxiliary rod and the free end of the second auxiliary rod respectively.

[0017] In one possible implementation of the first aspect, the reinforcement is a multi-zigzag link structure.

[0018] In an implementable embodiment of the first aspect, the free end of the clamping portion forms a first abutting surface, the connecting end of the clamping portion forms a second abutting surface, and the reinforcement is arranged on the first abutting surface.

[0019] In one possible implementation manner of the first aspect, the loading portion and the clamping portion are integrally formed into a U-shaped structure.

[0020] In an implementable embodiment of the first aspect, the auxiliary frame is made of memory elastic material.

[0021] In an implementable embodiment of the first aspect, the auxiliary frame is made of memory alloy.

[0022] In one possible implementation of the first aspect, the reinforcement is a rod-shaped structure.

[0023] In an embodiment of the first aspect, the auxiliary frame further includes an upper auxiliary part and a lower auxiliary part for connecting the balloon body.

[0024] In one embodiment of the first aspect, one end of the upper auxiliary part is connected to the support frame or the loading part, and the other end extends toward the inflow end of the support frame and toward the outside of the support frame to form the free end of the upper auxiliary part; and / or, one end of the lower auxiliary part is connected to the support frame or the loading part, and the other end extends toward the outflow end of the support frame to form the free end of the lower auxiliary part.

[0025] In one possible implementation of the first aspect, the upper auxiliary member and the lower auxiliary member are both rod structures, the upper auxiliary member is used to fix the upper part of the balloon body, and the lower auxiliary member is used to fix the lower part of the balloon body.

[0026] In one possible implementation of the first aspect, an upper suture hole is provided at the free end of the upper auxiliary component.

[0027] In one possible implementation of the first aspect, an upper suture hole is provided at the free end of the lower auxiliary component.

[0028] In an implementable embodiment of the first aspect, the free end of the lower auxiliary component is located in the holding space.

[0029] In an implementable embodiment of the first aspect, the upper auxiliary component includes a first upper auxiliary rod and a second upper auxiliary rod that are arranged opposite to each other, and the free ends of the first upper auxiliary rod and the second upper auxiliary rod are both provided with suture holes.

[0030] In an implementable embodiment of the first aspect, the lower auxiliary frame includes a first lower auxiliary rod and a second lower auxiliary rod, and the free end of the first lower auxiliary rod and the free end of the second lower auxiliary rod merge to form a lower auxiliary member free end.

[0031] In an implementable embodiment of the first aspect, one end of the first auxiliary rod and the second auxiliary rod are respectively engaged with the support frame to form an auxiliary rod joint, and the auxiliary rod joint is provided with a reinforcement block.

[0032] In an implementable embodiment of the first aspect, the connecting ends of the first upper auxiliary rod and the second upper auxiliary rod are respectively connected to the reinforcement block.

[0033] In an implementable embodiment of the first aspect, the connecting ends of the first lower auxiliary rod and the second lower auxiliary rod are connected to the reinforcement block.

[0034] In an implementation manner of the first aspect, the support frame includes a plurality of interconnected support rods, each of the support rods is interconnected to form a support frame having a plurality of openable portions, and support rods of adjacent openable portions form a connecting block.

[0035] In one possible implementation of the first aspect, the support rods are distributed in at least one row.

[0036] 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.

[0037] In an implementable embodiment of the first aspect, when the support frame is in an expanded state, the openable portion forms a diamond-shaped opening or a diamond-shaped opening.

[0038] In one possible implementation of the first aspect, at least some of the support rods are provided with anchoring members.

[0039] In one possible embodiment of the first aspect, the anchoring element is selected from teeth, thorns or hooks.

[0040] In an embodiment of the first 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 of the support frame, and the anchoring end of the lower anchoring member points to the outflow end of the support frame.

[0041] In an implementable embodiment of the first aspect, the upper anchor is arranged on a side away from the auxiliary frame, and the lower anchor is arranged on a side close to the auxiliary frame.

[0042] In an implementable embodiment of the first aspect, lower anchoring members are provided on the support rods or connection blocks located on both sides of the auxiliary frame.

[0043] In one possible implementation manner of the first aspect, when the support frame is in an expanded state, the support frame is in a semi-spherical shape.

[0044] In one possible implementation of the first aspect, at least three lugs are provided on the inflow end of the support frame for externally connecting components for delivering the heart valve repair assembly.

[0045] In an implementable embodiment of the first aspect, the length of the hanging ear close to the auxiliary frame side is longer than the length of the hanging ear away from the auxiliary frame side.

[0046] In an implementable embodiment of the first aspect, a threading hole is provided at the inlet end of each of the hanging ears.

[0047] In one embodiment of the first aspect, a portion of the scaffold is sutured with a membrane capable of promoting scaffold endothelialization, or sutures made of a material capable of promoting scaffold endothelialization are wrapped around the scaffold.

[0048] In one embodiment of the first aspect, the membrane promoting endothelialization of the scaffold is disposed on a portion of the scaffold away from the auxiliary scaffold, and / or the membrane promoting endothelialization of the scaffold is disposed on a portion of the scaffold close to the auxiliary scaffold.

[0049] In one possible implementation of the first aspect, the connecting block is a bone-like joint structure.

[0050] 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.

[0051] In one possible implementation manner of the first aspect, the balloon body is provided with at least one fixing port, and the fixing port is used for connecting to the auxiliary frame or for externally connecting a delivery member.

[0052] 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.

[0053] In one possible implementation manner of the first aspect, the covering film is made of a biocompatible material.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] In one embodiment of the first aspect, the fixing port includes an upper fixing port and a lower fixing port, the upper fixing port is provided at the proximal end of the balloon body, and the lower fixing port is provided at the distal end of the balloon body.

[0058] In one possible implementation manner of the first aspect, the upper fixing port is sealed by a covering film, and the covering film is made of a biocompatible material.

[0059] In one possible implementation manner of the first aspect, the lower fixing opening is constricted by a locking ring.

[0060] In one possible implementation of the first aspect, the locking ring is made of a medical imaging material.

[0061] 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;

[0062] 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.

[0063] The heart valve repair assembly and repair system provided in this application have, but are not limited to, the following beneficial effects:

[0064] 1) The heart valve repair assembly of the present application includes a support member, a balloon body and an auxiliary frame. After being compressed and delivered and implanted into the body, the clamping part of the auxiliary frame captures the native leaflets, and as it is gradually released, the auxiliary frame and the balloon body loaded on the auxiliary frame cooperate to clamp the native leaflets and make the abutting surface of the clamping part abut against the native leaflets, and make the balloon body cooperate with other native leaflets. Finally, the support frame is completely released and pressed against the heart tissue. The present application sets a reinforcement member on the abutting surface to increase the clamping area with the native leaflets and help reduce damage to the native leaflets.

[0065] 2) 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.

[0066] 3) 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

[0067] Figure 1 Shown is a schematic diagram of the overall structure of the repair component described in Example 1 of the present application.

[0068] Figure 2 Shown is a schematic diagram of the overall structure of the repair component described in Example 1 of the present application from a frontal perspective.

[0069] Figure 3 Shown is a partial structural schematic diagram of the side view of the repair component described in Example 1 of the present application.

[0070] Figure 4 Shown is a schematic diagram of the overall structure of the repair component described in Example 1 of the present application from a top view.

[0071] Figure 5 It shows a schematic diagram of the structure of the repair component described in Example 1 of the present application after the balloon body is removed.

[0072] Figure 6 Shown is a schematic diagram of the structure from a frontal perspective of the repair component described in Example 1 of the present application after the balloon body is removed.

[0073] Figure 7 Display as Figure 6 Enlarged view of part A in .

[0074] Figure 8 A cutting diagram showing the repair component described in Example 1 of the present application after the balloon body is removed.

[0075] Figure 9 A schematic diagram showing a portion of the structure of the repair component described in Example 2 of the present application from a side view.

[0076] Figure 10 Shown is a schematic diagram of the structure of the repair component described in Example 2 of the application after the balloon body is removed.

[0077] Figure 11 A schematic diagram showing the overall structure of the repair component described in Example 3 of the present application after the balloon body is removed.

[0078] Figure 12 Shown is 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.

[0079] Figure 13 Shown is a cutting diagram of the repair component described in Example 3 of the present application after the balloon body is removed.

[0080] Figure 14 It shows a partial structural schematic diagram of the repair component described in Example 3 of the present application after the balloon body is removed.

[0081] Figure 15 Display as Figure 14 Enlarged view of part B in .

[0082] Figure 16 Display as Figure 14 Enlarged view of part C in .

[0083] Figure 17 Shown is a first state diagram of the balloon skeleton for heart valve repair described in Example 4 of the present application.

[0084] Figure 18 Shown is a second state diagram of the balloon skeleton for heart valve repair described in Example 4 of the present application.

[0085] Figure 19 Shown is a schematic structural diagram of the balloon for heart valve repair described in Example 4 of the present application.

[0086] Figure 20 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.

[0087] Figure 21 Shown is a schematic diagram of the balloon coating for heart valve repair described in Example 5 of the present application.

[0088] Figure 22 A schematic diagram showing the heart valve repair assembly according to an embodiment of the present application being implanted in the mitral valve of the heart.

[0089] Description of Reference Numerals

[0090] 1 support frame

[0091] 11 Support rod

[0092] 111 First support rod

[0093] 101 Enhancement Block

[0094] 102 connection block

[0095] 103 Opening

[0096] 12 mounting ears

[0097] 121 First mounting ear

[0098] 122 Second mounting ear

[0099] 123 Third mounting ear

[0100] 131 Upper anchor

[0101] 132 Lower anchor

[0102] 2 Balloon

[0103] 21 Inner mesh skeleton

[0104] 22 Outer mesh skeleton

[0105] 23 Lamination

[0106] 231 First Lamination

[0107] 232 Second coating

[0108] 233 Third coating

[0109] 234 Fourth coating

[0110] 24 Upper fixing port

[0111] 25 Lower fixing port

[0112] 26 Locking ring

[0113] 3 Auxiliary frame

[0114] 31 reinforcement

[0115] 32 First auxiliary pole

[0116] 33 Second auxiliary pole

[0117] 34 Upper accessories

[0118] 341 upper suture hole

[0119] 342 First auxiliary pole

[0120] 343 Second auxiliary pole

[0121] 35 lower accessories

[0122] 351 upper suture hole

[0123] 352 First auxiliary pole

[0124] 353 Second auxiliary pole

[0125] 300 storage space

[0126] 301 First support surface

[0127] 302 Second supporting surface DETAILED DESCRIPTION Detailed Description of the Invention

[0129] 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 support frame are released, and the angle is adjusted to make the balloon body close to the other native valve leaflet, and the support frame is continued to be released and the precise position of the balloon body is adjusted, and finally the support frame is fixed 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 support frame 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.

[0130] 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 from flowing backward, 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 at the inflow end, and the outlet of the stent at the outflow end. "Proximal end" and "distal end" generally refer to the end closer to the operator, and the distal end refers to the end farther from the operator. "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, as 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.

[0131] 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.

[0132] 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.

[0133] Please see the attached Figure 1-22 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.

[0134] 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.

[0135] Example 1

[0136] See Figures 1-8, provides a heart valve repair assembly, including: a support frame 1, which is configured to press against heart tissue. A balloon body 2, which is configured to cooperate with each native leaflet. An auxiliary frame 3, which is arranged at the outflow end of the support frame 1, and the auxiliary frame 3 includes a loading portion close to the support frame 1 and a clamping portion away from the support frame 1, and 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 against the native leaflets, and a reinforcement member 31 is provided on the abutting surface. For example, refer to Figure 1 A reinforcement 31 is provided on the upper part 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 support frame 1, and the clamping portion is the portion of the auxiliary frame 3 away from the support frame 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 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 2 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.

[0137] In one embodiment, see Figure 1 、 Figure 3 and Figure 5 , the loading part and the clamping part are integrally formed. For more details, refer to Figure 5 The auxiliary frame 3 includes a first auxiliary rod 32 and a second auxiliary rod 33. One end of the first auxiliary rod 32 and the second auxiliary rod 33 are respectively connected to the support frame 1, and the other ends extend toward the outflow end of the support frame 1 to form the loading portion. After extending away from the support frame 1 and then bending, they extend toward the inflow end of the support 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 auxiliary rod 32 and the second auxiliary rod 33 can be connected to the support frame 1 by connecting parts, welding, or directly integrally formed.

[0138] For details, see Figure 5 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.

[0139] For more details, see Figure 1The 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.

[0140] For more details, see Figure 1 and Figure 5 Along the direction from the outflow end to the inflow end of the support frame 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, thereby ensuring the stability of the fixation of the balloon body 2.

[0141] For more details, see Figure 5 , along the direction from the outflow end to the inflow end of the support frame 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 31 is provided on the abutting surface of the clamping portion (specifically, the first abutting surface 301, which can be understood as forming the first abutting surface 301 on one side of the reinforcement member 31). 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 described above, along the outflow end to the inflow end of the support frame 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. For example, the slightly inward buckling Figure 5 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.

[0142] In one embodiment, see Figure 6 and Figure 7The 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 support frame 1 or the loading portion, and the other end extends toward the inflow end of the support frame 1 and toward the outside of the support frame 1 to form the upper auxiliary member free end. One end of the lower auxiliary member 35 is connected to the support frame 1 or the loading portion, and the other end extends toward the outflow end of the support frame 1 to form the lower auxiliary member free end.

[0143] For details, see Figure 1 、 Figure 6 and Figure 7 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 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.

[0144] For more details, see Figure 7 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.

[0145] In one embodiment, see Figure 5 and Figure 7One end of the first auxiliary rod 32 and the second auxiliary rod 33 are respectively connected to the support frame 1 to form an auxiliary rod joint. A reinforcement block 101 is provided at this auxiliary rod joint. The provision of the reinforcement block 101 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 101. 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 101. In other words, the reinforcement block 101 provides a connection point for the above components, which improves the connection stability.

[0146] In one embodiment, see Figure 1-Figure 7 The support frame 1 is a self-expanding mesh structure. After being implanted in the body in a compressed delivery state, the support frame 1 self-expands to form a preset shape of the support frame 1, which plays the role of connecting the delivery balloon body 2. The support frame 1 is delivered and implanted in the corresponding part of the body, such as the heart tissue near the valve ring of the atrium, which allows blood to enter the ventricle normally from the atrium. The important purpose of the support frame 1 is to be firmly fixed in the atrium and almost not affect the normal blood flow, and to withstand the load brought by the balloon body 2 due to the impact of the blood flow, so as to ensure the normal operation of the balloon body 2. The support frame 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 support frame 1 and the difficulty of pressing and gripping will have a crucial impact on whether the support frame 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.

[0147] For details, see Figure 1 and Figure 3 The support frame 1 includes a plurality of support rods 11 connected to each other, and each support rod 11 is connected to each other to form a support frame 1 with a plurality of openable portions, and the support rods 11 with adjacent openable portions form a connecting block 102. When the support frame 1 is deployed, the support frame 1 is in a semi-spherical shape. The local bending strain of the support frame 1 with this structure is small, and the compression and gripping difficulty is small. The support frame 1 is not easily damaged during the deformation process from compression to delivery to deployment. It is easier to deploy to a preset shape, and after deployment, the support frame 1 fits better with the atrial wall, so that the posture of the entire component is more stable after implantation in the heart. For more details, refer to Figure 3 The support frame 1 is a self-expanding mesh structure. When the support frame 1 is deployed, the openable portion forms an opening 103. Preferably, the opening 103 is a diamond-shaped opening or a diamond-like opening, which is conducive to the deformation process from the compressed delivery state to the deployed state.

[0148] In a specific embodiment, the support rods 11 are arranged in at least one row. After being implanted in the body in a compressed state, the support frame 1 expands by itself to form a support frame of a preset shape, which plays the role of connecting the delivery balloon body 2. After being delivered and implanted in the corresponding part of the body, such as the heart tissue near the atrial valve ring, it is anchored to the heart tissue through corresponding anchoring means to provide a stable support force. The overall area of ​​the support frame 2 and its structural stability will affect the blood flow performance or support capacity after implantation. The appropriate support frame 1 is selected according to actual needs. In this embodiment, refer to Figure 3 , the support rods 11 are selected to be arranged in a double row up and down, that is, the openings 103 formed are arranged in a double row up and down. Preferably, the upper openings located in the upper row and the lower openings located in the lower row are staggered to reduce the amount of material used in the support frame, that is, to reduce the implantation of foreign objects. In addition, the staggered upper openings and lower openings are beneficial to the deformation of the bracket from compression to expansion and the posture stability after expansion.

[0149] In one embodiment, see Figure 3 The aforementioned anchoring means is to provide anchors on the support rods 11. Preferably, at least a portion of the support rods 11 is provided with anchors, such as teeth, thorns, hooks, etc. Specifically, the anchors include an upper anchor 131 and a lower anchor 132. The anchoring end of the upper anchor 131 points toward the inflow end of the support frame 1, and the anchoring end of the lower anchor 132 points toward the outflow end of the support frame 1. The anchoring end refers to the end of the anchor that is anchored to the heart tissue. More preferably, the upper anchor 131 is located on the side of the support frame 1 away from the balloon body 2, and the lower anchor 132 is located on the side of the support frame 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 part 202 of the balloon body is impacted by the blood, and when the leaflets are closed, the rear part 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 anchor can maintain the stability of the assembly, and the above preferred anchor arrangement does not require an excessive number of anchors and can prevent the repair assembly from flipping by cooperating with the upper and lower anchors in special parts. Furthermore, the corresponding number of anchors can be set according to needs, for example, according to the number of layers of the support frame 1. In this embodiment, the anchor is a barb, and the barb is in the form of a barb connecting the support frame 1 and extending in the direction away from the support frame 1 to the free end of the barb.

[0150] In a specific embodiment, in addition to the above, it is also necessary to quickly endothelialize the support frame 1, that is, the support frame 1 is stably located in the atrial wall. Therefore, in this example, the support frame 1 is entirely or partially provided with a membrane that can promote the endothelialization of the support frame 1 or a suture that can promote the endothelialization of the support frame 1 is wrapped. Among them, the membrane that promotes the endothelialization of the support frame 1 or the suture that can promote the endothelialization of the support frame 1 is made of PET or PTFE. Preferably, 1) the support frame 1 is partially provided with a PET film, and the setting method is, for example, bonding or suturing. The specific setting position of the PET film can be at the support frame 1 on the side away from the balloon body 2 or at the support frame 1 on the side close to the balloon body 2, because the balloon body 2 has a tendency to flip the support frame 1 when impacted by blood flow, so that the above two positions are easy to quickly endothelialize, which is conducive to the rapid endothelialization of the support frame 1 in the atrial wall so that it is stably fixed in the atrial wall. Preferably, the PET film is set at the support frame 1 on the side away from the balloon body 2 and at the support frame 1 on the side close to the balloon body 2. 2) Sutures capable of promoting endothelialization are wrapped around each strut 11 of the entire stent 1. The sutures are wrapped around each strut 11 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 stent 1 increases the contact friction between the stent 1 and the atrial wall and facilitates cardiac tissue adhesion. When the sutures are made of a material capable of promoting endothelialization, such as PET, they can also promote rapid endothelialization of the stent 1.

[0151] In one embodiment, see Figure 3 、 Figure 5 and Figure 8 As mentioned above, in addition to connecting the supporting auxiliary frame 3 and thus supporting the balloon body 2, the support frame 1 also needs to bear the load brought by the balloon body 2 due to the impact of blood flow, so as to ensure the normal operation of the balloon body 2. Therefore, it is necessary to ensure that the support rod 11 on the support frame 1 does not interfere with the balloon body 2. The first support rod 111 located at the outflow end of the support frame 1 and close to the auxiliary frame is set to a non-interference state with the balloon body 2. The non-interference setting methods are listed as follows: 1) The first support rod 111 located at the outflow end of the support frame 1 and close to the auxiliary frame is bent toward the inner side of the support frame 1, that is, the two openings 103 on both sides of the auxiliary frame 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 first support rod 111 located at the outflow end of the support frame 1 and close to the auxiliary frame is shorter than that of the adjacent support rods, that is, the outflow end length of the openings 103 on both sides of the auxiliary frame 3 is shortened to prevent them from interfering with the balloon body 2.

[0152] In one embodiment, see Figure 1 and Figure 4At least two hooks 12 are provided at the inlet of the support frame 1 for externally delivering the components of the heart valve repair assembly. Each hook 12 is circumferentially arranged along the inlet (inflow end) of the support frame 1, and a threading hole is provided at the inflow end of each hook 12 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 12 can be selected to be consistent or inconsistent. The preferred embodiment of each hook 12 is that the lengths are inconsistent, the purpose of which is to make the support frame 1 on the side of the short hook be released and self-expanded into place first, which can prevent the support frame 1 from instantly collapsing from the delivery device and causing the fixed position of the balloon body 2 to shift. After the anchor on the support frame 1 is securely fitted to the appropriate atrial position, the remaining longer hooks are released to enhance the stability of the release process of the support frame 1. The preferred embodiment of this embodiment is that each hook is evenly distributed at the inflow end of the support frame 1.

[0153] For more details, see Figure 4 , further illustrated using a preferred example with three hanging ears, wherein the first hanging ear 121 is a short hanging ear, and the second hanging ear 122 and the third hanging ear 123 are long hanging ears. The first hanging ear 121 is located on the side of the support frame 1 away from the auxiliary frame 3. Since the position of the balloon body 2 is the most critical, the support frame 1 away from the balloon body 2 is released first, while the support frame 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 support frame 1 release.

[0154] Example 2

[0155] See Figure 9-10 , which is different from the specific embodiments in Example 1 in that, when the support frame 1 is deployed, the support frame 1 is more semi-spherical. The local bending strain of the support frame 1 of this structure is small, and the compression and gripping difficulty is small. The support frame 1 is not easily damaged during the deformation process from compression to delivery to deployment. It is easier to deploy to the preset shape and the support frame 1 fits better with the atrial wall after deployment, making the posture of the entire component more stable after implantation in the heart. For details, see Figure 10 , the support rods 11 at the inflow end of the stent 1 gather toward the first center C1 along an annular surface, and the first center is located at the inflow end of the stent 1. The annular surface can be an arcuate annular surface, and the first center C1 refers to the location at the inflow port of the stent 1, preferably at the center of the inflow port of the stent 1. The support rods 11 near the inflow end of the stent 1 gather toward the first center C1 along the annular surface, similar to the gathering structure of a bun or a garlic. The stent 1 with this structure has a small local bending strain and is easy to press and grip. The stent 1 is not easily damaged during the deformation process from compression to delivery to deployment, and is easier to deploy to a preset shape. After deployment, the stent 1 fits better with the atrial wall, making the posture of the entire assembly more stable after implantation in the heart.

[0156] More specifically, one end of each support rod 11 extends from the interface L1 to the first center C1 and converges to form the gathered portion of the support frame 1, and the other end of each support rod 11 extends from the interface L1 to the second center C2 and converges to form the supporting portion of the support frame 1. In order to meet the advantageous functions of the support frame 1 described above, the support frame 1 is preferably configured as a hemispherical shape, that is, the first center C1 is located at the center of the inlet of the support frame, the second center C2 is located at the center of the outflow of the support frame, and the line L2 connecting the first center C1 and the second center C2 is perpendicular to the interface L1.

[0157] For more details, see Figure 9 and Figure 10 The support frame 1 is a self-expanding mesh structure. When the support frame 1 is unfolded, the openable portion forms an opening 103, and one end of each opening 103 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 support frame 1.

[0158] For more details, see Figure 10 , each lug 12 converges toward the first center C1. Preferably, each lug 12 converges toward the first center C1 along an arc-shaped annular surface, that is, the lugs are also arranged to converge in an arc shape from the periphery toward the first center C1, so that the entire stent is more hemispherical. This shape allows the entire stent to better fit the atrial wall without causing the lugs to protrude too much and damage the atrial wall tissue.

[0159] Example 3

[0160] The difference from Example 1 is that, see Figure 11-13 Each strut 11 is circumferentially connected to form a mesh-like, self-expandable, stable stent 1, and each strut 11 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 stent 1 has a small shortening rate (i.e., when a compressed stent expands, its length shortens; the smaller the shortening rate, the smaller the change in the stent 1), which facilitates release and positioning after in vivo delivery; 3) The single-row stent 1 has a short overall length, which reduces 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 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 supporting forces. The single-row grid can effectively increase the adaptability of the stable stent to the atrial morphology, causing less damage to the myocardium.

[0161] Specifically, to maintain the stability of the support frame, refer to Figure 12 , from the front view, the front openings located in the front row and the rear openings located in the rear row are staggered.

[0162] For more details, see Figure 13 、 14 and Figure 16 The auxiliary frame 3 includes a first auxiliary rod 32 and a second auxiliary rod 33, and is arranged in a manner similar to that in Example 1 to form a clamping 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 1, form a U-shaped structure, 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 support frame 1, the first auxiliary rod 32 and the second auxiliary rod 33 forming the clamping portion gradually approach the loading space 300, that is, the lower side of the loading space 300 has a larger space to better accommodate the balloon body 2 and does not interfere with the movement of the balloon body 2; the upper side of the loading 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 2 fixation.

[0163] For more details, see Figure 14 and Figure 15 , each support rod 11 is connected to each other to form a support frame 1 with multiple openable parts, and the support rods 11 of adjacent openable parts form a connecting block 102. Preferably, the connecting block 102 is a bone joint structure to improve torsional resistance and rigidity.

[0164] Example 4

[0165] 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, see Figure 17-Figure 19, a specific embodiment is provided: the balloon body is made of woven metal wires, specifically, the grid skeleton includes an inner grid skeleton 21 and an outer grid skeleton 22, and the inner grid skeleton 21 and the outer grid skeleton 22 are preferably not fixedly arranged to form an elastic contact support effect. Of course, it is also possible to maintain a partial / local relatively fixed setting without affecting the elastic support effect. The relative fixing method can be selected as follows: 1) maintaining a certain friction force between the metal wires of the inner and outer grids so that the positions of the inner and outer grid skeletons after the inner and outer weaving are relatively fixed; 2) providing an adhesive layer on the surface of the grid skeleton and / or between adjacent layers of the grid skeleton, wherein the adhesive layer is formed by a polymer film, the polymer film is wrapped around the grid skeleton, and melted at a high temperature to achieve a strong bonding effect, which is convenient to use.

[0166] Preferably, each inner single grid of the inner layer grid skeleton 21 is staggered with each outer single grid of the outer layer grid skeleton 22, 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 metal 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.

[0167] Furthermore, see Figure 19 Some balloons require a coating 23 wrapped around the outside of the body to enclose the lattice framework of the balloon body 2 and mimic the function of native valve leaflets. This coating 23 is generally made of a smooth polymer film, and the adhesive layer is also made of a polymer film. At a certain temperature, the polymer film of the adhesive layer melts, thus bonding the coating layer. More specifically, the adhesive layer is preferably made of FEP (Fluorinated ethylene propylene), which can form a good adhesion with the coating 23 by treating it at approximately 300°C for a few minutes.

[0168] 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 20Taking 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 (expanded 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 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. 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 2 can be customized according to the imaging information of different individuals.

[0169] In one embodiment, see Figure 17 、 Figure 18 and Figure 19 The balloon body 2 is provided with at least one fixing port, which is used to connect a component for externally delivering the balloon body or a component for externally fixing the balloon body to the cardiac tissue at the native valve ring. For example, 1) a component for externally delivering the balloon body 2, such as a delivery tube-type compression delivery device. 2) a component for fixing the balloon body 2 to the cardiac tissue at the native valve ring, such as a clamping member provided somewhere on the balloon body 2, which is used to clamp the balloon body 2 to the cardiac tissue near the native valve leaflet or the valve ring, and keep the balloon body 2 stably in a suitable position to assist the diseased native valve leaflet group to complete the physiological switching function. The auxiliary frame 3 connected to the balloon body 2 in this application plays the role of connecting the balloon body 2 and cooperating with the balloon body 2 to clamp to the native valve leaflet to assist the native valve leaflet to achieve the switching function; 3) there may also be a support frame 1 indirectly connected to the balloon body 2, which plays the role of pressing against the cardiac tissue to further assist in supporting the balloon body 2 to maintain the balloon body 2 in a stable state.

[0170] In a specific embodiment, the fixing port on the balloon body 2 can be any part of the balloon body, and the connection method 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 opening is provided at the proximal end or distal end of the balloon body to form the fixing port, which is used to externally fix the balloon body to the component on the heart tissue at the native valve annulus. In this embodiment, refer to Figure 17 and Figure 18, providing a preferred connection method, an upper fixing port 24 is provided at the inflow end of the balloon body 2, and the balloon body is inserted into the auxiliary frame 3 through the upper fixing port 24. After the balloon body 2 is inserted into the auxiliary frame 3 through the upper fixing port 24, 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 24 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.

[0171] In another embodiment, see Figure 17 and Figure 18 The auxiliary frame 3 extends through the lower fixing opening 25 of the balloon body 2. The balloon body 2 at the lower fixing opening 25 is secured by a locking ring 26 and then positioned within the balloon body 2. The locking ring 26 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 26 not only locks the balloon body 2 into a closed configuration but also serves as a marker.

[0172] In one embodiment, see Figure 19 The balloon body 2 further includes a covering 23, which covers at least a portion of the lattice frame. The material of the covering 23 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 covering film 23 is provided outside the grid skeleton, and the covering film 23 is made of a biocompatible material, or a polymer material, or PET or E-PTFE.

[0173] Example 5

[0174] 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;

[0175] Specifically, the inner and outer two-layer grid is used as an example for specific description:

[0176] 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.

[0177] 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.

[0178] 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.

[0179] 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.

[0180] 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.

[0181] In one embodiment, see Figure 21 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.

[0182] Example 6

[0183] The preparation method of Example 5 was used to prepare the balloon for heart valve repair described in Example 5. Specifically:

[0184] 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.

[0185] S12. Provide a suitable capsule mold.

[0186] 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.

[0187] 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.

[0188] 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.

[0189] Example 7

[0190] A heart valve repair system is provided, comprising the heart valve repair component as described in Example 1.

[0191] 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.

[0192] 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 11 , 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.

Claims

1. A heart valve repair assembly comprising: A support frame (1) configured to press against cardiac tissue; The balloon body (2) is configured to cooperate with each native valve leaflet; An auxiliary frame (3) is arranged at the outflow end of the support frame (1), and the auxiliary frame (3) includes a loading portion close to the support frame (1) and a clamping portion away from the support frame (1), and 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 leaflet; Wherein, the abutting surface of the clamping portion abuts against the native leaflet, and a reinforcing member (31) is provided on the abutting surface; The balloon body (2) includes at least two layers of grid frames arranged inside and outside, the grid frames including an inner grid frame (21) and an outer grid frame (22), and the inner grid frame (21) and the outer grid frame (22) are not fixedly arranged, and each inner single grid of the inner grid frame (21) is staggered with each outer single grid of the outer grid frame (22), that is, each grid contains grid lines of its adjacent layer; The balloon body (2) further includes a covering (23), which covers at least a portion of the grid skeleton; in the working state and when 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.

2. The heart valve repair assembly according to claim 1, characterized in that: Include at least one of the following technical features: a1. The loading part and the clamping part are integrally formed; a2. The loading part and the clamping part are integrally formed into a U-shaped structure; a3. The auxiliary frame (3) further includes an upper auxiliary component (34) and a lower auxiliary component (35) for connecting the balloon body (2); a4. The auxiliary frame (3) is made of memory elastic material; a5. The reinforcement (31) is a rod-shaped structure.

3. The heart valve repair assembly according to claim 2, characterized in that: Include at least one of the following technical features: a11. The auxiliary frame (3) comprises a first auxiliary rod (32) and a second auxiliary rod (33); one end of the first auxiliary rod (32) and the second auxiliary rod (33) are respectively connected to the support frame (1), and the other ends thereof extend toward the outflow end of the support frame (1) to form the loading portion, and then extend toward the inflow end of the support frame (1) after being bent to form the clamping portion; a12, the free end of the clamping portion forms a first abutting surface (301), the connecting end of the clamping portion forms a second abutting surface (302), and the reinforcement member (31) is arranged on the first abutting surface (301); a31, one end of the upper auxiliary member (34) is connected to the support frame (1) or the loading portion, and the other end extends in the direction of the inflow end of the support frame (1) and outside the support frame (1) to form the upper auxiliary member free end; and / or, one end of the lower auxiliary member (35) is connected to the support frame (1) or the loading portion, and the other end extends in the direction of the outflow end of the support frame (1) to form the lower auxiliary member free end; a41. The auxiliary frame (3) is made of memory alloy.

4. The heart valve repair assembly according to claim 3, characterized in that: Include at least one of the following technical features: a111, the first auxiliary rod (32) and the second auxiliary rod (33) are arranged opposite to each other; a112, along the direction from the outflow end to the inflow end of the support frame (1), the first auxiliary rod (32) and the second auxiliary rod (33) forming the clamping portion gradually approach the holding space (300); a113, along the direction from the outflow end to the inflow end of the support frame (1), the first auxiliary rod (32) and the second auxiliary rod (33) forming the clamping portion gradually move away from each other; a114, 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); a115, the reinforcement (31) is a multi-zigzag connecting rod structure; a311, the upper auxiliary member (34) and the lower auxiliary member (35) are both rod structures, the upper auxiliary member (34) is used to fix the upper part of the balloon body (2), and the lower auxiliary member (35) is used to fix the lower part of the balloon body (2); a312, the free end of the upper auxiliary component (34) is provided with an upper suture hole (341); a313, the free end of the lower auxiliary component (35) is provided with a lower suture hole (351); a314, the free end of the lower auxiliary component (35) is located in the holding space (300); a315, the upper auxiliary component (34) comprises a first upper auxiliary rod (342) and a second upper auxiliary rod (343) arranged opposite to each other, and the free end of the first upper auxiliary rod (342) and the free end of the second upper auxiliary rod (343) are both provided with suture holes; a316. The lower auxiliary member (35) includes a first lower auxiliary rod (352) and a second lower auxiliary rod (353), and the free end of the first lower auxiliary rod (352) and the free end of the second lower auxiliary rod (353) merge to form a lower auxiliary member free end.

5. The heart valve repair assembly according to claim 4, characterized in that: One end of the first auxiliary rod (32) and the second auxiliary rod (33) are respectively joined to the support frame (1) to form an auxiliary rod joint, and the auxiliary rod joint is provided with a reinforcement block (101).

6. The heart valve repair assembly according to claim 5, characterized in that: The connecting ends of the first upper auxiliary rod (342) and the second upper auxiliary rod (343) are respectively connected to the reinforcement block (101); And / or, the connecting ends of the first lower auxiliary rod (352) and the second lower auxiliary rod (353) are connected to the reinforcement block (101).

7. The heart valve repair assembly according to any one of claims 1 to 6, characterized in that: The support frame (1) comprises a plurality of mutually connected support rods (11), wherein the support rods (11) are mutually connected to form a support frame (1) having a plurality of openable portions, and the support rods (11) of adjacent openable portions form a connecting block (102).

8. The heart valve repair assembly according to claim 7, characterized in that: Include at least one of the following technical features: b1, the support rods (11) are distributed in at least one row; b2. When the support frame (1) is in an unfolded state, the openable portion forms an opening (103); b3. Anchoring members are provided on at least part of the support rods (11); b4. When the support frame (1) is in the unfolded state, the support frame (1) is in a semi-spherical shape; b5. The inflow end of the support frame (1) is provided with at least three hanging ears (12) for externally connecting components for delivering the heart valve repair assembly; b6. Suturing part of the support frame (1) with a membrane that can promote endothelialization of the support frame (1), or wrapping sutures of a material that can promote endothelialization of the support frame (1) around the support frame (1); b7. The connecting block (102) has a bone-like joint structure.

9. The heart valve repair assembly according to claim 8, characterized in that: Include at least one of the following technical features: b11, each support rod (11) is arranged in a single row or in an upper and lower double row; b31. The anchoring member is selected from teeth, thorns or hooks; b32, the anchoring member comprises an upper anchoring member (131) and a lower anchoring member (132), the anchoring end of the upper anchoring member (131) points to the inflow end of the support frame (1), and the anchoring end of the lower anchoring member (132) points to the outflow end of the support frame (1); b51, the length of the hanging ear close to the auxiliary frame (3) is longer than the length of the hanging ear away from the auxiliary frame (3); b61. A membrane that promotes endothelialization of the support frame (1) is disposed on a portion of the support frame (1) away from the auxiliary frame (3), and / or a membrane that promotes endothelialization of the stable support frame (1) is disposed on a portion of the support frame (1) close to the auxiliary frame (3).

10. The heart valve repair assembly according to claim 9, characterized in that: Also includes at least one of the following technical features: b321, the upper anchoring member (131) is arranged on a side away from the auxiliary frame (3), and the lower anchoring member (132) is arranged on a side close to the auxiliary frame (3); b322, lower anchoring members (132) are provided on the support rods (11) or the connecting blocks (102) located on both sides of the auxiliary frame (3); b511. A threading hole is provided at the inlet end of each of the hanging ears (12).

11. The heart valve repair assembly according to any one of claims 1 to 6 or 8 to 10, characterized in that: Include at least one of the following technical features: c2. The balloon body (2) is provided with at least one fixing port, and the fixing port is used to connect to the auxiliary frame (3) or to connect to an external delivery member; c4. In the working state and in the direction of leaflet closing, the balloon body (2) is in a crescent-shaped arc shape; c5. In the working state and in the direction of blood flow, the balloon body (2) is conical or streamlined.

12. The heart valve repair assembly according to claim 11, characterized in that: The fixing port comprises an upper fixing port (24) and a lower fixing port (25); the upper fixing port (24) is provided at the proximal end of the balloon body (2), and the lower fixing port (25) 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: d1, the upper fixed opening (24) is sealed by a coating (23); d2. The upper fixing port (24) or the lower fixing port (25) is sutured with medical sutures or sutured with a thread of the same material as the balloon body (2), and sutured to the auxiliary frame (3); d3. The lower fixing opening (25) is tightened by a locking ring (26).

14. The heart valve repair assembly according to claim 13, characterized in that: In feature c3 or d1, the covering film (23) is made of a biocompatible material; And / or, in feature d3, the material of the locking ring (26) 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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