Stent for heart valve repair

Abstract

This invention provides a stent for heart valve repair in the field of medical device technology, comprising an outer frame and an inner frame, with the inner frame connected to the inside of the outer frame. The outer frame includes a first grid frame, which is composed of multiple first frame units. The inner frame includes a second grid frame, which is composed of multiple second frame units. The multiple first frame units are provided with lugs facing the inflow direction. During loading, the heart valve repair stent is connected to a delivery device via these lugs. The lugs include lug one and lug two, with the length of lug one being shorter than the length of lug two. During release, lug one detaches from the catheter on the delivery device before lug two detaches from the catheter. The inner frame is used to connect to the balloon. This invention uses two sets of lugs with relative size differences to achieve distributed release and utilizes the relative triangular stabilizing structure of the lugs and the stent body to improve the stability of the stent release and anchoring process.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a stent for heart valve repair. Background Technology

[0002] Mitral regurgitation is a common valvular heart disease, and clinical symptoms worsen with increasing regurgitation severity. Mitral valve repair or replacement are new technologies for treating severe mitral regurgitation, but they carry higher risks for elderly patients.

[0003] In the past decade or so, a variety of transcatheter mitral valve products have been developed. These devices can effectively treat diseased valves without open-chest surgery or cardiopulmonary bypass through minimally invasive intervention, improve patients' clinical symptoms, greatly reduce surgical trauma, and bring hope of cure to patients who cannot tolerate traditional open-chest surgery.

[0004] Currently, mitral valve replacement or mitral valve repair is the most common treatment for mitral regurgitation. Mitral valve replacement has problems such as high surgical difficulty, high risk, slow postoperative healing, and easy thrombosis. Mitral valve repair, which uses edge-to-edge clamping repair, has limited applicability, is difficult to completely eliminate regurgitation, and is prone to causing valve stenosis after surgery.

[0005] Based on the existing problems with repair devices, new repair devices, such as stent-type repair devices, are being developed both domestically and internationally. However, stent-type repair devices have not yet met current needs in terms of stability during delivery and release, as well as anchoring effect after release and implantation, and these aspects need to be improved. Summary of the Invention

[0006] In view of the deficiencies in the prior art, the purpose of this invention is to provide a stent for heart valve repair.

[0007] According to the present invention, a stent for heart valve repair includes an outer frame and an inner frame, wherein the inner frame is connected to the inner side of the outer frame;

[0008] The outer frame includes a grid frame one, which is composed of multiple frame units one; the inner frame includes a grid frame two, which is composed of multiple frame units two.

[0009] Multiple frame units are provided with lugs facing the inflow end, and the stent for heart valve repair is connected to the delivery device through the multiple lugs during loading;

[0010] The hanging ears include hanging ear one and hanging ear two. Multiple hanging ears one are provided on the same side of the inner frame unit one in the direction of the inflow end, and the length of multiple hanging ears one on the same side of the inner frame is equal.

[0011] On the side away from the inner frame, a plurality of frame units are provided with a plurality of hanging ears 2 in the direction of the inflow end, and the lengths of the plurality of hanging ears 2 on the side away from the inner frame are equal;

[0012] Furthermore, the length of each of the first hooks is less than the length of each of the second hooks. During the release process of the stent for heart valve repair, after the first hooks are detached from the catheter on the delivery device in advance, the second hooks are then detached from the catheter on the delivery device.

[0013] The inner frame is used to connect the external balloon body.

[0014] In some embodiments, the frame unit one is a rhomboid frame unit one, and the frame unit one includes an inflow end support rod one and an outflow end support rod one;

[0015] The two inflow end support rods are joined together in the inflow end direction to form an inflow end closed end one, and the two outflow end support rods are joined together in the outflow end direction to form an outflow end closed end one.

[0016] In some embodiments, the first mesh frame is a spherical mesh frame, and the first mesh frame further includes a common end portion, which includes an upper connecting portion and a lower connecting portion.

[0017] The upper connecting part is connected to one end of the two inflow direction support rods, and the lower connecting part is connected to one end of the two outflow direction support rods.

[0018] In some embodiments, a suture hole is provided on a plurality of the frame units, the suture hole being an upper suture hole and a lower suture hole, and an upper suture hole is provided on a plurality of the inflow end closed ends, and a lower suture hole is provided on a plurality of the outflow end closed ends.

[0019] In some embodiments, a plurality of the inflow end closing ends are provided on one side facing the inflow end direction;

[0020] The hook includes a connecting arm and a connecting head. One end of the connecting arm is connected to one of the multiple inflow end closing ends on one side, and the other end of the connecting arm is connected to the connecting head. A through hole is provided on the connecting head.

[0021] On the other side, multiple hanging ears are provided at the closed ends of the inflow end facing the direction of the inflow end;

[0022] The second hanging ear includes a second connecting arm and a second connecting head. One end of the second connecting arm is connected to one of the multiple inflow end closing ends on the other side, and the other end of the second connecting arm is connected to the second connecting head. The second connecting head is provided with a second through hole.

[0023] In some embodiments, the outer frame is further provided with barbs, the barbs including upward barbs and downward barbs;

[0024] Multiple upward barbs are disposed on one of the multiple outflow closed ends and one of the multiple common ends facing the inflow end direction, and multiple downward barbs are disposed on the other end of the multiple common ends facing the outflow end direction;

[0025] Furthermore, the multiple upward barbs and the multiple downward barbs are all bent at 30° to 60°.

[0026] In some embodiments, the second frame unit is a rhomboid frame unit, and the second frame unit includes a support rod in the inflow direction and a support rod in the outflow direction.

[0027] The two inflow end support rods are joined together in the inflow end direction to form an inflow end closed end two, and the two outflow end support rods are joined together in the outflow end direction to form an outflow end closed end two.

[0028] In some embodiments, the second mesh frame is a crescent-shaped mesh frame, and the second mesh frame also includes a common end portion, which includes an upper connecting portion and a lower connecting portion.

[0029] The upper connecting part 2 connects to one end of the two inflow direction support rods 2, and the lower connecting part 2 connects to one end of the two outflow direction support rods 2.

[0030] In some embodiments, multiple frame units 2 are provided with suture holes 2, each suture hole 2 including an upper suture hole 2 and a lower suture hole 2, and the inflow end closed end 2 is provided with an upper suture hole 2, and the outflow end closed end 2 is provided with a lower suture hole 2.

[0031] In some embodiments, the inner frame further includes an upper auxiliary component, which is provided on one end of one of the plurality of outflow end closing ends. The upper auxiliary component includes a connecting rod and a through hole.

[0032] The connecting rod is oriented towards the inflow end, with one end connected to the closed end of the outflow end and the other end connected to the through hole. The connecting rod is also provided with a plurality of protrusions.

[0033] In some embodiments, the inner frame further includes a common end three and a lower auxiliary component, wherein one end of the common end three facing the inflow direction is connected to one end of the outflow closing end two, and the other end of the common end three facing the outflow direction is connected to the lower auxiliary component;

[0034] The lower auxiliary component includes a connecting rod 2 and a through hole 4. The connecting rod 2 is arranged in the direction of the outflow end. One end of the connecting rod 2 is connected to the other end of the common end 3, and the other end of the connecting rod 2 is connected to the through hole 4.

[0035] In some embodiments, the inner frame further includes a clamping member, which includes a connecting rod three and a clamping end; the connecting rod three is arranged in the direction of the outflow end, one end of the connecting rod three is connected to the other end of the common end three, and the other end of the connecting rod three is connected to the clamping end, and the clamping member is a U-shaped clamping member.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] 1. The present invention achieves distributed release by setting two sets of relatively different size lugs on the top of the external frame, and improves the stability of the release and anchoring process of the stent for heart valve repair by utilizing the relative triangular stabilizing structure of multiple lugs and the stent body.

[0038] 2. By setting multiple sets of barbs located in different directions and positions, the present invention can cope with the impact of loads on the main body of the bracket under different conditions, so as to ensure that the bracket can be stably and reliably anchored in the expected position.

[0039] 3. By providing multiple suture holes and through holes on the inner frame, the inner frame is connected to the outer frame through the suture lines passing through the multiple suture holes and through holes, thereby improving the overall connection stability and reliability of the bracket of the present invention. Attached Figure Description

[0040] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:

[0041] Figure 1 This is an isometric schematic diagram of the stent for heart valve repair according to the present invention;

[0042] Figure 2 This is a frontal view of the stent for heart valve repair according to the present invention;

[0043] Figure 3 This is a side view schematic diagram of the stent for heart valve repair according to the present invention;

[0044] Figure 4 This is a top view schematic diagram of the stent for heart valve repair according to the present invention;

[0045] Figure 5 This is an isometric schematic diagram of the external strut on the stent for heart valve repair according to the present invention;

[0046] Figure 6 This is a front view schematic diagram of the upper outer frame of the stent for heart valve repair according to the present invention;

[0047] Figure 7 This is a partially enlarged schematic diagram of the common end of the outer frame of the stent for heart valve repair of the present invention;

[0048] Figure 8 This is a side view of the upper external frame of the stent for heart valve repair according to the present invention;

[0049] Figure 9 This is a top view of the external frame of the stent for heart valve repair according to the present invention;

[0050] Figure 10 This is an isometric schematic diagram of the inner stent of the stent for heart valve repair according to the present invention;

[0051] Figure 11 This is a front view of the inner frame of the stent for heart valve repair according to the present invention;

[0052] Figure 12 This is a partially enlarged schematic diagram of the common end portion of the inner frame of the stent for heart valve repair of the present invention;

[0053] Figure 13 This is a partially enlarged schematic diagram of the common end three, upper auxiliary component, lower auxiliary component, and clamping component of the inner frame of the stent for heart valve repair of the present invention;

[0054] Figure 14 This is a side view of the inner frame of the stent for heart valve repair according to the present invention;

[0055] Figure 15 This is a top view of the inner frame of the stent for heart valve repair according to the present invention.

[0056] Figure label:

[0057] Outer frame 1, Inner frame 2

[0058] Mesh Frame 1.11 Mesh Frame 2.21

[0059] Frame Unit 111 Inflow End Closed End 2112

[0060] Inflow direction support rod 1111; Outflow direction support rod 2113

[0061] Inflow closed end 1112 Outflow closed end 2114

[0062] Outflow end support rod 1113 Common end 212

[0063] Outflow end closed end 1114 Upper connecting part 2121

[0064] Common end 112 Lower connecting part 2122

[0065] Upper connecting part 1121 Upper suture hole 213

[0066] Lower connecting part 1122 Lower suture hole 214

[0067] Upper suture hole 113, total end 322

[0068] Lower suture hole 114, upper accessory 23

[0069] Lug 12 Connecting rod 231

[0070] Connecting arm 121, protrusion 2311

[0071] Connector 122, Through Hole 3232

[0072] Through hole 1221 Lower accessory 24

[0073] Lug 2.13, Connecting rod 2.241

[0074] Connecting arm 2 131 Through hole 4 242

[0075] Connector 2 132 Clamping part 25

[0076] Through hole 2 1321 Connecting rod 3 251

[0077] 14 barbs pointing upwards, 252 clamping end

[0078] Downward barbs 15, clamping space 253

[0079] Frame Unit 211 Inflow End 3

[0080] Inflow end support rod 2111 Outflow end 4 Detailed Implementation

[0081] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0082] Example 1

[0083] like Figure 1-15As shown, the stent for heart valve repair of the present invention includes an outer frame 1 and an inner frame 2, with the inner frame 2 connected to the inner side of the outer frame 1. The outer frame 1 includes a grid frame 11, which is composed of multiple frame units 111. The inner frame 2 includes a grid frame 21, which is composed of multiple frame units 211. Multiple frame units 111 are provided with lugs facing the inflow direction. The stent for heart valve repair is connected to a delivery device through these lugs during loading. The lugs include lug 12 and lug 23. On the same side as the inner frame 2, multiple frame units 111 are provided with multiple lugs 12 facing the inflow direction, and the lengths of these lugs 12 on the same side are equal. On the side away from the inner frame 2, multiple frame units 111 are provided with multiple lugs 23 facing the inflow direction, and the lengths of these lugs 23 on the side away from the inner frame 2 are equal. The length of multiple loops 12 is shorter than the length of multiple loops 23. During the deployment of the stent for heart valve repair, multiple loops 12 detach from the catheter on the delivery device in advance, and then multiple loops 23 detach from the catheter on the delivery device. The inner stent 2 is used to connect to the external balloon.

[0084] Frame unit 111 adopts a rhomboid frame unit, and frame unit 111 includes an inflow-end support rod 1111 and an outflow-end support rod 1113. The two inflow-end support rods 1111 converge towards the inflow-end to form an inflow-end closed end 1112, and the two outflow-end support rods 1113 converge towards the outflow-end to form an outflow-end closed end 1114. Grid frame 11 adopts a spherical grid frame, and grid frame 11 also includes a common end 112, which includes an upper connecting part 1121 and a lower connecting part 1122. The upper connecting part 1121 connects to one end of the two inflow-end support rods 1111, and the lower connecting part 1122 connects to one end of the two outflow-end support rods 1113. Multiple frame units 111 are provided with suture holes 1, including upper suture holes 113 and lower suture holes 114. Multiple inflow end closures 1112 are provided with upper suture holes 113, and multiple outflow end closures 1114 are provided with lower suture holes 114. Multiple hanging ears 12 are provided on one side of the multiple inflow end closures 1112 facing the inflow end. Each hanging ear 12 includes a connecting arm 121 and a connecting head 122. One end of the connecting arm 121 is connected to one side of the multiple inflow end closures 1112, and the other end of the connecting arm 121 is connected to the connecting head 122. The connecting head 122 is provided with a through hole 1221. Multiple hanging ears 2 13 are provided on the other side of the multiple inflow end closures 1112 facing the inflow end. The second lug 13 includes a second connecting arm 131 and a second connecting head 132. One end of the second connecting arm 131 is connected to one of the multiple inflow end closing ends 1112 on the other side, and the other end of the second connecting arm 131 is connected to the second connecting head 132. The second connecting head 132 is provided with a through hole 1321. The outer frame 1 is also provided with barbs, including upward barbs 14 and downward barbs 15.

[0085] Multiple upward-facing barbs 14 are disposed on multiple outflow-closing ends 1114 and multiple common ends 112 in the direction of inflow, and multiple downward-facing barbs 15 are disposed on the other end of multiple common ends 112 in the direction of outflow.

[0086] Multiple upward-facing barbs 14 and multiple downward-facing barbs 15 are all bent at 30° to 60°. Frame unit two 211 adopts a rhomboid frame unit two, and frame unit two 211 includes an inflow-end support rod two 2111 and an outflow-end support rod two 2113. The two inflow-end support rods two 2111 converge towards the inflow-end to form an inflow-end closed end two 2112, and the two outflow-end support rods two 2113 converge towards the outflow-end to form an outflow-end closed end two 2114. Grid frame two 21 adopts a crescent-shaped grid frame two, and grid frame two 21 also includes a common end two 212, which includes an upper connecting part two 2121 and a lower connecting part two 2122. The upper connecting part two 2121 connects to one end of the two inflow-end support rods two 2111, and the lower connecting part two 2122 connects to one end of the two outflow-end support rods two 2113. Multiple frame units 211 are provided with suture holes 2, including upper suture holes 213 and lower suture holes 214. The upper suture hole 213 is provided on the inflow end closed end 2112, and the lower suture hole 214 is provided on the outflow end closed end 2114. The inner frame 2 also includes an upper auxiliary component 23. The upper auxiliary component 23 is provided on one end of the multiple outflow end closed ends 2114. The upper auxiliary component 23 includes a connecting rod 231 and a through hole 232. The connecting rod 231 is oriented towards the inflow end. One end of the connecting rod 231 is connected to one end of the outflow end closed end 2114, and the other end of the connecting rod 231 is connected to the through hole 232. Multiple protrusions 2311 are provided on the connecting rod 231. The inner frame 2 also includes a common end portion 22 and a lower auxiliary component 24. One end of the common end portion 22 facing the inflow direction is connected to one end of the outflow closing end portion 2114, and the other end of the common end portion 22 facing the outflow direction is connected to the lower auxiliary component 24. The lower auxiliary component 24 includes a connecting rod 241 and a through hole 242. The connecting rod 241 is positioned facing the outflow direction, with one end connected to the other end of the common end portion 22, and the other end connected to the through hole 242. The inner frame 2 also includes a clamping component 25, which includes a connecting rod 251 and a clamping end 252. The connecting rod 251 is positioned facing the outflow direction, with one end connected to the other end of the common end portion 22, and the other end connected to the clamping end 252. The clamping component 25 is a U-shaped clamping component.

[0087] Specifically, in this embodiment, such as Figure 2 As shown, the present invention includes an outer frame and an inner frame, which are connected together by stitching, or by welding or riveting. The outer frame provides stable support, while the inner frame provides auxiliary support.

[0088] Specifically, in this embodiment, such as Figure 4 As shown, the external stent is implanted on the atrial side and anchored to the mitral valve annulus.

[0089] Specifically, in this embodiment, such as Figure 4 As shown, the main body of the outer frame is composed of a single row of polygonal grids, with the grids at the inflow end converging towards the inflow end and the grids at the outflow end converging towards the outflow end.

[0090] Specifically, in this embodiment, such as Figure 4 As shown, the inflow end of the outer frame has at least two lugs, which are used to connect to the conveyor conduit during loading.

[0091] Specifically, in this embodiment, such as Figure 4 As shown, the inflow end has two groups of hanging ears with different sizes between the two groups, but the size of the hanging ears within each group is the same.

[0092] Specifically, in this embodiment, such as Figure 4 As shown, the release process is divided into two steps, releasing one set of hooks each time, specifically the set of hooks closest to the inner frame. Figure 4 Group A's ear loops are shorter than the other group's. Figure 4 Group B), therefore during the release process ( Figure 4 (Group A) First, disconnect the ear loop from the delivery tube.

[0093] That is, the lugs on the side closest to the inner frame ( Figure 4 Group A) First, the delivery catheter is disconnected to facilitate the entire stent body to expand and open as much as possible. The barbs then anchor the stent to the patient's internal physiological tissues. Subsequently, the second set of loops is released. Figure 4 (Group B), complete the release of the entire stent.

[0094] The reason for releasing all the loops in two steps instead of all at once is that the stent of this invention is made of nickel-titanium alloy. At body temperature, the nickel-titanium stent will lose its restraint and expand rapidly. If it is released all at once, the stent and the delivery tube will pop out rapidly at the moment of separation, which will cause the release process to be unstable and thus the anchoring process cannot be controlled. In other words, the stent after release cannot guarantee long-term stable positioning.

[0095] Specifically, in this embodiment, such as Figure 4 As shown, the second set of ear loops ( Figure 4 (Group B) There should be no less than 2 of them to prevent the stent from swinging with the blood flow under the impact of blood flow after the first group of loops are released. Two or more loops and the delivery device can form a triangular stable structure to maintain the stability of the stent and ensure that the released stent is stable and controllable during the anchoring process.

[0096] Specifically, in this embodiment, such as Figure 4 As shown, the second set of ear loops ( Figure 4(Group B) The number of constraints on the main grid of the outer frame should not exceed 1 / 3. For example, if the outer frame is composed of 15 grids, the range of direct constraint connection of the second group of hanging ears should not exceed 5. Otherwise, under the constraint of the second group of hanging ears, the size of the support after self-expansion will be too small, making it difficult to achieve a smooth anchoring process on the inner frame side.

[0097] Specifically, in this embodiment, such as Figure 2 and Figure 6 As shown, the external frame is equipped with a series of barbs to resist the load of blood flow impacting the stent. The main loads of blood flow impacting the stent can be categorized as follows:

[0098] During ventricular contraction and leaflet closure, the stent is expected to flip in the -RY direction, at which point it is mainly supported by the barbs in the P1 and P2 regions.

[0099] During ventricular contraction and leaflet closure, the stent is expected to move in the +Z direction, at which point it is mainly supported by the barbs in the P1 and P3 regions.

[0100] When the atrium contracts and the leaflets open, the load on the stent is minimal, and the load is borne by the stent as a whole and the barbs in the P2 region.

[0101] Specifically, in this embodiment, such as Figure 11 and Figure 14 As shown, the inner frame includes a polygonal grid portion connected to the outer frame, and an auxiliary frame portion for connecting the external balloon, wherein the grid portion is located on the atrial side and the auxiliary frame portion is located on the ventricular side.

[0102] Specifically, in this embodiment, such as Figure 11 and Figure 14 As shown, the main outline of the polygonal grid part of the inner frame is consistent with that of the outer frame after it is shaped, so that the two can fit together perfectly and be constrained together.

[0103] Specifically, in this embodiment, such as Figure 11 and Figure 14 As shown, the polygonal grid section of the inner frame has stitching holes at the inflow and outflow ends for positioning and connection with the outer frame.

[0104] Specifically, in this embodiment, such as Figure 11 and Figure 14 As shown, the auxiliary frame part of the inner frame includes an upper auxiliary component and a lower auxiliary component. The upper auxiliary component is used for connecting and fixing the upper part of the balloon body, and the lower auxiliary component is used to pass through the balloon body and connect and fix the lower part of the balloon body.

[0105] In addition, the free end of the lower accessory is a leaflet clamping structure with a multi-bend linkage structure, which increases the clamping area with the original leaflet and improves clamping stability. The ends of the rods are bent in the thickness direction, which can reduce the impact damage to the original leaflet during the swinging process of the blood flow impact structure. Furthermore, the free end of the lower accessory is coated, which can further reduce damage to the leaflet.

[0106] Specifically, in this embodiment, such as Figure 11 and Figure 14 As shown, the upper and lower auxiliary components of the inner frame have multi-segment corrugated structures to prevent the balloon sutures from slipping on the rods, increasing the stability of the balloon and avoiding suture wear and breakage caused by repeated slippage on the rods. In addition, multiple suture holes on the outer and inner frames also ensure the reliability of the connection between the support and the balloon.

[0107] Working principle:

[0108] This invention achieves distributed release by incorporating two sets of hooks with varying sizes at the top of the outer stent. The relative triangular stabilizing structure of these hooks and the stent body enhances the stability of the stent's release and anchoring process. Multiple sets of barbs located in different directions and positions can withstand the impact of loads on the stent body under various conditions, ensuring stable and reliable anchoring at the intended position. Multiple suture holes and through-holes on the inner stent, through which sutures pass and connect to the outer stent, further improve the overall connection stability and reliability of the stent.

[0109] In the description of this application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0110] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A stent for heart valve repair, characterized in that, It includes an outer frame (1) and an inner frame (2), the inner frame (2) being connected to the inside of the outer frame (1), and the outer frame (1) and the inner frame (2) being connected separately; The outer frame (1) includes a first grid frame (11), which is composed of multiple first frame units (111). The inner frame (2) includes a second grid frame (21), which is composed of multiple second frame units (211). Multiple frame units (111) are provided with lugs facing the inflow end (3), and the stent for heart valve repair is connected to the delivery device through the multiple lugs during loading; The hanging ears include hanging ear one (12) and hanging ear two (13). Multiple frame units one (111) located on the same circumferential side as the inner frame (2) are provided with multiple hanging ears one (12) in the direction of the inflow end (3), and the lengths of multiple hanging ears one (12) on the same side as the inner frame (2) are equal. On the side away from the inner frame (2), a plurality of frame units 1 (111) are provided with a plurality of hanging ears 2 (13) in the direction of the inflow end (3), and the lengths of the plurality of hanging ears 2 (13) on the side away from the inner frame (2) are equal; Furthermore, the length of each of the first (12) loops is less than the length of each of the second (13) loops. During the release process of the stent for heart valve repair, after the first (12) loops are detached from the catheter on the delivery device in advance, the second (13) loops are then detached from the catheter on the delivery device. The inner frame (2) is used to connect the external balloon body.

2. The stent for heart valve repair according to claim 1, characterized in that, The frame unit one (111) includes a rhomboid frame unit one, and the frame unit one (111) includes an inflow direction support rod one (1111) and an outflow direction support rod one (1113); The two inflow end direction support rods (1111) are joined together in the direction of inflow end (3) to form inflow end closed end (1112), and the two outflow end direction support rods (1113) are joined together in the direction of outflow end (4) to form outflow end closed end (1114).

3. The stent for heart valve repair according to claim 2, characterized in that, The first grid frame (11) includes a spherical grid frame, and the first grid frame (11) also includes a common end (112), the common end (112) including an upper connecting part (1121) and a lower connecting part (1122); The upper connecting part (1121) connects to one end of the two inflow direction support rods (1111), and the lower connecting part (1122) connects to one end of the two outflow direction support rods (1113).

4. The stent for heart valve repair according to claim 3, characterized in that, A suture hole is provided on a plurality of the frame units (111), the suture hole includes an upper suture hole (113) and a lower suture hole (114), and an upper suture hole (113) is provided on a plurality of the inflow end closed ends (1112), and a lower suture hole (114) is provided on a plurality of the outflow end closed ends (1114).

5. The stent for heart valve repair according to claim 4, characterized in that, On one side, multiple inflow end closing ends (1112) are provided with multiple hanging ears (12) in the direction of inflow end (3); The first hanging ear (12) includes a first connecting arm (121) and a first connecting head (122). One end of the first connecting arm (121) is connected to one of the multiple inflow end closing ends (1112) on one side, and the other end of the first connecting arm (121) is connected to the first connecting head (122). A through hole (1221) is provided on the first connecting head (122). On the other side, multiple inflow end closures (1112) are provided with multiple hanging ears (13) in the direction of inflow end (3); The second hanging ear (13) includes a second connecting arm (131) and a second connecting head (132). One end of the second connecting arm (131) is connected to one of the multiple inflow end closing ends (1112) on the other side, and the other end of the second connecting arm (131) is connected to the second connecting head (132). The second connecting head (132) is provided with a second through hole (1321).

6. The stent for heart valve repair according to claim 5, characterized in that, The outer frame (1) is also provided with barbs, the barbs including upward barbs (14) and downward barbs (15); Multiple upward barbs (14) are disposed on one end of multiple outflow closed end (1114) and one end of multiple common end (112) in the direction of inflow end (3), and multiple downward barbs (15) are disposed on the other end of multiple common end (112) in the direction of outflow end (4); Furthermore, the multiple upward barbs (14) and the multiple downward barbs (15) are all bent at 30° to 60°.

7. The stent for heart valve repair according to claim 1, characterized in that, The second frame unit (211) includes a rhomboid frame unit, and the second frame unit (211) includes a support rod (2111) in the inflow direction and a support rod (2113) in the outflow direction. The two inflow end support rods (2111) are joined together in the direction of inflow end (3) to form inflow end closed end two (2112), and the two outflow end support rods (2113) are joined together in the direction of outflow end (4) to form outflow end closed end two (2114).

8. The stent for heart valve repair according to claim 7, characterized in that, The second grid frame (21) includes a crescent-shaped grid frame, and the second grid frame (21) also includes a common end portion (212), which includes an upper connecting portion (2121) and a lower connecting portion (2122). The upper connecting part 2 (2121) is connected to one end of the two inflow direction support rods 2 (2111), and the lower connecting part 2 (2122) is connected to one end of the two outflow direction support rods 2 (2113).

9. The stent for heart valve repair according to claim 8, characterized in that, The frame unit 2 (211) is provided with suture holes 2, the suture holes 2 include upper suture holes 2 (213) and lower suture holes 2 (214), and the inflow end closed end 2 (2112) is provided with upper suture holes 2 (213), and the outflow end closed end 2 (2114) is provided with lower suture holes 2 (214).

10. The stent for heart valve repair according to claim 9, characterized in that, The inner frame (2) also includes an upper auxiliary component (23), which is provided on one end of one of the multiple outlet end closing ends (2114). The upper auxiliary component (23) includes a connecting rod (231) and a through hole (232). The connecting rod (231) is arranged in the direction of the inflow end (3). One end of the connecting rod (231) is connected to one end of the outflow end closed end (2114), and the other end of the connecting rod (231) is connected to the through hole (232). A plurality of protrusions (2311) are provided on the connecting rod (231).

11. The stent for heart valve repair according to claim 10, characterized in that, The inner frame (2) also includes a common end three (22) and a lower auxiliary component (24). One end of the common end three (22) facing the inflow end (3) is connected to one end of the outflow end closed end two (2114), and the other end of the common end three (22) facing the outflow end (4) is connected to the lower auxiliary component (24). The lower auxiliary component (24) includes a connecting rod two (241) and a through hole four (242). The connecting rod two (241) is arranged in the direction of the outflow end (4). One end of the connecting rod two (241) is connected to the other end of the common end three (22), and the other end of the connecting rod two (241) is connected to the through hole four (242).

12. The stent for heart valve repair according to claim 11, characterized in that, The inner frame (2) also includes a clamping member (25), which includes a connecting rod (251) and a clamping end (252); The connecting rod three (251) is arranged in the direction of the outflow end (4), one end of the connecting rod three (251) is connected to the other end of the common end three (22), and the other end of the connecting rod three (251) is connected to the clamping end (252), and the clamping member (25) includes a U-shaped clamping member.

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