Heart valve repair clip

Abstract

The present invention discloses a heart valve repair clip, comprising: an outer clip having a pair of outer arms extending symmetrically from a proximal end toward a distal end, and a pair of clips connected to the inner proximal ends of the outer arms; an inner clip positioned between the pair of outer arms, the inner clip having a pair of inner arms extending symmetrically from a distal end toward a proximal end, the proximal ends of the inner arms pivotally connected to the proximal ends of the corresponding outer arms; the side surfaces of the inner arms are arcuate, so that the side surfaces of the symmetrical pair of inner arms form a quasi-elliptical shape. The present invention provides an elliptical inner clip that matches the valve's outer shape, reducing damage to the valve; and by forming the outer arms and clips into an integral structure, the overall structure of the clip can be simplified.

Description

Technical Field

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

[0002] For mitral and tricuspid valve regurgitation, the commonly used interventional treatment method is edge-to-edge repair, which forms two small holes when the heart expands to reduce the distance between the valve leaflets and minimize the occurrence of regurgitation during the heart's contraction period.

[0003] Among the current interventional treatment methods, edge-to-edge repair mainly includes transapical and transfemoral methods. Although the transfemoral method can minimize the damage to the patient, due to its complex path and small diameter of the femoral vein, it has high requirements for product precision and compression performance. Therefore, the structure of the repairer and conveyor is relatively complex and the cost is high, which to a certain extent limits its promotion and use.

[0004] However, some existing valve repair devices require considerable effort to pull back and tighten, which can easily damage the device. In severe cases, they can generate a large amount of debris or particles, which can remain in the patient's body and flow through the bloodstream, clogging blood vessels and causing other complications. While other repair devices address the difficulty of pulling back, they are complex in structure, making the procedures cumbersome for medical workers, increasing surgical time, and making medical accidents more likely to occur. Furthermore, the internal clips of existing valve repair devices are all flat. Once the heart valve is clamped into the repair clamp, the flat internal clip does not fit the shape of the valve itself, making it easy to damage the valve. Summary of the Invention

[0005] The present invention addresses the technical problem of the flat inner clip of existing valve repair clips. Once a heart valve is inserted into the clip, the flat inner clip does not conform to the valve's shape, easily damaging the valve. The present invention provides a new heart valve repair clip. By designing the inner clip's arms into an arc, the two opposing arc-shaped inner clip arms form an elliptical inner clip. This elliptical inner clip conforms to the valve's shape, minimizing damage to the valve.

[0006] The heart valve repair clip of the present invention has:

[0007] An outer clamp having a pair of outer clamp arms symmetrically extending from the proximal end to the distal end and a pair of clips respectively connected to the inner proximal ends of the outer clamp arms;

[0008] an inner clamp located between the pair of outer clamp arms, the inner clamp having a pair of inner clamp arms symmetrically extending from a distal end toward a proximal end, the proximal ends of the inner clamp arms being pivotally connected to the proximal ends of the corresponding outer clamp arms;

[0009] Wherein, in the natural clamping state, the side surface of the inner clamping arm is arc-shaped, so that the side surfaces of the symmetrical pair of inner clamping arms form an elliptical shape;

[0010] In the open state, the inner clamping arms are pulled into an approximately straight state, so that the side surfaces of the pair of symmetrical inner clamping arms form an inverted U shape;

[0011] In the retracted state, the proximal section of the inner clamp arm is squeezed by the outer clamp arm into an approximately straight line, so that the proximal side surfaces of the symmetrical pair of inner clamp arms form parallel lines close to each other; the distance between the distal sections of the pair of inner clamp arms is smaller than the distance between them in the natural clamping state.

[0012] The ratio of the minor axis to the major axis of the elliptical shape is 4 to 8:10.

[0013] Preferably, the distal end of the inner clip is a thickened end, and the thickness of the thickened end is 5~20:1 to the thickness of the inner clip arm. The inner clip arm has a transition section that is integrally connected to the proximal end surface of the thickened end and gradually becomes thinner from the distal end to the proximal end, and a uniform section connected to the transition section.

[0014] Preferably, the connection between the clip and the outer clamp arm is a proximal corner; the proximal end of the inner clamp arm is pivotally connected to the proximal corner.

[0015] Preferably, the heart valve repair clip further comprises:

[0016] A connecting shaft is provided, and the connecting shaft is simultaneously passed through the proximal end of the inner clamping arm and the proximal end bend.

[0017] Preferably, the proximal end of the inner clamp arm has an axle seat, the axle seat has an axle hole, and the connecting shaft is inserted into the axle hole.

[0018] Preferably, the inner center of the thickened end has a core hole for the core rod to pass through.

[0019] Preferably,

[0020] The outer clamp arm is integrally connected to the clip. In the case where the outer clamp arm and the clip are integrally formed, the clip as a part of the outer clamp arm is opened and closed naturally.

[0021] Preferably,

[0022] The outer clamping arm has an outer arm and an inner arm, and the outer arm is a bent long sheet from the proximal end to the distal end;

[0023] The inner arm is integrally bent and extends from the distal end of the outer arm to the proximal end, and the inner arm is substantially parallel to the outer arm;

[0024] The clip is bent again and extends from the proximal end of the inner arm to the distal end, and the distal end of the clip is close to the distal end of the inner arm.

[0025] Preferably, the distal end of the clip abuts against the distal end of the inner arm.

[0026] Preferably,

[0027] The outer arm comprises, from the distal end to the proximal end, an outer arm distal section with a first slope, an outer arm middle section with a second slope, and an outer arm proximal section with a third slope;

[0028] The inner arm comprises, from the distal end to the proximal end, an inner arm distal section having the first slope and an inner arm proximal section having the second slope;

[0029] The first slope is greater than the second slope, and the third slope is greater than the second slope.

[0030] Preferably,

[0031] The clip has a fourth slope that is between the first slope and the second slope.

[0032] Preferably, the clip has a clamping thorn on a side facing away from the outer clamping arm, and the leaflet is clamped by the clip and the inner clamping arm.

[0033] Preferably, the clip has a clamping thorn on a side facing the outer clamping arm, and the leaflet is clamped by the clip and the outer clamping arm.

[0034] Preferably, the distal end of the clip is provided with a protrusion which is wider at the distal end and narrower at the proximal end, and the inner clip is provided with a hollow groove which is narrower at the distal end and wider at the proximal end, and the protrusion can pass through the proximal end of the hollow groove.

[0035] Preferably, the clamping barbs are serrated.

[0036] Preferably,

[0037] The integral connection between the inner arm and the clip has a proximal corner, and a connecting shaft is passed through the proximal corner.

[0038] Preferably,

[0039] The outer side wall is connected to the inner side wall via a distal bend, and / or

[0040] The inner side wall is connected to the clip through the proximal corner.

[0041] Preferably,

[0042] The elasticity of the distal bend is greater than the elasticity of the inner side wall, so that the clamp can be folded to a smaller width when folded, and can be opened to a larger angle when opened.

[0043] Preferably, the heart valve repair clip further comprises:

[0044] A receiving structure is hollow inside and is connected to the proximal end of the outer clip, so that the outer clip and the inner clip can be received together inside.

[0045] Preferably, the storage structure has:

[0046] An N-sided base having N foldable side walls, wherein the distal end of the base integrally extends outwardly from an outer clamping arm of the outer clamp;

[0047] A support base, the support base having a proximal base and a distal base fixed to the distal end surface of the proximal base, the distal base having an N-gonal distal inner cavity, the foldable side wall of the base being inserted into the distal inner cavity of the distal base;

[0048] A sleeve having a receiving cavity therein, wherein the support seat is detachably connected to the receiving cavity of the sleeve via the proximal seat;

[0049] Wherein, N is a positive integer ≥ 3.

[0050] Preferably,

[0051] The proximal end of the foldable side wall of the base is provided with a buckle;

[0052] The proximal end of the distal seat of the support seat has a corresponding clamping hole;

[0053] The base is inserted into the support seat by snapping the snaps of the foldable side walls into the snap holes of the distal seat.

[0054] Preferably,

[0055] The inner surfaces of the distal inner cavity of the support seat are respectively provided with guide grooves leading to the clamping holes, providing a passage for the clamping buckle to be inserted into the clamping hole.

[0056] Preferably, the side edges of the foldable side walls have:

[0057] A connecting edge is located at a distal end of the side edge of the foldable side wall, and two adjacent foldable side walls are fixedly connected together by the respective connecting edges;

[0058] The non-connecting edge is located near the side of the foldable side wall, and an openable and closable gap is provided between the non-connecting edges of two adjacent foldable side walls.

[0059] Preferably,

[0060] The outer wall of the proximal portion of the support seat has a support external thread;

[0061] The proximal section of the sleeve receiving cavity is a fixed cavity, and the inner wall of the fixed cavity has an internal thread for a support;

[0062] The external thread of the support of the near-section seat is matched with the internal thread of the support in the sleeve, so that the support seat is detachably connected to the storage cavity of the sleeve.

[0063] Preferably, the distal section of the sleeve receiving cavity is a gradually enlarging gradient cavity, and the gradient cavity is used to accommodate a heart valve repair clip.

[0064] Preferably, the sleeve further has an annular cavity, the inner wall of the annular cavity has a conveying internal thread that can cooperate with the conveyor; the thread direction of the conveying internal thread is opposite to the thread direction of the internal thread of the support.

[0065] Preferably, the annular cavity sleeve is located outside the receiving cavity to reduce the length of the sleeve.

[0066] Preferably, the proximal section of the fixed cavity of the sleeve is a conveying cavity, the inner wall of the conveying cavity has an internal conveying thread, and the thread direction of the internal conveying thread is opposite to that of the external thread of the support.

[0067] Preferably,

[0068] The interior of the base is formed from the distal end to the proximal end along the axial direction, with a base hole and a base cavity being interconnected and capable of inserting a central core rod;

[0069] The interior of the support seat is axially connected from the distal end to the proximal end, and is formed by a distal inner cavity and a proximal through hole for inserting the core rod.

[0070] Wherein, the base cavity occupies all or part of the space of the distal segment inner cavity.

[0071] Preferably,

[0072] The inner diameter of the middle portion of the proximal through hole is consistent with the outer diameter of the core rod;

[0073] The inner diameters of both ends of the near-section through hole gradually increase.

[0074] Preferably, the base hole is a stepped hole with an inclined distal end surface.

[0075] The positive progress effect of the present invention is:

[0076] 1) The present invention provides an elliptical inner clip to match the valve shape, thereby reducing damage to the valve;

[0077] 2) The present invention provides a thickened end and an inner clip arm transition section at the distal end of the inner clip, thereby effectively stabilizing the elliptical shape of the inner clip and preventing the inner clip from being stretched and causing damage to the atrium;

[0078] 3) By forming the outer clamping arm and the clip into an integrally formed structure, the present invention simplifies the structure of the entire clamp and eliminates the need for redundant pull wires for pulling the clip. Furthermore, the integrally formed outer clamping arm and clip have a simple structure and are easy to manufacture, eliminating the risk of the clamp separating during subsequent use.

[0079] 4) The present invention provides a novel retractable structure that can well accommodate the inner and outer clips and reduce the volume of the retractable structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Figure 1 Schematic diagram of the three-dimensional structure of the heart valve repair clip of the present invention;

[0081] Figure 2A Schematic diagram of the three-dimensional structure of the inner clip 10 of the present invention;

[0082] Figure 2B is a schematic diagram of the three-dimensional structure of the inner clip 10 of the present invention from another angle;

[0083] Figure 3A This is a schematic side view of the structure of the heart valve repair clip of the present invention when it is expanded;

[0084] Figure 3B for Figure 3A A partial structural enlarged schematic diagram;

[0085] Figure 3C FIG1 is a schematic side view of the heart valve repair clip of the present invention when it is folded;

[0086] Figure 3D This is a side structural diagram of the heart valve repair clip of the present invention clamping the valve;

[0087] Figure 4A Schematic diagram of the three-dimensional structure of the heart valve repair clip base 31 of the present invention;

[0088] Figure 4B Schematic diagram of the three-dimensional structure of the heart valve repair clip support 32 of the present invention;

[0089] Figure 4C Schematic diagram of the cross-sectional structure of the heart valve repair clip support 32 of the present invention;

[0090] Figure 4D Schematic diagram of the cross-sectional structure of the heart valve repair clip sleeve 33 of the present invention;

[0091] Figure 4E FIG1 is a schematic diagram of the three-dimensional structure of a heart valve repair clip sleeve 33 according to another example of the present invention;

[0092] Figure 4F for Figure 4E Schematic diagram of the cross-section structure;

[0093] Figures 5A-5C Schematic diagram of the three-dimensional structure of the clip 22 and the inner clip arm 12 of another example of the heart valve repair clip of the present invention; DETAILED DESCRIPTION

[0094] The following describes the embodiments of the present invention through specific examples. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different viewpoints and applications without departing from the spirit of the present invention.

[0095] It should be noted that the terms "distal end," "proximal end," "distal section," and "proximal section" used in this invention are directional terms commonly used in the field of interventional medical devices. "Distal end" and "distal section" refer to the end away from the operator during surgery, while "proximal end" and "proximal section" refer to the end closer to the operator during surgery. "Axial" and "axis" refer to the direction of the line connecting the distal and proximal ends of the clamp. The slope described in this invention is based on a coordinate system with the clamp axis as the Y-axis and the axis perpendicular to the axis as the X-axis. The slope is the tangent of the angle between the tangent of the extended line and the X-axis.

[0096] like Figure 1 As shown, the heart valve repair clip of the present invention comprises an inner clip 10 , an outer clip 20 , a receiving structure 30 , and a connecting shaft 40 connecting the inner clip 10 and the outer clip 20 .

[0097] The inner clip of the present invention can be any inner clip of the valve repair clip in the prior art. Figures 2A and 2BAs shown, to better protect the valve 80 from damage, the inner clip 10 provided in this example has a distal end. This distal end can be similar to the distal end structure in the prior art. A preferred embodiment is to thicken the distal end block to form a thickened end 11, which is generally rectangular. A core hole 111 is defined at the inner center of thickened end 11 for the core rod 90 to pass through, but does not extend through the entire thickened end 11. A pair of inner clip arms 12 extend integrally from the distal end of the clip, i.e., thickened end 11, to the proximal end. Specifically, in the naturally clamped state, the inner clamp arm 12 extends as follows: Starting from the proximal surface of the rectangular thickened end 11, a pair of gradually thinning transition sections 121 of the inner clamp arm 12 are slowly extended in a mirror-symmetrical manner. The spacing between the transition sections of the inner clamp arm 12 gradually increases during the extension process, and the thickness of the inner clamp arm 12 gradually decreases from the distal end to the proximal end, eventually gradually changing to the thickness of the uniform section of the inner clamp arm 12. At this point, the axial length of the transition section of the inner clamp arm 12 is roughly equivalent to the thickness of the thickened end 11. Of course, the axial length of the transition section of the inner clamp arm 12 can also be greater or less than the thickness of the thickened end 11 without affecting the purpose of the present invention. The pair of inner clamp arms 12 then continue to extend toward the proximal end in a uniform thickness manner, and the spacing between them further gradually increases, but at a slower rate, until the tangent direction of the pair of inner clamp arms 12 is parallel to the axial direction of the inner clamp 10. At this point, the spacing between the inner arms 12 reaches a maximum value, B. This maximum spacing, or the ratio of the minor axis to the major axis of the inner clamp 10, is approximately 4 to 8:10. The inner arms 12 have now extended approximately halfway. The inner arms 12 then continue to extend toward the proximal end, but the spacing between them gradually decreases, mirroring the previous increase, until the spacing between the inner arms 12 roughly matches the length of the thickened end 11. Of course, it can also be slightly greater or less than the length of the thickened end 11 without affecting the purpose of the present invention. From the end of the transition section, the thickness of the inner arms 12 remains constant throughout the second half of their extension until they reach the proximal end of the inner clamp 10. This section is referred to as the uniform section 122. At this point, a slightly thicker axle seat 13, with an axle hole 14, begins to extend from the proximal midsection of the inner arms 12. The connecting shaft 40 pivotally extends through the shaft hole 14. The resulting inner clamp arm 12 has an arcuate side profile. The entire inner clamp 10 is symmetrical, with its side profile roughly elliptical, with the minor axis to major axis ratio being approximately 4-8:10. The resulting thickness ratio of the thickened end 11 of the inner clamp 10 to the thickness of the inner clamp arm 12 is approximately 5-20:1. Of course, these ratios are not strictly limited to this range; inner clamps with elliptical side profiles of other ratios can also achieve the objectives of the present invention.In this example, the distal end is thickened to form a thickened end 11 and a transition section for the inner clamp arms 12. This ensures that the inner clamp 10 maintains a relatively complete, elliptical shape during expansion, preventing it from being stretched into a completely parallel, elongated strip due to excessive thinness, thus preventing it from mismatching with the shape of the valve 80. Furthermore, the thickened distal end prevents the inner clamp 10 from being stretched excessively during expansion, which could cause the distal end of the inner clamp to contact the inner atrial wall and cause damage. When the core rod 90 is pushed distally, the proximal ends of the inner clamp arms 12 move in an arc toward the distal end. Driven by the core rod 90, the inner clamp arms 12 are gradually pulled into a nearly straight position, forming the side surfaces of the symmetrical pair of inner clamp arms 12 into an inverted U-shape. The proximal ends of the inner clamp arms 12 exert a force toward the outer arms 21, causing the distal ends of the outer arms 21 to move in an arc under this force, gradually opening the heart valve clip.

[0098] In the retracted state, the proximal portion of the inner clamp arm 12 is squeezed by the outer clamp arm 21 into an approximately straight state, so that the proximal side surfaces of the symmetrical pair of inner clamp arms 12 form parallel lines that are close to each other, and the distance between the distal sections is smaller than the distance between them in the natural clamping state. At this time, the side surfaces of the retracted pair of inner clamp arms 12 form an inverted vase shape.

[0099] The outer clip of the present invention can be any of the outer clips of the prior art valve repair clips. However, the structure of the outer clip itself is relatively complex, and the outer clip arm and the clip are assembled from parts. The clip requires a separate pull line to open and close, which further increases the complexity of the structure. Figures 3A to 3D As shown, this example also provides an outer clip 20 with a generally curved shape to adapt to the shape of the inner clip 10 so as to match the shape of the inner clip 10 and to well wrap and fit the inner clip 10 during the process of opening and closing the clip.

[0100] The outer clamp 20 in this example comprises a pair of integrally formed outer arms 21 and a pair of clips 22. The inner clamp 10 is positioned between these outer arms 21. The outer arms 21 further comprise an integrally formed outer arm 211 and inner arm 212. The outer clamp 20 extends from the proximal end of the clamp toward the distal end. Specifically, the proximal end of the clamp has a base 31, which is generally square in shape. The outer arm 211 is generally in the shape of a long bent sheet, and the extension process is as follows: starting from the two opposite sides of the distal end surface of the base 31, a pair of outer arm proximal sections 211a are symmetrically extended toward the distal end at a third slope. Of course, the third slope itself can also change slightly during the extension process of the outer arm proximal sections 211a, but the change range is not large; then, a pair of outer arm middle sections 211b are symmetrically extended toward the distal end at a second slope. The second slope itself can also change slightly during the extension process of the outer arm middle sections 211b, but the change radius is not large, and the second slope has a relatively substantial change relative to the third slope, and the absolute value of the third slope is greater than the absolute value of the second slope; then, a pair of outer arm distal sections 211c are symmetrically extended toward the distal end at the first slope. The first slope itself can also change slightly during the extension process of the outer arm distal sections 211c, but the change range is also not large, and the first slope has a relatively substantial change relative to the second slope, and the absolute value of the first slope is greater than the absolute value of the second slope. In this way, the extension process of the outer arm 211 is finally completed. It can be seen that the extension direction of the outer arm 211 is generally from the proximal end to the distal end. However, during the extension process, the extension direction is always away from the axis of the clamp, but it is always extended in an axis-symmetrical manner.

[0101] The inner arm 212 is also generally in the shape of a long, bent sheet, extending proximally from the distal end of the outer arm 211, approximately parallel to the outer arm 211. The extension stroke of the inner arm 212 is as follows: the distal end of the outer arm 211 bends approximately 180° inward, i.e., toward the clamp axis, and then extends into the inner arm 212's own extension direction, approximately antiparallel to the outer arm 211. This also means that the distal end of the inner arm 212 extends from the bent distal end of the outer arm 211, forming a bend angle 213. The outer wall 211 and the inner wall 212 are connected by the distal bend angle 213. The inner arm 212 then extends proximally at a first slope to form an inner arm distal segment 212a. The first slope of the inner arm 212 is the same as the first slope of the outer arm 211, and the extension stroke is also the same, thus ensuring that the inner arm 212 and the outer arm 211 are parallel. The inner arm proximal section 212b then continues to extend proximally at a second slope. Similarly, the second slope of the inner arm 212 is the same as the second slope of the outer arm 211, and the stroke is also the same. This completes the extension of the inner arm 212, eliminating the need for a third slope. Therefore, the inner arm 212 is shorter than the outer arm 211. At this point, the proximal end of the inner arm 212 is close to the center axis of the clamp. The elasticity of the distal bend is greater than that of the inner sidewall 212, allowing the clamp to be retracted to a smaller width and opened to a wider angle.

[0102] The clip 22 is used to capture the heart valve and is integrally formed with the outer arm 21. The clip 22 extends distally from the proximal end of the inner arm 212 of the outer arm 21. The specific process is as follows: The proximal end of the inner arm 212 bends approximately 180° toward the distal end and extends until it reaches a direction generally antiparallel to the inner arm 212. This forms the proximal end of the clip 22, meaning that the proximal end of the clip 22 bends and extends from the proximal end of the inner arm 212. The angle formed at this bend is the proximal bend 221. The inner sidewall 212 and the clip 22 are connected by the proximal bend 221. The clip 22 then continues distally extending at a fourth slope until it abuts the distal end of the inner arm 212. Alternatively, it may simply abut the distal end of the inner arm 212. The absolute value of this fourth slope can be between the absolute values of the first and second slopes, thereby forming the clip 22. The side of the clip 22, in this embodiment, facing away from the outer arm 21, also features serrated engaging spikes 222. These spikes increase friction between the clip 22 and the inner arm 12, preventing the leaflets from escaping after clamping. As can be seen from the structure described above, because the outer wall 211 and inner arm 212 of the outer arm 21, as well as the clip 22, are all formed from a single, integral piece of the same material, they move as a whole during the opening and closing of the clip. Unlike conventional outer clips, where the outer arm and clip cannot move as a whole, this is not the case.

[0103] As previously mentioned, the proximal end of the clip 22 and the proximal bend of the inner arm 212 form a proximal bend 221. A hole is also dug in the middle of the proximal bend 221, which matches the shaft seat 13 at the proximal end of the inner clamp arm 12. The connecting shaft 40 is also pivotally inserted into the proximal bend 221. Thus, the middle of the connecting shaft 40 is provided with the shaft hole 14 of the shaft seat 13, and the two sides of the proximal bend 221 are pivotally inserted into the two ends. When the two inner clamp arms 12 of the inner clamp 10 are opened or closed, they naturally drive the connecting shaft 40 to move. The outer clamp 20 is also inserted into the connecting shaft 40, and naturally drives the outer clamp arm 21 and the clip 22 of the outer clamp 20 to open and close synchronously. Therefore, no additional pull wire is required to pull the clamp to open and close, greatly simplifying the structure.

[0104] The present invention also has a storage structure, which can be a storage structure in the prior art. However, this example provides another storage structure 30, which is hollow inside and connected to the proximal end of the outer clip 20, so that the outer clip 20 and the inner clip 10 can be stored inside.

[0105] like Figures 4A to 4D As shown, the storage structure 30 has a base 31, a support seat 32 and a sleeve 33. The base 31 is an N-gon, where N is a positive integer greater than or equal to 3, such as a triangle, a quadrilateral, a pentagon, or a hexagon. The figure shows a quadrilateral base 31. The outer clamp arms 21 of the outer clamp 20 in the aforementioned example are integrally extended from both sides of the distal surface of the base 31. The interior of the base 31 is provided with a base hole 313 and a base cavity 314 that are interconnected from the distal end to the proximal end along the axial direction, into which the core rod 90 can be inserted. The base hole 313 is a stepped hole with an inclined distal end. The proximal end of the base 31 has N retractable side arms 311. The side of the retractable side wall 311 is divided into a connecting edge 311a and a non-connecting edge 311b. The connecting edge 311a is located at the distal end of the side of the retractable side wall, and the two adjacent retractable side walls 311 are fixedly connected together by their respective connecting edges 311a. The non-connecting edges 311b are located near the sides of the collapsible side walls 311. A gap, which can be opened and closed, exists between the non-connecting edges 311b of two adjacent collapsible side walls 311. Due to the existence of the gap, the two adjacent collapsible side walls 311 are not completely connected. This gap between the non-connecting edges 311b allows room for the base 31 to be inserted into the support base 32, allowing it to squeeze into the inner cavity of the support base 32. Each collapsible side wall 311 of the base 31 has a latch 312 at its proximal end. The latch 312 can be locked into the latch hole of the support base 32 to prevent the base 31 from being pulled out in the opposite direction.

[0106] The support base 32 comprises a proximal seat 321 and a distal seat 322 fixed to the distal end of the proximal seat 321. The distal seat 322 comprises an N-shaped distal cavity, and the retractable side arms 311 of the base 31 are inserted into the distal cavity of the distal seat 322. The proximal end of the distal seat 322 of the support base 32 comprises a corresponding latching hole 323; the latch 312 of the retractable side wall 311 is latched into the latching hole 323 of the distal seat 322, allowing the base 31 to be inserted into the support base 32. The inner surface of the distal cavity of the support base 32 comprises guide grooves 324 leading to the latching holes 323, providing a passage for the latch 312 to be inserted into the latching holes 323. The outer wall of the proximal seat 321 of the support base 32 comprises a support external thread 325, which can be threadedly connected to the sleeve 33. The interior of the support seat 32 is composed of a distal inner cavity 326 and a proximal through hole 327 for inserting the core rod 90, which are interconnected from the distal end to the proximal end along the axial direction. The base 31 is inserted into the distal inner cavity 326 of the distal seat 322, so that the base cavity 314 of the base 31 occupies all or part of the space of the distal inner cavity 326. The inner diameter of the middle part of the proximal through hole 327 is the same as or slightly larger than the outer diameter of the core rod 90, and the inner diameters of the two ends of the proximal through hole 327 gradually increase. When the core rod 90 is inserted into the proximal through hole 327, since the inner diameter of the middle part of the proximal through hole 327 is smaller, it is roughly the same as the outer diameter of the core rod 90. In this way, the middle part can provide appropriate support to the core rod 90, thereby increasing the stability of the core rod 90 during the insertion process. The larger inner diameters at both ends make it easier to insert and withdraw the core rod 90.

[0107] The sleeve 33 has a receiving cavity within it, and the support seat 32 is removably connected to the sleeve's receiving cavity via a proximal seat 321. The proximal portion of the sleeve's receiving cavity is a fixed cavity 331. The inner wall of the fixed cavity 331 has a support internal thread 332, and the inner diameter of the fixed cavity 331 remains fixed. The support internal thread 332 of the sleeve 33 is threadedly engaged with the support external thread 325 of the support seat 32, thereby removably connecting the proximal seat 321 of the support seat 32 to the fixed cavity 331. The distal portion of the sleeve 33's receiving cavity is a gradually increasing cavity 333, which is used to accommodate the inner clip 10 and outer clip 20 of the heart valve repair clip. The sleeve 33 also has an annular cavity 334, the inner wall of which has a delivery internal thread 335 that mates with a delivery device. The delivery internal thread 335 has an opposite thread direction to the support internal thread 332. A better design is that the annular cavity 334 is located outside the receiving cavity to reduce the length of the sleeve, thereby reducing the volume of the total clamp. Figures 4E-4F As shown, this example provides another type of thread. The proximal portion of the fixed lumen 331 of the sleeve 33 is a delivery lumen 3311. The inner wall of the delivery lumen 3311 has an internal delivery thread 335. The thread direction of the internal delivery thread 335 is opposite to that of the support external thread 332. The internal delivery thread 335 can be threadedly connected to the distal end of the delivery device for delivering the clip into the heart.

[0108] The working principle of the heart valve repair clip of the present invention is as follows:

[0109] In the natural state of the heart valve repair clip of the present invention, the outer clip 20 is wrapped around the inner clip 10 and stored in the storage structure 30. The core rod 90 is inserted into the sleeve 33 and passes through the proximal through-hole 327 of the support base 32, the base cavity 314 of the base 31, and the base hole 313. The distal end of the core rod 90 ultimately reaches the central hole 111 of the thickened end 11 of the inner clip 10. Further force is applied to the core rod 90. Since the central hole 111 is not completely penetrated, the inner clip 10 can be pushed out of the storage structure 30. Since the inner and outer clips 10 and 20 are connected, the outer clip 20 is also simultaneously pulled out. Before the inner and outer clips 10 and 20 are fully released from the storage structure 30, the outer clip 10 maintains a quasi-elliptical shape due to the space constraints of the gradual cavity 333 of the sleeve 33. After being completely pushed out of the gradient cavity 333, the inner clamp 10 continues to push against the core rod 90 because it is not subject to any constraints. The pair of curved inner clamp arms 12 of the inner clamp 10 will be slightly straightened due to the thrust. However, due to the presence of the thickened end 11 and the transition section at the distal end of the inner clamp arms 12, the two inner clamp arms 12 will not be pulled into a parallel straight state, and a certain distance between the two inner clamp arms 12 will still be retained. The connecting shaft 40 at the proximal end of the inner clamp arm 12 will also be driven to move toward the distal ends, and the outer clamp 20 will also be opened synchronously. Similarly, the integrally formed clip 22 will follow the outer clamp arm 21 to open, eliminating the need for additional pull wires to open the clip.

[0110] At this point, the heart valve 80 slowly enters the periphery of the inner clamp arm 12, and the core rod 90 is then pulled back, causing the inner clamp 10 to return to a substantially elliptical shape. This also simultaneously drives the clip 22 and the outer clamp arm 21 to capture the valve 80 between the inner clamp arm 12 and the outer clamp arm 21. The collapsed inner and outer clamps 10 and 20 firmly clamp the valve 80, and the delivery device is withdrawn, thus completing the repair of the heart valve 80. Since the collapsed inner clamp of the clipper returns to a substantially elliptical shape, it closely matches the outer shape of the valve 80, thereby minimizing damage to the valve 80.

[0111] like Figures 5A-5CThis is another embodiment of the heart valve repair clip provided by the present invention. The main difference from the previous embodiments is that in this embodiment, the valve leaflet is clamped between a clip 22 and an outer clamp arm 21. Correspondingly, a clamping spike 222 is located on the side of the clip 22 facing the outer clamp arm 21 and has a sawtooth shape. To separate the clip 22 and outer clamp arm 21 before capturing the valve leaflet, a protrusion 223 with a wider distal end and a narrower proximal end is added to the distal end of the clip 22. In this embodiment, the protrusion is T-shaped, but it can also be designed in an inverted trapezoidal or triangular shape. The inner clamp arm 12 is provided with a hollow groove 123 with a narrower distal end and a wider proximal end, which matches the protrusion 223. For example, the hollow groove 123 can be shaped like a regular T, trapezoid, or triangle.

[0112] In the initial state, the protrusion 223 is inserted into the hollow groove 123 so that the clip 22 is pressed against the inner clamp arm 12. In the process of pushing the core rod 90 to gradually open the heart valve repair clip, the clip 22 and the inner clamp arm 12 have a relative displacement, and the distal end of the clip 22 gradually moves toward the proximal end of the inner clamp arm 12, that is, the distal end of the protrusion 223 gradually approaches the proximal end of the hollow groove 123, but is still engaged in the hollow groove 123. After the heart valve repair clip is fully opened, with the help of external imaging Observe until the leaflet falls between the outer clamp arm 21 and the clip 22, adjust the direction of the outer clamp arm to the appropriate direction, continue to push the core rod 90 toward the distal end, the protrusion 223 separates from the hollow groove 123, and the clip 22 moves toward the outer clamp arm 21 under the action of the rebound force of the outer clamp arm 21 and clamps the leaflet. After clamping the leaflet, pull the core rod 90 back toward the proximal end, the outer clamp arm 21 drives the clip 22 to move toward the direction of the symmetry axis, and the inner clamp arm 12 returns to its original arc state until the clip 22 fits with the inner clamp arm 21.

[0113] Then, the sleeve 33 is rotated to gradually bring the outer clamp arm 21, the inner clamp arm 12 and the clip 22 together more tightly until the proximal ends of the two inner clamp arms 12 are approximately fitted together, thus completing the folding of the heart valve repair clip.

[0114] The present invention has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. A heart valve repair clip, comprising: An outer clamp having a pair of outer clamp arms symmetrically extending from the proximal end to the distal end and a pair of clips integrally connected to the inner proximal ends of the outer clamp arms; an inner clamp located between the pair of outer clamp arms, the inner clamp having a pair of inner clamp arms symmetrically extending from a distal end toward a proximal end, the proximal ends of the inner clamp arms being pivotally connected to the proximal ends of the corresponding outer clamp arms; It is characterized by: In the naturally clamped state, the side surfaces of the inner clamping arms are arc-shaped, so that the side surfaces of the symmetrical pair of inner clamping arms form an elliptical shape; In the open state, the inner clamping arms are pulled into an approximately straight state, so that the side surfaces of the pair of symmetrical inner clamping arms form an inverted U shape; In the retracted state, the proximal sections of the inner clamping arms are squeezed by the outer clamping arms into an approximately straight state, so that the proximal side surfaces of the symmetrical pair of inner clamping arms form parallel lines that are close to each other; the distance between the distal sections of the pair of inner clamping arms is smaller than the distance between them in the naturally clamped state; The distal end of the inner clip is a thickened end, and the ratio of the thickness of the thickened end to the thickness of the inner clip arm is 5-20:1; the inner clip arm has a transition section integrally connected to the proximal end surface of the thickened end, which gradually becomes thinner from the distal end to the proximal end, and a uniform section connected to the transition section; The connection between the clip and the outer clamp arm is a proximal bend; The proximal end of the inner clamp arm is pivotally connected to the proximal corner; The heart valve repair clip further comprises: A connecting shaft is provided, and the connecting shaft is simultaneously passed through the proximal end of the inner clamping arm and the proximal end bend.

2. The heart valve repair clip according to claim 1, wherein: The ratio of the minor axis to the major axis of the elliptical shape is 4 to 8:

10.

3. The heart valve repair clip according to claim 1, characterized in that The proximal end of the inner clamp arm is provided with an axle seat, the axle seat is provided with an axle hole, and the connecting shaft is passed through the axle hole.

4. The heart valve repair clip according to claim 1, wherein The inner center of the thickened end is provided with a core hole for the core rod to pass through.

5. The heart valve repair clip according to claim 1, characterized in that The outer clamping arm is integrally connected to the clamping piece.

6. The heart valve repair clip according to claim 5, characterized in that The outer clamping arm has an outer arm and an inner arm, and the outer arm is a bent long sheet from the proximal end to the distal end; The inner arm is integrally bent and extends from the distal end of the outer arm to the proximal end, and the inner arm is substantially parallel to the outer arm; The clip is bent again and extends from the proximal end of the inner arm to the distal end, and the distal end of the clip is close to the distal end of the inner arm.

7. The heart valve repair clip according to claim 6, wherein The distal end of the clip abuts the distal end of the inner arm.

8. The heart valve repair clip according to claim 6, characterized in that The outer arm comprises, from the distal end to the proximal end, an outer arm distal section with a first slope, an outer arm middle section with a second slope, and an outer arm proximal section with a third slope; The inner arm comprises, from the distal end to the proximal end, an inner arm distal section having the first slope and an inner arm proximal section having the second slope; The absolute value of the first slope is greater than the absolute value of the second slope, and the absolute value of the third slope is greater than the absolute value of the second slope.

9. The heart valve repair clip according to claim 8, characterized in that The clip has a fourth slope, and an absolute value of the fourth slope is between an absolute value of the first slope and an absolute value of the second slope.

10. The heart valve repair clip according to claim 5, 6 or 8, characterized in that The side of the clip facing away from the outer clip arm is provided with a clamping thorn, and the leaflet is clamped by the clip and the inner clip arm.

11. The heart valve repair clip according to claim 5, 6 or 8, characterized in that The clip has a clamping thorn on one side facing the outer clamping arm, and the leaflet is clamped by the clip and the outer clamping arm.

12. The heart valve repair clip according to claim 10, characterized in that The clamping thorn is serrated.

13. The heart valve repair clip according to claim 11, characterized in that The clamping thorn is serrated.

14. The heart valve repair clip according to claim 11, wherein The distal end of the clip is provided with a convex block which is wider at the distal end and narrower at the proximal end. The inner clip is provided with a hollow groove which is narrower at the distal end and wider at the proximal end. The convex block can pass through the proximal end of the hollow groove.

15. The heart valve repair clip according to claim 6, characterized in that The integral connection between the inner arm and the clip has a proximal corner, and a connecting shaft is passed through the proximal corner.

16. The heart valve repair clip according to claim 15, characterized in that The outer side wall is connected to the inner side wall via a distal bend, and / or The inner side wall is connected to the clip through the proximal corner.

17. The heart valve repair clip according to claim 16, characterized in that The elasticity of the distal bend is greater than the elasticity of the inner side wall.

18. The heart valve repair clip according to claim 1, characterized in that The heart valve repair clip further comprises: A receiving structure is hollow inside and is connected to the proximal end of the outer clip, so that the outer clip and the inner clip can be received together inside.

19. The heart valve repair clip according to claim 18, characterized in that The storage structure has: An N-sided base having N foldable side walls, wherein the distal end of the base integrally extends outwardly from an outer clamping arm of the outer clamp; A support base, the support base having a proximal base and a distal base fixed to the distal end surface of the proximal base, the distal base having an N-gonal distal inner cavity, the foldable side wall of the base being inserted into the distal inner cavity of the distal base; A sleeve having a receiving cavity therein, wherein the support seat is detachably connected to the receiving cavity of the sleeve via the proximal seat; Wherein, N is a positive integer ≥ 3.

20. The heart valve repair clip according to claim 19, characterized in that The proximal end of the foldable side wall of the base is provided with a buckle; The proximal end of the distal seat of the support seat has a corresponding clamping hole; The base is inserted into the support seat by snapping the snaps of the foldable side walls into the snap holes of the distal seat.

21. The heart valve repair clip according to claim 20, characterized in that The inner surfaces of the distal inner cavity of the support seat are respectively provided with guide grooves leading to the clamping holes, providing a passage for the clamping buckle to be inserted into the clamping hole.

22. The heart valve repair clip according to claim 19, characterized in that The side edges of the collapsible side walls have: A connecting edge is located at a distal end of the side edge of the foldable side wall, and two adjacent foldable side walls are fixedly connected together by the respective connecting edges; The non-connecting edge is located near the side of the foldable side wall, and an openable and closable gap is provided between the non-connecting edges of two adjacent foldable side walls.

23. The heart valve repair clip according to claim 19, characterized in that The outer wall of the proximal portion of the support seat has a support external thread; The proximal section of the sleeve receiving cavity is a fixed cavity, and the inner wall of the fixed cavity has an internal thread for a support; The external thread of the support of the near-section seat is matched with the internal thread of the support in the sleeve, so that the support seat is detachably connected to the storage cavity of the sleeve.

24. The heart valve repair clip according to claim 23, characterized in that The distal end of the sleeve receiving cavity is a gradually increasing gradient cavity.

25. The heart valve repair clip according to claim 23 or 24, characterized in that The sleeve further comprises an annular cavity, the inner wall of which comprises an internal conveying thread which can cooperate with the conveyor; the thread direction of the internal conveying thread is opposite to the thread direction of the internal thread of the support.

26. The heart valve repair clip according to claim 25, characterized in that The annular cavity sleeve is located outside the receiving cavity.

27. The heart valve repair clip according to claim 23 or 24, characterized in that The proximal section of the fixed cavity of the sleeve is a conveying cavity, and the inner wall of the conveying cavity has a conveying internal thread, and the thread direction of the conveying internal thread is opposite to that of the external thread of the support.

28. The heart valve repair clip according to claim 19, characterized in that The interior of the base is formed from the distal end to the proximal end along the axial direction, with a base hole and a base cavity being interconnected and capable of inserting a central core rod; The interior of the support seat is axially connected from the distal end to the proximal end, and is formed by a distal inner cavity and a proximal through hole for inserting the core rod. Wherein, the base cavity occupies all or part of the space of the distal segment inner cavity.

29. The heart valve repair clip according to claim 28, characterized in that The inner diameter of the middle portion of the proximal through hole is consistent with the outer diameter of the core rod; The inner diameters of both ends of the near-section through hole gradually increase.

30. The heart valve repair clip according to claim 28, characterized in that The base hole is a stepped hole with an inclined distal end surface.

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