Mitral valve clip

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a mitral valve clip. The mitral valve clip comprises a U-shaped elastic sheet which can be bent, the U-shaped elastic sheet is a U-shaped structure composed of two sheet bodies, and further comprises at least two anti-twist devices which are respectively arranged on the two sheet bodies to prevent the U-shaped elastic sheet from being twisted. The application adds a plurality of anti-twist devices on the U-shaped elastic sheet, so that the U-shaped elastic sheet can be effectively prevented from being twisted.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a mitral valve clamp. Background Technology

[0002] In the cardiovascular system, natural heart valves (such as the aortic, pulmonary, mitral, and tricuspid valves) play a crucial role in ensuring a proper and positive flow of blood. However, these valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency. These disease processes include degenerative processes (such as Barlow's disease or fibroelastosis), inflammatory processes (such as rheumatic heart disease), and infectious processes (such as endocarditis). Additionally, damage to the left or right ventricle from pre-heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (such as cardiomyopathy) can distort the geometry of natural valves, leading to their dysfunction. The vast majority of patients undergoing valve surgery, such as mitral valve surgery, have degenerative diseases that cause leaflet dysfunction in natural valves (e.g., the mitral valve), resulting in prolapse and regurgitation.

[0003] Taking the mitral valve as an example, mitral regurgitation can be caused by a variety of different mechanical defects in the mitral valve or the left ventricular wall. The valve leaflets, the valve cords connecting the leaflets to the papillary muscles, or the papillary muscles themselves, or the left ventricular wall, may be damaged or otherwise dysfunctional. Typically, the valve annulus may be damaged, swollen, or weakened, thus limiting the mitral valve's ability to fully close against greater pressures from the left ventricle; this damage can lead to serious cardiovascular injury or death.

[0004] For many years, the definitive treatment for such damaged valves has been surgical repair or replacement during open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Consequently, elderly and frail patients with defective heart valves often go untreated. Recently, transvascular techniques have been developed for the introduction and implantation of prosthetic devices in a much less invasive manner compared to open-heart surgery. One specific transvascular technique used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, ascending along the inferior vena cava and into the right atrium, then puncturing the septum and inserting the catheter into the left atrium.

[0005] During these surgical procedures, a clamp is used to hold the leaflets. The U-shaped spring in the clamp is the outermost structure of the clamp and is used to close the held leaflets. However, when the clamp is opened, the U-shaped spring bears a large supporting force. Since the cross-sectional area of ​​the U-shaped spring is long and narrow, it can be seen as a flat and elongated sheet. The U-shaped spring is prone to twisting, which affects its stability. Summary of the Invention

[0006] The present invention addresses the technical problem that the U-shaped spring sheet of the clamp is subjected to a large supporting force when it is opened, which easily causes torsion and affects its stability. The purpose is to provide a mitral valve clamp.

[0007] A mitral valve clamp includes: a U-shaped spring that can be bent;

[0008] The U-shaped spring sheet is a U-shaped structure composed of two connected sheet-like bodies;

[0009] Also includes:

[0010] At least two anti-torsion devices are respectively disposed on the two sheet-like bodies to prevent the U-shaped spring sheet from twisting.

[0011] As a preferred embodiment, the anti-torsion device includes:

[0012] Two connectors are set at a preset distance relative to each other along the width direction of the U-shaped spring piece. Each connector has a through groove, and movable grooves are respectively cut into the side walls on both sides of the through groove.

[0013] A main rod is fixed at both ends to the two connecting pieces, and its length direction is the width direction of the U-shaped spring piece;

[0014] A movable rod has two ends passing through the movable groove and is arranged parallel to the main rod;

[0015] Two buckles are connected to both ends of the movable rod, respectively, and their sides abut against the through groove;

[0016] The two connectors or any pair of the two through slots are arranged at an angle relative to each other.

[0017] As a preferred embodiment, the two connectors are inclined inward to form an included angle α, wherein the included angle α is an acute angle.

[0018] The buckle abuts against the outer wall inside the through groove.

[0019] As a preferred embodiment, the two connectors are inclined outward to form an included angle β, wherein the included angle β is an obtuse angle.

[0020] The buckle abuts against the inner wall of the through groove.

[0021] As a preferred embodiment, the two through slots are inclined inward to form an included angle θ, where the included angle θ is an acute angle.

[0022] The buckle abuts against the outer wall inside the through groove.

[0023] As a preferred embodiment, the two through slots are inclined outward to form an included angle δ, wherein the included angle δ is an obtuse angle.

[0024] The buckle abuts against the inner wall of the through groove.

[0025] As a preferred embodiment, the acute angle range is 80°≤α or θ≤89°.

[0026] As a preferred embodiment, the obtuse angle ranges from 91°≤β or δ≤100°.

[0027] As a preferred embodiment, one end of the connector is provided with a notch;

[0028] The main rod is provided with a groove along its length, and the groove is positioned opposite to the notch.

[0029] The anti-torsion device further includes:

[0030] An inner rod is disposed within the groove, with both ends constrained between the groove and the notch, and can rotate freely within the groove.

[0031] As a preferred embodiment, the movable rod is provided with slots at both ends;

[0032] The buckle engages with the slot.

[0033] As a preferred embodiment, the inner wall of the buckle is provided with a groove to increase the elasticity of the buckle and facilitate the buckle to be inserted into the groove.

[0034] As a preferred embodiment, a reinforcing hole is provided in the groove, and an adhesive is injected into the reinforcing hole;

[0035] When the buckle engages with the slot, the buckle is bonded to the slot with the adhesive to secure it firmly.

[0036] As a preferred embodiment, a reinforcing hole is provided in the groove, and an internal thread is provided in the reinforcing hole;

[0037] When the buckle engages with the slot, the buckle and slot are fixed by bolts threaded into the reinforcing hole.

[0038] As a preferred embodiment, the movable rod is evenly provided with a plurality of concave and convex stripes in the circumferential direction, the length direction of the concave and convex stripes is the axial direction of the movable rod, and the concave and convex stripes are located between the two slots.

[0039] As a preferred embodiment, the raised and recessed stripes are toothed stripes.

[0040] As a preferred embodiment, a sliding piece is provided on at least one side wall of the buckle. The sliding piece has a smooth arc-shaped structure, and the inner wall of the through groove is a smooth inner wall. The sliding piece abuts against the inner wall of the through groove, and the buckle is slidably connected to the inner wall of the through groove through the sliding piece.

[0041] As a preferred embodiment, the sliding piece is higher than the side wall of the buckle, and when the buckle is set on the slot, the sliding piece is located on the side abutting the inner wall of the through slot.

[0042] As a preferred embodiment, the sliding pieces are provided on both sides of the buckle to facilitate the installation of the buckle.

[0043] As a preferred embodiment, the shortest distance between the notch and the movable groove is H;

[0044] The average thickness of the sheet-like body is I;

[0045] Therefore, H is 2 / 3 to 1 times I.

[0046] As a preferred embodiment, both of the U-shaped spring pieces have a wavy structure, and the wavy structure of the two pieces is consistent, so that the distance between any position of the two pieces is the same.

[0047] The positive and progressive effects of this invention are as follows: This invention uses a mitral valve clamp, which has the following advantages:

[0048] 1. Adding several anti-torsion devices to the U-shaped spring can effectively prevent the U-shaped spring from twisting;

[0049] 2. The relative inclination of the two connectors or two through slots in the anti-torsion device achieves an inclined setting. When the buckle rests against the outside or inside of the through slot, the reaction force generated by the through slot on the buckle is not the same as the axis of the movable rod, but has a component force pointing in the direction of the main rod. Under the action of this component force, the buckle will approach the main rod, thereby driving the movable rod to clamp the U-shaped spring piece and prevent the U-shaped spring piece from twisting.

[0050] 3. The inner rod can rotate freely within the groove, allowing the anti-torsion device to slide freely on the U-shaped spring. Since it is impossible to determine exactly where the U-shaped spring twists, the anti-torsion device can move freely on the U-shaped spring when it does not twist. However, when the U-shaped spring twists, the anti-torsion device moves to the position where the U-shaped spring twists, and the U-shaped spring will push against the movable rod, overcoming the force exerted by the through groove on the latch and moving away from the inner rod. Similarly, the force generated by the movable rod on the U-shaped spring also restricts the twisting of the U-shaped spring.

[0051] 4. The buckle has a slot, which increases its elasticity and makes it easier for the buckle to be inserted into the slot;

[0052] 5. Reinforcing holes are provided inside the groove. By injecting glue or other adhesives into the reinforcing holes, the buckle is securely fixed to the groove.

[0053] 6. The fixing of the slots and buckles is further enhanced by using bolts to secure them;

[0054] 7. The concave-convex stripe design increases the friction between the movable rod and the U-shaped spring. When clamping the twisted U-shaped spring, it will not slip and cause the anti-twist device to slip away, thus preventing the problem of failing to clamp the twisted U-shaped spring.

[0055] 8. The sliding piece on one side of the buckle has a smooth arc-shaped structure with a smooth surface. The inner surface of the through groove is also smooth, which facilitates the relative sliding of the sliding piece and the through groove.

[0056] 9. The closest distance H between the notch of the connector and the movable groove is 2 / 3 to 1 times the average thickness of the U-shaped spring sheet. This design is because the relatively thin parts of the U-shaped spring sheet are easy to twist, so the anti-twist device is located as close as possible to the thinner parts of the U-shaped spring sheet to achieve more effective control of the twist of the two sheet-like parts in the U-shaped spring sheet.

[0057] 10. The U-shaped spring has a wavy shape around its perimeter, and the wavy shape on both sides is consistent, meaning the horizontal width is the same at any position. This prevents the U-shaped spring from becoming narrower at one point, causing force concentration and large deformation. The wavy design also prevents concentrated deformation on the sides of the U-shaped spring. Because the U-shaped spring has curved edges, the direction of force is constantly changing, making it less likely for force to concentrate at one point. Therefore, the wavy design further prevents the U-shaped spring from twisting. It also ensures that the anti-torsion device must travel a curved path when sliding freely on the U-shaped spring, meaning the path is longer and not straight, thus increasing the stability of the anti-torsion device and making it less likely to slide directly to the bottom under gravity. Attached Figure Description

[0058] Figure 1 This is a front view of the present invention in the clamped state;

[0059] Figure 2 for Figure 1 A 3D image of an umbrella in operation;

[0060] Figure 3 for Figure 2 The main view;

[0061] Figure 4 This is a front view of a connection relationship between the U-shaped spring and the anti-torsion device of the present invention;

[0062] Figure 5 This is a perspective view showing another connection relationship between the U-shaped spring and the anti-torsion device of the present invention;

[0063] Figure 6 for Figure 5 Side view;

[0064] Figure 7(a) is a perspective view of the anti-torsion device of the present invention;

[0065] Figure 7(b) is the front view of Figure 7(a);

[0066] Figure 7(c) is a magnified view of a portion of Figure (b);

[0067] Figure 8(a) is another perspective view of the anti-torsion device of the present invention;

[0068] Figure 8(b) is the front view of Figure 8(a);

[0069] Figure 8(c) is a magnified view of a portion of Figure 8(a);

[0070] Figure 9(a) is another front view of the anti-torsion device of the present invention;

[0071] Figure 9(b) is a magnified view of a portion of Figure 9(a);

[0072] Figure 10(a) is another front view of the anti-torsion device of the present invention;

[0073] Figure 10(b) is a magnified view of a portion of Figure 10(a);

[0074] Figure 11 This is a perspective view of the connector of the present invention;

[0075] Figure 12 This is a perspective view of the main rod of the present invention;

[0076] Figure 13(a) is a perspective view of the connection between the movable rod and the buckle of the present invention;

[0077] Figure 13(b) is a magnified view of a portion of Figure 13(a);

[0078] Figure 14(a) is a perspective view of the movable rod of the present invention;

[0079] Figure 14(b) is a magnified view of a portion of Figure 14(a);

[0080] Figure 15(a) is a perspective view of one type of buckle of the present invention;

[0081] Figure 15(b) is another perspective view of the buckle of the present invention;

[0082] Figure 15(c) is another perspective view of the buckle of the present invention;

[0083] Figure 15(d) is a three-dimensional view of Figure 15(c) from another perspective;

[0084] Figure 16 This is a diagram showing the positional relationship between the notch and the movable groove of the present invention;

[0085] Figure 17 This is a cross-sectional view showing the connection relationship between the U-shaped spring and the lotus petal clamping component of the present invention;

[0086] Figure 18 for Figure 17 A schematic diagram of a structure after coating;

[0087] Figure 19 This is a schematic diagram of one structure of the elastic clip of the present invention;

[0088] Figure 20 This is a schematic diagram of another structure of the elastic clip of the present invention;

[0089] Figure 21 for Figure 20 A side view. Detailed Implementation

[0090] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below with reference to specific illustrations.

[0091] In this invention, the mitral valve clamp can present multiple states during actual surgical applications, such as an extended state, an umbrella-shaped state, a clamped state, and a closed state. The mitral valve clamp of this invention is implanted via a delivery catheter / delivery sheath of a delivery device. The delivery sheath of this delivery device is inserted into the left atrium through the septum, and the mitral valve clamp of this invention extends from the delivery sheath in an extended state. When the mitral valve clamp of this invention is delivered to the position where it enters the left ventricle within the mitral valve, it is partially opened to present an umbrella shape. At this time, the elastic clamps on the clamping components on both sides are operated to capture the natural valve leaflets. After capturing the natural valve leaflets, the mitral valve clamp of this invention changes from the umbrella-shaped state to the clamped state, until it reaches the closed state to clamp it onto the natural mitral valve.

[0092] In this invention, when describing a mitral valve clamp, "proximal end" refers to the side of the clamp located on the delivery device or in the direction of the user-operated end when the mitral valve clamp is in the clamped state; correspondingly, "distal end" refers to the side of the clamp located away from the delivery device or in the direction of the user-operated end when the mitral valve clamp is in the clamped state. For example, as... Figure 1 As shown, "proximal" refers to the upper side, and "distal" refers to the lower side.

[0093] In this invention, the spatial term "length direction of the U-shaped spring" refers to the direction along the proximal and distal ends, and the spatial term "width direction of the U-shaped spring" refers to the direction perpendicular to the length direction of the U-shaped spring. In this document, "length direction of the U-shaped spring" refers to the vertical direction, and "width direction of the U-shaped spring" refers to the front-back direction.

[0094] Reference Figures 1 to 6 A mitral valve clamp includes a U-shaped spring 110, which is bendable and is a U-shaped structure composed of two sheet-like bodies 111 connected together. A hinge structure 112 is provided at the proximal end of each sheet-like body 111 for proximal hinge engagement with the inner clamp 210.

[0095] The mitral valve clamp also includes at least two anti-torsion devices 300, which are disposed on the sheet body 111 and prevent the U-shaped spring sheet 110 from twisting.

[0096] Several anti-torsion devices 300 can be placed on the U-shaped spring 110. Generally, no more than 5 anti-torsion devices 300 are used, otherwise the weight of the mitral valve clamp will increase too much and affect its performance.

[0097] In some embodiments, refer to Figure 5 and Figure 6 Both sheet-like bodies 111 of the U-shaped spring 110 have a wavy structure. The wavy structure of the two sheet-like bodies 111 is consistent, so that the distance between any position of the two sheet-like bodies 111 is the same.

[0098] The U-shaped spring 110 has a wavy shape around its perimeter, and the wavy shape on both sides is consistent, meaning the horizontal width is the same at any position. This prevents the U-shaped spring 110 from becoming too narrow at any point, causing force concentration and large deformation. The wavy design also prevents concentrated deformation on the sides of the U-shaped spring 110. Because the U-shaped spring 110 has curved edges, the direction of force is constantly changing, making it less likely for force to concentrate at any one point. Therefore, the wavy design further prevents the U-shaped spring 110 from twisting. It also ensures that the anti-torsion device 300 must travel a curved path when sliding freely on the U-shaped spring 110, meaning the path is longer and not straight. This increases the stability of the anti-torsion device 300, making it less likely to slide directly to the bottom under gravity.

[0099] In some embodiments, refer to Figures 7(a) to 10(b) The anti-torsion device 300 includes two connectors 310, a main rod 320, a movable rod 330, and two buckles 340.

[0100] Reference Figures 1 to 6Two connectors 310 are positioned at a preset distance along the width direction of the U-shaped spring 110, and the distance between the two connectors 310 is greater than the width of the U-shaped spring 110. The length direction of the connector 310 (i.e., the direction in which the connector 310 and the movable rod 330 are approximately in the same direction) is the width direction of the U-shaped spring 110. (Refer to...) Figure 11 Each connector 310 has a through groove 311, the length direction of which is perpendicular to the length direction of the connector 310. Movable grooves 312 are respectively cut into the side walls of the through groove 311. The movable grooves 312 are preferably waist-shaped grooves.

[0101] Reference Figures 7(a) to 10(b) The main body rod 320 is fixed at both ends to two connecting pieces 310, and the length direction of the main body rod 320 is the width direction of the U-shaped spring piece 110. The two ends of the movable rod 330 pass through the movable groove 312, and the movable rod 330 is arranged parallel to the main body rod 320. Two latches 340 are connected to the two ends of the movable rod 330, and their sides abut against the through groove 311. The two ends of the movable rod 330 are restricted within the through groove 311 by the latches 340 at both ends.

[0102] Either pair of the two connectors 310 or the two through slots 311 are inclined relative to each other. That is, the two connectors 310 are inclined relative to each other, either inward or outward. Alternatively, the two through slots 311 are inclined relative to each other, either inward or outward.

[0103] With the anti-torsion device 300 designed above, the buckle 340 on the movable rod 330 abuts against the inner wall of the through groove 311, so that the movable rod 330 has a certain pre-tightening force. The connecting piece 310 is elastic. When the movable rod 330 drives the buckle 340 away from the main rod 320, since the connecting piece 310 or the through groove 311 is inclined, the reaction force generated by the connecting piece 310 or the through groove 311 on the buckle 340 is not the same as the axis of the movable rod 330, but has a component force pointing in the direction of the main rod 320. Under the action of this component force, the buckle 340 will approach the main rod 320, thereby driving the movable rod 330 to clamp the U-shaped spring piece 110 and prevent the U-shaped spring piece 110 from twisting.

[0104] In some embodiments, refer to Figures 7(a) to 7(c) The two connectors 310 are inclined inward to form an included angle α, which is an acute angle. The preferred range of the acute angle is 80°≤α≤89°. The buckle 340 abuts against the outer wall inside the through groove 311.

[0105] In some embodiments, refer to Figures 8(a) to 8(c)The two connectors 310 are inclined outward to form an included angle β, which is an obtuse angle. The preferred range of the obtuse angle is 91°≤β≤100°. The buckle 340 abuts against the inner wall of the through groove 311.

[0106] In some embodiments, refer to Figures 9(a) to 9(b) The two through slots 311 are inclined inward to form an included angle θ, which is an acute angle. The preferred range of the acute angle is 80°≤θ≤89°. The buckle 340 abuts against the outer wall inside the through slot 311.

[0107] In some embodiments, refer to Figures 10(a) to 10(b) The two through slots 311 are inclined outward to form an included angle δ, which is an obtuse angle. The preferred range of the obtuse angle is 91°≤δ≤100°. The buckle 340 abuts against the inner wall of the through slot 311.

[0108] In some embodiments, refer to Figure 11 One end of the connector 310 has a notch 313, and the through groove 311 is located at the other end of the connector 310. (Refer to...) Figure 12 The main body rod 320 has a groove 321 along its length, which is opposite to the notch 313. The groove 321 is preferably an arc-shaped groove.

[0109] Reference Figures 7(a) to 10(b) The anti-torsion device 300 also includes an inner rod 350, which is disposed within a groove 321. Both ends of the inner rod 350 are confined between the groove 321 and the notch 313, allowing it to rotate freely within the groove 321. When the anti-torsion device 300 is mounted on the U-shaped spring 110, the sheet-like body 111 of the U-shaped spring 110 is located between the inner rod 350 and the movable rod 330.

[0110] The inner rod 350 can rotate freely within the groove 321, allowing the anti-torsion device 300 to slide freely on the U-shaped spring 110. Since it is impossible to determine where the torsion occurs on the U-shaped spring 110, the anti-torsion device 300 can move freely on the U-shaped spring 110 when it is not torsion. However, when the U-shaped spring 110 is torsion, the anti-torsion device 300 moves to the position where the U-shaped spring 110 is torsion. The U-shaped spring 110 will push against the movable rod to overcome the force of the through groove on the latch and move away from the inner rod 350. Similarly, the force generated by the movable rod on the U-shaped spring 110 also restricts the torsion of the U-shaped spring 110.

[0111] In some embodiments, refer to Figures 13(a) to 14(b) The movable rod 330 has slots 331 at both ends, which are annular grooves arranged around the circumference of the movable rod 330. The buckle 340 engages with the slots 331.

[0112] In some embodiments, refer to Figures 14(a) to 14(b) The movable rod 330 is evenly provided with several concave and convex stripes 332 around its circumference. The length direction of the concave and convex stripes 332 is the axial direction of the movable rod 330, and the concave and convex stripes 332 are located between two slots 331.

[0113] The raised and recessed stripe design increases the friction between the movable rod and the U-shaped spring, preventing slippage that could cause the anti-torsion device to slip away and thus prevent the U-shaped spring from being clamped when it is twisted.

[0114] In some embodiments, the raised and recessed stripes 332 are toothed stripes.

[0115] In some embodiments, referring to FIG15(a), a slot 341 is provided on the inner wall of the buckle 340 to increase the elasticity of the buckle 340 and facilitate the buckle 340 to be inserted into the slot 331.

[0116] In some embodiments, referring to FIG15(b), a reinforcing hole 342 is provided in the slot 341, and adhesive is injected into the reinforcing hole 342. When the buckle 340 is engaged with the slot 331, the buckle 340 is bonded to the slot 331 by the adhesive to secure it firmly.

[0117] In some embodiments, a reinforcing hole 342 is provided in the slot 341, and an internal thread is provided in the reinforcing hole 342. When the buckle 340 is engaged with the slot 331, the buckle 340 and the slot 331 are fixed by bolts threadedly connected to the reinforcing hole 342, thereby further improving the fixing stability.

[0118] In some embodiments, referring to Figures 15(c) and 15(d), at least one side wall of the buckle 340 is provided with a sliding piece 343, the sliding piece 343 is a smooth arc-shaped structure, the inner wall of the through groove 311 is a smooth inner wall, the sliding piece 343 abuts against the inner wall of the through groove 311, and the buckle 340 is slidably connected to the inner wall of the through groove 311 through the sliding piece 343.

[0119] In some embodiments, referring to FIG15(d), the sliding piece 343 is higher than the side wall of the buckle 340. When the buckle 340 is disposed on the slot 331, the sliding piece 343 is located on the side of the inner wall of the through slot 311.

[0120] In some embodiments, sliding pieces 343 are provided on both sides of the buckle 340 to facilitate the installation of the buckle 340, without needing to distinguish which side of the buckle is against the through groove 311.

[0121] In some embodiments, refer to Figure 16 The shortest distance between the notch 313 and the movable groove 312 is H; the average thickness of the sheet 111 is I; therefore, H is 2 / 3 to 1 times I.

[0122] The closest distance H between the notch 313 of the connector and the movable groove 312 is 2 / 3 to 1 times the average thickness of the sheet 111 of the U-shaped spring 110. This design is because the relatively thin parts of the U-shaped spring 110 are easy to twist, so the anti-twist device 300 is located as close as possible to the thinner parts of the U-shaped spring 110 to achieve more effective control over the twisting of the two sheet 111 in the U-shaped spring 110.

[0123] In some embodiments, the mitral valve clamp further includes a connecting block 120, as shown in the reference. Figure 1 The connecting block 120 can be located on the outer wall of the distal end of the U-shaped spring 110.

[0124] In some embodiments, refer to Figure 5 The connecting block 120 has a threaded hole 121 for threading the drive shaft of the conveying device. The threaded hole 121 extends proximally through the U-shaped spring 110 and communicates with the U-shaped spring 110. The threaded hole 121 is used for threaded connection with the drive shaft of the conveying device, which drives the mitral valve clamp of the present invention to switch to various different states.

[0125] In some embodiments, the mitral valve clamp further includes a connecting block 120, as shown in the reference. Figure 17 The connecting block 120 can also be located on the distal inner wall of the U-shaped spring 110. By embedding the connecting block 120, the length of the mitral valve clamp is reduced, and the amplitude of its swing during valve opening and closing is reduced, thereby reducing the risk of valve tearing damage caused by the inertial force generated by the swing of the mitral valve clamp.

[0126] In some embodiments, the connecting block 120 has a threaded hole 121 for threading the drive shaft of the conveying device.

[0127] In some embodiments, the connecting block 120 and the U-shaped spring 110 are integrally formed.

[0128] In some embodiments, the mitral valve clamp further includes two lotus petal clamping members 130, the distal end of which is rotatably connected to the connecting block 120, and the proximal end of which abuts against the outer walls on both sides of the proximal end of the U-shaped spring 110.

[0129] In some embodiments, the connecting block 120 is provided with a rotating hole, and the distal end of the lotus petal clamping member 130 is provided with a rotating shaft. The distal end of the lotus petal clamping member 130 is rotatably connected to the connecting block 120 by inserting the rotating shaft into the rotating hole. The rotatable connection method ensures that the lotus petal clamping member 130 will not affect the force required for the opening and closing of the U-shaped spring 110. Moreover, the covering method ensures that the lotus petal clamping member 130 will not separate from the U-shaped spring 110. Therefore, even if the lotus petal clamping member 130 is rotatably connected to the connecting block 120, it will not move freely within the body.

[0130] The present invention achieves a detachable connection between the U-shaped spring 110 and the lotus petal clamp 130 through the connecting block 120. The detachable connection of the lotus petal clamp 130 allows the mitral valve clamp to adapt to the differences in heart valves of different users by using a wider, narrower, longer, or shorter lotus petal clamp 130 according to the size, thickness, and other parameters of the user's heart valve.

[0131] In some embodiments, refer to Figure 17 The lotus petal clamping component 130 comprises an integrally formed upper rod and two lower rods from its proximal end to its distal end. The upper rod has an inverted U-shaped structure, with its horizontal section located on the outer wall of the proximal end of the U-shaped spring piece, and its two vertical sections concave inward to form an arc-shaped bend. The proximal ends of the two lower rods are integrally connected to the distal ends of the two vertical sections of the upper rod, and the distal end of the upper rod is rotatably connected to the connecting block.

[0132] In some embodiments, a film 133 is provided on the outside of the lotus petal clamping member 130, and the film 133 covers the lotus petal clamping member 130.

[0133] The present invention uses the arc-shaped bending design of the two vertical sections of the upper rod to make the mitral valve clamp fit the valve better under the clamping of the lotus petal clamping part 130 after clamping the valve leaf, so as to promote the fit of the valve with the covering membrane 133 and the mitral valve clamp.

[0134] In some embodiments, the angle between the tangent at the point of maximum curvature in the vertical segment of the upper rod and the lower rod is an obtuse angle.

[0135] In some embodiments, refer to Figure 18 The film 133 covers the U-shaped spring sheet 110, so that a film buffer surface 134 is formed on the inner side of the lotus petal clamping member 130 by the film 133.

[0136] After the mitral valve clamp of the present invention clamps the leaflet, the outer side of the inner clamp 210 of the mitral valve clamp can abut against the membrane buffer surface 134, and the membrane 133 is relatively flexible and can deform autonomously to adapt to the inner clamp, thereby indirectly increasing the clamping force of the mitral valve clamp.

[0137] In some embodiments, refer to Figure 1 The mitral valve clamp also includes two clamping assemblies, which can be retracted within the U-shaped spring 110. Each clamping assembly includes an inner clamp 210, an elastic clamp 220, and a clamping protrusion 230. The proximal end of the inner clamp 210 is hinged to one side of the proximal end of the U-shaped spring 110. The elastic clamp 220 is fixed to the inner clamp 210 and can open and close proximal to the inner clamp 210. The outer surface of the elastic clamp 220 has clamping spikes 221 and a cavity area 222, with the clamping spikes 221 facing the inner clamp 210. The clamping protrusion 230 is located inside the inner clamp 210, and the position of the clamping protrusion 230 corresponds to that of the cavity area 222.

[0138] The present invention uses the elastic clip 220 and the inner clip 210 in the clamping assembly to clamp the leaflet. By providing a clamping protrusion 230 on the inner side of the inner clip 210, when the elastic clip 220 clamps the leaflet and is located inside the inner clip 210, the valve can be partially lifted by the clamping protrusion 230 and embedded into the cavity area 222. This greatly reduces the risk of the valve being scratched by the sharp barb due to lateral movement of the valve relative to the clamping barb 221.

[0139] In some embodiments, the elastic clip 220 is provided with a control wire through hole, and an external control wire is detachably connected to the control wire through hole. The external control wire controls the opening and closing of the elastic clip 220.

[0140] In some embodiments, the inner clip 210, the elastic clip 220, and the clamping protrusion 230 are all covered with a film.

[0141] In some embodiments, refer to Figure 19 The elastic clip 220 includes a barbed clip 223, a buffer layer 224, and a light clip 225 from the outside to the inside. The inner side of the barbed clip 223 has clamping barbs 221.

[0142] The elastic clip 220 of this invention can adopt the following three-layer structure. The outer two layers increase the clamping force of the elastic clip 220 on the valve, making the valve clamping stable. The middle buffer layer 224 firstly buffers the inertial force generated by the mitral valve clamp during the swinging process with the opening and closing of the valve, which is directly transmitted to the valve through the clamping spikes 221 of the clip 223, thus preventing valve tearing. Secondly, the direct contact between the clip 223 and the light clip 225 can easily cause sliding misalignment, resulting in uneven clamping force of the elastic clip 220. The buffer layer 224 can have a large frictional force with the clip 223 and the light clip 225 respectively, preventing misalignment between the clip 223 and the light clip 225. If a thicker clip 223 is used directly, the clip 223 may experience fatigue fracture because each opening and closing of the valve will cause a small movement of the clip 223, resulting in a relatively low fatigue life of the clip 223. The elastic clip 220 of this invention with its multi-layer composite structure effectively improves its fatigue life.

[0143] In some embodiments, the spike clip 223 and the light clip 225 are metal clips made of metal to clamp the valve with a certain degree of rigidity.

[0144] In some embodiments, the buffer layer 224 is a silicone pad made of medical-grade silicone to provide better cushioning.

[0145] In some embodiments, the buffer layer 224 is bonded to the spike clip 223 and the light clip 225 respectively using a medical silicone adhesive.

[0146] In some embodiments, medical silicone adhesive is directly bonded as a buffer layer 224 between the spike clip 223 and the optical clip 225. By directly using medical silicone adhesive to bond the spike clip 223 and the optical clip 225, although there is no obvious buffer layer 224, the medical silicone adhesive acts as a buffer layer 224 of a certain thickness, although it is relatively thin compared to an obvious buffer layer 224.

[0147] In some embodiments, the thickness of the optical clip 225 is T1, the thickness of the buffer layer 224 is T2, and the thickness of the spike clip 223 is T3; wherein T1 = T3, 1 / 2T1 ≤ T2 ≤ 3 / 2T1.

[0148] Since setting the buffer layer 224 would weaken the effect of the light clip 225 in enhancing the support of the spike clip 223, and if the buffer layer 224 is too thin, it will not have a buffering effect, the present invention adopts a buffer layer 224 of the above-mentioned thickness.

[0149] In some embodiments, refer to Figure 19 The elastic clip 220 has a fastening end 226 at its distal end, and the elastic clip 220 is fixed to the inner clip 210 through the fastening end 226.

[0150] In some embodiments, refer to Figures 1 to 3 The fastening end 226 is fixed to the inner side of the inner clamp 210, and the fastening end 226 serves as the clamping protrusion 230. This allows the elastic clamp 220 to be firmly fixed to the inner clamp 210, and also to work together with the cavity area 222 as the clamping protrusion 230 to protect the clamped leaflet.

[0151] In some embodiments, the distal end of the inner clamp 210 is provided with an inner clamp connecting hole connecting the inner and outer sides; the fastening end 226 passes through the inner clamp connecting hole and is fixed to the outer surface of the inner clamp 210. This design ensures that even if the connection between the elastic clamp 220 and the inner clamp 210 fails, the external placement of the fastening end 226 provides a reaction force. This reaction force acts on the inner clamp 210 from the outside, stably connecting the inner clamp 210 and the elastic clamp 220 to hold the leaflet.

[0152] In some embodiments, refer to Figure 20 The fastening end 226 is an elastic sheet that bends outward from the proximal end and then inward from the proximal end. The setting of the elastic sheet, combined with the application of the clamping spike 221, makes the elastic clamp 220 more clamping.

[0153] In some embodiments, refer to Figure 19 and Figure 20 The elastic clamp 220 has a through groove in the middle that connects the inside and outside. The through groove serves as a cavity area 222, and the clamping spikes 221 are arranged around the cavity area 222.

[0154] In some embodiments, when the elastic clip 220 has a three-layer structure, through grooves are provided on the spike clip 223, the buffer layer 224 and the optical clip 225. The through groove after the spike clip 223, the buffer layer 224 and the optical clip 225 are stacked is the cavity area 222.

[0155] In some embodiments, when the elastic clip 220 has a three-layer structure, a fastening end is provided at the distal end of the spike clip 223, the buffer layer 224 and the optical clip 225. The fastening end after the spike clip 223, the buffer layer 224 and the optical clip 225 are stacked is the fastening end 226.

[0156] In some embodiments, refer to Figure 20 and Figure 21 The clamping spikes 221 are in multiple groups, and each group of clamping spikes 221 has at least one sharp spike. The multiple groups of clamping spikes 221, from proximal to distal, include a first clamping spike 2211 and multiple groups of second clamping spikes 2212. The distance between the first clamping spike 2211 and the adjacent second clamping spike 2212 is Y, and the distance between two adjacent second clamping spikes 2212 is L, where L≥Y.

[0157] Since the first clamping spur 2211 is located at the closest end and is the furthest from the fastening end 226, but is the first spur to bind the valve, the distance between the first clamping spur 2211 and the adjacent second clamping spur 2212 is set to be relatively short in order to increase the spur density and facilitate reliable capture of the valve.

[0158] In some embodiments, 1.5mm≤L≤3mm, 1.0mm≤Y≤2.5mm.

[0159] In some embodiments, the second clamping spur 2212 is in N groups, where 2 ≤ N ≤ 6. For example... Figure 21 As shown, the second clamping spur 2212 consists of two sets.

[0160] In some embodiments, the clamping spikes 221 are all inclinedly disposed on the outer side of the elastic clip 220, and the inclination direction of the clamping spikes 221 is the distal direction; the included angle between the clamping spikes 221 and the elastic clip 220 is 35° to 45°.

[0161] In some embodiments, the angle between the first clamping spike 2211 and the elastic clip 220 is greater than the angle between the second clamping spike 2212 and the elastic clip 220.

[0162] In some embodiments, the included angles between the second clamping spikes 2212 and the elastic clips 220 within the same group are equal. The included angles between multiple groups of second clamping spikes 2212 and elastic clips 220 are equal or gradually decrease from the proximal end to the distal end.

[0163] like Figure 21 As shown, the angle α1 between the first clamping spur 2211 and the elastic clip 220, and the angles α2 and α3 between the second clamping spur 2212 and the elastic clip 220 from the proximal end to the distal end are respectively, where α1 > α2 ≥ α3. This can be extended to the case of more clamping spurs.

[0164] Since the first clamping spur 2211 is located at the closest point, the valve thickness is greatest at the location of the first clamping spur 2211 when the elastic clip 220 holds the valve. Therefore, the first clamping spur 2211 needs a larger puncture distance, and thus its tilt angle needs to be larger. The valve at the distal end is relatively thinner, and the puncture distance can be relatively smaller. Furthermore, since the purpose of the tilted clamping spur 221 is not only to puncture the valve, but also to clamp the valve relative to the elastic clip 220, further fixing the valve and preventing it from being torn by the spur, the multiple second clamping spurs 2212 are also designed with varying tilt angles.

[0165] In some embodiments, such as Figure 1 As shown, an inner clamp 210 is provided with an inner clamping partition 211; the distal end of the first clamping spike 2211 abuts against the proximal side of the inner clamping partition 211. The proximal end of the fastening end 226 is located on the distal side of the inner clamping partition 211; the second clamping spike 2212 is located inside the fastening end 226. Figure 1 As shown, in the clamped state, the inner clamping septum 211 separates the first clamping spur 2211 and the second clamping spur 2212. The design of the inner clamping septum 211 makes the thicker proximal valve bend during clamping, so as to further prevent the valve from falling off from the proximal end.

[0166] In some embodiments, the mitral valve clamp further includes a connecting structure, one connecting structure corresponding to two sets of clamping assemblies. A connecting seat is fixedly mounted at the proximal end of the connecting structure, providing a connecting seat that allows the mitral valve clamp to be detachably connected to an external delivery device. The distal end of the connecting structure is hinged to each of the two sets of clamping assemblies. The connecting structure has two connecting pieces 420, the distal end of which is hinged to the distal end of the inner clamp 210 in one set of clamping assemblies.

[0167] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A mitral valve clamp, comprising: A U-shaped spring sheet that can be bent; Its characteristic is that the U-shaped spring sheet is a U-shaped structure composed of two sheet-like bodies connected together; Also includes: At least two anti-torsion devices are respectively disposed on the two plate-like bodies to prevent the U-shaped spring from twisting, and the anti-torsion devices include: Two connectors are set at a preset distance relative to each other along the width direction of the U-shaped spring piece. Each connector has a through groove, and movable grooves are respectively cut into the side walls on both sides of the through groove. A main rod is fixed at both ends to the two connecting pieces, and its length direction is the width direction of the U-shaped spring piece; A movable rod has two ends passing through the movable groove and is arranged parallel to the main rod; Two buckles are connected to both ends of the movable rod, respectively, and their sides abut against the through groove; The two connectors or any pair of the two through slots are arranged at an angle relative to each other; The two connectors are inclined inward to form an included angle α, where the included angle α is acute and ≥ 80°, and the buckle abuts against the outer wall of the through groove; or, the two connectors are inclined outward to form an included angle β, where the included angle β is obtuse and ≥ 91°, and the buckle abuts against the inner wall of the through groove; or, the two through grooves are inclined inward to form an included angle θ, where the included angle θ is acute and ≤ 89°, and the buckle abuts against the outer wall of the through groove; or, the two through grooves are inclined outward to form an included angle δ, where the included angle δ is obtuse and ≤ 100°, and the buckle abuts against the inner wall of the through groove. A notch is provided at one end of the connector; The main rod is provided with a groove along its length, and the groove is positioned opposite to the notch. The anti-torsion device also includes: An inner rod is disposed within the groove, with both ends constrained between the groove and the notch, and can rotate freely within the groove.

2. The mitral valve clamp as described in claim 1, characterized in that, The movable rod is provided with slots at both ends; The buckle engages with the slot.

3. The mitral valve clamp as described in claim 2, characterized in that, The inner wall of the buckle is provided with a groove to increase the elasticity of the buckle and facilitate the buckle to be inserted into the groove.

4. The mitral valve clamp as described in claim 3, characterized in that, The groove is provided with a reinforcing hole, and the reinforcing hole is filled with adhesive; When the buckle engages with the slot, the buckle is bonded to the slot with the adhesive to secure it firmly.

5. The mitral valve clamp as described in claim 3, characterized in that, The groove is provided with a reinforcing hole, and the reinforcing hole is provided with an internal thread; When the buckle engages with the slot, the buckle and slot are fixed by bolts threaded into the reinforcing hole.

6. The mitral valve clamp as described in claim 2, characterized in that, The movable rod is evenly provided with a plurality of concave and convex stripes in a circumferential direction, the length direction of the concave and convex stripes is the axial direction of the movable rod, and the concave and convex stripes are located between the two slots.

7. The mitral valve clamp as described in claim 6, characterized in that, The raised and recessed stripes are tooth-shaped stripes.

8. The mitral valve clamp as described in claim 2, characterized in that, At least one side wall of the buckle is provided with a sliding piece, the sliding piece is a smooth arc-shaped structure, the inner wall of the through groove is a smooth inner wall, the sliding piece abuts against the inner wall of the through groove, and the buckle is slidably connected to the inner wall of the through groove through the sliding piece.

9. The mitral valve clamp as described in claim 8, characterized in that, The sliding piece is higher than the side wall of the buckle. When the buckle is set on the slot, the sliding piece is located on the side that abuts against the inner wall of the through slot.

10. The mitral valve clamp as described in claim 8 or 9, characterized in that, The buckle has sliding pieces on both sides to facilitate its installation.

11. The mitral valve clamp as described in claim 1, characterized in that, The shortest distance between the notch and the movable groove is H; The average thickness of the sheet-like body is I; Therefore, H is 2 / 3 to 1 times I.

12. The mitral valve clamp as described in claim 1, characterized in that, Both of the U-shaped spring sheets have a wavy structure, and the wavy structure of the two sheets is consistent.

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