Transapical mitral valve replacement device

Abstract

The present invention belongs to the field of medical device technology, and specifically relates to a mitral valve replacement device. A transapical mitral valve replacement device comprises: a stent mechanism having an outer frame and an inner frame connected to the outer frame; a leaflet mechanism located within the inner frame; the leaflet mechanism comprises: a plurality of artificial leaflets, the plurality of artificial leaflets being sequentially connected to form a leaflet mechanism with an outer circumference of a circular ring structure, the leaflet mechanism being connected to the inner side wall of the inner frame, and the middle portion of the leaflet mechanism being unidirectionally openable and removable. The leaflet mechanism composed of multiple independent artificial leaflets has a leaflet mechanism with a function similar to a "one-way valve", and the structure is more stable and reliable.

Description

Technical Field

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

[0002] Valvular regurgitation is a common valvular disease, such as mitral regurgitation and tricuspid regurgitation. Mitral regurgitation is caused by valvular insufficiency. When the left ventricle contracts, blood flows from the left ventricle into the aorta and the left atrium, where resistance is lower. The left atrium receives blood from the pulmonary veins as well as blood from the left ventricle. Therefore, increased left atrial pressure can cause increased pressure in the pulmonary veins and pulmonary capillaries, leading to dilation and congestion. At the same time, the left ventricular diastolic volume load increases, causing the left ventricle to enlarge. In acute mitral regurgitation, a sudden increase in the amount of blood flowing back into the left atrium can cause a sharp increase in left atrial and pulmonary venous pressure, leading to acute pulmonary edema.

[0003] Currently, there are two main surgical methods for treating mitral regurgitation: open-chest surgery and minimally invasive surgery. Due to the large surgical trauma, high risk, and long-term and expensive rehabilitation treatment required after open-chest surgery, a large number of patients are unwilling to accept this treatment method. Minimally invasive surgery provides doctors with a new treatment method with less trauma, fewer complications, and faster postoperative recovery. During minimally invasive surgery, the problem of mitral regurgitation can be solved by using a mitral valve replacement device. Existing mitral valve replacement devices usually use a leaflet mechanism set in an inner frame to avoid regurgitation. The leaflet mechanism uses artificial leaflets to achieve one-way opening and closing. If the size of the inner frame changes, the artificial leaflets in the inner frame also need to change in size. Once the size is improperly adjusted, the artificial leaflets will still cause regurgitation due to incomplete closure when used. Summary of the Invention

[0004] The present invention aims to provide a transapical mitral valve replacement device to solve the technical problem that when the size of the inner frame changes, regurgitation still occurs due to improper adjustment of the size of the artificial valve leaflet.

[0005] A transapical mitral valve replacement device comprising:

[0006] A support mechanism comprising an outer frame and an inner frame connected to the outer frame;

[0007] a leaflet mechanism located in the inner frame;

[0008] The leaflet mechanism comprises:

[0009] A plurality of artificial valve leaflets are sequentially connected to form a valve leaflet mechanism with an outer circumference of a circular ring structure. The valve leaflet mechanism is connected to the inner side wall of the inner frame, and the middle part of the valve leaflet mechanism can be opened and closed in one direction.

[0010] As a preferred embodiment, the transapical mitral valve replacement device further comprises:

[0011] a covering mechanism, covering the stent mechanism, wherein the covering mechanism and the artificial valve leaflet are sutured to each other to form a suture line track;

[0012] The artificial valve leaflet comprises a valve leaflet body, wherein at least one of the outer contour of the distal end of the valve leaflet body or the suture line trajectory has:

[0013] One lobe has an arc at the base and an arc-shaped structure at the distal end;

[0014] Two leaflet side arcs are respectively located on both sides of the leaflet bottom arc, and the distal ends are also arc-shaped structures;

[0015] The leaflet bottom arc is tangentially connected to the leaflet side arcs on both sides to form the distal end of the artificial leaflet.

[0016] As a preferred solution, the leaflet bottom arc is an arc formed by the first center and the first radius;

[0017] The two leaflet side arcs are respectively a first leaflet side arc and a second leaflet side arc, the first leaflet side arc is an arc formed by the second first center and the second radius, and the second leaflet side arc is another arc formed by the second second center and the second radius;

[0018] A line connecting the first center, the second-first center, and the second-second center forms an equilateral triangle.

[0019] As a preferred solution, the side length of the equilateral triangle is greater than the diameter of the leaflet bottom arc and smaller than the width of the leaflet body.

[0020] As a preferred embodiment, the artificial valve leaflet has an axial valve leaflet symmetry line;

[0021] The first circle center is located on the leaflet symmetry line, and the second-first circle center and the second-second circle center are symmetrical about the leaflet symmetry line.

[0022] As a preferred embodiment, at least one of the outer contour of the proximal end of the leaflet body or the suture line trajectory has:

[0023] A leaflet top arc is located on the proximal end side of the leaflet bottom arc, and the proximal end is an arc-shaped structure.

[0024] As a preferred solution, the leaflet top arc is an arc formed by a third center and a third radius, and the third center is located on the leaflet symmetry line.

[0025] As a preferred solution, the distance from the third circle center to the first circle center is N times the side length of the equilateral triangle, preferably three times.

[0026] As a preferred embodiment, the artificial valve leaflet further comprises:

[0027] two ears, respectively located on both sides of the proximal end of the leaflet body;

[0028] The artificial valve leaflet is connected to the valve leaflet suture hole in the inner frame through the ear part, and two adjacent ears are connected to the same valve leaflet suture hole, so that the proximal edges of the two adjacent artificial valve leaflets are in close contact.

[0029] As a preferred embodiment, the ear portion includes:

[0030] an upper ear, located proximal to the heart;

[0031] a lower ear portion, located at the distal end side of the upper ear portion;

[0032] An avoidance groove has an opening on its side and is located between the upper ear portion and the lower ear portion, and the upper ear portion and the lower ear portion are separated by the avoidance groove.

[0033] As a preferred solution, the length of the avoidance groove is no more than 2 / 3 of the width of the ear portion to prevent the upper ear portion and the lower ear portion from being torn and split.

[0034] As a preferred embodiment, the distal edge of the leaflet body is provided with:

[0035] An anti-wear edge strip is connected to the leaflet body by suturing.

[0036] The positive progress of the present invention is that the present invention uses a transapical mitral valve replacement device, which has the following advantages:

[0037] 1. The leaflet mechanism composed of multiple independent artificial leaflets has a leaflet mechanism with a function similar to a "one-way valve" and is more stable and reliable.

[0038] 2. At least one of the outer contour of the leaflet body or the suture line trajectory is limited to a certain geometric relationship, and the artificial leaflets manufactured are surrounded by a leaflet mechanism for use in a transapical mitral valve replacement device, which has better performance and can effectively avoid regurgitation.

[0039] 3. When the size of the inner frame is adjusted, it is directly adjusted according to the limited geometric relationship and still has the same performance as before the adjustment.

[0040] 4. The design of the artificial valve leaflets, especially the ear design, allows the proximal edges of adjacent artificial valve leaflets to be in close contact, preventing reflux caused by incomplete closure.

[0041] 5. The upper and lower ears are used to fix the artificial valve leaflets, which realizes that the ears are not connected to the covering mechanism, and can effectively prevent reflux caused by blood leakage due to the holes in the inner frame covering valve leaflets.

[0042] 6. The design of the anti-wear edge strip first increases the tear resistance of the distal end of the leaflet body, and secondly reduces the damage to the artificial leaflet caused by the friction between the distal end of the leaflet body and the membrane, thereby increasing the service life of the artificial leaflet. Moreover, the setting of the anti-wear edge strip is equivalent to a buffer layer between the artificial leaflet and the membrane, which effectively buffers the tearing force of the artificial leaflet on the membrane during the opening and closing process, thereby increasing the service life of the stent mechanism. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic structural diagram of an embodiment of the present invention;

[0044] FIG2( a ) is a schematic diagram of an expansion of the outer frame covering of the present invention;

[0045] FIG2( b ) is a schematic diagram of a connection between the outer frame covering and the outer frame of the present invention;

[0046] Figure 3 A schematic diagram of the deployment of the inner frame coating of the present invention;

[0047] Figure 4 A schematic diagram of the structure of the connection film of the present invention;

[0048] FIG5( a ) is a schematic diagram of an unfolded artificial valve leaflet of the present invention;

[0049] FIG5( b ) is a schematic diagram of a portion of the connection between the artificial valve leaflet and the inner frame covering and the inner frame of FIG5( a );

[0050] FIG6( a ) is another schematic diagram of the deployment of the artificial valve leaflet of the present invention;

[0051] FIG6( b ) is a schematic diagram of a portion of the connection between the artificial valve leaflet and the inner frame covering and the inner frame of FIG6( a );

[0052] FIG6( c ) is a schematic diagram of the overall connection between the artificial valve leaflet, the inner frame covering and the inner frame of FIG6( a );

[0053] Figure 7 Another schematic diagram of the deployment of the artificial valve leaflet of the present invention;

[0054] Figure 8 A geometric relationship diagram of the artificial valve leaflet of the present invention;

[0055] FIG9( a ) is a perspective view of a connection between an outer frame and an inner frame of the present invention;

[0056] FIG9( b ) is a front view of FIG9( a );

[0057] FIG10( a ) is a front view of the outer frame in FIG9( a );

[0058] FIG10( b ) is a top view of FIG10( a );

[0059] FIG11( a ) is a front view of the inner frame in FIG9( a );

[0060] FIG11( b ) is a schematic structural diagram of another embodiment of FIG11( a );

[0061] FIG12( a ) is another top view of the outer frame of the present invention;

[0062] FIG12( b ) is a top view of the inner frame corresponding to FIG12( a );

[0063] FIG13( a ) is another top view of the outer frame of the present invention;

[0064] FIG13( b ) is a partial enlarged view of FIG13( a );

[0065] FIG14( a ) is another top view of the outer frame of the present invention;

[0066] FIG14( b ) is a partial enlarged view of FIG14( a );

[0067] Figure 15 This is a front view of the outer frame when the straight side of the D-shaped profile of the present invention is not provided with barbs;

[0068] Figure 16 A positional relationship diagram of the outer frame and the inner frame of the present invention;

[0069] Figure 17 A schematic diagram of the structure of the mitral valve;

[0070] Figure 18 This is a schematic diagram of an application of the present invention. DETAILED DESCRIPTION

[0071] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0072] In the present invention, when describing a transapical mitral valve replacement device, "proximal" refers to the side of the transapical mitral valve replacement device located on the delivery device or in the direction of the end manipulated by the user, and accordingly, "distal" refers to the side of the transapical mitral valve replacement device or in the direction away from the end manipulated by the user.

[0073] In the present invention, when describing a transapical mitral valve replacement device, "proximal end" refers to the side of the transapical mitral valve replacement device close to the apex, and correspondingly, "distal end" refers to the side of the transapical mitral valve replacement device away from the apex.

[0074] In the present invention, when describing a transapical mitral valve replacement device, "axial" refers to the direction between the "proximal end" and the "distal end".

[0075] Reference Figures 1 to 8 A transapical mitral valve replacement device includes a stent mechanism and a coating mechanism, wherein the stent mechanism comprises an outer frame 100 and an inner frame 200, the outer frame 100 and the inner frame 200 being connected to each other. The coating mechanism is coated on the stent mechanism.

[0076] In some embodiments, the coating mechanism includes an outer frame coating 300, an inner frame coating 400, and a connecting coating 500. The outer frame coating 300 is coated on the outer frame 100; the inner frame coating 400 is coated on the inner frame 200; and the connecting coating 500 connects the outer frame coating 300 and the inner frame coating 400 respectively.

[0077] The coating mechanism of the present invention includes an outer frame coating, an inner frame coating and a connecting coating. The outer frame coating is covered on the outer frame, and the inner frame coating is covered on the inner frame. Through the design of the connecting coating, the independent outer frame coating and the inner frame coating are connected into a whole, which greatly increases the stability of the transapical mitral valve replacement device and effectively prevents the inner frame from shaking in the outer frame.

[0078] In some embodiments, referring to FIG. 2( a ) and FIG. 2 ( b ), the outer frame coating 300 is a semi-circular ring structure when unfolded. The outer frame coating 300 surrounds the outer side of the outer frame 100 and covers the outer surface of the outer frame 100 .

[0079] In some embodiments, the distal edge of the outer frame coating 300 protrudes from the distal end of the outer frame 100 and is turned inward to the inner side of the outer frame 100, so that the distal edge of the outer frame coating 300 covers the distal end of the outer frame 100; the outer frame coating 300 located on the inner side of the outer frame 100 is connected to the connecting coating 500.

[0080] The distal end edge of the outer frame coating 300 is protruded from the distal end top of the outer frame 100 , leaving a margin for connection with the connecting coating 500 . Since the valve edges will inevitably have burrs and other defects during the cutting process, in order to prevent the edges of the coating from scratching the inner wall of the heart, when the connecting coating 500 is connected to the outer frame coating 300, the edges of the outer frame coating 300 are tilted inward and cannot contact the inner wall of the heart. The connection between the outer frame coating 300 and the connecting coating 500 is also on the inner side of the outer frame coating 300, so that the edges of the coating will not scratch the inner wall of the heart. More preferably, the connecting coating 500 is located on the inner side of the outer frame coating 300, that is, when looking from the distal end to the proximal end, the distal edge of the outer frame coating 300 can be seen, but the outer edge of the connecting coating 500 cannot be seen because the outer edge of the connecting coating 500 is blocked by the outer frame coating 300, that is, the connecting coating 500 is located on the inner side of the outer frame coating 300, which further ensures that the outer edge of the connecting coating 500 cannot scratch the inner wall of the heart.

[0081] In some embodiments, referring to FIG2( a ), the outer frame film 300 is provided with a plurality of outer frame film slots 310 , which correspond to the barbs 161 on the outer frame 100 . Referring to FIG2( b ), when the outer frame film 300 is wrapped around the outer frame 100 , the barbs 161 on the outer frame 100 pass through the outer frame film slots 310 .

[0082] In some embodiments, referring to FIG. 2( a ), at least one arc-shaped gap is formed on the outer frame coating 300 , and the arc-shaped gap serves as a plurality of outer frame coating slots 310 .

[0083] In some embodiments, reference Figure 3 When unfolded, the inner frame covering 400 forms a long, strip-shaped structure, wrapping around the inner side of the inner frame 200 and covering the inner surface of the inner frame 200. The distal end of the inner frame covering 400 has a tooth-shaped structure 410, which is turned outward to the outside of the inner frame 200 and connected to the inner skirt portion 240 at the distal end of the inner frame 200. The inner frame covering 400 with the tooth-shaped structure 410 at the distal end provides a more secure fit to the inner frame 200, facilitating suturing. The number of teeth in the tooth-shaped structure 410 is determined by the number of inner diamond-shaped supports 241 in the inner skirt portion 240. After being turned over, each tooth is positioned between two adjacent inner diamond-shaped supports 241.

[0084] In some embodiments, the tooth-shaped structure 410 is fixedly connected to the inner skirt portion 240 at the distal end of the inner frame 200 by suturing. Other fixed connection methods may also be used.

[0085] In some embodiments, reference Figure 3The connection between the tooth-shaped structure 410 and the long strip structure forms a cuff mark 420; the connecting film 500 is connected to the cuff mark 420. The connecting film 500 is connected to the cuff mark 420 on the inner frame covering 400. The cuff mark 420 does not contact the heart tissue, so the edge of the connecting film 500 and the connection with the cuff mark 420 will not scratch the heart tissue.

[0086] In some embodiments, reference Figure 3 The inner frame covering 400 is provided with a leaflet hole 430, through which the artificial leaflet passes and is fixed to the inner frame 200. When there are three artificial leaflets, such as Figure 3 As shown in FIG, three leaflet holes 430 are provided on the inner frame covering 400. When there are two artificial leaflets, two leaflet holes 430 are provided on the inner frame covering 400. The number of leaflet holes 430 is determined according to the number of artificial leaflets.

[0087] In some embodiments, reference Figure 4 The connecting film 500 is annular in structure. The outer edge of the connecting film 500 is connected to the outer frame film 300 and is located between the outer frame film 300 and the outer frame 100. That is, the outer edge of the connecting film 500 is enclosed within the outer frame film 300. The inner edge of the connecting film 500 is connected to the inner frame film 400 at the flange mark line 420.

[0088] Since burrs and other defects are inevitable on the edges of the coating during the cutting process, in order to prevent the edges of the coating from scratching the inner wall of the heart, the outer edge of the circular ring of the connecting coating 500 is located on the inner side of the outer frame coating 300 when connected to the outer frame coating 300, so that the outer edge of the connecting coating 500 is covered in the outer frame coating 300 and cannot contact the inner wall of the heart. The edge of the outer frame coating 300 is tilted inward and cannot contact the inner wall of the heart, so the edge of the coating will not scratch the inner wall of the heart. The inner edge of the circular ring of the connecting coating 500 is connected to the flange marking line of the inner frame coating 400, which does not contact the heart tissue, so the inner edge of the connecting coating 500 will not scratch the heart tissue. By providing the connecting coating 500 , the originally independent outer frame coating 300 and the inner frame coating 400 are connected into a whole, thereby increasing the stability of the transapical mitral valve replacement device and effectively preventing the inner frame 200 from shaking in the outer frame 100 .

[0089] In some embodiments, the outer frame covering film 300 , the inner frame covering film 400 and the connecting covering film 500 are all made of an impermeable PET composite film, and the impermeable PET composite film has a layer of PET sewing film.

[0090] In some embodiments, a layer of TPU spun film is provided on at least one side of the PET film near the stent structure. Specifically, the outer frame film 300 has a layer of TPU spun film near the outer frame 100, the inner frame film 400 has a layer of TPU spun film near the inner frame 200, and the connecting film 500 has a layer of TPU spun film on the side facing the gap between the outer frame 100 and the inner frame 200. Because PET is still permeable to blood, a layer of TPU spun film is provided on the side of the film near the stent structure. The smooth and dense TPU spun film effectively prevents blood from penetrating the film.

[0091] In some embodiments, a layer of TPU spun film is provided on both sides of the PET film.

[0092] A layer of TPU spun film can be placed on both sides of the PET film. However, a single layer of TPU spun film can be sufficient to prevent permeation of the PET film. Therefore, applying a layer of TPU spun film to both sides of the PET film is also acceptable to further prevent permeation. Furthermore, placing the TPU spun film only on the side closest to the support mechanism is preferred because this prevents direct contact between the TPU spun film and the external environment. Since TPU spun film is more susceptible to adsorbing airborne impurities than PET film, this design effectively prevents the TPU spun film from absorbing airborne impurities.

[0093] Examples 1 to 8

[0094] Step Sa:

[0095] Measure V1 mL of tetrahydrofuran and slowly pour it into a blue-capped bottle. Then, measure V2 mL of N,N-dimethylformamide and slowly pour it into the blue-capped bottle. Add large magnetic stirring beads. Place the blue-capped bottle on a magnetic stirrer and adjust the speed to high speed r1, so that the solution inside the blue-capped bottle forms a vortex. Weigh TPU particles and slowly add them to the blue-capped bottle through the funnel. Maintaining the speed r1, continue stirring for t1 hour to completely dissolve the TPU particles. Adjust the magnetic stirrer speed to low speed r2 and continue stirring for t2 hours until no bubbles are visible in the solution. This will result in a TPU-containing solution of tetrahydrofuran and N,N-dimethylformamide at a concentration C, suitable for electrospinning.

[0096] Step Sb:

[0097] Fill an ultrasonic cleaner with purified water. Place a 6x6-inch PET sewing membrane in a 1L glass beaker and add 200±10mL of 75% ethanol / water solution. Place the beaker in an ultrasonic cleaning tank and ultrasonically clean it at frequency F1 for 3 minutes. After the ultrasonic cleaning is complete, discard the 75% ethanol / water solvent and add 500±10mL of injection water. Soak the PET sewing membrane in this water for 2 minutes. After the soaking period, replace the 500±10mL injection water and place the membrane in an ultrasonic cleaning tank. Ultrasonic cleaning is performed at frequency F2 for 4 minutes. Remove the PET sewing membrane and air dry it to obtain a clean PET sewing membrane.

[0098] Step S1

[0099] Lay the clean PET sewing film from step Sb flat on a dust-free release paper (e.g., release paper, silicone paper, etc.), ensuring it is smooth and wrinkle-free. Secure the edges 5 mm apart with tape. Then, place the dust-free paper with the PET sewing film flat on the receiving plate of the electrospinning machine. The size of the dust-free paper must match the stroke of the electrospinning machine to prevent the spinning from spraying out of the dust-free paper area.

[0100] Use a syringe to draw 60 mL of the TPU-containing tetrahydrofuran and N,N-dimethylformamide mixed solution obtained in step Sa. Mount the syringe to a push pump. Connect the syringe tip to an infusion line, which in turn connects to a nozzle. Insert a needle into the nozzle outlet. Start the push pump and slowly push the solution from the syringe into the needle. Stop pushing when droplets form at the needle. Wipe any liquid from the needle with a dust-free cloth.

[0101] Adjust the X- and Y-axis speeds of the electrospinning machine to W1 mm / s and W2 mm / s, respectively, and adjust the pump frequency to F3. Turn on the X- and Y-axis switches of the electrospinning machine, and start normal movement and liquid discharge at a liquid discharge rate of W3. Turn on the voltage switch, adjust the voltage, and start spinning. After film spraying is complete, turn off the voltage, pump, and electrospinning machine. Remove the initial PET composite film along with the dust-free paper and place it in a designated location to air dry. The composite film surface should be clean and free of visible impurities.

[0102] Step S2

[0103] Wipe the inside of the two pieces of glass with a dust-free cloth dipped in 75% ethanol or 0.1% chlorhexidine and let it dry for 15 minutes. Remove the dust-free paper from the initial PET composite film and place it on the center surface of the glass. Align the other glass and press the initial PET composite film tightly between the two glasses flat and without wrinkles. Use clamps to fix the glass on all sides to ensure that the initial PET composite film does not move. Turn on the oven 30 minutes in advance and set the temperature to T℃. Place the initial PET composite film clamped by the glass in a constant temperature oven at T℃ for drying time t5, and then let it dry naturally for 30 minutes to obtain the final anti-penetration PET composite film.

[0104] Step S3

[0105] In Examples 7 and 8, a PET composite film with a TPU film spun on one side is obtained, which is then naturally laid flat on a dust-free release paper in the reverse direction, and steps S1 and S2 and their process parameters are repeated to obtain a PET composite film with TPU spun films spun on both sides.

[0106] Table 1 Preparation process parameters of the anti-permeation PET composite film of Examples 1 to 8

[0107]

[0108]

[0109] Table 1 (required) Preparation process parameters of the anti-permeation PET composite film of Examples 1 to 8

[0110]

[0111]

[0112] Effect embodiment

[0113] Prosthetic heart valve in vitro fluid dynamics testing was conducted in a Vivitro in vitro pulsatile flow simulator according to method 7.2.3 of YY / T 1449.3-2016. This method evaluates prosthetic heart valve indicators such as effective opening area and total regurgitation percentage using pulsatile pressure and flow waveforms under physiological conditions. Under simulated cardiac output of 5 L / min, a simulated heart rate of 70 cycles per minute, systolic period of 35%, and a mean aortic pressure of 100 mmHg, single-layer PET film, double-layer PET film, and the PET composite film prepared in Example 1 with TPU spun film on one side were observed and tested, and the sealing performance of the sutured films was verified by combining the test data with leakage. Table 2 shows this.

[0114] Table 2 Valve fluid dynamics performance test

[0115]

[0116]

[0117] Table 2 (Continued) Valve fluid dynamics performance test

[0118]

[0119] As shown in Table 2, the 0.21 mm thick PET composite membrane with TPU spun film on one side, prepared in Example 1, reduced blood leakage from 7.24 mL to 0.63 mL compared to a 0.2 mm thick single-layer PET membrane, significantly reducing blood permeation. Even compared to a 0.4 mm thick double-layer PET membrane, the 0.21 mm thick PET composite membrane with TPU spun film on one side, prepared in Example 1, reduced blood leakage from 1.4 mL to 0.63 mL, demonstrating that TPU spun film can significantly reduce blood leakage from sutured membranes.

[0120] Furthermore, TPU membranes possess excellent hemocompatibility and biocompatibility. Experiments in pigs, sheep, and other animals have demonstrated that composite TPU membranes enhance the adhesion, ingrowth, and spreading of endothelial cells on the stent, accelerating the endothelialization process. Because TPU is a highly elastic polymer material, it effectively adheres to the native annulus after valve implantation and release, significantly reducing blood permeability and effectively minimizing paravalvular leakage. A single layer of TPU coating can achieve the same effect as three layers of PET film. The composite TPU spun membrane with PET effectively prevents blood from penetrating, enhancing blood permeability.

[0121] In some embodiments, reference Figures 5(a) to 8 The transapical mitral valve replacement device further includes a leaflet mechanism, which is located within the inner frame 200. The leaflet mechanism includes a plurality of artificial leaflets 600, which are sequentially connected to form a leaflet mechanism having an outer circumference of a circular ring. The leaflet mechanism is connected to the inner sidewall of the inner frame 200, and the middle portion of the leaflet mechanism can open and close in one direction.

[0122] In some embodiments, the artificial valve leaflet 600 and the covering structure are sutured to form a suture line track. Figures 5(a) to 8 , the artificial valve leaflet 600 includes a valve leaflet body 610.

[0123] Since the size of the inner frame 200 has different specifications according to actual needs, and as the size of the inner frame 200 changes, the artificial leaflet 600 also needs to change in size. When the artificial leaflet 600 is sutured to each other by the covering mechanism, a suture line track will be formed. When the suture line track is consistent with the outer contour of the leaflet body, the outer contour of the leaflet body 610 and / or the suture line track have a certain geometric relationship, and the performance of the artificial leaflet 600 is better. When the suture line track is inconsistent with the outer contour of the leaflet body, when the outer contour of the leaflet body 610 does not conform to the geometric relationship, the suture line track contour must conform to the geometric relationship. Therefore, at least one of the outer contour of the distal end of the leaflet body 610 or the suture line track has a certain geometric relationship. The following takes the outer contour of the leaflet body 610 having a certain geometric relationship as an example:

[0124] Reference Figure 8 The outer contour of the distal end of the leaflet body 610 includes a leaflet base arc 611 and two leaflet side arcs. The distal end of the leaflet base arc 611 is an arc-shaped structure. The two leaflet side arcs are located on both sides of the leaflet base arc 611, and the distal ends of the leaflet side arcs are also arc-shaped structures. The leaflet base arc 611 is tangentially connected to the leaflet side arcs on both sides to form the distal end of the artificial leaflet 600.

[0125] In some embodiments, the leaflet bottom arc 611 is an arc formed by the first center O1 and the first radius R1; the two leaflet side arcs are the first leaflet side arc 612a and the second leaflet side arc 612b, the first leaflet side arc 612a is an arc formed by the second center O21 and the second radius R2, and the second leaflet side arc 612b is another arc formed by the second center O22 and the second radius R2; the line connecting the first center O1, the second center O21 and the second center O22 is an equilateral triangle.

[0126] In some embodiments, the side length L of the equilateral triangle is greater than the diameter of the leaflet base arc 611 and less than the width D of the leaflet body. This can prevent the artificial valve leaflet 600 from forming a narrow, long, or short leaflet shape, which would affect the performance of the leaflet and thus the performance of the artificial valve leaflet 600.

[0127] In some embodiments, the artificial leaflet has an axial leaflet symmetry line I; the first circle center O1 is located on the leaflet symmetry line I, and the second circle center O21 and the second circle center O22 are symmetrical about the leaflet symmetry line I.

[0128] In some embodiments, the proximal outer contour of the leaflet body 610 has a leaflet top arc 613, which is located on the proximal side of the leaflet bottom arc 611, and the proximal end of the leaflet top arc 613 is an arc-shaped structure.

[0129] In some embodiments, the leaflet top arc 613 is an arc formed by a third center O3 and a third radius R3, and the third center O3 is located on the leaflet symmetry line I.

[0130] In some embodiments, the distance from the third center O3 to the first center O1 is N times the side length L of the equilateral triangle. Preferably, the distance from the third center O3 to the first center O1 is three times the side length L of the equilateral triangle, that is, the distance from the third center O3 to the first center O1 is 3L.

[0131] In some embodiments, reference Figures 5(a) to 8 The artificial valve leaflet 600 further includes two ears 620. The two ears 620 are respectively located on both sides of the proximal end of the valve leaflet body 610. The ears 620 are used to connect with the inner frame 200 to fix each artificial valve leaflet 600.

[0132] In some embodiments, referring to Figure 5(b), when the artificial leaflet 600 is installed, the ear 620 passes through the leaflet hole 430 of the inner frame covering 400 and is connected to the leaflet suture hole 232 of the inner frame 200, and is sutured to the leaflet body 610 after bypassing the leaflet suture hole 232. Two adjacent ears 620 are connected to the same leaflet suture hole 232, so that the proximal edges of the two adjacent artificial leaflets 600 are in close contact, thereby preventing blood reflux due to incomplete closure of the leaflet mechanism.

[0133] In some embodiments, referring to FIG6( a ), the ear portion 620 includes an upper ear portion 621, a lower ear portion 622, and an escape groove 623. The upper ear portion 621 is located proximal to the ear portion 621; the lower ear portion 622 is located distal to the upper ear portion 621; and the escape groove 623 is open on its side and located between the upper ear portion 621 and the lower ear portion 622, separating the upper ear portion 621 from the lower ear portion 622. In a specific implementation, the escape groove 623 can be formed by cutting a groove from the side toward the center of the original ear portion 620, with the upper ear portion 621 formed proximal to the escape groove 623 and the lower ear portion 622 formed distal to the escape groove 623.

[0134] In some embodiments, referring to Figures 6(b) and 6(c), when installing the artificial valve leaflet 600, the upper ear portion 621 is folded over at the avoidance groove 623, and the lower ear portion 622 is sequentially passed through the leaflet hole 430 of the inner frame covering 400 and the leaflet suture hole 232 of the inner frame 200. The frame where the leaflet suture hole 232 is located is snapped into the position of the avoidance groove 623. The inner frame covering 400 is clamped between the upper ear portion 621 and the lower ear portion 622 and sutured together. Two adjacent ears 620 are connected to the same leaflet suture hole 232, so that the proximal edges of the two adjacent artificial valve leaflets 600 are in close contact, preventing blood reflux caused by incomplete closure of the leaflet mechanism. Compared with Figure 5(b), this method can effectively prevent blood reflux caused by blood leakage caused by the leaflet hole 430 of the inner frame covering 400.

[0135] In some embodiments, the length of the avoidance groove 623 is generally no greater than 2 / 3 of the width of the ear portion 620 to prevent the upper ear portion 621 and the lower ear portion 622 from being torn and split.

[0136] In some embodiments, reference Figure 7 The distal end edge of the leaflet body 610 is provided with an anti-wear edge strip 630, and the anti-wear edge strip 630 is connected to the leaflet body 610 by suturing. The anti-wear edge strip 630 is firmly fixed to the leaflet body by suturing, and the setting of the anti-wear edge strip 630 firstly increases the tear resistance of the distal end of the leaflet body 610, and secondly reduces the damage to the artificial leaflet caused by the friction between the distal end of the leaflet body 610 and the membrane, thereby increasing the service life of the artificial leaflet. Moreover, the setting of the anti-wear edge strip 630 is also equivalent to a buffer layer between the artificial leaflet and the membrane, which effectively buffers the tearing force of the artificial leaflet on the membrane during the opening and closing process, thereby increasing the service life of the anti-reflux stent.

[0137] In some embodiments, reference Figures 9(a) to 10(b) The outer frame 100 includes, from the proximal end to the distal end, a tether end 110, an external connecting portion 120, a support portion 130, and an outer skirt portion 140, which are sequentially connected. When the outer frame 100 is covered with the outer frame coating 300, at least the tether end 110 is exposed from the outer frame coating 300. As shown in Figures 2(b) and 9(a), both the tether end 110 and the external connecting portion 120 are exposed from the outer frame coating 300.

[0138] The tether end 110 is in a bunched shape, referring to Figure 18Tether end 110 is connected to tether 310. After tether end 110 is pulled, tether 310 is secured via apical spacer 320. The present invention abandons the traditional method of connecting tether 310 to the inner frame. Instead, tether 310 is connected to outer frame 100. When the tether is subjected to force, it is first transmitted to outer frame 100, then to inner frame 200, and finally to the leaflet mechanism within inner frame 200. This method has a relatively minimal impact on the opening and closing of the leaflets within the leaflet mechanism.

[0139] The proximal end of the external connecting portion 120 is connected to the distal end of the tether end 110, and the external connecting portion 120 is connected to the inner frame 200. The support portion 130 has a hollow, columnar structure, which accommodates the inner frame 200. The distal end of the outer skirt portion 140 has a gathered structure, with a D-shaped cross-section. The gathered structure at the distal end of the external frame 100 prevents the tip from puncturing the inner wall of the heart.

[0140] In some embodiments, referring to Figures 10(a) and 10(b), a tether end 110 includes a plurality of tether link brackets 111, each of which is independent of the other, and each of which has a tether hole 112. The independence of the tether link brackets increases the flexibility of the tether end, i.e., the tether link brackets do not exert mutual forces, effectively increasing the angular adaptability of the tether end, allowing for a certain degree of angular deviation. Furthermore, the tether end facilitates heat setting during processing of the outer frame, reducing processing costs.

[0141] In some embodiments, the proximal end and the distal end of the tether link bracket 111 are both square structures, and the square structure has a tether hole 112, so that square connection frames are formed at the proximal end and the distal end of the tether link bracket 111 respectively.

[0142] In some embodiments, the proximal end and the distal end of the square connection frame are provided with rounded corners, so that the square connection frame 113 forms an octagonal structure.

[0143] In some embodiments, as shown in FIG10( a ), when the bracket is unfolded into a flat surface, the left and right side surfaces of the tether link bracket 111 are parallel to each other. The left and right side surfaces of the square connecting frame 113 are parallel to each other, which further facilitates gripping the tether end. Furthermore, the left and right side surfaces of the tether link bracket 111 and the square connecting frame 113 are also parallel to each other.

[0144] In some embodiments, referring to Figures 10(a) and 10(b), the external connection part 120 includes a plurality of external connection rods 121, the proximal ends of the external connection rods 121 are respectively connected to the distal ends of the tether ends 110, and the external connection rods 121 are inclined outward from the proximal ends to the distal ends, so that the plurality of external connection rods 121 form a hollow frustum-like structure, and the external frame 100 is connected to the internal frame 200 through the external connection rods 121.

[0145] In some embodiments, referring to Figures 10(a) and 10(b), the distal end of each outer connecting rod 121 is provided with an outer suture hole 122. Referring to Figure 11(a), the inner frame 200 is provided with an inner suture hole 212, and the outer frame 100 and the inner frame 200 are sutured together by suturing the outer suture holes 122 and the inner suture holes 212.

[0146] In some embodiments, the diameter of the outer suture hole 122 is larger than the diameter of the inner suture hole 212 , so as to reduce the matching accuracy between the inner frame 200 and the outer frame 100 .

[0147] In some embodiments, referring to Figures 12(a) and 12(b), the outer suture hole 122 and the inner suture hole 212 are both long waist-shaped holes, and the length direction of the waist-shaped hole is the length direction of the outer connecting rod 121. Since the outer connecting rod 121 is inclined outward from the proximal end to the distal end, the waist-shaped hole is also inclined outward from the proximal end to the distal end.

[0148] Both the outer suture hole and the inner suture hole are designed as long waist-shaped holes, which increases the number of suture turns. That is, compared with ordinary round suture holes, it is easier to sew multiple turns of suture, preventing the suture from breaking and causing the separation of the inner frame and the outer frame; and the long suture holes reduce the matching accuracy between the inner frame and the outer frame, thereby reducing the processing cost, because compared with traditional circular suture holes, the long suture holes can allow a certain degree of axial displacement between the outer frame and the inner frame, and the inner frame and the outer frame are both cut from stainless steel or nickel-titanium tubes or cobalt-chromium tubes, but it should be noted here that the material used can be any material that can be implanted in the human body, so its circumferential deviation is small, so this design focuses on solving the axial deviation between the inner frame and the outer frame.

[0149] In some embodiments, the outer frame 100 and the inner frame 200 may be connected by riveting, bolting or welding.

[0150] In some embodiments, a gasket is provided between the outer frame 100 and the inner frame 200 to prevent friction between the outer frame 100 and the inner frame 200 and to act as a buffer between the outer frame 100 and the inner frame 200 .

[0151] In some embodiments, referring to Figure 10(a), the support portion 130 includes a plurality of X-shaped brackets 131, each X-shaped bracket 131 having two proximal connecting rods 1311 and two distal connecting rods 1312 connected to each other, the proximal end of the proximal connecting rod 1311 being connected to the distal end of the outer connecting portion 120, and the distal end of the distal connecting rod 1312 being connected to the proximal end of the outer skirt portion 140, if the X-shaped brackets 131 form the support portion 130.

[0152] In some embodiments, the angle between the two proximal connecting rods 1311 is greater than the angle between the two distal connecting rods 1312 .

[0153] In some embodiments, the proximal connecting rod 1311 is inclined inward from the proximal end to the distal end, and the distal connecting rod 1312 is inclined outward from the proximal end to the distal end. The proximal connecting rod 1311 and the distal connecting rod 1312 are smoothly connected, so that the X-shaped stent 131 forms a structure with an inward concave middle portion of the outer peripheral surface. In order to better stick to the native valve leaflet and its annulus, it should be noted that the inward concave structure here can be formed by the outward expansion of the outer skirt portion 140, the X-shaped stent 131 body can be an inward concave structure, or the X-shaped stent 131 itself can be straight and, after a smooth transition connection with the outer skirt portion 140, is concave relative to the outer skirt portion 140.

[0154] In some embodiments, referring to FIG. 10( a ), the outer skirt portion 140 includes a plurality of outer diamond-shaped brackets 141 . Each outer diamond-shaped bracket 141 has a V-shaped connecting rod 1411 and an inverted V-shaped connecting rod 1412 connected to each other. The proximal end of the V-shaped connecting rod 1411 is connected to the distal end of the support portion 130 . The plurality of outer diamond-shaped brackets 141 form an outer skirt portion 140 having a D-shaped cross-section. At least the inverted V-shaped connecting rod 1412 tilts inward from the proximal end to the distal end, forming a convergent structure.

[0155] Reference Figure 17 The mitral valve 400 generally has a cross-section approximately in the shape of a D, with a front leaflet 410 and a rear leaflet 420 , so the outer skirt portion 140 also forms a structure with a cross-section having a D-shaped profile.

[0156] In some embodiments, referring to FIG. 10( a ), the inwardly contracting angle of the inverted V-shaped connecting rod 1412 is α, with a range of 10°≤α≤20°, and preferably 15°. Excessively large contraction angles can affect the endothelialization rate of the outer skirt portion 140 . Therefore, an appropriate contraction angle can meet the endothelialization rate while protecting the heart's inner wall from collision and puncture by the distal end of the outer skirt portion 140 .

[0157] In some embodiments, the V-shaped connecting rod 1411 tilts outward from the proximal end to the distal end to form an outward-expanding structure. The V-shaped connecting rod 1411 and the inverted V-shaped connecting rod 1412 are smoothly connected, causing the outer skirt portion 140 to form a structure in which the middle of the outer peripheral surface protrudes outward.

[0158] In some embodiments, referring to FIG. 10( a ), the outward expansion angle of the V-shaped connecting rod 1411 is β, and the range of β is 15°≤β≤75°.

[0159] In some embodiments, the angle β of the curved side closer to the D-shaped profile is greater than the angle β of the straight side closer to the D-shaped profile, and the difference between the angle β and the straight side is no less than 25°. Specifically, referring to FIG10(a) and FIG10(b), the flare angle β decreases as the skirt edge approaches the left side, and increases as the skirt edge approaches the right side. However, the difference between the maximum flare angle β and the minimum flare angle β is no less than 25°.

[0160] In some embodiments, the difference between the angle β of the curved side close to the D-shaped profile and the angle β of the straight side close to the D-shaped profile is 30°, and the angle β of the straight side close to the D-shaped profile is at least 30°.

[0161] The opening and closing ranges of the anterior leaflet 410 and the posterior leaflet 420 are different, and the structural dimensions of the junction between the left atrium and the mitral valve ring are different. By designing a gradual outward expansion structure, the outer skirt portion 140 of the outer frame can fit closely to the inner wall of the heart, thereby increasing the stability of the transapical mitral valve replacement valve device after installation.

[0162] In some embodiments, reference Figure 13(a) to Figure 14(b)At least one marking member 150 is provided on the outer frame 100. Preferably, two marking members 150 are provided on the outer frame 100. The two marking members 150 are respectively located on the two outer diamond-shaped brackets 141 on the straight side of the D-shaped profile. Both marking members 150 are located at the distal end of the two outer diamond-shaped brackets 141, that is, the marking members 150 are located on the distal end side of the inverted V-shaped connecting rod 1412. Referring to Figures 13(b) and 14(b), the two marking members 150 are located at a predetermined distance from each other on one side of the outer diamond-shaped bracket 141, that is, the marking members 150 are located on the side of the distal end of the inverted V-shaped connecting rod 1412. The marker is used to identify the position of the external frame, so the two markers 150 do not have to be symmetrical about the symmetry line 250 perpendicular to the straight side of the D-shaped contour. They can be normally set on any two external diamond-shaped brackets 141 located on the straight side of the D-shaped contour, thereby being able to determine the position of the transapical mitral valve replacement valve device. It should be stated that the two markers 150 are set at a preset distance from each other on one side of the external diamond-shaped bracket 141, which may include setting the marker 150 at the distal end of the inverted V-shaped connecting rod 1412, and when only one marker 150 is set, the difference from the embodiment of setting two markers 150 is that only one of the two markers 150 is removed, and one marker 150 is retained.

[0163] In some embodiments, referring to FIG. 13( b ), the marking member 150 is a protruding semicircular raised member, and the marking member 150 is integrally formed with the outer diamond-shaped bracket 141 .

[0164] In some embodiments, referring to FIG. 14( a ) and FIG. 14 ( b ), the marker 150 is a marking hole provided on the outer diamond-shaped bracket 141 , and a radiopaque marking material (“marker”) is installed in the marking hole.

[0165] The marking member of the present invention can be any form of protrusion or marking hole equipped with radiopaque marking material, as long as it can be easily observed by the operator under the imaging equipment.

[0166] In some embodiments, reference Figures 9(a) to 10(a) 、 Figure 15 The outer frame 100 is further provided with a barb portion 160, which is inclined outward from the proximal end to the distal end.

[0167] The barbs are designed to grasp the native mitral valve leaflets, assisting in sealing the valve system and reducing post-implant paravalvular leakage. Furthermore, after implantation, when the left atrium contracts, the implanted leaflets are dislodged by blood, placing less pressure on the valve device. However, during ventricular contraction, the implanted leaflets are closed, placing greater pressure on the valve device. Without restraint, the valve device could break away from the native annulus and slip into the left atrium. While the apical tether holds the valve device in place, the barbs of the valve device hook onto the native leaflets, helping to distribute the force of the apical tether, reducing stress on the heart muscle and minimizing damage to the heart. Furthermore, the device prevents the native mitral valve leaflets from freely moving within the heart. For example, if the anterior leaflet were to reverse under the pressure of blood, it could cause aortic obstruction, endangering the patient's life. By clamping the native leaflets between the barbs and the external frame, this prevents free movement of the native leaflets.

[0168] In some embodiments, the barb portion 160 includes a plurality of inverted V-shaped barbs 161 , the proximal ends of the inverted V-shaped barbs 161 are respectively connected to the outer frame 100 , and the inverted V-shaped barbs 161 are tilted outward from the proximal end to the distal end and exposed outside the outer frame 100 , and the plurality of inverted V-shaped barbs 161 form the barb portion 160 .

[0169] In some embodiments, the inverted V-shaped barb 161 is inclined outward at an angle of 5° to 15°.

[0170] In some embodiments, the inverted V-shaped barbs 161 located on the straight side of the D-shaped profile are vertical barbs that are not inclined to the outside, or, referring to Figure 15 , no inverted V-shaped barb 161 is provided on the straight side of the D-shaped profile.

[0171] Because the anterior leaflet of the mitral valve is close to the aorta, and the protruding barbs may affect the aorta and cause aortic dysfunction, the barbs close to the aorta are removed, that is, the barbs on the straight side of the D-shaped contour are removed, or the barb structure here is retained but no longer protrudes outward. By using the adjacent barb structure at this position to fix the mitral valve, the protruding barb structure is prevented from affecting the function of the aorta.

[0172] In some embodiments, both sides of the proximal end of the inverted V-shaped barb 161 are integrally connected to the proximal end connecting rods 1311 of two adjacent X-shaped brackets 131. A plurality of inverted V-shaped barbs 161 are evenly distributed on the support portion 130.

[0173] In some embodiments, referring to FIG. 10 (a) and FIG. 10 (b), FIG. 12 (a), Figure 15The outer frame 100 includes a tether end 110, an external connection portion 120, a support portion 130 and an outer skirt portion 140 connected in sequence from the proximal end to the distal end. The tether link brackets 111 of the tether end 110 are independent of each other. The proximal end and the distal end of each tether link bracket 111 respectively have a square connection frame, and the middle of the square connection frame has a tether hole 112. The number of external connecting rods 121 in the external connection portion 120 is the same as that of the tether link bracket 111. The proximal end of each external connecting rod 121 is connected to the distal end of a corresponding tether link bracket 111. The distal end of the external connecting rod 121 is provided with an external suture hole 122, which can be a circular hole or a waist-shaped hole. The number of X-shaped brackets 131 in the support portion 130 is determined by the number of external connecting rods 121. The two proximal connecting rods 1311 of each X-shaped bracket 131 are connected to the distal ends of two adjacent external connecting rods 121. The number of external diamond-shaped brackets 141 in the outer skirt portion 140 is determined by the number of X-shaped brackets 131. The proximal end of the V-shaped connecting rod 1411 in each outer diamond-shaped bracket 141 is connected to a distal connecting rod 1312 of the X-shaped bracket 131. Adjacent outer diamond-shaped brackets 141 are connected at their midpoints.

[0174] For example, the outer frame 100 is provided with six tether link brackets 111, which are parallel to each other and form the tether end 110. The six tether link brackets 111 are independently connected to six external connecting rods 121, which expand outward to form the external connecting portion 120. Two adjacent external connecting rods 121 are connected to the proximal end of the same X-shaped bracket 131, so there are also six X-shaped brackets 131, and the six X-shaped brackets 131 form the support portion 130. Because the proximal end of each V-shaped connecting rod 1411 is connected to a distal end connecting rod 1312 of the X-shaped bracket 131, twelve external diamond-shaped brackets 141 are required. The twelve external diamond-shaped brackets 141 are connected in sequence to form the outer skirt portion 140.

[0175] In some embodiments, the outer frame 100 is made of stainless steel, nickel-titanium tube, or cobalt-chromium tube cut into one piece. That is, the tether end 110, outer connecting portion 120, support portion 130, outer skirt portion 140, marker 150, and barb portion 160 are made of stainless steel, nickel-titanium tube, or cobalt-chromium tube cut into one piece.

[0176] In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer suture holes 122 arranged side by side, the two marking members 150 are protruding semicircular raised members, and the barbs 160 are evenly arranged on the supporting portion 130 .

[0177] In some embodiments, the outer connecting portion 120 in the outer frame 100 has two circular outer suture holes 122 arranged side by side, the two marking members 150 are marking holes with radiopaque marking materials installed therein, and the barbs 160 are evenly arranged on the supporting portion 130 .

[0178] In some embodiments, the outer suture hole 122 on the outer connection portion 120 in the outer frame 100 is a long waist-shaped hole, the two marking parts 150 are protruding semicircular raised components, and the barbs 160 are evenly arranged on the support portion 130.

[0179] In some embodiments, the external connection portion 120 in the external frame 100 has two circular external suture holes 122 arranged side by side, and the two marking parts 150 are protruding semicircular raised components. There is no inverted V-shaped barb 161 on the straight side of the D-shaped profile, and the inverted V-shaped barbs 161 at other positions are evenly arranged on the support portion 130.

[0180] In some embodiments, the external connection portion 120 in the external frame 100 has two circular external suture holes 122 arranged side by side, and the two marking members 150 are marking holes with non-transmissive marking materials installed inside. There is no inverted V-shaped barb 161 on the straight side of the D-shaped profile, and the inverted V-shaped barbs 161 at other positions are evenly arranged on the support portion 130.

[0181] In some embodiments, referring to Figures 9(a), 9(b) and 11(a), the inner frame 200 includes an inner connecting portion 210, a plurality of stent connecting rods 220, a leaflet connecting portion 230 and an inner skirt portion 240, which are sequentially connected from the proximal end to the distal end. The inner connecting portion 210 is a folded structure, and the inner connecting portion 210 is connected to the outer frame 100. The plurality of stent connecting rods 220 are arranged to be inclined outward from the proximal end to the distal end. The leaflet connecting portion 230 is connected to the leaflet mechanism. The inner skirt portion 240 and the leaflet connecting portion 230 are both hollow columnar structures, which can accommodate the leaflet mechanism.

[0182] In some embodiments, the internal connection portion 210 includes a plurality of internal connecting rods 211 each having internal suture holes 212 therein. These internal suture holes 212 facilitate the suture connection between the inner frame 200 and the outer frame 100. The plurality of internal connecting rods 211 are arranged to tilt outward from their proximal ends to their distal ends, forming a collapsed structure. The angle of inclination of the internal connecting rods 211 matches that of the external connecting rods 121, ensuring a highly secure connection between the two.

[0183] Specifically, the inner suture holes 212 and the outer suture holes 122 are sutured to achieve the suture connection between the inner frame 200 and the outer frame 100. The inner suture holes 212 can be two circular suture holes as shown in Figure 11 (a) or waist-shaped holes as shown in Figure 12 (b).

[0184] In some embodiments, the leaflet connection portion 230 includes several leaflet connection rods 231, each of which has a leaflet suture hole 232. The leaflet suture hole 232 is used to suture the inner frame 200 and the leaflet mechanism. Several leaflet connection rods 231 form the leaflet connection portion 230.

[0185] In some embodiments, referring to Figure 11(a), the leaflet connecting rod 231 is an integer multiple of n, where n is a positive integer greater than or equal to 2. The total number of leaflet connecting rods 231 is generally not greater than 24. Too many leaflet connecting rods 231 will affect the grip of the stent. This embodiment is explained using one of the integer multiples of 3, i.e., 6 leaflet connecting rods 231. Each leaflet connecting rod 231 is provided with a leaflet suture hole 232. However, it should be noted that not every leaflet suture hole 232 must be sutured with an artificial leaflet. Corresponding selections are made according to needs to decide whether to suture the artificial leaflet.

[0186] In some embodiments, referring to FIG. 11( a ), this embodiment is still explained by taking an integer multiple of 3, namely 6 leaflet connecting rods 231 , as an example, and a leaflet suture hole 232 is provided every at least one leaflet connecting rod 231 .

[0187] As shown in FIG11( a ), the leaflet connection portion 230 has six leaflet connection rods 231 , each of which is connected to two adjacent inner connection rods 211 via two obliquely arranged support connection rods 220 . When a leaflet suture hole 232 is provided on one leaflet connection rod 231 , the two leaflet connection rods 231 on the adjacent side are not provided with a leaflet suture hole 232 . This structure is suitable for a leaflet mechanism having three leaflets. When a leaflet mechanism having two leaflets is used, two symmetrically arranged leaflet connection rods 231 may be provided with leaflet suture holes 232 , while the other leaflet connection rods 231 are not provided with leaflet suture holes 232 , that is, when a leaflet suture hole 232 is provided on one leaflet connection rod 231 , the two leaflet connection rods 231 on the adjacent side are not provided with a leaflet suture hole 232 .

[0188] When the number of leaflet connecting rods 231 is changed, the arrangement of the leaflet suture holes 232 can also be changed according to actual needs. This can be achieved through simple adjustments, so it will not be described in detail.

[0189] In some embodiments, referring to FIG11( b ), the width of the leaflet connecting rods 231 without leaflet suture holes 232 is 1 / 3 to 1 / 2 of the overall width of the leaflet connecting rods 231 with leaflet suture holes 232. This design enhances the compressibility of the stent while also reducing the strength difference between the leaflet connecting rods 231 with and without leaflet suture holes 232, thereby improving the mechanical balance of the stent.

[0190] In order to allow the number of leaflets to be freely adjusted, such as three leaflets and two leaflets can be used freely, and also to reduce the force imbalance of the inner frame 200, as shown in Figure 11(a), leaflet suture holes 232 are provided on the leaflet connecting rods 231.

[0191] 11( a ), the inner skirt portion 240 includes a plurality of inner diamond-shaped brackets 241 , which form a hollow columnar structure. One inner diamond-shaped bracket 241 in the inner frame 200 corresponds to two outer diamond-shaped brackets 141 in the outer frame 100 .

[0192] Although the outer diamond-shaped brackets 141 of the outer frame 100 have a D-shaped cross-section, the outer diamond-shaped brackets 141 of the skirt are evenly distributed and correspond to the inner diamond-shaped brackets 241 of the inner frame 200. For each inner diamond-shaped bracket 241 of the inner frame 200, two outer diamond-shaped brackets 141 of the outer frame 100 are associated.

[0193] In some embodiments, reference Figure 16 The cross section of the inner frame 200 has a symmetry line 250 perpendicular to the straight side of the D-shaped profile. The at least two inner suture holes 212 of the inner frame 200 and the at least two inverted V-shaped barbs 161 of the outer frame 100 are located on the symmetry line. Figure 16 As shown, the leftmost inverted V-shaped barb 161 and the rightmost inverted V-shaped barb 161 can smoothly clamp the native anterior leaflet and the native posterior leaflet, and the adjacent barb structure can also assist in clamping the native leaflets, while also providing a basis for subsequent membrane covering.

[0194] In some embodiments, the inner frame 200 is made of stainless steel, nickel-titanium tube, or cobalt-chromium tube cut into one piece. That is, the inner connecting portion 210, the plurality of stent connecting rods 220, the leaflet connecting portion 230, and the inner skirt portion 240 are made of stainless steel, nickel-titanium tube, or cobalt-chromium tube cut into one piece.

[0195] In some embodiments, the inner connecting portion 210 in the inner frame 200 has an inner suture hole 212 , which is a long waist-shaped hole. Each leaflet connecting rod 231 has a leaflet suture hole 232 .

[0196] In some embodiments, the inner connecting portion 210 in the inner frame 200 has two circular inner suture holes 212 , and each leaflet connecting rod 231 has a leaflet suture hole 232 .

[0197] In some embodiments, the transapical mitral valve replacement device of the present invention is still suitable for transcatheter delivery methods. Figure 18 When the present invention is used to prevent valvular regurgitation, one end of a tether 310 is connected to the tether end 110 of the outer frame 100, and the other end of the tether 310 is secured via an apical spacer 320, which can be conventional. With this securing method, when force is applied to the tether 310, it is first transmitted to the outer frame 100, then to the inner frame 200, and finally to the leaflet mechanism within the inner frame 200. This has a relatively minimal impact on the opening and closing of the leaflets within the leaflet mechanism.

[0198] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A transapical mitral valve replacement device comprising: A support mechanism comprising an outer frame and an inner frame connected to the outer frame; a leaflet mechanism located in the inner frame; a coating mechanism, covering the support mechanism; Characterized in that the leaflet mechanism comprises: A plurality of artificial valve leaflets, wherein the plurality of artificial valve leaflets are sequentially connected to form a valve leaflet mechanism having an outer circumference of a circular ring structure, the valve leaflet mechanism being connected to the inner side wall of the inner frame, and the middle portion of the valve leaflet mechanism being capable of unidirectional opening and closing; the covering mechanism and the artificial valve leaflets are sutured to each other to form a suture line track; Wherein, the artificial valve leaflet includes a valve leaflet body, and the suture line trajectory has: A leaflet bottom arc, the distal end of which is an arc-shaped structure, wherein the leaflet bottom arc is an arc formed by the first center and the first radius; Two leaflet side arcs are symmetrically located on both sides of the leaflet base arc, the two leaflet side arcs are respectively a first leaflet side arc and a second leaflet side arc, the first leaflet side arc is an arc formed by the second first center and the second radius, and the second leaflet side arc is another arc formed by the second second center and the second radius; The leaflet bottom arc is tangently connected to the first leaflet side arc and the second leaflet side arc, and the line connecting the first circle center, the second first circle center and the second second circle center forms an equilateral triangle; The side length of the equilateral triangle is greater than the diameter of the leaflet bottom arc and less than the width of the leaflet body.

2. The transapical mitral valve replacement device according to claim 1, wherein: The artificial valve leaflet has an axial valve leaflet symmetry line; The first circle center is located on the leaflet symmetry line, and the second-first circle center and the second-second circle center are symmetrical about the leaflet symmetry line.

3. The transapical mitral valve replacement device according to claim 2, wherein: The proximal outer contour of the leaflet body has: A leaflet top arc is located proximal to the leaflet bottom arc.

4. The transapical mitral valve replacement device according to claim 3, wherein: The leaflet top arc is an arc formed by a third center and a third radius, and the third center is located on the leaflet symmetry line.

5. The transapical mitral valve replacement device according to claim 4, wherein: The distance from the third circle center to the first circle center is three times the side length of the equilateral triangle.

6. The transapical mitral valve replacement device according to any one of claims 1 to 5, wherein: The artificial valve leaflet further comprises: two ears, respectively located on both sides of the proximal end of the leaflet body; The artificial valve leaflet is connected to the valve leaflet suture hole in the inner frame through the ear portion, and two adjacent ears are connected to the same valve leaflet suture hole.

7. The transapical mitral valve replacement device according to claim 6, wherein: The ear portion comprises: One upper ear; a lower ear, located at the distal end side of the upper ear; An avoidance groove has an opening on its side and is located between the upper ear and the lower ear. The upper ear and the lower ear are separated by the avoidance groove.

8. The transapical mitral valve replacement device according to claim 7, wherein: The length of the avoidance groove is no more than 2 / 3 of the width of the ear.

9. The transapical mitral valve replacement device according to claim 1, wherein: The distal end edge of the leaflet body is provided with: An anti-wear edge strip is connected to the leaflet body by suturing.

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