Transapical mitral valve replacement valve device

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a mitral valve replacement valve device. The mitral valve replacement valve device comprises a support mechanism, an outer support, and an inner support connected to the outer support; a covering mechanism covering the support mechanism; the covering mechanism comprises an outer support covering film covering the outer support, an inner support covering film covering the inner support, and a connecting covering film connecting the outer support covering film and the inner support covering film. The covering mechanism is divided into the outer support covering film, the inner support covering film, and the connecting covering film. The outer support covering film covers the outer support, the inner support covering film covers the inner support, and the independent outer support covering film and the inner support covering film are connected into a whole through the design of the connecting covering film, so that the stability of the mitral valve replacement valve device is greatly increased, and the inner support is effectively prevented from shaking in the outer support.

Description

Technical Field

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

[0002] Valvular regurgitation is a common valvular disease, such as mitral regurgitation and tricuspid regurgitation. Mitral regurgitation occurs due to valvular insufficiency. During left ventricular systole, blood flows from the left ventricle into the aorta and the less resistant left atrium. The left atrium receives blood from both the pulmonary veins and the regurgitated blood from the left ventricle. Therefore, increased left atrial pressure can lead to increased pressure in the pulmonary veins and pulmonary capillaries, resulting in dilation and congestion. Simultaneously, the diastolic volume load of the left ventricle increases, causing left ventricular enlargement. In acute mitral regurgitation, the sudden increase in regurgitated blood in the left atrium can cause a rapid rise in pressure in the left atrium and pulmonary veins, leading to acute pulmonary edema.

[0003] Currently, there are two main surgical treatments for mitral regurgitation: open-heart surgery and minimally invasive medical surgery. Open-heart surgery is often avoided by many patients due to its significant surgical trauma, high risks, and long-term, expensive rehabilitation. Minimally invasive medical surgery offers doctors a new treatment method with less trauma, fewer complications, and faster postoperative recovery. During minimally invasive medical surgery, mitral valve replacement devices can resolve mitral regurgitation. Traditional mitral valve replacement devices use a separate membrane application method, which can lead to instability between the inner and outer frame, causing the mitral valve replacement device to become unstable. Summary of the Invention

[0004] This invention addresses the technical problem of existing mitral valve replacement devices using a separate membrane, which leads to easy shaking between the inner and outer frames and causes device instability. The purpose is to provide a transapical mitral valve replacement device.

[0005] A transapical mitral valve replacement device includes:

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

[0007] A film-coating mechanism is applied to the support mechanism;

[0008] The coating mechanism includes:

[0009] An outer frame covering is provided to cover the outer frame.

[0010] An inner frame is covered with a film;

[0011] A connecting film is used to connect the outer frame film and the inner frame film respectively.

[0012] As a preferred embodiment, the outer frame covering is a semi-circular structure, with the outer frame covering surrounding the outside of the outer frame and covering the outer surface of the outer frame.

[0013] As a preferred embodiment, the distal edge of the outer frame covering film protrudes beyond the distal end of the outer frame and is turned inward to the inside of the outer frame, so that the distal edge of the outer frame covering film covers the distal end of the outer frame.

[0014] The outer frame covering located inside the outer frame is connected to the connecting covering.

[0015] As a preferred embodiment, the outer frame covering is provided with:

[0016] Several slots in the outer frame's film coating correspond to the barbed structures on the outer frame;

[0017] When the outer frame is covered by the film, the barbs on the outer frame pass through the slots in the outer frame film.

[0018] As a preferred embodiment, the outer frame covering film has at least one arc-shaped slit, which serves as a plurality of slots in the outer frame covering film.

[0019] As a preferred embodiment, the inner frame covering film has a long strip structure, and the inner frame covering film surrounds the inner side of the inner frame and covers the inner side of the inner frame;

[0020] The distal end of the inner frame covering has a toothed structure, which is turned outward to the outside of the inner frame and connected to the inner skirt edge of the distal end of the inner frame.

[0021] As a preferred embodiment, the toothed structure is fixedly connected to the inner skirt edge by stitching.

[0022] As a preferred embodiment, a flange marking line is formed at the connection between the toothed structure and the elongated structure;

[0023] The connecting film is connected to the flange marking line.

[0024] As a preferred embodiment, the inner frame covering film is provided with leaflet holes, which allow artificial leaflets to pass through and be fixed to the inner frame.

[0025] As a preferred embodiment, the connecting membrane has a circular structure, the outer edge of the connecting membrane is connected to the outer frame membrane, the outer edge of the connecting membrane is located between the outer frame membrane and the outer frame, and the outer edge of the connecting membrane covers the outer frame membrane;

[0026] The inner edge of the connecting film is connected to the flange marking line of the inner frame film.

[0027] As a preferred embodiment, the outer frame covering, the inner frame covering, and the connecting covering are all made of impermeable PET composite film, and the impermeable PET composite film has a layer of PET stitching film.

[0028] As a preferred embodiment, at least one TPU spinning film is provided on the side of the PET film close to the support mechanism, that is, one TPU spinning film is provided on the side of the outer frame film close to the outer frame, one TPU spinning film is provided on the side of the inner frame film close to the inner frame, and one TPU spinning film is provided on the side of the connecting film facing the gap between the outer frame and the inner frame.

[0029] As a preferred embodiment, a TPU spun film is provided on both sides of the PET coating to further improve the blood's impermeability.

[0030] The present invention also provides a method for preparing the impermeable PET composite membrane of the present invention, comprising the following steps:

[0031] S1, On an electrospinning machine, a mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute is pushed onto a clean PET stitch film surface for spinning to obtain an initial PET composite film.

[0032] S2, the initial PET composite film is dried at high temperature to obtain an impermeable PET composite film with a TPU spun film spun on one side.

[0033] As a preferred embodiment, in step S1, a mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute is pushed at a dispensing rate of 0.6 to 1.5 mL / h, with a TPU concentration of 0.09 to 0.2.0 g / mL.

[0034] As a preferred embodiment, in step S1, the frequency of the push pump is 7.0-9.0 Hz, preferably 7.0-8.0 Hz, the speed of the X-axis and Y-axis of the electrospinning machine is 7.5-8.0 mm / s, preferably 7.5 mm / s, and the speed of the Y-axis is 1.5-2.5 mm / s, preferably 1.5 mm / s.

[0035] As a preferred embodiment, in step S1, spinning is performed at a voltage of 15–20 kV, preferably 16–16.5 kV.

[0036] As a preferred embodiment, in step S1, a clean PET suture film is laid flat on a dust-free paper.

[0037] As a preferred embodiment, in step S2, the initial PET composite film is dried at a high temperature of 120-150°C, preferably 140°C, for 20-40 minutes, preferably 30 minutes.

[0038] As a preferred option, in step S2, the initial PET composite film is flattened and sandwiched between two clean and sterile glass surfaces, and then dried at high temperature.

[0039] As a preferred embodiment, the following steps, which are not sequential, are included before step S1:

[0040] Sa, TPU particles are completely dissolved in a mixed solvent of tetrahydrofuran and N,N-dimethylformamide under high-speed stirring to obtain a mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute; and / or,

[0041] Sb, ultrasonic cleaning of PET suture membrane to obtain clean PET suture membrane.

[0042] As a preferred embodiment, in step Sa, the volume ratio of tetrahydrofuran to N,N-dimethylformamide in the mixed solvent is 1:0.3 to 3.0, preferably 1:0.8 to 1.2.

[0043] As a preferred embodiment, in step Sa, the high-speed stirring speed is 500-750 rpm, preferably 650 rpm, and the stirring time is 3-7 hours, preferably 6 hours.

[0044] As a preferred embodiment, in step Sa, the concentration of TPU in the mixed solution is 0.09–0.2 g / mL, preferably 0.15 g / mL.

[0045] As a preferred option, in step Sa, after the TPU particles are completely dissolved under high-speed stirring, they are then stirred at low speed until no bubbles are present.

[0046] As a preferred option, in step Sa, the mixture is stirred at a low speed of 30-55 rpm, preferably 30 rpm, for 0.5-1.5 hours, preferably 1 hour.

[0047] As a preferred embodiment, in step Sb, the device is first ultrasonically cleaned in a 75% ethanol solution, and then ultrasonically cleaned in water for injection.

[0048] As a preferred embodiment, in step Sb, the device is first ultrasonically cleaned in a 75% ethanol solution at 20-70 kHz, preferably 40 kHz, for 5-20 minutes, preferably 15 minutes, and then ultrasonically cleaned in injection water at 10-70 kHz, preferably 40 kHz, for 5-15 minutes, preferably 15 minutes.

[0049] The method of the present invention further includes step S3: repeating steps S1 and S2, spinning the other surface of the anti-permeability PET composite film with TPU spun film on one side and drying it at high temperature to obtain an anti-permeability PET composite film with TPU spun film on both sides.

[0050] As a preferred embodiment, the transapical mitral valve replacement device further includes:

[0051] A single-leaf mechanism is located within the inner frame;

[0052] The leaflet mechanism includes:

[0053] Several artificial petals are connected in sequence to form a petal mechanism with an outer ring structure. The petal mechanism is connected to the inner side wall of the inner frame, and the middle part of the petal mechanism can be opened and closed in one direction.

[0054] As a preferred embodiment, the artificial leaflet comprises:

[0055] The main body of the leaflet has a convex structure at the distal end;

[0056] Two auricles are located on either side of the proximal end of the main body of the leaflet.

[0057] As a preferred embodiment, when installing the artificial leaflet, the auricle passes through the leaflet hole of the inner frame membrane and connects to the leaflet suture hole of the inner frame, and then bypasses the leaflet suture hole and is sutured to the leaflet body. Two adjacent auricles are connected to the same leaflet suture hole, so that the proximal edges of two adjacent artificial leaflets are in close contact.

[0058] As a preferred embodiment, the ear includes:

[0059] The upper ear, located on the proximal side;

[0060] The lower ear is located on the distal end side of the upper ear;

[0061] A clearance groove with an opening on the side is located between the upper ear and the lower ear, separating the upper ear and the lower ear through the clearance groove;

[0062] When installing the artificial leaflet, the upper ear is folded over at the clearance groove, and the lower ear is passed through the leaflet hole of the inner frame membrane and the leaflet suture hole of the inner frame in sequence. The frame where the leaflet suture hole is located is inserted into the clearance groove. The inner frame membrane is clamped between the upper ear and the lower ear and sutured together. Two adjacent ears are connected to the same leaflet suture hole, so that the proximal edges of two adjacent artificial leaflets are in close contact.

[0063] As a preferred embodiment, the length of the clearance groove is no greater than 2 / 3 of the width of the ear, in order to prevent the upper ear and the lower ear from tearing apart.

[0064] As a preferred embodiment, the distal edge of the leaflet body is provided with:

[0065] An anti-abrasion strip is connected to the leaflet body by stitching.

[0066] The positive and progressive effects of this invention are as follows: This invention uses a transapical mitral valve replacement device, which has the following advantages:

[0067] 1. The diaphragm covering mechanism is divided into an outer frame diaphragm, an inner frame diaphragm, and a connecting diaphragm. The outer frame diaphragm covers the outer frame, and the inner frame diaphragm covers the inner frame. Through the design of the connecting diaphragm, the independent outer frame diaphragm and inner frame diaphragm 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.

[0068] 2. Each membrane in the coating mechanism is made of PET woven material. To prevent blood penetration, a TPU spun membrane is added on the side near the support mechanism. The TPU spun membrane is smooth and dense, effectively preventing blood from passing through the coating mechanism.

[0069] 3. The design of the artificial valve leaflets, especially the auricle design, ensures that the proximal edges of adjacent artificial valve leaflets are in close contact, preventing backflow caused by incomplete closure.

[0070] 4. The artificial valve is fixed by using the upper and lower ear parts, which achieves the method of not connecting the ear part to the covering mechanism, and can effectively prevent backflow caused by blood leakage due to the hole of the inner frame covering valve.

[0071] 5. The design of the anti-abrasion edge strip firstly increases the tear resistance of the distal end of the leaflet body, and secondly reduces the damage to the artificial leaflet caused by friction between the distal end of the leaflet body and the membrane, thus improving the service life of the artificial leaflet. Moreover, the anti-abrasion edge strip also acts as a buffer layer between the artificial leaflet and the membrane, effectively buffering the tearing force on the membrane during the opening and closing of the artificial leaflet, thereby increasing the service life of the support mechanism. Attached Figure Description

[0072] Figure 1 This is a schematic diagram of a structure according to an embodiment of the present invention;

[0073] Figure 2(a) is a schematic diagram of one unfolding of the outer frame covering of the present invention;

[0074] Figure 2(b) is a schematic diagram of a connection between the outer frame covering film and the outer frame of the present invention;

[0075] Figure 3 This is a schematic diagram showing one unfolded version of the inner frame covering of the present invention;

[0076] Figure 4 This is a schematic diagram of a structure for connecting the coating according to the present invention;

[0077] Figure 5(a) is a schematic diagram of the unfolded artificial leaflet of the present invention;

[0078] Figure 5(b) is a schematic diagram of the connection between the artificial leaflet and the inner frame covering membrane and part of the inner frame in Figure 5(a);

[0079] Figure 6(a) is another schematic diagram of the unfolded artificial leaflet of the present invention;

[0080] Figure 6(b) is a schematic diagram of the connection between the artificial leaflet and the inner frame covering membrane and part of the inner frame in Figure 6(a);

[0081] Figure 6(c) is a schematic diagram of the overall connection between the artificial leaflet, the inner frame covering membrane, and the inner frame in Figure 6(a);

[0082] Figure 7 This is another schematic diagram showing the unfolded shape of the artificial leaflet of the present invention;

[0083] Figure 8 This is a geometric diagram of the artificial leaflet of the present invention;

[0084] Figure 9(a) is a perspective view of the connection between the outer frame and the inner frame of the present invention;

[0085] Figure 9(b) is the front view of Figure 9(a);

[0086] Figure 10(a) is the front view of the external frame in Figure 9(a);

[0087] Figure 10(b) is a top view of Figure 10(a);

[0088] Figure 11(a) is the front view of the inner frame in Figure 9(a);

[0089] Figure 11(b) is a schematic diagram of another embodiment of Figure 11(a);

[0090] Figure 12(a) is another top view of the outer frame of the present invention;

[0091] Figure 12(b) is a top view of the internal frame corresponding to Figure 12(a);

[0092] Figure 13(a) is another top view of the outer frame of the present invention;

[0093] Figure 13(b) is a magnified view of a portion of 13(a);

[0094] Figure 14(a) is another top view of the outer frame of the present invention;

[0095] Figure 14(b) is a magnified view of a portion of Figure 14(a);

[0096] Figure 15 This is a front view of the outer frame when the straight edge of the D-shaped profile of the present invention is not provided with barbs;

[0097] Figure 16 This is a diagram showing the positional relationship between the outer frame and the inner frame of the present invention;

[0098] Figure 17 This is a schematic diagram of one structure of the mitral valve;

[0099] Figure 18 This is a schematic diagram illustrating one application of the present invention. Detailed Implementation

[0100] 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.

[0101] In this 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 operated by the user, and correspondingly, "distal" refers to the side of the transapical mitral valve replacement device located on the delivery device or in the direction away from the end operated by the user.

[0102] In this invention, when describing a transapical mitral valve replacement device, "proximal end" refers to the side of the transapical mitral valve replacement device closer to the apex of the heart, and correspondingly, "distal end" refers to the side of the transapical mitral valve replacement device farther from the apex of the heart.

[0103] In this invention, when describing a transapical mitral valve replacement device, "axial" refers to the direction between the "proximal end" and the "distal end".

[0104] Reference Figures 1 to 8 A transapical mitral valve replacement device includes a stent mechanism and a covering mechanism. The stent mechanism has an outer frame 100 and an inner frame 200, which are interconnected. The covering mechanism covers the stent mechanism.

[0105] The laminating mechanism includes an outer frame laminating 300, an inner frame laminating 400, and a connecting laminating 500. The outer frame laminating 300 covers the outer frame 100; the inner frame laminating 400 covers the inner frame 200; and the connecting laminating 500 connects the outer frame laminating 300 and the inner frame laminating 400 respectively.

[0106] The diaphragm covering mechanism of the present invention includes an outer frame diaphragm, an inner frame diaphragm, and a connecting diaphragm. The outer frame diaphragm covers the outer frame, and the inner frame diaphragm covers the inner frame. Through the design of the connecting diaphragm, the independent outer frame diaphragm and inner frame diaphragm 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.

[0107] In some embodiments, referring to Figures 2(a) and 2(b), the outer frame covering 300 is a semi-circular structure when unfolded, and the outer frame covering 300 surrounds the outside of the outer frame 100 and covers the outer surface of the outer frame 100.

[0108] In some embodiments, the distal edge of the outer frame covering 300 protrudes beyond the distal end of the outer frame 100 and folds inward to the inside of the outer frame 100, so that the distal edge of the outer frame covering 300 covers the distal end of the outer frame 100; the outer frame covering 300 located inside the outer frame 100 is connected to the connecting covering 500.

[0109] The distal edge of the outer frame covering 300 protrudes beyond the top of the distal end of the outer frame 100 to allow for connection with the connecting covering 500. Because imperfections such as burrs inevitably occur at the edges during valve cutting, to prevent the diaphragm edge from scratching the inner wall of the heart, when the connecting diaphragm 500 is connected to the outer frame diaphragm 300, the edge of the outer frame diaphragm 300 is tilted inward so that it cannot contact the inner wall of the heart. The connection point between the outer frame diaphragm 300 and the connecting diaphragm 500 is also inside the outer frame diaphragm 300, thus preventing the diaphragm edge from scratching the inner wall of the heart. More preferably, the connecting diaphragm 500 is located inside the outer frame diaphragm 300. That is, when looking from the distal end to the proximal end, the distal edge of the outer frame diaphragm 300 can be seen, but the outer edge of the connecting diaphragm 500 cannot be seen because the outer edge of the connecting diaphragm 500 is blocked by the outer frame diaphragm 300. In other words, the connecting diaphragm 500 is located inside the outer frame diaphragm 300, which further ensures that the outer edge of the connecting diaphragm 500 cannot scratch the inner wall of the heart.

[0110] In some embodiments, referring to FIG2(a), the outer frame covering 300 is provided with a plurality of outer frame covering slots 310, which correspond to the barbs 161 on the outer frame 100. Referring to FIG2(b), when the outer frame covering 300 covers the outer frame 100, the barbs 161 on the outer frame 100 pass through the outer frame covering slots 310.

[0111] In some embodiments, referring to FIG2(a), at least one arc-shaped slit is provided on the outer frame covering 300, the arc-shaped slit serving as a plurality of outer frame covering slots 310.

[0112] In some embodiments, refer to Figure 3 When unfolded, the inner frame covering 400 is a long strip structure that surrounds the inner side of the inner frame 200 and covers its inner surface. The distal end of the inner frame covering 400 has a toothed structure 410, which is turned outwards to the outside of the inner frame 200 and connects to the inner skirt edge 240 at the distal end of the inner frame 200. The toothed structure 410 at the distal end of the inner frame covering 400 provides a closer fit to the inner frame 200, facilitating suturing. The number of teeth in the toothed structure 410 can be determined based on the number of inner rhomboid supports 241 in the inner skirt edge 240. Each tooth, after being turned outwards, is located between two adjacent inner rhomboid supports 241.

[0113] In some embodiments, the toothed structure 410 and the inner skirt edge 240 at the distal end of the inner frame 200 are fixedly connected by stitching, or other fixed connection methods may be used.

[0114] In some embodiments, refer to Figure 3 A flange marking line 420 is formed at the connection between the toothed structure 410 and the elongated structure; the connecting membrane 500 is connected to the flange marking line 420. The connecting membrane 500 is connected to the flange marking line 420 on the inner frame membrane 400. The flange marking line 420 does not come into contact with the heart tissue, so the edge of the connecting membrane 500 and the connection with the flange marking line 420 will not scratch the heart tissue.

[0115] In some embodiments, refer to Figure 3 The inner frame membrane 400 is provided with leaflet holes 430, through which artificial leaflets pass and are fixed to the inner frame 200. When there are three artificial leaflets, such as... Figure 3 As shown, 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.

[0116] In some embodiments, refer to Figure 4 The connecting membrane 500 has a circular structure. The outer edge of the connecting membrane 500 is connected to the outer frame membrane 300. The outer edge of the connecting membrane 500 is located between the outer frame membrane 300 and the outer frame 100, that is, the outer edge of the connecting membrane 500 covers the outer frame membrane 300. The inner edge of the connecting membrane 500 is connected to the flange marking line 420 of the inner frame membrane 400.

[0117] Because imperfections such as burrs inevitably occur at the edges during the cutting process of the diaphragm, in order to prevent the edges of the diaphragm from scratching the inner wall of the heart, the outer edge of the circular ring connecting the diaphragm 500 is located inside the outer frame diaphragm 300 when it is connected to the outer frame diaphragm 300. This ensures that the outer edge of the connecting diaphragm 500 is covered by the outer frame diaphragm 300 and cannot contact the inner wall of the heart. The edge of the outer frame diaphragm 300 is also inclined inward and cannot contact the inner wall of the heart, thus preventing the diaphragm edges from scratching the inner wall of the heart. The inner edge of the circular ring connecting the diaphragm 500 connects to the flange marking line of the inner frame diaphragm 400, and this point does not contact the heart tissue, so the inner edge of the connecting diaphragm 500 will not scratch the heart tissue. By connecting the diaphragm 500, the originally independent outer frame diaphragm 300 and inner frame diaphragm 400 are connected into a whole, which increases the stability of the transapical mitral valve replacement device and effectively prevents the inner frame 200 from shaking in the outer frame 100.

[0118] In some embodiments, the outer frame covering 300, the inner frame covering 400, and the connecting covering 500 are all made of impermeable PET composite film, wherein the impermeable PET composite film has a layer of PET stitching film.

[0119] In some embodiments, at least one TPU spun film is provided on the side of the PET coating closest to the support structure. Specifically, a TPU spun film is provided on the side of the outer frame coating 300 closest to the outer frame 100, a TPU spun film is provided on the side of the inner frame coating 400 closest to the inner frame 200, and a TPU spun film is provided on the side of the connecting coating 500 facing the gap between the outer frame 100 and the inner frame 200. Since PET material can still be permeated by blood, a TPU spun film is provided on the side of the coating closest to the support structure. The TPU spun film is smooth and dense, effectively preventing blood from permeating the coating.

[0120] In some embodiments, a TPU spun film is disposed on both sides of the PET film.

[0121] A TPU spun film can be applied to both sides of the PET coating. However, applying a single TPU spun film to one side is sufficient to prevent PET coating penetration. Therefore, applying a TPU spun film to both sides of the PET coating is also acceptable, further preventing penetration. Furthermore, it is preferable to apply the TPU spun film only to the side closest to the support structure. This is because this arrangement prevents the TPU spun film from directly contacting the external environment, as TPU spun film is more prone to absorbing impurities from the air than PET coating. The above design effectively prevents the TPU spun film from absorbing impurities from the air.

[0122] Examples 1-8

[0123] Step Sa:

[0124] 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 same bottle; add a large magnetic stir bead. Place the blue-capped bottle on a magnetic stirrer and adjust the speed to high (r1) to create a vortex in the solution. Weigh out TPU particles and slowly add them into the blue-capped bottle through a funnel. Maintain the stirring speed (r1) and continue stirring for t1 hours until the TPU particles are completely dissolved. Adjust the magnetic stirrer speed to low (r2) and continue stirring for t2 hours until no obvious bubbles remain in the solution. A mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute, with a concentration of C, is obtained and can be used for electrospinning.

[0125] Step Sb:

[0126] Add purified water to the ultrasonic cleaner. Place a 6×6 inch PET suture film in a 1L glass beaker and add 200±10mL of 75% ethanol aqueous solution. Then place the beaker in the ultrasonic cleaning tank and ultrasonically clean at frequency F1 for t3 minutes. After ultrasonic cleaning, discard the 75% ethanol aqueous solution and inject 500±10mL of injection water. Immerse the PET suture film in the water for 2 minutes. After immersion, replace the water with 500±10mL of injection water and place the beaker in the ultrasonic cleaning tank. Ultrasonically clean at frequency F2 for t4 minutes. Remove the PET suture film and allow it to air dry to obtain a clean PET suture film.

[0127] Step S1

[0128] Lay the clean PET stitching film obtained in step Sb flat on a dust-free release paper (such as anti-stick paper, silicone paper, etc.), ensuring the PET stitching film is flat and wrinkle-free, and secure it with tape around the edges for 5mm. Then, smoothly attach the dust-free paper with the PET stitching film onto 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 fibers from being ejected outside the dust-free paper area.

[0129] Draw 60 mL of the mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute obtained in step Sa using a syringe. Fix it to the push pump, connect the syringe tip to the infusion tubing, and connect the other end of the infusion tubing to the nozzle. Insert the needle into the nozzle outlet. Turn on the push pump to slowly advance the solution from the syringe to the needle. When a droplet appears at the needle tip, stop pushing and wipe the liquid that has flowed out of the needle tip clean with a lint-free cloth.

[0130] Adjust the X-axis and Y-axis speeds of the electrospinning machine to W1 mm / s and W2 mm / s respectively, and adjust the frequency of the push pump to F3. Turn on the switches for the X-axis, Y-axis, and push pump of the electrospinning machine to begin normal movement and liquid dispensing, with a liquid dispensing speed of W3. Turn on the voltage switch, adjust the voltage, and begin spinning. After film spraying is complete, turn off the voltage, push pump, and movement of the electrospinning machine in sequence. Remove the initial PET composite film along with the lint-free paper and place it in a designated location to air dry naturally. The surface of the composite film should be clean and free of obvious impurities.

[0131] Step S2

[0132] Wipe the inside surfaces of both glass panes with a lint-free cloth dampened with 75% ethanol or 0.1% benzalkonium chloride solution, and let them air dry for 15 minutes. After peeling off the lint-free paper, place the initial PET composite film on the center surface of the glass pane, aligning it with the other glass pane. Press the initial PET composite film firmly and smoothly between the two glass panes, without any wrinkles. Secure the glass panes with clips to prevent the initial PET composite film from shifting. Preheat the oven 30 minutes in advance, setting the temperature to T℃. Place the initial PET composite film, held between the glass panes, into the constant temperature oven at T℃ for t5 minutes, then allow it to air dry naturally for 30 minutes to obtain the final impermeable PET composite film.

[0133] Step S3

[0134] In Examples 7-8, a PET composite film with a single-sided TPU film is obtained, which is then laid flat in reverse on a dust-free release paper. Steps S1 and S2 and their process parameters are repeated to obtain a PET composite film with TPU spun film on both sides.

[0135] Table 1. Preparation process parameters of the impermeable PET composite membranes in Examples 1-8

[0136]

[0137]

[0138] Table 1 (Required) Preparation process parameters of the impermeable PET composite membranes in Examples 1-8

[0139]

[0140]

[0141] Effect Example

[0142] Following the requirements of method 7.2.3 in YY / T 1449.3-2016, the in vitro hydrodynamic testing of artificial heart valves was conducted using the Vivitro in vitro pulsating flow simulator. This method assesses the effective opening area and total regurgitation percentage of the artificial heart valve under physiological conditions using pulsating pressure and flow waveforms. Under simulated cardiac output of 5 L / min, simulated heart rate (70 cycles per minute, 35% systolic), and mean aortic pressure of 100 mmHg, the artificial heart valves corresponding to single-layer PET membranes, double-layer PET membranes, and the PET composite membrane with one side spun with TPU fibers prepared in Example 1 were observed and tested after suturing. The leakage rate was combined with the test data to verify the sealing performance of the suture membrane. See Table 2 for details.

[0143] Table 2. Valve Hydrodynamic Performance Testing

[0144]

[0145] Table 2 (continued) Valve Hydrodynamic Performance Testing

[0146]

[0147] As shown in Table 2, the PET composite membrane with a total thickness of 0.21 mm and one side spun with TPU fiber membrane prepared in Example 1 reduced blood leakage from 7.24 mL to 0.63 mL compared to a single-layer PET membrane with a thickness of 0.2 mm, significantly reducing blood permeation. Even compared to a double-layer PET membrane with a thickness of 0.4 mm, the blood leakage of the PET composite membrane with a total thickness of 0.21 mm and one side spun with TPU fiber membrane prepared in Example 1 was reduced from 1.4 mL to 0.63 mL, indicating that the TPU fiber membrane can significantly reduce blood leakage from the suture membrane.

[0148] Furthermore, TPU membranes exhibit excellent blood compatibility and biocompatibility. Animal experiments in pigs and sheep have demonstrated that composite TPU membranes enhance endothelial cell adhesion, ingrowth, and spread on the scaffold, accelerating the endothelial cell formation process. Because TPU is a highly elastic polymer material, it effectively conforms to the original valve annulus after valve implantation, significantly reducing blood permeability and paravalvular leakage. A single-layer TPU membrane can achieve the effect of a three-layer PET membrane. The TPU-spun PET composite membrane effectively prevents blood permeation, improving blood impermeability.

[0149] In some embodiments, refer to Figures 5(a) to 8 The transapical mitral valve replacement device also includes a leaflet mechanism located within the inner frame 200. The leaflet mechanism comprises several artificial leaflets 600, which are sequentially connected to form a leaflet mechanism with an outer ring structure. The leaflet mechanism is connected to the inner wall of the inner frame 200, and its central portion can open and close in one direction.

[0150] In some embodiments, refer to Figures 5(a) to 8 The artificial leaflet 600 includes a leaflet body 610 and two auricles 620. The distal end of the leaflet body 610 has a protruding structure. The two auricles 620 are located on both sides of the proximal end of the leaflet body 610. The auricles 620 are used to connect with the inner frame 200 to fix each artificial leaflet 600.

[0151] In some embodiments, referring to FIG5(b), when installing the artificial leaflet 600, the ear portion 620 passes through the leaflet hole 430 of the inner frame covering membrane 400 and connects to the leaflet suture hole 232 of the inner frame 200, and after bypassing the leaflet suture hole 232, it is sutured to the leaflet body 610. Two adjacent ears 620 are connected to the same leaflet suture hole 232, so that the proximal edges of two adjacent artificial leaflets 600 are in close contact, preventing blood backflow caused by incomplete closure of the leaflet mechanism.

[0152] In some embodiments, referring to FIG6(a), the ear portion 620 includes an upper ear portion 621, a lower ear portion 622, and a clearance groove 623. The upper ear portion 621 is located on the proximal end side; the lower ear portion 622 is located on the distal end side of the upper ear portion 621; the clearance groove 623 has an open side and is located between the upper ear portion 621 and the lower ear portion 622, separating the upper ear portion 621 and the lower ear portion 622. In a specific implementation, a groove can be cut from the side to the middle on the existing ear portion 620 to form the clearance groove 623, with the upper ear portion 621 formed on the proximal end side of the clearance groove 623 and the lower ear portion 622 formed on the distal end side of the clearance groove 623.

[0153] 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 at the clearance groove 623, and the lower ear portion 622 is sequentially passed through the leaflet hole 430 of the inner frame membrane 400 and the leaflet suture hole 232 of the inner frame 200. The frame where the leaflet suture hole 232 is located is engaged in the clearance groove 623. The inner frame membrane 400 is clamped between the upper ear portion 621 and the lower ear portion 622 and sewn together. Two adjacent ears 620 are connected to the same leaflet suture hole 232, causing the proximal edges of two adjacent artificial valve leaflets 600 to be in close contact, preventing blood backflow caused by incomplete closure of the valve mechanism. Compared with Figure 5(b), this method can effectively prevent blood backflow caused by blood leakage due to the leaflet hole 430 of the inner frame membrane 400.

[0154] In some embodiments, the length of the clearance groove 623 is generally no more than 2 / 3 of the width of the ear 620, in order to prevent the upper ear 621 and the lower ear 622 from tearing apart.

[0155] In some embodiments, refer to Figure 7 The distal edge of the leaflet body 610 is provided with an anti-abrasion strip 630, which is connected to the leaflet body 610 by stitching. This stitching method ensures a secure fixation, and the anti-abrasion 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 friction between the distal end of the leaflet body 610 and the covering membrane, thus improving the service life of the artificial leaflet. Furthermore, the anti-abrasion strip 630 also acts as a buffer layer between the artificial leaflet and the covering membrane, effectively cushioning the tearing force exerted on the covering membrane during the opening and closing of the artificial leaflet, further increasing the service life of the anti-reflux stent.

[0156] In some embodiments, the artificial leaflet 600 and the covering mechanism are sutured together to form a suture line track.

[0157] Since the dimensions of the inner frame 200 vary depending on actual needs, the dimensions of the artificial leaflet 600 also need to change accordingly. When the artificial leaflets 600 are stitched together in the covering mechanism, a suture line trajectory is formed. When this suture line trajectory coincides with the outer contour of the leaflet body, the outer contour of the leaflet body 610 and / or the suture line trajectory have a defined geometric relationship, resulting in better performance of the artificial leaflet 600. When the suture line trajectory does not coincide with the outer contour of the leaflet body, or when the outer contour of the leaflet body 610 does not conform to this geometric relationship, the suture line trajectory contour must conform to this geometric relationship. Therefore, at least one of the distal outer contour of the leaflet body 610 or the suture line trajectory has a defined geometric relationship. The following example uses the outer contour of the leaflet body 610 having a defined geometric relationship:

[0158] Reference Figure 8 The distal outer contour of the leaflet body 610 has a leaflet basal arc 611 and two leaflet lateral arcs. The distal end of the leaflet basal arc 611 is an arc-shaped structure. The two leaflet lateral arcs are located on both sides of the leaflet basal arc 611, and their distal ends are also arc-shaped. The leaflet basal arc 611 is tangentially connected to the two leaflet lateral arcs on both sides to form the distal end of the artificial leaflet 600.

[0159] In some embodiments, the leaflet bottom arc 611 is an arc formed by a first center O1 and a first radius R1; the two leaflet side arcs are a first leaflet side arc 612a and a second leaflet side arc 612b, the first leaflet side arc 612a is an arc formed by a second center O21 and a second radius R2, and the second leaflet side arc 612b is another arc formed by a second center O22 and a second radius R2; the line connecting the first center O1, the second center O21 and the second center O22 is an equilateral triangle.

[0160] 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 avoids the artificial leaflet 600 from forming a narrow, elongated, or short, humped shape, which would affect the performance of the leaflet and thus the performance of the artificial leaflet 600.

[0161] In some embodiments, the artificial leaflet has an axial leaflet symmetry line I; the first center O1 is located on the leaflet symmetry line I, and the second center O21 and the second center O22 are symmetrical about the leaflet symmetry line I.

[0162] In some embodiments, the proximal outer contour of the leaflet body 610 has a leaflet apex arc 613, which is located on the proximal side of the leaflet basal arc 611, and the proximal end of the leaflet apex arc 613 has an arc-shaped structure.

[0163] In some embodiments, the leaflet apex arc 613 is an arc formed by a third center O3 and a third radius R3, with the third center O3 located on the leaflet symmetry line I.

[0164] 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.

[0165] In some embodiments, refer to Figures 5(a) to 8 The artificial leaflet 600 also includes two auricles 620. The two auricles 620 are located on both sides of the proximal end of the leaflet body 610. The auricles 620 are used to connect with the inner frame 200 to fix each artificial leaflet 600.

[0166] In some embodiments, referring to FIG5(b), when installing the artificial leaflet 600, the ear portion 620 passes through the leaflet hole 430 of the inner frame covering membrane 400 and connects to the leaflet suture hole 232 of the inner frame 200, and after bypassing the leaflet suture hole 232, it is sutured to the leaflet body 610. Two adjacent ears 620 are connected to the same leaflet suture hole 232, so that the proximal edges of two adjacent artificial leaflets 600 are in close contact, preventing blood backflow caused by incomplete closure of the leaflet mechanism.

[0167] In some embodiments, refer to Figures 9(a) to 10(b) The outer frame 100 includes, from proximal to distal, a tether end 110, an outer connecting portion 120, a support portion 130, and an outer skirt portion 140 connected in sequence. When the outer frame 100 is covered with an outer frame covering 300, at least the tether end 110 is exposed outside the outer frame covering 300. As shown in Figures 2(b) and 9(a), both the tether end 110 and the outer connecting portion 120 are exposed outside the outer frame covering 300.

[0168] The rope end 110 is in a constricted shape, see reference. Figure 18 The tether end 110 is connected to the tether 310. After the tether 310 pulls the tether end 110, it is fixed by the apical pad 320. This invention abandons the traditional method of connecting the tether 310 to the inner frame, and instead connects the tether 310 to the outer frame 100. After the tether is under force, it needs to be transmitted to the outer frame 100 first, then to the inner frame 200, and finally to the leaflet mechanism in the inner frame 200. This method has a relatively small impact on the opening and closing of the leaflets in the leaflet mechanism.

[0169] The proximal end of the outer connecting part 120 connects to the distal end of the tethering end 110, and the outer connecting part 120 connects to the inner frame 200. The support part 130 has a hollow, columnar structure, and the inner frame 200 can be accommodated inside the support part 130. The distal end of the outer skirt part 140 has a tapered structure, and the outer skirt part 140 has a skirt with a D-shaped cross-section. The distal end of the outer frame 100 has a tapered structure to prevent the sharp point from puncturing the inner wall of the heart.

[0170] In some embodiments, referring to Figures 10(a) and 10(b), the tether end 110 has a plurality of tether link supports 111, which are independent of each other, and each tether link support 111 has a tether hole 112. The independence of the tether link supports firstly increases the flexibility of the tether end, that is, the individual tether link supports will not exert forces on each other, effectively increasing the angular adaptability of the tether end, allowing for a certain degree of angular deviation. Secondly, it facilitates the heat setting of the outer frame, reducing processing costs.

[0171] In some embodiments, the proximal and distal ends of the rope-tying rod bracket 111 are both square structures, and the square structures have rope holes 112, which causes square connecting frames to be formed at the proximal and distal ends of the rope-tying rod bracket 111, respectively.

[0172] In some embodiments, the proximal and distal ends of the square connecting frame are provided with rounded corners, so that the square connecting frame forms an octagonal-like structure.

[0173] In some embodiments, referring to FIG10(a), when the bracket is unfolded into a plane, the left and right sides of the rope connecting rod bracket 111 are planes, and each plane is parallel to the other. The design that the left and right sides of the square connecting frame are planes and that each plane is parallel to the other is more conducive to gripping the rope end. Furthermore, the rope connecting rod bracket 111 and the left and right sides of the square connecting frame are also parallel to each other.

[0174] In some embodiments, referring to Figures 10(a) and 10(b), the outer connecting part 120 includes a plurality of outer connecting rods 121, the proximal ends of the outer connecting rods 121 being connected to the distal ends of the tethering ends 110 respectively, and the outer connecting rods 121 are inclined outward from the proximal ends to the distal ends, so that the plurality of outer connecting rods 121 form a hollow frustum-shaped structure, and the outer frame 100 is connected to the inner frame 200 through the outer connecting rods 121.

[0175] In some embodiments, referring to Figures 10(a) and 10(b), each outer connecting rod 121 has an outer suture hole 122 at its distal end. Referring to Figure 11(a), the inner frame 200 has an inner suture hole 212, and the outer frame 100 and the inner frame 200 are sutured together through the outer suture hole 122 and the inner suture hole 212 to achieve a suture connection.

[0176] In some embodiments, the diameter of the outer suture hole 122 is larger than the diameter of the inner suture hole 212. This is to reduce the fitting accuracy between the inner frame 200 and the outer frame 100.

[0177] In some embodiments, referring to Figures 12(a) and 12(b), both the outer suture hole 122 and the inner suture hole 212 are elongated waist-shaped holes. 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.

[0178] Both the outer and inner suture holes are elongated, waist-shaped designs, increasing the number of suture loops. Compared to ordinary round suture holes, this design makes it easier to perform multi-loop sutures, preventing suture breakage and separation of the inner and outer frames. Furthermore, the elongated suture holes reduce the precision required for the fit between the inner and outer frames, thus lowering manufacturing costs. This is because, compared to traditional round suture holes, elongated suture holes allow for a certain degree of axial displacement between the inner and outer frames. Both the inner and outer frames are cut from stainless steel, nickel-titanium, or cobalt-chromium tubing. It should be noted that any material suitable for implantation can be used, resulting in minimal circumferential deviation. Therefore, this design primarily focuses on addressing the axial deviation between the inner and outer frames.

[0179] In some embodiments, the outer frame 100 and the inner frame 200 may be connected by riveting, bolting or welding.

[0180] 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 provide a buffer between the outer frame 100 and the inner frame 200.

[0181] In some embodiments, referring to FIG10(a), the support portion 130 includes a plurality of X-shaped brackets 131, each X-shaped bracket 131 having two proximal end connecting rods 1311 and two distal end connecting rods 1312 connected to each other. The proximal end of the proximal end connecting rod 1311 is connected to the distal end of the outer connecting portion 120, and the distal end of the distal end connecting rod 1312 is connected to the proximal end of the outer skirt portion 140. The X-shaped brackets 131 form the support portion 130.

[0182] In some embodiments, the included angle between the two proximal connecting rods 1311 is greater than the included angle between the two distal connecting rods 1312.

[0183] 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, causing the X-shaped stent 131 to form a structure with the middle of its outer peripheral surface concave inward. This is to better secure it to the original leaflet and its annulus. It should be noted that the concave structure here can be formed with the outer skirt edge 140 being outwardly expanded, or the X-shaped stent 131 itself can be a concave structure, or the X-shaped stent 131 itself can be straight and, after a smooth transition connection with the outer skirt edge 140, be concave relative to the outer skirt edge 140.

[0184] In some embodiments, referring to FIG10(a), the outer skirt portion 140 includes a plurality of outer diamond-shaped supports 141, each outer diamond-shaped support 141 having an interconnected V-shaped connecting rod 1411 and an inverted V-shaped connecting rod 1412. The proximal end of the V-shaped connecting rod 1411 is connected to the distal end of the support portion 130, and the plurality of outer diamond-shaped supports 141 form an outer skirt portion 140 with a D-shaped cross-section. At least the inverted V-shaped connecting rod 1412 is inclined inward from the proximal end to the distal end, forming a convergent structure.

[0185] Reference Figure 17 The mitral valve 400 typically has a cross-section approximately D-shaped, with anterior leaflet 410 and posterior leaflet 420. Therefore, the outer skirt edge 140 also forms a structure with a D-shaped cross-section.

[0186] In some embodiments, referring to FIG10(a), the inward angle of the inverted V-shaped connecting rod 1412 is α, and the value of angle α is in the range of 10°≤α≤20°, and angle α is preferably 15°. If the closing angle is too large, it will affect the speed of endothelialization of the outer skirt edge 140. Therefore, an appropriate closing angle can meet the endothelialization speed and protect the inner wall of the heart from being punctured by the distal end of the outer skirt edge 140.

[0187] In some embodiments, the V-shaped connecting rod 1411 is inclined outward from the proximal end to the distal end to form an outwardly expanding structure. The V-shaped connecting rod 1411 and the inverted V-shaped connecting rod 1412 are smoothly connected, causing the outer skirt edge 140 to form a structure in which the middle of the outer peripheral surface protrudes outward.

[0188] In some embodiments, referring to FIG10(a), the V-shaped connecting rod 1411 expands outward at an angle β, and the range of β is 15°≤β≤75°.

[0189] In some embodiments, the angle β of the arc side closer to the D-shaped contour is greater than the angle β of the straight side closer to the D-shaped contour, and the difference between the two is not less than 25°. That is, referring to Figures 10(a) and 10(b), the outward expansion angle β is smaller closer to the left side of the skirt and larger closer to the right side of the skirt. However, the difference between the maximum outward expansion angle β and the minimum outward expansion angle β is not less than 25°.

[0190] In some embodiments, the difference between the angle β on the arc side near the D-shaped profile and the angle β on the straight side near the D-shaped profile is 30°, and the angle β on the straight side near the D-shaped profile is at least 30°.

[0191] The anterior leaflet 410 and the posterior leaflet 420 have different opening and closing ranges, and their structural dimensions at the junction of the left atrium and the mitral valve annulus are different. By designing a gradually expanding structure, the outer skirt edge 140 of the outer frame can fit tightly against the inner wall of the heart, which increases the stability of the transapical mitral valve replacement device after installation.

[0192] In some embodiments, refer to Figures 13(a) to 14(b) The outer frame 100 is provided with at least one marker 150. Preferably, the outer frame 100 is provided with two markers 150. The two markers 150 are respectively located on the two outer diamond brackets 141 on the straight side of the D-shaped profile. Both markers 150 are located at the distal end of the two outer diamond brackets 141, that is, the markers 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 markers 150 are arranged at a predetermined distance away from each other on one side of the outer diamond bracket 141, that is, the markers 150 are arranged on the distal end side of the inverted V-shaped connecting rod 1412. The markers are used to identify the position of the external frame, so the two markers 150 do not necessarily have to be symmetrical about the line of symmetry 250 perpendicular to the straight side of the D-shaped profile. They can be normally set on any two outer rhomboid supports 141 located on the straight side of the D-shaped profile, thereby determining the position of the transapical mitral valve replacement device. It should be noted that the two markers 150 being set at a predetermined distance from each other on one side of the outer rhomboid support 141 can include setting the markers 150 at the distal end of the inverted V-shaped connecting rod 1412. Moreover, when only one marker 150 is set, the difference from the embodiment with two markers 150 is that only one of the two markers 150 is removed, and one marker 150 is retained.

[0193] In some embodiments, referring to FIG13(b), the marker 150 is a protruding semi-circular protrusion member, and the marker 150 is integrally formed with the outer diamond-shaped bracket 141.

[0194] In some embodiments, referring to Figures 14(a) and 14(b), the marker 150 is a marker hole provided on the outer diamond-shaped bracket 141, and a non-transparent marker material (“marker”) is installed in the marker hole.

[0195] The marker of the present invention can be any form of protrusion or a marker hole with a non-transparent marking material, as long as it is easy for the operator to observe under imaging equipment.

[0196] In some embodiments, refer to Figures 9(a) to 10(a) , Figure 15 The outer frame 100 is also provided with a barb part 160, which is inclined outward from the proximal end to the distal end.

[0197] The barbs are used to grip the original mitral valve leaflets to ensure a complete seal of the valvular system, reducing paravalvular leakage after implantation. Additionally, after implantation, during left atrial contraction, the implanted leaflets are pushed open by blood flow, resulting in lower pressure on the valve device. Conversely, during ventricular contraction, the implanted leaflets are closed, leading to extremely high blood pressure. Without restraint, the valve device could detach from the original valve annulus and slip into the left atrium. The presence of the apical tether restrains the valve device in place, but the barbs hook the original leaflets, helping to distribute the force of the apical tether and reduce stress on the heart muscle, thus minimizing potential damage. Secondly, it prevents the original mitral valve leaflets from moving freely within the heart. For example, if the anterior leaflet were to reverse under the pressure of blood flow, it could cause aortic blockage, endangering the user's life. Clamping the original leaflets between the barbs and the external frame prevents free movement of the original leaflets.

[0198] In some embodiments, the barb portion 160 includes a plurality of inverted V-shaped barbs 161, the proximal ends of which are connected to the outer frame 100 respectively, and the inverted V-shaped barbs 161 are inclined 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.

[0199] In some embodiments, the inverted V-shaped barb 161 is tilted outward at an angle of 5° to 15°.

[0200] In some embodiments, the inverted V-shaped barbs 161 located on the straight edge side of the D-shaped profile are vertical barbs that do not tilt outwards, or, refer to Figure 15 No inverted V-shaped barbs are provided on the straight side of the D-shaped profile 161.

[0201] Because the anterior leaflet of the mitral valve is close to the aorta, and the outward-protruding barbs may affect the aorta and cause aortic dysfunction, the barbs near the aorta are removed, that is, the barbs on the straight side of the D-shaped outline are removed, or the barb structure at this location is retained but no longer protrudes outward. By using the barb structure adjacent to this location to fix the mitral valve, the outward-protruding barb structure is prevented from affecting the function of the aorta.

[0202] In some embodiments, the proximal ends of the inverted V-shaped barbs 161 are integrally connected to the proximal 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.

[0203] In some embodiments, referring to Figures 10(a), 10(b), and 12(a), Figure 15 The outer frame 100 includes, from its proximal end to its distal end, a tethering end 110, an outer connecting portion 120, a support portion 130, and an outer skirt portion 140 connected in sequence. The tethering rod supports 111 of the tethering end 110 are independent of each other. Each tethering rod support 111 has a square connecting frame at both its proximal and distal ends, with a tethering hole 112 in the center of the square connecting frame. The number of external connecting rods 121 in the outer connecting portion 120 is the same as the number of tethering rod supports 111. The proximal end of each external connecting rod 121 is connected to the distal end of a corresponding tethering rod support 111. The distal end of each external connecting rod 121 is provided with an external sewing hole 122, which can be a circular hole or a waist-shaped hole. The number of X-shaped brackets 131 in the support section 130 is determined according to the number of outer connecting rods 121. The two proximal connecting rods 1311 of each X-shaped bracket 131 are connected to the distal ends of the two adjacent outer connecting rods 121, respectively. The number of outer diamond-shaped brackets 141 in the outer skirt section 140 is determined according to 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 one distal connecting rod 1312 of the X-shaped bracket 131, and the middle parts of adjacent outer diamond-shaped brackets 141 are connected.

[0204] For example, the outer frame 100 is provided with six rope-tying rod supports 111, which are parallel to each other and form a rope end 110. Each of the six rope-tying rod supports 111 is independently connected to six external connecting rods 121, which expand outward to form an outer connecting part 120. Two adjacent external connecting rods 121 are connected to the proximal end of the same X-shaped support 131, so there are also six X-shaped supports 131, which form a support part 130. Since the proximal end of each V-shaped connecting rod 1411 is connected to a distal end connecting rod 1312 of the X-shaped support 131, twelve outer diamond supports 141 are needed, which are connected in sequence to form an outer skirt part 140.

[0205] In some embodiments, the outer frame 100 is integrally made of stainless steel, nickel-titanium, or cobalt-chromium tubing. That is, the tether end 110, the outer connecting part 120, the support part 130, the outer skirt part 140, the marker 150, and the barb part 160 are integrally made of stainless steel, nickel-titanium, or cobalt-chromium tubing.

[0206] In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer stitching holes 122 arranged side by side, two marking members 150 are protruding semi-circular protrusions, and barbs 160 are evenly arranged on the support portion 130.

[0207] In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer stitching holes 122 arranged side by side, two marking members 150 are marking holes in which non-transparent marking material is installed, and barbs 160 are evenly arranged on the support portion 130.

[0208] In some embodiments, the outer stitching hole 122 on the outer connecting part 120 of the outer frame 100 is an elongated waist-shaped hole, the two marking members 150 are protruding semi-circular protrusions, and the barbs 160 are evenly arranged on the support part 130.

[0209] In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer stitching holes 122 arranged side by side, and two marking members 150 are protruding semi-circular protrusions. No inverted V-shaped barbs 161 are provided on the straight side of the D-shaped profile, and inverted V-shaped barbs 161 are evenly arranged on the support portion 130 at other positions.

[0210] In some embodiments, the outer connecting portion 120 of the outer frame 100 has two circular outer stitching holes 122 arranged side by side, and two marking members 150 are marking holes with non-transparent marking material installed inside. No inverted V-shaped barbs 161 are provided on the straight side of the D-shaped profile, and inverted V-shaped barbs 161 are evenly arranged on the support portion 130 at other positions.

[0211] In some embodiments, referring to Figures 9(a), 9(b), and 11(a), the inner frame 200 includes, from the proximal end to the distal end, an inner connecting portion 210, a plurality of support connecting rods 220, a leaflet connecting portion 230, and an inner skirt portion 240 connected in sequence. The inner connecting portion 210 is a folding structure and is connected to the outer frame 100. The plurality of support connecting rods 220 are inclined outward from the proximal end to the distal end. The leaflet connecting portion 230 is connected to the leaflet mechanism. Both the inner skirt portion 240 and the leaflet connecting portion 230 are hollow columnar structures that can accommodate the leaflet mechanism.

[0212] In some embodiments, the inner connecting portion 210 includes a plurality of inner connecting rods 211, each having an inner stitching hole 212. The inner frame 200 and the outer frame 100 are stitched together through the inner stitching holes 212. The plurality of inner connecting rods 211 are arranged outwardly from the proximal end to the distal end to form a closing structure. The inclination angle of the inner connecting rods 211 is consistent with the inclination angle of the outer connecting rods 121, to achieve a highly fitted connection between the two.

[0213] Specifically, the inner suture hole 212 and the outer suture hole 122 are sutured together to achieve the suture connection between the inner frame 200 and the outer frame 100. The inner suture hole 212 can be two circular suture holes as shown in Figure 11(a), or it can be a waist-shaped hole as shown in Figure 12(b).

[0214] In some embodiments, the leaflet connecting portion 230 includes a plurality of leaflet connecting rods 231, each leaflet connecting rod 231 having a leaflet sewing hole 232, through which the inner frame 200 is sewn together with the leaflet mechanism, and the plurality of leaflet connecting rods 231 form the leaflet connecting portion 230.

[0215] In some embodiments, referring to FIG11(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 no more than 24. Too many leaflet connecting rods 231 will affect the gripping of the support. This embodiment takes an integer multiple of 3, i.e., 6 leaflet connecting rods 231, as an example for explanation. 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. The appropriate selection is made according to the needs to determine whether to suture an artificial leaflet.

[0216] In some embodiments, referring to FIG11(a), a leaflet suture hole 232 is provided at least one leaflet connecting rod 231.

[0217] As shown in Figure 11(a), the leaflet connecting part 230 has six leaflet connecting rods 231, each of which is connected to two adjacent inner connecting rods 211 via two inclined bracket connecting rods 220. When a leaflet connecting rod 231 has a leaflet suture hole 232, the two adjacent leaflet connecting rods 231 on one side do not have leaflet suture holes 232. This structure is suitable for leaflet mechanisms consisting of three leaflets. When using a leaflet mechanism consisting of two leaflets, two symmetrically arranged leaflet connecting rods 231 can be selected to have leaflet suture holes 232, while the other leaflet connecting rods 231 do not have leaflet suture holes 232. That is, when a leaflet connecting rod 231 has a leaflet suture hole 232, the four adjacent leaflet connecting rods 231 on one side do not have leaflet suture holes 232.

[0218] When the number of leaflet connecting rods 231 is changed, the setting of leaflet suture holes 232 can also be changed according to actual needs. This can be achieved through simple adjustments, so it will not be elaborated further.

[0219] In some embodiments, referring to FIG11(b), the width of the leaflet connecting rod 231 without the leaflet suture hole 232 is 1 / 3 to 1 / 2 of the overall width of the leaflet connecting rod 231 with the leaflet suture hole 232. This design enhances the compressibility of the stent and also reduces the strength difference between the leaflet connecting rod 231 with and without the leaflet suture hole 232, thus promoting the mechanical balance of the stent.

[0220] In order to allow the number of leaflets to be adjusted freely, such as three leaflets versus two leaflets, and also to reduce the stress imbalance of the inner frame 200, as shown in Figure 11(a), leaflet connecting rods 231 are provided with leaflet sewing holes 232.

[0221] In some embodiments, referring to FIG11(a), the inner skirt edge 240 includes a plurality of inner rhomboid supports 241, which form a hollow columnar structure. One inner rhomboid support 241 in the inner frame 200 corresponds to two outer rhomboid supports 141 in the outer frame 100.

[0222] Although the skirt cross-section of the outer diamond-shaped support 141 in the outer frame 100 is designed with a D-shaped profile, the outer diamond-shaped supports 141 of the skirt are evenly distributed and correspond to the inner diamond-shaped supports 241 of the inner frame 200. One inner diamond-shaped support 241 of the inner frame 200 corresponds to two outer diamond-shaped supports 141 of the outer frame 100.

[0223] In some embodiments, refer to Figure 16 The inner frame 200 has a symmetry line 250 in its cross-section perpendicular to the straight edge of the D-shaped profile. At least two internal suture holes 212 of the inner frame 200 and at least two inverted V-shaped barbs 161 of the outer frame 100 are located on this 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 original anterior leaflet and the original posterior leaflet. Their adjacent barb structures can also assist in clamping the original leaflets, and at the same time provide a basis for subsequent cladding.

[0224] In some embodiments, the inner frame 200 is integrally formed from stainless steel, nickel-titanium, or cobalt-chromium tubing. That is, the inner connecting part 210, the plurality of support connecting rods 220, the leaf connecting part 230, and the inner skirt part 240 are integrally formed from stainless steel, nickel-titanium, or cobalt-chromium tubing.

[0225] In some embodiments, the inner connecting portion 210 in the inner frame 200 has an inner suture hole 212, which is an elongated waist-shaped hole, and each leaflet connecting rod 231 has a leaflet suture hole 232.

[0226] 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.

[0227] In some embodiments, the transapical mitral valve replacement device of the present invention is still applicable to catheter delivery methods. (See also...) Figure 18 When applied to prevent valvular regurgitation, one end of the tether 310 is connected to the tether end 110 of the outer frame 100, and the other end of the tether 310 is fixed by an apical pad 320, which can be a prior art device. In this fixing method, when the tether 310 is under stress, the stress 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 small impact on the opening and closing of the leaflets within the leaflet mechanism.

[0228] 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 transapical mitral valve replacement device, comprising: A support mechanism having an outer frame and an inner frame connected to the outer frame; A single-leaf mechanism is located within the inner frame; A film-coating mechanism is applied to the support mechanism; The coating mechanism is characterized in that it comprises: An outer frame covering is provided to cover the outer frame. An inner frame is covered with a film to cover the inner frame; A connecting membrane is provided, which connects the outer frame membrane and the inner frame membrane respectively; The leaflet mechanism includes: Several artificial leaflets are sequentially connected to form a leaflet mechanism with an outer ring structure. The leaflet mechanism is connected to the inner sidewall of the inner frame, and the middle part of the leaflet mechanism can open and close in one direction. The covering mechanism is stitched together with the artificial leaflets to form a suture line track. The artificial leaflet includes a leaflet body, and the suture trajectory has: The leaflet bottom arc has an arc-shaped structure at the distal end. The leaflet bottom arc is a segment of an arc formed by the first center and the first radius. Two leaflet lateral arcs are symmetrically located on both sides of the leaflet bottom arc. The two leaflet lateral arcs are the first leaflet lateral arc and the second leaflet lateral arc, respectively. The first leaflet lateral arc is a segment of an arc formed by a second center and a second radius, and the second leaflet lateral arc is another segment of an arc formed by a second center and a second radius. The bottom arc of the leaflet is tangentially connected to the first side arc of the leaflet and the second side arc of the leaflet, and the line connecting the first center, the second first center, and the second second center forms an equilateral triangle. The side length of the equilateral triangle is greater than the diameter of the bottom arc of the leaflet and less than the width of the leaflet body.

2. The transapical mitral valve replacement device as described in claim 1, characterized in that, The outer frame covering has a semi-circular structure, and the outer frame covering surrounds the outside of the outer frame and covers the outer surface of the outer frame.

3. The transapical mitral valve replacement device as described in claim 2, characterized in that, The distal edge of the outer frame covering film protrudes beyond the distal end of the outer frame and folds inward to the inside of the outer frame, so that the distal edge of the outer frame covering film covers the distal end of the outer frame. The outer frame covering located inside the outer frame is connected to the connecting covering.

4. The transapical mitral valve replacement device as described in claim 1, characterized in that, The outer frame membrane is provided with: Several slots in the outer frame's film coating correspond to the barbed structures on the outer frame; When the outer frame is covered by the film, the barbs on the outer frame pass through the slots in the outer frame film.

5. The transapical mitral valve replacement device as described in claim 4, characterized in that, At least one arc-shaped slit is provided on the outer frame covering film, and the arc-shaped slit serves as a plurality of slots in the outer frame covering film.

6. The transapical mitral valve replacement device as described in claim 1, characterized in that, The inner frame covering is a long strip structure, and the inner frame covering surrounds the inner side of the inner frame and covers the inner side of the inner frame; The distal end of the inner frame covering has a toothed structure, which is turned outward to the outside of the inner frame and connected to the inner skirt edge of the distal end of the inner frame.

7. The transapical mitral valve replacement device as described in claim 6, characterized in that, The toothed structure is fixedly connected to the inner skirt edge by stitching.

8. The transapical mitral valve replacement device as described in claim 6, characterized in that, A flange marking line is formed at the connection between the toothed structure and the elongated structure; The connecting film is connected to the flange marking line.

9. The transapical mitral valve replacement device as described in claim 1, characterized in that, The inner frame membrane is provided with leaflet holes, through which artificial leaflets pass and are fixed to the inner frame.

10. The transapical mitral valve replacement device as described in claim 1, characterized in that, The connecting membrane has a circular structure, the outer edge of the connecting membrane is connected to the outer frame membrane, the outer edge of the connecting membrane is located between the outer frame membrane and the outer frame, and the outer edge of the connecting membrane covers the outer frame membrane; The inner edge of the connecting film is connected to the flange marking line of the inner frame film.

11. The transapical mitral valve replacement device as described in claim 1, characterized in that, The outer frame covering, the inner frame covering, and the connecting covering are all made of impermeable PET composite film, and the impermeable PET composite film has a layer of PET stitching film.

12. The transapical mitral valve replacement device as described in claim 11, characterized in that, At least one TPU spinning film is provided on the side of the PET composite film near the support mechanism, that is, the outer frame film is provided with a TPU spinning film on the side near the outer frame, the inner frame film is provided with a TPU spinning film on the side near the inner frame, and the connecting film is provided with a TPU spinning film on the side facing the gap between the outer frame and the inner frame.

13. The transapical mitral valve replacement device as described in claim 12, characterized in that, A TPU spun film is disposed on both sides of the PET composite film.

14. The transapical mitral valve replacement device as described in claim 1, characterized in that, The artificial leaflet includes: The main body of the leaflet has a convex structure at the distal end; Two auricles are located on either side of the proximal end of the main body of the leaflet.

15. The transapical mitral valve replacement device as described in claim 14, characterized in that, When the artificial leaflet is installed, the ear passes through the leaflet hole of the inner frame membrane and connects to the leaflet suture hole of the inner frame, and then passes around the leaflet suture hole and is sutured to the leaflet body. Two adjacent ears are connected to the same leaflet suture hole.

16. The transapical mitral valve replacement device as described in claim 14, characterized in that, The ear includes: The upper ear, located on the proximal side; The lower ear is located on the distal end side of the upper ear; A clearance groove with an opening on the side is located between the upper ear and the lower ear, separating the upper ear and the lower ear through the clearance groove; When installing the artificial leaflet, the upper ear is folded over at the clearance groove, and the lower ear is passed through the leaflet hole of the inner frame membrane and the leaflet suture hole of the inner frame in sequence. The frame where the leaflet suture hole is located is inserted into the clearance groove. The inner frame membrane is clamped between the upper ear and the lower ear and sutured together. Two adjacent ears are connected to the same leaflet suture hole, so that the proximal edges of two adjacent artificial leaflets are in close contact.

17. The transapical mitral valve replacement device as described in claim 16, characterized in that, The length of the clearance groove is no greater than 2 / 3 of the width of the ear.

18. The transapical mitral valve replacement device as described in claim 14, characterized in that, The distal edge of the leaflet body is provided with: An anti-abrasion strip is connected to the leaflet body by stitching.

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