Transapical Mitral Valve Replacement Balloon-Expandable Valve Device

Abstract

A balloon-expandable valve device for transapical mitral valve replacement according to the present invention includes: a soft outer frame and a rigid inner frame. An outer layer of film is wrapped around the outer side surface of the soft outer frame. The distal end of the outer layer of film has a double-layer film. The distal end of the soft outer frame is inserted into the double-layer film and a certain axial distance is reserved between the distal end of the soft outer frame and the distal end of the double-layer film to form a margin space for the elongation of the soft outer frame. The proximal section of the inner layer of film is wrapped around the inner side surface of the rigid inner frame, and the distal section of the inner layer of film extends from the proximal section of the inner layer of film to the middle section of the soft outer frame and is wrapped around the middle section of the inner side surface of the soft outer frame. In the present invention, the inner film of the outer frame is wrapped around the inner side surface of the soft outer frame, and the distal end does not extend to the distal end of the inner side of the soft outer frame, that is, the distal end of the inner film of the outer frame is not covered by the inner side surface of the outer layer of film folded to the inner side of the soft outer frame, thereby removing the limitation on the axial length of the soft outer frame during the compression and elongation process.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a balloon-expandable valve device for transapical mitral valve replacement. Background Art

[0002] Valve regurgitation is a common valve disease, such as mitral regurgitation, tricuspid regurgitation, etc. Among them, mitral regurgitation is due to incomplete valve closure. During left ventricular systole, blood flows from the left ventricle into the aorta and the left atrium with less resistance. In addition to receiving the blood returning from the pulmonary veins, the left atrium also receives the blood regurgitated from the left ventricle. Therefore, the increase in left atrial pressure can cause the increase in pulmonary vein and pulmonary capillary pressure, and then dilation and congestion; at the same time, the volume load during left ventricular diastole increases, and the left ventricle expands. In acute mitral insufficiency, a large amount of regurgitant blood suddenly increases in the left atrium, which can cause a sharp rise in left atrial and pulmonary vein pressure, leading to acute pulmonary edema.

[0003] Currently, the main methods for treating mitral regurgitation through surgery are mainly two types: surgical thoracotomy and minimally invasive medical surgery. Due to the large surgical trauma, high risk, and long-term and expensive postoperative rehabilitation treatment of surgical thoracotomy, a large number of patients are reluctant to accept this treatment method; while minimally invasive medical surgery provides a new treatment method with less trauma, fewer complications, and faster postoperative rehabilitation for doctors. When performing minimally invasive medical surgery, the mitral regurgitation problem can be solved through a balloon-expandable valve device for mitral valve replacement.

[0004] However, the following problems often exist in the traditional balloon-expandable valve device for mitral valve replacement during use:

[0005] (1) Due to the relatively soft inner frame and the problem of insufficient number of repeating units that make up its structure, usually during use, the ability to withstand the impact of blood flow is weak, and the phenomenon of large deformation of the unstable state of the inner frame appears, resulting in the unstable state of the corresponding artificial valve leaf and unable to cooperate at the ideal position.

[0006] (2) The design and connection and suture methods of the inner frame and the outer frame film severely limit the compression and elongation space of the valve and the stent, and then cause the phenomenon of large distortion of the valve during the compression process of the stent, seriously affecting blood flow.

[0007] Therefore, it is necessary to make improvements to solve the above problems. Summary of the Invention

[0008] Aiming at the technical problem that the design and connection and suture methods of the inner frame and the outer frame film in the prior art severely limit the compression and elongation space of the valve and the stent, and then cause the phenomenon of large distortion of the valve during the compression process of the stent, seriously affecting blood flow, one of the purposes of the present invention is to provide a balloon-expandable valve device for transapical mitral valve replacement.

[0009] The transapical mitral valve replacement balloon-expandable valve device of the present invention comprises:

[0010] A stent having a soft outer stent and a rigid inner stent, wherein the rigid inner stent is located within the soft outer stent;

[0011] A membrane covering the stent;

[0012] Preferably, the membrane comprises:

[0013] An outer layer membrane covering the outer side surface of the soft outer stent. The distal end of the outer layer membrane has a double-layer membrane. The distal end of the soft outer stent is inserted into the double-layer membrane and there is a certain axial distance reserved between the distal end of the soft outer stent and the distal end of the double-layer membrane to form a margin space for the elongation of the soft outer stent;

[0014] An inner layer membrane. The proximal section of the inner layer membrane covers the inner side surface of the rigid inner stent. The distal section of the inner layer membrane extends from the proximal section of the inner layer membrane to the middle section of the soft outer stent and covers the middle section of the inner side surface of the soft outer stent.

[0015] Preferably, the inner layer membrane has:

[0016] An inner stent inner membrane covering the inner side surface of the rigid inner stent;

[0017] An outer stent inner membrane covering the middle section of the inner side surface of the soft outer stent and sutured to the corresponding position of the outer layer membrane. The distal end of the inner stent inner membrane is connected to the proximal end of the outer stent inner membrane.

[0018] Preferably, the distal end of the inner stent inner membrane is integrally connected to the proximal end of the outer stent inner membrane.

[0019] Preferably, the distal end of the inner stent inner membrane and the proximal end of the outer stent inner membrane are sutured and connected to form a suture knot, and the suture knot is located on the side of the inner layer membrane facing the outer layer membrane.

[0020] Preferably, the distal end of the outer stent inner membrane is closely sutured to the middle section on the inner side of the outer layer membrane against the middle section of the soft outer stent.

[0021] Preferably, the proximal end of the inner stent inner membrane and the proximal end of the outer layer membrane are closely sutured and connected together against the soft outer stent and the rigid inner stent.

[0022] Preferably, the outer film covering has an outer frame outer film covering the outer side of the soft outer frame. The distal end of the outer frame outer film is the outer layer of the double-layer film. The outer layer of the double-layer film continues to extend and then folds inward to adhere to the inner side of the outer frame outer film to form the inner layer of the double-layer film. The inner layer of the double-layer film is closely attached to the distal end of the soft outer frame and is sutured to the inner side of the outer frame outer film.

[0023] Preferably, the outer film covering is in a fan-shaped ring structure. Five arc-shaped slits are provided on the outer film covering. The barbs on the soft outer frame respectively pass through the arc-shaped slits of the outer film covering.

[0024] The inner frame inner film is in a strip-shaped structure. At least three lobe holes are provided on the inner frame inner film, which are in a long strip waist shape. The long strip waist-shaped holes correspond to the lobe suture holes on the rigid inner frame.

[0025] The outer frame inner film is in a circular ring structure.

[0026] Preferably, both the outer film covering and the inner film covering adopt anti-permeation PET composite films. The anti-permeation PET composite film has a layer of PET suture film.

[0027] Preferably, at least one layer of TPU spun film is provided on the side of the PET suture film close to the stent mechanism, that is, one layer of TPU spun film is provided on the side of the outer film covering close to the soft outer frame, one layer of TPU spun film is provided on the side of the inner frame inner film close to the rigid inner frame, and one layer of TPU spun film is provided on the side of the outer frame inner film facing the soft outer frame.

[0028] Preferably, the soft outer frame has 6 outer repeating units in the circumferential direction. Each of the outer repeating units has an outer connecting rod inclined inward near the proximal end.

[0029] The rigid inner frame is located inside the soft outer frame. The rigid inner frame has 6n inner repeating units in the circumferential direction. Adjacent consecutive n inner repeating units are in a group. Each group of inner repeating units corresponds to one of the outer repeating units. The proximal end of each group of inner repeating units has an inner connecting rod inclined inward. The inner connecting rod is connected to the outer connecting rod, where n≥2 and n is a natural number.

[0030] Preferably, each outer repeating unit of the soft outer frame sequentially includes, from the distal end to the proximal end:

[0031] Two adjacent rhomboid-like frames. The rhomboid-like frames of the 6 outer repeating units are adjacent to each other to form the outer skirt part of the soft outer frame, and its cross-section has a D-shaped contour.

[0032] A large V-shaped frame, the distal ends of the large V-shaped frame are respectively connected to the proximal ends of the two adjacent rhombus-like frames; the large V-shaped frames of the 6 outer repeating units are adjacent to each other in pairs to form the outer support part of the soft outer frame, presenting a quasi-cylindrical structure, and accommodating the hard inner frame therein;

[0033] The outer connecting rod, the distal end of the outer connecting rod is connected to the proximal end of the large V-shaped frame; the outer connecting rods of the 6 outer repeating units form the outer connecting part of the soft outer frame;

[0034] A tether connecting rod, the distal end of the tether connecting rod is connected to the proximal end of the outer connecting rod; the tether connecting rods of the 6 outer repeating units form the tether end of the bracket.

[0035] Preferably, the rhombus-like frame has:

[0036] An inverted V-shaped connecting rod, the inverted V-shaped connecting rod inclines inward from the proximal end to the distal end, forming a converging structure;

[0037] A V-shaped connecting rod, the distal end of the V-shaped connecting rod, the proximal end of the inverted V-shaped connecting rod are integrally connected to the corresponding outer skirt connection point, the proximal end of the V-shaped connecting rod is integrally connected to the distal end of the large V-shaped frame, and the V-shaped connecting rod inclines outward from the proximal end to the distal end, forming an outward expanding structure.

[0038] Preferably, the large V-shaped frame has from the proximal end to the distal end:

[0039] Two proximal end connecting rods, the proximal end connecting rods incline inward from the proximal end to the distal end, and the proximal ends of the two proximal end connecting rods are integrally connected to the distal end of the outer connecting rod at the same time;

[0040] Two distal end connecting rods, the two distal end connecting rods incline outward from the proximal end to the distal end, the proximal end of the distal end connecting rod, the distal end of the corresponding proximal end connecting rod are integrally connected to the corresponding outer support connection point, and the distal end of the distal end connecting rod is integrally connected to the proximal end of the V-shaped connecting rod, so that the large V-shaped frame forms a structure with the middle of the outer peripheral surface indented inward.

[0041] Preferably, a barb is provided on the large V-shaped frames of the 5 outer repeating units on the arc side of the D-shaped profile, presenting an inverted V shape, and the two proximal ends of the inverted V-shaped barb are integrally connected to the two proximal end connecting rods of the corresponding large V-shaped frame near the outer support connection point.

[0042] Preferably, the inverted V-shaped barbs incline outward from the proximal end to the distal end and expose outside the soft outer frame, and the barbs of the 5 outer repeating units enclose a barb portion. Preferably, the angle of the outward inclination of the inverted V-shaped barbs is 5°-15°.

[0043] Preferably, the outer connecting rod inclines outward from the proximal end to the distal end, so that a plurality of the outer connecting rods enclose a hollow frustum-shaped structure.

[0044] Preferably, the tether end is in a barbell shape, with square connecting frames at both ends, and the tether holes are arranged in the square connecting frames, and the tether holes are circular holes.

[0045] Preferably, each inner repeating unit of the rigid inner frame successively includes from the distal end to the proximal end:

[0046] A V-shaped inflow frame, and the distal ends of the V-shaped inflow frames of the 6n inner repeating units are connected adjacent to each other in pairs to enclose the inner skirt portion of the rigid inner frame, and its cross-section is a circular contour;

[0047] A rhomboid-like middle frame, with inner support connection points at the central positions of both sides of the rhomboid-like middle frame. The distal end of the rhomboid-like middle frame is correspondingly connected to the proximal end of the V-shaped inflow frame. The rhomboid-like middle frames of the 6n inner repeating units are connected adjacent to each other in pairs with the inner support connection points to enclose the inner support portion of the rigid inner frame, presenting a hollow columnar structure;

[0048] A hexagonal-like outflow frame, the distal end of the hexagonal-like outflow frame is correspondingly connected to the proximal end of the rhomboid-like middle frame. The two side rods of the hexagonal-like outflow frames of the 6n inner repeating units are adjacently connected to each other in pairs to enclose the leaflet connection portion of the rigid inner frame, presenting a hollow columnar structure. The leaflet connection portion is integrally connected to the inner support portion correspondingly and internally accommodates a leaflet mechanism; the distal end of one inner connecting rod is integrally connected to the middle of the proximal ends of the hexagonal-like outflow frames of the adjacent continuous n inner repeating units.

[0049] Preferably, one side rod of the continuous 2n hexagonal-like outflow frames is a leaflet connecting rod, and the leaflet connecting rod has leaflet suture holes, and the rigid inner frame is sutured and connected to the leaflet mechanism through the leaflet suture holes.

[0050] Preferably, the width of the side rod of the hexagonal-like outflow frame without the leaflet suture holes is 1 / 3-1 / 2 of the overall width of the leaflet connecting rod provided with the leaflet suture holes.

[0051] Aiming at the technical problem in the prior art that the insufficient number of repeating units in the composition structure of the inner frame causes the inner frame to be unstable and the bearing capacity for the impact of blood flow is weak, the second object of the present invention is to provide a stent for a transapical mitral valve replacement balloon-expandable valve device.

[0052] The stent for the transapical mitral replacement balloon-expandable valve device of the present invention comprises:

[0053] A soft outer frame, which has 6 outer repeating units in the circumferential direction, and each of the outer repeating units has an outwardly inclined outer connecting rod near the proximal end;

[0054] A rigid inner frame, which is located inside the soft outer frame, and the rigid inner frame has 6n inner repeating units in the circumferential direction. Adjacent and consecutive n inner repeating units form a group, and each group of inner repeating units corresponds to one of the outer repeating units; the proximal end of each group of inner repeating units has an inwardly inclined inner connecting rod, and the soft outer frame and the rigid inner frame are connected by connecting the inner connecting rod with the outer connecting rod, where n≥2 and n is a natural number.

[0055] Preferably, 2≤n≤6.

[0056] The distal end of the inner connecting rod is connected to the proximal end of the connection part between two adjacent groups of inner repeating units.

[0057] Preferably, the outer connecting rod has outer suture holes; the inner connecting rod has inner suture holes; the inner connecting rod and the outer connecting rod are connected and adhered to each other by suturing through the inner suture holes and the outer suture holes.

[0058] Preferably, the aperture of the outer suture hole is larger than that of the inner suture hole.

[0059] Preferably, the outer suture hole and the inner suture hole are respectively two circular holes spaced at a certain distance or a long strip-shaped waist-shaped hole, and the length direction of the waist-shaped hole is the length direction of the outer connecting rod.

[0060] Preferably, the outer connecting rod is connected to the inner connecting rod by riveting, bolts or welding.

[0061] Preferably, each outer repeating unit of the soft outer frame sequentially comprises from the distal end to the proximal end:

[0062] Two adjacent rhomboid-like frames, and the central positions of the two sides of the rhomboid-like frame have outer skirt connection points. The rhomboid-like frames of the 6 outer repeating units are connected adjacent to each other with the outer skirt connection points to form the outer skirt part of the soft outer frame, and its cross-section has a D-shaped contour;

[0063] A large V-shaped frame, the central positions of both sides of the large V-shaped frame have outer support connection points, and the distal ends of the large V-shaped frame are respectively connected to the proximal ends of the two adjacent rhombus-like frames; the large V-shaped frames of the 6 outer repeating units are connected adjacent to each other with the outer support connection points to form the outer support part of the soft outer frame, presenting a cylindrical-like structure, and accommodating the hard inner frame inside;

[0064] The outer connecting rod, the distal end of the outer connecting rod is connected to the proximal end of the large V-shaped frame; the outer connecting rods of the 6 outer repeating units form the outer connecting part of the soft outer frame;

[0065] A tether connecting rod, the distal end of the tether connecting rod is connected to the proximal end of the outer connecting rod; the tether connecting rods of the 6 outer repeating units form the tether end of the bracket.

[0066] Preferably, the rhombus-like frame has:

[0067] An inverted V-shaped connecting rod, the inverted V-shaped connecting rod inclines inward from the proximal end to the distal end, forming a converging structure;

[0068] A V-shaped connecting rod, the distal end of the V-shaped connecting rod, the proximal end of the inverted V-shaped connecting rod are integrally and correspondingly connected to the outer skirt connection point, the proximal end of the V-shaped connecting rod is integrally connected to the distal end of the large V-shaped frame, and the V-shaped connecting rod inclines outward from the proximal end to the distal end, forming an outward expanding structure.

[0069] Preferably,

[0070] The inward converging angle of the inverted V-shaped connecting rod is α, where 10° ≤ α ≤ 20°, and α is preferably 15°;

[0071] The outward expanding angle of the V-shaped connecting rod is β, where 15° ≤ β ≤ 75°.

[0072] Preferably, the V-shaped connecting rod and the inverted V-shaped connecting rod are integrally and smoothly connected, so that the skirt part forms a structure with the middle of the outer peripheral surface protruding outward.

[0073] Preferably, the angle β near the arc side of the D-shaped contour is greater than the angle β near the straight side of the D-shaped contour, and the difference between the two is not less than 25°.

[0074] Preferably, the difference between the angle β near the arc side of the D-shaped contour and the angle β near the straight side of the D-shaped contour is 30°, and the angle β near the straight side of the D-shaped contour is at least 30°.

[0075] Preferably, the large V-shaped frame has from the proximal end to the distal end:

[0076] Two proximal connecting rods, the proximal connecting rods incline inward from the proximal end to the distal end, and the proximal ends of the two proximal connecting rods are integrally connected to the distal end of the outer connecting rod at the same time;

[0077] Two distal connecting rods, the two distal connecting rods incline outward from the proximal end to the distal end, the proximal end of the distal connecting rod, the distal end of the corresponding proximal connecting rod and the corresponding outer support connection point are integrally connected, and the distal end of the distal connecting rod is integrally connected to the proximal end of the V-shaped connecting rod, so that the large V-shaped frame forms a structure with the middle of the outer peripheral surface indented inward.

[0078] Preferably, one barb is provided on the large V-shaped frame of the 5 outer repeating units on the arc side of the D-shaped profile, in an inverted V shape, and the two proximal ends of the inverted V-shaped barb are respectively integrally connected to the two proximal connecting rods of the corresponding large V-shaped frame near the outer support connection point.

[0079] Preferably, the inverted V-shaped barb inclines outward from the proximal end to the distal end and exposes outside the soft outer frame, and the barbs of the 5 outer repeating units enclose a barb portion.

[0080] Preferably, the angle of the outward inclination of the inverted V-shaped barb is 5° to 15°.

[0081] Preferably, the outer connecting rod inclines outward from the proximal end to the distal end, so that a plurality of the outer connecting rods enclose a hollow frustum-shaped structure.

[0082] Preferably, the tether end is in the shape of a barbell, with square connecting frames at both ends, and the tether holes are provided in the square connecting frames, and the tether holes are circular holes.

[0083] Preferably, two marking members are provided on the soft outer frame, on the two rhomboid-like frames on the straight side of the D-shaped profile, and near the distal ends of the two rhomboid-like frames, and the two marking members are arranged on one side of the rhomboid-like frame at a preset distance from each other.

[0084] Preferably, the marking member is a convex semi-circular member, and the marking member is integrally formed with the rhomboid-like frame.

[0085] Preferably, the marking member is a marking hole provided on the rhomboid-like frame, and a radiopaque marking material is installed in the marking hole.

[0086] Preferably, for the rigid inner frame, each inner repeating unit sequentially includes from the distal end to the proximal end:

[0087] A V-shaped inflow frame, the distal ends of the V-shaped inflow frames of the 6n inner repeating units are adjacent to each other in pairs to form the inner skirt portion of the rigid inner frame, and its cross-section is a circular contour;

[0088] A kind of rhomboid middle frame, the central positions of the two sides of the rhomboid middle frame have inner support connection points, the distal ends of the rhomboid middle frame are correspondingly connected to the proximal ends of the V-shaped inflow frame, and the rhomboid middle frames of the 6n inner repeating units are adjacent to each other in pairs with the inner support connection points to form the inner support portion of the rigid inner frame, presenting a hollow columnar structure;

[0089] A kind of hexagonal outflow frame, the distal ends of the hexagonal outflow frame are correspondingly connected to the proximal ends of the rhomboid middle frame, the two side rods of the hexagonal outflow frames of the 6n inner repeating units are adjacent to each other in pairs to form the leaf connection portion of the rigid inner frame, presenting a hollow columnar structure, the leaf connection portion is integrally connected to the inner support portion correspondingly, and a leaf mechanism is accommodated inside; the distal end of one inner connecting rod is integrally connected to the middle of the proximal ends of the hexagonal outflow frames of the adjacent continuous n inner repeating units.

[0090] Preferably, the contour of the rhomboid middle frame sequentially includes from the distal end to the proximal end:

[0091] A distal end curve protruding towards the distal end direction, the midpoint of the distal end curve is a distal end maximum point, and the distal end curve is the farthest from the radial center line of the rhomboid middle frame at the distal end maximum point;

[0092] Two axially symmetric distal end straight lines, the distal ends of the two distal end straight lines are integrally connected to the proximal ends of the distal end curve respectively;

[0093] Two axially symmetric middle curves, the distal ends of the two middle curves are integrally connected to the proximal ends of the corresponding distal end straight lines respectively, the inner support connection points are located at the midpoints of the middle curves, and the middle curves are the farthest from the axial center line of the rhomboid middle frame at the inner support connection points;

[0094] Two axially symmetric proximal end straight lines, the distal ends of the two proximal end straight lines are integrally connected to the proximal ends of the corresponding middle curves respectively;

[0095] A proximal end curve protruding towards the proximal end direction, the midpoint of the proximal end curve is a proximal end maximum point, and the proximal end curve is the farthest from the radial center line of the rhomboid middle frame at the proximal end maximum point.

[0096] Preferably, the distance from the distal end maximum point to the radial center line of the rhomboid middle frame is greater than or equal to the distance from the proximal end maximum point to the radial center line of the rhomboid middle frame.

[0097] Preferably, a side rod of 2n consecutive hexagonal outflow frames is a leaflet connecting rod, and the leaflet connecting rod has a leaflet suturing hole, through which the rigid inner frame and the leaflet mechanism are sutured and connected.

[0098] Preferably, the leaflet suture holes are two circular holes spaced a certain distance apart or are a long waist-shaped hole.

[0099] Preferably, the width of the side rod of the hexagonal outflow rack without the leaflet suture hole is 1 / 3-1 / 2 of the overall width of the leaflet connecting rod with the leaflet suture hole.

[0100] Preferably, the cross section of the hard inner frame has a symmetry line perpendicular to the straight side of the D-shaped profile, and the two inner suture holes of the hard inner frame and an inverted V-shaped barb of the soft outer frame are both located on the symmetry line.

[0101] Preferably, the inclination angle of the inner connecting rod is consistent with the inclination angle of the outer connecting rod of the soft outer frame, the outer connecting rods of the 6 outer repeating units form the outer connecting part of the soft outer frame, presenting a retracted structure, and the inner connecting rods of the 6n inner repeating units form the inner connecting part of the hard inner frame, presenting a retracted structure.

[0102] Preferably, the soft outer frame is a soft outer frame made by cutting a nickel-titanium tube in one piece; and the hard inner frame is a hard inner frame made by cutting a cobalt-chromium tube in one piece.

[0103] The positive and progressive effects of the present invention are:

[0104] 1. The present invention first sets a plurality of inner repeating units corresponding to one outer repeating unit, and increases the number of repeating units constituting the rigid inner frame structure, which can improve the hardness of the rigid inner frame structure itself. Secondly, it is further made of cobalt-chromium alloy material in one piece, which can further increase the hardness of the rigid inner frame. Compared with the traditional self-expanding transapical mitral valve device, when the blood flow impacts the artificial valve leaflets, the rigid inner frame of the present invention has higher stability, smaller deformation, and more stable posture of the artificial valve leaflets, so that the artificial valve leaflets can work in an ideal position.

[0105] 2. The present invention divides the coating mechanism into an outer coating and an inner coating, wherein the inner coating is further divided into an inner frame inner coating and an outer frame inner coating; the outer coating is coated on the outer side of the soft outer frame, and the inner frame inner coating is coated on the inner side of the hard inner frame. At this time, the outer frame inner coating is coated on the inner side of the soft outer frame, and the distal end does not extend to the distal end of the inner side of the soft outer frame, that is, the distal end of the outer frame inner coating is not coated on the inner side of the outer coating folded to the inner side of the outer frame, thereby removing the limitation of the axial length of the soft outer frame during the compression and elongation process.

[0106] 3. The present invention designs a double-layer film on the distal end of the outer-layer film covering. A certain axial distance is reserved at the distal end of the double-layer film to form a margin space for the elongation of the soft outer frame, providing an elongation space in the axial direction of the soft outer frame during the compression process of the stent, and effectively reducing the influence of the film covering on the compression deformation of the stent.

[0107] 4. The present invention extends the inner-layer film covering to the middle section of the soft outer frame and sutures it to the middle section of the inner side of the soft outer frame and the outer-layer film covering, avoiding blood from penetrating between the outer-layer film covering and the inner-layer film covering. BRIEF DESCRIPTION OF THE DRAWINGS

[0108] Figure 1A is a three-dimensional structure diagram of the present invention;

[0109] Figure 1B is Figure 1A the front view of

[0110] Figure 1C is Figure 1A the top view of

[0111] Figure 1D is Figure 1A the bottom view of

[0112] Figure 2 is a structure diagram of the film covering of the present invention;

[0113] Figure 3A is a three-dimensional structure diagram of the soft outer frame of the present invention;

[0114] Figure 3B is Figure 3A the front view of

[0115] Figure 3C is Figure 3A a schematic diagram of the angle of the rhomboid-like frame of the soft outer frame;

[0116] Figure 3D is a structure diagram of the D-shaped profile;

[0117] Figure 4A is a top view of an implementation structure of the soft outer frame of the present invention;

[0118] Figure 4B is Figure 4A a partial enlarged view of

[0119] Figure 4C is a front view of the soft outer frame of the present invention when it is unfolded flat;

[0120] Figure 4D is Figure 4C a partial enlarged view at the distal end of

[0121] Figure 4E is Figure 4C a partial enlarged view at the proximal end of

[0122] Figure 5A a top view of an implementation structure of the rigid inner frame of the present invention;

[0123] Figure 5B is Figure 5A the front view of

[0124] Figure 5C is Figure 5A the top view of

[0125] Figure 5D is Figure 5C the bottom view of

[0126] Figure 5E a front view of the present invention when the rigid inner frame is unfolded flat;

[0127] Figure 5F - 5G a partial enlarged view of the rigid inner frame of the present invention;

[0128] Figure 5H a contraction diagram of the rigid inner frame of the present invention;

[0129] Figure 6 is Figure 5E a partial enlarged view of

[0130] Figure 7 a positional relationship diagram of the soft outer frame and the rigid inner frame of the present invention;

[0131] Figure 8 a schematic connection diagram of the outer layer film and the soft outer frame of the present invention;

[0132] Figure 9 a flat unfolded view of the outer layer film;

[0133] Figure 10 a schematic connection diagram of the inner frame inner membrane and the rigid inner frame;

[0134] Figure 11 a sectional view of the connection position of the stent mechanism and the film covering mechanism;

[0135] Figure 12 a flat unfolded view of the inner frame inner membrane;

[0136] Figure 13 a flat unfolded view of the outer frame inner membrane;

[0137] Figure 14 an implantation diagram of the transapical mitral valve replacement balloon-expandable valve device in the heart. Detailed implementation manners

[0138] The following describes the embodiments of the present invention through specific examples. Those skilled in the art can easily understand the other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0139] It should be noted that in the present invention, the terms "proximal end" and "distal end" are used as orientation terms, which are common terms in the field of interventional medical devices. The "proximal end" refers to the side of the balloon-expandable valve device for transapical mitral valve replacement close to the apex of the heart, and the "distal end" refers to the side of the balloon-expandable valve device for transapical mitral valve replacement away from the apex of the heart. The "axial direction" refers to the direction between the "proximal end" and the "distal end". The "central axis" refers to the direction of the connection line between the maximum value points on the proximal end curve and the distal end curve of the inner contour of the rhomboid-like middle frame on the rigid inner frame.

[0140] As Figure 1A - 1D 、 Figure 2 and Figure 14 shown, the present invention is a balloon-expandable valve device for transapical mitral valve replacement, including a soft outer frame 100, a rigid inner frame 200 located inside the soft outer frame 100, an outer layer of film 300 covering the outer side surface of the soft outer frame 100, and an inner layer of film 400 covering the inside of the rigid inner frame 200 and the inside of the soft outer frame 100. Of course, it may also include an artificial valve leaf 500 disposed inside the rigid inner frame 200.

[0141] As Figure 3A to 3B shown, since the soft outer frame 100 of the present invention is made of materials such as nitinol, compared with the cobalt-chromium alloy used for the rigid inner frame 200, nitinol is relatively soft, so it is called the soft outer frame. Of course, the soft outer frame 100 can also be made of other relatively soft alloy materials, which is also feasible. Divided axially, the soft outer frame 100 sequentially includes an integrally connected outer skirt portion 110, an outer support portion 120, an outer connection portion 130, and a tether end 140 from the distal end to the proximal end. At the same time, divided radially, the soft outer frame 100 is composed of 6 outer repeating units in the circumferential direction. Each outer repeating unit sequentially includes from the distal end to the proximal end: two adjacent rhomboid-like frames 111 (that is, one-sixth of the outer skirt portion 110), a large V-shaped frame 121 (similarly, one-sixth of the outer support portion 120), an outer connecting rod 131 (that is, one-sixth of the outer connection portion 130), and a tether connecting rod 141 (that is, one-sixth of the tether end 140).

[0142] As an example, the soft outer frame 100 is integrally formed by cutting a nickel-titanium alloy material. The outer skirt portion 110 of the soft outer frame 100 is formed by enclosing six outer repeating units of rhomboid-like frames 111 adjacent to each other in pairs at outer skirt connection points 112. The rhomboid-like frame 111 is roughly similar to a rhombus structure. Each outer repeating unit is composed of 2 rhomboid-like frames 111. Therefore, the outer skirt portion 110 enclosed by 6 outer repeating units has 12 rhomboid-like frames 111. The central positions of the two side edges of the rhomboid-like frame 111 are the outer skirt connection points 112. The adjacent rhomboid-like frames 111 are connected adjacent to each other in pairs at the outer skirt connection points 112, enclosing a D-shaped cross-sectional contour, so as to be consistent with the outer contour of the native valve annulus. Taking the outer skirt connection point 112 as the demarcation point, the rhomboid-like frame 111 is integrally connected by an inverted V-shaped connecting rod 1111 at the distal end and a V-shaped connecting rod 1112 at the proximal end. That is, a proximal end of the inverted V-shaped connecting rod 1111 and a distal end of the V-shaped connecting rod 1112 are integrally connected correspondingly at an outer skirt connection point 112; another proximal end of the inverted V-shaped connecting rod 1111 and another distal end of the V-shaped connecting rod 1112 are integrally connected at another corresponding outer skirt connection point 112, thus forming the rhomboid-like frame 111. Moreover, in terms of appearance, the inverted V-shaped connecting rod 1111 inclines inward from the proximal end to the distal end, forming a converging structure; the V-shaped connecting rod 1112 inclines outward from the proximal end to the distal end, forming an outward expanding structure. That is to say, the distal end of the soft outer frame 100 is a converging structure, which can prevent the tip from piercing the inner wall of the heart.

[0143] In a preferred example, as Figure 3C to 3D shown, the angle of inward convergence of the inverted V-shaped connecting rod 1111 is α, where 10° ≤ α ≤ 20°, and α is preferably 15°; if the convergence angle is too large, it will affect the endothelialization speed of the outer skirt portion 110 of the soft outer frame 100. Therefore, an appropriate convergence angle can not only meet the endothelialization speed of the outer skirt portion 110, but also protect the inner wall of the heart from being pierced by the collision of the distal end of the outer skirt portion 110. The angle of outward expansion of the V-shaped connecting rod 1112 is β, where 15° ≤ β ≤ 75°. The integral smooth connection of the inverted V-shaped connecting rod 1111 and the V-shaped connecting rod 1112 causes the outer skirt portion 110 to form a structure with the middle of the outer peripheral surface protruding outward. The angle β of the arc side close to the D-shaped contour is greater than the angle β of the straight side close to the D-shaped contour. Preferably, the difference between the two is not less than 25°; more preferably, the difference between the angle β of the arc side close to the D-shaped contour and the angle β of the straight side close to the D-shaped contour is 30°, and the angle β of the straight side close to the D-shaped contour is at least 30°.

[0144] In a preferred example, at least one marking member 150 is provided on the soft outer frame 100. As Figure 4A to 4DAs shown, two marking members 150 are provided, respectively located on two rhomboid-like frames 111 on the straight-edge side of the D-shaped contour, and near the distal ends of the two rhomboid-like frames 111, that is, the marking members 150 are located near the distal ends of the inverted V-shaped connecting rod 1111. The two marking members 150 are arranged on one side of the rhomboid-like frame 111 at a preset distance away from each other, that is, arranged on the side near the distal end of the inverted V-shaped connecting rod 1111. The marking members 150 are used to distinguish the position of the soft outer frame 100. Therefore, the two marking members 150 do not necessarily need to be symmetric about the symmetry line 260 perpendicular to the straight edge of the D-shaped contour. They can be normally arranged on any two rhomboid-like frames 111 on the straight-edge side of the D-shaped contour, so as to determine the position of the transapical mitral valve replacement balloon-expandable valve device. It should be noted that the two marking members 150 being arranged on one side of the rhomboid-like frame 111 at a preset distance away from each other can include arranging the marking members 150 at the distal ends of the inverted V-shaped connecting rod 1111. Moreover, when only one marking member 150 is provided, the difference from the embodiment with two marking members 150 is that only one of the two marking members 150 is removed and the other one is retained. In addition, the marking member 150 is a protruding semi-circular convex member, and the marking member 150 is integrally formed with the rhomboid-like frame 111. In addition, the marking member 150 can also be a marking hole provided on the rhomboid-like frame 111, and a radiopaque marking material ("marker") is installed in the marking hole. At the same time, the marking member 150 can be any form of convexity or a marking hole installed with a radiopaque marking material, as long as it is convenient for the operator to observe under the imaging device.

[0145] As an example, in the radial direction, the outer support portion 120 is formed by enclosing six large V-shaped frames 121 of outer repeating units adjacent to each other in pairs at the outer support connection points 122, presenting a cylindrical-like structure and accommodating the rigid inner frame 200 inside. As the name implies, the large V-shaped frame 121 is similar to a V-shaped structure. The two distal ends of the large V-shaped frame 121 are respectively correspondingly connected to the proximal ends of two adjacent rhomboid-like frames 111. The central positions of the two side edges of the large V-shaped frame 121 are the outer support connection points 122. Taking the outer support connection point 122 as the demarcation point, the large V-shaped frame 121 includes two proximal connecting rods 1211 and two distal connecting rods 1212 in sequence from the proximal end to the distal end.

[0146] The proximal connecting rod 1211 inclines inward from the proximal end to the distal end, and the proximal ends of the two proximal connecting rods 1211 are integrally connected to the distal end of the outer connecting rod 131 at the same time; the distal connecting rod 1212 inclines outward from the proximal end to the distal end, and the proximal end of the distal connecting rod 1212 is integrally connected to the distal end of the corresponding proximal connecting rod 1211 at the corresponding outer support connection point 122, and the distal end of the distal connecting rod 1212 is integrally connected to the proximal end of the corresponding V-shaped connecting rod 1112, so that the large V-shaped frame 121 forms a structure with the middle of the outer peripheral surface indenting inward. Such a structure can better adapt to the structure of the heart and install the rigid inner frame 200.

[0147] In addition, a barb 123 is respectively arranged inside each of the five outer repeating units of the arc-shaped side of the D-shaped profile within the large V-shaped frame 121, presenting an inverted V shape. The two proximal ends of the inverted V-shaped barb 123 are integrally connected to the two proximal end connecting rods 1211 of the corresponding large V-shaped frame 121 near the outer support connection point 122. Meanwhile, the inverted V-shaped barb 123 inclines outward from the proximal end to the distal end and protrudes outside the soft outer frame 100. The angle of inclination of the inverted V-shaped barb 123 to the outside is 5° to 15°. The barb portion 150 is used to grasp the native mitral valve leaflets, assisting in the overall sealing of the valve system to reduce the occurrence of paravalvular leakage after the implantation of the valve device. In addition, after the valve device is implanted, when the left atrium contracts, the implanted valve leaflets are washed open by the blood, and the pressure of the blood flow on the valve device is relatively small, and the valve device is not affected. However, when the ventricle contracts, the implanted valve leaflets are in a closed state, and the pressure of the blood flow on the valve device is extremely high. Without restraint, the valve device will separate from the native valve annulus and slip into the left atrium. The design of the central apex tether 600 of the device can, firstly, restrain the valve device in place, and the barbs on the valve device hook the native valve leaflets, which is beneficial for sharing the force on the apex tether, reducing the force on the heart muscle, and thus reducing the damage to the heart. Secondly, it can prevent the native mitral valve leaflets from moving freely in the heart. For example, if the anterior leaflet is reversed under the scouring of the blood, it will cause aortic blockage, thus endangering the life safety of the user. Clamping the native valve leaflets between the barb 123 and the soft outer frame 100 can prevent the native valve leaflets from moving freely in the heart. Moreover, because the anterior leaflet of the mitral valve is close to the aorta, the outwardly protruding barbs on the soft outer frame 100 may affect the aorta, resulting in abnormal aortic function. Therefore, the barbs 123 near the aorta position are removed, that is, the barbs 123 on the straight side of the D-shaped profile are removed, and the native mitral valve is fixed using the adjacent barb structure, thereby preventing the outwardly protruding barb 123 structure on the soft outer frame 100 from affecting the function of the aorta. That is to say, the barbs 123 of the five outer repeating units on the arc-shaped side of the D-shaped profile enclose a barb portion 150. In other words, no inverted V-shaped barbs 123 are provided on the straight side of the D-shaped profile, and the native valve is fixed using the adjacent V-shaped barbs 123 to prevent the formation of a V-shaped barb 123 bulge here from affecting the function of the aorta, which is equivalent to the shape of the soft outer frame 100 being more matched and anastomosed with the position of the anterior leaflet of the mitral valve close to the aorta.

[0148] As an example, the outer connection part 130 is surrounded by outer connecting rods 131 of 6 outer repeating units, forming a hollow frustum-shaped horn-like structure. The outer connecting rod 131 is generally rod-shaped, but in an inclined manner. The distal end of the outer connecting rod 131 is integrally connected to the proximal end of the large V-shaped frame 121. The outer connecting rod 131 inclines outward from the proximal end to the distal end, causing the 6 outer connecting rods to surround the outer connection part 130 with a hollow frustum-shaped structure. At the same time, outer suture holes 132 are provided at the proximal ends of the outer connecting rods 131. The outer suture holes 132 can be two circular holes arranged side by side at a certain distance, or a long strip-shaped waist-shaped hole. The length direction of the waist-shaped hole is the length direction of the outer connecting rod 131.

[0149] As an example, the tether end 140 is surrounded by tether connecting rods 141 of 6 outer repeating units in parallel with each other, forming a columnar structure. As Figure 4E shown, the distal end of the tether connecting rod 141 is integrally connected to the proximal end of the corresponding outer connecting rod 131. The tether connecting rod 141 is barbell-shaped, with square connecting frames 1411 at both ends. The proximal and distal ends of the square connecting frame 1411 are provided with rounded corners, and a tether hole 1412 in the shape of a circular hole is provided in the middle. It should be noted that when the soft outer frame 100 is unfolded into a plane, the left and right side surfaces of the tether connecting rod 141 and the square connecting frame 1411 are planes, and the planes are parallel to each other.

[0150] As Figure 5A to 5H shown, the rigid inner frame 200 of the present invention is formed of a relatively rigid material, so it is a balloon-expandable valve. The relatively rigid material can be, for example, cobalt-chromium alloy, which is harder than the traditional nitinol alloy. Because materials such as cobalt-chromium alloy have good rigidity and high hardness, they can stabilize the artificial valve leaflets, and can better ensure that under the impact of blood flow, the deformation of the inner stent is smaller and the posture of the artificial valve leaflets is more stable. Of course, other relatively rigid alloy materials can also be adopted for the rigid inner frame 200 of the present invention, which does not affect the realization of the purpose of the present invention. The traditional inner frame is a nitinol inner frame, which is self-expandable and relatively soft. Under impact, the deformation is relatively large, and the artificial valve leaflets cannot cooperate at an ideal position. The soft outer frame 100 needs to adapt to the cardiac valve annulus, so the material is relatively soft. The rigid inner frame 200 needs to support the valve leaflets, so a relatively rigid material is selected.

[0151] In this example, the rigid inner frame 200 is integrally cut from a cobalt-chromium alloy material. Therefore, the entire rigid inner frame 200 is also an integrally formed structure. Looking at the overall structure, the rigid inner frame is generally a hollow cylindrical frame structure. Divided axially, the rigid inner frame 200 sequentially includes an inner skirt portion 210, an inner support portion 220, a leaflet connection portion 230, and an inner connection portion 240 from the distal end to the proximal end. Divided radially, the rigid inner frame 200 has 6n inner repeating units in the circumferential direction. Adjacent consecutive n inner repeating units are grouped together, and each group of inner repeating units corresponds to an outer repeating unit of the soft outer frame 100. There is an axial connection between adjacent two groups of inner repeating units. At the proximal end of the axial connection, an inner connecting rod 241 is correspondingly connected. The inner connecting rod 241 is connected in parallel with the outer connecting rod 131 of the soft outer frame 100 so that the soft outer frame 100 and the rigid inner frame 200 are connected and the rigid inner frame 200 is arranged inside the soft outer frame 100. In this example, n is a natural number greater than or equal to 2. Preferably, 2 ≤ n ≤ 6. A better way is that n is 2. Each inner repeating unit is divided axially and sequentially includes, from the distal end to the proximal end: a V-shaped inflow frame 211, a rhombus-like middle frame 221, and a hexagonal-like outflow frame 231.

[0152] As an example, the inner skirt portion 210 is formed by connecting the distal ends of the V-shaped inflow frames 211 of 6n inner repeating units adjacent to each other in pairs, and its cross-section is a circular contour. The V-shaped inflow frame 211 has two axially symmetrically arranged inflow rods. The proximal ends of the two inflow rods are integrally connected. The distal end of the inflow rod is integrally connected to the distal end of an inflow rod of an adjacent V-shaped inflow frame 211. After the distal ends of the two inflow rods are integrally connected, a smooth inflow head is formed. The width of the inflow head is approximately the sum of the widths of the two inflow rods. The distal end of the inflow head is in a semi-circular arc shape. The proximal ends of the two inflow rods are integrally connected to form a structure similar to a curved trapezoid. The width of the bottom edge at the distal end of the curved trapezoid is approximately the sum of the widths of the two inflow rods, and the width of the bottom edge at the proximal end of the curved trapezoid is approximately the width of a single inflow rod.

[0153] As an example, the inner support portion 220 is also composed of 6n rhombus-like middle frames 221 of inner repeating units. The central positions of the two side edges of the rhombus-like middle frame 221 are the inner support connection points 222. The rhombus-like middle frames 221 are connected adjacent to each other at the inner support connection points 222 to enclose the inner support portion 220, showing a hollow column-like structure. It should be noted here that the radial width of the inner support portion 220 at the inner support connection point 222 is approximately twice the radial width of a single rhombus-like middle frame 221 at the inner support connection point 222. That is, adjacent rhombus-like middle frames 221 are integrally connected at the inner support connection point 222, and do not share the same inner support connection point 222, but two inner support connection points 222 are adjacent to each other closely. The distal end of the rhombus-like middle frame 221 is integrally connected to the proximal end of the V-shaped inflow frame 211, that is, the curved trapezoid structure.

[0154] As shown Figure 6 in the figure, the inner contour of the rhombus-like middle frame 221 is successively composed of a distal curve BC connected integrally from the distal end to the proximal end, a first distal straight line AB and a second distal straight line CD, a first middle curve DE and a second middle curve AH, a first proximal straight line EF and a second proximal straight line GH, and a proximal curve FG. Among them, the distal curve BC can be regarded as composed of two curves concave inward to the central axis and integrally connected at the distal end, and includes a maximum point P1. This maximum point P1 is also a similar curved trapezoid structure in the physical object. The curved trapezoid at the distal end of the rhombus-like middle frame 221 and the curved trapezoid at the proximal end of the V-shaped inflow frame 211 are axially symmetric about the radial center line therebetween. The first distal straight line AB and the second distal straight line CD are equal in length and axially symmetric, and the first proximal straight line EF and the second proximal straight line GH are equal in length and axially symmetric. The lengths of the first distal straight line AB and the second distal straight line CD are greater than or equal to the lengths of the first proximal straight line GH and the second proximal straight line EF. The first middle curve DE is an arc protruding outward circumferentially away from the axial center line of the rhombus-like middle frame 221, and can be regarded as a parabola rotated 90° clockwise, and includes a maximum point P2, that is, the inner support connection point. The second middle curve AH is an arc protruding outward circumferentially away from the axial center line of the rhombus-like middle frame 221, and can be regarded as a parabola rotated 90° counterclockwise, and includes a maximum point P4. The proximal curve FG can be regarded as composed of two curves concave inward to the axial center line and integrally connected at the proximal end, and includes a maximum point P3. The first middle curve DE and the second middle curve HA are symmetric with respect to the axial center line of the rhombus-like middle frame 221, and the maximum points P2 and P4 are at the same horizontal height. It should be noted that in the physical object, both P2 and P4 are inner support connection points 222, and the vertical distance from the maximum point P1 to this horizontal height is greater than or equal to the vertical distance from the maximum point P3 to this horizontal height. As an example, the vertical distance from the maximum point P1 to this horizontal height can be 1 - 2.5 times the vertical distance from the maximum point P3 to this horizontal height, that is, the length of the frame contour formed by P4 - P1 - P2 extending along the longitudinal axis of the rhombus-like middle frame 221 is greater than or equal to the length of the frame contour formed by P4 - P3 - P2 extending along the longitudinal axis of the rhombus-like middle frame 221. In addition, the included angle between the two curves of the distal curve BC is less than or equal to the included angle between the two curves of the proximal curve FG.

[0155] As an example, the leaflet connection part 230 is formed by two adjacent rods of the hexagonal outflow frame 231 of 6n inner repeating units, presenting a hollow columnar structure, which is integrally connected to the proximal end of the inner support part 220, and contains a leaflet mechanism 250. The distal end of the hexagonal outflow frame 231 is integrally connected to the proximal end of the rhombus-shaped middle frame 221, i.e., the maximum point P3. A side rod of 2n consecutive hexagonal outflow frames 231 is a leaflet connection rod 232, and the leaflet connection rod 232 has a leaflet suture hole 233, through which the rigid inner frame 200 and the leaflet mechanism 250 are sutured and connected. The leaflet suture hole 233 can be two circular holes arranged side by side and spaced a certain distance apart, or it can be a long strip waist-shaped hole. It should be noted that the width of the side rod of the hexagonal outflow frame 231 without the leaflet suture hole 233 is 1 / 3-1 / 2 of the overall width of the leaflet connecting rod 232 with the leaflet suture hole 233. Such a design enhances the compressibility of the stent, while also reducing the strength difference between the leaflet connecting rod 232 with the leaflet suture hole 233 and the leaflet connecting rod 232 without the leaflet suture hole 233, thereby promoting the mechanical balance of the stent. In some preferred embodiments, the side rod is integrally connected to the distal end of the inner connecting rod 241 of the inner connecting portion 240. Although there is no leaflet suture hole, the width of the side rod is also widened. The width of the widened side rod is roughly similar to the width of the leaflet connecting rod 232. The widened side rod increases the rigidity of the rigid inner frame 200 and plays a better supporting role.

[0156] As an example, the inner connecting portion 240 is surrounded by 6 inner connecting rods 241 of 6n inner repeating units and presents a folded structure. The proximal ends of the two adjacent groups of inner repeating units at the axial connection are correspondingly connected to an inner connecting rod 241, and the distal end of the inner connecting rod 241 is integrally connected to the proximal end of the hexagonal outflow frame 231 of the n inner repeating units, for example, it is integrally connected to the side rod having the same width as the leaflet connecting rod 232 or is integrally connected to the leaflet connecting rod 232. In addition, the inclination angle of the inner connecting rod 241 is consistent with the inclination angle of the outer connecting rod 131 of the soft outer frame 100. An inner suture hole 242 is provided on the inner connecting rod 241; the aperture of the outer suture hole 132 must be greater than or equal to the aperture of the inner suture hole 242. The inner suture hole 242 and the outer suture hole 132 are sewn together so that the inner connecting rod 241 and the outer connecting rod 131 are closely connected to each other. At the same time, the outer connecting rod 131 can be connected to the inner connecting rod 241 by riveting, bolting or welding.

[0157] As an example, Figure 7As shown, the cross section of the hard inner frame 200 has a symmetry line 260 perpendicular to the straight side of the D-shaped profile, and the two inner suture holes 242 of the hard inner frame 200 and an inverted V-shaped barb 123 of the soft outer frame 100 are both located on the symmetry line 260.

[0158] like Figure 2 As shown, the coating mechanism of the present invention comprises an outer coating 300 attached to the outer side surface of the stent and an inner coating 400 attached to the inner side surface of the stent.

[0159] As an example, Figure 8 and Figure 9 As shown, the outer coating 300 is roughly a fan-shaped structure after being unfolded, and the two straight sides of the fan are sutured to form a hollow truncated cone. The truncated cone-shaped outer coating 300 is coated on the outer side of the soft outer frame 100. A better way is that the proximal end of the outer coating 300 passes over the proximal end of the outer support part 120 and directly reaches the distal end of the outer connection part 130 and is close to the distal end of the outer connection part 130. The distal end of the outer coating 300 crosses the distal end of the soft support 100 and turns inward to form a double-layer membrane 320, that is, the double-layer membrane 320 passes over the distal end of the soft outer frame 100. That is, the distal end of the double-layer membrane 320 is located on the distal side of the distal end of the soft outer frame 100. Specifically, the outer coating 300 has an outer frame outer membrane 310 coated on the outer side of the soft outer frame 100. It should be noted that the distal end of the outer film 310 of the outer frame is the outer layer 321 of the double-layer film 320, and the outer layer 321 of the double-layer film 320 continues to extend and then folds inward over the distal end of the soft outer frame 100 to fit the inner side of the outer film 310 of the outer frame to form the inner layer 322 of the double-layer film 320. In other words, the distal end of the soft outer frame 100 is inserted into the double-layer film 320 but does not abut against the distal end of the double-layer film 320, so that the distal end of the double-layer film 320 and the distal end of the soft outer frame 100 inserted in its internal space form a certain axial spacing. This axial spacing provides a margin space for the compression and elongation of the soft outer frame 100, which can be set to 1mm to 3mm, preferably, set to 2mm, and serves as a deformation space for the axial elongation of the soft outer frame during the compression of the stent, so as to reduce the limiting effect of the coating on the compression deformation of the stent. Since the edges of the covering film will inevitably have burrs and other defects during the cutting process, in order to prevent the edges of the covering film from scratching the inner wall of the heart, the edge of the inner layer 322 of the double-layer film 320 exceeds the distal end of the soft outer frame 100 and is sutured and attached to the inner side of the outer film 310 of the outer frame, so that the edge of the outer layer covering film 300 cannot contact the inner wall of the heart, thereby preventing the edge of the covering film from scratching the inner wall of the heart. Figure 10 As shown, the planar unfolded view of the outer coating 300 is a fan-shaped structure with five arc-shaped gaps, and the five barbs 123 on the soft outer frame 100 pass through the arc-shaped gaps of the outer coating 300 respectively.

[0160] As an example, the proximal segment of the inner layer film 400 is wrapped around the inner side of the inner rigid frame 200 of the inner frame, and the distal segment extends from the proximal segment of the inner layer film 400 to the distal end and wraps around the middle section of the inner side of the soft outer frame 100. For a more intuitive and clear explanation, as Figure 2 and Figure 10 shown, further, the inner layer film 400 is split into an inner frame inner film 410 wrapped around the inner side of the inner rigid frame 200 of the inner frame and an outer frame inner film 420 wrapped around the inner side of the soft outer frame. As Figure 12 to Figure 13 shown, the planar development view of the inner frame inner film 410 is a rectangular structure. After the two sides of the rectangular structure are stitched, it forms a hollow cylindrical shape. The proximal end of the cylindrical inner frame inner film 410 reaches the proximal end of the leaflet connection part 230 of the inner rigid frame 200 of the inner frame and is flush with the proximal end of the outer layer film 300. The proximal ends of the inner frame inner film 410 and the outer layer film 300 are closely attached to the soft outer frame 100 and the inner rigid frame 200 of the inner frame and are stitched and connected together. The planar development view of the outer frame inner film 420 is an annular shape. The inner frame inner film 410 is provided with at least 3 leaflet holes 440 near the proximal end, which are in a long strip waist shape. The leaflet holes 440 correspond to the leaflet suture holes 233 of the leaflet connecting rods 232 on the inner rigid frame 200 of the inner frame. The two sides of the outflow end of the artificial leaflet 500 are passed through the leaflet holes 440 and stitched at the leaflet suture holes 233 of the inner rigid frame 200 of the inner frame. Moreover, the distal end of the outer frame inner film 420 is located at the middle section of the soft outer frame 100 and is stitched to the corresponding position of the outer layer film 300 on the outer side of the middle section of the soft outer frame 100. Preferably, the distal end of the outer frame inner film 420 is closely attached to the middle section of the soft outer frame 100 and is stitched to the middle section on the inner side of the outer layer film 300. In this way, the gap between the outer layer film 300 and the inner layer film 400 can be stitched to prevent blood from flowing into the gap and forming thrombus. In addition, the proximal end of the outer frame inner film 420 is stitched and connected to the distal end of the inner frame inner film 410, and the two are stitched and connected to form a stitching knot 430. As Figure 11 shown, the stitching knot 430 is located on the side of the inner layer film 400 facing the outer layer film 300. It should be noted that taking the distal end of the inner rigid frame 200 of the inner frame as the demarcation line, there are two situations. One situation is that the stitching knot 430 is located on the distal side of the distal end of the inner rigid frame 200 of the inner frame, that is, closely attached to the inner side of the soft outer frame 100 and facing the outer layer film 300. Another situation is that the stitching knot 430 is located on the proximal side of the distal end of the inner rigid frame 200 of the inner frame and is closely attached to the inner side of the inner rigid frame 200 of the inner frame. However, no matter which situation, the stitching knot 430 is wrapped in the gap clamped by the inner layer film 400 and the outer layer film 300. Therefore, when blood passes through the inner rigid frame 200 of the inner frame, the inner layer film 400 can form a relatively smooth channel.

[0161] As an example, both the outer film layer 300 and the inner film layer 400 are made of anti-permeation PET composite films, and the anti-permeation PET composite film has a layer of PET suture film. It should be noted that at least one layer of TPU spunbonded film is provided on the side of the PET suture film close to the stent mechanism. Since the PET material can still undergo blood permeation, while the TPU spunbonded film is smooth and dense and can effectively prevent blood from passing through the film, a layer of TPU spunbonded film is provided on the side of the film close to the stent mechanism, that is, a layer of TPU spunbonded film is provided on the side of the outer film layer 300 close to the soft outer frame 100, a layer of TPU spunbonded film is provided on the side of the inner frame inner membrane 410 close to the rigid inner frame 200, and a layer of TPU spunbonded film is provided on the side of the outer frame inner membrane 420 facing the soft outer frame 100. In addition, a layer of TPU spunbonded film can be provided on both sides of the PET film, but setting only one layer of TPU spunbonded film on one side can meet the problem of preventing the PET film from permeating, so it is also possible to attach a layer of TPU spunbonded film on both sides of the PET film, which can further prevent the permeation problem. At the same time, it is a preferred solution to set the TPU spunbonded film only on the side close to the stent mechanism, because this setting prevents the TPU spunbonded film from directly contacting the external environment, because the TPU spunbonded film is more likely to adsorb impurities in the air than the PET film, and the above design effectively prevents the TPU spunbonded film from absorbing impurities in the air.

[0162] As an example, the preparation method of the anti-permeation PET composite film includes the following steps:

[0163] Step Sa:

[0164] Measure V1 mL of tetrahydrofuran and slowly pour it into a blue-capped bottle; then measure V2 mL of N,N-dimethylformamide and also slowly pour it into the blue-capped bottle; add a large magnetic stirring bead. Place the blue-capped bottle on a magnetic stirrer and adjust the rotation speed to high speed r1 to make the solution in the blue-capped bottle form a vortex. Weigh TPU particles and slowly add them to the blue-capped bottle along the funnel. Maintain the rotation speed of r1 and continuously stir for t1 hours until the TPU particles are completely dissolved. Adjust the rotation speed of the magnetic stirrer to low speed r2 and continuously stir for t2 hours until there are no obvious bubbles in the solution, obtaining a mixed solution of tetrahydrofuran and N,N-dimethylformamide containing TPU solute with a concentration of C, which can be used for electrospinning.

[0165] Step Sb:

[0166] Add purified water to the ultrasonic cleaner. Place a 6×6-inch PET suture membrane in a 1L glass beaker and add 200 ± 10 mL of 75% ethanol aqueous solution. Then place the beaker in the ultrasonic cleaning tank and ultrasonically clean for t3 minutes at frequency F1. After the ultrasonic cleaning is completed, discard the 75% ethanol water solvent, inject 500 ± 10 mL of injection water, and soak the PET suture membrane in water for 2 minutes. After the soaking is completed, replace the injection water with 500 ± 10 mL again, place it in the ultrasonic cleaning tank, and ultrasonically clean for t4 minutes at frequency F2. Take out the PET suture membrane and let it dry to obtain a clean PET suture membrane.

[0167] Step S1

[0168] Lay the clean PET suture membrane obtained in step Sb flat on a dust-free release paper (such as anti-sticking paper, silicone oil paper, etc. are also acceptable), ensure that the PET suture membrane is flat and without wrinkles, and fix the four edges with a 5 mm tape. Then stick the dust-free paper with the PET suture membrane flat on the receiving plate of the electrospinning machine. The size of the dust-free paper should match the travel of the electrospinning machine to avoid the spinning jet from spraying out of the dust-free paper area.

[0169] Use a syringe to draw 60 mL of the mixed solution of tetrahydrofuran and N,N-dimethylformamide containing the TPU solute obtained in step Sa, fix it on the push pump, connect the head end of the syringe to the infusion pipeline, connect the other end of the infusion pipeline to the nozzle, and insert a needle at the outlet of the nozzle. Turn on the push pump to slowly push the solution in the syringe to the needle. When droplets appear at the needle, stop pushing and wipe the liquid flowing out of the needle with a dust-free cloth.

[0170] Adjust the speeds of the X-axis and Y-axis 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 of the X-axis, Y-axis and push pump of the electrospinning machine to start normal movement and liquid discharge, and the liquid discharge speed is W3. Turn on the voltage switch, adjust the voltage, and start spinning. After the film spraying is completed, turn off the voltage, push pump, and the movement of the electrospinning machine in sequence, take off the initial PET composite membrane together with the dust-free paper, and place it at the designated position to dry naturally. The surface of the composite membrane is clean and without obvious impurities.

[0171] Step S2

[0172] Wipe the inner surfaces of the two pieces of glass with a lint-free cloth dipped in 75% ethanol or 0.1% benzalkonium bromide, and air dry for 15 minutes. After uncovering the dust-free paper of the initial PET composite film, place it on the central surface of the glass, align the other piece of glass, and tightly press the initial PET composite film between the two pieces of glass flat and without wrinkles. Use clips to fix the four sides of the glass to ensure that the initial PET composite film will not move. Turn on the oven 30 minutes in advance and set the temperature to T °C. Place the initial PET composite film clamped by the glass in the constant temperature oven at T °C, dry for a time t5, and then air dry for 30 minutes to obtain the final anti-permeation PET composite film.

[0173] Step S3

[0174] Place the obtained PET composite film spun with a single-sided TPU film, and then lay it flat reversely and naturally on the dust-free release paper. Repeat Step S1 and S2 and their process parameters to obtain a PET composite film spun with TPU spinning films on both sides.

[0175] The present invention has been described in detail with reference to the accompanying drawings and embodiments. Those of ordinary skill in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not constitute a limitation to the present invention, and the present invention will take the scope defined by the appended claims as the protection scope.

Claims

1. A transapical mitral valve replacement balloon-expandable valve device, comprising: A stent having a soft outer stent and a rigid inner stent, the rigid inner stent being located within the soft outer stent; A membrane covering the stent; Characterized in that the membrane comprises: An outer layer membrane covering the outer side surface of the soft outer stent, the distal end of the outer layer membrane having a double-layer membrane. The outer layer membrane has an outer membrane of the outer stent covering the outer side surface of the soft outer stent. The distal end of the outer membrane of the outer stent is the outer layer of the double-layer membrane. The outer layer of the double-layer membrane continues to extend and then turns inward and adheres to the inner side of the outer membrane of the outer stent and is sutured to the outer membrane of the outer stent to form the inner layer of the double-layer membrane. The distal end of the soft outer stent is passed through the double-layer membrane and a certain axial distance is reserved from the distal end of the double-layer membrane to form a margin space for the elongation of the soft outer stent; An inner layer membrane, the proximal section of the inner layer membrane covering the inner side surface of the rigid inner stent, and the distal section of the inner layer membrane extending from the proximal section of the inner layer membrane to the middle section of the soft outer stent and covering the middle section of the inner side surface of the soft outer stent and being sutured and connected to the inner side of the middle section of the outer layer membrane; The inner layer membrane has: An inner membrane of the inner stent covering the inner side surface of the rigid inner stent; An inner membrane of the outer stent covering the middle section of the inner side surface of the soft outer stent and sutured to the corresponding position of the outer layer membrane. The distal end of the inner membrane of the inner stent is connected to the proximal end of the inner membrane of the outer stent; The distal end of the inner membrane of the outer stent is closely attached to the middle section of the soft outer stent and sutured to the middle section of the inner side of the outer layer membrane; The edge of the inner layer of the double-layer membrane is closely attached to and exceeds the distal end of the soft outer stent and is sutured to the inner side of the outer membrane of the outer stent.

2. The transapical mitral replacement balloon-expandable valve device according to claim 1, wherein The distal end of the inner membrane of the inner stent is integrally connected to the proximal end of the inner membrane of the outer stent.

3. The transapical mitral replacement balloon-expandable valve device according to claim 1, wherein, The distal end of the inner membrane of the inner stent is sutured and connected to the proximal end of the inner membrane of the outer stent to form a suture knot, and the suture knot is located on the side of the inner layer membrane facing the outer layer membrane.

4. The transapical mitral valve replacement balloon-expandable valve device according to claim 1, characterized in that The proximal end of the inner membrane of the inner stent and the proximal end of the outer layer membrane are closely attached to the soft outer stent and the rigid inner stent and sutured and connected together.

5. The transapical mitral valve replacement balloon-expandable valve device according to claim 1, characterized in that The outer layer membrane is in a sector ring shape, and 5 arc-shaped slits are opened on the outer layer membrane, and the barbs on the soft outer stent respectively pass through the arc-shaped slits of the outer layer membrane; The inner layer membrane comprises an inner membrane of the inner stent and an inner membrane of the outer stent. The inner membrane of the inner stent is in a strip shape, and at least 3 leaflet holes are opened on the inner membrane of the inner stent, in a long strip waist shape, and the long strip waist-shaped holes correspond to the leaflet suture holes on the rigid inner stent; The inner membrane of the outer stent is in a circular ring shape.

6. The transapical mitral replacement balloon-expandable valve device according to claim 1, wherein, Both the outer layer membrane and the inner layer membrane adopt a permeation-proof PET composite membrane, and the permeation-proof PET composite membrane has a PET suture membrane.

7. The transapical mitral replacement balloon-expandable valve device according to claim 1, characterized in that, At least one layer of TPU spun film is provided on the side of the PET suture film close to the stent mechanism, that is, one layer of TPU spun film is provided on the side of the outer covering film close to the soft outer frame, one layer of TPU spun film is provided on the side of the inner frame inner film close to the hard inner frame, and one layer of TPU spun film is provided on the side of the outer frame inner film facing the soft outer frame.

8. The transapical mitral replacement balloon-expandable valve device according to claim 1, characterized in that, The soft outer frame has 6 outer repeating units in the circumferential direction, and each of the outer repeating units has an outwardly inclined outer connecting rod near the proximal end; The hard inner frame is located inside the soft outer frame. The hard inner frame has 6n inner repeating units in the circumferential direction. Adjacent consecutive n inner repeating units are grouped together, and each group of inner repeating units corresponds to one of the outer repeating units; the proximal end of each group of inner repeating units has an inwardly inclined inner connecting rod, and the inner connecting rod is connected to the outer connecting rod, where n≥2 and n is a natural number.

9. The transapical mitral valve replacement balloon-expandable valve device according to claim 8, wherein Each outer repeating unit of the soft outer frame sequentially includes from the distal end to the proximal end: Two adjacent rhomboid-like frames. The rhomboid-like frames of the 6 outer repeating units are adjacent to each other to form the outer skirt portion of the soft outer frame, and its cross-section has a D-shaped profile; A large V-shaped frame. The distal ends of the large V-shaped frame are respectively connected to the proximal ends of the two adjacent rhomboid-like frames; the large V-shaped frames of the 6 outer repeating units are adjacent to each other to form the outer support portion of the soft outer frame, which has a cylindrical-like structure and houses the hard inner frame inside; The outer connecting rod. The distal end of the outer connecting rod is connected to the proximal end of the large V-shaped frame; the outer connecting rods of the 6 outer repeating units form the outer connecting portion of the soft outer frame; A tether connecting rod. The distal end of the tether connecting rod is connected to the proximal end of the outer connecting rod; the tether connecting rods of the 6 outer repeating units form the tether end of the stent.

10. The transapical mitral replacement balloon-expandable valve device according to claim 9, characterized in that, The rhomboid-like frame has: An inverted V-shaped connecting rod. The inverted V-shaped connecting rod inclines inward from the proximal end to the distal end, forming a converging structure; A V-shaped connecting rod. The distal end of the V-shaped connecting rod, the proximal end of the inverted V-shaped connecting rod are integrally connected corresponding to the outer skirt connection point. The proximal end of the V-shaped connecting rod is integrally connected to the distal end of the large V-shaped frame. The V-shaped connecting rod inclines outward from the proximal end to the distal end, forming an outwardly expanding structure.

11. The transapical mitral valve replacement balloon-expandable valve device according to claim 9, wherein, The large V-shaped frame has from the proximal end to the distal end: Two proximal end connecting rods. The proximal end connecting rods incline inward from the proximal end to the distal end, and the proximal ends of the two proximal end connecting rods are integrally connected to the distal end of the outer connecting rod at the same time; Two distal end connecting rods. The two distal end connecting rods incline outward from the proximal end to the distal end. The proximal end of the distal end connecting rod, the distal end of the corresponding proximal end connecting rod are integrally connected to the corresponding outer support connection point. The distal end of the distal end connecting rod is integrally connected to the proximal end of the V-shaped connecting rod, causing the large V-shaped frame to form a structure with a concave middle part on the outer peripheral surface.

12. The transapical mitral replacement balloon-expandable valve device according to claim 11, characterized in that, The large V-shaped frame of the five outer repeating units on the arc side of the D-shaped profile is provided with a barb, which is in an inverted V shape. The two proximal ends of the inverted V-shaped barb are integrally connected to the two proximal end connecting rods of the corresponding large V-shaped frame near the outer support connection point.

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