WO2022077794A1 - 一种植入式假体瓣膜装置及其植入方法 - Google Patents

一种植入式假体瓣膜装置及其植入方法 Download PDF

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Publication number
WO2022077794A1
WO2022077794A1 PCT/CN2021/072484 CN2021072484W WO2022077794A1 WO 2022077794 A1 WO2022077794 A1 WO 2022077794A1 CN 2021072484 W CN2021072484 W CN 2021072484W WO 2022077794 A1 WO2022077794 A1 WO 2022077794A1
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WO
WIPO (PCT)
Prior art keywords
buffer
frame body
leaflet
fixing
prosthetic valve
Prior art date
Application number
PCT/CN2021/072484
Other languages
English (en)
French (fr)
Inventor
杨威
赵婧
Original Assignee
上海臻亿医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Priority to US17/625,729 priority Critical patent/US20220362013A1/en
Priority to EP21839309.8A priority patent/EP4011332A4/en
Publication of WO2022077794A1 publication Critical patent/WO2022077794A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the invention relates to the technical field of medical devices, in particular to a prosthetic valve device implanted in the heart.
  • the heart contains four chambers, the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart.
  • the ventricular inflow tract is formed between the atrium and the ventricle, the left ventricle and the aorta form the left ventricular outflow tract, and the right ventricle and the pulmonary artery form the right ventricular outflow tract.
  • the valves at the left ventricular inflow tract and the right ventricular inflow tract are the mitral valve and the tricuspid valve, respectively.
  • the valves are all composites, including the valve annulus, valve leaflets, chordae tendineae, and papillary muscles, and some literature also includes the ventricular wall.
  • the chordae tendineae serve as a support device connecting the mitral valve leaflets and the myocardium, and are distributed between the valve leaflets and the ventricular wall.
  • the subvalvular structures of the mitral valve (chordae tendineae, papillary muscles, ventricular wall, etc.) play an important role in maintaining the structure and function of the left ventricle, and the original valve structure should be preserved as much as possible during surgery. Therefore, when replacing the native valve with a transcatheter implanted prosthetic valve prosthesis, it is also necessary to adapt to the structure of the native valve as much as possible to reduce the damage of the prosthetic valve to the native valve structure.
  • the size of the mitral valve annulus is anatomically much larger than the size of the aortic valve annulus, the part of the support body of the prosthetic valve implanted in the mitral valve to match the prosthetic valve leaflets is no matter in the circumferential diameter or the axial direction A larger size is required in terms of height, resulting in a larger size of the prosthetic structure under the mitral valve after the prosthetic valve is implanted into the mitral valve, and there is a greater risk of damage to the subvalvular structure of the native valve assembly. For some patients with mitral valve regurgitation, there is no calcified part on the valve, and the existing working principle of using the radial support force generated between the prosthetic valve and the native valve to prevent the displacement of the prosthetic valve cannot be used.
  • the tricuspid valve is similar in structure to the mitral valve and also includes leaflets, annulus, chordae tendineae, papillary muscles and myocardium. Therefore, the prosthetic structure of the heart valve that replaces the native mitral valve can also be used to replace the native tricuspid valve, and the size of the prosthetic valve varies according to the size of the native valve.
  • the mitral valve prosthesis is anchored on the tissue, which is prone to a greater risk of damage to the native tissue;
  • the present invention provides an implantable prosthetic valve device, which can solve the above-mentioned defects in the prior art.
  • An implantable prosthetic valve device comprising a hollow, cylindrical frame body, the frame body comprising a leaflet fixing portion for fixing artificial valve leaflets, and the artificial valve leaflet is fixed at a predetermined position on the inner circumference of the leaflet fixing portion , one end of the frame body is a first fixing part that plays an anchoring role, and along the axial direction, the frame body further comprises a first fixing part located between the first fixing part and the valve leaflet fixing part A buffer part and a second buffer part located between the other end of the frame body and the valve leaflet fixing part, wherein at least one of the first buffer part and the second buffer part has an axial direction directional elasticity.
  • the prosthetic valve device is anchored at the native valve annulus through the first fixing part, of course, other anchoring structures can also be assisted in anchoring;
  • the leaflet fixing part is located in the middle section of the frame body along the axial direction, used for fixing
  • the valve leaflet fixing portion has a certain height along the axial direction.
  • the impact force exerted on the valve during the flushing of blood flow can be reduced due to the buffering function of the first buffer part or the second buffer part, thereby improving the frame body. improved fatigue resistance and improved leaflet durability.
  • the valve leaflet fixing portion can move in the axial direction, the risk of friction between the valve leaflet fixing portion and the native valve annulus is increased, and during long-term use, the native valve annulus of the heart will be damaged. Therefore, further, at least part of the outer periphery of the leaflet fixing portion is provided with a buffer sealing portion, so as to reduce the friction between the frame body and the tissue.
  • the frame body is in contact with the native valve annulus through the buffer seal.
  • the buffer seal can also Reduce paravalvular leakage.
  • the buffer sealing portion is a buffer skirt, which is evenly distributed along the outer circumference of the valve leaflet fixing portion, and the buffer sealing portion at least includes a first sealing layer and a second sealing layer, wherein the first sealing layer is A sealing layer is covered on the outer surface of the valve leaflet fixing part, and the second sealing layer is covered on the outer surface of the first sealing layer.
  • the first sealing layer covering the outer surface of the valve leaflet fixing part can play a sealing role to prevent paravalvular leakage, and the buffer sealing part has at least a double-layer structure to reduce friction with the tissue.
  • the outer surface of the second sealing layer is composed of numerous evenly distributed microstructures, the microstructures extend outward and have compression-resilient properties, such as a plush outer surface, when the valve is up and down During movement, the microstructure on the outer surface plays a buffering effect to reduce the friction between the frame body and the tissue.
  • the first sealing layer is selected from a material with good sealing properties, such as at least one of PET or PTFE
  • the second sealing layer is selected from a material with low friction force, good sealing performance and good biocompatibility materials such as pile or loop layers like velvet, velvet, velvet, etc.
  • the other end of the frame body is a second fixing portion, the first fixing portion and the second fixing portion are respectively used for anchoring, wherein the first fixing portion and the second fixing portion are respectively used for anchoring.
  • the included angle between each of the fixing parts and the axis of the frame body is ⁇ , and ⁇ is 45° ⁇ 90°.
  • the larger ⁇ is, the larger the contact area between the first fixed part, the second fixed part and the tissue is, the smaller the ⁇ is, the smaller the contact area is, the larger the contact area is, the more conducive to anchoring, and the obstruction to blood flow smaller.
  • the included angle ⁇ between each of the first buffer portion and the second buffer portion and the axis of the frame body is not greater than the included angle ⁇ , which can reduce the number of the first buffer portion and the second buffer portion. The resistance of the buffer to blood flow makes the blood flow smoothly.
  • the first buffer portion and the second buffer portion respectively have elasticity in the axial direction, providing space for the leaflet fixing portion to move up and down in the axial direction.
  • the leaflet fixing part can move up and down in the axial direction, so as to play a buffering role when the heart contracts or relax, and improve the fatigue resistance of the frame body .
  • the frame body is formed in one piece.
  • each part of the frame body is manufactured separately and then connected, and the connection is performed by using a connection medium, and the connection medium is at least one of a bracket structure or a skirt.
  • the connection method can be welding, gluing or suturing.
  • the first buffer portion or the second buffer portion includes at least one secondary structure
  • the secondary structure may be a closed annular structure and is disposed coaxially with the valve leaflet fixing portion
  • one of the secondary structures is formed by connecting two wave-shaped primary structures
  • the wave-shaped primary structure includes a number of wave crests and wave troughs
  • one of the wave-shaped primary structures is arranged opposite to the wave trough part of the other wave-shaped primary structure, so that the first buffer part and the second buffer part can obtain elasticity in the axial direction.
  • a predetermined position between a wave crest portion and a wave trough portion adjacent to the wave crest portion is a connection site, and another wave is connected through the connection point at a predetermined position.
  • the first-level structure is used for connection, and the connection method can choose braided connection.
  • the first buffer portion or the second buffer portion is composed of several secondary structures, wherein each of the secondary structures extends in the axial direction and has elasticity in the axial direction, and several of the secondary structures extend in the axial direction and have elasticity in the axial direction.
  • the secondary structures are evenly distributed along the circumference of the frame body.
  • the secondary structure may be a wavy structure, or the secondary structure may be a helical structure.
  • the first buffer portion and the second buffer portion are respectively covered with a skirt, the skirt is made of an elastic material, or the skirt is covered with a predetermined redundancy. .
  • the skirt plays a certain sealing role to prevent paravalvular leakage.
  • the present invention also provides a method for implanting a prosthetic valve device, including providing an implantable prosthetic valve device, the device comprising a frame body, the frame body comprising a leaflet fixing portion for fixing the artificial valve leaflets, The artificial valve leaflet is fixed at a predetermined position on the inner circumference of the valve leaflet fixing portion, and one end of the frame body is a first fixing portion that plays an anchoring role.
  • the frame body further comprises a a first buffer part between the first fixing part and the leaflet fixing part and a second buffer part located between the other end of the frame body and the leaflet fixing part, wherein the first buffer part , At least one of the second buffer parts has elasticity in the axial direction.
  • the valve leaflet fixing portion when at least one of the first buffer portion and the second buffer portion has elasticity in the axial direction, the valve leaflet fixing portion can be Moving up and down along the axial direction, when the heart contracts or relaxes, it can provide a buffer function, reduce the force applied to the frame body, and improve the fatigue resistance of the frame body; at the same time, the valve has an axial movement buffer space, which increases the The buffer for the movement of the valve leaflet is enlarged, and the fatigue resistance and durability of the valve leaflet are improved.
  • the implantable prosthetic valve device and method of the present invention provides a buffering effect through the buffer sealing portion.
  • the buffer sealing portion can reduce the friction between the valve and the tissue and reduce the damage to the tissue. At the same time, it plays a sealing role, which can reduce paravalvular leakage.
  • the implantable prosthetic valve device and method of the present invention utilizes a material with small frictional force and good sealing performance as the material of the buffer sealing portion, so that when the valve moves, the damage to the native tissue is small, and the valve can be reduced at the same time. Weekly leak.
  • the angle ⁇ between the first fixing portion, the second fixing portion and the axis of the frame body is 45° to 90°.
  • the included angle ⁇ between the axes of the main bodies is not greater than the included angle ⁇ , which can reduce the resistance of the first buffer part and the second buffer part to blood flow, and make the blood flow smoothly.
  • FIG. 1 is a schematic cross-sectional view of an implantable prosthetic valve device according to Embodiment 1 of the present invention
  • FIG. 2 is a schematic diagram of the overall structure of the buffer sealing portion of Embodiment 1 of the present invention.
  • FIG. 3 is a partial structural schematic diagram of the implantable prosthetic valve device according to Embodiment 1 of the present invention.
  • FIG. 4 is a schematic diagram of a flattened structure of the first fixing portion or the second fixing portion according to Embodiment 1 of the present invention.
  • FIG. 5 is a schematic diagram of the secondary structure of the first buffer portion or the second buffer portion in Embodiment 1 of the present invention.
  • FIG. 6 is a schematic diagram of a flattened structure of the first buffer portion or the second buffer portion according to Embodiment 2 of the present invention.
  • FIG. 7 is a schematic perspective view of the secondary structure of Example 2 of the present invention.
  • frame main body 200 artificial leaflet 230; leaflet fixing part O; buffer sealing part 300; first buffer part B1; second buffer part B2; first sealing layer 301; second sealing layer 302; first Fixed part A1; second fixed part A2; secondary structure 400; primary structure 410.
  • valve has the same meaning as “prosthetic valve device”.
  • leaflet has the same meaning as “prosthetic leaflet”.
  • Axial refers to the axial direction of the frame body, and “outer” refers to the direction radially outward from the center of the frame body.
  • Height refers to the dimension in the axial direction, and “length” refers to the dimension in the radial direction.
  • velvet is a general term for cut pile silk fabrics, with a fluff layer on the surface. , so it presents the unique luster of velvet.
  • the term “velvet” is the name of a silk fabric whose pile warps form the loop or pile layer on the surface of the fabric.
  • the term “velveteen” is woven with a pile weave and then cut pile finishing, and the surface has a dense, flat, standing and shiny pile layer.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • This embodiment provides an implantable prosthetic valve device, including a hollow, cylindrical frame body 200, the frame body 200 includes a leaflet fixing portion O for fixing the artificial valve leaflet 230, and the artificial valve leaflet 230 is fixed on the valve leaflet fixing portion At a predetermined position on the inner circumference of O, one end of the frame body 200 is the first fixing portion A1, and along the axial direction, the frame body 200 further includes a first buffer located between the first fixing portion A1 and the leaflet fixing portion O part B1 and a second buffer part B2 located between the other end of the frame body 200 and the leaflet fixing part O, wherein at least one of the first buffer part B1 and the second buffer part B2 has elasticity in the axial direction , and at least part of the outer periphery of the leaflet fixing portion O is provided with a buffer sealing portion 300 .
  • the prosthetic valve device is fixed at the native valve annulus by the first fixing part A1, of course, other anchoring structures can also be assisted for anchoring;
  • the leaflet fixing part O is located in the middle section of the frame body 200 along the axial direction,
  • the leaflet fixing portion O has a certain height along the axial direction.
  • the leaflet fixing portion O is located between the first buffer portion B1 and the second buffer portion B2, and when at least one of the first buffer portion B1 and the second buffer portion B2 has elasticity in the axial direction, it can provide an axial
  • the buffer function in the direction enables the leaflet fixing part O to move in the axial direction.
  • the impact force exerted by the blood on the frame body 200 can be reduced due to the buffering function of the first buffer part B1 or the second buffer part B2, thereby improving the frame Fatigue resistance of the main body 200 .
  • the valve has a movement buffer space in the axial direction, which increases the buffering of the movement of the valve leaflet and improves the fatigue resistance and durability of the valve leaflet.
  • the leaflet fixing part O is located in the middle section of the frame body. Since the leaflet fixing part O can move in the axial direction, the risk of friction between the frame structure at the leaflet fixing part O and the native valve annulus is increased. Damage to the native valve annulus of the heart. Therefore, further, at least a part of the outer periphery of the leaflet fixing portion O is provided with a buffer sealing portion 300 to reduce the friction between the frame body 200 and the tissue.
  • the frame body 200 is in contact with the native valve annulus through the buffer seal portion 300. When the valve moves up and down, the buffer seal portion 300 can reduce the relative movement between the valve leaflet fixing portion O and the native valve annulus, and reduce the relationship between the valve frame structure and the native valve annulus. friction, thereby reducing tissue damage. Meanwhile, the valve leaflet buffer portion 300 is arranged on the outer periphery of the valve leaflet fixing portion, and can also play a role of sealing, thereby reducing paravalvular leakage.
  • FIGS. 1-5 it is a schematic structural diagram of the implantable prosthetic valve device in this embodiment.
  • the buffer sealing portion 300 is a buffer skirt, which is evenly arranged along the outer circumference of the valve leaflet fixing portion O, and can be arranged by sewing or wrapping.
  • the buffer sealing part 300 at least includes a first sealing layer 301 and a second sealing layer 302 , wherein the first sealing layer 301 is covered on the outer surface of the valve leaflet fixing part O, and the second sealing layer 302 is covered outside the first sealing layer 301 surface.
  • the first sealing layer 301 covering the outer surface of the valve leaflet fixing portion O can play a sealing role to prevent paravalvular leakage, and the buffer sealing portion 300 is double-layered to reduce friction with tissues.
  • the buffer sealing portion 300 may also have a structure of three layers, four layers or even more layers, which will not be repeated here.
  • the second sealing layer 302 is a plush layer with a plush outer surface, and the outer surface of the second sealing layer 302 is composed of numerous evenly distributed microstructures, wherein the microstructures extend outward And it has the performance of compression and rebound. Specifically, the length of the plush microstructure extending outward is 0.1-2.0 mm.
  • the buffer sealing portion 300 provides compression and rebound functions through the plush outer surface, so as to achieve the effect of reducing the friction between the frame body 200 and the tissue.
  • the material of the first sealing layer 301 is selected from at least one of PET or PTFE to improve sealing performance and reduce paravalvular leakage.
  • the material of the second sealing layer 302 is a material with low friction force and good sealing performance, so that the second sealing layer 302 has the advantages of low friction force and good sealing performance.
  • the second sealing layer 302 can specifically be velvet, velvet, velvet and the like.
  • the second sealing layer 302 covers the outermost of the valve leaflet fixing portion O and is in contact with the tissue. When the valve moves up and down in the axial direction, the second sealing layer 302 can reduce the friction between the valve and the tissue and reduce the damage to the tissue.
  • both ends of the frame body 200 are anchoring structures, and the other end of the frame body 200 is the second fixing part A2.
  • the first fixing part A1 is located in the atrium, It is the atrial flange segment
  • the second fixing part A2 is located in the ventricle, and is the ventricular flange segment.
  • the first fixing part A1 and the second fixing part A2 clamp the native tissue (including the native valve leaflet and the native valve annulus) between A1 and A2. between, to achieve the role of anchoring the valve.
  • the first fixing portion A1 and the second fixing portion A2 have the same structure, that is, the same flange structure.
  • the included angle ⁇ between the first fixing portion A1, the second fixing portion A2 and the axis of the frame body 200 is 45° ⁇ 90°.
  • FIG. 3 which is a schematic diagram of a partial structure of the frame body of this embodiment, arrows The direction shown is the direction of blood flow.
  • the larger ⁇ is, the larger the contact area between the first fixing part A1, the second fixing part A2 and the tissue is; the smaller the hindrance.
  • FIG. 4 is a flattened view of an embodiment of the support structure F of the first fixing part A1 or the second fixing part A2, which is formed by staggering evenly arranged support rods, and the staggered support rods form a diamond grid,
  • the diamond mesh can change dynamically as it contracts and expands.
  • the support structure F may also be a grid structure composed of other closed geometric shapes (eg, heart shape, water drop shape, etc.), which will not be repeated here.
  • the first fixing part A1 and the second fixing part A2 are respectively provided with skirts, and the skirts can be arranged on the inner side, the outer side or the inner and outer sides of the two fixing parts at the same time.
  • the material of the skirt can be PET or PTFE to reduce flap Weekly leak.
  • the included angle ⁇ is not greater than the included angle ⁇ , which can reduce the number of the first buffer portion. B1.
  • the resistance of the second buffer part B2 to blood flow, so that the blood flow is smooth. As shown in FIG. 3 , when ⁇ , the first buffer portion B1 or the second buffer portion B2 has little resistance to blood flow, and when ⁇ ⁇ 2> ⁇ , the buffer portion significantly hinders blood flow.
  • the frame body 200 is in direct contact with the valve annulus tissue at the valve leaflet fixing portion O.
  • the first buffer portion B1 and the second buffer portion B2 of the frame body have elasticity along the axial direction, respectively, and are the valve leaflets.
  • the fixed portion O provides a space for up and down movement in the axial direction, so as to play a buffering role.
  • the first buffer portion B1 and the second buffer portion B2 are formed by connecting at least one secondary structure 400, such as welding, sewing, etc.
  • the secondary structure 400 is a closed annular structure and is connected to the valve leaflet fixing portion O. Coaxial setup. Referring to FIG.
  • a secondary structure 400 is formed by connecting two wave-shaped primary structures 410, and the wave-shaped primary structure 410 includes several wave crests and wave troughs,
  • the crest portion of one wave-shaped primary structure 410a is disposed opposite to the wave trough portion of the other wave-shaped primary structure 410b, so that the first buffer portion B1 and the second buffer portion B2 can be obtained along the axial direction.
  • directional elasticity is a flattened view of a secondary structure 400, wherein a secondary structure 400 is formed by connecting two wave-shaped primary structures 410, and the wave-shaped primary structure 410 includes several wave crests and wave troughs.
  • a connection point that is, in a secondary structure 400, two wave-shaped primary structures 410 is connected at the respective predetermined connection points, and the connection method can be braiding, sewing, welding or gluing.
  • first buffer portion B1 and the second buffer portion B2 are respectively covered with skirts, the skirts are made of elastic materials, or the skirts are covered with a predetermined redundancy.
  • the area where the first buffer part B1 and the second buffer part B2 are located is a buffer area, and the skirt can cover the inner side, the outer side, or the inner and outer sides of the bracket in the buffer area. Paravalvular leakage.
  • the rigidity of the first fixing part A1 and the second fixing part A2 is higher than that of other parts of the frame body 200 .
  • the first buffer portion B1 and the second buffer portion B2 play a buffering role and have elasticity in the axial direction.
  • the leaflet fixing part O is used to support the artificial valve leaflet, so it needs to have a certain rigidity. Therefore, the rigidity of the leaflet fixing part O is smaller than that of the first fixing part A1 and the second fixing part A2, but greater than that of the first buffer part B1 , the stiffness of the second buffer portion B2.
  • the valve leaflet fixing portion O is a grid structure, such as a rhombus grid structure, and the artificial valve leaflet 230 is fixed at the valve leaflet fixing portion O, such as by suturing, wherein the artificial valve leaflet 230 is fixed on the valve leaflet fixing portion O.
  • the leaflet fixing portion O Between the upper and lower ends of the leaflet fixing portion O, when the first buffer portion B1 and the second buffer portion B2 elastically expand and contract, damage to the artificial valve leaflet 230 can be avoided.
  • the frame body 200 can be made by integral molding.
  • each part of the frame body 200 that is, the first fixing part A1 , the first buffer part B1 , and the leaflet fixing part O ,
  • the second fixing part A2 and the second buffer part B2 can be manufactured separately, and then connected by a connecting medium.
  • the connection medium may be the above-mentioned bracket structure F, or the connection medium may be a skirt.
  • the connection method can be welding, gluing or suturing.
  • each part of the frame body 200 is a frame structure with mesh holes, which is woven or cut from metal materials, such as nickel-titanium alloy or other biocompatible materials with shape memory properties, or Choose elastically or plastically deformable materials, such as balloon-expandable materials.
  • the prosthetic leaflets 230 are dynamically switched between open and closed states in which the prosthetic leaflets 230 close or converge in sealing abutment, which may or may not be the same number as the native leaflets.
  • Prosthetic leaflets 230 may be formed from any suitable material or combination of materials, and may be selected from biological tissue such as chemically stable tissue from a heart valve from an animal such as a porcine, or pericardial tissue from an animal such as bovine (bovine pericardium) or Sheep (sheep pericardium) or pig (porcine pericardium) or equine (horse pericardium), can also be made from small intestinal submucosal tissue.
  • synthetic materials such as expanded polytetrafluoroethylene or polyester can also be selected.
  • thermoplastic polycarbonate urethanes polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylenes are also included.
  • biocompatible polymers optionally including polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicones Polyesters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using them.
  • prosthetic leaflets 230 have a surface that is treated (or reacted with) an anticoagulant, including, but not limited to, heparinized polymers.
  • the frame body 200 is a columnar structure
  • the cross section of the frame body 200 can be one or a combination of a circle, an ellipse, a D shape, and a petal shape
  • the two ends of the frame body 200 are
  • the flange section acts as an anchor.
  • first fixing part A1 and the second fixing part A2 have the same structure
  • first buffer part B1 and the second buffer part B2 have the same structure.
  • the same structure means that the size, shape and inclination angle are respectively the same. is a symmetrical structure.
  • first fixing portion A1 and the second fixing portion A2 may also have different structures, such as having different sizes or different inclination angles
  • the first buffering portion B1 and the second buffering portion B2 also have different structures. It can be in different structures, and details are not described here.
  • This embodiment provides an implantable prosthetic valve device, wherein the structure of the implantable prosthetic valve device is similar to that of Embodiment 1, and the difference lies in the structure of the first buffer portion B1 or the second buffer portion B2 .
  • the first buffer portion B1 or the second buffer portion B2 is composed of a plurality of secondary structures 400 , wherein each two The secondary structures 400 extend in the axial direction and have elasticity in the axial direction, and several secondary structures 400 are uniformly distributed along the circumferential direction of the frame body 200 .
  • the secondary structure 400 is a helical structure, as shown in FIG. 7 .
  • Several secondary structures 400 are arranged in the axial direction, so that the first buffer part B1 and the second buffer part B2 can obtain elasticity in the axial direction.

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Abstract

一种植入式假体瓣膜装置及其植入方法，包括框架主体（200），框架主体（200）包括用于固定人工瓣叶（230）的瓣叶固定部（O）、位于框架端部的第一固定部（A1），沿轴向方向，框架主体（200）还包括位于第一固定部（A1）与瓣叶固定部（O）之间的第一缓冲部（B1）以及位于框架主体（200）另一端部与瓣叶固定部（O）之间的第二缓冲部（B2），其中，第一缓冲部（B1）、第二缓冲部（B2）中的至少一者具有沿轴向方向的弹性。该假体瓣膜装置，植入目标位置后，当心脏收缩和舒张时，由于第一缓冲部（B1）或第二缓冲部（B2）具有轴向方向的弹性，因此可提供缓冲功能，瓣叶固定部（O）可以沿轴向运动，从而能够减小血流施加在框架主体（200）上的冲击力，进而能够提高框架主体（200）的耐疲劳性，提高瓣叶的耐久性。

Description

一种植入式假体瓣膜装置及其植入方法 技术领域
本发明涉及医疗器械技术领域，特别涉及一种植入心脏内的假体瓣膜装置。
背景技术
心脏含有四个心腔，左心房与左心室位于心脏左侧，右心房与右心室位于心脏右侧。心房与心室间形成心室流入道，左心室与主动脉形成左室流出道，右心室与肺动脉形成右室流出道。左室流入道和右室流入道处存在具有“单向阀”功能的瓣膜，保证心腔内血液的正常流动。当该瓣膜出现问题时，心脏血液动力学改变，心脏功能异常，称为瓣膜性心脏病。
随着社会经济的发展和人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明75岁以上的老年人群瓣膜性心脏病发病率高达13.3％。目前，采用传统外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。经导管二尖瓣的置换/修复术具有无需开胸、创伤小、患者恢复快等优点，受到了专家学者的广泛关注。
左室流入道、右室流入道处的瓣膜分别为二尖瓣、三尖瓣，瓣膜均为组合体，包括瓣环、瓣叶、腱索和***肌，部分文献中也包含心室壁。腱索作为连接二尖瓣瓣叶与心肌的支撑装置，分布在瓣叶与心室壁之间。二尖瓣的瓣下结构(腱索、***肌、心室壁等)对维持左心室结构及功能起着重要作用，外科手术中尽量保留原生瓣膜结构。因此，采用经导管植入人工瓣膜假体替换原生瓣膜时也需尽量适应原生瓣膜的结构，降低假体瓣膜对原生瓣膜结构的破坏。
由于解剖学上二尖瓣的瓣环尺寸远大于主动脉瓣瓣环尺寸，植入二尖瓣 的假体瓣膜的支撑主体中用以匹配假体瓣叶的部分无论在周向直径还是轴向高度上均需要更大的尺寸，导致假体瓣膜植入二尖瓣后其瓣下的假体结构尺寸较大，对原生瓣膜组合体的瓣下结构存在较大的损伤风险。对于部分二尖瓣反流患者，其瓣膜上无钙化部分，无法采用现有的利用假体瓣膜与原生瓣膜间产生的径向支撑力来防止假体瓣膜移位的工作原理。
三尖瓣作为右心脏的房室瓣，其结构与二尖瓣类似，也包含瓣叶、瓣环、腱索、***肌及心肌。因此替换原生二尖瓣的心脏瓣膜假体结构也可以应用于代替原生三尖瓣，根据原生瓣膜尺寸不同假体瓣膜尺寸不同。
虽然二尖瓣瓣膜置换技术飞速发展，但是在瓣膜支架的设计上仍存在一些公认的难题：
1、二尖瓣假体锚固在组织上，容易对原生组织存在较大的损伤风险；
2、二尖瓣瓣膜支架的耐疲劳性较差；
3、二尖瓣瓣膜瓣叶的耐疲劳性较差。
发明内容
本发明提供了一种植入式假体瓣膜装置，可以解决现有技术中的上述缺陷。
本发明的技术方案如下：
一种植入式假体瓣膜装置，包括中空、柱状的框架主体，所述框架主体包括用于固定人工瓣叶的瓣叶固定部，人工瓣叶固定在所述瓣叶固定部内周的预定位置处，所述框架主体的一个端部为起到锚固作用的第一固定部，沿轴向方向，所述框架主体还包括位于所述第一固定部与所述瓣叶固定部之间的第一缓冲部以及位于所述框架主体另一端部与所述瓣叶固定部之间的第二缓冲部，其中，所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性。
其中，假体瓣膜装置通过第一固定部锚固在原生瓣环处，当然，还可以辅助其他的锚固结构进行锚固；瓣叶固定部位于框架主体的沿轴向方向的中 间段部分，用于固定人工瓣叶，瓣叶固定部沿轴向方向具有一定的高度。当所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性时，可提供沿轴向方向的缓冲功能，使瓣叶固定部可以沿轴向运动。假体瓣膜装置植入目标位置后，当心脏收缩和舒张时，由于第一缓冲部或第二缓冲部的缓冲功能，能够减小血流冲刷时施加在瓣膜上的冲击力，从而提高框架主体的耐疲劳性，提高瓣叶的耐久性。
由于瓣叶固定部可以沿轴向运动，因此增大了瓣叶固定部与原生瓣环之间的摩擦风险，长期使用时，会对心脏的原生瓣环造成损伤。因此，进一步的，所述瓣叶固定部的外周至少部分配置有缓冲密封部，以减少所述框架主体与组织间的摩擦。框架主体通过缓冲密封部与原生瓣环接触，在瓣膜上下运动时，由于缓冲密封部的缓冲作用减少框架主体与原生瓣环之间的摩擦，从而减少对组织的损伤，同时缓冲密封部还可以减少瓣周漏。
在一些实施例中，所述缓冲密封部为缓冲裙边，沿所述瓣叶固定部的外周均匀布设，所述缓冲密封部至少包括第一密封层及第二密封层，其中，所述第一密封层覆设在所述瓣叶固定部外表面，所述第二密封层覆设在所述第一密封层外表面。其中，覆设在瓣叶固定部外表面的第一密封层能够起到密封的作用，防止瓣周漏，缓冲密封部通过至少双层的结构以减少与组织之间的摩擦。
在一些实施例中，所述第二密封层的外表面由无数均布的微结构组成，所述的微结构向外延伸并具有压缩回弹的性能，如毛绒的外表面，当瓣膜上下运动时，外表面微结构起到缓冲效果，达到减少框架主体与组织间的摩擦的效果。
在一些实施例中，所述第一密封层的选择密封性好的材料，如PET或PTFE中的至少一种，所述第二密封层选择摩擦力小、密封性好且生物相容性良好的材料如类似丝绒、天鹅绒、平绒等的绒毛层或绒圈层。
在一些实施例中，所述框架主体另一端部为第二固定部，所述第一固定部、所述第二固定部分别用于锚固，其中，所述第一固定部、所述第二固定部各自与所述框架主体的轴线之间的夹角为α，α为45°～90°。其中，α越 大，第一固定部、第二固定部与组织间的接触面积越大，α越小，该处的接触面积越小，接触面积越大越有利于锚固，且对血流的阻碍越小。
在一些实施例中，所述第一缓冲部、所述第二缓冲部各自与所述框架主体的轴线之间的夹角β不大于夹角α，可减少第一缓冲部、所述第二缓冲部对血流的阻力，使血液流动畅通。
在一些实施例中，所述第一缓冲部、所述第二缓冲部分别具有沿轴向方向的弹性，为所述瓣叶固定部提供沿轴向方向上下运动的空间。当第一缓冲部、第二缓冲部分别具有沿轴向的弹性时，瓣叶固定部可以沿轴向上下运动，从而在心脏收缩或舒张时起到缓冲的作用，提高框架主体的耐疲劳性。
在一些实施例中，所述框架主体采用一体成型的方式制成。在一些实施例中，所述框架主体的各部分分别制造而成再连接，所述的连接为采用连接介质进行连接，所述的连接介质至少为支架结构或裙边中的一种。当支架结构作为连接介质时，连接方式可以为焊接、胶接或缝合的方式。
在一些实施例中，所述第一缓冲部或所述第二缓冲部包括至少一个二级结构，所述二级结构可以为一封闭的环形结构且与所述瓣叶固定部同轴设置，其中，一个所述二级结构由两个波浪形一级结构连接而成，所述波浪形一级结构包括若干的波峰部和波谷部，在一个所述二级结构中，一个所述波浪形一级结构的波峰部与另一所述波浪形一级结构的波谷部相对设置，从而使第一缓冲部、所述第二缓冲部获得沿轴向方向的弹性。
在一些实施例中，在一个所述波浪形一级结构中，一个波峰部与该波峰部相邻的波谷部之间的预定位置处为连接位点，通过所述连接位点与另一个波浪形一级结构进行连接，连接的方式可以选择编织连接。
在一些实施例中，所述第一缓冲部或所述第二缓冲部由若干二级结构组成，其中，每一所述二级结构沿轴向延伸并具有沿轴向方向的弹性，若干所述二级结构沿所述框架主体的周向均匀分布。其中，二级结构可以为一波浪形结构，或所述二级结构为一螺旋结构，当二级结构沿轴向设置时，使所述第一缓冲部、所述第二缓冲部获得轴向方向的弹性。
在一些实施例中，所述第一缓冲部、所述第二缓冲部分别覆设有裙边， 该裙边由具有弹性的材料制成，或该裙边覆设时具有预定的冗余量。裙边起到一定的密封作用，用于防止瓣周漏。
本发明还提供了一种植入假体瓣膜装置的方法，包括提供一种植入式假体瓣膜装置，所述装置包括框架主体，所述框架主体包括用于固定人工瓣叶的瓣叶固定部，人工瓣叶固定在所述瓣叶固定部内周的预定位置处，所述框架主体的一个端部为起到锚固作用的第一固定部，沿轴向方向，所述框架主体还包括位于所述第一固定部与所述瓣叶固定部之间的第一缓冲部以及位于所述框架主体另一端部与所述瓣叶固定部之间的第二缓冲部，其中，所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性。
与现有技术相比，本发明的有益效果如下：
第一，本发明的植入式假体瓣膜装置及方法，当所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性，可以使瓣叶固定部能够沿轴向上下运动，当心脏收缩或舒张时，可提供缓冲功能，减小了施加在框架主体上的力，提高了框架主体的耐疲劳性；同时瓣膜存在轴向上的运动缓冲空间，增大了瓣叶运动的缓冲，提高了瓣叶的耐疲劳性、耐久性。
第二，本发明的植入式假体瓣膜装置及方法，通过缓冲密封部提供缓冲作用，当瓣膜沿轴向上下运动时，缓冲密封部可减少瓣膜与组织的摩擦，减少对组织的损伤，同时起到密封作用，可减少瓣周漏。
第三，本发明的植入式假体瓣膜装置及方法，利用小的摩擦力且密封性好的材料作为缓冲密封部的材料，在瓣膜运动时，对原生组织的损伤小，同时可减少瓣周漏。
第四，本发明的植入式假体瓣膜装置及方法，第一固定部、第二固定部与框架主体的轴线之间的夹角α为45°～90°，α越大，第一固定部、第二固定部与组织间的接触面积越大，α越小，该处的接触面积越小，接触面积越大越有利于锚固，且对血流的阻碍越小；第二缓冲部与框架主体的轴线之间的夹角β不大于夹角α，可减少第一缓冲部、第二缓冲部对血流的阻力，使血液流动畅通。
当然，实施本发明的任一产品并不一定需要同时达到以上所述的所有优 点。
附图说明
图1是本发明实施例1的植入式假体瓣膜装置的截面示意图；
图2是本发明实施例1的缓冲密封部的整体结构示意图；
图3是本发明实施例1的植入式假体瓣膜装置的部分结构示意图；
图4是本发明实施例1的第一固定部或第二固定部的展平结构示意图；
图5是本发明实施例1的第一缓冲部或第二缓冲部的二级结构示意图；
图6是本发明实施例2的第一缓冲部或第二缓冲部的展平结构示意图；
图7是本发明实施例2的二级结构的立体示意图。
附图标记：框架主体200；人工瓣叶230；瓣叶固定部O；缓冲密封部300；第一缓冲部B1；第二缓冲部B2；第一密封层301；第二密封层302；第一固定部A1；第二固定部A2；二级结构400；一级结构410。
具体实施方式
在本发明的描述中，需要说明的是，术语“瓣膜”与“假体瓣膜装置”具有相同的含义。术语“瓣叶”与“人工瓣叶”具有相同的含义。“轴向”指的是框架主体的轴向，“外”指的是自框架主体中心沿径向向外的方向。“高度”指的是沿轴向方向的尺寸，“长度”指的是沿径向方向的尺寸。
在本发明的描述中，需要说明的是，术语“丝绒”是割绒丝织物的统称，表面有绒毛层，绒毛层上的绒毛大都由专门的经丝被割断后所构成，由于绒毛平行整齐，故呈现丝绒所特有的光泽。术语“天鹅绒”是以绒经在织物表面构成绒圈层或绒毛层的丝织物名。术语“平绒”是采用起绒组织织制再经割绒整理，表面具有稠密、平齐、耸立而富有光泽的绒毛层。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示 或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
下面结合具体实施例，进一步阐述本发明。
实施例1
本实施例提供一种植入式假体瓣膜装置，包括中空、柱状的框架主体200，框架主体200包括用于固定人工瓣叶230的瓣叶固定部O，人工瓣叶230固定在瓣叶固定部O内周的预定位置处，框架主体200的一个端部为第一固定部A1，沿轴向方向，框架主体200还包括位于第一固定部A1与瓣叶固定部O之间的第一缓冲部B1以及位于框架主体200另一端部与瓣叶固定部O之间的第二缓冲部B2，其中，第一缓冲部B1、第二缓冲部B2中的至少一者具有沿轴向方向的弹性，且瓣叶固定部O的外周至少部分配置有缓冲密封部300。
其中，假体瓣膜装置通过第一固定部A1固定在原生瓣环处，当然，还可以辅助其他的锚固结构进行锚固；瓣叶固定部O位于框架主体200的沿轴向方向的中间段部分，用于固定人工瓣叶230，瓣叶固定部O沿轴向方向具有一定的高度。瓣叶固定部O位于第一缓冲部B1、第二缓冲部B2之间，当第一缓冲部B1、第二缓冲部B2中的至少一者具有沿轴向方向的弹性时，可提供沿轴向方向的缓冲功能，使瓣叶固定部O可以沿轴向运动。假体瓣膜装置植入目标位置后，当心脏收缩和舒张时，由于第一缓冲部B1或第二缓冲部 B2的缓冲功能，能够减小血液施加在框架主体200上的冲击力，从而提高框架主体200的耐疲劳性。同时瓣膜存在轴向上的运动缓冲空间，增大了瓣叶运动的缓冲，提高了瓣叶的耐疲劳性、耐久性。
瓣叶固定部O位于框架主体的中间段处，由于瓣叶固定部O可以沿轴向运动，因此增大了瓣叶固定部O处的框架结构与原生瓣环的摩擦风险，长期使用时，会对心脏的原生瓣环造成损伤。因此，进一步的，瓣叶固定部O的外周至少部分配置有缓冲密封部300，以减少框架主体200与组织间的摩擦。框架主体200通过缓冲密封部300与原生瓣环接触，在瓣膜上下运动时，缓冲密封部300能够减少瓣叶固定部O与原生瓣环之间的相对移动，减少瓣膜框架结构与原生瓣环之间的摩擦，从而减少对组织的损伤。同时瓣叶缓冲部300布设在瓣叶固定部的外周，还能起到密封的作用，从而减少瓣周漏。
参见图1-图5，为本实施例中植入式假体瓣膜装置的结构示意图。
本实施例中，缓冲密封部300为缓冲裙边，沿瓣叶固定部O的外周均匀布设，可通过缝合或包覆的方式设置。缓冲密封部300至少包括第一密封层301及第二密封层302，其中，第一密封层301覆设在瓣叶固定部O外表面，第二密封层302覆设在第一密封层301外表面。其中，覆设在瓣叶固定部O外表面的第一密封层301能够起到密封的作用，防止瓣周漏，缓冲密封部300通过双层结构以减少与组织之间的摩擦。当然，在其他实施例中，除上述的双层结构外，缓冲密封部300还可以为三层、四层甚至更多层的结构，此处不再赘述。
本实施例中，第二密封层302为一毛绒层，具有毛绒的外表面，第二密封层302的外表面由无数均布的微结构组成，其中，所述的微结构向外延伸并具有压缩回弹的性能，具体的，毛绒微结构向外延伸的长度为0.1～2.0mm。缓冲密封部300通过毛绒的外表面，提供压缩和回弹功能，达到减少框架主体200与组织间的摩擦的效果。
具体的，第一密封层301的材料选自PET或PTFE中的至少一种，提高密封性能，减少瓣周漏。第二密封层302的材料为摩擦力小且密封性好的材料，使第二密封层302具有摩擦力小、密封性好的优点。其中，第二密封层 302具体可为丝绒、天鹅绒、平绒等。第二密封层302覆盖在瓣叶固定部O的最外侧，与组织接触，当瓣膜沿轴向上下运动时，第二密封层302可减少瓣膜与组织的摩擦，减少对组织的损伤。
参见图1，本实施例中，框架主体200的两个端部均为锚固结构，框架主体200的另一端部为第二固定部A2，植入心脏后，第一固定部A1位于心房内，为心房法兰段，第二固定部A2位于心室内，为心室法兰段，第一固定部A1、第二固定部A2将原生组织(包括原生瓣叶和原生瓣环)夹在A1与A2之间，达到锚固瓣膜的作用。第一固定部A1、第二固定部A2为相同的结构，即同为法兰结构。具体的，第一固定部A1、第二固定部A2与框架主体200的轴线之间的夹角α为45°～90°，参见图3，为本实施例的框架主体的部分结构示意图，箭头所示方向为血流方向。其中，α越大，第一固定部A1、第二固定部A2与组织间的接触面积越大，α越小，该处的接触面积越小，接触面积越大越有利于锚固，且对血流的阻碍越小。
具体的，图4为第一固定部A1或第二固定部A2的支架结构F的一个实施例的展平图，由均匀排布的支架杆交错而成，交错的支架杆组成菱形网格，当其收缩和膨胀时，菱形网格可动态变化。当然，在其他实施例中，所述的支架结构F还可以为由其他闭合几何形状(如心形、水滴形等)组成的网格结构，此处不再赘述。第一固定部A1、第二固定部A2分别布设有裙边，裙边可以布设在两个固定部的内侧、外侧或内外侧同时覆设，裙边的材料可以为PET或PTFE，以减少瓣周漏。
本实施例中，第一缓冲部B1、第二缓冲部B2与框架主体的轴线之间分别具有一预定的夹角β，优选的，夹角β不大于夹角α，可减少第一缓冲部B1、第二缓冲部B2对血流的阻力，使血液流动畅通。如图3所示，当β<α时，第一缓冲部B1或第二缓冲部B2对血流的阻挡少，当β＝β2>α时，缓冲部分对血流存在明显阻碍。
本实施例中，框架主体200在瓣叶固定部O与瓣环组织直接接触，优选的，框架主体的第一缓冲部B1、第二缓冲部B2分别具有沿轴向方向的弹性，为瓣叶固定部O提供沿轴向方向上下运动的空间，从而起到缓冲的作用。
本实施例中，第一缓冲部B1、第二缓冲部B2由至少一个二级结构400连接而成，如焊接、缝合等，二级结构400为一封闭的环形结构且与瓣叶固定部O同轴设置。参见图5，为一个二级结构400的展平图，其中，一个二级结构400由两个波浪形一级结构410连接而成，波浪形一级结构410包括若干的波峰部和波谷部，在一个二级结构400中，一个波浪形一级结构410a的波峰部与另一波浪形一级结构410b的波谷部相对设置，从而使第一缓冲部B1、第二缓冲部B2获得沿轴向方向的弹性。
具体的，在一个波浪形一级结构410中，波峰部与该波峰部相邻的波谷部之间的预定位置处作为连接位点，即一个二级结构400中，两个波浪形一级结构410在各自的预定的连接位点处进行连接，所述的连接方式可以为编织、缝合、焊接或胶接的方式。
进一步的，本实施例中，第一缓冲部B1、第二缓冲部B2分别覆设有裙边，该裙边由具有弹性的材料制成，或该裙边覆设时具有预定的冗余量。第一缓冲部B1、第二缓冲部B2所在的区域为缓冲区域，该裙边可以覆盖在缓冲区域的支架的内侧、外侧或内外侧同时设置，裙边起到一定的密封作用，用于防止瓣周漏。
进一步的，由于第一固定部A1、第二固定部A2需要起到锚固的作用，因此，第一固定部A1、第二固定部A2的刚度较框架主体200其他部分的刚度大。第一缓冲部B1、第二缓冲部B2起到缓冲的作用，具有沿轴向的弹性，因此，第一缓冲部B1、第二缓冲部B2的刚度较框架主体200其他部分的刚度小。瓣叶固定部O用于支撑人工瓣叶，所以需要具有一定的刚度，因此，瓣叶固定部O的刚度小于第一固定部A1、第二固定部A2的刚度，但大于第一缓冲部B1、第二缓冲部B2的刚度。
本实施例中，瓣叶固定部O为网格结构，如菱形网格结构，人工瓣叶230固定在瓣叶固定部O处，如通过缝合的方式固定，其中，人工瓣叶230固定在瓣叶固定部O的上下两个端部之间，这样当第一缓冲部B1、第二缓冲部B2产生弹性伸缩时，可避免对人工瓣叶230造成损伤。
本实施例中，框架主体200可以采用一体成型的方式制成，当然，在其 他实施例中，框架主体200的各部分，即第一固定部A1、第一缓冲部B1、瓣叶固定部O、第二固定部A2、第二缓冲部B2可以分别制造，再通过连接介质连接而成。其中，该连接介质可以为上述的支架结构F，或者，该连接介质可以为裙边。当支架结构作为连接介质时，连接方式可以为焊接、胶接、缝合的方式。
本实施例中，框架主体200的各部分为具有网格孔的框架结构，采用金属材料编织或切割而成，如采用镍钛合金或其他具有形状记忆特性的生物相容材料制成，也可以选择可弹性或可塑性变形的材料，如球囊可扩张的材料。人工瓣叶230在打开和闭合两种状态间动态切换，在所述闭合状态中，人工瓣叶230以密封抵接的方式合紧或会合，其数量可以与原生瓣叶相同或不同。人工瓣叶230可以由任意合适的材料或材料的组合形成，可选择生物组织例如来自动物(如猪)的心脏瓣膜的化学性稳定的组织，或者是动物的心包组织例如牛(牛心包)或羊(羊心包)或猪(猪心包)或马(马心包)，也可以由小肠粘膜下组织制成。此外，也可以选择合成材料，例如，膨体聚四氟乙烯或聚酯。可选地，还包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯、以及超高分子量聚乙烯。另外还包括生物相容的聚合物，可选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯、以及使用它们的嵌段共聚物。可选地，人工瓣叶230具有抗凝剂进行处理(或与之反应)的表面，所述抗凝剂包括但不限于肝素化聚合物。
本实施例中，框架主体200为柱状结构，框架主体200的横截面可以为圆形、椭圆形、D形、花瓣形中的一种或多种的组合，框架主体200的两个端部为法兰段，起到锚固的作用。
本实施例中，第一固定部A1、第二固定部A2具有相同结构，第一缓冲部B1、第二缓冲部B2具有相同结构，相同结构指的是大小、形状、倾斜的角度分别相同，即为对称结构。当然，在其他实施例中，第一固定部A1、第二固定部A2也可以为不同的结构，如具有不同的大小或具有不同的倾斜角 度，第一缓冲部B1、第二缓冲部B2也可以为不同的结构，此处不再赘述。
实施例2
本实施例提供一种植入式假体瓣膜装置，其中，所述的植入式假体瓣膜装置与实施例1的结构类似，不同之处在于第一缓冲部B1或第二缓冲部B2的结构。
参见图6，为第一缓冲部B1或第二缓冲部B2的展平图，本实施例中，第一缓冲部B1或第二缓冲部B2由若干二级结构400组成，其中，每一二级结构400沿轴向延伸并具有沿轴向方向的弹性，若干二级结构400沿框架主体200的周向均匀分布。
具体的，本实施例中，二级结构400为一螺旋结构，如图7所示。若干二级结构400沿轴向设置，从而使第一缓冲部B1、第二缓冲部B2获得轴向方向的弹性。
以上公开的仅为本发明优选实施例。优选实施例并没有详尽叙述所有的细节，也不限制该发明仅为所述的具体实施方式。应该理解，这些实施例仅用于说明本发明，而不用于限定本发明的保护范围。在实际应用中本领域技术人员根据本发明做出的改进和调整，仍属于本发明的保护范围。
显然，根据本说明书的内容，可作很多的修改和变化。本说明书选取并具体描述这些实施例，是为了更好地解释本发明的原理和实际应用，从而使所属领域技术人员能很好地利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。

Claims (13)

  1. 一种植入式假体瓣膜装置，其特征在于，包括框架主体，
    所述框架主体包括用于固定人工瓣叶的瓣叶固定部，人工瓣叶固定在所述瓣叶固定部内周的预定位置处，所述框架主体的一个端部为起到锚固作用的第一固定部，沿轴向方向，所述框架主体还包括位于所述第一固定部与所述瓣叶固定部之间的第一缓冲部以及位于所述框架主体另一端部与所述瓣叶固定部之间的第二缓冲部，其中，所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性。
  2. 根据权利要求1所述的植入式假体瓣膜装置，其特征在于，所述瓣叶固定部的外周至少部分配置有缓冲密封部，以减少所述框架主体与组织间的摩擦。
  3. 根据权利要求2所述的植入式假体瓣膜装置，其特征在于，所述缓冲密封部至少包括第一密封层及第二密封层，其中，所述第一密封层覆设在所述瓣叶固定部外表面，所述第二密封层覆设在所述第一密封层外表面。
  4. 根据权利要求3所述的植入式假体瓣膜装置，其特征在于，所述第二密封层的外表面由无数均布的微结构组成，所述的微结构向外延伸并具有压缩回弹的性能。
  5. 根据权利要求3所述的植入式假体瓣膜装置，其特征在于，所述第一密封层的材料选自PET或PTFE中的至少一种，所述第二密封层的材料为摩擦力小且密封性好的材料。
  6. 根据权利要求1-5任一所述的植入式假体瓣膜装置，其特征在于，所述框架主体的另一端部为第二固定部，所述第一固定部、所述第二固定部分别用于锚固，其中，所述第一固定部、所述第二固定部各自与所述框架主体的轴线之间的夹角为α，α为45°～90°。
  7. 根据权利要求6所述的植入式假体瓣膜装置，其特征在于，所述第一缓冲部、所述第二缓冲部各自与所述框架主体的轴线之间的夹角β不大于夹角α。
  8. 根据权利要求1-5任一或7所述的植入式假体瓣膜装置，其特征在于，所述第一缓冲部、所述第二缓冲部分别具有沿轴向方向的弹性，为所述瓣叶固定部提供沿轴向上下运动的空间。
  9. 根据权利要求1所述的植入式假体瓣膜装置，其特征在于，所述第一缓冲部或所述第二缓冲部包括至少一个二级结构，其中，一个所述二级结构由两个波浪形一级结构连接而成，所述波浪形一级结构包括若干的波峰部和波谷部，在一个所述二级结构中，一个所述波浪形一级结构的波峰部与另一所述波浪形一级结构的波谷部相对设置。
  10. 根据权利要求9所述的植入式假体瓣膜装置，其特征在于，在一个所述波浪形一级结构中，一个波峰部与该波峰部相邻的波谷部之间的预定位置处为连接位点。
  11. 根据权利要求1所述的植入式假体瓣膜装置，其特征在于，所述第一缓冲部或所述第二缓冲部由若干二级结构组成，其中，每一所述二级结构沿轴向延伸并具有沿轴向方向的弹性，若干所述二级结构沿所述框架主体的周向均匀分布。
  12. 根据权利要求1所述的植入式假体瓣膜装置，其特征在于，所述第一缓冲部、所述第二缓冲部分别覆设有裙边，该裙边由具有弹性的材料制成，或该裙边覆设时具有预定的冗余量。
  13. 一种植入假体瓣膜装置的方法，其特征在于，包括提供一种植入式假体瓣膜装置，所述装置包括框架主体，所述框架主体包括用于固定人工瓣叶的瓣叶固定部，人工瓣叶固定在所述瓣叶固定部内周的预定位置处，所述框架主体的一个端部为起到锚固作用的第一固定部，沿轴向方向，所述框架主体还包括位于所述第一固定部与所述瓣叶固定部之间的第一缓冲部以及位于所述框架主体另一端部与所述瓣叶固定部之间的第二缓冲部，其中，所述第一缓冲部、所述第二缓冲部中的至少一者具有沿轴向方向的弹性。
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