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WO2018120949A1 - 瓣膜假体 - Google Patents

瓣膜假体 Download PDF

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Publication number
WO2018120949A1
WO2018120949A1 PCT/CN2017/103902 CN2017103902W WO2018120949A1 WO 2018120949 A1 WO2018120949 A1 WO 2018120949A1 CN 2017103902 W CN2017103902 W CN 2017103902W WO 2018120949 A1 WO2018120949 A1 WO 2018120949A1
Authority
WO
WIPO (PCT)
Prior art keywords
skirt
valve prosthesis
fixed
bracket
edge
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2017/103902
Other languages
English (en)
French (fr)
Inventor
刘世红
陈国明
李�雨
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Microport Cardioflow Medtech Co Ltd
Original Assignee
Shanghai Microport Cardioflow Medtech Co Ltd
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 Shanghai Microport Cardioflow Medtech Co Ltd filed Critical Shanghai Microport Cardioflow Medtech Co Ltd
Priority to EP17888410.2A priority Critical patent/EP3563804B1/en
Priority to JP2019535373A priority patent/JP7106547B2/ja
Priority to KR1020197021589A priority patent/KR102426953B1/ko
Priority to ES17888410T priority patent/ES2979140T3/es
Priority to US16/474,490 priority patent/US11547559B2/en
Publication of WO2018120949A1 publication Critical patent/WO2018120949A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F2/2412—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
    • 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
    • A61F2/02—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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/0017—Angular shapes
    • A61F2230/0026—Angular shapes trapezoidal
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0052—T-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
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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 present invention relates to the field of medical device technology, and in particular to a valve prosthesis.
  • transcatheter valve replacement does not require thoracotomy and extracorporeal circulation support. It is a treatment method with less trauma, less complications, quick postoperative recovery, and less painful and acceptable patient.
  • Valve products have been continuously updated and improved, and several products have been used in clinical applications. However, current transcatheter valve prosthesis products still have some drawbacks and are not reasonable enough.
  • the present invention provides a valve prosthesis comprising a stent, a leaflet and a skirt; wherein the stent comprises an inflow end, an outflow end, and a plurality of axially connected bands, the band comprising a circumference a plurality of mesh structural units arranged; the leaflets and the skirt are respectively fixed to the On the bracket;
  • the upper portion of the skirt is provided with a notch, the skirt is fixed to the leaflet through the notch, and the skirt further includes a first protrusion extending toward the outflow end of the bracket, the first One end of the protrusion is connected to the notch, and the other end is connected to the bracket.
  • the other end of the first protrusion is located at 1/2 to 2/3 of the height of the leaflet.
  • the number of the first protrusions does not exceed the number of mesh structural units that are fixed to the band in which the stent is located.
  • the number of the first protrusions is 1-9.
  • the upper portion of the skirt is provided with a plurality of the notches, each of the notches being fixed with one piece of the leaflets, and the number of the first protrusions in one of the notches is not more than three.
  • the first protrusion is in a zigzag shape, a trapezoidal shape or a sinusoidal shape.
  • the skirt further includes a second protrusion, one end of which is connected to a lower portion of the skirt, and the other end is fixed to an inflow end of the bracket.
  • the second protrusion is toothed, trapezoidal or sinusoidal.
  • the number of the second protrusions does not exceed the number of the net-like structural units in the circumferential direction at the inflow end of the bracket.
  • the number of the second protrusions is 3 to 12.
  • the skirt is composed of at least one skirt unit having an upper edge and a lower edge, the notch being disposed at an upper edge of the skirt unit, the boundary of the notch comprising a leaflet Fixed edge.
  • the shape of the fixed edge of the leaflet includes a concave curved structure that is convex toward the lower edge.
  • the skirt further comprises a tumbling structure disposed outside the bracket.
  • the skirt is composed of at least one skirt unit having an upper edge and a lower edge, the notch being disposed at an upper edge of the skirt unit, the boundary of the notch comprising a leaflet a fixed side, the skirt unit including a body and an inflow end from the body toward the bracket Extending the formed crease portion, the tumbling portion forms the tumbling structure, and a lower edge of the skirt unit forms an edge of the hem portion.
  • the skirt further comprises a second protrusion, one end of the second protrusion is connected to the edge of the crease portion, and the other end is fixed to the bracket outside the bracket.
  • the other end of the second protrusion is fixed to the mesh structure unit in the first row of wavelength bands from the inflow end of the bracket.
  • the length of the body of the skirt unit is 1.5 to 2 times the length of the tumbling portion.
  • the side edges of the skirt unit are connected to each other to form a splicing line
  • the splicing line of the staking portion comprises a straight line extending outward of the bracket or a curve convex toward the outside of the bracket.
  • the notch comprises two sub-notches, respectively located at an upper edge of an adjacent side of an adjacent skirt unit or an upper edge of a left and right side of a skirt unit.
  • the boundary of the sub-notch includes a sub-lobed fixed edge
  • the sub-lobed fixed edge includes a concave curved structure that protrudes toward a lower edge of the skirt unit.
  • the adjacent lobes are fixed at the same radius of curvature at the abutment.
  • the length ratio of the adjacent side of the auxiliary leaflets is 1:3 to 3:1.
  • the first protrusion is located in a sub-notch, and the first protrusion is in a zigzag shape, a trapezoidal shape, a sine wave shape, a right triangle shape or a right angle trapezoid.
  • a first protrusion is further disposed at an upper portion of the skirt, and the first protrusion extends toward the outflow end of the bracket and is fixed to the bracket, so that the skirt is enhanced on the one hand.
  • the strength of the connection between the side and the stent on the other hand, when the implantation position of the valve prosthesis is low, the height of the anti-valve leakage can be increased by the first protrusion, thereby avoiding leakage of part of the blood flow from the stent, thereby improving the leakage of the valve. Effect.
  • the other end of the first protrusion is located at 1/2 to 2/3 of the height of the leaflet, thus ensuring that the valve prosthesis can work normally and reduce the increase in the height of the flap leakage.
  • the amount of material used in the skirt can also reduce the risk of thrombosis.
  • FIG. 1 is a schematic structural view of a valve prosthesis in an expanded state according to a first embodiment of the present invention
  • FIG. 2 is a schematic structural view showing a combination of a skirt and a leaflet according to Embodiment 1 of the present invention
  • FIG. 3 is a schematic structural view of a skirt unit according to Embodiment 1 of the present invention.
  • Figure 4 is a schematic view showing the deployed state of the valve prosthesis according to the second embodiment of the present invention.
  • Figure 5 is a schematic view showing the valve prosthesis of the second embodiment of the present invention disposed in the aorta;
  • Figure 6 is a schematic structural view of a skirt unit according to a second embodiment of the present invention.
  • Figure 7 is a structural schematic view showing the combination of the skirt and the leaflets according to the second embodiment of the present invention.
  • Figure 8 is a schematic structural view of a skirt unit according to a third embodiment of the present invention.
  • Fig. 9 is a structural schematic view showing the combination of a skirt and a leaflet in a preferred embodiment of the third embodiment of the present invention.
  • valve prosthesis of the present invention will be further described in detail below with reference to Figures 1-8. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.
  • proximal, lower or lower and distal, upper or upper are viewed from the direction of blood flow through the valvular prosthesis, although “proximal”, “lower” or “lower” and “ Remote” “Upper” or “upper end” is not limiting, but “proximal”, “lower” or “lower” generally refers to the end of the blood flowing into the valve prosthesis, and the “distal”, “upper” or “upper end” Usually refers to the end of the blood vessel that exits the valve prosthesis.
  • valve prosthesis of the present invention is specifically an interventional prosthetic heart valve prosthesis for replacing a diseased valve, but is not limited thereto.
  • the valve prosthesis of the present invention is described in further detail below in conjunction with specific embodiments.
  • FIG. 1 is a schematic structural view of a valve prosthesis according to a first embodiment of the present invention.
  • FIG. 2 is a schematic structural view of a skirt and a leaflet according to a first embodiment of the present invention
  • FIG. 3 is a schematic view of the present invention.
  • the valve prosthesis 10 includes a stent 1, a leaflet 2, and a skirt 3.
  • the bracket 1 includes an inflow end and an outflow end, and the direction from the inflow end to the outflow end is the axial direction of the bracket 1.
  • the leaflets 2 are at least three pieces, and the leaflets 2 are sequentially connected and fixed to the stent 1.
  • the upper portion of the skirt 3 is provided with a notch 321 , and the skirt 3 is fixed to the leaflet 2 via a notch 321 .
  • the skirt 3 further includes a first protrusion 323 extending toward the outflow end of the bracket 1 .
  • One end of the protruding portion 323 is connected to the notch 321 and the other end is fixed to the bracket 1.
  • the outflow end corresponds to a direction in which blood flow flows out
  • the inflow end corresponds to a direction in which blood flow flows in.
  • the bracket 1 further includes a plurality of axially coupled bands, wherein each of the bands includes a plurality of network members arranged circumferentially, the mesh units being composed of a plurality of poles end to end.
  • each of the bands includes a plurality of network members arranged circumferentially, the mesh units being composed of a plurality of poles end to end.
  • the invention fixes the first protruding portion 323 with the bracket 1 , increases the strength of the connection of the skirt 3 to the bracket 1 , and on the basis of ensuring the connection strength, when the implantation position of the valve prosthesis 10 is low, the first protrusion is passed.
  • the portion 323 can also increase the height of the anti-valve leak and improve the effect of the anti-valve leak.
  • the first protrusion 323 and the skirt 3 can be separately produced.
  • the skirt 3 is composed of at least one skirt unit 31, and at this time, the notch 321 is provided at the upper edge 32 of the skirt unit 31.
  • the leaflets 2 and the skirt 3 are fixedly connected by a notch 321.
  • the number of the notches 321 is not necessarily related to the number of the skirt units 31 constituting the skirt 3, and one skirt unit 31 may be provided with a plurality of notches 321, or one skirt unit 31 may not be provided with a notch.
  • the boundary of the gap 321 includes a leaflet fixed edge 322 to correspond to the leaflet 2 (shown in Figure 1).
  • the shape of the leaflet fixed edge 322 includes a concave curved structure that is convex toward the lower edge 33 of the skirt unit 31, preferably an arcuate structure, such as a centrally symmetrical arc, preferably the shape of the fixed edge 322 of the leaflet
  • the leaflets 2 match.
  • the skirt 3 is made by sequentially connecting three skirt units 31.
  • the leaflets 2 are three pieces.
  • the skirt unit 31 has oppositely disposed upper and lower edges 32, 33 which are located on the upper edge 32 of the skirt unit 31.
  • the boundary of the notch 321 is a leaflet fixed edge 322 to correspond to the leaflet 2 (shown in Figure 2).
  • the leaflets 2 and the skirt 3 are first sewn together and then mounted together in the expandable stent 1 to form the valve prosthesis 10.
  • the boundary between the skirt 3 and the bracket 1 is along the upper edge 32 and the lower edge 33 of the skirt unit 31, so that the fixing between the skirt 3 and the bracket 1 is achieved.
  • the stitching boundary when the two opposite sides of one skirt unit 31 are spliced is the splicing line 34 (the splicing line 34 is not actually a suture for stitching).
  • the opposite sides of the skirt unit 31 are further provided with an extended edge 35 (shown in FIG. 3), which facilitates the connection between adjacent skirt units 31 and forms a splicing line 34.
  • the splicing line 34 is a straight line or a non-linear line, specifically It is set according to the side profile of the bracket 1. With such a setting, the skirt 3 can be attached to the bracket 1 during assembly.
  • the other end of the first protrusion 323 is located at 1/2 to 2/3 of the height of the leaflet 2 (more clearly shown in FIG. 1), such an arrangement increases the leakage height of the flap On the one hand, on the one hand, it ensures that the valve prosthesis can work normally, on the other hand, the skirt material is reduced, and on the other hand, the risk of thrombosis can be reduced.
  • the height of the leaflet 2 refers to the lower edge of the leaflet 2 (ie, the junction with the notch 321) fixed to the stent 1 from the upper edge of the leaflet 2 (ie, the end near the outflow end of the stent 1).
  • the other end of the first protrusion 323 refers to an end of the first protrusion 323 fixed behind the bracket near the outflow end of the bracket 1.
  • the present invention is not particularly limited in shape of the first protruding portion 323 as long as the first protruding portion 323 covers at least a part of the mesh structural unit of the stent 1.
  • the first protruding portion 323 has a zigzag shape, a trapezoidal shape, a sinusoidal shape, a similar shape thereof, or the like.
  • the first protrusion 323 is sewn to at least two opposing poles constituting the mesh unit to fix the first protrusion 323 to the bracket 1.
  • the number of the first protruding portions 323 is set according to the number of mesh structural units that are fixed on the wavelength band of the bracket 1. In one embodiment, the number of the first protrusions 323 matches or is less than the number of mesh structural units on the band. Preferably, the number of the first protrusions 323 in the skirt 3 is 1 to 9, and more preferably, the first protrusions 323 are uniformly arranged circumferentially. Preferably, the number of the first protruding portions 323 in one of the notches 321 is not more than three, and more preferably two to three.
  • the skirt 3 further includes a second protrusion 331 having one end connected to the lower portion of the skirt 3 and the other end fixed to the inflow end of the bracket 1.
  • the second protruding portion 331 is disposed at a lower edge 33 of the skirt unit 31, and the second protruding portion 331 extends toward the inflow end of the bracket 1 and flows into the bracket 1 The end is fixed.
  • the shape of the second protrusion 331 is not particularly limited, and is preferably in a zigzag shape, a trapezoidal shape, a sinusoidal shape, or the like.
  • the number of the second protrusions 331 is according to the inflow end of the bracket 1
  • the number of circumferentially oriented grid-like structural units is set.
  • the number of the second protrusions 331 matches the number of the mesh structure units or is smaller than the number of the mesh structure units, preferably 3 to 12.
  • the leaflet 2 and the skirt 3, the skirt 3 and the stent 1, the leaflet 2 and the stent 1, the leaflet 2 and the leaflet 2, and the skirt unit 31 and the skirt unit 31 The fixation is fixed by suture stitching, and the suture is more preferably a medical suture made of a polymer material.
  • the manner of fixing in the present invention is not limited to the manner of using a suture, and other means such as glue bonding may also be employed.
  • the present invention is not particularly limited in the manner in which the first protruding portion and the skirt unit are connected.
  • the first protruding portion and the skirt unit may be separately prepared, and then joined by sewing or the like, or the first protruding portion and the skirt unit may be integrally formed.
  • the manner in which the second protrusion is connected to the skirt unit is not particularly limited, and may be a fixed connection or an integral molding.
  • FIG. 4 is a schematic view showing the deployed state of the valve prosthesis according to the second embodiment of the present invention
  • FIG. 5 is a schematic view showing the valve prosthesis according to the second embodiment of the present invention disposed in the aorta
  • Fig. 6 is a schematic structural view of a skirt unit according to a second embodiment of the present invention
  • Fig. 7 is a structural schematic view showing a combination of a skirt and a leaflet according to a second embodiment of the present invention.
  • the skirt 3 is formed by splicing three skirt units 31.
  • a notch 321 is defined in the upper edge 32 of each of the skirt units 31.
  • the boundary of each notch 321 is a leaflet fixed edge 322 and corresponds to a leaflet 2, that is, each of the skirt units 31 is fixed by the leaflet fixing edge 322.
  • the two first protruding portions 323 are located in a notch 321, and the first protruding portion 323 extends toward the outflow end of the bracket 1 and is fixed to the bracket 1.
  • the skirt 3 further includes a tumbling structure disposed outside the bracket 1.
  • the skirt unit 31 includes, in addition to the body 311, a tumbling portion 312 extending from the body 311 toward the inflow end of the bracket 1, and the hem portion 312 forms a The sew structure is described.
  • the lower end of the body 311 is connected to the upper end of the grooving portion 312 (in FIGS. 6 and 7 , the boundary line I is taken as an example to show the boundary between the body 311 and the staking portion 312, but the boundary line I should be recognized.
  • the lower edge 33 of the skirt unit 31 is located at the lower end of the tumbling portion 312, and the hem portion 312 is fixed to the bracket 1 by the lower edge 33.
  • the staking portion 312 may be integrally formed with the body 311 or may be separately assembled with the body 311, and is not limited thereto. Referring to FIG. 5, when the valve prosthesis 10 is implanted into a human body, the tumbling structure can fill a gap between the stent 1 and the human tissue to overcome the deformation of the stent 1 and the annulus caused by the deformation of the stent 1 after deployment. A leak problem between 20.
  • the length of the body 311 of the skirt unit 31 is 1.5 to 2 times the length of the flap portion 312. If the tumbling portion 312 is too short, it cannot be sutured to the designated position, and the inflow end portion of the bracket 1 may puncture the skirt 3; if the staking portion 312 is too long, it may cause a fluffy effect. Too much material, increasing the overall contour of the product as a whole.
  • the length of the body 311 of the skirt unit 31 refers to the linear distance from the upper edge 32 of the skirt unit 31 to the lower end of the body 311 (ie, the boundary line I), and the hem portion 312 The length refers to the linear distance from the upper end of the tumbling portion 312 (i.e., at the boundary line I) to the lower edge 33 of the skirt unit 31.
  • the tumbling portion 312 is folded from the inflow end of the bracket 1 toward the outflow end of the bracket 1 and fixed to the outer circumference of the bracket 1.
  • the splicing line of the hem portion 312 includes a straight line extending outward of the bracket or a curve convex toward the outside of the bracket.
  • the suture portion 312 is formed into a fluffy state by suturing, and the paravalvular leakage can be more effectively prevented. That is, after the stent 1, the skirt 3 and the leaflets 2 are sewn together, the crease structure of the skirt 3 does not abut against the outer surface of the stent 1 but leaves a certain gap therebetween.
  • the skirt includes a second protrusion 331 extending from a lower edge of the hem 312 (ie, a lower edge 33 of the skirt unit 31) for The outer side of the bracket 1 is fixed. That is, one end of the second protruding portion 331 is connected to the lower edge 33 of the skirt unit 31, and the other end is fixed to the outer side of the bracket 1.
  • the second protruding portion 331 has a zigzag shape, a trapezoidal shape, a sinusoidal shape or a similar shape thereof, and such an outer shape design is more convenient to be fixed to the bracket 1.
  • the second protrusion 331 is sewn to the mesh structure unit fixed on the band of the bracket 1 , such as the mesh structure unit in the first row of the band from the inflow end of the bracket 1 . (It can also be fixed to other positions of the bracket 1 depending on the actual situation).
  • the fixed connection with the first row of bands increases the connection strength based on the increased height of the anti-valve leakage, which reduces the material and reduces the risk of thrombosis compared to some embodiments such as suturing to the second row of bands. .
  • the number of the second protruding portions 331 is set in accordance with the number of mesh structural units to which the bracket 1 is fixed. In one embodiment, the number of the second protrusions 331 matches or is less than the number of mesh structural units on the band in which they are located. In some embodiments, the number of the second protrusions 331 is 3-12. The second protrusions 331 are preferably evenly arranged outside the bracket 1 .
  • the skirt 3 is still an annular structure and is formed by splicing three skirt units 31.
  • the skirt 3 is provided with three notches to correspond to three leaflets 2, each of which is provided at the notch.
  • the notch includes two sub-notches, which are a first sub-notch 321a and a second sub-notch 321b, respectively, which are respectively placed on the upper edge of the adjacent side of the adjacent skirt unit, that is,
  • the first sub-notch 321a and the second sub-notch 321b are respectively located at the upper edges of the left and right sides of the skirt unit.
  • the first protrusion is located at the sub-notch, and a first protrusion is disposed at each sub-notch.
  • the skirt unit 31' includes an upper edge 32' and a lower edge 33', wherein the first sub-notch 321a is placed on the left side of the upper edge 32' of the skirt unit 31' for use with the left
  • the second sub-notch 321b on the adjacent skirt unit 31' constitutes a complete notch; the second sub-notch 321b is arranged on the skirt
  • the right side of the upper edge 32' of the unit 31' is configured to form a complete notch with the first sub-notch 321a on the right adjacent skirt unit 31'; preferably the first sub-notch 321a and the second sub-notch 321b Symmetrical arrangement.
  • the first sub-gap 321a is provided with a first sub-lobed fixed edge 322a
  • the second sub-notch 321b is provided with a second sub-lobed fixed edge 322b.
  • the first sub-notch 321a on the skirt unit 31' and the second sub-notch 321b on the left adjacent skirt unit 31' form a complete notch 321 '
  • the first sub-lobed fixed edge 322a on 31' and the second sub-lobed fixed edge 322b on the left adjacent skirt unit 31' form a complete leaflet fixed edge 322'.
  • the two skirt units 31' are fixedly coupled to a leaflet 2.
  • first sub-gap 321a on the remaining skirt unit 31' and the second sub-gap 321b on the adjacent skirt unit 31' are also arranged as such.
  • each of the skirt units 31' is provided with a first sub-notch 321a and a second sub-notch 321b.
  • the skirt unit 31' may also be provided only.
  • the number of sub-notches included in the entire skirt 3 should be a double number and set in pairs.
  • the sub-lobed fixed edge includes a concave curved structure that is convex toward the lower edge of the skirt unit, preferably an arc-shaped structure, and more preferably a circular arc structure.
  • a concave curved structure that is convex toward the lower edge of the skirt unit, preferably an arc-shaped structure, and more preferably a circular arc structure.
  • the radius of curvature of the joint of the fixed leaflet is equal.
  • the leaflet fixed edge 322' may also have other shapes, and the invention is not particularly limited.
  • the skirt 3 further includes two first projections 323a and 323b.
  • the first protruding portion 323a is located on the first sub-notch 321a and extends toward the outflow end of the bracket 1 and is fixed to the bracket 1.
  • the first protrusion 323b is located on the second sub-notch 321b and also extends for fixing to the bracket 1.
  • the first protrusions 323a and 323b extend toward the outflow end of the stent 1 and are fixed to the stent 1, such as a suture connection (see FIGS. 4 and 5 for the state after the connection).
  • the first protrusions 323a and 323b are symmetrically arranged.
  • the invention fixes the first protrusion with the bracket 1 , increases the strength of the connection of the skirt 3 to the bracket 1 , and on the basis of ensuring the connection strength, when the implantation position of the valve prosthesis 10 is low, the first protrusion is passed. It is also possible to increase the height of the anti-valve leak, thereby preventing part of the blood flow from leaking from the stent 1 and improving the effect of preventing the valve leakage.
  • the first protruding portion may have a shape such as a right-angled triangle or a right-angled trapezoid, in addition to a zigzag shape, a trapezoidal shape, or a sinusoidal shape.
  • the first protrusion 323a of one of the skirt units 31' and the first protrusion 323b of the other skirt unit 31' may form a zigzag protrusion or a trapezoidal shape. unit.
  • the two adjacent skirt units 31' are spliced by stitching or the like, and the stitching limit when stitching each other is the splicing line 34, and the two ends of the splicing line 34 are respectively fixed by the adjacent two sub-lobes.
  • the length ratio of the adjacent sub-lobe fixed edge is 1:3 to 3:1.
  • the length ratio of the first sub-lobed fixed edge 322a to the second sub-lobed fixed edge 322b may be 1:3. 1:2, 1:1, 2:1, 3:1 or other suitable ratio.
  • the splicing line 34 is a straight line in this embodiment, and one end of the straight line intersects the adjacent two leaflet fixed sides 322a, 322b, and the other end intersects perpendicularly to the lower edge of the skirt unit. At this time, the stitching line 34 is located at a shorter path between the fixed leaf edge 322' and the lower edge 33' of the skirt unit 31', so that the number of stitches to be stitched when stitching the stitching thread is also minimized, thereby reducing the stitching time. The risk of coming to improve the safety of use.
  • the shape of the splicing line 34 is not particularly limited in the present invention, and may be a curved or other irregularly shaped structure.
  • the leaflet fixed edge 322' is a centrally symmetrical arc (i.e., the first sub-lobed fixed edge 322a of the skirt unit 31' coincides with the second sub-lobed fixed edge 322b' of the skirt unit 31'.
  • the intersection of the splicing line 34 and the leaflet fixed edge 322', the first sub-lobed fixed edge 322a and the second sub-lobed fixed edge 322b' joint coincide with each other, and located at the leaflet fixed edge 322' (by The first sub-lobed fixed edge 322a and the second sub-lobed fixed edge 322b' are formed at one-half, and thus here is also the closest to the lower edge 33' of the skirt 3 on the fixed-edge 322' of the leaflet position.
  • the stitching line 34 formed is the shortest and the stitching holes are the least.
  • a first protrusion is further disposed at an upper portion of the skirt and the leaflet, and the first protrusion extends toward the outflow end of the bracket and is fixed to the bracket, such that one The aspect enhances the strength of the connection between the skirt and the bracket.
  • the height of the paravalvular leakage can be increased by the first protrusion, thereby preventing part of the blood flow from leaking from the stent. And improve the effect of anti-valve leakage.
  • the other end of the first protrusion is located at 1/2 to 2/3 of the height of the leaflet, so that the valve prosthesis can be operated normally and the number of the valve prosthesis is increased.
  • the material of the skirt reduces the risk of thrombosis.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种瓣膜假体（10），包括支架（1）、瓣叶（2）和裙边（3），支架（1）包括流入端、流出端、以及多个轴向连接的波段，波段包括周向布置的多个网状结构单元，瓣叶（2）和裙边（3）分别固定于支架上（1），裙边（3）的上部设有缺口（321），裙边（3）通过缺口（321）与瓣叶（2）固定，裙边（3）还包括向支架的流出端方向延伸的第一突出部（323），第一突出部（323）的一端与缺口（321）连接，另一端与支架（1）固定，如此，一方面增强了裙边（3）与支架（1）连接的强度，另一方面当瓣膜假体（10）植入位置偏低时，通过第一突出部（323）可增加防瓣周漏的高度，从而避免部分血流从支架（1）泄漏，进而提升防瓣周漏的效果。

Description

瓣膜假体 技术领域
本发明涉及医疗器械技术领域，特别涉及一种瓣膜假体。
背景技术
随着人类寿命的延长和人口的老年化，瓣膜疾病的发病率越来越高。根据国外资料记载，年龄大于65岁的人群中，有2％～7％的人存在瓣膜病，而在欧美国家位于冠心病和高血压病之后，居第三位。每年有成千上万的患者能从外科瓣膜假体置换术中获益，但即使在发达国家，仍有大量严重瓣膜病变的患者因为疾病晚期、高龄以及存在多种合并症等原因而不能接受外科手术治疗，经导管瓣膜假体产品的出现和产品性能的不断完善，无疑为这部分病人带来了福音，提供了一种有效的治疗方法。
研究表明：对于无法进行外科换瓣或外科换瓣手术存在高风险的患者，这项新技术是安全有效的。与外科手术相比，经导管瓣膜置换术无需开胸及体外循环支持，是一种创伤小、并发症少、术后康复快、患者痛苦小、容易接受的治疗方法。
瓣膜产品经过不断的更新改良，目前已有数种产品应用于临床。然而，目前的经导管瓣膜假体产品仍然存在着一些弊端和不够合理的地方。
发明内容
本发明的目的在于提供一种瓣膜假体，以降低瓣膜植入后存在的瓣周漏以及血栓等问题。
为实现上述目的，本发明提供了一种瓣膜假体，包括支架、瓣叶和裙边；其中，所述支架包括流入端、流出端、以及多个轴向连接的波段，所述波段包括周向布置的多个网状结构单元；所述瓣叶和所述裙边分别固定于所 述支架上；
所述裙边的上部设有缺口，所述裙边通过所述缺口与所述瓣叶固定，所述裙边还包括向所述支架的流出端方向延伸的第一突出部，所述第一突出部的一端与所述缺口连接，另一端与所述支架连接。
优选地，所述第一突出部的另一端位于所述瓣叶高度的1/2～2/3处。
优选地，所述第一突出部的数量不超过其固定在支架所在波段上的网状结构单元的数量。
优选地，所述第一突出部的数量为1～9个。
优选地，所述裙边的上部设有多个所述缺口，每个所述缺口与一片所述瓣叶固定，一个所述缺口中的第一突出部的数量不超过3个。
优选地，所述第一突出部为锯齿状、梯形状或正弦波状。
优选地，所述裙边还包括第二突出部，所述第二突出部的一端与所述裙边的下部连接，另一端与所述支架的流入端固定。
优选地，所述第二突出部为齿状、梯形状或正弦波状。
优选地，所述第二突出部的数量不超过所述支架的流入端处周向方向上网状结构单元的数量。
优选地，所述第二突出部的数量为3～12个。
优选地，所述裙边由至少一个裙边单元所组成，所述裙边单元具有上边缘和下边缘，所述缺口设置于所述裙边单元的上边缘，所述缺口的边界包括瓣叶固定边。
优选地，所述瓣叶固定边的形状包括向所述下边缘方向凸起的内凹曲线结构。
优选地，所述裙边还包括布置于所述支架外部的翻缝结构。
优选地，所述裙边由至少一个裙边单元所组成，所述裙边单元具有上边缘和下边缘，所述缺口设置于所述裙边单元的上边缘，所述缺口的边界包括瓣叶固定边，所述裙边单元包括本体和从所述本体向所述支架的流入端方向 延伸形成的翻缝部，所述翻缝部形成所述翻缝结构，且所述裙边单元的下边缘形成所述翻缝部的边缘。
优选地，所述裙边还包括第二突出部，所述第二突出部的一端与所述翻缝部的边缘连接，另一端在支架外部与支架固定。
优选地，所述第二突出部的另一端与自所述支架的流入端起第一排波段中的网状结构单元相固定。
优选地，所述裙边单元的所述本体的长度是所述翻缝部的长度的1.5～2倍。
优选地，所述裙边单元的侧边相互连接形成一拼接线，所述翻缝部的拼接线包含一向支架外侧延伸的直线或向支架外侧凸起的曲线。
优选地，所述缺口包括两个子缺口，所述两个子缺口分别位于相邻裙边单元相邻的一侧的上边缘或一裙边单元的左右侧的上边缘。
优选地，所述子缺口的边界包括子瓣叶固定边，所述子瓣叶固定边包括向所述裙边单元的下边缘方向凸起的内凹曲线结构。
优选地，相邻接的子瓣叶固定边于邻接处的曲率半径相等。
优选地，相邻接的子瓣叶固定边的长度比为1∶3～3∶1。
优选地，所述第一突出部位于子缺口，所述第一突出部为锯齿状、梯形状、正弦波状、直角三角形或直角梯形。
综上所述，本发明的瓣膜假体，在裙边的上部处另设置了第一突出部，该第一突出部向支架的流出端方向延伸并与支架固定，如此，一方面增强了裙边与支架连接的强度，另一方面当瓣膜假体植入位置偏低时，通过第一突出部可增加防瓣周漏的高度，从而避免部分血流从支架泄漏，进而提升防瓣周漏的效果。
特别地，第一突出部的另一端位于瓣叶高度的1/2～2/3处，这样一来，在增加防瓣周漏高度的情况下，确保了瓣膜假体能够正常工作，而且减少了裙边的材料使用量，且同时还能降低血栓形成的风险。
附图说明
图1是本发明实施例一的瓣膜假体展开状态的结构示意图；
图2是本发明实施例一的裙边与瓣叶组合后的结构示意图；
图3是本发明实施例一的裙边单元的结构示意图；
图4是本发明实施例二的瓣膜假体展开状态的示意图；
图5是本发明实施例二的瓣膜假体布置于主动脉内的示意图；
图6是本发明实施例二的裙边单元的结构示意图；
图7是本发明实施例二的裙边与瓣叶组合后的结构示意图；
图8是本发明实施例三的裙边单元的结构示意图；
图9是本发明实施例三中较佳实施例的裙边与瓣叶组合后的结构示意图。
附图标记说明如下：
10-瓣膜假体；1-支架；2-瓣叶；3-裙边；31、31’-裙边单元；311-本体；312-翻缝部；
32、32’-裙边之上边缘；321-缺口；321a-第一子缺口：321b-第二子缺口：322、322’-瓣叶固定边；322a-第一子瓣叶固定边；322b-第二子瓣叶固定边；33、33’-裙边之下边缘；34-拼接线；35-扩展边；323、323a、323b-第一突出部；331-第二突出部；I-边界线；20-瓣环。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图1～8对本发明提出的瓣膜假体作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
在本文中，“近端、下部或下端”以及“远端、上部或上端”是从心脏血液流过瓣膜假体的方向来看，尽管“近端”、“下部”或“下端”以及“远端”、 “上部”或“上端”并非是限制性的，但是“近端”、“下部”或“下端”通常指接近血液流入瓣膜假体的一端，而“远端”、“上部”或“上端”通常是指接近血液流出瓣膜假体的一端。
如在本说明书和所附权利要求中所使用的，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。如在本说明书和所附权利要求中所使用的，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。此外，“内”或“内部”或“内侧”是指靠近支架远离人体组织的一侧，“外”或“外部”或“外侧”是指支架接近人体组织的一侧。
此外，本发明的瓣膜假体具体为一种介入式人工心脏瓣膜假体，用于置换发生病变的瓣膜，但不以此为限。以下结合具体实施方式对本发明的瓣膜假体作进一步详细描述。
<实施例一>
参阅图1至图3，图1是本发明实施例一的瓣膜假体展开状态的结构示意图，图2是本发明实施例一的裙边与瓣叶组合后的结构示意图，图3是本发明实施例一的裙边单元的结构示意图。
如图1至图3所示，所述瓣膜假体10包括支架1、瓣叶2和裙边3。本发明中，所述支架1包括流入端和流出端，并限定流入端至流出端的方向为支架1的轴向方向。所述瓣叶2至少为三片，所述瓣叶2依次连接并固定于支架1上。所述裙边3的上部设有缺口321，通过缺口321将裙边3与瓣叶2固定，所述裙边3还包括向支架1的流出端方向延伸的第一突出部323，所述第一突出部323的一端与缺口321连接，另一端与支架1固定。其中，所述流出端对应于血流流出的方向，所述流入端对应于血流流入的方向。
本发明中，所述支架1还包括多个轴向连接的波段，其中每个波段包括周向布置的多个网状结构单元，所述网状结构单元由多个波杆首尾连接组成。本领域技术人员可以根据需求选择合适的波段数，以及选择每个波段的网状 结构单元的形状、大小、密度，以及波杆的杆宽、大小。本发明将第一突出部323与支架1固定，增加了裙边3与支架1连接的强度，而且在保证连接强度的基础上，当瓣膜假体10植入位置偏低时，通过第一突出部323还可以增加防瓣周漏的高度，提升防瓣周漏的效果。显然，可以分别制作第一突出部323和裙边3。
进一步，如图2所示，所述裙边3由至少一个裙边单元31所组成，此时，所述缺口321设置于该裙边单元31的上边缘32。一般而言，所述瓣叶2与裙边3通过缺口321来固定连接。但是缺口321的数量与组成裙边3的裙边单元31的数量没有必然的关系，可以一个裙边单元31设有多个缺口321，也可以一个裙边单元31不设有缺口。进一步，所述缺口321的边界包括瓣叶固定边322，以对应于瓣叶2(显示于图1)。所述瓣叶固定边322的形状包括向裙边单元31的下边缘33方向凸起的内凹曲线结构，优选为弧形结构，例如中心对称的圆弧，优选瓣叶固定边322的形状与瓣叶2相匹配。
在本实施例中，所述裙边3为由三个裙边单元31依次连接所制成。在本实施例中，所述瓣叶2为三片。在三个裙边单元31中，所述裙边单元31具有相对设置的上边缘32和下边缘33，所述缺口321位于裙边单元31的上边缘32上。进一步，所述缺口321的边界为瓣叶固定边322，以对应于瓣叶2(显示于图2)。
在一个示范性操作中，所述瓣叶2和裙边3首先缝合在一起，进而一起安装于可扩张的支架1内制成瓣膜假体10。其中裙边3与支架1所缝合的边界是沿着裙边单元31的上边缘32和下边缘33，从而实现裙边3和支架1间的固定。
此外，一个裙边单元31的两相对侧边拼接时的缝合界限即为拼接线34(该拼接线34实际上不是缝合用的缝合线)。本实施例中，所述裙边单元31的两相对侧还设有扩展边35(显示于图3)，所述扩展边35便于相邻的裙边单元31之间连接，并形成拼接线34。所述拼接线34为直线或非直线，具体 根据支架1的侧面轮廓来设定。这样的设定，组装时可使裙边3贴紧支架1。
在一个优选方案中，所述第一突出部323的另一端位于瓣叶2高度的1/2～2/3处(更清楚显示于图1)，这样的设置，在增加防瓣周漏高度的前提下，一方面确保了瓣膜假体能够正常工作，另一方面减少了裙边材料，再一方面还可以降低血栓形成的风险。需要说明的是，所述瓣叶2高度指的是与支架1固定后的瓣叶2的下边缘(即与缺口321连接处)距离瓣叶2的上边缘(即靠近支架1的流出端的一端)沿支架1轴向的最大直线距离。相应地，所述第一突出部323的另一端指的是固定在支架后的第一突出部323靠近支架1的流出端的一端。
进一步，本发明对第一突出部323的形状没有特别的限制，只要所述第一突出部323至少覆盖支架1的网状结构单元的一部分即可。优选，所述第一突出部323呈锯齿状、梯形状、正弦波状及它们的类似形状等。缝合时，将第一突出部323与组成该网状结构单元的至少两个相对的波杆缝合，以使第一突出部323与支架1固定。
进一步，所述第一突出部323的数量根据其固定在支架1的所在波段上的网状结构单元的数量来设定。在一个实施例中，所述第一突出部323的数量与所述波段上的网状结构单元的数量相匹配或小于网状结构单元的数量。优选，所述裙边3中所述第一突出部323的数量为1～9个，更优选所述第一突出部323周向均匀布置。优选，在一个缺口321中的第一突出部323不超过3个，更优选为2～3个。
在另一实施例中，所述裙边3还包括第二突出部331，所述第二突出部331的一端与裙边3的下部连接，另一端与支架1的流入端固定。具体如图1和图3所示，所述第二突出部331设置在裙边单元31的下边缘33，所述第二突出部331向支架1的流入端方向延伸，并与支架1的流入端固定。所述第二突出部331的形状没有特别的限制，优选呈锯齿状、梯形状、正弦波状或它们的类似形状。优选地，所述第二突出部331的数量根据支架1的流入端 周向方向上网状结构单元的数量来设定。在一个实施例中，所述第二突出部331的数量与所述网状结构单元的数量相匹配或小于所述网状结构单元的数量，优选为3～12个。
在本实施例中，所述瓣叶2与裙边3，裙边3与支架1，瓣叶2与支架1，瓣叶2与瓣叶2，以及裙边单元31与裙边单元31之间的固定，通过缝合线缝合固定，所述缝合线更优选为高分子材料制成的医用缝合线。但是本发明中固定的方式不限于采用缝合线的方式，还可以采用诸如胶水粘合等其他方式。本发明对第一突出部、裙边单元连接方式没有特别的限制。例如所述第一突出部、裙边单元可以分别制备，然后通过缝合等方式连接，又或者所述第一突出部、裙边单元一体成型。同样，所述第二突出部与裙边单元连接方式也没有特别的限制，可以是固定连接，也可以是一体成型。
<实施例二>
与实施例一类似，参阅图4至图7，图4是本发明实施例二的瓣膜假体展开状态的示意图，图5是本发明实施例二的瓣膜假体布置于主动脉内的示意图，图6是本发明实施例二的裙边单元的结构示意图，图7是本发明实施例二的裙边与瓣叶组合后的结构示意图。本实施例中与实施例一完全相同的元件或执行相同功能的元件采用相同的附图标记。
如图4～7所示，所述裙边3由三个裙边单元31拼接而成。每片裙边单元31的上边缘32上开设有一缺口321，各缺口321的边界即为瓣叶固定边322并对应于一瓣叶2，即每片裙边单元31通过瓣叶固定边322固定连接一片瓣叶2。进一步，两个第一突出部323位于一个缺口321中，所述第一突出部323向支架1的流出端方向延伸，并与支架1固定。
与实施例一相比，本实施例中，所述裙边3还包括布置于支架1外部的翻缝结构。如图6所示，所述裙边单元31除了本体311之外，还包括从本体311向支架1的流入端方向延伸形成的翻缝部312，所述翻缝部312形成了所 述翻缝结构。具体来说，所述本体311的下端与翻缝部312的上端连接(图6和图7中，以边界线I为示例显示本体311与翻缝部312的边界，但是应认识到边界线I为虚设的结构，仅便于解释说明)，所述裙边单元31的下边缘33则位于翻缝部312的下端，通过下边缘33所述翻缝部312与支架1固定。所述翻缝部312既可以与本体311一体成型，也可以与本体311分体组装，具体不作限定。参阅图5，当瓣膜假体10被植入到人体后，所述翻缝结构可以填塞支架1与人体组织之间的缝隙，以克服因支架1展开后的形变不足而导致支架1与瓣环20之间的泄漏问题。
优选地，所述裙边单元31之本体311的长度是翻缝部312长度的1.5～2倍。如果翻缝部312过短，则没法缝合到指定位置，所述支架1的流入端端部会戳破裙边3；如果翻缝部312过长，则在保证蓬松效果的基础上，会造成材料过多，增大产品整体的最大轮廓。其中，所述裙边单元31之本体311的长度是指所述裙边单元31的上边缘32至本体311的下端(即边界线I所示处)的直线距离，所述翻缝部312的长度是指翻缝部312的上端(即边界线I所示处)至裙边单元31的下边缘33的直线距离。
使用状态下，如图4和图5所示，翻缝部312自支架1的流入端朝支架1的流出端方向翻折并固定在支架1的外周。优选，所述翻缝部312的拼接线包含一向支架外侧延伸的直线，或者向支架外侧凸起的曲线。这样，通过缝合，所述翻缝部312形成蓬松状态，可以更加有效的防止瓣周漏。即支架1、裙边3和瓣叶2缝合在一起后，所述裙边3的翻缝结构非紧贴支架1的外表面而是两者之间留有一定的空隙。
进一步，所述裙边包括第二突出部331，所述第二突出部331从所述翻缝部312的下边缘(亦即所述裙边单元31的下边缘33)上延伸出用于与支架1外侧固定。即所述第二突出部331的一端与所述裙边单元31的下边缘33连接，另一端与支架1外侧固定。所述第二突出部331呈锯齿状、梯形状、正弦波状或者是它们的类似形状，这样的外形设计较方便与支架1固定。在一 个实施例中，所述第二突出部331与其固定在支架1的所在波段上的网状结构单元相缝合，如与自支架1的流入端起第一排波段中的网状结构单元相缝合(也可固定到支架1的其他位置，因实际情况而定)。与第一排波段相固定连接，在提升了防瓣周漏高度的基础上，增加了连接强度，较一些诸如缝合到第二排波段的实施例相比，减少了材料，降低了血栓的风险。
与第一突出部323类似地，所述第二突出部331的数量根据其固定在支架1所在波段上的网状结构单元的数量来设定。在一个实施例中，所述第二突出部331的数量与所在波段上的网状结构单元的数量相匹配或小于网状结构单元的数量。在一些实施例中，所述第二突出部331的数量为3～12个。所述第二突出部331优选均匀布置在支架1的外侧。
<实施例三>
本实施例中与实施例一完全相同的元件或执行相同功能的元件采用相同的附图标记。以下主要描述本实施例与实施例一的区别。
本实施例中，所述裙边3仍为环形结构并由三个裙边单元31拼接而成，所述裙边3设有三个缺口，以对应于三片瓣叶2，每个缺口处设有两个第一突出部。与实施例二相比，所述缺口包括两个子缺口，分别是第一子缺口321a和第二子缺口321b，分别置于相邻裙边单元相邻接的一侧的上边缘，也就是说，对于具有多个裙边单元的裙边而言，其中部分缺口由两个子缺口组成，且所述两个子缺口分别位于相邻的两个裙边单元上；或者对于只包含一裙边单元的裙边而言，第一子缺口321a和第二子缺口321b分别位于该裙边单元的左右侧的上边缘。所述第一突出部位于所述子缺口，如每个子缺口处设置一个第一突出部。
如图8所示，所述裙边单元31’包括上边缘32’和下边缘33’，其中第一子缺口321a置于裙边单元31’的上边缘32’的左侧，用于与左邻接的裙边单元31’上的第二子缺口321b组成一完整的缺口；所述第二子缺口321b布置在裙边 单元31’的上边缘32’的右侧，用于与右邻接的裙边单元31’上的第一子缺口321a组成一完整的缺口；优选所述第一子缺口321a和第二子缺口321b对称布置。所述第一子缺口321a设有第一子瓣叶固定边322a，所述第二子缺口321b设有第二子瓣叶固定边322b。进一步如图9所示，所述裙边单元31’上的第一子缺口321a与左邻接的裙边单元31’上的第二子缺口321b组成一完整的缺口321’，所述裙边单元31’上的第一子瓣叶固定边322a与左邻接的裙边单元31’上的第二子瓣叶固定边322b组成一完整的瓣叶固定边322’。这样，两个裙边单元31’与一瓣叶2固定连接。其余裙边单元31’上的第一子缺口321a与邻接的裙边单元31’上的第二子缺口321b也是如此布置。虽然图9所示实施例中，每个裙边单元31’上均设有第一子缺口321a和第二子缺口321b，本领域技术人员应当理解，裙边单元31’上也可以只设有第一子缺口321a和第二子缺口321b中的一个，或者不设置子缺口。此外，整个裙边3所包含的子缺口的数目应当为双数，并且成对设置。
本实施例中，所述子瓣叶固定边包括向裙边单元的下边缘方向凸起的内凹曲线结构，优选为弧形结构，更优选为圆弧结构。为了使拼合后的瓣叶固定边322’为一圆滑的曲线，优选子瓣叶固定边接头处曲率半径相等。当然该瓣叶固定边322’也可以为其他形状的结构，本发明不作特别的限定。
继续参考图8，所述裙边3还包括两个第一突出部323a和323b。所述第一突出部323a位于第一子缺口321a上，并向支架1的流出端方向延伸且与支架1固定。同样，第一突出部323b位于第二子缺口321b上，同样延伸出用于与支架1固定。所述第一突出部323a和323b向支架1的流出端方向延伸并与支架1固定，如缝合连接(连接后的状态可参阅图4和图5)。优选，所述第一突出部323a和323b对称布置。本发明将第一突出部与支架1固定，增加了裙边3与支架1连接的强度，而且在保证连接强度的基础上，当瓣膜假体10植入位置偏低时，通过第一突出部还可以增加防瓣周漏的高度，从而避免部分血流从支架1内泄露，提升防瓣周漏的效果。
进一步，在本实施例中，所述第一突出部除了可以为锯齿状、梯形状、正弦波状之外，还可以为直角三角形、直角梯形等形状。这样，两片裙边单元31’缝合后，其中一片裙边单元31’的第一突出部323a与另一片裙边单元31’的第一突出部323b可以形成一锯齿状突出部或梯形状突出部。
与上述实施例类似，两相邻裙边单元31’通过缝合等方式进行拼接，且相互缝合时的缝合界限即为拼接线34，并且拼接线34的两端分别位于相邻两子瓣叶固定边的相接处和裙边单元的下边缘处。优选，相邻接的子瓣叶固定边长度比为1∶3～3∶1，例如，第一子瓣叶固定边322a与第二子瓣叶固定边322b的长度比值可以是1∶3、1∶2、1∶1、2∶1、3∶1或者其他合适的比值。该拼接线34于本实施例中为直线，且该直线的一端与相邻两瓣叶固定边322a、322b相交，另一端沿直线垂直相交于裙边单元的下边缘。此时，拼接线34位于瓣叶固定边322’与裙边单元31’的下边缘33’之间的路径较短，使得缝合拼接线时所要缝合的针数也最少，进而降低缝合时所带来的风险，提高使用安全性。然而，本发明对拼接线34的形状不作特别的限制，也可以是弧形或其他不规则形状的结构。
图9中，所述瓣叶固定边322’为中心对称圆弧(即裙边单元31’的第一子瓣叶固定边322a与裙边单元31’的第二子瓣叶固定边322b’一致)，此时拼接线34与瓣叶固定边322’的交点，第一子瓣叶固定边322a与第二子瓣叶固定边322b’接头处相互重合，且位于瓣叶固定边322’(由第一子瓣叶固定边322a与第二子瓣叶固定边322b’组成)的二分之一处，故而此处也是瓣叶固定边322’上与裙边3的下边缘33’距离最近的位置。当两相邻裙边单元31’在此处缝合时，所形成的拼接线34最短，缝合孔最少。
综上所述，本发明的瓣膜假体，在裙边与瓣叶连接的上部处另设置了第一突出部，该第一突出部向支架的流出端方向延伸并与支架固定，如此，一方面增强了裙边与支架连接的强度，另一方面当瓣膜假体植入位置偏低时，通过第一突出部可增加防瓣周漏的高度，从而避免部分血流从支架泄漏，进 而提升防瓣周漏的效果。
特别地，所述第一突出部的另一端位于瓣叶高度的1/2～2/3处，这样在增加防瓣周漏高度的情况下，确保了瓣膜假体能够正常工作，而且减少了裙边的材料，并降低了血栓形成的风险。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (23)

  1. 一种瓣膜假体，其特征在于，包括支架、瓣叶和裙边，其中，
    所述支架包括流入端、流出端、以及多个轴向连接的波段，所述波段包括周向布置的多个网状结构单元；所述瓣叶和所述裙边分别固定于所述支架上；
    所述裙边的上部设有缺口，所述裙边通过所述缺口与所述瓣叶固定，所述裙边还包括向所述支架的流出端方向延伸的第一突出部，所述第一突出部的一端与所述缺口连接，另一端与所述支架固定。
  2. 如权利要求1所述的瓣膜假体，其特征在于，所述第一突出部的另一端位于所述瓣叶高度的1/2～2/3处。
  3. 如权利要求1所述的瓣膜假体，其特征在于，所述第一突出部的数量不超过其固定在支架所在波段上的网状结构单元的数量。
  4. 如权利要求3所述的瓣膜假体，其特征在于，所述第一突出部的数量为1～9个。
  5. 如权利要求3所述的瓣膜假体，其特征在于，所述裙边的上部设有多个所述缺口，每个所述缺口与一片所述瓣叶固定，一个所述缺口中的第一突出部的数量不超过3个。
  6. 如权利要求1所述的瓣膜假体，其特征在于，所述第一突出部为锯齿状、梯形状或正弦波状。
  7. 如权利要求1所述的瓣膜假体，其特征在于，所述裙边还包括第二突出部，所述第二突出部的一端与所述裙边的下部连接，另一端与所述支架的流入端固定。
  8. 如权利要求7所述的瓣膜假体，其特征在于，所述第二突出部为齿状、梯形状或正弦波状。
  9. 如权利要求7所述的瓣膜假体，其特征在于，所述第二突出部的数量 不超过所述支架的流入端处周向方向上网状结构单元的数量。
  10. 如权利要求9所述的瓣膜假体，其特征在于，所述第二突出部的数量为3～12个。
  11. 如权利要求1所述的瓣膜假体，其特征在于，所述裙边由至少一个裙边单元所组成，所述裙边单元具有上边缘和下边缘，所述缺口设置于所述裙边单元的所述上边缘，所述缺口的边界包括瓣叶固定边。
  12. 如权利要求11所述的瓣膜假体，其特征在于，所述瓣叶固定边的形状包括向所述下边缘方向凸起的内凹曲线结构。
  13. 如权利要求1所述的瓣膜假体，其特征在于，所述裙边还包括布置于所述支架外部的翻缝结构。
  14. 如权利要求13所述的瓣膜假体，其特征在于，所述裙边由至少一个裙边单元所组成，所述裙边单元具有上边缘和下边缘，所述缺口设置于所述裙边单元的上边缘，所述缺口的边界包括瓣叶固定边，所述裙边单元包括本体和从所述本体向所述支架的流入端方向延伸形成的翻缝部，所述翻缝部形成所述翻缝结构，且所述裙边单元的下边缘形成所述翻缝部的边缘。
  15. 如权利要求14所述的瓣膜假体，其特征在于，所述裙边还包括第二突出部，所述第二突出部的一端与所述翻缝部的边缘连接，另一端在支架外部与支架固定。
  16. 如权利要求15所述的瓣膜假体，其特征在于，所述第二突出部的另一端与自所述支架的流入端起第一排波段中的网状结构单元相固定。
  17. 如权利要求14所述的瓣膜假体，其特征在于，所述裙边单元的所述本体的长度是所述翻缝部的长度的1.5～2倍。
  18. 如权利要求14所述的瓣膜假体，其特征在于，所述裙边单元的侧边相互连接形成一拼接线，所述翻缝部的拼接线包含一向支架外侧延伸的直线或向支架外侧凸起的曲线。
  19. 如权利要求11所述的瓣膜假体，其特征在于，所述缺口包括两个子 缺口，所述两个子缺口分别位于相邻裙边单元相邻的一侧的上边缘或一裙边单元的左右侧的上边缘。
  20. 如权利要求19所述的瓣膜假体，其特征在于，所述子缺口的边界包括子瓣叶固定边，所述子瓣叶固定边包括向所述裙边单元的下边缘方向凸起的内凹曲线结构。
  21. 如权利要求19所述的瓣膜假体，其特征在于，相邻接的子瓣叶固定边于邻接处的曲率半径相等。
  22. 如权利要求19所述的瓣膜假体，其特征在于，相邻接的子瓣叶固定边的长度比为1：3～3：1。
  23. 如权利要求19所述的瓣膜假体，其特征在于，所述第一突出部位于子缺口，所述第一突出部为锯齿状、梯形状、正弦波状、直角三角形或直角梯形。
PCT/CN2017/103902 2016-12-28 2017-09-28 瓣膜假体 Ceased WO2018120949A1 (zh)

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KR1020197021589A KR102426953B1 (ko) 2016-12-28 2017-09-28 인공 판막
ES17888410T ES2979140T3 (es) 2016-12-28 2017-09-28 Prótesis de válvula
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EP3563804A1 (en) 2019-11-06
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