WO2021002766A1 - Cadre de valve cardiaque extensible par ballonnet et son procédé de fabrication - Google Patents

Cadre de valve cardiaque extensible par ballonnet et son procédé de fabrication Download PDF

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Publication number
WO2021002766A1
WO2021002766A1 PCT/PL2020/000057 PL2020000057W WO2021002766A1 WO 2021002766 A1 WO2021002766 A1 WO 2021002766A1 PL 2020000057 W PL2020000057 W PL 2020000057W WO 2021002766 A1 WO2021002766 A1 WO 2021002766A1
Authority
WO
WIPO (PCT)
Prior art keywords
frame
sheet
locks
sheets
receiving means
Prior art date
Application number
PCT/PL2020/000057
Other languages
English (en)
Inventor
Emil Plowiecki
Leszek Hurkala
Beata Gwiazdowska-Nowotka
Original Assignee
Balton Sp. Z O.O.
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 Balton Sp. Z O.O. filed Critical Balton Sp. Z O.O.
Priority to EP20743895.3A priority Critical patent/EP3993735A1/fr
Priority to CN202080044027.4A priority patent/CN114007547A/zh
Publication of WO2021002766A1 publication Critical patent/WO2021002766A1/fr

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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
    • A61F2/2415—Manufacturing methods
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • 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
    • 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
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0058—X-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
    • A61F2230/006—Y-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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2250/0015—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 density or specific weight
    • A61F2250/0017—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 density or specific weight differing in yarn density
    • 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
    • A61F2250/0026—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 surface 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
    • 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
    • A61F2250/0036—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 thickness
    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the object of the invention is a balloon-expandable heart valve frame and a method for manufacturing the balloon-expandable heart valve frame serving as a support element for mounting a valve, the whole assembly being used to replace a native heart valve.
  • the invention relates to a method for manufacturing the valve frame, i.e. a skeleton (stent) for mounting valve cusps, the entire frame assembly with valve cusps (prosthesis) being dedicated to minimally invasive procedures performed, e.g. endovascularly by means of catheter endovascular systems introduced into the patient's body percutaneously.
  • a skeleton stent
  • valve cusps prosthesis
  • Such methods include methods based on self-expandable constructions of a frame, in which the frame is made of materials with shape memory, as well as the second group of methods - based on balloon- expandable frames, in which a frame initially clamped on a balloon takes on its expected expanded shape by filling balloon.
  • a self-expandable valve frame can provide minimal responses, i.e. contract and expand, during heartbeats, which can affect valve cusps embedded inside the frame, whose functions can be disrupted, and the whole assembly can disadvantageously affect the surrounding tissue due to micro- movements.
  • a disadvantage of valves using self-expandable frames also involves their lower radial force. The frame of a valve must guarantee its proper pressing against the surrounding tissue and maintaining a correct position during the operation of the valve in the longer term.
  • the radial force of the valve frame must be higher than, for example, in typical endovascular stents.
  • Balloon-expandable frames enable obtaining q higher radial force.
  • the placement of markers in various areas on the valve frame allows better control of the position of the valve during implantation.
  • Balloon- expandable valves are shorter than self-expandable ones, due to which there is a lower risk of closing and hindering the access to coronary vessels.
  • valve frames Both types of valve frames have a folded position with a smaller diameter for delivery in the endovascular system and an unfolded position with a larger diameter, when they are embedded, implanted in their target location. Therefore, apart from the requirements signalled above, the valve frame must have the ability to attain a small diameter in the folded position, i.e. clamped on the balloon in the case of a balloon-expandable frame.
  • Heart valve frames made of metal or metal alloys, usually balloon- expandable, are known for example from publications US5411552A, US5855601A, EP1057460A1 , EP 1330213A and WO2006127756A2.
  • EP0975280A1 there is a known stent cut out of a metal sheet, which is wound into a cylindrical form, the elongated edges of an element cut out of the sheet being connected such that they overlap each other, due to which the construction of the stent is strengthened along this segment.
  • the edges of the sheet overlapping each other can be connected by gluing or welding, as well as by riveting in several points, as shown in figs. 2 and 2A.
  • the surfaces of the stent can have various patterns cut out, e.g. linear segments connected by transverse struts. Such design causes thickening of the stent in an area connecting the edges of the sheet.
  • the frame is delivered to the patient’s body in a rolled form, which allows considerable reduction of its diameter during delivery to the target 5 location.
  • the object of the invention is a balloon-expandable heart valve frame made of a sheet of metal or metal alloys, having a strut-based, multirow construction with a part with smaller cells and a part with larger cells,
  • the frame is made of a sheet of material made of metal or metal alloys with a fixed, anisotropic crystalline structure, imposed by the direction of fibres created during plastic processing, in such a manner that the side of the sheet which forms an annular periphery of the frame is placed at an angle of from 0° to 85° relative to said structure.
  • the fixed connectors formed of locks and lock-receiving means are offset relative to each other, the following one relative to the preceding one, in the same direction on the periphery relative to the frame axis, preferably, they are positioned on the periphery of the frame along a skewed line relative to the frame axis or along a curve or in a spiral manner against the frame axis.
  • the frame is provided with elements mounting the commissures of the valve, preferably three such elements, which are placed at even distances from each other on the periphery of the frame.
  • These elements are provided with protrusions opposite in pairs, preferably between 2 and 20 such protrusions, which are tilted relative to the axis of the element mounting the commissures at an angle falling within a range of from 5 to 60°.
  • Some of the protrusions are tilted towards one frame edge and some of the protrusions are tilted towards the opposite, second frame edgte.
  • the protrusions are provided with bulges on their ends.
  • the width (a) of arms, which enclose larger cells of the frame on its edge is at least 10% larger than that of the arms in the inner part of the frame, with smaller cells
  • the width (e) of the arms, which enclose the smaller cells of the frame on its edge opposite to the smaller cells is at least 10% larger than that of the arms in the inner part of the frame, with smaller cells.
  • the object of the invention is also a method for manufacturing a balloon-expandable heart valve frame, characterised by comprising the steps of:
  • step b1) or b2) rolling the sheet produced in step b1) or b2) into a cyjindrical shape and fixedly connecting the edge of the sheet provided with locks to the opposite edge provided with lock-receiving means, the connection of edges being effected along the lines of their abutment,
  • step c) in a case when in step c) the frame is produced from a sheet only with the cut-out locks and lock-receiving means, produced in step b1 , the entire valve frame pattern is also cut out,
  • step b1) when the frame is made of more than one sheet, optionally two, three or four sheets, single-layered or multi-layered, then the consecutive sheets are connected next to each other, such that they form consecutive parts on the periphery of the frame, and a connector based on the locks and the lock-receiving means is formed between all parts in accordance with step b1), which is followed by step c), or in accordance with step b2), which is followed by steps c) and d).
  • the method uses sheets of material made of metal or metal alloys with a fixed, anisotropic crystalline structure, imposed by the direction of fibres created during plastic processing, in such a manner that the .side of the sheet which forms the annular periphery of the frame is placed at an angle of from 0° to 85° relative to said structure imposed by the flow direction of the metal or metal alloys.
  • the locks and their corresponding lock-receiving means are cut out in the consecutive rows of strut members along a skewed or spiral line or along a curve, in relation to the axis of symmetry of the ultimately manufactured frame, such that the connectors which are formed of the locks and the lock-receiving means are arranged on the surface of the frame in a skewed or spiral line or along a curve.
  • a step or steps of heat and/or plastic processing is additionally used.
  • fig. 1 presents a general layout of a method for manufacturing a valve frame from a sheet of metal or a metal alloy in two versions, the final product being an annular valve frame
  • fig. 2 shows a magnified fragment of the valve frame with multirow locks and their corresponding lock-receiving means, in a disconnected position
  • fig. 3 presents a fragment of the valve frame of fig. 2 with the locks in a position connected to the lock-receiving means
  • fig. 4 shows a magnified fragment of the frame with indicated widths of the individual struts or elements of the valve frame pattern
  • fig. 5 presents a fragment of the frame and several magnified types of locks in the valve frame
  • fig. 1 presents a general layout of a method for manufacturing a valve frame from a sheet of metal or a metal alloy in two versions, the final product being an annular valve frame
  • fig. 2 shows a magnified fragment of the valve frame with multirow locks and their corresponding lock-receiving means, in a disconnected
  • FIG. 6 shows an example of a final valve frame with connectors formed by the locks and with elements for mounting the commissure of the valve, with an“S” area marked;
  • fig. 7 shows a magnified“S” area of fig. 6, as a fragment of the frame with a sample distribution of markers in the form of black dots;
  • fig. 8 shows several magnified examples of elements for mounting the commissures of the valve;
  • fig. 9 presents one magnified example of an element for mounting the commissure of the valye.
  • Figures 2, 3, 4, 5, 7, 8, 9 show only a segment of the frame, what has been signalled by wavy lines on the sides of images.
  • the entire frame according to the invention, at least partially annular, is presented in fig. 1 and in fig. 6.
  • a material in the form of specially prepared sheets of metal or metal alloys which sheets, by subjecting the material to special processing, exhibit anisotropy of the crystalline structure of the base rfiaterial, obtained by proper orientation of the crystalline structure during the preparation of a blank.
  • Said effect of an arranged, linear crystalline structure of metal (a metal alloy) occurring in the entire sheet of which the frame is made follows the direction of fibres generated when subjecting it to plastic processing.
  • Such anisotropic arrangement of the structure in a sheet of metal or a metal alloy in which fibres are arranged linearly can be achieved by any known methods of plastic processing, such as, e.g. cold rolling, with or without additional heat processing.
  • the method according to the invention uses rectangular or square sheets with dimensions which are fixed for the dimensions ⁇ of the target stent frame, or it is also possible to use sheets with a surplus on sheet margins, so that their specified dimensions (length and width) are not applied until cutting out the frame or cutting out the locks or cutting out the strut- based construction.
  • sheet 1A in which the longer side of the blank follows the direction of fibres created during plastic processing
  • sheet 1 B in which the longer side of the blank is transverse to the direction of fibres created during plastic processing
  • sheet 1C in which the longer side of the blank is at an angle of 5° to 85° relative to the direction of fibres created during plastic processing.
  • a type 1A or 1 C sheet is used, which means the use of sheets in which the side of the sheet which forms an annular periphery of the frame follows the direction of fibres created during plastic processing, or it is at an angle of from 5° to 85° relative to the direction of fibres created during, plastic processing.
  • the side of the sheet which forms an annular periphery of the frame is at an angle of from 0°to 85° relative to the direction of fibres created during plastic processing; preferably falls within a range between 0° and 60° or between 0° and 45°; or it is preferably close to 0° or falls within a range between 0° and 30°, preferably 0° and 20° or 0° and 10°; or it is close to 45° and falls within a range between 35° and 55°.
  • Such orientation of the crystalline structure in the sheet allows using the anisotropy of the structure of the material in order to modify the mechanical properties of the valve frame, and in particular increase its radial force.
  • sheet 1A in which, after cutting out the profile (pattern) of the valve frame, the linear arrangement of the crystalline structure in accordance with the direction of fibres created during its processing extends in a direction transverse (at an angle of 90°) in relation to the axis of symmetry of the valve frame, because of the radial force of the final product.
  • sheet 1 C in which the linear arrangement of the crystalline structure of the metal (metal alloy) is skewed in relation to the axis of the final valve frame, cut from a tube, i.e. at an angle in the range of between 5° and 85° relative to this axis, because of the physical features of the resulting frame, i.e. increased radial force.
  • the crystalline structure of type 1 B sheets is the most similar to the structure of typical frames cut from a prepared metal tube.
  • the crystalline arrangement of this type is less preferable in terms of radial force. Hpwever, due to the presence of heavy crumpling of material, resulting from the rolling process, the mechanical properties of such an oriented structure will differ from the mechanical properties of a material generated by typical methods used to manufacture metal tubes.
  • a sheet in the form of a laminate resulting from superimposing and combining two, three or four sheets, each sheet of which has an anisotropic crystalline structure, different from the others e.g. by using two sheets with a crosswise arrangement of the flow direction of the material.
  • a multi-layered sheet (preferably two-layered sheet) constructed in such a manner will allow taking advantage of the anisotropy of mechanical properties of the individual layers of material to improve the mechanical properties of the final product: the valve frame.
  • each of its layers is arranged linearly relative to its crystalline structure, and preferably in these combined layers it is either directed perpendicular to the frame axis or at an angle falling within a range of between 5° and 85° relative to this axis.
  • the multi-layered sheet is a two-layered sheet and the layers are arranged crosswise, meaning that each one of the layers has an arranged, linear skewed crystalline structure relative to the frame axis, but the linear structure of one layer relative to the other layer differs by 90° or 45°, or the crossing of structures falls within a range of between 10 and 80°.
  • the method according to the invention can proceed in the first version (the left side of fig. 1 ), such that locks and technical means receiving these locks are cut out on the opposite edges from a sheet, i.e. from the blank 1 A or 1 B or 1 C or from a multi-layered sheet produced from at least two such sheets (step 1 D), followed by rolling the blank and fixedly connecting the edges with locks to the opposite edges comprising the lock-receiving means (step 1 F), resulting in an annulus or an at least partially annular form, and subsequently a latticed frame pattern constituting the final product - a valve frame - is cut out in the following step (1 H).
  • the whole outline of the valve frame is cut out from the sheet, meaning its latticed construction along with the locks and the lock-receiving means placed on the opposite edge in relation to these locks.
  • the cut-out outline of the frame is wound, the locks are fastened, and subsequently they are fixedly connected, which results in obtaining the final product - the valve frame with target pattern.
  • the first or second method it is possible to proceed with the first or second method with such a modification that more than one sheet of material is used, e.g. two or three or four sheets of material, in such a manner that the consecutive sheets constitute the consecutive parts of the frame annulus periphery, and a connector based on the combined (joined) locks and lock-receiving means is formed between them.
  • more than one sheet of material e.g. two or three or four sheets of material
  • edges with locks are connected to the opposite edges, meaning those with the lock-receiving means, retaining one plane of the product, i.e. elements with opposite edges are connected in a position moved face to face, with no mutual overlapping of the elements of sheets in any area. In this manner, a single layer of the material - the sheet - is retained in the sheet connection area.
  • the generated connector is either substantially the same as the remaining part of the frame, or it is only slightly different from the thickness of other areas of the frame construction.
  • the cutting of locks in the consecutive rows of frame struts proceeds at an angle relative to the axis of symmetry of the final frame.
  • the frame has a multirow construction, i.e. it consists of rows of struts surrounding rows of cells (eyelets), and each row of struts has its assigned lock and its corresponding lock-receiving means. Therefore, the locks also have a multirow form and they have the form of protruding studs, shaped in a manner adjusted to the shape of the means receiving these studs.
  • the locks engage the lock-receiving means, i.e. the locks and the lock-receiving means are mutually adjusted in shape in order to cause an effect of hooking, catching the individual rows of frame struts.
  • a connector formed from the locks and the lock-receiving means bonds each row of struts.
  • said connectors are consecutively offset relative to each other on the periphery of the frame, so that the connector from the first row of struts (on the first frame edge) is the most distant from the connector from the last row of struts (on the second frame edge).
  • Such mutual offset of the consecutive neighbouring connectors can extend such that the neighbouring connectors form a skewed line relative to the frame axis, or they extend along a curve or along a spiral line on the outer surface of the frame.
  • An example of implementation of the method according to the invention used sheets produced in a cold rolling process made of cobalt and chromium alloys, 0.4-J0.5 mm thick, the frame having been made in two versions presented in fig. 1 , in which the cutting steps proceeded using the laser method, and the connection of locks and lock-receiving means proceeded using the technique of welding or soldering.
  • the frame was made from one sheet with a two-layered construction, with a cross-wise arrangement of the crystalline structure of layers. '
  • the valve frame according to the invention is made of, i.e. it comprises in its construction a sheet or sheets connected in a cylindrical shape, out of which the frame pattern is cut out, so that it has a latticed (meshed) construction consisting of two areas: an area with smaller cells 5 located at one end of the frame 2 and an area with larger cells 6 located at the opposite end of the frame 2, the construction of the frame consisting of several rows of struts, which in the inner area with smaller cells 5 of the frame 2 form nodes X-, so that four arms (couplings) Y extend from each of them, and the cells of this area have the shape of a regular polygon.
  • the rows of smaller cells 5 in the neighbouring rows are offset relative to each other by half of a cell, relative to the frame axis, so that the nodes X, in every second row of these nodes, are situated in one line along the frame (one above the other).
  • the area with smaller cells ends with the tops V, which in pairs form the arms Y extending from the nodes X in a row neighbouring the edge row of the cells 5.
  • the area with larger cells 6 neighbours the area with smaller cells and it is formed such that mutually parallel brackets Z extend from the tops U of the arms Y in a row surrounding the smaller cells in the last row (ending the area of small cells), passing on the frame edge through the couplings W into arms ending the frame with tops analogical to the tops V on the opposite end of the frame 2.
  • the larger cells 6 of the frame 2 have the shape of a regular polygon, whose two lower edges and two upper edges are formed of arms Y neighbouring each other in pairs, and two longer opposite sides parallel to the frame axis are formed of brackets Z.
  • the brackets Z in the frame are arranged substantially parallel to each other.
  • the length of the larger cells 6 is at least 10% larger than the length of the smaller cells 5, said dimensions being assessed in the expanded position of the frame, relative to the axis of symmetry of the frame.
  • the individual elements of the strut-based construction of the frame with the pattern presented in a fragment in fig. 2 can have a varying width, as shown in more detail in fig. 4, where the widths of the arms Y and the brackets Z have been indicated in the individual rows of struts of tffe valve frame.
  • the width d of the arms Y equals the width c of the arms Y in the neighbouring row of arms (in the opposite arms surrounding the smaller cell of the meshed structure); the width of the arms b in the outermost row surrounding the larger cells at the side of the smaller cells can be larger by approx.
  • the width f of the bracket Z located in the area of larger cells, can be larger by 5% to 30% of the width c, or it equals 1 to 1.2 times the width of the strut c, and the width a and e of the arms Y from the outermost rows, located on the opposite edges ending the frame, is larger by 10% to 150% of the width c, or it equals 1.2 to 2 times the width c.
  • Such distribution of the width of individual elements of the frame pattern has provided the attainment of proper frame geometry during expansion of the frame with a valve on a balloon; it has provided the attainment of proper radial force and rigidity in the upper part of the frame necessary to maintain the commissures of the mounted valve.
  • the frame based on the above design can also have another form, i.e. another number of rows, struts, another size thereof; it can also have another meshed shape, e.g. the arms of the individual struts can be undulated, sinusoidal, elongated, connected by additional couplings in a lengthwise and/or transverse direction in relation to the frame axis.
  • the designs of valve frames known from prior art dedicated to implantation in the procedure of expansion on a balloon, as well as, in an auxiliary manner, the designs of stents can be applied to manufacturing of the frame using the method according to the invention.
  • the cut-out construction of the frame in an assembled state, clamped on a balloon should provide a minimal size of the prosthesis, i.e. the cut-out elements of frame patterns in a folded position abut each other, so that the contracted structure would form a cylindrical shape with a minimal diameter, and during expansion it would easily unfold and expand in a transverse direction caused by the filling of the balloon.
  • the frame is cut out of a sheet or sheets of material which, after combining, forms the shape of an annulus; however, during expansion of the frame on a balloon, it is possible to attain a modified shape of the frame, which can be cuplike at one side or have an extended form at both ends, etc.
  • the frame 2 is provided with locks 3 and, at the side abutting these locks, with receiving means 4 for these locks.
  • Fig. 2 presents an example of a frame pattern fragment with the locks 3 in a disconnected position, and fig. 3 in a connected position, due to which a fixed connector 7 is subsequently formed.
  • the locks 3 are shaped in the form of studs protruding beyond the outline of the frame, provided with concave and convex elements on the side, which is to be hooked to analogical elements of means 4 receiving the locks 3.
  • the number of the used assemblies of locks 3 and lock-receiving means 4 corresponds to the number of rows of struts forming the outline of the frame.
  • Fig. 5 presents several examples of locks 3A, 3B, 3C, 3D, 3E which are used in a multirow arrangement in the frame.
  • the simplest form of the used lock can be the form of a single hook 3D or 3E, seated on the lock stud, to which corresponds the reversed reflection of this hook in the form of the lock-receiving means.
  • Such a design of the connectors is supposed to provide mutual hooking of these elements.
  • the locks can also have the form of a more complex polygonal chain 3A, teeth, e.g. triple teeth 3C, or a double hook, as well as the form of convex rounded forms 3B.
  • the frame according to the invention also comprises mounting elements 8 intended to mount the commissures - the areas where the cusps forming the valve meet, the elements 8 being placed in the frame in such a manner that they replace certain brackets Z, together with the four arms Y forming the larger cells of the frame.
  • the whole construction should be stable and symmetrical due to the symmetry of the acting forces.
  • the remaining 6, 9, 12 or 15 brackets Z are distributed symmetrically among the three elements mounting the commissures.
  • the use of a branched element for mounting the commissures is preferable in that it is easy to put sutures in the step of mounting the valve/the valve material. Due to the presence of first protrusions 18 for attaching suture threads and second protrusions 19 arranged symmetrically at the opposite side of the element 8 for attaching suture threads, it is easier to mount - sew the valve in.
  • the element for mounting commissures comprises at least two protrusions 18, 19 arranged opposite each other. For mounting the valve, it is also possible to use openings 20, with which the element 8 for mounting the commissures is provided.
  • the tilt of the protrusions 18, 19 relative to the axis of the mounting element 8 can fall within a range of between 5° and 80°, preferably between 5° and 60°.
  • the solution preferably reduces the diameter of the frame with the valve clamped on the balloon and protects the material of the cusps in the place of the formation of commissures against possible damage when introducing the frame into the area of implantation.
  • the element 8 comprises straight skewed protrusions 18, 19 and openings 20 which are also used to mount threads/sutures, or constitute an area for markers.
  • the element for mounting the commissures additionally comprises lower protrusions directed opposite to the remaining protrusions, towards the second frame edge, to additionally protect the sutures against slipping.
  • the protrusions 18, 19 are provided with widened ends or with bulges on their ends, providing protection against the slipping of threads/sutures.
  • Version 8E presents another variant of the element for mounting commissures, lacking the central openings.
  • Fig. 7 presents the possible areas of placing radiographic markers in the valve frame. From a clinical point of view, such markers can define key locations for the elements of the frame and the valve, e.g. a marker 9 of the element 8 indicates location for the mounting of the commissures, markers 10, 17 of the tops V indicate two outermost ends of the valve frame.
  • the markers 11 of the brackets Z indicate space for placing the valve and distinguish the position of the brackets Z from elements for mounting the commissures (where two markers are placed).
  • the markers 12 of the nodes X along with the markers 13, 14, 15, 16 of the arms Y allow assessing the position of the whole area with the smaller frame cells.
  • the markers can take on a circular, oval or polygonal shape. Depending on the place of their positioning on the frame, they can differ in size.
  • the markers can be placed on each row of struts or every 2, 3, 4 or 6 struts.

Landscapes

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

Abstract

L'invention concerne un cadre de valve cardiaque extensible par ballonnet constitué d'une feuille de métal ou d'alliages métalliques, dont la construction à rangées multiples est basée sur des entretoises, avec une partie comportant des cellules plus petites et une partie comportant des cellules plus grandes, caractérisé en ce que le cadre (2) est constitué d'au moins une feuille de matériau en métal ou en alliages métalliques de structure cristalline anisotrope directionnelle fixe imposée par la direction des fibres créées pendant le traitement du plastique auquel la ou les feuilles ont été soumises, la ou les feuilles comportant éventuellement deux ou trois couches, et chaque couche présentant une structure cristalline anisotrope directionnelle fixe, et la construction du cadre étant prévue, dans une zone de raccord de la ou des feuilles, avec des mèches plates (3) et des moyens opposés de réception de mèches (4) lesquels forment ensemble des connecteurs fixes disposés en rangées multiples, de telle sorte qu'un connecteur soit associé à une rangée d'éléments d'entretoise dans la structure de cadre. L'invention a aussi pour objet un procédé de fabrication du cadre de la valve cardiaque décrit.
PCT/PL2020/000057 2019-07-01 2020-06-18 Cadre de valve cardiaque extensible par ballonnet et son procédé de fabrication WO2021002766A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP20743895.3A EP3993735A1 (fr) 2019-07-01 2020-06-18 Cadre de valve cardiaque extensible par ballonnet et son procédé de fabrication
CN202080044027.4A CN114007547A (zh) 2019-07-01 2020-06-18 球囊可膨胀心脏瓣膜框架以及用于制造球囊可膨胀心脏瓣膜框架的方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PL430463A PL243171B1 (pl) 2019-07-01 2019-07-01 Rozprężalna na balonie, ażurowa rama zastawki serca i sposób wytwarzania rozprężalnej na balonie, ażurowej ramy zastawki serca
PLP.430463 2019-07-01

Publications (1)

Publication Number Publication Date
WO2021002766A1 true WO2021002766A1 (fr) 2021-01-07

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EP (1) EP3993735A1 (fr)
CN (1) CN114007547A (fr)
PL (1) PL243171B1 (fr)
WO (1) WO2021002766A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411552A (en) 1990-05-18 1995-05-02 Andersen; Henning R. Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US5855601A (en) 1996-06-21 1999-01-05 The Trustees Of Columbia University In The City Of New York Artificial heart valve and method and device for implanting the same
EP0975280A1 (fr) 1998-01-26 2000-02-02 Medtronic Ave, Inc. Extenseurs endoluminaux et leur fabrication
EP1057460A1 (fr) 1999-06-01 2000-12-06 Numed, Inc. Dispositif de soupape de remplacement et procédé d'implantation d'une telle soupape
WO2002076348A1 (fr) 2001-03-23 2002-10-03 Edwards Lifesciences Corporation Valvules cardiaques enroulées à effet invasif minimum
US20030055495A1 (en) 2001-03-23 2003-03-20 Pease Matthew L. Rolled minimally-invasive heart valves and methods of manufacture
EP1330213A1 (fr) 2000-10-31 2003-07-30 Jacques Seguin Support tubulaire de mise en place, par voie percutanee, d'une valve cardiaque de remplacement
WO2006127756A2 (fr) 2005-05-24 2006-11-30 Edwards Lifesciences Corporation Prothese de valvule cardiaque a deploiement rapide
US20080262628A1 (en) * 2004-01-12 2008-10-23 Angiomed Gmbh & Co. Medizintechnik Kg Mri Compatible Implant Comprising Electrically Conductively Closed Loops

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9687346B2 (en) * 2013-03-14 2017-06-27 Edwards Lifesciences Corporation Multi-stranded heat set annuloplasty rings
US9549816B2 (en) * 2014-04-03 2017-01-24 Edwards Lifesciences Corporation Method for manufacturing high durability heart valve

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5411552A (en) 1990-05-18 1995-05-02 Andersen; Henning R. Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US5855601A (en) 1996-06-21 1999-01-05 The Trustees Of Columbia University In The City Of New York Artificial heart valve and method and device for implanting the same
EP0975280A1 (fr) 1998-01-26 2000-02-02 Medtronic Ave, Inc. Extenseurs endoluminaux et leur fabrication
EP1057460A1 (fr) 1999-06-01 2000-12-06 Numed, Inc. Dispositif de soupape de remplacement et procédé d'implantation d'une telle soupape
EP1330213A1 (fr) 2000-10-31 2003-07-30 Jacques Seguin Support tubulaire de mise en place, par voie percutanee, d'une valve cardiaque de remplacement
WO2002076348A1 (fr) 2001-03-23 2002-10-03 Edwards Lifesciences Corporation Valvules cardiaques enroulées à effet invasif minimum
US20030055495A1 (en) 2001-03-23 2003-03-20 Pease Matthew L. Rolled minimally-invasive heart valves and methods of manufacture
US20080262628A1 (en) * 2004-01-12 2008-10-23 Angiomed Gmbh & Co. Medizintechnik Kg Mri Compatible Implant Comprising Electrically Conductively Closed Loops
WO2006127756A2 (fr) 2005-05-24 2006-11-30 Edwards Lifesciences Corporation Prothese de valvule cardiaque a deploiement rapide

Also Published As

Publication number Publication date
EP3993735A1 (fr) 2022-05-11
PL243171B1 (pl) 2023-07-10
PL430463A1 (pl) 2021-01-11
CN114007547A (zh) 2022-02-01

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