WO2016055262A1 - Prothèse de remplacement de valvule aortique - Google Patents

Prothèse de remplacement de valvule aortique Download PDF

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Publication number
WO2016055262A1
WO2016055262A1 PCT/EP2015/071744 EP2015071744W WO2016055262A1 WO 2016055262 A1 WO2016055262 A1 WO 2016055262A1 EP 2015071744 W EP2015071744 W EP 2015071744W WO 2016055262 A1 WO2016055262 A1 WO 2016055262A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
tubular body
longitudinal
end portion
longitudinal end
Prior art date
Application number
PCT/EP2015/071744
Other languages
English (en)
Inventor
Stanislas Piot
Original Assignee
Xpand Medical SAS
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 Xpand Medical SAS filed Critical Xpand Medical SAS
Publication of WO2016055262A1 publication Critical patent/WO2016055262A1/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
    • A61F2/2418—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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-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
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • 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

Definitions

  • the present invention generally relates to an aortic valve replacement prosthesis, especially an aortic valve replacement prosthesis that is implatable via an approach through the aorta or through an transapical approach.
  • Heart valve diseases affect approximately 300000 people worldwide per year. Those diseases involve abnormal leaflet tissue (e.g. excess tissue growth, tissue
  • the invention may provide an aortic valve replacement prosthesis which is radially compressible and re-expandable so as to be implantable via a catheter device, comprising a tubular body which has a circumference, which extends along a longitudinal axis and which comprises a first longitudinal end portion which in an implanted state of the prosthesis faces an ascending aorta side of a native aortic valve, a second longitudinal end portion which in the implanted state of the prosthesis faces a ventricular side of the native valve, and an intermediate portion connecting the first and second end portions with each other, wherein the tubular body has an inner circumferential surface and an outer circumferential surface, which extend at least substantially concentrically to the longitudinal axis, wherein the inner circumferential surface defines an inner lumen of the tubular body, and wherein the first and second longitudinal end portions and the intermediate portion of the tubular body are made of a wire-type structure including a plurality of interconnected first wire elements, a plurality of radial protrusions
  • Each radial protrusion may be formed by a single/individual second wire element.
  • the valve may be e.g. an artificial valve (e.g. comprising or consisting of biological, composite or mechanical materials/properties).
  • an artificial valve e.g. comprising or consisting of biological, composite or mechanical materials/properties.
  • the second longitudinal end portion may be made of a wire-type structure including a plurality of first wire elements which are
  • the complete tubular body is made of a wire-type structure including a plurality of first wire elements which are interconnected such as to form a mesh-type structure.
  • at least in the implanted condition of the prosthesis at least that part of the intermediate portion that is adjacent to those end portions of the second wire elements which face the second longitudinal end portion of the tubular body has a higher radial strength than the first longitudinal end portion of the tubular body.
  • At least in the implanted condition of the prosthesis at least that part of the second longitudinal end portion of the tubular body that extends between the intermediate portion of the tubular body and a longitudinal extremity of the second longitudinal end portion has a higher radial strength than the first longitudinal end portion, and wherein, optionally, at least in the implanted condition of the prosthesis, the second longitudinal end portion, at its longitudinal extremity, has a radial strength lower than the remainder of the second longitudinal end portion.
  • the said higher radial strength may be an inherent (material) property of those parts described to have such a higher radial strength.
  • the said higher radial strength of the said parts may be achieved by dimensioning the implant at these parts in such a manner that, in the implanted condition of the prosthesis, these parts are subjected to/experience a larger permanent radial compression, wherein a corresponding increased radial counter force is provided by these parts which permanently/always tend to re-expand themselves to their original diameter/outer dimension as provide in the non-implanted fully expanded condition of the prosthesis.
  • an outer diameter of the first longitudinal end portion is larger than an outer diameter of the intermediate portion and larger than an outer diameter of the second longitudinal end portion, wherein optionally the intermediate portion has an outer diameter smaller than an outer diameter of the second longitudinal end portion, and wherein optionally the first longitudinal end portion has a bowl shape with a curved convex outer contour.
  • an outer diameter of that part of the intermediate portion, which is longitudinally between the respective opposite end portions of the second wire elements, is the smallest outer diameter of the tubular body.
  • an outer diameter of a perimeter around the radial protrusions fixedly connected to the tubular body is larger than an outer diameter of the second longitudinal end portion and is optionally smaller than an outer diameter of the first longitudinal end portion.
  • a first circumferential groove is defined between the first longitudinal end portion of the tubular body and the radial protrusion, which is open to a radial outside of the prosthesis.
  • a second circumferential groove is defined between the second longitudinal end portion of the tubular body and the radial protrusions, which is open to a radial outside of the prosthesis. While said circumferential groove is referred to as the "second" groove, it is independent from the first circumferential groove and may be provided even if there is no first circumferential groove (that is, the second circumferential groove may also be a first circumferential groove).
  • a perimeter extending through that end portions of the second wire elements, which face the first longitudinal end portion of the tubular body has a diameter larger than a perimeter extending through the end portions of the second wire elements, which face the second longitudinal end portion of the tubular body.
  • the dimensions and/or sizes as described for prostheses described in this application generally refer to the free-expanded condition of prosthesis (that is, expanded state outside any constricting surrounding). Accordingly, the dimensions and/or sites in an re-expanded implanted condition may be different because of constrictions provided by surrounding tissue.
  • Such a process may comprise forwarding the prosthesis in a radially compressed state to the native aortic valve, e.g.
  • the prosthesis in the connection channel relative to the native aortic valve, such that it extends at least partially through the native aortic valve (e.g. is located at least with a part (e.g. the second longitudinal end portion) thereof on an axial level of the native annulus or an area adjacent thereto), such that the longitudinal axis along which the tubular body extends and the longitudinal connection channel axis are at least substantially aligned, and such that the radial protrusions of the prosthesis are at least substantially located on the ascending aorta side on a longitudinal level of at least one native coronary ostium portion and/or adjacent thereto (e.g.
  • the prosthesis spaced in direction towards the aorta or the ventricular chamber), radially expanding the prosthesis to an expanded state, thereby dilating the at least one native ostium portion using at least one or several of the radial protrusions or using the radial protrusions.
  • the process may comprise, when the prosthesis is forwarded using a transfemoral approach, forwarding the prosthesis so that at least the radial protrusions are at least substantially fully located on the ventricular side of the annulus (e.g. on a longitudinal level of a sinotubular junction of a heart), moving the prosthesis, in its expanded state, in a direction towards the ascending aorta, whereby the radial protrusions are moved longitudinally over the annulus in a condition radially pressed thereagainst.
  • the radial protrusions are moved from an aortic side of the native annulus in a direction towards the ventricular side until the radial protrusions abut against an inwardly protruding circumferential native abutment, e.g. provided or being the native annulus.
  • the earlier-mentioned approach may be used for the case that the radial protrusions were, e.g. accidentally, moved beyond the said abutment, whereby the prosthesis can then be re-arranged by being moved backwards towards the aortic side with the protrusions being moved over the abutment (e.g. native valve annulus) in a condition radially pressed thereagainst.
  • the process may comprise, when longitudinally positioning the prosthesis, positioning the prosthesis such that the radial protrusions are located on a
  • Figure 1 shows a schematic view of an aortic valve of a human heart.
  • Figure 2 shows a side view of an embodiment of an aortic valve replacement prosthesis according to the present invention in an expanded state.
  • Figures 3a and 3b show perspective views of an embodiment of an aortic valve replacement prosthesis according to the present invention.
  • Figure 4a shows a top view of an embodiment of an aortic valve replacement prosthesis according to the present invention.
  • Figures 4b and 4c show schematic side views of embodiments of an aortic valve replacement prosthesis according to the present invention.
  • Figure 5 shows a detail view of a radial protrusion of an aortic valve replacement prosthesis according to the present invention.
  • Figures 6a and 6b each show a schematic side view of a tubular body with a single second wire element supported thereon.
  • Figure 6c shows a schematic bottom view of the tubular body with the single second wire element shown in Figs. 6a and 6b.
  • Figure 6d shows a schematic side view and a virtual coordinate system for explaining an outer contour of second wire elements of an aortic valve replacement prosthesis according to the present invention.
  • Figures 6e to 6I show further views of aortic valve replacement prostheses according to embodiments of the present invention.
  • Figure 7 shows a schematic side view of an embodiment of an aortic valve replacement prosthesis according to the present invention.
  • Figure 8 shows a schematic view of an embodiment of an aortic valve replacement prosthesis according to the present invention in a radially compressed state and a catheter device used to implant the prosthesis.
  • Figure 9 shows a schematic view of an embodiment of an aortic valve replacement prosthesis according to the present invention in an implanted condition.
  • an aortic valve 1 has native leaflets 5 and a native circumferential annulus 10 to which said native leaflets 5 are connected.
  • the annulus 10 separates an ascending aorta side 15 and a ventricular side 20 of the native valve 1 .
  • the aorta 16 is located on the ascending aorta side 15, and the left ventricular chamber 21 is located on the ventricular side 20.
  • the aortic valve 1 is provided in a connection channel 25 that connects the left ventricular chamber 21 and the
  • connection channel 25 has a circumferential connection channel wall structure 35 made from native heart tissue.
  • coronaries with the aorta 16 in order to provide blood flow for the heart muscle are located on the ascending aorta side 15 in respective native ostium portions 45. That is, each of the several coronary ostia 40 is located in its native ostium portion 45.
  • the coronary ostium portions 45 have a distance from the native annulus 10 along the longitudinal connection channel axis 30 and are located in an area generally referred to as aortic sinus which has an sinotubular junction. (Those coronary ostia are located in proximity of an area generally referred to as sinotubular junction. Variation on implantation side do however exist.
  • an aortic valve replacement prosthesis 50 may be provided for functional replacement of a native aortic valve 1 of a human or animal heart. That is, a prosthesis 50 may serve as an artificial valve that allows blood to generally flow in only one direction through the connection channel 25 (here, from the left ventricular chamber 21 to the aorta 16) and may prevent blood leakage in the direction from the aorta 6 to the ventricular chamber 21 .
  • the prosthesis 50 comprises a tubular body 55.
  • the tubular body may extend along a (virtual) longitudinal axis 60 and may comprise a first longitudinal end portion 65 and a second longitudinal end portion 70.
  • the first and second longitudinal end portions 65, 70 may be located on, with respect to longitudinal axis 60, opposite ends of the tubular body 55.
  • the first longitudinal end portion 65 face the ascending aorta side 1 5 (e.g. the sinotubular junction) and the second longitudinal end portion 65 may face the ventricular side 20.
  • the prosthesis 50 may be configured such that, when it is in the implanted state, the first longitudinal end portion 65 of the tubular body 55 is located on the aorta side 15 (e.g.
  • the second longitudinal end portion 70 is located on the ventricular side 20 of the native annulus 10, e.g. within the connection channel 25 but not or not fully extending into the ventricular chamber 21 , that is, the second longitudinal end portion 70 is located, e.g., within the LVOT (Left Ventricular Outflow Tract).
  • the tubular body 55 further comprises an intermediate portion 75.
  • the intermediate portion 75 may be provided longitudinally between the first and second end portions 65, 70 and may connect the first and second end portions 65, 70.
  • a circumference of the tubular body 55 may be defined in a, with respect to the longitudinal axis 60, circumferential direction 61 . Further, herein a direction referred to as "radial” may be at least substantially or exactly perpendicular to the longitudinal axis 60.
  • the tubular body 55 may have a longitudinal length L1 that is defined along the longitudinal axis 60 between the first and second longitudinal end portions 65, 70, that is, e.g. between the longitudinal ends (of the first and second longitudinal end portions 65, 70, respectively,) of the tubular body 55.
  • the longitudinal length L1 may define the maximum longitudinal extension of the prosthesis 50.
  • the tubular body 55 or parts thereof, e.g. the first longitudinal end portion 65, the intermediate portion 75 and/or the second longitudinal end portion 70 thereof, may be made of a wire-type structure.
  • the wire-type structure may comprise or consist of one or more first wire element(s) 80.
  • the first wire element(s) 80 may comprise or consist of wires made of plastic (e.g. PP, PS, PET, Nylon, Teflon or the like), metal (e.g. Nitinol, steel, nickel, nickel alloys, or other alloys), combinations thereof and/or other materials
  • Said first wire elements 80 may be interconnected, e.g. by welding, soldering, gluing, or the like or by wire rings.
  • the wire-type structure may also comprise first wire elements 80 that are formed to be monolithically interconnected.
  • the first wire elements 80 may for example have a diameter between 0.1 and 3 mm, e.g. 0.2 to 0.5 mm, 0.5 to 0.7 mm, although also other diameters are envisaged. All first wire elements 80 may have the same diameter or first wire elements 80 which have different diameters may be used to form the first longitudinal end portion 65, the intermediate portion 75 and/or the second longitudinal end portion 70 ,
  • the wire-type structure may comprise a mesh-type structure. That is, the first wire elements 80 may be interconnected in junction portions 81 (one is exemplarily referenced in Figure 2) such as to form a mesh structure having (e.g. consisting of) a plurality of net or mesh elements 82.
  • Each mesh element 82 may generally have the shape of a parallelogram as shown e.g. in Figure 2, or may have a square-shape or rectangular shape or circular shape or other shape.
  • the mesh elements 82 may all have the same general shape or may have different shapes. Further, the mesh elements 82 may all have substantially the same size or may have different sizes. For example (as is shown e.g. in Figs.
  • some or all of the mesh elements 82 may have a shape comprising two V- shapes that are interconnected at the free ends thereof, wherein one V-shape (e.g. the one that faces the first longitudinal end portion 65) consists of two V-legs 82a, and wherein the other V-shape (e.g.
  • a blunt V-shape that consists of two V-legs 82a that are interconnected with a V-bottom 82b and said V-bottom 82b, which may face (and/or form at least a part of) the respective longitudinal end portion 65, 70 such as to form a blunt longitudinal end of the tubular body 55 as is shown e.g. in Figs. 3a and 3b.
  • only the second longitudinal end portion 70 (and, for example, as shown in Fig. 6d, also additionally a part of the intermediate portion 75 that is adjacent to the second longitudinal end portion 70 of the tubular body 55 and is located such as to face the ventricular side 20 in the implanted state) may be made of a mesh-type structure having mesh elements 82, while the rest of the tubular body 55 may be made from first wire elements 80 that do not form a mesh-type structure.
  • the intermediate portion 75 of the tubular body 55 may comprise first wire elements 80 which are not directly or indirectly connected with each other (i.e. are separate from each other) axially (with respect to longitudinal axis 60) between the first and second longitudinal end portions 65, 70 or portions adjacent thereto.
  • first wire element 80 there may be a single first wire element 80 extending around the circumference of the tubular body 55 at the first longitudinal end portion 65, and several second wire elements 80 which may extend parallel to the longitudinal axis 60 and perpendicular to said single first wire element 80 towards the second longitudinal end portion 70, which is made of second wire elements 80 which form a mesh-type structure having mesh elements 82.
  • first longitudinal end portion 65 may be made of a mesh-type structure having mesh elements 82 so that generally only the intermediate portion 75 or a part thereof of the tubular body 55 is made of first wire elements 80 which do not form a mesh-type structure having mesh elements 82.
  • first longitudinal end portion 65, the intermediate portion 75 and the second longitudinal end portion 70 are all made of a mesh-type structure formed by first wire elements 80 that are
  • junction portions 81 interconnected in junction portions 81 to form mesh elements 82.
  • the tubular body 55 may have an inner circumferential surface 85 and an outer circumferential surface 90.
  • the inner circumferential surface 85 may define an inner lumen (e.g. inner hollow space) 95 of the tubular body 55.
  • the inner lumen 95 may be accessible via the first and second longitudinal end portions 65, 70 which may be provided with
  • the tubular body 55 may be provided with a fluid tight sealing liner (also referred to as skirt) (not shown) that may be provided on at least a part of or the complete inner and/or outer circumferential surface 85, 90 in order to prevent blood from flowing into or out of the inner lumen 95 via the inner or the outer, respectively, circumferential surface 85, 95 and/or to seal the prosthesis 50 against paravalvular leakage, if for example the complete inner and/or the outer circumferential surface 85, 90 is provided with the sealing liner, blood may only flow into or out of the inner lumen 95 via the first and second longitudinal end portions 65, 70.
  • the said liner may be passive or active in nature.
  • a radial sealing may or may not only occur once this liner comes in contact with components of the blood, or may only be leak tight after interacting actively of passively with components of blood.
  • an inner liner made of a material which swells (i.e. increases its volume) when in contact with blood may be provided that swells from its position on the inner side of the tubular body 55 through the tubular body 55 (e.g. the mesh elements 82 thereof) to the outside of the tubular body 55 in order to seal the prosthesis 50 against paravalvular leakage.
  • the tubular body 55 may define an outer diameter D1 at the first longitudinal end portion 65 thereof and may define an outer diameter D2 at the second longitudinal end portion 70 thereof.
  • the tubular body 55 may further define an outer diameter D3 at the intermediate portion 75.
  • the outer diameters D , D2 and D3 may be defined perpendicular to the longitudinal axis 60 and may for example respectively be measured along a straight line from the outer circumferential surface 90 over the longitudinal axis 60 to the outer circumferential surface 90.
  • the diameter D3 may be defined generally halfway (with respect to the longitudinal axis 60) between the first and second longitudinal end portions 65, 70 or an area adjacent thereto and facing the second longitudinal end portion 70 as shown in Figure 2.
  • Diameter D3 may be the smallest outer diameter of the tubular body 55.
  • the position of diameter D3 may alternatively or additionally be defined on the basis of other features of the prostheses, which will be described further below.
  • the tubular body 55 may, at least when the prosthesis 50 is expanded, define a generally cylindrical outer shape. That is, the outer diameter (and/or an inner diameter) of the tubular body 55 may be generally or exactly constant from the first longitudinal end portion 65 to the second longitudinal end portion 70.
  • D1 , D2 and D3 may all have the same value as e.g. is schematically shown in Fig. 6d.
  • outer diameter D1 may be larger than outer diameter D2 and/or may be larger than outer diameter D3.
  • outer diameter D2 may be larger than outer diameter D3.
  • outer diameter D1 may have a value in a range of 25 to 50mm, e.g. 35-50 mm
  • D2 may have a value in a range of/between 18 and 35 mm, e.g. 30-35 mm
  • D3 may have a value in a range of 16 and 35 mm, e.g. 25-35 mm.
  • the first longitudinal end portion 65 may have a crown or bowl shape as shown e.g. in Figure 2.
  • the bowl shape may have a curved convex contour.
  • an outer diameter of the tubular body 55 may be largest at the first longitudinal end portion 65 and may continuously decrease along the longitudinal axis 60 until it reaches a minimum value in the intermediate portion 75, for example longitudinally between the opposite end portions 110a, 1 10b of a second wire element 100
  • Said outer diameter may increase from this minimum value in a direction further along the longitudinal axis 60, so that a waist portion 1 15 which is open to the radial outside of the tubular body 55 is formed.
  • Said waist portion 115 may define the smallest outer diameter of the tubular body 55.
  • Said outer diameter may remain substantially constant or may increase slightly further along the longitudinal axis 60 towards the second longitudinal end portion 70, such that a cylinder shape or a slightly conical shape, respectively, as shown e.g. in Figure 2, of a part of the tubular body 55 is achieved.
  • the maximum diameter of said bowl-shape may be located adjacent to the first longitudinal end portion 65, e.g. in a distance of 2 to 20 mm, e.g. 2 to 12 mm from the first longitudinal end portion 65 towards the second longitudinal end portion 70
  • the prosthesis 50 may further comprise a plurality of radial protrusions 100, e.g. 3, 4, 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15 or more radial protrusions 100.
  • the radial protrusions 100 may be provided on the outer
  • the radial protrusions 100 may be circumferential!y spaced from each other, at least when the prosthesis 50 is expanded. All protrusions 100 may have the same circumferential distance from each other, i.e. may be equidistantly spaced around the circumference of the tubular body 55, or may have different circumferential distances from each other.
  • the radial protrusions 100 may be fixedly connected to the tubular body 55, or may be connectable to the tubular body 55. That is, the radial protrusions 100 may be provided separate from the tubular body 55 and may be attached to the tubular body 55, i.e. when implanting the prosthesis 50 to a native aortic valve 1 .
  • the radial protrusions 100 may be formed by second wire elements 110 and/or may consist of (respective single/individual) second wire elements 1 10.
  • the second wire elements 1 10 may be made of a material chosen from the materials that were mentioned above with respect to the first wire elements 80 and may e.g. be made of a metal wire and/or from plastic wire or other wires.
  • the second and first wire elements 80, 1 10 may all be made of the same or of different materials and may have the same or different diameters.
  • the second and/or first wire elements 80, 1 0 may have a constant diameter.
  • the second and/or first wire elements 80, 1 10 may have a circular longitudinal cross section or a different cross section, e.g. an elliptical cross section.
  • Each second wire element 1 10 may have a generally longitudinal shape and may have two opposite (longitudinal) end portions 110a, 1 10b.
  • the second wire elements 1 10 may be provided integrally with the tubular body 55, e.g. with the first interconnected wire elements 80 thereof.
  • the second wire elements 1 10 may be glued, soldered, welded or otherwise connected to the first wire elements 80.
  • the first and second wire elements 80, 1 10 may be interlooped (connected using a loop/knot of first and/or second wire elements).
  • the second wire elements 1 10 may be connected with the tubular body 55 via the two respective longitudinal end portions 1 10a, 1 10b thereof, so that e.g. both end portions of a respective second wire element 1 10 are supported on the tubular body 55.
  • each radial protrusion 100 may be formed by a single/individual second wire element 1 10.
  • Said single second wire elements 1 10, e.g. the end portions 110a, 110b thereof, may be connected to the first wire elements 80 that may form the tubular body 55.
  • Each end portion 1 10a, 1 10b of a second wire element 110 may be connected to a junction portion 81 of first wire elements 80, i.e. to a portion where first wire elements 80 are interconnected to each other.
  • the radial protrusions 100 may also be integrally formed/connected with the tubular body 55, that is, e.g., with the first wire elements 80 of the tubular body 55, for example, in a monolithic manner.
  • the diameter D3 may be defined at a longitudinal level (with reference to the longitudinal axis of the tubular body 55) of and/or in the vicinity of (and/or adjacent) to the radial protrusions 100, that is, e.g. the second wire elements 1 10.
  • a straight virtual axis 11 1 may be defined between the opposite end portions 1 10a, 1 10b of a second wire element 1 10 when it is supported on the tubular body 55.
  • the radial protrusions 100 may protrude radially and outwardly from the outer circumferential surface 90 of the tubular body 55 and may thereby increase an outer diameter of the prosthesis 50.
  • the radial protrusions 00 may form an open cage- structure that allows fluid to flow into and out of a space defined radially between the outer circumferential surface 90 of the tubular body 55 and the outer contour 1 0c of the second wire elements 110.
  • the distance L2 between the two opposite end portions 1 10a, 1 0b of a second wire element 1 10, when they are connected to tubular body 55 or supported thereon, along the longitudinal axis 60 may correspond to the longitudinal length L1 of the tubular body 55.
  • said distance L2 between the two opposite end portions 1 10a, 1 10b of a second wire element 1 10 along the longitudinal axis 60 may be shorter than the longitudinal length L1 of the tubular body 55.
  • the distance L2 may be maximally 1 /3 or 1/4 or 1 /5 or 1/6 or 1/7 or 1/8 or 1 /9 or 1/10 or less of the longitudinal length L1 of the tubular body 55.
  • All of the second wire elements 1 10 that form the radial protrusions 100 may have an at least substantially smooth outer contour 1 10c.
  • the outer contour 1 10c may be, with respect to longitudinal axis 60, the radially outer face/outer surface of a second wire element 1 10 when it is supported on the tubular body 55.
  • substantially smooth may mean that the outer contour 110c of each second wire element 110, when it is supported on the tubular body 55, lacks any sharp edges, kinks, hooks, barbs, barbed hooks, flukes and the like, at least with respect to the longitudinal direction.
  • the outer contour 1 10c may additionally or alternatively be, with respect to a direction along the longitudinal axis 60 -but not necessarily in a circumferential direction 61 -, free of radial undercuts, and, accordingly may not form any hooks or hook-type loops with respect to the longitudinal direction. This may mean that, according to embodiments, along an arbitrary radius (rectilinear virtual line/axis) that is perpendicular to longitudinal axis 60, there may be not more than one point in which said radius intersects with a single second wire element 1 10 (e.g. with a longitudinal axis thereof) .
  • Figs. 6a and 6b each show a side view of a tubular body 55 which is provided with one single exemplary second wire element 1 10 which is supported with the two opposite end portions 1 10a, 1 10b thereof on the outer circumferential surface 90.
  • the tubular body 55 with the second wire element 1 10 supported thereon is rotated 90 degrees around the longitudinal axis 60 from the position shown in Fig. 6a.
  • Figure 6c shows the same configuration which is shown in Figs. 6a and 6b but shows a bottom view, i.e. a view along the longitudinal axis 60 towards the second longitudinal end portion 70.
  • the second wire element 1 10 may deviate in the circumferential direction 61 from the straight virtual axis 1 1 1 so as to provide an undercut with respect to the circumferential direction 61 , while, as is apparent from Fig. 6b, it has a smooth outer contour 10c which is free of radial undercuts with respect to the longitudinal axis 60. It is further apparent from Figs. 6a to 6c, that according to embodiments of the invention, any radius which is perpendicular to longitudinal axis 60, intersects any second wire element 1 10 not more than once. It is noted that the protrusions 100 shown or described in the other embodiments may also have a structure as described in connection with the protrusions shown in Figs. 6a - 6c.
  • Figure 6d shows a schematic side view of prosthesis 50 having a single exemplary second wire element 110 together with a virtual coordinate system X, Y for further explaining an outer contour 1 10c of the second wire elements 1 10.
  • a smooth outer contour may mean that the outer contour 1 10c of each second wire element 1 10, when it is supported on the tubular body 55, lacks sharp edges, kinks, hooks, barbs and the like.
  • the outer contour 1 10c may be described by a mathematical function that has derivatives of all orders.
  • Said mathematical function may also define only one singie function value X (representing a point of the outer contour 110c) for each point Y on the straight virtual axis 1 1 1 , at least when a trace of the outer contour 1 10c is projected on a two-dimensional plane which comprises the straight virtual axis 1 11 and is generally radial with respect to tubular body 55.
  • the outer contour 1 10c may be smooth and may be free of radial undercuts, at least with respect to longitudinal direction of tubular body 55.
  • Figure 6e shows a schematic perspective view of a second wire element 110 according to an embodiment.
  • the second wire elements 100 may meander back and forth (e.g. defining a sinus curve or the like) in the circumferential direction 61 while they are smooth and free of radial undercuts with respect to the longitudinal direction.
  • virtual line A which may be substantially parallel to longitudinal axis 60
  • the second wire elements 1 10 may have tangential/circumferential undercuts 122 with respect to the longitudinal direction of tubular body 55.
  • the second wire elements 1 10 may not have any radial undercuts with respect to the longitudinal direction (direction of longitudinal axis 60) as is visualized by virtual line B (which may be radial with respect to longitudinal axis 60) which may intersect only once with the (each) second wire element 1 10 (e.g. outer contour 110c thereof).
  • undercuts e.g. undercuts 122 shown in Fig. 6e
  • undercuts may increase a contact area of the second wire elements 1 10 with native tissue which may prevent/reduce trauma, reduce maximum strain/force on the native tissue and/or may prevent a puncture/rupture of the native tissue.
  • Figures 6f and 6g show schematic partial front and a top views, respectively, of a prosthesis 50 according to a further embodiment.
  • the second wire elements 1 10 may have substantially a (semi) circular
  • the second wire elements 1 10 do not necessarily have to be pivoted in the circumferential direction but may also be arranged radially when seen along the longitudinal axis 60 (that is, when seen from the first 65 to the second 70 longitudinal end portion or vice versa).
  • Figure 6h shows a schematic side view of a second wire element 1 10 according to a further embodiment.
  • the second wire elements 1 10 may have a substantially triangular configuration with respect to the longitudinal direction.
  • Said triangular configuration may have a blunt radially outer edge in order to provide a smooth outer contour 1 10c.
  • Said wire elements 1 10 may or may not have
  • undercuts with respect to the circumferential direction 61 are smooth and free of radial undercuts with respect to the longitudinal direction.
  • Figure 6i shows a schematic front view of a second wire element 1 10 according to a further embodiment, similar to the one shown in Fig. 6h.
  • second wire elements 1 which generally define a kind of volcano-shape with a convexly rounded peak, may have concavely curved legs (as shown in Fig. 6i) or may have substantially rectilinear/straight legs, as long as said legs define a substantially smooth radial outer contour 1 10c that is, at least with respect to the longitudinal direction, free of radial undercuts.
  • Figure 6j shows a schematic top view of an exemplary second wire element 1 10.
  • the opposite end portions 1 10a and 1 10b of a second wire element 1 10 may be offset from each other in the circumferential direction 61 so that straight virtual axis 11 1 (not shown in Fig. 6j for better clarity) and longitudinal axis 60 define skew lines as is further elaborated below.
  • Figure 6k shows a schematic side view of an exemplary second wire element 1 0 according to an embodiment.
  • the second wire element 1 10 shown in Fig. 6k is similar to the one shown in Fig. 5.
  • a curvature of a second wire element 1 10 according to the invention may be achieved by
  • interconnected substantially rectilinear portions that define an angle with each other so that a (macroscopic) curvature is defined by the interconnected rectilinear portions.
  • Figure 61 shows a schematic view of a prosthesis 50 having one second wire element 1 10.
  • the tubular body 55 may according to the present invention have a generally cylindrical configuration.
  • the second wire elements 1 10 may also be free of any circumferential undercuts and therefore extend in such a way that a projection or trace of the second wire elements 1 10 on the outer circumferential surface 90 does not deviate in the circumferential direction 62 from the straight virtual axis 1 1 1 .
  • the opposite end portions 1 10a, 1 10b may define the maximum longitudinal extensions of each second wire element 1 10c when it is supported on the tubular body 55. That is, no point of a second wire element 1 10 may be closer to the first or second longitudinal end portion 65, 70 than the opposite end portions 1 10a and 110b, respectively.
  • the second wire elements 1 10 may be configured such that said straight virtual axis 1 1 1 is parallel to the longitudinal axis 60, as e.g. shown in Figs. 6a to 6d, or intersects the longitudinal axis 60, as shown e.g. in Figs. 2, 3a, 3b, 4a and 5.
  • Said straight virtual axis 1 1 1 and the longitudinal axis 60 may also be skew lines, i.e. they may neither be parallel to each other nor ever intersect (even when assuming an infinite length), as is shown e.g. in Fig. 7 or Fig. 6] and further elaborated below.
  • the end portions 1 10a of the second wire elements 1 10 which face the first longitudinal end portion 65 of tubular body 55 may define a larger or smaller diameter D5 than the end portions 1 10b which face the second longitudinal end portion 70.
  • a diameter D5 of a perimeter that is defined by all those opposite end portions 1 10a which face the first longitudinal end portion 65 may be larger than a diameter D6 of a perimeter that is defined by all those end portions 110b which face the second longitudinal end portion 70.
  • FIG. 11 1 is parallel to the longitudinal axis 60 of the tubular body 55.
  • Figure 7 which shows a schematic view of a prosthesis 50
  • said straight virtual axis 1 1 and the longitudinal axis 60 are neither parallel nor ever intersect, but define skew lines.
  • An outer diameter D4 (radial with respect to longitudinal axis 60) of a perimeter around the radial protrusions 100 when they are fixedly connected to the tubular body 55 may be defined.
  • Said diameter D4 may be defined as the largest diameter of a perimeter around the radial protrusions 100.
  • diameter D4 may define the maximum radial extension of the outer contour 110c of a second wire element 1 10 from the longitudinal axis 60.
  • Diameter D4 may be larger than diameter D2. Additionally or alternatively, diameter D4 may be smaller than diameter D1 .
  • diameter D4 may be larger than diameter D3.
  • the second wire elements 110 may (at least in a portion thereof, e.g. a portion adjacent to diameter D4) have a first diameter in a radial direction of the tubular body 55 and a second diameter in the circumferential direction 61 , wherein the second diameter may be larger than the first diameter and may have e.g. a value of two-times or more, three-times or more, four-time or more, five-times or more or ten-times or more of the first diameter, and wherein optionally the first and second diameters have generally the same value in an of the opposite end portions 110a, 10b and/or an area adjacent thereto.
  • a first outer circumferential groove 130 which is open to a radial outer side of the prosthesis 50 may be defined between the first longitudinal end portion 65 and the radial protrusions 100 (e.g. an axial level of diameter D4 thereof). That is, said first outer circumferential groove 130 may be formed by the outer circumferential surface 90 (at least a part thereof that is adjacent to the opposite end portions 1 10a and faces the first longitudinal end portion 65) of the tubular body 55 together with the outer contour 110c of the second wire elements 1 10.
  • a second outer circumferential groove 135 which is open to a radial outer side of the prosthesis 50 may be defined between the second longitudinal end portion 70 and the radial protrusions 100 (e.g. an axial level of diameter D4 thereof). That is, said second outer circumferential groove 135 may be formed by the outer circumferential surface 90 (at least a part thereof that is adjacent to the opposite end portions 1 10b and faces the second d longitudinal end portion 70) of the tubular body 55 together with the outer contour 10c (or at least a part thereof) of the second wire elements 110.
  • the second outer circumferential groove 135 which is open to a radial outer side of the prosthesis 50 may be defined between the second longitudinal end portion 70 and the radial protrusions 100 (e.g. an axial level of diameter D4 thereof). That is, said second outer circumferential groove 135 may be formed by the outer circumferential surface 90 (at least a part thereof that is adjacent to the opposite end portions 1 10b and faces the second d longitudinal end portion 70
  • the circumferential groove 135 may be formed by the radial protrusions 100 (e.g. at least that part thereof, which is located between the axial level of maximum diameter (D4) and the opposite end portions 1 10b (which face the second longitudinal end portion 70) and at least that part of the tubular body 55 which is located between said opposite end portions 1 10b and the second longitudinal end portion 70 (that may have a slightly increasing outer diameter along the longitudinal axis 60 towards the second longitudinal end portion 70 such that a conical part of the tubular body 55 is achieved as is described above).
  • the second outer circumferential groove 135 may be configured to engage with native tissue.
  • the tubular body 55 may comprise at least one first wire element 80, or a plurality (e.g.
  • first wire elements 80 which extends/extend axially (with respect to longitudinal axis 60) between the respective opposite end portions 10a, 1 10b of the second wire elements 1 10 and radially (with respect to longitudinal axis 60) inwards of the second wire elements 110, wherein said first wire element(s) 80 may form a mesh-type structure having mesh elements 82 or may not form a mesh-type structure (c.f. Fig. 6d). That is, according to the invention there may be at least one first wire element 80 radially inwards of the second wire elements 1 10 that extends axially at least between the opposite end portions 1 10a, 110b of the second wire elements 1 10.
  • the waist portion 1 15 may be provided on an axial level of tubular body 55 between the opposite end portions 1 10a, 1 10b of the second wire elements 1 10 when they are supported on the tubular body 55.
  • an artificial valve 120 may be provided in the inner lumen 95 so as to restrict blood flow in order to provide the function of a native aortic valve 1 .
  • the artificial valve 120 may for example comprise three artificial leaflets 121 that are fixedly attached to the inner lumen 95 of the tubular body 55.
  • the artificial valve 120 may be configured to restrict blood flow to a direction from the ventricular chamber 21 towards the aorta 16 when the prosthesis 50 is implanted.
  • each artificial leaflet 121 may be connected to the inner lumen 95 (i.e an inner side) of tubular body 55 (only) in an fixation area which is longitudinally defined between two axial leaflet levels 121 a and 121 b that are spaced from each other along the longitudinal axis 60, wherein axial leaflet level 121 a faces the first longitudinal end portion 65 and axial leaflet level 121 b faces the second longitudinal end portion 70.
  • Axial leaflet level 121 a may be located on an axial level of the waist portion 115 or an area adjacent thereto.
  • axial leaflet level 121 a may be located spaced, e.g. slightly spaced, from the waist portion 1 15 in a direction towards the first longitudinal end portion 65 as shown e.g. in Figs. 4b and 4c.
  • artificial leaflet outflow support portions 121 c may be provided which are connected to a respective mesh element 82 to fixate the artificial leaflets 121 on to the tubular body 55.
  • the axial leaflet level 121 b may be located adjacent to the second longitudinal end portion 70 as is shown in Figure 4b, for example at an axial level of those junction portions 81 which are longitudinally closest to the second longitudinal end portion 70.
  • the prosthesis 50 may for example comprise an outer liner.
  • an inflow portion of the artificial leaflet 121 i.e. a portion of the leaflet 121 which faces the second longitudinal end portion 70 may be connected e.g. to a single mesh element 121 .
  • Figures 4b and 4c show exemplarily the connection of the artificial leaflet 121 with an inner liner, wherein the line referenced with 121 represents the portion, on which the artificial leaflet 121 is connected to the inner liner. It is noted that the configuration shown in Fig. 4b and 4c may also be achieved when using an outer liner. In this case, the artificial leaflet(s) 121 may be connected through the tubular body 55 (e.g. the mesh elements 82 thereof) with the outer liner.
  • Axial leaflet level 121b may also be located at an axial level of opposite end portions 1 10b or an area longitudinally adjacent thereto, e.g. spaced from an axial level of the opposite end portions 1 10b in a direction towards the second longitudinal end portion 70.
  • an inflow portion of the artificial leaflet 121 may be connected to e.g. two mesh elements 82 (e.g. two junction portions 81 ) .
  • the prosthesis 50 may for example comprise and inner and/or an outer liner as described above.
  • Axial leaflet levels 121 a and 121 b may also be located at other positions, e.g.
  • the prosthesis 50 may be radially (with respect to longitudinal axis 60) compressible and re-expandable.
  • the prosthesis 50 may for example be expanded using an elastic force that is generated when the prosthesis 50 is compressed and which is released when an external constraint is removed.
  • the prosthesis 50 may for example be radially compressed in an inner lumen 210 of a catheter device 200 and may self-expand by an elastic force and/or by a balloon and/or by other means, when the prosthesis is forwarded from the inner lumen 210 of the catheter device 200 (for example when the external constraint, here the catheter device 200, is removed which may allow the elastic force to expand the prosthesis 50).
  • the elastic force that may re-expand the prosthesis 50 may be provided by the first wire elements 80 of the tubular body 55 which may be radially compressed when the prosthesis 50 is radially compressed.
  • a radial force that opposes the radial compression of the first wire elements 80 i.e. the elastic force that expands the prosthesis 50
  • the elastic force that expands the prosthesis 50 may be
  • the radial force, or in other words, the radial strength, of the tubular body 55 may be highest in an area that is adjacent to the opposite end portions 1 10b which face the second longitudinal end portion 70 (for example adjacent to the end portions 1 10b and located between the end portions 1 10b and the second longitudinal end portion 70).
  • the radial strength of the tubular body 55 may be lowest in an area of the first and second longitudinal end portions 65, 70.
  • a high radial strength of the tubular body 55 in an area adjacent to the opposite end portions 1 10b may facilitate fixating the prosthesis 50 in the connection channel 25 (c.f. Fig. 1 ), as the prosthesis 50 is configured to be slightly radially compressed in an area adjacent to the opposite end portions 10b by the connection channel 25 when the prosthesis 50 is implanted.
  • a higher radial strength in this area may result in a higher radial force and therefore higher friction between the connection channel 25 and the prosthesis 50. Higher friction may result in a better fixation of the prosthesis 50 and may allow to fixate the prosthesis 50 in the implanted state permanently without any further/additional fixation means.
  • said area adjacent to the opposite end portions 1 10b and between the end portions 110b and the second longitudinal end portion 70 may provide 50% or more, e.g. 60% or more, 70% or more or 80% or more, of the total force which holds the prosthesis 50 permanently in place when the prosthesis 50 is implanted.
  • the axial level of said area of the prosthesis 50 which may, according to embodiments, provide at least a part of or the full radial force that holds the prosthesis 50 in place as described is schematically marked by double arrow F1 .
  • the prosthesis 50 may be held in its intended place by a form fit between the outer contour of the prosthesis 50 and anatomic features of the heart.
  • a radial strength of the radial protrusions 100 may be the same as the one of the tubular body 55 or it may be higher or lower. According to embodiments, the radial protrusions 100 have a radial strength that is the lowest radial strength of the prosthesis 50. According to other embodiments, the radial protrusions 100 have a radial strength that is the highest radial strength of the prosthesis 50. For example, the radial strength of the radial protrusions 100 may have a value of 10% or less, 30% or less, 50% or less, or 80% or less compared to the radial strength the tubular body 55 at an axial level of the protrusions 100.
  • the radial protrusions 100 may also have a higher radial strength than the tubular body 55.
  • the radial strength of the radial protrusions 100 may have a value of 100% or more, 120% or more, 150% or more, or 200% or more compared to the radial strength of the tubular body 55 at an axial level of the protrusions 100.
  • a lower radial strength of the tubular body 55 in an area of the first and/or second longitudinal end portions 65, 70 may reduce trauma to tissue in contact with said portions when the prosthesis 50 is implanted and the heart is beating.
  • the second longitudinal end portion 70 (and/or an area adjacent thereto) may have a higher strength than the intermediate portion 75.
  • Such a configuration may ensure stability of the anchoring of the prosthesis 50 when implanted and may help to avoid distal migration of the prosthesis 50.
  • prosthesis is arranged at least partially within the connection channel 25 of the aortic valve 1 such that the longitudinal axis 60 of the tubular body 55 and the longitudinal connection channel axis 30 are aligned, e.g. such that the two axes 30, 60 are substantially parallel and/or coaxial.
  • the prosthesis 50 may be positioned such that the radial protrusions 100 are at least substantially, e.g. fully, located on the ascending aorta side 15, e.g. on a longitudinal level of at least one native coronary ostium portion 45 or adjacent thereto. That is, the radial protrusions 100 may be located such that at least one (e.g.
  • native ostium portion 45 is located axially between the opposite end portions 110a, 110b of the second wire elements 100 that form the radial protrusions 100 and/or such that at least one native ostium portion 45 is located axial!y spaced in a direction towards the aorta 16 or the ventricular chamber 21 from the opposite end portions 1 10b which face the first longitudinal end portion 65 of the tubular body 55.
  • the at least one native ostium portion 45 may be located 1 to 3 mm, 3 to 5 mm, 5 to 7 mm, 7 to 9 mm, 9 to 12 mm, 12 to 15 mm, and/or 15 to 20 mm from the opposite end portions 1 10a or from an axial level of outer diameter D4 (e.g. when D4 is defined as the maximum outer diameter of the radial protrusions 100).
  • the radial protrusions 100 may be located on an axial level of the sinotubular junction of a heart.
  • the prosthesis may be configured such that, when the prosthesis 50 is implanted, the native leaflets 5 (e.g. free ends thereof) are located at least partially, e.g. fully, axially between the level on which diameter D4 is defined and the second longitudinal end portion 70.
  • diameter D4 is defined as the maximum outer diameter of a perimeter of the radial protrusions 100
  • the free ends of the native leaflets 5 may be located between the native annulus 10 and the axial level of diameter D4 when the prosthesis 50 is implanted.
  • the prosthesis 50 may be configured such that the native leaflets 5 (e.g.
  • the free ends of the native leaflets 5 may be located at an axial level of the opposite end portions 1 10b of the second wire elements 1 10 or adjacent thereto in the second outer circumferential groove 135.
  • the native leaflets 5 and/or the native annulus 10 and/or tissue adjacent thereto may act as a provider of a counter force to the radial force of the prosthesis 50.
  • the prosthesis 50 e.g. when it is configured such that it is -in a fully expanded state in which no external force acts on the prosthesis 50- radially slightly larger than a diameter formed by said native leaflets 5 and/or the native annulus 10 and/or tissue adjacent thereto, be held in place by a radial force generated in an area of the second circumferential groove 135.
  • the native leaflets 5 and/or the native annulus 10 and/or tissue adjacent thereto may be caught (e.g. engaged) in the second circumferential groove 135 by a radial force generated by the prosthesis 50 which presses against the native leaflets 5 and/or the annulus and/or tissue adjacent thereto and the respective counter force provided by the leaflets/annulus/tissue.
  • Positioning the radial protrusions 100 relative to a native coronary ostium portion 45 as described above may stretch or dilate the native coronary ostium portion 45 by increasing a (native) diameter of the aorta 16 or sinotubular junction in an area of the radial protrusions 100.
  • the mentioned dilation of native tissue by the radial protrusions 100 is illustrated by a double arrow in Fig. 9.
  • Stretching or dilating the native coronary ostium portion 45 may prevent clogging of the native coronary ostium portion 45 and/or may enable better fluid flow between the aorta 16 and the native coronary ostium 40.
  • the radial protrusions 100 may provide for dilation adjacent and/or above the coronary ostium, thereby causing an inrease in surface area available for blood flow to the coronary ostia.
  • each second wire element 1 10 may be supported on two longitudinal end portions 1 0a » 1 10b thereof on the tubular body 55, a high stability and durability of the radial protrusions 100 may be achieved.
  • the smooth outer contour 1 10c of the second wire elements 1 10 may allow to forward and retract the prosthesis 50 smoothly from and into, respectively, the inner lumen 2 0 of a catheter device 200.
  • the smooth outer contour 1 10c which is, with respect to the longitudinal/axial direction, free of radial undercuts may slide smoothly along an edge surface 220 of the catheter device 200 allowing efficient retraction of the prosthesis 50 into the inner lumen 210 of the catheter device 200.
  • a native aortic valve 1 has native leaflets 5 and a native circumferential annulus 10 that separates an ascending aorta side 15 and a ventricular side 20, wherein the native aortic valve 1 is in a connection channel 25, which extends substantially along a longitudinal connection channel axis 30 and which has a circumferential connection channel wall structure 35, wherein native coronary ostia 40 are located in respective native ostium portions 45 on the ascending aorta side 15 spaced from the native annutus 10 in a direction of the longitudinal connection channel axis 30.
  • Implanting the prosthesis 50 may comprise forwarding the prosthesis 50 in a radially compressed state (c.f. Fig. 8) to the native aortic valve 1 .
  • a radially compressed state c.f. Fig. 8
  • any known approach may be used, e.g. a transfermoral approach through the aorta 16 or a transapical approach through the apex of the heart.
  • the prosthesis 50 may be forwarded using the catheter device 200 while the prosthesis 50 is radially compressed in/by the inner lumen 210 of the catheter device 200.
  • the prosthesis 50 may be positioned within the connection channel 25 (e.g. using the catheter device 200) such that the prosthesis 50 is at least partially surrounded by the circumferential connection channel structure 35.
  • the prosthesis 50 may be positioned such that the longitudinal axis 60 of the tubular body 55 thereof is aligned with the longitudinal connection channel axis 30.
  • the prosthesis 50 may be positioned so that the longitudinal axis 60 of the tubular body 55 is at least substantially parallel or coaxial to the longitudinal connection channel axis 30.
  • the prosthesis 50 may further be longitudinally positioned such that the radial protrusions 100 (and/or the opposite end portions 1 10a, 1 10b of a second wire element 100) of the prosthesis 50 are at least substantially located on the ascending aorta side 15 on a longitudinal level of at least one native coronary ostium portion 45 or adjacent thereto as described above.
  • the prosthesis 50 may be positioned such that the radial protrusions 100 are located on a longitudinal level (with respect to longitudinal connection channel axis 30) of the sinotubular junction of a heart.
  • Implanting the prosthesis 50 may further comprise radially (re-)expanding the prosthesis 50 to its expanded state. Radially expanding the prosthesis 50 may be achieved by using an elastic force of the prosthesis 50 as described above.
  • the catheter device 200 may be retraced while the prosthesis 50 is forwarded from the inner lumen 210 of the catheter device. Accordingly, the prosthesis 50 may be pushed out from the inner lumen 210 and expand by the elastic force as described above. According to the invention, expansion may also be driven by an external expansion device such as an inflatable balloon or the like.
  • At least one or more or all radial protrusion 100 may be in contact with at least one native coronary ostium portion 45 or tissue on substantially the same axial level and may dilate or stretch said native coronary ostium portion 45.
  • said dilation or stretching may result in a widened opening (ostium) of the native coronary 40.
  • Said widened opening may allow better blood flow between the aorta and the native coronary.
  • implanting the prosthesis 50 may further comprise forwarding the prosthesis 50 in an radially compressed state or in an expanded state from an initial position on the aorta side 15 in the aorta 16 (or in the sinotubular junction) in such a way via the native annulus 10, that at least the radial protrusions 100 (or the second wire elements 1 10) of the prosthesis 50 are substantially fully, e.g. fully, located on the ventricular side 20 of the native annulus 10.
  • Implanting the prosthesis 50 may further comprise moving the prosthesis 50 (in its expanded state) in a direction towards the aorta 16, whereby the radial protrusions 100 are moved longitudinally over the native valve annulus 19 in a condition radially pressed thereagainst.
  • the radial protrusions 100 are formed by second wire elements 1 10 that have a smooth outer contour 1 10c and, with respect to the longitudinal/axial direction, are free of radial undercuts, hooks, barbs, kinks and the like, the prosthesis 50 -in its (e.g. fully) expanded state- (e.g.
  • the radial protrusions 100 thereof may be moved from the ventricular side 20 to the aorta side 15 via the native annulus 10, as the radial protrusions 100 cannot get entangled with native tissue (that smoothly slides along the outer contour 110c) and as the radial protrusions 100 do not cause tissue trauma.
  • the prosthesis 50 and a method for implanting such a prosthesis may for example enable replacement of a native aortic valve 1 via a transfemoral approach, as a failure, such as positioning the prosthesis 50 too far on the ventricular side 20, may be corrected by retracting the prosthesis 50 over the annulus 10 back to the aorta side 15 without causing dangerous tissue entanglement or trauma.
  • 100/second wire elements 1 10 may be combined with any configuration of the tubular body 55. It is further noted that according to embodiments it is not necessary that all radial protrusions 100/second wire elements 110 have the same configuration, but a prosthesis 50 may have differently configured radial protrusions 100/second wire elements 1 10.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic 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

L'invention concerne une prothèse de remplacement de valvule aortique (50) qui est radialement compressible et re-extensible de manière à être implantable par l'intermédiaire d'un dispositif de cathéter (200), ladite prothèse pouvant comprendre un corps tubulaire (55) qui a une certaine circonférence, qui s'étend le long d'un axe longitudinal (60) et qui comprend une première partie terminale longitudinale (65) qui, dans un état implanté de la prothèse, fait face au côté de l'aorte ascendante (15) de la valvule aortique native (1), une seconde partie terminale longitudinale (70) qui, dans l'état implanté de la prothèse, fait face au côté ventriculaire (20) de la valvule native (1), et une partie intermédiaire (75) reliant la première et la seconde partie terminale (65, 70), le corps tubulaire (55) ayant une surface circonférentielle interne (85) et une surface circonférentielle externe (90) qui s'étendent de manière au moins sensiblement concentrique à l'axe longitudinal (60), la surface circonférentielle interne (85) définissant une lumière interne (95) du corps tubulaire (55), et la première et la seconde partie terminale longitudinale (65, 70) et la partie intermédiaire (75) du corps tubulaire (55) étant constituées d'une structure de type fil comprenant plusieurs plusieurs éléments fils interconnectés.
PCT/EP2015/071744 2014-10-06 2015-09-22 Prothèse de remplacement de valvule aortique WO2016055262A1 (fr)

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DE102014114464.3 2014-10-06
DE102014114464.3A DE102014114464A1 (de) 2014-10-06 2014-10-06 Aortenventilersatz-Prothese

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Cited By (2)

* Cited by examiner, † Cited by third party
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CN111110402A (zh) * 2020-01-09 2020-05-08 南京圣德医疗科技有限公司 一种结构贴合的经导管主动脉瓣膜植入装置
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