WO2020016842A1 - Prothèse valvulaire cardiaque, en particulier appropriée pour une implantation par voie transcathéter - Google Patents

Prothèse valvulaire cardiaque, en particulier appropriée pour une implantation par voie transcathéter Download PDF

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Publication number
WO2020016842A1
WO2020016842A1 PCT/IB2019/056188 IB2019056188W WO2020016842A1 WO 2020016842 A1 WO2020016842 A1 WO 2020016842A1 IB 2019056188 W IB2019056188 W IB 2019056188W WO 2020016842 A1 WO2020016842 A1 WO 2020016842A1
Authority
WO
WIPO (PCT)
Prior art keywords
armature
valve
radially
flaps
armature according
Prior art date
Application number
PCT/IB2019/056188
Other languages
English (en)
Other versions
WO2020016842A8 (fr
Inventor
Franco Vallana
Maria Curcio
Matteo Antoniotti
Original Assignee
Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.S.
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 Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.S. filed Critical Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.S.
Priority to EP19759745.3A priority Critical patent/EP3823559A1/fr
Publication of WO2020016842A1 publication Critical patent/WO2020016842A1/fr
Publication of WO2020016842A8 publication Critical patent/WO2020016842A8/fr

Links

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

Definitions

  • Heart valve prosthesis particularly suitable for transcatheter implantation
  • the present invention is generally in the field of heart valve prostheses; in particular, the invention refers to a heart valve prosthesis, particularly suitable for transcatheter implantation.
  • Armatures for prosthetic heart valves are known, which comprise a tubular or annular portion suitable to accommodate the valve, and a structure (cup-shaped, mushroom- shaped, globe-shaped, etc.), which is insertable into one of the cavities of a patient’s heart and helps to hold the tubular portion in place.
  • An example of an armature for a prosthetic valve of this type is known from the document EP 2 982 336 Al , wherein the drum or annular element which houses the prosthetic valve is insertable into the annulus , so as to prevent the closure of the flaps of the native valve.
  • the flaps of the native valve may compress the annular element, with the risk that the resulting crushing will induce a deformation of the same annular element, such as to affect the operation of the prosthetic valve contained therein (which may, for example, not close properly).
  • a prosthesis configured to hold the flaps of the native valve is known from the document WO 2018/099484, which describes an armature equipped with a tubular structure (suitable to house the prosthetic valve) from which radial formations branch off which hold the flaps of the native valve in the open position.
  • radial formations are configured to clamp the annulus so that the armature is anchored thereto and held in place.
  • the effects of clamping the annulus and spreading the native valve flaps are achieved by the radial formations being essentially in the form of a horizontal S, with an ascending portion (which, at its apex, engages the lower side of the annulus ), and a descending portion (which engages the native valve flaps).
  • An object of the present invention is to remedy the aforementioned problems.
  • an armature for a prosthetic heart valve includes, in addition to the tubular drum (suitable to house the prosthetic valve) and the cup structure (or similar), a plurality of radially expandable formations which, branching off from the body of the armature, spread apart in such a way as to push the flaps of the native valve outwards (when the armature is inserted in the biological implantation site), so as to prevent or hinder the movement thereof and avoid direct contact with this tubular drum, where, however, the armature is configured in such a way as to avoid anchoring to the annulus of the native heart valve.
  • the flaps of the native valve are held in an open position by the radial formations, without directly compressing the annular element that houses the prosthetic valve (and, therefore, without inducing deformations or crushing) and limiting or completely inhibiting the contact between the flaps and this annular element, so as to avoid further damage to the former, leading to lacerations or ruptures that could cause calcification and/or embolization of the tissue.
  • the armature is not fixed to the annulus, there is no risk that the deterioration of the anatomical structure of the implant will compromise the anchoring of the armature and the functionality of the radial formations.
  • Figure 1 is a schematic perspective view of an armature inserted in a mitral implant site, according to an embodiment of the present invention
  • Figures 2 and 3 are respectively a schematic perspective view and a schematic view orthogonal to the longitudinal axis of an armature, wherein are visible the radially projecting formations, suitable to counteract the closure of the native valve, and the prosthetic valve housed in the annular element, according to an embodiment of the present invention
  • Figures 4 A to 4C are schematic views of an armature in three alternative embodiments, wherein the radial formations branch off respectively from the globe structure, from the interface edge between the globe structure and the tubular drum, and from an edge of that drum which is distal relative to the globe structure;
  • Figures 5A to 5D are schematic views of a plurality of shapes that the cross section of the annular element may assume in a radially expanded configuration.
  • an armature 1 for a prosthetic valve 13 (preferably a mitral valve) is expandable and collapsible radially so as to be insertable into a cavity in a patient’s heart and extends along a longitudinal axis x.
  • this longitudinal axis x is configured in such a way that the armature 1, when placed in the anatomical implant site, is essentially coaxial with respect to the native valve.
  • the armature 1 comprises an annular or tubular element 10, suitable to support the mitral prosthetic valve 13, and an anchoring frame 12, suitable to be inserted into the left atrium of a patient’s heart (to help anchor the same valve prosthesis in place)' and is connected to an upper edge lOa of the annular element 10, proximal to such anchoring frame 12.
  • the anchoring frame 12, known per se, is preferably configured as a cup (but other shapes are possible, such as a globe, a dome, a mushroom, a ball, a half-sphere, etc.).
  • the armature 1 further comprises a plurality of radial formations 14, radially spreadable relative to the body 9 so as to present a greater radial extension relative to the annular element 10 (in other words, the radial formations 14 protrude radially on the outside of the annular element 10).
  • These radial formations 14 are suitable to hold the flaps 15 of the native valve in the open position, so as to prevent or limit the movements thereof and to avoid direct contact between these flaps 15 and the annular element 10, but are further configured so as to avoid an anchoring of the armature 1 to the annulus of a native heart valve by means of said radial formations 14.
  • the radial formations 14 are configured in such a way as to engage the flaps of the native valve (and, according to an embodiment, the connection portion between the two radially extended sides of the annulus), avoiding the engagement of this second side of the annulus that faces the ventricle.
  • the portion of the radial formations 14 suitable to enter into contact with the annulus and the flaps of the native heart valve has a monotonic trend (more specifically, a decreasing monotonic trend, when the armature 1 is placed in the anatomical implant site).
  • the radial formations 14 do not have portions folded upwards, which allow the annulus to tighten and anchor the armature 1 there (as contemplated in the prior art).
  • the radial formations 14 have a curved profile, having a concavity turned towards a direction radially external with respect to the armature 1, so as to adapt to the profile of the annulus and to fold radially towards the outside of the body 9.
  • At least part of the radial formations 14 are configured in the shape of elongated elements spaced circumferentially and having a first end l4a fixed to the body 9, and a second free end l4b, outermost radially, which is capable of pushing the flaps 15 of the native valve outwards radially.
  • the radial formations 14 are configured in the shape of a collar or circumferential collar sections, having a first edge !4a fixed to the body 9, and a second free edge l4b, and outermost radially, suitable to press radially on the flaps 15 of the native valve.
  • the collar or collar portion may be described as an element which, in the collapsed configuration of the armature 1 , extends longitudinally and circumferentially, and then radially spreads into the expanded configuration of the armature 1.
  • the collar may extend continuously along an entire circumference, or it may extend along circumferential sectors (so as to form, for example, petals in the expanded configuration).
  • the anchoring function of the armature 1 in the anatomical implant site is performed by the anchoring frame 12, which may have an at least partially spherical or globular shape.
  • the anchoring frame 12 is configured to face a majority portion of the inner surface of the left atrium of a patient’s heart so as to engage this atrium with a higher anchoring force.
  • the anchoring frame 12 may be configured to extend along the meridians of the sphere from the annulus to above this equator.
  • At least part of the radial formations 14 are fixed to the anchoring frame 12.
  • At least part of the radial formations 14 are fixed to the upper edge lOa of interconnection between the annular element 10 and the anchoring frame 12.
  • At least part of the radial formations 14 are fixed to an edge lOb of the annular element 10, distal relative to the anchoring frame 12. This lower edge lOb faces the left ventricle of the heart when the armature 1 is inserted into the anatomical mitral implantation site.
  • the armature 1 may comprise radial formations 14 of even more types.
  • it may simultaneously include radial formations 14 configured as elongated elements or collar portions, and/or fixed at different points of the body 9.
  • the armature 1 is configured so as to be implantable by means of a transcatheter.
  • the annular element 10 assumes, in the radially expanded condition, a cylindrical shape (as schematically illustrated in Figure 5A).
  • the annular element 10 may take an elliptical configuration (as schematically illustrated in Figure 5B), or a“bean” configuration (as schematically illustrated in Figures 5C and 5D).
  • FIGS. 5A-5D are shown, merely by way of example, the relationships that bind some geometric elements approximately indicative of the shape that the cross section of the annular element 10 may assume.

Abstract

Armature (1) pour une prothèse valvulaire cardiaque (13), se prolongeant le long d'un axe longitudinal (x) et radialement extensible et repliable, comprenant un corps (9) qui comprend un élément annulaire (10), supportant la valvule prothétique (13), une structure d'ancrage (12), qui est insérée dans une cavité du cœur d'un patient, et une pluralité de formations radiales (14), déployables radialement par rapport au corps (9) pour maintenir les lambeaux (15) de la valvule native en position ouverte, l'armature (1) étant conçue de manière à éviter un ancrage à l'anneau d'une valvule cardiaque native.
PCT/IB2019/056188 2018-07-20 2019-07-19 Prothèse valvulaire cardiaque, en particulier appropriée pour une implantation par voie transcathéter WO2020016842A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19759745.3A EP3823559A1 (fr) 2018-07-20 2019-07-19 Prothèse valvulaire cardiaque, en particulier appropriée pour une implantation par voie transcathéter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102018000007382 2018-07-20
IT102018000007382A IT201800007382A1 (it) 2018-07-20 2018-07-20 Protesi valvolare cardiaca, adatta in particolar modo ad essere impiantata per via transcatetere.

Publications (2)

Publication Number Publication Date
WO2020016842A1 true WO2020016842A1 (fr) 2020-01-23
WO2020016842A8 WO2020016842A8 (fr) 2021-02-18

Family

ID=63896512

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/056188 WO2020016842A1 (fr) 2018-07-20 2019-07-19 Prothèse valvulaire cardiaque, en particulier appropriée pour une implantation par voie transcathéter

Country Status (3)

Country Link
EP (1) EP3823559A1 (fr)
IT (1) IT201800007382A1 (fr)
WO (1) WO2020016842A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016134239A1 (fr) * 2015-02-20 2016-08-25 4C Medical Technologies, Inc. Dispositifs, systèmes et procédés de traitement cardiaque
WO2017079698A1 (fr) * 2015-11-06 2017-05-11 Micor Limited Prothèse de valvule mitrale
WO2018099484A1 (fr) * 2016-12-02 2018-06-07 Sino Medical Sciences Technology Inc. Valvule cardiaque à profil bas et système de pose

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016134239A1 (fr) * 2015-02-20 2016-08-25 4C Medical Technologies, Inc. Dispositifs, systèmes et procédés de traitement cardiaque
WO2017079698A1 (fr) * 2015-11-06 2017-05-11 Micor Limited Prothèse de valvule mitrale
WO2018099484A1 (fr) * 2016-12-02 2018-06-07 Sino Medical Sciences Technology Inc. Valvule cardiaque à profil bas et système de pose

Also Published As

Publication number Publication date
EP3823559A1 (fr) 2021-05-26
WO2020016842A8 (fr) 2021-02-18
IT201800007382A1 (it) 2020-01-20

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