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EP-3415119-B1 - PROSTHESIS FOR CARDIOVASCULAR VALVE

EP3415119B1EP 3415119 B1EP3415119 B1EP 3415119B1EP-3415119-B1

Inventors

  • RIGHINI, GIOVANNI
  • ZANON, SARAH

Dates

Publication Date
20260506
Application Date
20111114

Claims (15)

  1. A prosthesis for a cardiac atrio-ventricular valve, comprising valve leaflets, the prosthesis comprising: - a prosthetic member (205) comprising a support structure (210) having a peripheral wall which defines a through-hole, - a valve structure which is supported by the support structure (210) and which comprises prosthetic leaflets (220a-220c) which are configured to selectively close the through-hole of the support structure (210) so as to restore, during use, the functionality of a unidirectional valve, and - an anchoring member (225) wherein the anchoring member (225) and the support structure (210) of the prosthetic member (205) are configured so as to be coupled each other, after implantation in the body of a patient, co-operating in order to entrap and lock the valve leaflets (135a - 135b) of the cardiac atrio-ventricular valve of the patient between the peripheral wall of the support structure (210) and the anchoring member (225) so as to keep the prosthesis (200) in position, wherein a seating (230) is defined on the support structure (210), conjugate to the anchoring member (225), the support structure (210) and the anchoring member (225) being configured and having dimensions so that they are connected with interference so as to lock the anchoring member (225) in the seating (230), and wherein the prosthetic member (205) and the anchoring member (225) being configured to be arranged at opposite sides of valve leaflets so that when the anchoring member (225) is matched to the support structure (210), said valve leaflets remain locked between the support structure (210) and the anchoring member (225).
  2. A prosthesis according to claim 1, wherein the support structure (210) comprises at least one face (427B; 427C) which is folded about itself in order to form at least one lip (428B, 429B; 428C) which defines a corresponding edge of the seating (430B; 430C).
  3. A prosthesis according to claim 1 or claim 2, wherein the support structure (210) is provided with protrusions (426A) which project radially therefrom to define at least one edge of the seating (430A; 430C).
  4. A prosthesis according to claim 3, wherein each protrusion (426A) has a C-like shape which is defined by two opposing fingers, the protrusions being successively arranged along a peripheral wall of the support structure (210) so as to define the outline of a channel (430A) which brings about the seating of the anchoring member (225).
  5. A prosthesis according to any one of the preceding claims, wherein the prosthetic member (205) comprises an engagement structure which leans out externally from the peripheral wall and which is capable of engaging, during the implantation of the prosthesis in the body of the patient, with the valve leaflets (135a - 135b) of the cardiac atrio-ventricular valve in order to drag them inside the anchoring member (225) where they are locked between the anchoring member (225) and the peripheral wall of the support structure (210).
  6. A prosthesis according to any one of the preceding claims, wherein the seating (230) is a circumferential groove (226) which is formed on an outer surface of the peripheral wall of the support structure (210).
  7. A prosthesis according to any one of the preceding claims, wherein the anchoring member (210) is connected to the support structure (210) in a stable manner.
  8. A prosthesis according to any one of preceding claims, wherein the the anchoring member (225) is a ring, preferably a substantially circular ring, and/or the anchoring member (225) is collapsible.
  9. A prosthesis according to any one of the preceding claims, wherein the anchoring member (225) comprises a main structure (530, 545, 550) having free ends which can be closed to bring the anchoring member from an open configuration to a closed configuration having a structural continuity.
  10. A prosthesis according to claim 9, wherein the main structure (530, 545, 550) of the anchoring member may be closed by a closure structure to restore the structural continuity to the anchoring member (525F), and wherein preferably the main structure (530) of the anchoring member is tubular and comprises a through-hole which extends over the entire extent thereof, the closure structure (535-537) comprising a filiform structure (535).
  11. A prosthesis according to claim 9 or claim 10, wherein the main structure (530) of the anchoring member may be closed by means of a closure wire (535), preferably by tensioning the closure wire (535).
  12. A prosthesis according to any one of the preceding claims, wherein the support structure (210) and the anchoring member (225) have original shapes when they are separated from each other and final shapes, which are different from the original ones, when they match each other, respectively.
  13. A prosthesis according to any one of the preceding claims, wherein the support structure (210) and the anchoring member (225) are collapsible in order to facilitate introduction inside the body of a patient and are expandable owing to the effect of resilient return, plastically or in a resilient/plastic manner, during use, in order to lock the valve leaflets (135a - 135b) of the cardiac atrio-ventricular valve between the expanded anchoring member (225) and the expanded support structure (210).
  14. A prosthesis according to any one of the preceding claims, wherein the anchoring member (225) may be coated, at least in the portion thereof intended to come into contact with the valve leaflets (135a - 135b), with a synthetic material or with a biological material, and/or wherein the anchoring member (225) is reinforced with one or more inner portions of biologically compatible polymer material, or metal, or alloys based on titanium, cobalt or chromium.
  15. A kit for restoring the functionality of a cardiac atrio-ventricular valve comprising a prosthesis (200) according to any one of claims 1 to 14 and instructions for introducing, positioning and implanting the prosthesis (200) in the body of a patient in such a manner as to entrap and lock the valve leaflets (135a - 135b) of the cardiac atrio-ventricular valve of the patient between the peripheral wall of the support structure (210) and the anchoring member (225) so as to keep the prosthesis (200) in position.

Description

The solution in accordance with one or more embodiments of the present invention relates to the field of prostheses. More specifically, that solution relates to prostheses for cardiovascular valves. Prostheses for cardiovascular valves are used to fulfil the normal physiological function of making the flow of blood in the heart unidirectional. Implanting a prosthesis for a cardiac valve is a fairly complex intervention, generally carried out in open heart conditions. Furthermore, to that end, the natural beating of the heart is often interrupted, using extra-corporeal circulation of the blood or using artificial systems for pumping the blood. Percutaneous transcatheter techniques have also been used recently, wherein the prosthesis is implanted in the heart with transluminal access via a peripheral inlet with low invasiveness, for example, starting from the femoral arteries. To that end, the prosthesis is radially compressed; a guidance system, generally a catheter, guides the prosthesis as far as the implantation site thereof; once the prosthesis has been correctly positioned, it is released by the guidance system and expands, for example, owing to resilient return or by a balloon positioned therein being inflated, so as to recover the operating dimensions thereof. A problem of known prostheses for cardiac valves is anchoring them at the implantation site. In the case of implantation with a surgical technique, the prosthesis can be anchored by means of sutures in the tissue of the implantation site. It is also possible to use staples which are mounted on a main body thereof and which are secured to the tissue of the implantation site [cf. US 2008/0077235]. In the case of an implantation procedure with a transcatheter technique, the prosthesis can be anchored to the implantation site with pressure by means of a radial force which is directed outwards and which is applied to the annulus of the native valve by the prosthesis when it is expanded. Furthermore, the prosthesis can also be provided with an outer radial groove, in which the annulus is fixed, or teeth or hooks which become engaged in the tissue of the implantation site. WO 2008/029296 discloses a prosthesis for a heart valve including a separate or combined anchor that folds around the malfunctioning native valve leaflets, sandwiching them in a manner so as to securely anchor the replacement valve in a precise, desired location. FR 2874813 discloses a prosthesis for a heart aortic valve, made of two pieces with an anchor that is chirurgcally fastened to the heart walls. In any case, with the prostheses of known type, it is difficult to obtain reliable anchoring which can prevent displacements and migrations of the prosthesis itself. Furthermore, it is difficult to ensure good sealing at the interface between the prosthesis and the implantation site which can prevent paravalvular losses with reflux of blood. It is also difficult to limit the impact of the prosthesis on the anatomy and/or physiology of the implantation site which could bring about negative interactions with the function of the prosthesis. Those problems are exacerbated in the case of prostheses for the mitral valve. The mitral valve is subjected to greater differences of pressure than the other heart valves; this involves greater demands for reliability of the anchoring thereof at the implantation site. Furthermore, the mitral valve is positioned between two open spaces (that is to say, the left atrium and the left ventricle) so that it does not provide any interface with well-identified anatomical characteristics for anchoring the prosthesis. The anchoring of the prosthesis is also impeded by the presence of a very complex subvalvular apparatus (that is to say, chordae tendinae and papillary muscles). The most common pathology of the mitral valve is of a degenerative type, generally associated with prolapse of the annulus of the valve; therefore, the annulus of the damaged mitral valve does not provide a consistent and solid structure against which the prosthesis can expand and be anchored, but instead any radial force applied by the prosthesis to the annulus is counter-productive for the pathology of the mitral valve, making the anchoring of the prosthesis unstable and very unreliable over time. In addition, the implantation of a prosthesis without carrying out beforehand the removal of the damaged mitral valve may involve deformation of the mitral valve itself, with the risk of creating interference with the flow of arterial blood in systole, bringing about an effect known as Systolic Anterior Motion or SAM. In general terms, the solution in accordance with one or more embodiments of the present invention is based on the idea of providing a prosthetic system with a system for anchorage on the valve leaflets of the cardiovascular valve whose functionality it is desirable to restore without it therefore being necessary to carry out precautionary removal thereof via the surgical route