Device for plastic surgery of the mitral valve

Abstract

An annuloplasty device for plastic surgery of the mitral valve to be implanted in subjects affected by valvular heart diseases causing stenosis and/or insufficiency, including at least one curved body, to be implanted coplanar with the native mitral annulus, characterized in that the curved body has at least two portions extended in different planes with respect to that in which the curved body lies, adapted to assist the heart surgeon in the operations of repair of the mitral apparatus of a patient affected by stenosis and/or insufficiency, the curved body having at least two descending portions to be inserted inside the mitral orifice, adapted to provide a grip for the anchoring of a prolapsed leaflet and/or of a biological tissue biocompatible with the human organism and/or of tendinous elements, when the device is applied to the damaged mitral apparatus of a patient.

1 . A device for plastic surgery of a mitral valve, to be implanted in subjects affected by valvular heart diseases causing stenosis and/or insufficiency, comprising:
 at least one curved body, to be implanted coplanar with the native mitral annulus, wherein said curved body has at least two portions extended in different planes with respect to that in which said curved body lies, adapted to assist a surgeon in the operations of repair of a mitral apparatus of a patient affected by stenosis and/or insufficiency, said curved body having at least two descending portions to be inserted inside the mitral orifice, adapted to provide a grip for anchoring a prolapsed leaflet and/or of a biological tissue biocompatible with a human organism and/or of tendinous elements when said device is applied to the damaged mitral apparatus of a patient.   
     
     
         2 . The device according to  claim 1 , wherein the curved body has an oval profile, said curved body being represented by an annular portion having profile similar to that of the common rings for annuloplasty currently used for restoring a functional and correct mitral valvular activity, and in that the at least two portions depart from said annular portion, being extended inside the valvular orifice when the device is implanted in the mitral apparatus of the patient, said annular portion having the descending portions directed, at the height of the commissures, like shoe vamps in a manner so as to form, with the plane in which said body lies, an angle comprised between 80° and 100°, said at least two descending portions departing from the center of the minor arcs of said oval profile. 
     
     
         3 . The device according to  claim 1 , wherein the curved body is represented by at least two curved portions to be arranged coplanar with the native annulus at the height of the commissures, said device comprising at least one curved portion to be arranged at the height of one valvular commissure and at least another curved portion to be arranged at the height of the commissure opposite to the first, and in that each curved portion has at least one descending portion to be inserted inside the valvular orifice, and extended in a manner so as to form an angle comprised between 80° and 100° with respect to the plane in which the curved portion lies, the portion departing from the center of such curved portion. 
     
     
         4 . The device according to  claim 3 , wherein the ends of the descending portions, turned towards the valvular orifice, are shaped as an L or they are shaped as two converging Ls, said ends defining, in the latter case, a section of material joining said descending portions and inserted inside the orifice, said device having the section extended inside the valvular orifice. 
     
     
         5 . The device according to  claim 1 , wherein the curved body is represented by a body defining an open curve to be implanted in part coplanar with the native mitral annulus and in part inside the valvular orifice, said curved body being represented by the curved portion, to be extended coplanar with the native annulus, and having the ends descending inside the orifice when said device is implanted, said ends of the curved portion representing the descending portions. 
     
     
         6 . The device according to  claim 1 , wherein the curved body is represented by a body defining an open curve to be implanted in part coplanar with the native mitral annulus and in part inside the valvular orifice, said curved body being represented by the curved portion, to be extended coplanar with the native annulus, and having the ends descending inside the orifice when said device is implanted, said ends of the curved portion representing the descending portions of the device and in that said descending portions are substantially U-shaped with the concavity turned upward, or they are shaped as an L, or they are shaped with one U-shaped and the other L-shaped. 
     
     
         7 . The device according to  claim 1 , wherein the portions descending towards the left ventricle have an overturned “L” shaped progression, being connected on the upper part to the annular portion or to the curved body, being centrally extended by two to eight millimeters, preferably four millimeters, towards the valvular lumen inside the mitral orifice, hence giving rise to the descending portion with respect to the plane identified by the annular portion or by the curved body, said descending portion having an angle comprised between 80° and 100°, preferably an angle of about 90°. 
     
     
         8 . The device according to  claim 1 , wherein it optionally comprises un biological tissue biocompatible with the human organism, adapted to be assembled, by means of suture, to the descending portions of the device. 
     
     
         9 . The device according to  claim 1 , wherein the tissue is made of bovine pericardium or of any other tissue, available on the market, that is biocompatible with the human organism. 
     
     
         10 . The device according to  claim 1 , wherein it is made of a material biocompatible with the human organism. 
     
     
         11 . The device according to  claim 1 , wherein it is made of a solid material that is sufficiently malleable so as to be manually modeled by the surgeon as required, and sufficiently rigid to maintain the conformation thereof unchanged following the stresses imparted by the heartbeat. 
     
     
         12 . The device according to  claim 1 , wherein it is made of a material having a thickness comprised between 0.1 cm and 0.5 cm, with regard to the portion representing the curved body, and a thickness comprised between 0.05 cm and 0.5 cm with regard to the portions representing the descending portions. 
     
     
         13 . The device according to  claim 1 , wherein it is made of a material having a thickness of 2 mm with regard to the portion representing the curved body, and a thickness of 1 mm with regard to the portions representing the descending portions. 
     
     
         14 . The device according to  claim 1 , wherein it has the descending portions of a length comprised between 0.5 and 3.5 centimeters, preferably between 1 and 2 centimeters. 
     
     
         15 . A method for using plastic surgery of the mitral valve to be implanted in subjects affected by valvular heart diseases causing stenosis and/or insufficiency, comprising the following steps:
 implanting a mitral apparatus in a patient affected by stenosis and/or insufficiency, the apparatus having at least one curved body coplanar with the native mitral annulus, and having at least two portions extended in different planes with respect to that in which said curved body lies, and   inserting the at least two descending portions inside the mitral orifice, adapted to provide a grip for the anchoring of a prolapsed leaflet and/or of a biological tissue biocompatible with the human organism and/or of tendinous elements when said device is applied to the damaged mitral apparatus of a patient.