Degenerative Valvular Disease Specific Annuloplasty Rings

Abstract

Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases, such as fibroelastic deficiency (FED), Marfan's or Barlow's. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes. A bulge on the sewing cuff forms a step on the outflow side for ease of suturing, which may be indicated by a suture line.

1 . A method of manufacturing an annuloplasty ring, comprising:
 referencing the characteristic shape of the annulus of a heart valve afflicted by a degenerative heart valve disease; and   forming the annuloplasty ring with a size and shape that corresponds to the characteristic shape of the annulus.   
     
     
         2 . The method of  claim 1 , wherein the characteristic shape of the annulus of the heart valve afflicted by the degenerative heart valve disease is obtained partly by echocardiographic and intraoperative measurements of an afflicted annulus. 
     
     
         3 . The method of  claim 2 , wherein the valve annulus is the mitral valve annulus, and the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus. 
     
     
         4 . The method of  claim 1 , wherein the valve annulus is the mitral valve annulus, and the degenerative heart valve disease manifests as mitral valve regurgitation. 
     
     
         5 . The method of  claim 1 , wherein the valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming the ring to have a major axis and a minor axis, and a size and shape symmetric about the minor axis that preserves or restores full leaflet mobility to the patient's mitral valve. 
     
     
         6 . The method of  claim 5 , wherein the size and shape of the ring addresses the problems of excess tissue and related valve dysfunction commonly seen in degenerative valvular diseases. 
     
     
         7 . The method of  claim 6 , wherein the size and shape of the ring conforms to the annulus shape for Barlow's disease for rings having a size of 34 mm or larger. 
     
     
         8 . The method of  claim 1 , wherein the valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming an anterior segment opposite a posterior segment, and two side segments, and varying the flexibility around the ring periphery with the posterior segment being more flexible than the anterior segment. 
     
     
         9 . The method of  claim 1 , wherein the valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming generally a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and for rings having a size of 34 mm or larger reducing the prominence of the D-shape such that the ring is more circular. 
     
     
         10 . The method of  claim 1 , wherein the valve annulus is the mitral valve annulus, and wherein the step of forming the ring comprises forming an anterior segment opposite a posterior segment, and two side segments, and forming the ring to be three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>1. 
     
     
         11 . The method of  claim 10 , wherein the ratio C/D is about 3:1. 
     
     
         12 . An annuloplasty ring for correcting a patient's valve annulus afflicted by a degenerative heart valve disease, comprising:
 a ring body defining a periphery, the ring body having a size and shape that corresponds to the characteristic shape of the heart valve afflicted by the degenerative heart valve disease for that annulus size.   
     
     
         13 . The annuloplasty ring of  claim 12 , wherein the characteristic shape of the annulus of the heart valve afflicted by the degenerative heart valve disease is obtained partly by echocardiographic and intraoperative measurements of an afflicted annulus. 
     
     
         14 . The annuloplasty ring of  claim 14 , wherein the patient's valve annulus is the mitral valve annulus, and the measurements include transverse diameter, antero-posterior diameter, and at least three oblique dimensions extending from the geometric center of the annulus to the posterior aspect of the annulus. 
     
     
         15 . The annuloplasty ring of  claim 12 , wherein the patient's valve annulus is the mitral valve annulus and the degenerative heart valve disease manifests as mitral valve regurgitation. 
     
     
         16 . The annuloplasty ring of  claim 12 , wherein the patient's valve annulus is the mitral valve annulus, and wherein the ring body defines a major axis and a minor axis has a size and shape symmetric about the minor axis that preserves or restores full leaflet mobility to the patient's mitral valve. 
     
     
         17 . The annuloplasty ring of  claim 17 , wherein the size and shape of the ring body addresses the problems of excess tissue and related valve dysfunction commonly seen in degenerative valvular diseases. 
     
     
         18 . The annuloplasty ring of  claim 18 , wherein the size and shape of the ring body conforms to the annulus shape for Barlow's disease for rings having a size of 34 mm or larger. 
     
     
         19 . The annuloplasty ring of  claim 12 , wherein the patient's valve annulus is the mitral valve annulus, and the ring body periphery has an anterior segment opposite a posterior segment, and two side segments. 
     
     
         20 . The annuloplasty ring of  claim 19 , wherein the ring body has varying flexibility around its periphery with the posterior segment being more flexible than the anterior segment. 
     
     
         21 . The annuloplasty ring of  claim 19 , wherein the ring body generally defines a D-shape in plan view with a relatively straight anterior segment opposite a curved posterior segment, and for rings having a size of 34 mm or larger the D-shape diminishes and becomes generally more circular. 
     
     
         22 . The annuloplasty ring of  claim 19 , wherein the ring body is three-dimensional with the center of the anterior segment rising to a height C and the center of the posterior segment rising to height D above a common datum plane, wherein the ratio C/D>1. 
     
     
         23 . The annuloplasty ring of  claim 21 , wherein the ratio C/D is about 3:1.