looking first at fig1 there is shown a normal mitral valve v . mitral valve v is shown in its closed position , with its posterior leaflet pl and its anterior leaflet al properly engaging one another . also shown is the valve &# 39 ; s posterior annulus pa and its anterior annulus aa . looking next at fig2 there is shown a regurgitant mitral valve rv . regurgitant mitral valve rv is shown in its closed position , with posterior leaflet pl in a prolapsed condition and failing to properly engage anterior leaflet al , thus leaving a regurgitant orifice ro therebetween . looking next at fig3 a mitral shield 5 is shown affixed to the posterior annulus pa of the valve rv so as to prevent prolapse of the posterior leaflet pl and thereby ameliorate mitral regurgitation . more particularly , mitral shield 5 comprises a shaped sheet of material which is sized to the circumference of the mitral annulus . this sheet may be uniform in thickness or specifically shaped to match the surface of the mitral valve . when affixed to the valve annulus , the sheet will project over a portion of the orifice of the mitral valve . in most cases , the sheet will be oriented over the posterior leaflet pl , such as is shown in fig3 thereby providing an area of contact for the anterior mitral leaflet al and reducing or eliminating regurgitation due to leaflet prolapse by the posterior leaflet pl . a perforated shield over the affected leaflet will be sufficient to prevent leaflet prolapse while maintaining adequate blood flow . thus , in fig1 a plurality of radially elongated perforations 10 are provided in mitral shield 5 . alternatively , circular perforations , such as the circular perforations 10 provided in the mitral shield 5 shown in fig2 may also be provided . still other perforation configurations , in both shape and number , will be apparent to those skilled in the art in view of the present disclosure . the mitral shield may be constructed of biological material ( e . g ., human or bovine pericardium ) or non - biological material ( e . g ., dacron , ptfe , a biocompatible plastic , a biocompatible metal such as titanium , nitinol wire , etc ). it may also consist of autologous cells grown on a matrix or frame . the sheet may be attached to the annulus using sutures , staples , wire , medical grade adhesives or other means of fixation . thus , for example , in fig1 staples 15 are shown attaching shield 5 to the annulus of the valve . if the posterior annulus is dilated , a solid portion of a shield will fill the void and provide a contact surface for the anterior leaflet . thus , for example , in fig5 there is shown a mitral shield 105 which is substantially solid . in fig6 there is shown a mitral shield 105 which is solid except for pre - formed suture holes 120 . in fig7 there is shown a mitral shield 105 which is solid and includes integral fixation staples 125 . it should be appreciated that the native posterior valve leaflet may either be excised or left in situ when the mitral shield 105 is employed . looking next at fig8 there is shown a solid crescent shield 205 which is configured to correct posterior leaflet flail , and which is also provided with a mid - line projection 230 to support the anterior leaflet al from prolapsing . in fig9 there is shown a wire frame shield 305 for addressing posterior and / or anterior leaflet prolapse only . and in fig1 , there is shown a mitral shield 405 combining a solid shield portion and perforations 410 and integral staples 425 around the entire annulus circumference . alternative designs of the same invention allow for correcting one or both leaflets while maintaining adequate blood flow . the shield may also be used in conjunction with other mitral valve repair techniques and devices . although the device described is intended primarily for mitral valve repair , it is also contemplated that the same or substantially similar apparatus and methodology may be used in repairing other cardiac valves , including the tricuspid , pulmonary and aortic valves .
a valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet .