Patent Publication Number: US-2020297492-A1

Title: Heart valve sizing ring for valve-sparing aortic root remodeling procedures

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This patent document claims priority to earlier filed U.S. Provisional Patent Application Ser. No. 61/713,115, filed Oct. 12, 2012, and is a continuation-in-part of U.S. patent application Ser. No. 13/658,050, filed Oct. 23, 2012, and U.S. patent application Ser. No. 13/871,327, filed on Apr. 26, 2013, and U.S. patent application Ser. No. 16/251,965, filed on Jan. 18, 2019, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Technical Field 
     The present patent document relates generally to heart valve sizing rings and more particularly to a heart valve sizing ring configured for valve-sparing aortic root remodeling procedures. 
     2. Background of the Related Art 
     Referring to  FIGS. 1 and 2 , during valve-sparing aortic root remodeling procedures sutures  14  are aligned at the base of the heart valve  10 . The aortic wall is resected and sculpted to preserve three anchor points for the heart valve where the leaflets  12  meet, i.e. the commissures  16 . Sutures  18  are placed above the commissures  16 . The sutures  14  at the base of the valve  10  are used to anchor the graft to the heart and to stabilize (and often “downsize”) the aortic root. The sutures  18  above the commissures  16  are anchored to the upper “tube” portion of the graft where they are positioned high enough to allow the commissures  16  to be “resuspended” helping to correct geometry of the valve  10 . 
     However, if the correct graft size is not selected during the repair, the surgeon may not be able to properly reshape the valve  10 , thereby leading prolonged and/or suboptimal surgical operations which could lead to complications and poor outcomes. 
     Therefore, there is a perceived need in the industry for a method and device to allow a surgeon to easily size and test a valve repair in valve-sparing aortic root remodeling procedures. 
     SUMMARY OF THE INVENTION 
     The present invention solves the problems of the prior art by providing a heart valve sizing ring system that includes and outer ring and an interlocking inner ring. The inner ring further includes a tubular portion that can be used to test and simulate whether the heart valve has been properly sized prior to installing a permanent graft prosthesis. The tubular portion may additionally include suture holders at the top to aid the surgeon in recreating valve geometry and function by “suspending” the commissures within the tubular portion thus assisting with evaluation/testing of proper graft/valve size selection. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where: 
       Do:  FIG. 1  shows an aortic heart valve with sutures being installed at the base of the valve; 
         FIG. 2  shows an aortic heart valve after excess and/or diseased aortic tissue has been resected using a technique that preserves the valve itself. More sutures are placed circumferentially; 
         FIG. 3  shows the heart valve sizing system supporting the heart valve therein for testing the size of the graft prior to placement; and 
         FIG. 4  shows a partial cross-section of a suture being trapped between the inner ring and the outer ring. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to  FIGS. 3 and 4 , a first embodiment of the heart valve sizing ring is shown generally over a heart valve that has been resected and sculpted at  100 . The heart valve sizing ring  100  includes an outer ring  102 , and inner ring  104  that interlocks with the outer ring  102 , and a tubular portion  106  (simulating a graft) extending from the inner ring  104 . 
     Sutures  14  at the base of the heart valve  10  are captured between the inner and outer rings  102 , 104 , thereby temporarily anchoring the heart valve sizing ring  100  to the heart valve  10 . The inner and outer rings  102 ,  104 , may include a concave and convex surfaces  102   a ,  104   b , to facilitate retention of the sutures  14 . The surfaces may optionally be coated with a rubber-type of coating to gently grip the sutures and prevent slipping. Because the inner and outer rings  102 ,  104  form a rigid structure, the precise size of the annular diameter is provided during evaluation. 
     The valve commissures  16  are suspended temporarily using the suture holders  108 , such as slots, via the commissure sutures  18 . This allows for the valve leaflet  12  distance and apposition to be properly evaluated by creating a “quick preview” of what valve function would be like should a graft of that size be selected. Several different graft sizes can be tested and compared in a relatively short time prior to final graft selection. Note that this system can be used with either a “straight” tube graft or with a “Valsalva” type of tube graft (in which the sides of the graft “bow” outward slightly). 
     The pictured slots as suture holders  108  represent one embodiment that may facilitate commissural suspension, though, this could be accomplished by other mechanisms as well, such as clipping the commissure sutures  18  to the tube wall, etc. The material of the tubular portion  106  is not restricted and can be made of a stiffer material than the graft prosthesis if it is only being used for sizing purposes. The slots  108  can have an additional rubber-type of coating or some other material that is advantages in gently gripping and holding the commissure sutures  18 . 
     It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be within the scope of the present invention.