Fresh donor heart valve sizer and method of use

A method of measuring the annulus size of a fresh donor heart valve, comprising:

• obtaining a fresh donor heart valve having a lumen and an inwardly-directed valve annulus within the lumen;
• providing a sizer having an axially-extending sizing portion adapted to fit within the lumen with an exterior surface that increases in size from a forward end along its axis;
• inserting the forward end of the sizing portion into the lumen of the donor heart valve;
• halting insertion of the sizing portion into tho lumen of the donor heart valve at a predetermined resistance to further insertion;
• and
• determining the valve annulus size based on the distance that the sizing portion is inserted into the lumen.

A method of manufacturing prosthetic heart valves, comprising:

• providing a supply of fresh donor heart valve isolations at a slaughterhouse;
• measuring the annulus size of the fresh donor heart valve isolations using a sizer having a sizing portion for insertion within the lumen of the donor heart valve isolations, the sizer being configured to identify the size of more than two sizes of the donor heart valve isolations;
• selecting a subset of the supply based on the step of measuring;
• shipping the subset of the supply from the slaughterhouse to a valve manufacturing facility;
• and
• fabricating at least one prosthetic heart valve from a donor heart valve isolation selected from the subset.