Systems and methods for assembling components of a fabric-covered prosthetic heart valve

A method of assembling a prosthetic heart valve, comprising:

• providing a generally tubular support stent that includes multiple cusps curved toward an axial inflow end alternating with multiple commissures projecting toward an axial outflow end, the support stent having an undulating outflow edge;
• wrapping a tubular length of fabric over the support stent;
• retaining tension in the tubular length of fabric using mechanization such that the fabric is held tautly along the undulating outflow edge;
• and
• forming a seam in the tubular length of fabric adjacent the inflow edge of the support stent.

A method of assembling a prosthetic heart valve, comprising:

• providing a generally tubular heart valve support stent that includes a first edge and an axially-opposite second edge;
• wrapping a tubular length of fabric over the first edge of the support stent such that two free ends of the tubular length of fabric continue past the second edge;
• retaining tension in the tubular length of fabric such that the fabric is held tautly along the first edge;
• mapping the peripheral contour of the second edge of the support stent with an imaging system;
• and
• forming a seam in the tubular length of fabric closely adjacent the second edge of the support stent using an automated sewing system having a needle whose position relative to the second edge is responsive to the mapped contour of the second edge.

A system for assembling components of a flexible leaflet prosthetic heart valve having a generally tubular fabric-covered support stent defining a central axis, the system comprising:

• a mandrel for retaining tension without manual assistance in a tubular length of fabric wrapped over an outflow end of a heart valve support stent, wherein the outflow end includes an undulating contour and the mandrel is adapted to retain tension in the tubular length of fabric so that it conforms to the undulating contour,
• wherein the undulating contour of the outflow end includes multiple cusps curved toward an axial inflow end alternating with multiple commissures projecting toward an axial outflow end, and the mandrel includes separate clamps for the fabric corresponding to the stent cusps,
• wherein there are three inflow cusps and three outflow commissures alternating around a periphery of the support stent, and wherein the mandrel clamps the fabric beyond an axial inflow end of the stent in peripheral locations corresponding to the cusps,
• wherein the mandrel includes an outer clamping mechanism comprising three clamp members oriented 120° apart in each of which is adapted to clamp a section of fabric,
• wherein the mandrel includes an inner clamping mechanism comprising two disks between which one end of the tubular length of fabric may be clamped;
• and
• a means for forming a seam in the tubular length of fabric adjacent the inflow end of the support stent to enclose the support stent.