Seamless Tubular Extracellular Matrix Prosthetic Valve and Method for Forming Same

A seamless prosthetic valve, comprising:

• a continuous tubular structure having an inner lumen, outer abluminal surface, first and second ends, a triple walled intermediate portion, and first and second valve leaflets, said tubular structure comprising acellular small intestine submucosa (SIS), said SIS comprising less than 4% DNA content and a dry weight bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellurization and a tensile strength of at least 9 N,
• said first and second valve leaflets being configured to transition from a first position, wherein fluid flow in a first direction through said seamless prosthetic valve is unrestricted, to a second position, wherein fluid flow in a second direction through said seamless prosthetic valve is restricted,
• said triple walled intermediate portion being formed by everting said first end of said tubular structure over said tubular structure to form a double walled first end and a doubled wall portion proximal to and extending from said double walled end, and reverting said first end of said tubular structure over said double walled end of said tubular structure,
• said first and second valve leaflets being formed in said tubular structure lumen by suturing said triple walled intermediate portion at two commissure connection points, wherein said first and second valve leaflets comprise two restrained regions and two unrestrained regions.

A seamless prosthetic valve, comprising:

• a continuous tubular structure having an inner lumen, outer abluminal surface, first and second ends, a triple walled intermediate portion, and first and second valve leaflets, said tubular structure comprising mesothelial tissue from a mammalian tissue source,
• said first and second valve leaflets being configured to transition from a first position, wherein fluid flow in a first direction through said seamless prosthetic valve is unrestricted, to a second position, wherein fluid flow in a second direction through said seamless prosthetic valve is restricted,
• said triple walled intermediate portion being formed by everting said first end of said tubular structure over said tubular structure to form a double walled first end and a doubled wall portion proximal to and extending from said double walled end, and reverting said first end of said tubular structure over said double walled end of said tubular structure,
• said first and second valve leaflets being formed in said tubular structure lumen by suturing said triple walled intermediate portion at two commissure connection points, wherein said first and second valve leaflets comprise two restrained regions and two unrestrained regions.

A seamless prosthetic valve, comprising:

• a continuous tubular structure having an inner lumen, outer abluminal surface, first and second ends, a triple walled intermediate portion, and first, second and third valve leaflets, said tubular structure comprising mesothelial tissue from a mammalian tissue source,
• said first, second and third valve leaflets being configured to transition from a first position, wherein fluid flow in a first direction through said seamless prosthetic valve is unrestricted, to a second position, wherein fluid flow in a second direction through said seamless prosthetic valve is restricted,
• said triple walled intermediate portion being formed by everting said first end of said tubular structure over said tubular structure to form a double walled first end and a doubled wall portion proximal to and extending from said double walled end, and reverting said first end of said tubular structure over said double walled end of said tubular structure,
• said first, second and third valve leaflets being formed in said tubular structure lumen by suturing said triple walled intermediate portion at three commissure connection points, wherein said first, second and third valve leaflets comprise three restrained regions and three unrestrained regions.