Multilayer bioabsorbable scaffolds and methods of fabricating
A bioabsorbable scaffold composed of a multilayer structure of alternating layers of different polymers is disclosed. The multilayer structure can have 20 to 1000 layers and the individual thickness of the layers can be 0.2 to 5 microns. A method of making the scaffold including a layer multiplying extrusion process is disclosed.
1. A stent comprising a bioresorbable scaffolding including a plurality of structural elements, the structural elements made of a multilayer structure consisting of alternating bioresorbable polymer layers,
wherein the multilayer structure extends between a luminal layer and an abluminal layer of the bioresorbable polymer layers,
wherein the layers alternate between a layer of higher strength and stiffness and a layer of greater flexibility wherein a thickness of each of the layers is between about 0.2 and 5 microns and a thickness of the structural elements is between 100 and 200 microns.
2. The stent of claim 1 , wherein the multilayer structure includes between 20 and 1000 layers.
3. The stent of claim 1 , wherein the multilayer structure comprises alternating layers of a bioresorbable polymer A and a bioresorbable polymer B, wherein the polymer A is an aliphatic polyester with a glass transition temperature (Tg) above 37 deg C and the polymer B is an aliphatic polyester with a Tg below 25 deg C.
4. The stent of claim 1 , wherein the multilayer structure comprises alternating layers of a bioresorbable polymer A and a bioresorbable polymer B, wherein the polymer A is a poly(L-lactide) (PLLA) polymer or copolymer with L-lactide content of greater than 80 mol % and the polymer B is a copolymer of PLLA and at least 20 mol % of caprolactone, trimethylene carbonate, or 4-hydroxybutyrate.
5. The stent of claim 1 , wherein the multilayer structure comprises alternating layers of a bioresorbable polymer A and a bioresorbable polymer B, wherein the polymer A is a poly(L-lactide) (PLLA) polymer or copolymer with L-lactide content of greater than 80 mol % and the polymer B is a polymer including a hydrophilic polymer component.
6. The stent of claim 1 , wherein the multilayer structure comprises alternating layers of a bioresorbable polymer A and a bioresorbable polymer B, wherein the polymer A is a PLLA polymer or copolymer with L-lactide content of greater than 80 mol % and the polymer B is a di-block copolymer of the form X-Y, where the X block is PLLA, polyglycolide (PGA), or poly(L-lactide-co-glycolide) (PLGA) and the Y block is polycaprolactone (PCL), polytrimethylene carbonate (PTMC), poly(4-hydroxybutyrate) (P4HB), or polyethylene glycol (PEG).
7. The stent of claim 1 , wherein the multilayer structure comprises alternating layers of a bioresorbable polymer A and a bioresorbable polymer B, wherein the polymer A is a PLLA polymer or copolymer with L-lactide content of greater than 80 mol % and the polymer B is a tri-block copolymer of the form X-Y-X, where the X block is PLLA, PGA, or PLGA and the Y block is PCL, PTMC, P4HB, or PEG.