Implantable scaffolds having biodegradable components and methods of manufacturing and use thereof

A balloon-scaffold assembly for use in a peripheral vessel, comprising:

• an inflatable balloon of a balloon catheter, wherein the inflatable balloon is expandable to a minimum diameter of about 2.9 mm at about 6.0 ATMs of pressure and expandable to a maximum diameter of about 3.7 mm at about 16.0 ATMs of pressure, wherein the inflatable balloon is also characterized by an upward sloping compliance curve;
• and
• an endovascular scaffold crimped onto the inflatable balloon in a delivery configuration, wherein the endovascular scaffold comprises:
• a plurality of undulating rings, and
• a plurality of interconnecting struts connecting the plurality of undulating rings to one another,
• wherein portions of the inflatable balloon extend through void spaces in between the plurality of undulating rings when the plurality of undulating rings are radially compressed into the delivery configuration, and
• wherein the inflatable balloon provides structural support to the endovascular scaffold during delivery.

A method of supporting a peripheral vessel using a balloon-scaffold assembly, the method comprising:

• introducing a flexible guidewire to a target site within the peripheral vessel;
• advancing a delivery catheter comprising a balloon-scaffold assembly over the guidewire to the target site;
• exposing the balloon-scaffold assembly at the target site, wherein the balloon-scaffold assembly comprises:
• a balloon of a balloon catheter, and
• an endovascular scaffold crimped onto the balloon in a delivery configuration, wherein the endovascular scaffold comprises:
• a plurality of undulating rings, and
• a plurality of interconnecting struts connecting the plurality of undulating rings to one another,
• wherein at least some of the interconnecting struts are configured to biodegrade over a degradation period after deployment,
• wherein portions of the balloon extend through void spaces in between the plurality of undulating rings when the plurality of undulating rings are radially compressed into the delivery configuration, and
• wherein the balloon provides structural support to the endovascular scaffold during delivery;
• inflating the balloon to radially expand the endovascular scaffold to an expanded configuration at the target site;
• deflating the balloon;
• and
• withdrawing the delivery catheter and the balloon from the peripheral vessel, wherein the endovascular scaffold in the expanded configuration provides support for the peripheral vessel at the target site.

A method of making an endovascular scaffold for use in a peripheral vessel, the method comprising:

• dipping a mandrel in a polymeric solution such that a dip-coated substrate forms on the mandrel;
• forming a plurality of undulating rings from the dip-coated substrate, wherein the plurality of undulating rings are radially compressible into a delivery configuration and expandable from the delivery configuration to an expanded configuration when deployed;
• and
• forming a plurality of interconnecting struts connecting the plurality of undulating rings, wherein at least some of the interconnecting struts are configured to biodegrade over a degradation period when the endovascular scaffold is deployed within the peripheral vessel.