Biodegradable supporting device

Abstract

A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

1 . An in vivo supporting device, comprising:
 a biodegradable metal scaffold; and   a biodegradable polymer coating covering at least a portion of said biodegradable metal scaffold,   wherein said biodegradable polymer coating has a degradation rate that is faster than the degradation rate of said biodegradable metal scaffold and wherein said supporting device comprises magnesium as a component that is less than 50% w/w, less than 50% w/v or less than 50% v/v of said supporting device.   
     
     
         2 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold comprises an alloy comprising magnesium. 
     
     
         3 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold is made from a magnesium alloy having a magnesium content of at least 96 wt. %, a manganese content of at least 1 wt. %, and at least one metal from the rare earth metal group in the amount of at least 0.5 wt. %. 
     
     
         4 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold is made from a magnesium alloy having a magnesium content of 96-97.9 wt. %, a manganese content of 1.6-2 wt. %, and at least one metal from the rare earth metal group in the amount of 0.5-2 wt. %. 
     
     
         5 . The in vivo supporting device of  claim 2 , wherein said biodegradable metal scaffold is made from a magnesium alloy having a magnesium content of 97.45 wt. %, a manganese content of 1.8 wt. %, and a cerium content of 0.75 wt. %. 
     
     
         6 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold comprises metal struts, wherein said metal struts are covered by said biodegradable polymer coating, wherein said coating has one or more holes that allow direct contact of the metal strut with a body fluid when said supporting device is placed inside a body lumen. 
     
     
         7 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold comprises metal struts, and wherein said biodegradable polymer coating partially covers said metal struts but does not cover openings between said struts. 
     
     
         8 . The in vivo supporting device of  claim 7 , further comprising a biodegradable polymer covering that covers the exterior surface of said metal scaffold, including openings between said metal struts. 
     
     
         9 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold comprises metal struts, and wherein said biodegradable polymer coating covers said metal struts and openings between said struts. 
     
     
         10 . The in vivo supporting device of  claim 9 , wherein said covering comprises an agent that prevents or reduces the post-implantation hyperplastic response. 
     
     
         11 . The in vivo supporting device of  claim 1 , wherein the in vivo supporting device is a heart failure closure device for atrial septal defect (ASD), patent foramen ovale (PFO) or ventricular septal defect (VSD) or a device for fistula and aneurysm closures. 
     
     
         12 . The in vivo supporting device of  claim 1 , wherein said biodegradable polymer coating is a multi-layer coating comprising an outer layer having a first degradation rate and an inner layer having a second degradation rate, wherein said first degradation rate is faster than said second degradation rate. 
     
     
         13 . The in vivo supporting device of  claim 12 , wherein said outer layer comprises a first agent that prevents or reduces the post-implantation hyperplastic response. 
     
     
         14 . The in vivo supporting device of  claim 13 , wherein said first agent is paclitaxel or sirolimus or other non proliferant. 
     
     
         15 . The in vivo supporting device of  claim 14 , wherein said inner layer comprises a second agent that prevents or reduces the post-implantation hyperplastic response. 
     
     
         16 . The in vivo supporting device of  claim 15 , wherein said second agent is paclitaxel, or sirolimus. 
     
     
         17 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold is a self-expandable scaffold that expands after implantation and wherein said biodegradable polymer coating is an elastic coating that expands with said biodegradable metal scaffold. 
     
     
         18 . The in vivo supporting device of  claim 17 , wherein said biodegradable polymer coating comprises paclitaxel, sirolimus or stem cells. 
     
     
         19 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold is a self-expandable scaffold that expands after implantation and wherein said biodegradable polymer coating is a coating that forms fissures when said biodegradable metal scaffold is expands in vivo. 
     
     
         20 . The in vivo supporting device of  claim 19 , wherein said multi-layer biodegradable polymer coating is permeable to body fluid. 
     
     
         21 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold constitutes less than 50 wt % of said supporting device. 
     
     
         22 . (canceled) 
     
     
         23 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold has a magnesium content that is less than 50 wt % of said supporting device. 
     
     
         24 . The in vivo supporting device of  claim 1 , wherein said biodegradable metal scaffold comprises magnesium as a constituent that is less than 50% w/w, less than 50% w/v or less than 50% v/v of said scaffold. 
     
     
         25 . The in vivo supporting device of  claim 1 , wherein said biodegradable polymer coating comprises a biodegradable polymer and metal particles. 
     
     
         26 . The in vivo supporting device of  claim 25 , wherein said metal particles are selected from particles of iron, magnesium, tantalum, zinc and alloys thereof. 
     
     
         27 . The in vivo supporting device of  claim 25 , wherein said metal particles are nanoparticles. 
     
     
         28 . The in vivo supporting device of  claim 1 , wherein said biodegradable polymer is an elastic coating that allows the device to be used in non-conforming lesions. 
     
     
         29 - 30 . (canceled)