Pediatric application of bioabsorbable polymer stents in infants and children with congenital heart defects

Abstract

Methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents are described. The treatments reduce or eliminate the adverse affects of congenital heart defects or may be palliative.

1 . (canceled) 
     
     
         2 . A method of treating peripheral pulmonary artery stenosis in a human infant or child patient comprising:
 deploying one or more bioabsorbable polymer scaffolds in one or more narrowed segments in one or more peripheral branches of a pulmonary artery of a human infant or child in need of treatment of peripheral pulmonary stenosis,   wherein the deployed bioabsorbable scaffolds provide support at the segments at an increased diameter to allow increased blood flow which facilitates development of the lungs of the patient for a period of time,   wherein the deployed scaffolds are configured to eventually completely absorb away.   
     
     
         3 . The method of  claim 2 , wherein the one or more scaffolds maintain a radial strength of at least 200 mmHg for at least 6 months. 
     
     
         4 . The method of  claim 2 , wherein prior to deployment, the scaffolds are constrained at a reduced diameter by a sheath and are deployed by removing the sheath and allowing the scaffolds to self-expand to the increased diameter. 
     
     
         5 . The method of  claim 2 , wherein prior to deployment, the scaffolds are constrained at a reduced diameter around a balloon and are deployed by expanding the balloon which expands the scaffolds to the increased diameter. 
     
     
         6 . The method of  claim 2 , further comprising implanting an additional bioabsorbable scaffold at the site of deployment of at least one of the scaffolds after it has partially or completely absorbed, wherein the additional scaffold is deployed at a greater diameter than (new) the absorbed scaffold to accommodate for growth in the pulmonary branch. 
     
     
         7 . The method of  claim 2 , further comprising performing surgical repair in the heart 1 to 2 years after deployment of the scaffolds. 
     
     
         8 . The method of  claim 2 , wherein one or more of the bioabsorbable polymer scaffolds comprise poly(L-lactide-co-glycolide). 
     
     
         9 . The method of  claim 2 , wherein one or more of the bioabsorbable polymer scaffolds comprises poly(L-lactide). 
     
     
         10 . The method of  claim 2 , wherein a radial strength of the scaffold at deployment is at least 400 mmHg. 
     
     
         11 . The method of  claim 2 , wherein a radial strength of the scaffold at deployment is at least 600 mmHg. 
     
     
         12 . The method of  claim 2 , wherein deployment comprises self-expansion of the scaffold from a compressed state to a target diameter. 
     
     
         13 . The method of  claim 12 , wherein the target diameter is 2 to 5 mm. 
     
     
         14 . The method of  claim 12 , wherein the target diameter is a diameter that provides normal lung development in the patient. 
     
     
         15 . The method of  claim 2 , wherein the period of time is at least 3 months. 
     
     
         16 . The method of  claim 2 , wherein the deployed scaffolds are configured to completely absorb away in 1 to 2 years.