Drug eluting scaffold for kidney-related disease

Abstract

Methods of treating renal cancers and other kidney-related inflammatory disorders with a bioabsorbable polymer scaffold (such as a stent) are described. The treatments are provided as alternative to complete or partial surgical removal of a diseased kidney.

1 - 28 . (canceled) 
     
     
         29 . A method of treating a kidney-related disease in a human patient comprising:
 a. deploying a scaffold comprising a first therapeutic agent in the lumen of a blood vessel with direct access to a diseased kidney;   b. delivering a therapeutically effective amount of the first therapeutic agent from the scaffold to the diseased kidney over an extended period of time,   wherein the radial strength of the scaffold is sufficient to secure the scaffold in the lumen of the blood vessel without expanding or without significantly expanding the size of the lumen of the blood vessel.   
     
     
         30 . The method of  claim 29 , wherein after deployment of the scaffold the diameter of the lumen of the blood vessel increases by an amount selected from the group consisting of about 15% or less, about 10% or less, and about 5% or less. 
     
     
         31 . The method of  claim 29 , wherein after deployment of the scaffold the diameter of the lumen of the blood vessel retains its original size. 
     
     
         32 . The method of  claim 29 , wherein the scaffold is a bioabsorbable polymer scaffold. 
     
     
         33 . The method of  claim 32 , wherein the bioabsorbable polymer scaffold comprises a polymer matrix coated upon a polymer substrate. 
     
     
         34 . The method of  claim 33 , wherein the polymer substrate and/or the polymer matrix comprise the first therapeutic agent. 
     
     
         35 . The method of  claim 33 , wherein the polymer substrate has a crystallinity selected from the group consisting of about 20% to 60%, about 30% to 60%, about 35% to 45%, about 40% to 60%, and about 40% to 50%. 
     
     
         36 . The method of  claim 29 , wherein the kidney-related disease is selected from the group consisting of a kidney cancer and a kidney-related inflammatory disease. 
     
     
         37 . The method of  claim 36 , wherein the kidney cancer is selected from the group consisting of renal cell carcinoma, urothelial cell carcinoma, squamous cell carcinoma, juxtaglomerular cell tumor (reninoma), angiomyolipoma, renal oncocytoma, bellini duct carcinoma, clear-cell sarcoma, mesoblastic nephroma, Wilms' tumor, mixed epithelial stromal tumor, clear cell adenocarcinoma, transitional cell carcinoma, inverted papilloma, renal lymphoma, teratoma, carcinosarcoma, and carcinoid tumor of the renal pelvis. 
     
     
         38 . The method of  claim 36 , wherein the kidney-related inflammatory disease is selected from the group consisting of glomerulonephritis, interstitial nephritis, tubulo-interstitial nephritis, pyelonephritis, lupus nephritis, IgA nephritis, and chronic allograft rejection. 
     
     
         39 . The method of  claim 29 , wherein the kidney-related disease is selected from the group consisting of chronic kidney disease, diabetic nephropathy, focal segmental glomerulosclerosis, reflux nephropathy, glomerulonephrosis and polycystic renal disease. 
     
     
         40 . The method of  claim 29 , wherein the diameter of the scaffold is selected from the group consisting of 2 to 8 mm, 4 to 7 mm, 3 to 5 mm, and 2.5 to 3.5 mm. 
     
     
         41 . The method of  claim 29 , wherein the length of the scaffold is selected from the group consisting of 8 to 38 mm, 8 to 12 mm, 12 to 18 mm, 15 to 18 mm, 18 to 24 mm, and 18 to 38 mm. 
     
     
         42 . The method of  claim 29 , wherein the scaffold is tubular. 
     
     
         43 . The method of  claim 29 , wherein the scaffold is a stent. 
     
     
         44 . The method of  claim 29 , wherein the extended period of time for delivery of the first therapeutic agent is selected from the group consisting of at least 3 months, at least 6 months, at least 9 months, at least 12 months, at least 18 months, at least 24 months, and at least 36 months. 
     
     
         45 . The method of  claim 29 , wherein the first therapeutic agent is selected from the group consisting of everolimus, halofuginone, ruboxistaurin, sirolimus, zotarolimus, temsirolimus, pimecrolimus and biolimus. 
     
     
         46 . The method of  claim 29 , wherein the bioabsorbable polymer scaffold comprises a bioabsorbable polymer selected from the group consisting of poly(DL-lactide), poly(L-lactide), poly(L-lactide), poly(L-lactide-co-D,L-lactide), polymandelide, polyglycolide, poly(lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), poly(ester amide), poly(ortho esters), poly(glycolic acid-co-trimethylene carbonate), poly(D,L-lactide-co-trimethylene carbonate), poly(trimethylene carbonate), poly(lactide-co-caprolactone), poly(glycolide-co-caprolactone), poly(tyrosine ester), polyanhydride, derivatives thereof, and combinations thereof. 
     
     
         47 . The method of  claim 29 , wherein the scaffold further comprises a second therapeutic agent, and the method further comprises a step of delivering a therapeutically effective amount of the second therapeutic agent from the scaffold to the diseased kidney over an extended period of time. 
     
     
         48 . The method of  claim 47 , wherein the second therapeutic agent is selected from the group consisting of halofuginone, ruboxistaurin, sirolimus, everolimus, zotarolimus, temsirolimus, pimecrolimus and biolimus.