Narrow profile composition-releasing expandable medical balloon catheter

Abstract

The present invention relates to a composition-eluting balloon catheter ( 100 ) having a proximal ( 20 ) and distal ( 15 ) end, comprising an elongated catheter tube ( 6 ) with an inflation lumen ( 7 ) extending therewithin and at least one inflatable balloon ( 4 ) towards the distal end ( 15 ) in fluid communication with the inflation lumen ( 7 ), wherein the balloon ( 4 ) in the uninflated condition is provided as one or a plurality of folded wings ( 10′, 10 ″), and composition ( 12′, 12 ″) is provided essentially exclusively within the folds of the wings ( 10′, 10 ″), wherein the balloon ( 4 ) in the uninflated condition is further provided with a relief structure ( 30 ) comprising at least one groove on the outside of the folded wings ( 10′, 10 ″), configured to substantially reduce in depth in an inflated state of the balloon ( 4 ), and whereby the at least one groove is essentially devoid of composition ( 12′, 12 ″).

1 - 17 . (canceled) 
     
     
         18 . A composition-eluting balloon catheter ( 100 ) having a proximal ( 20 ) and distal ( 15 ) end, comprising an elongated catheter tube ( 6 ) with an inflation lumen ( 7 ) extending therewithin and at least one inflatable balloon ( 4 ) having a central longitudinal balloon axis (B-B′) towards the distal end ( 15 ) in fluid communication with the inflation lumen ( 7 ), wherein:
 the balloon ( 4 ) in the uninflated condition is configured as a one or a plurality of folded wings ( 10 ′,  10 ″), and 
 composition ( 12 ′,  12 ″) is provided essentially exclusively within the folds of the wings ( 10 ′,  10 ″) in such a manner that release of the composition is reduced or prevented until after inflation of the balloon has commenced, 
 wherein the balloon ( 4 ) in the folded condition is further provided with a relief structure ( 30 ) comprising at least one groove on the outside of the folded wings ( 10 ′,  10 ″), configured to substantially reduce in depth in an inflated state of the balloon ( 4 ), 
 wherein the at least one groove ( 32 ) crosses the outer edge of at least one folded wing ( 10 ′,  10 ″) and 
 whereby each and every groove is essentially devoid of composition ( 12 ′,  12 ″). 
 
     
     
         19 . Balloon catheter according to  claim 18 , wherein the at least one groove ( 32 ) has a directional component which is transverse to the central longitudinal axis (B-B′) of the balloon ( 4 ). 
     
     
         20 . Balloon catheter according to  claim 18 , whereby the at least one groove ( 32 ) extends at a predetermined angle with regard to the longitudinal axis of the balloon ( 4 ). 
     
     
         21 . Balloon catheter according to  claim 18 , wherein at least two grooves ( 33 ,  34 ) extend from the distal end ( 15 ) to the proximal end ( 20 ) of the balloon ( 4 ) and cross each other. 
     
     
         22 . Balloon catheter according to  claim 18 , whereby the at least one groove ( 32 ) is ring or oval shaped, and has a directional component which is transverse to a central longitudinal axis (B-B′) of the balloon ( 4 ). 
     
     
         23 . Balloon catheter according to  claim 18 , wherein the composition comprises paclitaxel. 
     
     
         24 . Balloon catheter according to  claim 18 , wherein the composition comprises:
 one or more of paclitaxel, melatonin, thalidomide, sirolimus, zotarolimus, everolimus, biolimus, 17-β estradiol, actinomucin D, docetaxel, and/or any derivatives thereof, or   one or more of cis-platin, paclitaxel, etoposide, amasecrine, teniposide, irinotecan, toptecan, doxorubicin, epirubicin, bleomycin, and/or any derivatives thereof, or   one or more of penicillin, erythromycin, ampicillin, clindamycin, tetracycline, streptomycin, amoxicillin, cefaclor, lincomycin, clarithromycin, cephalosporins, azithromycin, doxycycline, ciprofloxacin, cefuroxime, levofloxacin, chloramphenicol, minocycline, penicillins, vancomycin, kanamycin, gentamicins, neomycin, ceftriaxone, bacitracin, oxacillin, cloxacillin, cephalothin, amoxicillin, dicloxacillin, aminoglycosides, methicillin, carbenicillin, gentamicin, trimethoprim, oxytetracycline, rifampin, tetracyclines, polymyxins, cephalexin, chlortetracycline, metronidazole and/or any derivatives thereof.   
     
     
         25 . Balloon catheter according to  claim 18 , wherein the balloon is provided with a hydrophilic coating onto which the composition ( 12 ′,  12 ″) is at least partially disposed. 
     
     
         26 . Balloon catheter according to  claim 25 , wherein the hydrophilic coating is any of polyvinylpyrrolidone (PVP) or copolymers containing N-vinylpyrrolidone, poly (meth) acrylic acid or copolymers containing (meth) acrylic acid or (meth) acrylic acid esters, polyacrylamides, polyvinylalcohol and copolymers of partially saponified vinylacetate copolymers, polyethylenglycol, polyvinylmethylether, polyvinylmethylether-maleic anhydride and copolymers containing maleic-anhydride or maleic-acidesters or copolymers containing vinylmethylether, or copolymers thereof, or water soluble polysaccharides or derivatives thereof such as carboxymethylcellulose (CMC) or hydroxyethylcellulose or Xanthane or a derivative thereof to the liquid for wetting a hydrophilic coating. 
     
     
         27 . Balloon catheter according to  claim 18 , further provided with a stent. 
     
     
         28 . Balloon catheter according to  claim 27 , wherein the stent is made from any of stainless steel, tantalum, titanium alloy, nitinol, cobalt alloy, cobalt-chromium-nickel alloy, cobalt-chromium alloy, cobalt-chromium F562, or magnesium alloys. 
     
     
         29 . Process for obtaining a composition-eluting balloon catheter ( 100 ) having a proximal ( 20 ) and distal ( 15 ) end, comprising an elongated catheter tube ( 6 ) with an inflation lumen ( 7 ) extending therewithin and at least one inflatable balloon ( 4 ) having a central longitudinal balloon axis (B-B′) towards the distal end ( 15 ) in fluid communication with the inflation lumen ( 7 ), wherein the balloon ( 4 ) in the uninflated condition is configured as one or a plurality of folded wings ( 10 ′,  10 ″) comprising the steps:
 a) applying the composition ( 12 ′,  12 ″) at least partially over one or both surfaces of the balloon wing; 
 b) folding the balloon wings ( 10 ′,  10 ″) around the central longitudinal balloon axis (B-B′) such that applied composition ( 12 ′,  12 ″) is disposed within the folds of the wings; 
 c) removing excess composition ( 12 ′,  12 ″) from the surface of the folded balloon; and 
 d) applying a relief structure ( 30 ) to the balloon ( 4 ) in the folded condition, comprising at least one groove on the outside of the folded wings ( 10 ′,  10 ″), configured to substantially reduce in depth in an inflated state of the balloon ( 4 ), wherein the at least one groove ( 32 ) crosses the outer edge of at least one folded wing ( 10 ′,  10 ″) and wherein each and every groove is essentially devoid of composition ( 12 ′,  12 ″). 
 
     
     
         30 . Process according to  claim 29 , wherein:
 one or both surfaces of the balloon wings ( 10 ′,  10 ″) are at least partially with a hydrophilic coating, prior to application of the composition; and   the composition ( 12 ′,  12 ″) is applied in a solution of organic solvent preferably methanol, propanol, acetone, or ethyl acetate, more preferably ethanol, at least partially over the coated surface;   
     
     
         31 . Process according to  claim 29 , wherein the at least one groove ( 32 ) has a directional component which is transverse to the central longitudinal axis (B-B′) of the balloon ( 4 ). 
     
     
         32 . Process according to  claim 29 , wherein the at least one groove ( 32 ) extends at a predetermined angle with regard to the longitudinal axis of the balloon ( 4 ). 
     
     
         33 . Process according to  claim 29 , wherein at least two grooves ( 33 ,  34 ) extend from the distal end ( 15 ) to the proximal end ( 20 ) of the balloon ( 4 ) and cross each other. 
     
     
         34 . Process according to  claim 29 , wherein the at least one groove ( 32 ) is ring or oval shaped, and has a directional component which is transverse to a central longitudinal axis (B-B′) of the balloon ( 4 ). 
     
     
         35 . A composition-eluting balloon catheter ( 100 ) obtainable by a process according to any of  claims 29  to  34 . 
     
     
         36 . Balloon catheter according to claim any of  claims 18  to  28 , further provided with a guidewire lumen for a rapid exchange catheter or an over the wire catheter mode of operation.