Medical balloon coated with therapeutic agent, carboxylic acid, and salt thereof
Inventors
D'Onofrio, Simone • Bellucci, Federica • PELLEGRINI, PAOLO • Pallavicini, Piersandro
Assignees
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Publication Number
US-9675734-B2
Publication Date
2017-06-13
Expiration Date
Abstract
A coated medical balloon that includes a polymeric material having a surface with a therapeutic agent-containing mixture coated thereon, wherein the mixture includes a therapeutic agent, an unsaturated carboxylic acid, and a salt of the unsaturated carboxylic acid.
Core Innovation
The invention relates to a coated medical balloon and a balloon catheter in which a polymeric balloon surface carries a therapeutic agent-containing mixture. The mixture is coated on the surface and includes a therapeutic agent, an unsaturated carboxylic acid, an alkali metal salt of the unsaturated carboxylic acid, and an optional excipient. In certain embodiments, the unsaturated carboxylic acid is selected from fatty acids having a (C6-C20) carbon chain with a single cis C=C bond.
In certain embodiments, the coating mixture further specifies an acid to salt ratio within a range of 80:20 to 20:80, or within a range of 60:40 to 40:60. The therapeutic agent is identified as Taxane in some embodiments, including paclitaxel.
The described mixture and ratio constraints are used to support therapeutic agent transfer to a diseased vessel wall while reducing particulate and supporting uniform coating manufacturing. Comparative release and in vitro cytotoxicity testing are described in the document.
Claims Coverage
Independent claims are present for coated medical balloons, coated balloon catheters, and methods of reducing the amount of therapeutic agent on a coated balloon. Across these independent claims, the main inventive features include the coating mixture composition, the structural restriction on the unsaturated carboxylic acid, and acid-to-salt ratio limitations in certain claims.
Therapeutic agent-containing coating mixture on a polymeric balloon surface
A coated medical balloon comprising a polymeric material having a surface with a therapeutic agent-containing mixture coated thereon, wherein the mixture comprises a therapeutic agent, an unsaturated carboxylic acid, an alkali metal salt of the unsaturated carboxylic acid, and an optional excipient.
Unsaturated carboxylic acid defined by cis C=C bond in C6-C20 fatty acid
The unsaturated carboxylic acid is selected from fatty acids having a (C6-C20) carbon chain with a single cis C=C bond.
Acid-to-salt ratio constrained for the therapeutic mixture
A coated medical balloon comprising a surface having a therapeutic agent-containing mixture coated thereon, wherein the mixture comprises a therapeutic agent, an unsaturated carboxylic acid, a salt of the unsaturated carboxylic acid, and an optional excipient, wherein the ratio of acid to salt is within a range of 60:40 to 40:60.
Distal inflatable polymeric balloon catheter with the therapeutic mixture
A balloon catheter comprising an elongated catheter shaft having proximal and distal ends and an inflatable balloon located close to the distal end, wherein the balloon comprises a polymeric material having a surface with a therapeutic agent-containing mixture coated thereon.
Method of coating to reduce therapeutic agent amount on a coated balloon
A method of reducing the amount of therapeutic agent on a coated balloon by combining components comprising a therapeutic agent, an unsaturated carboxylic acid, a salt of the unsaturated carboxylic acid, and an optional excipient to form a mixture, and coating the mixture onto the surface of the medical balloon.
Across the independent claims, the document claims coated medical balloons and balloon catheters with polymeric surfaces coated by a therapeutic agent-containing mixture that includes an unsaturated carboxylic acid and its alkali metal salt, optionally with an excipient, where the unsaturated carboxylic acid is restricted to C6-C20 fatty acids having a single cis C=C bond. Additional independent claim coverage narrows the acid-to-salt ratio and includes methods of reducing therapeutic agent amount by forming the mixture and coating it onto the balloon surface.
Stated Advantages
Reduced particulate.
Improved drug transfer to a diseased vessel wall.
Improved release characteristics supported by comparative release testing.
Uniform coating manufacturing.
Higher in vitro cytotoxicity versus a reference coating, including paclitaxel savings at lower coating density.
Documented Applications
Therapeutic agent delivery to a diseased vessel using a balloon catheter, by advancing the catheter and inflating the balloon to contact the vessel wall and deliver the agent from the balloon surface.
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