Local delivery of drugs from self assembled coatings
Inventors
Esfand, Roseita • Santerre, J. Paul • Tjahyadi, Sylvia • Ilagan, Bernadette
Assignees
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Abstract
The invention relates to oligofluorinated coatings and their use in drag delivery. The oligofluorinated coatings are compositions comprising formula (XVII). These coatings are used in a method of delivering a biologically active agent to a tissue surface in a mammalian tissue. This method occurs by contacting the surface with the coating including an oligofluorinated oligomer and a biologically active agent wherein the coating resides on the tissue surface and release the biologically active agent to the tissue surface.
Core Innovation
The disclosed subject matter provides a method for delivering paclitaxel to a site in a vessel using a balloon catheter having a surface with a coating comprising paclitaxel and an oligofluorinated oligomer of formula (III). The balloon catheter is inserted into the vessel, positioned near the site, deployed into a deformed and expanded configuration to contact the vessel wall, and removed while leaving at least a portion of the coating remaining at the site in the absence of an implanted medical device.
The oligofluorinated oligomer of formula (III) includes oligo as polytetramethyleneoxide, B as a hard segment formed from hexamethylene diisocyanate, n as an integer from 1 to 10, and F_T as a polyfluoroorgano group formed from 1H,1H,2H,2H-perfluoro-1-octanol. Prior to deploying the balloon, from 45 to 95% (w/w) of the paclitaxel is retained on the balloon.
The description also characterizes a transient medical device coating as self-assembled and including an oligofluorinated oligomer with a fluorinated domain acting as a shield. The coating is formed on a device surface and is configured to remain associated with a mammalian tissue surface when the device is removed, and the document also mentions hydrophobic antiproliferative drugs, including paclitaxel and rapamycin macrolides, as well as drug eluting balloon applications.
Claims Coverage
The independent claims center on balloon catheter delivery using a coating comprising paclitaxel and a specified oligofluorinated oligomer of formula (III), together with a requirement that 45 to 95% (w/w) of paclitaxel is retained on the balloon prior to deployment. Four inventive features are represented across the provided claim coverage.
Paclitaxel delivery using an oligofluorinated balloon coating
A method for delivering paclitaxel to a site in a vessel using a balloon catheter having a coating comprising paclitaxel and an oligofluorinated oligomer of formula (III), where oligo is polytetramethyleneoxide, B is a hard segment formed from hexamethylene diisocyanate, n is an integer from 1 to 10, and F_T is a polyfluoroorgano group formed from 1H,1H,2H,2H-perfluoro-1-octanol; inserting the balloon catheter into the vessel; positioning near the site; deploying into a deformed and expanded configuration to contact the vessel wall; and removing the balloon catheter with at least a portion of the coating remaining at the site in the absence of an implanted medical device.
Paclitaxel retention on the balloon prior to deployment
Prior to deploying the balloon catheter to contact the vessel wall, from 45 to 95% (w/w) of the paclitaxel is retained on the balloon.
Inhibiting restenosis at a vessel site with the same balloon coating
A method for inhibiting restenosis at a site in a vessel using a balloon catheter having a coating comprising paclitaxel and an oligofluorinated oligomer of formula (III), with the same defined oligomer features; inserting; positioning near the site; applying paclitaxel to the vessel wall by deploying into a deformed and expanded configuration; and removing the balloon catheter with at least a portion of the coating remaining at the site.
Transient medical device coating with fluorinated shield
A self-assembled transient medical device coating includes an oligofluorinated oligomer with a fluorinated domain acting as a shield, is formed on a device surface, and is configured to remain associated with a mammalian tissue surface when the device is removed.
The claims are directed to balloon catheter delivery and restenosis inhibition using a coating containing paclitaxel and a specifically defined oligofluorinated oligomer of formula (III), with defined pre-deployment paclitaxel retention and post-removal retention of at least a portion of the coating at the site.
Stated Advantages
Reducing blood activation.
Reducing premature release.
Potential excretable behavior of the coating to reduce inflammatory risk from residual carrier material.
Documented Applications
Drug eluting balloon applications for balloon catheter coatings including paclitaxel retention/release and biological evaluation.
Methods for inhibiting restenosis at a site in a vessel using a balloon catheter coating comprising paclitaxel and the specified oligofluorinated oligomer.
Local drug delivery of paclitaxel to a vessel wall from a transient balloon catheter, with at least a portion of the coating remaining at the site after removal.
Reducing protein adsorption, for example BSA on coated nylon films.
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