Non-occluding balloon for cardiovascular drug delivery

A method for fabricating a non-occluding medical balloon for use on a catheter device, the method comprising:

• providing a balloon preform having a sidewall defining a central passage and having at least one inflation passage disposed in the sidewall;
• blowing the balloon preform into an expanded balloon;
• supporting the inner surface of the expanded balloon;
• sealing, at each end of the balloon, the passage walls together across a portion of the inflation passage and forming a perfusion port through the sidewall into the central passage;
• and
• removing the support from the inner surface of the balloon.

A non-occluding medical balloon apparatus comprising:

• a proximal preform portion including a sidewall having an outer surface, an inner surface defining a central passage, and at least one inflation passage disposed between the outer and inner surfaces;
• a nosecone defining an extension of the central passage;
• an expanded balloon portion disposed between, and connected to, the proximal preform portion and the nosecone, the expanded balloon portion including:
• a substantially cylindrical central portion having a nominal diameter that is greater than a proximal diameter of the proximal preform portion and greater than a distal diameter of the nosecone;
• a proximal end portion connected between the central portion and the proximal preform portion and tapering from the nominal diameter of the central portion to the proximal diameter of the proximal preform portion;
• a distal end portion connected between the central portion and the nosecone and tapering from the nominal diameter of the central portion to the distal diameter of the nosecone;
• each of the proximal end portion, central portion and distal end portion including respective expanded sidewalls having respective expanded outer surfaces, respective expanded inner surfaces defining respective expanded central passages, and at least one respective expanded inflation passage disposed between the respective outer and inner expanded surfaces;
• and
• wherein each inflation passage of the proximal preform portion is in fluid communication with a corresponding expanded inflation passage of the expanded balloon portion;
• wherein, on each of the proximal and distal end portions of the expanded balloon portion, areas of the outer and inner sidewalls are sealed together;
• wherein, within each sealed-together area of the outer and inner sidewalls, a hole is cut through the sidewall into the expanded central passage to form perfusion port;
• and
• a fluid-tight guide wire lumen is disposed through the central passage of the proximal preform portion, the respective expanded central passages of the balloon portion and the central passage of the nose cone.