Narrow profile composition-releasing expandable medical balloon catheter

Inventors

Horvers, Ronald Adrianus Maria

Assignees

Blue Medical Devices BV

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Publication Number

US-9610427-B2

Patent

Publication Date

2017-04-04

Expiration Date


Abstract

A process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of a one or more foldable wings with a hydrophilic coating, applying a composition as a coating on the coated surface and providing the composition within a fold of the one or more foldable wings, and folding the one or more foldable wings to seal the composition by the one or more foldable wings to prevent/reduce its release until after inflation of the balloon. Another process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of the one or more foldable wings with a hydrophilic coating-composition mixture and providing the composition by the one or more foldable wings, and folding the one or more foldable wings to seal the composition between the fold of the one or more foldable wings to prevent/reduce its release until after an inflation of the balloon.

Core Innovation

The invention is directed to a process for making a folded composition-eluting balloon catheter in which an inflatable balloon is configured as one or more foldable wings in an uninflated condition. The wings are folded around a central longitudinal balloon axis to provide a folded composition-eluting balloon, and a coating and a composition are applied such that the composition is provided essentially exclusively within a fold of the foldable wings.

To control release, the folded condition includes a relief structure comprising at least one groove on the outside of the one or more foldable wings. The groove is configured to substantially reduce in depth in an inflated condition and crosses an outer edge of at least one foldable wing, so that the relief structure seals the composition between the folds to prevent and/or reduce release of the composition until after inflation.

The process further applies a hydrophilic coating on one or both surfaces of the foldable wings, in combination with a composition applied essentially exclusively within a fold. The relief structure may be formed by groove features including a directional component transverse to the central longitudinal balloon axis or by crimping a pattern on the folded balloon exterior.

Claims Coverage

The document includes two independent claims. Both claims cover a process that coats foldable-wing balloon surfaces with a hydrophilic coating, positions a composition essentially exclusively within the fold, folds the wings around a central longitudinal balloon axis, and uses a relief structure with grooves configured to reduce in depth upon inflation to seal the composition until after inflation.

Relief-structure sealing of fold-contained composition until after inflation

Form a folded composition-eluting balloon catheter in which the balloon in a folded condition comprises a relief structure comprising at least one groove on the outside of one or more foldable wings, configured to substantially reduce in depth in an inflated condition of the balloon; the groove crosses an outer edge of at least one foldable wing so the relief structure seals the composition between the fold of the one or more foldable wings to prevent and/or reduce a release of the composition until after an inflation of the balloon.

Hydrophilic-coating and fold-exclusive composition placement on foldable wings

Coat one or both surfaces of the one or more foldable wings with a hydrophilic coating such that one or both surfaces are provided with a coated surface, and apply a composition as a coating on the coated surface such that the composition is provided essentially exclusively within a fold of the one or more foldable wings.

Folding around central longitudinal balloon axis to provide folded composition-eluting balloon

After coating and applying the fold-exclusive composition, fold the one or more foldable wings around the central longitudinal balloon axis, thereby providing a folded composition-eluting balloon.

Relief-structure grooves configured to substantially reduce in depth upon inflation and cross wing outer edge

Provide a balloon that in a folded condition comprises a relief structure comprising at least one groove on the outside of the one or more foldable wings configured to substantially reduce in depth in an inflated condition of the balloon, wherein the at least one groove crosses an outer edge of at least one folded wing.

Coating with mixture comprising hydrophilic coating and composition, fold-exclusive after coating

Coat one or both surfaces of the one or more foldable wings with a mixture comprising a hydrophilic coating and a composition, such that the composition is provided essentially exclusively within a fold of the one or more foldable wings.

Across both independent claims, the inventive coverage centers on placing a composition essentially exclusively within folds of foldable wings coated with a hydrophilic coating, and employing an external groove-based relief structure that substantially reduces in depth upon inflation to seal the composition between folds until after inflation.

Stated Advantages

Reduce and/or prevent release of the composition until after inflation of the balloon.

Substantially reduce in depth of the groove structure in the inflated condition to support sealing behavior.

Documented Applications

Use in a composition-eluting balloon catheter configured with a foldable-wing balloon and a relief structure to seal a composition until after inflation.

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