Catheter system including an embolism protection device

摘要

The present invention relates to a device for the prevention of air embolisms during a catheterization procedure. The device includes a bulb element configured to secure to a sheath assembly. The bulb element includes a flexible wall, including a proximal section and a distal section, and an interior chamber in fluid communication with a pressurized fluid source. The proximal section of the bulb element includes a proximal hub, and the distal section of the bulb element includes a distal hub. The bulb element is collapsible, under the action of an external force, from a first, relaxed state in which the interior chamber has a first volume, to a second, collapsed state in which the interior chamber has a second volume less than the first volume, and wherein the bulb element is configured to assume its first, relaxed state in the absence of the external force.

主权项

1. A device for use in combination with a sheath assembly for inhibiting air embolisms during a catheterization procedure, the sheath assembly including an interior lumen having a proximal opening, the device comprising:
a seal liquid source containing a seal liquid; a bulb element configured to be secured to the sheath assembly, the bulb element including:
a proximal section and a distal section and including a flexible, resilient outer wall surrounding an interior chamber in fluid communication with the seal liquid source;
a proximal hub on the proximal section of the bulb element, the proximal hub including a proximal hub opening;a distal hub on the distal section of the bulb element opposite the proximal hub, the distal hub including a distal hub opening and being configured for coupling the device to the sheath assembly, the interior chamber being positioned between the proximal and distal hubs; wherein the proximal and distal hub openings are positioned such that, when the device is coupled to the sheath assembly, the proximal and distal hub openings are generally axially aligned with the proximal opening of the interior lumen of the sheath assembly; wherein the bulb element is configured to allow introduction of the seal liquid into the interior chamber to substantially fill the interior chamber with the seal liquid thereby inhibiting the introduction of gas into the interior lumen of the sheath as an elongate medical device is inserted through the interior chamber and into the interior lumen of the sheath; and wherein the bulb element is collapsible, under the action of an external force, from a first, relaxed state in which the interior chamber has a first volume, to a second, collapsed state in which the interior chamber has a second volume that is less than the first volume and the seal liquid and gas in the interior chamber are purged from the interior chamber to the seal liquid source, wherein the bulb element is configured to assume its first, relaxed state in the absence of the external force to at least partially fill the interior chamber from the seal liquid source.