US 7,722,568 B2Granted

Expandable intra-aortic balloon pump sheath

AssigneeOnset Medical Corporation

InventorsJay A. Lenker, Joseph Bishop, George F. Kick, Edward J. Nance

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Abstract

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Claims20

Dependent claims

A method of instrumenting the aorta of a patient for the purpose of introducing and removing an intra-aortic balloon pump catheter comprising the steps of:

routing a guidewire into the aorta from a femoral or iliac artery access point on a patient;
inserting a sheath with a pre-inserted dilator into the patient's femoral or iliac artery over the guidewire, and advancing the sheath to a treatment or diagnostic site within the aorta, wherein the sheath comprises a distal expandable region which is collapsed in diameter;
introducing an intra-aortic balloon pump catheter into the aorta of the patient through the sheath;
performing counterpulsation with the intra-aortic balloon pump catheter;
expanding a dilator within the sheath, thus expanding the distal region of the sheath, wherein a frill-size lumen exists within at least the distal region of the sheath;
collapsing the dilator by an action applied at the proximal end of said dilator;
withdrawing the dilator from the distal, expandable region of the sheath;
withdrawing the deflated intra-aortic balloon pump catheter into the distal, expandable region of the sheath;
and
removing the sheath and intra-aortic balloon pump catheter from the patient.

7 more elements

A method of introducing and removing an intra-aortic balloon pump catheter comprising:

inserting at least a portion of an introducer into a patient's femoral or iliac artery, the introducer comprising a sheath, a pre-mounted dilator, and a intra-aortic balloon pump, the sheath comprising a collapsed distal region, the dilator comprising a dilator balloon positioned within the distal region of the sheath, the intra-aortic balloon pump comprising a pump balloon positioned distal to the dilator and the distal region of the sheath;
advancing the pump balloon to a treatment or diagnostic site within the aorta;
performing counterpulsation with the intra-aortic balloon pump catheter;
advancing the collapsed distal region of the sheath to the treatment or diagnostic site;
inflating the dilator balloon, thereby expanding the collapsed distal region of the sheath;
deflating the dilator balloon;
withdrawing the dilator balloon from the expanded distal region of the sheath;
withdrawing the pump balloon into the expanded distal region of the sheath;
and
removing the sheath and pump balloon from the patient.

7 more elements

Dependencies are inferred from the claim text.

Facts

Application: 12/021,097Filed 28 Jan 2008 · us provisional application
Priority: 29 Jan 2007
Published: US 2008/0183136 A131 Jul 2008
Granted: 25 May 2010
Term ends: Not estimatedThe source records don’t support an estimate.

Classification3 codes

A61M 25/0662
Body-piercing guide needles or the like: guide tubes
A61M 2025/0024
By the form of the lumen, e.g. cross-section, variable diameter: expandable catheters or sheaths
A61M
Devices for delivering substances into the body