Direct access atherectomy devices and methods of use

• US 8,551,112 B2
• Filed: 06/25/2012
• Issued: 10/08/2013
• Est. Priority Date: 01/14/2002
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Thornton, Peter
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/532,632
• Publication Number:
  US 20120265225A1
• Time in Patent Office: 470 Days
• Field of Search: 606/127, 606/194, 606/200, 606/159, 600/104
• US Class Current: 606/127
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30

Abstract

An atherectomy device has cannula systems having lumens adapted for insertion of a blood filter and an atherectomy catheter useful for performing atherectomy directly on a patient'"'"'s cardiovascular tissue. Other embodiments include a lumen for arterial perfusion useful in providing oxygenated blood to the aorta during cardiopulmonary bypass. The distal end of the atherectomy catheter includes an assembly that has a pincer, a loop with or without a mesh, laser, hydraulics, or other suitable mechanism adapted for removing atheroma from a cardiac or vascular tissue. Methods of using the systems for vascular atherectomy are also disclosed herein.

Claims

1. A device for accessing the interior of a blood vessel from the exterior thereof and for removing an atheroma from the interior of a blood vessel, comprising:

a cannula system having a first lumen that extends from a proximal end outside of the blood vessel to a first distal port positionable in the interior of the blood vessel;

a second lumen that extends from a proximal end outside of the blood vessel to a second distal port positional in the interior of the blood vessel;

a third lumen that extends from a proximal end outside of the blood vessel to a third distal port positionable in the interior of the blood vessel;

a filter insertable through the first lumen so as to extend through the first distal port into the interior of the blood vessel; and

an atherectomy catheter insertable through the second lumen so as to extend through the second distal port into the interior of the blood vessel, the atherectomy catheter comprising;

a tubular sheath having an open distal end and a lumen extending from a proximal end to the open distal end; and

an elongate member extending through the lumen of the sheath and having a distal end terminating in an atheroma removal element.

2. The device of claim 1 wherein the third lumen has a perfusion port at its distal end.

3. The device of claim 1 wherein the elongate member is movable axially in the lumen of the sheath between a first position in which the atheroma removal element is retracted within the lumen of the sheath, and a second position in which the atheroma removal element extends from the open distal end of the sheath, the atheroma removal element being operable to remove the atheroma by direct access to the interior of the blood vessel while the filter captures embolic debris in the interior of the blood vessel.

4. The device of claim 1 wherein the distal end of the third lumen is angled relative to the proximal end of the third lumen to facilitate blood flow into the aorta.

5. The device of claim 1, further comprising a hemostatic valve in at least one of the first, second or third lumens of the cannula system.