Direct access atherectomy devices and methods of use

• US 8,206,403 B2
• Filed: 07/11/2007
• Issued: 06/26/2012
• Est. Priority Date: 01/14/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Thornton, Peter
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US11/776,427
• Publication Number:
  US 20080015629A1
• Time in Patent Office: 1,812 Days
• Field of Search: 606/194, 606/200, 606/127, 606/159, 606/170, 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 catheters A61B2017/22072
• 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 containing 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 with 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 method for aortic atherectomy by direct access, comprising the steps of:

inserting an elongate tubular member into the aorta upstream of the inominate artery;

wherein the elongate tubular member further comprises a lumen for arterial blood perfusion;

infusing oxygenated blood through the lumen for arterial blood perfusion;

inserting an atherectomy catheter through the elongate tubular member into the aorta; and

removing an aortic atheroma by operating the atherectomy catheter;

wherein the atherectomy catheter comprises a sheath having a lumen that communicates with an opening at a distal end of the sheath; and

wherein the sheath terminates distally in a sharpened edge.

2. The method of claim 1, further comprising the steps of:

inserting a blood filter through the elongate tubular member into the aorta; and

expanding the filter to substantially cover the lumen of the aorta downstream of the aortic atheroma.

3. The method of claim 2, wherein the filter is placed upstream of the inominate artery.

4. The method of claim 2, wherein the filter captures emboli dislodged during removal of the aortic atheroma.

5. The method of claim 1, wherein the atherectomy assembly comprises an elongate member that extends through the lumen of the sheath and includes a loop that extends distally beyond the opening of the sheath, the loop being operable to remove aortic atheroma.

6. The atherectomy device of claim 5, wherein the loop includes a mesh disposed about a circumference of the loop.

7. The method of claim 1, wherein the atherectomy assembly comprises a clipping instrument operable from a proximal end of the catheter.

8. The method of claim 1, wherein the atherectomy assembly comprises a laser.

9. The method of claim 1, wherein the atherectomy assembly comprises a hydraulic instrument.