Direct access atherectomy devices and methods of use

• US 8,882,782 B2
• Filed: 10/07/2013
• Issued: 11/11/2014
• Est. Priority Date: 01/14/2002
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Thornton, Peter
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/047,877
• Publication Number:
  US 20140039380A1
• Time in Patent Office: 400 Days
• Field of Search: 606/127, 606/194, 606/159, 606/200, 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 and method 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 method for aortic atherectomy, comprising

inserting a cannula system into the aorta upstream of the inominate artery, the cannula comprising:

a first lumen that extends from a proximal end outside of the blood vessel to a first distal port positioned 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 positioned in the interior of the blood vessel; and

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

infusing oxygenated blood through the third lumen for arterial blood perfusion;

inserting an atherectomy assembly through the second lumen and into the aorta; and

removing an aortic atheroma by operating the atherectomy assembly.

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

inserting a blood filter through the second lumen and into the aorta; and

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

3. The method of claim 2, wherein the blood 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 a sheath having a lumen that communicates with an opening at a distal end of the sheath.

6. The method of claim 5, 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.

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

8. The method of claim 5, wherein the sheath of the atherectomy assembly terminates distally in a sharpened edge.

9. The method of claim 1, wherein the first, second, and third distal ports are all positioned upstream of the inominate artery.

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

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

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

13. The method 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.

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

15. A method for aortic atherectomy, comprising

inserting a cannula system into the aorta upstream of the inominate artery, the cannula comprising:

a first lumen that extends from a proximal end outside of the blood vessel to a first distal port positioned 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 positioned in the interior of the blood vessel; and

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

infusing oxygenated blood through the third lumen for arterial blood perfusion;

inserting an atherectomy assembly through the second lumen and into the aorta, wherein the first, second, and third distal ports are all positioned upstream of the inominate artery;

removing an aortic atheroma by operating the atherectomy assembly.

16. The method of claim 15, further comprising the steps of:

inserting a blood filter through the second lumen and into the aorta; and

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

17. The method of claim 16, wherein the filter captures emboli dislodged during removal of the aortic atheroma.

18. The method of claim 16, wherein the blood filter is placed upstream of the inominate artery.

19. The method of claim 15, 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.

20. The method of claim 15, wherein the atherectomy assembly comprises a sheath having a lumen that communicates with an opening at a distal end of the sheath.