Implantable cerebral protection device and methods of use

• US 6,499,487 B1
• Filed: 08/17/2000
• Issued: 12/31/2002
• Est. Priority Date: 12/23/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Hattori, Sachiko, McKenzie, John
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/642,570
• Time in Patent Office: 866 Days
• Field of Search: 623/1.31, 623/1.3, 623/1.36, 623/1.51, 623/902, 623/11.11, 623/66.1, 623/23.64, 623/23.7, 623/1.39, 623/903, 623/1.1, 623/23.68, 606/108, 606/191, 606/194, 606/195, 606/200, 606/198, 604/8, 128/898
• US Class Current: 128/898
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

Described are devices and methods for diverting emboli away from the carotid arteries in the aorta. The devices are aortic diverters that generally comprise a hollow tube with a substantially cylindrical or conical wall, which is impermeable to emboli and which has open ends that allow blood to enter one end, flow through the tube and exit the other end. Additionally, snowshoe aortic diverters, which are planar rather than cylindrical are also shown. The methods of the invention generally include the steps of providing an aortic diverter carried by an intravascular catheter, introducing the intravascular catheter into the vascular system, advancing the intravascular catheter into the aortic arch to the region of the carotid arteries, and deploying the aortic diverter.

Claims

1. A method for protecting a patient against cerebral embolization, said method comprising the steps of:

providing an aortic diverter comprising an elongate tube having a wall impermeable to emboli, the tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the tube, and exit the distal end;

inserting the aortic diverter in the aortic arch; and

positioning the aortic diverter so that the proximal end of the aortic diverter is upstream of the brachiocephalic trunk and the distal end of the aortic diverter is downstream of the left subclavian artery or the left brachiocephalic trunk, wherein emboli passing through the aortic arch flow through the aortic diverter and are diverted from the carotid arteries to the peripheral vasculature.

2. The method of claim 1, wherein the aortic diverter has a frustoconical shape.

3. The method of claim 1, wherein the wall of the aortic diverter is permeable to blood.

4. The method of claim 1, wherein the aortic diverter is inserted through an incision in the aortic arch.

5. The method of claim 1, wherein the aortic diverter is inserted percutaneously and advanced through the descending aorta.

6. The method of claim 1 further comprising the step of securing the aortic diverter to the lumen of the aorta.

7. A method for protecting a patient against cerebral embolization, comprising the steps of:

providing a generally cylindrical membrane impermeable to emboli and having a first substantially circular edge and a second substantially circular edge;

inserting the membrane into the aorta; and

positioning the membrane in the aortic arch so that the first edge of the membrane is upstream of the brachiocephalic trunk and the second edge of the membrane is downstream of the left subclavian artery or the left brachiocephalic trunk, wherein emboli passing through the aortic arch flow through the cylindrical membrane and are diverted from the carotid arteries to the peripheral vasculature.

8. The method of claim 7, wherein the membrane has a frustoconical shape.

9. The method of claim 7, wherein the membrane is permeable to blood.

10. The method of claim 7, wherein the membrane is inserted through an incision in the aortic arch.

11. The method of claim 7, wherein the membrane is inserted percutaneously and advanced through the descending aorta.

12. The method of claim 7, further comprising the step of securing the membrane to the lumen of the aorta.

13. An aortic diverter insertable in an aorta for diverting emboli away from the carotid arteries comprising a hollow tube impermeable to emboli, said tube being curved at an angle for placement in the aortic arch and having a substantially circular proximal edge with an opening and a substantially circular distal edge with an opening.

14. The aortic diverter of claim 13, wherein the tube is a flexible windsock.

15. The aortic diverter of claim 13, wherein the tube is impermeable to blood.

16. The aortic diverter of claim 13, wherein the tube comprises a woven material.

17. The aortic diverter of claim 13, further comprising a flexible sleeve secured to the proximal edge, the sleeve being adapted to frictionally engage the lumen of the aorta.

18. The aortic diverter of claim 13, wherein the tube is expandable between a compressed condition for percutaneous delivery to the aortic arch and an expanded condition for frictional engagement with the lumen of the aorta.

19. The aortic diverter of claim 13, wherein the tube comprises a mesh material.

20. A method for protecting a patient against cerebral embolization, said method comprising the steps of:

providing an aortic diverter comprising an elongate tube having a wall impermeable to emboli, the tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of the aorta, and a distal end, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the tube, and exist the distal end;

positioning the aortic diverter within the aortic arch; and

securing the aortic diverter to the lumen of the aorta, the proximal end of the aortic diverter extending upstream of the brachiocephalic trunk.

21. The method of claim 20, wherein the aortic diverter is secured to the lumen of the aorta by frictionally engaging the lumen of the aorta.

22. The method of claim 20, wherein the aortic diverter is frictionally engaged to the lumen of the aorta by radially expanding the aortic diverter into frictional engagement to the lumen of the aorta.

23. The method of claim 20, wherein the aortic divert comprises a sleeve secured to the proximal end of the elongate tube, the sleeve being adapted to frictionally engage the lumen of the aorta, and wherein the aortic diverter is secured to the lumen of the aorta by frictionally engaging the sleeve to the lumen of the aorta.

24. The method of claim 23, wherein the sleeve is frictionally engaged by radially expanding the sleeve into frictional engagement to the lumen of the aorta.

25. The method of claim 20, wherein the aortic diverter is secured to the lumen of the aorta by suturing the aortic diverter to the lumen of the aorta.