Implantable cerebral protection device and methods of use

• US 6,258,120 B1
• Filed: 12/23/1997
• Issued: 07/10/2001
• Est. Priority Date: 12/23/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: McKenzie, John, Hattori, Sachiko
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Nguyen, Tram A.
• Application Number:
  US08/996,532
• Time in Patent Office: 1,295 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 623/1.31, 623/1.36, 623/1.39, 623/11.11, 623/23.64, 623/23.68, 623/23.7, 623/902, 623/903, 606/108, 606/191, 606/194, 606/195, 606/198, 606/200, 604/8, 128/898
• US Class Current: 623/1.36
• 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

The present invention is directed to 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 disclosed. 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;

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 downstream of the brachiocephalic trunk.

2. The method of claim 1 wherein the aortic diverter is secured to the lumen of the aorta by suturing the aortic diverter to the lumen of the aorta.

3. The method of claim 1 wherein the aortic diverter is secured to the lumen of the aorta with a hook.

4. The method of claim 1 wherein the aortic diverter is secured to the lumen of the aorta by frictionally engaging the lumen of the aorta.

5. The method of claim 1 wherein the aortic diverter 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.

6. The method of claim 1 wherein the sleeve is frictionally engaged by radially expanding the sleeve into frictional engagement to the lumen of the aorta.

7. An aortic diverter insertable into an aorta for diverting emboli away from the carotid arteries, comprising:

a hollow tube comprising a substantially cylindrical or conical wall having a plurality of openings permeable to blood and impermeable to emboli, wherein, when the hollow tube is deployed, an area defined by said plurality of openings is smaller than a surface area of the remainder of the wall, the hollow tube having a proximal end terminating in a substantially circular edge adapted to fill the lumen of an aorta, and a distal end, wherein the proximal and distal ends are substantially open allowing blood to enter the proximal end, flow through the hollow tube, and exit the distal end; and

an anchoring mechanism for securing the hollow tube to the lumen of the aorta.

8. The aortic diverter of claim 7 wherein the plurality of openings comprises every opening on the wall of the hollow tube.

9. The aortic diverter of claim 8 wherein each of said plurality of openings is defined by an area which captures emboli 2.5 mm in diameter or larger and is permeable to blood.

10. The aortic diverter of claim 8, wherein each of said plurality of openings is defined by an area which captures emboli 0.02 mm in diameter or larger and is permeable to blood.

11. The aortic diverter of claim 8, wherein the anchoring mechanism comprises a sleeve secured to the proximal end of the hollow tube, the sleeve being adapted to frictionally engage the lumen of the aorta.

12. The aortic diverter of claim 8, wherein the anchoring mechanism comprises at least one suture.

13. The aortic diverter of claim 8, wherein the anchoring mechanism comprises at least one hook.

14. The aortic diverter of claim 8, wherein the anchoring mechanism comprises the proximal end of the hollow tube, wherein the proximal end of the hollow tube is adapted to frictionally engage the lumen of the aorta.

15. The aortic diverter of claim 8, wherein the wall is expandable between a compressed state for percutaneous delivery of the diverter and a radially expanded state for frictional engagement with the lumen of the aorta.