Embolic protection device

• US 10,617,507 B2
• Filed: 08/30/2017
• Issued: 04/14/2020
• Est. Priority Date: 11/29/2006
• Status: Active Grant

• Current Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Original Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Inventors: Belson, Amir
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/691,471
• Publication Number:
  US 20170360547A1
• Time in Patent Office: 958 Days
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An embolic protection device for use in a patient'"'"'s blood vessel, such as the aorta, has an approximately cylindrical outer structure made of a filter mesh material and an approximately conical inner structure also made of a filter mesh material. On the downstream end of the embolic protection device, the wider end of the conical inner structure is joined to the cylindrical outer structure. The upstream end of the embolic protection device is open for blood to flow between the conical inner structure and the cylindrical outer structure. The space between the conical inner structure and the cylindrical outer structure defines a collection chamber for captured emboli. The narrow upstream end of the conical inner structure has a catheter port with a resilient seal that is sized for passage of a catheter shaft. The filter mesh material may be self-supporting or it may be supported on a resilient-framework or an inflatable framework.

Claims

1. A method for capturing emboli, said method comprising:

providing an embolic protection device on a delivery catheter, said embolic protection device comprising a cylindrical outer sleeve and a conical inner structure, wherein a wide base of the conical inner structure is positioned at a downstream end of the cylindrical outer sleeve and a narrow end of the conical inner structure is located at an upstream end of the cylindrical outer sleeve;

positioning the delivery catheter to place embolic protection device in the aortic arch so that the cylindrical outer sleeve covers the aortic vessels and the upstream end faces the heart, wherein emboli generated upstream of the emboli protection device flow into and are trapped within a collection chamber defined at the downstream end between the cylindrical outer sleeve and conical inner structure;

releasing the embolic protection device from the delivery catheter in the aorta;

removing the delivery catheter from the aortic arch while the embolic protection device remains within the aortic arch;

advancing a therapeutic catheter through a port in the embolic protection device after the delivery catheter has been removed from the aortic arch;

removing the therapeutic catheter from the embolic protection device;

advancing a retrieval catheter upwardly through the aorta to position a distal end of the retrieval catheter adjacent the downstream end of the embolic protection device after the therapeutic catheter has been removed from the port in the embolic protection device;

securing a capture member carried by the retrieval catheter to a connecting member on the embolic protection device;

drawing elongate member in a distal direction to pull the embolic protection device into the retrieval catheter; and

removing the retrieval catheter from the aortic arch while the embolic protection device remains within the retrieval catheter.

2. A method as in claim 1, wherein the port is located in a tapered end of the conical inner structure.

3. A method as in claim 1, wherein the cylindrical sleeve comprises a mesh filter material.

4. A method as in claim 3, wherein the inner conical structure comprises a mesh filter material.

5. A method as in claim 4, wherein the mesh filter materials of the inner conical structure and the cylindrical sleeve have the same pore size.

6. A method as in claim 5, wherein the pore size is in the range from 0.1 mm to 1 mm.

7. A method as in claim 3, wherein the mesh filter material of the inner conical structure is sized to stop macroemboli and the pore size of the cylindrical outer sleeve is sized to stop microemboli.

8. A method as in claim 3, wherein a portion of the cylindrical outer sleeve away from the aortic arch vessels comprises an impermeable material.

9. A method as in claim 1, wherein the embolic protection device is self-supporting in the deployed configuration.

10. A method as in claim 9, wherein positioning comprises releasing the embolic protection device from a compressed condition so that the device self-expands within the aorta.

11. A method as in claim 10, wherein the cylindrical outer sleeve and the conical inner structure comprise resilient mesh filter materials.

12. A method as in claim 1, wherein the cylindrical outer sleeve and the conical inner structure comprise filter mesh material supported by a framework.

13. A method as in claim 12, wherein the support framework is resilient and the device is self-expanding.

14. A method as in claim 2, wherein the upstream port comprises a resilient seal sized for the catheter.

15. A method as in claim 12, further comprising expanding the support framework at the downstream end of the cylindrical outer sleeve by inflating the support framework.

16. A method as in claim 1, wherein the connecting member circumscribes the downstream end of the cylindrical outer sleeve to close the downstream end of the cylindrical outer sleeve and pull the cylindrical outer sleeve and emboli trapped therein into the retrieval catheter as the elongate member is drawn in the distal direction.

17. A method as in claim 1, further comprising securing a capture member carried by the retrieval catheter to a connecting member on the embolic protection device.