Introducer sheath with embolic protection

• US 10,617,510 B2
• Filed: 12/20/2017
• Issued: 04/14/2020
• Est. Priority Date: 01/06/2012
• Status: Active Grant

• Current Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Original Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Inventors: Russell, Scott, Belson, Amir
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US15/848,762
• Publication Number:
  US 20180110607A1
• Time in Patent Office: 846 Days
• CPC Class Codes: A47C 19/02 Parts or details of bedsteads not fully covered in a single one of the following subgroups, e.g. bed rails, post rails
• CPC Class Codes: A47C 19/12 Folding bedsteads travelling or camp beds A47C17/64
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2002/015 Stop means therefor
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The embolic protection device comprises an embolic filter attached to an inner sheath. The embolic filter includes at least a first catheter access port and a second catheter port. At least the first catheter port will typically be radially expandable to receive catheters of different diameters and will be located at an atypical end of an aero conical structure at a downstream end of the filter.

Claims

1. An embolic protection device, said device comprising:

a cylindrical porous mesh filter having an open distal end, a closed proximal end, an interior including a collection chamber, a radially collapsed delivery configuration, and a radially expanded configuration; and

a sheath having a distal end, a proximal end, and an inner lumen extending from the proximal end to the distal end, said distal end of the sheath being fixedly attached to a proximal end of the cylindrical porous mesh filter and said inner lumen being configured to allow passage of a catheter therethrough;

wherein the closed proximal end of the cylindrical porous mesh filter is fixedly attached to the distal end of the sheath and has a radially expandable port configured to receive catheters of different diameters therethrough; and

wherein a first catheter may be introduced into the interior of the cylindrical porous mesh filter through the inner lumen of the sheath and a second catheter may be introduced into the interior of the cylindrical porous mesh filter though the expandable port.

2. An embolic protection device as in claim 1, wherein the radially expandable port is disposed at an apical end of a conical inner portion of the closed proximal end of the cylindrical porous mesh filter.

3. An embolic protection device as in claim 1, wherein the distal end of the sheath is fixedly attached to a port on the proximal end of the cylindrical porous mesh filter.

4. An embolic protection device as in claim 2, wherein the conical inner portion defines the collection chamber between an inner surface of a cylindrical outer wall and an outer surface of the conical inner portion, wherein the apical end of the conical inner portion is oriented toward the open upstream end of the embolic filter.

6. An embolic protection device as in claim 4, wherein the open distal end of the cylindrical porous mesh filter is configured to allow blood to flow between the conical inner portion and the cylindrical outer portion, with a space between the conical inner portion and the cylindrical outer portion defining the collection chamber for captured emboli.

7. An embolic protection device as in claim 1, wherein the cylindrical porous mesh filter self-expands into the expanded configuration when the filter is in the deployed configuration.

8. An embolic protection device as in claim 7, wherein the cylindrical porous mesh filter comprises a fabric of knitted, woven, or nonwoven fibers, filaments, or wires having a pore size chosen to prevent emboli over a predetermined size from passing through.

9. An embolic protection device as in claim 7, wherein the cylindrical porous mesh filter is made of a resilient metal, polymer material, a malleable material, a plastically deformable material, a shape-memory material, or combinations thereof.

10. An embolic protection device as in claim 1, wherein the cylindrical porous mesh filter has an anti-thrombogenic coating on its surface.

11. An embolic protection device as in claim 1, wherein the cylindrical porous mesh filter has a pore size in the range of about 1 mm to about 0.1 mm.

12. An embolic protection device as in claim 1, further comprising a resilient seal positioned within the expandable port for forming a seal around a catheter passing through the expandable port.

13. An embolic protection system comprising:

an embolic protection device as in claim 1; and

a delivery sheath having a lumen there through configured to restrain the embolic filter in its radially collapsed delivery configuration when the embolic filter is there within, wherein the embolic filter deploys into its radially expanded configuration when the embolic filter is advanced out of the outer delivery sheath.

14. An embolic protection system comprising:

an embolic protection device as in claim 1; and

a stylet configured to be advanced through the sheath lumen and the embolic filter to elongate the embolic filter to assume its radially collapsed delivery configuration, wherein the embolic filter deploys into its radially expanded configuration when the stylet is removed from the embolic filter.

15. A method for advancing a catheter over a patient'"'"'s aortic arch having aortic side vessels, said method comprising:

providing an embolic protection device as in claim 1;

advancing the sheath through the patient'"'"'s aorta to position the cylindrical porous mesh filter over the aortic arch;

radially expanding the cylindrical porous mesh filter within the aortic arch to cover the aortic side vessels with the open distal end facing the patient'"'"'s heart to direct blood flow through the upstream end and emboli into the collection chamber, wherein blood free from emboli flows through the porous mesh into the aortic side vessels;

advancing the first catheter through the inner lumen of the sheath, through the interior of the cylindrical porous mesh filter, and toward the heart; and

advancing the second catheter through the though the expandable port, through the interior of the cylindrical porous mesh filter, and toward the heart.

16. A method as in claim 15, further comprising performing a first diagnostic or interventional procedure with the first catheter and performing a second diagnostic or interventional procedure with the second catheter.

17. A method as in claim 15, wherein the sheath is used to advance the cylindrical porous mesh filter through a delivery sheath that constrains the embolic protection device in its radially collapsed configuration while it is being delivered.

18. A method as in claim 17, wherein radially expanding the cylindrical porous mesh filter comprises proximally retracting the delivery sheath relative to the embolic protection device to release the embolic protection device from radial constraint.

19. A method as in claim 15, further comprising performing an interventional procedure with the first catheter positioned through the first port and introducing contrast media through a second catheter positioned through the inner sheath and second port while the interventional procedure is being performed.

20. A method as in claim 19, wherein the interventional procedure is delivery of a prosthetic aortic valve.

5. An embolic protection device 4, wherein the conical inner portion is positioned inside the cylindrical outer wall and has a wider proximal end joined to a proximal of the cylindrical outer cylindrical outer wall to form the closed proximal end.