Integrated embolic protection devices

• US 9,827,085 B2
• Filed: 10/26/2016
• Issued: 11/28/2017
• 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:
  US15/335,322
• Publication Number:
  US 20170042659A1
• Time in Patent Office: 398 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

Embolic Protection elements are integrated with a catheter or access sheath for any catheter. A catheter shaft has an embolic filter slidably mounted on a distal portion of a catheter shaft. A proximal stop for limits proximal movement of the embolic filter, and a distal stop for limits distal movement of the embolic filter. The filter has a porous mesh material defining a collection chamber for captured emboli and has a collapsed and a deployed configuration. The filter may be collapsed by an access sheath used with the catheter. An access sheath may have a tubular main body and an embolic filter mounted on the distal portion of the tubular main body. The embolic filter may evert into the central lumen of the sheath or may be constrained on the exterior of the sheath with a larger diameter outer tube.

Claims

1. A method for introducing a catheter through an access sheath having integrated embolic protection, said method comprising:

positioning the access sheath in a blood vessel with an open distal end of the access sheath directed against the direction of blood flow;

deploying an embolic filter about the open distal end of the access sheath, wherein a cylindrical outer portion of the embolic filter contacts a wall of the blood vessel and a conical inner portion defines a collection chamber between an inner surface of the cylindrical outer portion and an outer surface of the conical inner portion, wherein the conical inner portion is oriented to collect emboli in the blood in the collection chamber; and

introducing a catheter through a lumen of the access sheath while the embolic filter remains deployed about the open distal end of the access sheath.

2. A method as in claim 1, wherein the access sheath is positioned through a tubular outer delivery sheath that maintains the embolic filter in an undeployed retracted condition when the embolic filter is therewithin, and wherein the embolic filter deploys into the deployed expanded configuration when the embolic filter is advanced out of the tubular outer delivery sheath.

3. A method as in claim 1, wherein the blood vessel is the aorta.

4. A method as in claim 3, wherein the cylindrical outer portion of the embolic filter covers the ostia of the cerebral arteries of the aortic arch.

5. A method as in claim 1, wherein a distal end of the conical inner portion of the filter is fixedly attached to the open distal end of the access sheath and a distal end of the cylindrical outer portion of the filter is open and free of attachment to the access sheath.

6. A method as in claim 5, the conical inner portion is positioned inside the cylindrical outer portion and has a wider proximal end joined to the cylindrical outer portion.

7. A method as in claim 6, wherein a distal end of the embolic filter is open for 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.

8. A method as in claim 1, further comprising deploying a stent-like support scaffold about the cylindrical outer portion of the filter for supporting the cylindrical outer portion.

9. A method as in claim 1, wherein the deploying the embolic filter comprises releasing the embolic filter from constraint to allow the embolic filter to self-expand.

10. A method as in claim 1, further comprising pulling on a graspable structure to close the distal end of the cylindrical outer portion and seal the collection chamber.

11. A method as in claim 10, further comprising withdrawing the filter from the blood vessel after the distal end of the cylindrical outer portion has been closed.

12. A method as in claim 1, further comprising introducing a second catheter, guide-wire, delivery sheath, or other surgical tool through a closeable access port in the filter.

13. A method as in claim 1, further comprising performing at least one of a valve replacement, balloon valvuloplasty, and blood vessel ablation with the catheter that has been introduced.

14. A method for introducing a catheter through an access sheath having integrated embolic protection, said method comprising:

positioning the access sheath in a blood vessel with an open distal end of the access sheath directed against the direction of blood flow;

deploying an embolic filter about the open distal end of the access sheath, wherein a cylindrical outer portion of the embolic filter contacts a wall of the blood vessel and a conical inner portion defines a collection chamber between an inner surface of the cylindrical outer portion and an outer surface of the conical inner portion, wherein the conical inner portion is oriented to collect emboli in the blood in the collection chamber; and

introducing a catheter through a lumen of the access sheath while the embolic filter remains deployed about the open distal end of the access sheath; and

wherein a distal end of the conical inner portion of the filter is fixedly attached to the open distal end of the access sheath and a distal end of the cylindrical outer portion of the filter is open and free of attachment to the access sheath.

15. A method as in claim 14, the conical inner portion is positioned inside the cylindrical outer portion and has a wider proximal end joined to the cylindrical outer portion.

16. A method as in claim 15, wherein a distal end of the embolic filter is open for 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.