Integrated embolic protection devices

• US 10,166,094 B2
• Filed: 10/24/2017
• Issued: 01/01/2019
• 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
• Application Number:
  US15/792,620
• Publication Number:
  US 20180042390A1
• Time in Patent Office: 434 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 with an integrated embolic protection element comprises a catheter shaft, an embolic filter slidably mounted on a distal portion of the shaft, a proximal stop for limiting the proximal movement of the embolic filter, and a distal stop for limiting the distal movement of the embolic filter. The filter comprises 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 comprise 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. An introducer sheath having integrated embolic protection, said introducer sheath comprising:

an access sheath having a lumen with an open distal end; and

an embolic filter comprising a porous mesh material having a cylindrical outer portion and a inner portion defining a collection chamber for captured emboli, the filter having a collapsed configuration and a deployed configuration wherein the collection chamber is defined between an inner surface of the cylindrical outer portion and an outer surface of the inner portion and an outer periphery of the cylindrical outer portion of the filter is configured to contact a blood vessel wall to direct blood flow and potential emboli into the collection chamber;

wherein a distal end of the inner portion of the mesh is attached to the open distal end of the access sheath and a distal end of the cylindrical outer portion of the mesh is open and free of attachment to the access sheath, wherein the lumen of the access sheath is available to introduce different devices.

2. The introducer sheath of claim 1, wherein the inner portion is positioned inside the cylindrical outer portion and has a wider proximal end joined to the cylindrical outer portion and a narrow distal end which is attached to the distal portion of the access sheath, and wherein a distal end of the embolic filter is open for blood to flow between the inner portion and the cylindrical outer portion, with a space between the inner portion and the cylindrical outer portion defining the collection chamber for captured emboli.

3. The introducer sheath of claim 1, further comprising a stent-like support scaffold coupled to the cylindrical outer portion of the porous mesh material for supporting the cylindrical outer portion.

4. The introducer sheath of claim 3, wherein the stent-like support scaffold has a collapsed configuration and an expanded configuration, and wherein the stent-like support scaffold self-expands into the expanded configuration when the filter is in the deployed condition.

5. The introducer sheath of claim 3, wherein the stent-like support scaffold is made of a resilient metal, polymer material, a malleable material, a plastically deformable material, a shape-memory material, or combinations thereof.

6. The introducer sheath of claim 1, further comprising a pull loop or other graspable structure coupled to the distal end of the cylindrical outer portion for closing the collection chamber.

7. The introducer sheath of claim 1, further comprising at least one retraction member coupled to the cylindrical outer portion for facilitating the retraction of the embolic filter into the undeployed configuration.

8. The introducer sheath of claim 1, wherein the cylindrical outer portion comprises at least one closeable side port for the introduction of a second catheter, guide-wire, delivery sheath, or other surgical tool therethrough.

9. The introducer sheath of claim 1, wherein the porous mesh material has a collapsed configuration and an expanded configuration, and wherein the porous mesh material self-expands into the expanded configuration when the filter is in the deployed configuration.

10. The introducer sheath of claim 1, wherein the porous mesh material 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.

11. The introducer sheath of claim 1, wherein the porous mesh material is made of a resilient metal, polymer material, a malleable material, a plastically deformable material, a shape-memory material, or combinations thereof.

12. The introducer sheath of claim 1, wherein the porous mesh material has an antithrombogenic coating on its surface.

13. The introducer sheath of claim 1, wherein porous mesh material has a pore size in the range of about 1 mm to about 0.1 mm.

14. The introducer sheath of claim 1, wherein a distal end of the access sheath is configured to form a seal to prevent passage of emboli over a predetermined size therethrough.

15. The introducer sheath of claim 1, wherein the catheter is insertable through a tubular outer delivery sheath, wherein the tubular outer delivery sheath maintains the embolic filter in the undeployed retracted condition when the embolic filter is therewithin, and wherein the embolic filter is free to deploy into the deployed expanded configuration when the embolic filter is advanced out of the tubular outer delivery sheath.

16. A system for catheter-based interventional procedures, the system comprising:

the introducer sheath of claim 1; and

a tubular outer delivery sheath through which the catheter is advanced, wherein the tubular outer delivery sheath maintains the embolic filter in the undeployed retracted condition when the embolic filter is therewithin, and wherein the embolic filter is free to deploy into the deployed expanded configuration when the embolic filter is advanced out of the tubular outer delivery sheath.

17. A system for catheter-based interventional procedures, the system comprising:

the introducer sheath of claim 1; and

a catheter deliverable through a central lumen of the introducer sheath.

18. The system for catheter-based interventional procedures of claim 17, wherein the catheter is coupled to at least one of a valve replacement delivery element, an expandable structure for balloon valvuloplasty, and an energy delivery element for ablation.