Embolic protection device

• US 10,016,267 B2
• Filed: 02/07/2014
• Issued: 07/10/2018
• Est. Priority Date: 08/27/2002
• Status: Active Grant

• Current Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Original Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Inventors: Belson, Amir
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US14/175,042
• Publication Number:
  US 20140155929A1
• Time in Patent Office: 1,614 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The embolic protection device (10) has an expandable tubular structure supporting a filter mesh material (12). The embolic protection device is compressed to a small diameter for insertion into a patient'"'"'s aorta, then expanded within the aorta with the filter mesh material positioned to allow blood to enter sidebranch vessels connected to the aorta and to prevent embolic material from entering the sidebranch vessels. The filter mesh material may be configured with waves or undulations (26) for increased surface area and/or with two layers of mesh material to provide additional protection against embolization and to prevent inadvertent occlusion of the sidebranch vessels.

Claims

1. An embolic protection device for deployment within a patient'"'"'s aorta comprising:

an expandable structure consisting of a tubular filter mesh material, the structure having a compressed configuration wherein the structure is compressed to a small width configured for insertion into the patient'"'"'s aorta and an expanded configuration, wherein the filter mesh material is configured to expand to conform to or be held over the aortic vessels of the patient'"'"'s aorta, wherein the filter mesh material consists of an inner layer of filter mesh and an outer layer of filter mesh, wherein the outer layer covers the inner layer, and wherein each of the inner layer and the outer layer comprises a self-expanding metal wire mesh structure, and wherein the filter mesh material is free from external support.

2. The embolic protection device of claim 1, wherein the inner layer of filter mesh comprises a coarse mesh material and the outer layer of filter mesh comprises a fine mesh material.

3. The embolic protection device of claim 1, wherein the inner layer and the outer layer are arranged so that blood can flow between the inner layer and the outer layer whereby the arch vessels will continue to receive blood flow even if the inner layer in front of one or more of the arch vessels becomes clogged.

4. The embolic protection device of claim 1, wherein the expandable structure is woven of resilient wires and/or fibers to form the filter mesh.

5. The embolic protection device of claim 1, wherein the filter mesh material is in a tubular configuration.

6. The embolic protection device of claim 1, wherein the filter mesh material is configured with waves or undulations.

7. The embolic protection device of claim 1, wherein at least a portion of the device is coated with an anti-thrombogenic coating.

8. The embolic protection device of claim 7, wherein the anti-thrombogenic coating comprises heparin.

9. The embolic protection device of claim 8, wherein the inner layer of filter mesh comprises a coarse mesh material and the outer layer of filter mesh comprises a fine mesh material.

10. The embolic protection device of claim 1, further comprising a delivery tube sized and configured to hold the expandable structure in its compressed position.

11. The embolic protection device of claim 1, wherein the tubular configuration is open at each end.

12. A method of providing embolic protection for sidebranch vessels connected to a patient'"'"'s aorta comprising:

introducing an embolic protection device into the patient'"'"'s aorta, the embolic protection device consisting of an expandable tubular structure consisting of filter mesh material, the structure having a compressed configuration wherein the structure is compressed to a small width for insertion into the patient'"'"'s aorta and an expanded configuration, wherein the filter mesh material expands to conform to or be held over the aortic vessels of the patient'"'"'s aorta such that the filter mesh material allows blood to enter the aortic vessels connected to the patient'"'"'s aorta but prevents embolic material from entering the aortic vessels, wherein the filter mesh material is configured with an inner layer of filter mesh and an outer layer of filter mesh, wherein the outer layer covers the inner layer, and wherein each of the inner layer and the outer layer comprises a self-expanding metal wire mesh structure, and wherein the expandable tubular structure remains in place without external support.

13. The method of claim 12, wherein the inner layer of filter mesh comprises a coarse mesh material and the outer layer of filter mesh comprises a fine mesh material.

14. The embolic protection device of claim 12, wherein the inner layer and the outer layer are arranged so that blood can flow between the inner layer and the outer layer whereby the arch vessels will continue to receive blood flow even if the inner layer in front of one or more of the arch vessels becomes clogged.

15. The method of claim 12, wherein the expandable structure is woven of resilient wires and/or fibers to form the filter mesh.

16. The method of claim 12, wherein the filter mesh material is configured with waves or undulations.

17. The method of claim 12, wherein at least a portion of the device is coated with an anti-thrombogenic coating.

18. The method of claim 17, wherein the anti-thrombogenic coating comprises heparin.

19. The method of claim 12, wherein introducing comprises releasing the compressed embolic protection device from a delivery tube which holds the embolic protection device in its compressed position.

20. The method of claim 12, wherein the tubular configuration is open at each end.