Embolic protection during percutaneous heart valve replacement and similar procedures

• US 8,206,412 B2
• Filed: 06/22/2009
• Issued: 06/26/2012
• Est. Priority Date: 06/23/2008
• Status: Active Grant

• Current Assignee: Lumen Biomedical, Inc.
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Galdonik, Jason A., Ogle, Matthew F., Anderson, Edward, Webster, Mark W. I.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): CRONIN, ASHLEY L
• Application Number:
  US12/489,108
• Publication Number:
  US 20090326575A1
• Time in Patent Office: 1,100 Days
• Field of Search: 604/8, 604/9, 606/108, 606/191, 606/194, 606/198, 606/200, 623/2.11
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/012 Multiple filtering units
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• 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 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

Various devices are described to provide filtering of flow from the aorta to the left carotid artery and the right carotid artery. The filters can be brought into a desired position through one or more peripheral arteries. A single filter device can provide the desired filtering or a plurality of devices can be used. In particular a single filter device can span between the brachiocephalic artery and the left carotid artery. These filter devices can be used effectively to capture emboli generated during procedures on the heart so that emboli do not travel to the patient'"'"'s brain where the emboli can cause a stroke or other adverse event. In particular, these filters can be used during percutaneous procedures on the heart, such as endovascular heart valve replacement.

Claims

1. A method for providing embolic protection during an endovascular procedure on a patient'"'"'s heart, the method comprising:

delivering one or more vascular filter elements with guide structure through the right subclavian artery to position the one or more vascular filter elements or components thereof into the right carotid artery or the brachiocephalic artery and into the left carotid artery to filter flow into both carotid arteries from the aorta,

wherein the guide structure spans between the brachiocephalic artery and the left carotid artery with at least a portion of the guide structure extended into the left carotid artery and with at least a portion of the guide structure extending in a distal direction from the distal end of the one or more vascular filter elements.

2. The method of claim 1 wherein the one or more filter elements comprises two filter elements with a first filter element positioned to filter flow into the left carotid artery and a second filter element positioned to filter flow into the right carotid artery with placement of the second filter element in the right carotid artery or in the brachiocephalic artery.

3. The method of claim 1 wherein the one or more filter elements are delivered over the guide structure.

4. The method of claim 1 wherein the guide structure is retrieved and the one or more filter elements are left untethered inside the arteries during the performance of an endovascular procedure on the heart.

5. The method of claim 1 wherein the one or more filter elements are removed from the arteries following performance of an endovascular procedure on the heart.

6. The method of claim 5 wherein at least a portion of the retrieval process is accompanied by aspiration.

7. The method of claim 1 further comprising performing an endovascular procedure on the heart while the one or more filters are filtering flow into the right common carotid artery and the left common carotid artery.

8. The method of claim 7 wherein the endovascular procedure on the heart comprises an endovascular replacement of a heart valve.

9. The method of claim 1 wherein the one or more filter elements have a delivery/retrieval configuration and a deployment configuration, and the method farther comprising transitioning the one or more filter elements between the delivery/retrieval and deployment configurations simultaneously or sequentially.

10. The method of claim 1 wherein the one or more filter elements are self-extendable.

11. The method of claim 1 wherein the one or more filter elements are delivered through a catheter that is delivered through the right subclavian artery.

12. The method of claim 1 wherein the one or more filter elements are associated with a catheter that extends through the right subclavian artery into the left common carotid artery.

13. The method of claim 12 wherein the catheter further comprises an expandable structure mounted on the exterior of the catheter.

14. The method of claim 13 wherein the expandable structure comprises an occlusive balloon.

15. The method of claim 1 wherein the one or more filter elements are retrieved through a catheter that is connected to an aspiration device at or near the proximal end of the catheter.

16. The method of claim 1 wherein the one or more filter elements are attached to the guide structure, wherein the guide structure comprises a corewire and an overtube with, the corewire extending through a lumen of the overtube, wherein the one or more filter elements comprise one or more filters that comprises surface capillary fibers having a first configuration in a bundle with a low profile and an extended configuration with the centers of the fibers flaring outward from the guide structure, and wherein the relative movement of the corewire and the overtube transitions the fibers from the low profile configuration to the extended configuration.

17. The method of claim 1 wherein the guide structure comprises one or more corewires within one or more overtubes to facilitate the delivery and/or retrieval, of the filter elements.

18. The method of claim 1 comprising delivering one filter element wherein the filter element spans the distance between the brachiocephalic artery and the left carotid artery.

19. The method of claim 1, wherein the delivering step delivers at least two vascular filter elements through the right subclavian artery to position the at least two vascular filter elements to filter flow into the right carotid artery and the left carotid artery,

wherein the at least two filter elements comprise a first filter element positioned to filter flow into the left carotid artery and a second filter element proximal to the first filter element positioned to filter flow into the right carotid artery with placement of the second filter element in the right carotid artery or in the brachiocephalic artery.

20. The method of claim 19 wherein the at least two filter elements having delivery/retrieval and deployment configurations and the method further comprises transitioning the filter elements between the delivery/retrieval and deployment configurations simultaneously or sequentially.

21. The method of claim 19 wherein the at least two filter elements are self-extendable.

22. The method of claim 19 wherein the guide structure comprises one or more corewires within one or more overtubes to facilitate the delivery and/or retrieval of the filter elements.

23. A method for the endovascular replacement of a heart valve, the method comprising:

delivering one or more vascular filter elements with a guide structure through the right subclavian artery to position the one or more filter elements or components thereof into the right carotid artery or the brachiocephalic artery and into the left carotid artery to filter flow through both carotid arteries while the guide structure spans between the brachiocephalic artery and the left carotid artery with at least a portion of the guide structure extended into the left carotid artery; and

delivering a heart valve delivery catheter through the descending aorta or the left subclavian artery to the heart to effect at least a step related to removal of a heart valve or the placement of a prosthetic heart valve.

24. The method of claim 23 wherein the guide structure is retrieved to leave the one or more filter elements untethered inside the arteries during the performance of the endovascular replacement of a heart valve.

25. The method of claim 23 wherein the filter elements are removed from the arteries following performance of the endovascular replacement of the heart valve.

26. The method of claim 25 wherein at least a part of the removal process is accompanied by aspiration.