Embolic protection during percutaneous heart valve replacement and similar procedures

• US 8,382,788 B2
• Filed: 08/25/2011
• Issued: 02/26/2013
• 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
• Application Number:
  US13/218,183
• Publication Number:
  US 20110313445A1
• Time in Patent Office: 551 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 filter device for filtration within the vasculature comprising

a) an elongated delivery structure having a proximal end and a distal end, the elongated delivery structure comprising a tubular element and a guide structure, the tubular element having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the guide structure slidably extends through the lumen of the tubular element, and the guide structure has a proximal end and a distal end that extends beyond the distal end of the tubular element;

b) a first filter element comprising a first filter basket and having an opening into the first filter basket wherein the first filter element is attached at or near the distal end of the tubular element with the opening of the first filter basket oriented toward the distal end of the elongated delivery structure; and

c) a second filter element comprising a second filter basket having an opening into the second filter basket and a proximal strut connecting the second filter basket to the guide structure at a position proximal to the opening of the second filter basket with the opening of the second filter basket oriented toward the proximal end of the elongated delivery structure,

wherein the second filter basket and its strut can be extended beyond the distal end of the tubular element.

2. The filter device of claim 1 wherein the first filter element and the second filter element can be spaced apart at least about four centimeters.

3. The filter device of claim 1 wherein the first filter basket and the second filter basket each comprises a membrane with pores.

4. The filter device of claim 3 wherein the pores have diameters from about 50 microns to about 250 microns.

5. The filter device of claim 3 wherein each filter basket comprises a frame to support the membrane.

6. The filter device of claim 5 wherein the frame comprises a metal.

7. The filter device of claim 3 wherein the membrane comprises a polymer.

8. The filter device of claim 1 wherein the first filter basket and/or the second filter basket have a windsock shape.

9. The filter device of claim 1 wherein at least a portion of the guide structure extends in a distal direction from the second filter basket.

10. The filter device of claim 1 wherein at least one of the basket type filter elements is self extending.

11. The filter device of claim 1 wherein the length of the elongated delivery structure between the first filter basket and the second filter basket can span between the brachiocephalic artery and the left carotid artery along the aortic arch.

12. A method for blocking emboli from entering into the carotid arteries from the aorta, the method comprising:

delivering the filter device of claim 1 by tracking the elongated delivery structure through the right subclavian artery along the aortic arch to position the second filter element to filter flow into the left carotid artery and the first filter element in the brachiocephalic artery to filter flow into the right carotid artery, with the length of the elongated delivery structure between the first filter element and the second filter element spans between the brachiocephalic artery and the left carotid artery along the aortic arch.

13. The method of claim 12 wherein the filter device is removed from the arteries following a performance of an endovascular procedure on the heart.

14. The method of claim 13 wherein at least a portion of the removal process is accompanied by aspiration.

15. The method of claim 12 further comprising performing an endovascular procedure on the heart while the filter elements are filtering flow into the carotid arteries.

16. The method of claim 15 wherein the endovascular procedure on the heart comprises an endovascular replacement of a heart valve.

17. The method of claim 15 wherein the endovascular procedure on the heart comprises repair of a heart valve.

18. The method of claim 12 further comprising 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.

19. The method of claim 12 wherein the filter elements have a delivery/retrieval configuration and a deployment configuration, and wherein at least one of the filter elements is self-extendable.

20. The method of claim 12 wherein the filter elements are released from a sheath during the delivery.

21. The method of claim 12 wherein the filter elements are delivered through a catheter.

22. The method of claim 12 wherein the filter elements are retrieved through a catheter that is connected to an aspiration device at or near the proximal end of the catheter.