Device and method for delivery of medical devices to a cardiac valve

• US 10,433,946 B2
• Filed: 03/31/2015
• Issued: 10/08/2019
• Est. Priority Date: 05/08/2011
• Status: Active Grant

• Current Assignee: Emboline, Inc. (CardioLogical Solutions, Inc.)
• Original Assignee: SWAT Medical AB
• Inventors: Krahbichler, Erik
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US14/675,483
• Publication Number:
  US 20150202038A1
• Time in Patent Office: 1,652 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2230/0071 spherical
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient comprises an elongate sheath with a first lumen, a distal end for positioning at a heart valve, a second lumen that extends parallel to or in the sheath, and an expandable embolic protection filter. The filter is arranged to extend from an orifice of the second lumen and, in the expanded, covers ostia of the side branch vessels in the aortic arch.

Claims

1. A method for transvascularly delivering a medical device to a cardiac valve of a patient, said method comprising:

introducing a catheter in a relaxed state into said vascular system, said catheter comprising an elongate sheath having a first lumen a second lumen that extends coaxially with said first lumen along a portion of said elongate sheath between a proximal end of said elongate sheath and a distal end of said elongate sheath;

navigating said distal end of said elongate sheath through said vascular system to a site of said cardiac valve;

covering ostia of the side branch vessels in the aortic arch by expanding an embolic protection unit from said second lumen and thereby stabilizing the distal portion of said catheter at the site of said cardiac valve;

said embolic protection unit comprising an embolic filter that expands to a substantially planar shape; and

delivering a medical device through the first lumen of said elongate sheath to said site of said heart valve while said embolic protection unit covers said ostia, captures or deflects embolic material, and allows blood to flow from the aortic arch into the side branch vessels.

2. The method of claim 1, wherein said embolic protection unit covers three ostia of three side branch vessels in said aortic arch.

3. The method of claim 1, wherein said expanding of said embolic protection unit comprises expanding said embolic protection unit to a non-tubular shape over said ostia.

4. The method of claim 1, said method further comprising:

locking at least a portion of said catheter in a locked shape before delivering said medical device to said site of said heart valve and returning said elongate sheath to said relaxed state and

withdrawing said elongate sheath in said relaxed state from the vasculature of said patient.

5. The method of claim 4, wherein said locking at least a portion of said catheter in a locked shape comprises locking a plurality of locking members of an elongate member positioned inside said first lumen and wherein said returning said elongate sheath to said relaxed state comprises unlocking said plurality of locking members.

6. The method of claim 5, wherein said locking members comprise a releasable latch, a draw string, a squeezing mechanism, or combinations thereof.

7. The method of claim 4, wherein said locking at least a portion of said catheter in a locked shape comprises locking a distal portion of the catheter arranged in the ascending aorta, the aortic arch, and the descending aorta.

8. The method of claim 7, wherein said embolic protection unit is connected off-center to said delivery unit.

9. The method of claim 1, further comprising delivering said embolic protection unit through said second lumen using a delivery unit connected to said embolic protection unit.

10. A method for stabilizing a catheter in an aortic arch, said method comprising:

introducing a catheter comprising a first lumen and a second lumen into a vascular system;

navigating a distal end of the catheter to said aortic arch;

expanding an embolic protection unit from the first lumen to engage an inner surface of said aortic arch and cover the ostia of side branch vessels of the aortic arch, said embolic protection unit expanding to a substantially planar shape with a distal end that is directly unconnected from the catheter; and

delivering a medical device through the second lumen and near a cardiac valve while the embolic protection unit blocks embolic material from entering the side branch vessels of the aortic arch and while the embolic protection unit also allows passage of blood into the side branch vessels;

wherein said embolic protection unit is connected to a delivery unit inside said lumen, thereby limiting the movement of the catheter within the aortic arch.

11. The method of claim 10, wherein said embolic protection unit is connected off-center to said delivery unit.

12. The method of claim 11, wherein said expanding of said embolic protection unit comprises expanding said embolic protection unit to a non-tubular shape over said ostia.

13. A method for transvascularly delivering a medical device to a cardiac valve of a patient, said method comprising:

introducing an elongate sheath into said vascular system, said elongate sheath having a first channel and a second channel;

navigating a distal end of said elongate sheath through said vascular system to an ascending aortic arch;

covering ostia of the side branch vessels in the aortic arch by expanding an embolic protection unit from said first channel into a substantially planar shape;

allowing passage of blood from the aortic arch through said embolic protection unit while deflecting or capturing emboli;

introducing a catheter into said second channel, said catheter having a lumen;

navigating a distal end of said catheter through said second channel to a site of said cardiac valve; and

delivering a medical device through the second channel of said elongate sheath to said site of said heart valve while said embolic protection unit covers said ostia.