Device for delivery of medical devices to a cardiac valve

• US 9,023,101 B2
• Filed: 05/07/2012
• Issued: 05/05/2015
• Est. Priority Date: 05/08/2011
• Status: Active Grant

• Current Assignee: SWAT Medical AB
• Original Assignee: SWAT Medical AB
• Inventors: Krahbichler, Erik
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US14/115,088
• Publication Number:
  US 20140228942A1
• Time in Patent Office: 1,093 Days
• Field of Search: 623/2.11
• US Class Current: 623/2.11
• 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 state, covers ostia of the side branch vessels in the aortic arch.

Claims

1. A transvascular catheter device comprising:

an elongate sheath with a first lumen and a distal end, said distal end being configured for positioning at a heart valve,

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 said distal end,

an expandable embolic protection filter having an unexpanded delivery shape and a non-tubular expanded shape, and

a plurality of radially expandable units arranged for temporarily positioning said elongate sheath at a desired position in relation to said cardiac valve when said expandable units are in an expanded state

wherein;

at least a portion of said expandable embolic protection filter is arranged to extend from an orifice of said second lumen;

said orifice is positioned proximally with respect to said distal end of said elongate sheath;

the embolic protection filter is constructed so that, when extended from said orifice, the embolic protection filter expands from the unexpanded delivery shape to a substantially planar shape that covers ostia of side branch vessels in an aortic arch and stabilizes said distal end of said sheath; and

said elongate sheath comprises releasable locking members configured to controllably lock at least a portion of said elongate sheath in a locked shape.

2. The transvascular catheter device according to claim 1, wherein said embolic protection filter comprises a connection point arranged off-centre on said embolic protection filter and configured for connection to a delivery means.

3. The transvascular catheter device according to claim 1, wherein said second lumen is affixed to or integral with said elongate sheath and wherein said embolic protection filter is configured such that, when in an expanded state, said filter anchors a portion of said sheath in the aortic arch.

4. The transvascular catheter device according to claim 1, further comprising an elongate member that is retractably insertable into said first lumen and wherein a distal end portion of said elongate member comprises-said plurality of radially expandable units.

5. The transvascular catheter device of claim 4, wherein said elongate member comprises a proximal marker and is configured to be retractably inserted into said first lumen to a length equal to a distance between the distal end of said sheath and said proximal marker.

6. The transvascular catheter device of claim 1, wherein said elongate sheath is configured to be transvascularly delivered in a relaxed state and to transition from said relaxed state to said locked state by said releasable locking members.

7. The transvascular catheter device of claim 1, wherein said second lumen is affixed to or integral with an outer portion of said elongate sheath;

or wherein said second lumen is affixed to or integral with an inside portion of said elongate sheath.

8. The transvascular catheter device of claim 1, wherein said plurality of radially expandable units comprises expandable balloons.

9. The transvascular catheter device of claim 8, wherein said plurality of radially expandable units comprises three expandable balloons positioned radially equidistant around a longitudinal axis of said elongate sheath.

10. The transvascular catheter device of claim 1, wherein said plurality of radially expandable units comprises expandable mechanical levers retractable into said sheath.

11. The transvascular catheter device of claim 1, wherein said elongate sheath comprises radiopaque fiducial markers.

12. The transvascular catheter device of claim 1, wherein said locking members comprise one or more of a draw string, a releasable latch, and a squeezing mechanism.

13. A kit comprising the transvascular catheter device of claim 1 and a medical device for a cardiac valve.

14. The kit of claim 13, wherein said medical device is an artificial replacement valve or an annuloplasty implant.

15. The kit of claim 13, wherein said cardiac valve is an aortic valve of said patient or a mitral valve.

16. The transvascular catheter device of claim 1, wherein said plurality of radially expandable units comprises sponges that are retractable into said sheath.

17. The transvascular catheter device of claim 1, wherein said device is configured for transaxial delivery.

18. The transvascular catheter device of claim 1, wherein said device is configured for transfemoral delivery.

19. A transvascular catheter device comprising:

an elongate sheath with a first lumen and a distal end, said distal end being configured for positioning at a heart valve,

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 said distal end,

an expandable embolic protection filter having a delivery shape and a non-tubular expanded shape, and

one or more radially expandable units arranged for temporarily positioning said elongate sheath at a desired position in relation to said cardiac valve when said expandable units are in an expanded state

wherein;

at least a portion of said expandable embolic protection filter is arranged to extend from an orifice of said second lumen;

said orifice is positioned proximally with respect to said distal end of said elongate sheath;

the embolic protection filter is constructed so that, when extended from said orifice, the embolic protection filter expands from a delivery shape to a non-tubular shape that covers ostia of side branch vessels in an aortic arch and stabilizes said distal end of said sheath.