Device For Delivery Of Medical Devices To A Cardiac Valve

• US 20140228942A1
• Filed: 05/07/2012
• Published: 08/14/2014
• Est. Priority Date: 05/08/2011
• Status: Active Grant

• Current Assignee: SWAT Medical AB
• Original Assignee: Contego AB
• Inventors: Krahbichler, Erik
• Granted Patent: US 9,023,101 B2
• Time in Patent Office: Days
• 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 (1) is disclosed for transvascular delivery of a medical device to a cardiac valve region of a patient. The catheter device comprises an elongate sheath (2) with a lumen and a distal end (3) for positioning at a heart valve (6), and a second channel (7) that extends parallel to, or in, said elongate sheath, an expandable embolic protection unit (8), such as a filter, wherein at least a portion of the expandable embolic protection unit is arranged to extend from an orifice of the second channel, wherein the embolic protection unit is non-tubular, extending substantially planar in the expanded state for covering ostia of the side branch vessels in the aortic arch.

Claims

1. A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient, said catheter device comprising

an elongate sheath with a lumen and a distal end for positioning at a heart valve, and

a second channel that extends parallel to, or in, said elongate sheath,

an expandable embolic protection unit, such as a filter, wherein at least a portion of said expandable embolic protection unit is arranged to extend from an orifice of said second channel, wherein said embolic protection unit is non-tubular, extending substantially planar in said expanded state for covering ostia of the side branch vessels in the aortic arch.

2. The catheter device according to claim 1, comprising a delivery unit connectable to said embolic protection unit at a connection point, wherein said connection point is arranged off-centre at the embolic protection unit such that said delivery unit is connectable off-center to said embolic protection unit.

3. The catheter device according to claim 1 or 2, wherein said embolic protection unit is arranged to stabilize said distal end of said sheath when said embolic protection unit is expanded out of said second channel.

4. The catheter device according to claim 3, wherein said embolic protection unit is an anchor to said sheath when in an expanded state.

5. The catheter device according to any of claims 1-4, comprising a plurality of expandable units being arranged for temporarily positioning said elongate sheath in relation to said cardiac valve when in an expanded state;

and

wherein said elongate sheath comprises releasable locking members for controllably locking said elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to said cardiac valve by said expandable units in order to stabilize said elongate sheath.

6. The catheter device according to claim 5, comprising an elongate member with a distal end portion comprising said plurality of radially expandable units, wherein said elongate member is retractably insertable into said lumen.

7. The catheter device of claims 5 and 6, wherein said elongate sheath is deliverable transvascularly in said relaxed state for transiting from said relaxed state to said locked state when positioned in relation to said cardiac valve by said expandable units, and wherein said elongate member is retractable from said lumen together with said plurality of radially expandable units when collapsed, for said elongate sheath being locked and, when said elongate member is retracted, said lumen is accessible for said delivery of said medical device to said cardiac valve region.

8. The catheter device of any claims 1-7, wherein said second channel is affixed or integral with on the outer portion of said elongate sheath;

or wherein said second channel is affixed on or integral with the inside portion of said elongate sheath.

9. The catheter device of claim 5, wherein said plurality of radially expandable units comprises expandable balloons, preferably three balloons positioned radially equidistant around a longitudinal axis of said elongate sheath.

10. The catheter device of claims 5, wherein said plurality of radially expandable units comprises expandable mechanical levers, or swellable units, such as sponges, retractable into said sheath.

11. The catheter device of claim 6, wherein said elongate member is retractably inserted into said elongate sheath'"'"'s lumen to a length equal to the distance between the distal end and a proximal marker.

12. The catheter device of claims 1-11, wherein said elongate sheath comprises radiopaque fiducial markers.

13. The catheter device of claim 5, wherein said locking members are comprised in the list of a draw string, releasable latches, or a squeezing mechanism.

14. The catheter device of any of claims 1-13, wherein said medical device is an artificial replacement valve or a valve repair device, such as an annuloplasty implant.

15. The catheter device of any of claims 1-14, wherein said cardiac valve is an aortic valve of said patient;

or a mitral valve of said patient.

16. A kit of a catheter device of any of claims 1-15 and a medical device for a cardiac valve.

17. A system for transvascularly delivering a medical device to a cardiac valve of a patient, said system comprising

a catheter comprising an elongate sheath with a lumen in a relaxed state for minimally invasively introducing into said vascular system;

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

an expandable embolic protection unit, such as a filter, wherein at least a portion of said expandable embolic protection unit is arranged to extend from an orifice of said second channel, wherein said embolic protection unit is non-tubular, extending substantially planar in said expanded state for covering ostia of the side branch vessels in the aortic arch,

a plurality of radially expandable units at least temporarily provideable at said distal end of said elongate sheath;

wherein said radially expandable units are arranged for expanding to temporarily position said distal end in relation to said cardiac valve;

and locking members of said catheter which, when released, maintain said sheath in a structurally locked state to maintain its spatial position relative said cardiac valve;

whereby said expandable units are arranged to allow for increased blood flow around said sheath when returned to a non expanded configuration while said locked state is maintained for delivering a medical device through the lumen of said locked elongate sheath to said heart valve;

and wherein said elongate sheath is arranged to return to said relaxed state when said locking members are released for withdrawing said elongate sheath in said relaxed state from the vasculature of said patient.

18. A method of transvascularly delivering a medical device to a cardiac valve of a patient comprising:

introducing a catheter comprising an elongate sheath with a lumen in a relaxed state into said vascular system;

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

expanding an embolic protection unit from a second channel in said sheath to cover ostia of the side branch vessels in the aortic arch and to stabilize a distal end of said sheath at the cardiac valve,

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

19. Method according to claim 18, wherein said embolic protection unit is expanded to a non-tubular, substantially planar shape over said ostia.

20. Method according to claim 18 or 19, comprising,

radially expanding expandable units of said catheter or an elongate member positioned beyond a distal end of said sheath, to temporarily position in relation to said valve said elongate sheath;

releasing locking members of said catheter to maintain said elongate sheath in a locked state;

delivering a medical device through the lumen of said locked elongate sheath to said heart valve;

releasing said locking members to return said elongate sheath to said relaxed state; and

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

21. Method according to any of claims 18-20 comprising,

inserting an elongate member with a distal end portion comprising a plurality of said radially expandable units, into said lumen of said elongate sheath;

advancing said elongate member through said elongate sheath to said distal end of said elongate sheath;

retracting said expandable units and withdrawing said elongate member from the lumen of the elongate sheath.