Device For Delivery Of Medical Devices To A Cardiac Valve

Abstract

A catheter device and method are disclosed for transvascular delivery of a medical device to a cardiac valve region of a patient. The catheter device comprises an elongate sheath with releasable locking members for controllably locking the elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to a cardiac valve. Furthermore, alignment members are provided to provide for a desired positioning in relation to the cardiac valve. Embolic protection is further provided.

What is claimed is: 
     
         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 introducer sheath with a lumen and a distal portion with a distal end, wherein said distal end is configured to be arranged in the ascending aorta and has a locking configuration;   said distal portion comprising fewer than three radially expandable units,   said expandable unit(s) being arranged for temporarily positioning said elongate sheath centrally in relation to said aortic cardiac valve when in an expanded state outside said distal end portion of said elongate introducer sheath; and   wherein said elongate sheath can be controllably locked in said locking configuration along said distal portion when said elongate sheath is positioned in relation to said cardiac valve by said fewer than three expandable units in order to stabilize said elongate sheath, wherein said distal portion is the portion to be arranged in the ascending aorta.   
     
     
         2 . The catheter device of  claim 1 , wherein said fewer than three radially expandable units are integrally formed with the sheath. 
     
     
         3 . The catheter device of  claim 1 , wherein said fewer than three radially expandable units comprises expandable balloons, expandable mechanical levers, or swellable units. 
     
     
         4 . The catheter device of  claim 3 , wherein said fewer than three radially expandable units is positioned equidistant around a longitudinal axis of said elongate sheath. 
     
     
         5 . The catheter device of any of  claim 1  wherein said elongate sheath comprises radiopaque fiducial markers. 
     
     
         6 . The catheter device of any of  claim 1 , wherein said medical device is an artificial replacement valve or a valve repair device. 
     
     
         7 . 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 having a locking configuration, and   at least one expandable unit arranged at a distal end of said sheath positionable in the ascending aorta of said patient and being arranged for temporarily positioning said elongate sheath in relation to said cardiac valve when in an expanded state,   an elongate member with a distal end portion comprising a plurality of radially expandable units, wherein said elongate member is retractably insertable into said lumen,   said expandable units being arranged for temporarily positioning said elongate sheath centrally in relation to said cardiac valve in an expanded state outside of said elongate sheath in said locking configuration; and   wherein said distal end of said catheter is configured to be arranged in the ascending aorta.   
     
     
         8 . The catheter device of  claim 7 , wherein said elongate member is retractable from said lumen together with said plurality of radially expandable units when collapsed. 
     
     
         9 . The catheter device of  claim 7 , wherein said at least one radially expandable unit is integrally formed with the sheath. 
     
     
         10 . The catheter device of  claim 7 , said at least one radially expandable units comprises expandable balloons, expandable mechanical levers, or swellable units. 
     
     
         11 . The catheter device of  claim 7 , wherein said at least one radially expandable units is positioned equidistant around a longitudinal axis of said elongate sheath. 
     
     
         12 . The catheter device of  claim 7 , wherein said elongate sheath comprises radiopaque fiducial markers. 
     
     
         13 . The catheter device of any of  claim 1 , wherein said medical device is an artificial replacement valve or a valve repair device. 
     
     
         14 . A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient including the aortic valve of said patient, said catheter device comprising:
 an elongate sheath with an outside, a lumen, a distal end and a distal end portion, wherein said distal end of said sheath is configured to be arranged in the ascending aorta and have a locking configuration; and   at least one of radially expandable unit for apposition with an aortic arch inner tissue lumen tissue when expanded, said at least one of radially expandable unit being arranged on the outside of the sheath at said distal end portion, and said at least one radially expandable unit is configured for positioning said elongate sheath with its distal end in the ascending aorta portion of the aortic arch, and said distal end of said elongate sheath being configured to be oriented towards said aortic valve when inserted into the aorta and at a distance from said aortic valve downstream in blood flow direction as well as locked and centrally positioned in relation to said aortic valve when the expandable unit is in an expanded state.   
     
     
         15 . The catheter device of  claim 14 , wherein said at least one radially expandable unit is integrally formed with the sheath. 
     
     
         16 . The catheter device of  claim 14 , said at least one radially expandable units comprises expandable balloons, expandable mechanical levers, or swellable units. 
     
     
         17 . The catheter device of  claim 14 , wherein said at least one radially expandable units is positioned equidistant around a longitudinal axis of said elongate sheath. 
     
     
         18 . The catheter device of  claim 14 , wherein said elongate sheath comprises radiopaque fiducial markers. 
     
     
         19 . The catheter device of  claim 14 , wherein said medical device is an artificial replacement valve or a valve repair device.