Catheter Device And Method For Delivery Of Medical Devices In The Aorta

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 a lumen and a distal end for positioning at a target site e.g. a heart valve.

1 - 17 . (canceled) 
     
     
         18 . A catheter device for transvascular delivery of a medical device to a target region, such as a heart valve region, of a patient, comprising an elongate sheath with a lumen, a proximal end, a distal end, and a distal end portion including said distal end is configured to be positioning at, or in the vicinity to, or adjacent to said target region, such as said heart valve region, wherein said elongate sheath has an increasing flexibility towards said distal end. 
     
     
         19 . The catheter device according to  claim 18 , comprising at least one, preferably a plurality of expandable units being arranged for temporarily positioning said elongate sheath in relation to said cardiac valve when in an expanded state. 
     
     
         20 . The catheter device according to  claim 18 , 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. 
     
     
         21 . The catheter device of  claim 18 , wherein said plurality of radially expandable units comprises expandable balloons, preferably three balloons positioned radially equidistant around a longitudinal axis of said elongate sheath. 
     
     
         22 . The catheter device of  claim 21 , wherein said plurality of radially expandable units comprises expandable mechanical levers, or swellable units, such as sponges, retractable into said sheath. 
     
     
         23 . The catheter device of  claim 18 , wherein said medical device is an artificial replacement valve or a valve repair device, wherein said cardiac valve preferably is an aortic valve of said patient. 
     
     
         24 . A kit of a catheter device of  claim 18  and a medical device for a cardiac valve, such as an artificial replacement valve. 
     
     
         25 . A catheter device for transvascular delivery of a medical device to a target region, such as a heart valve region, of a patient, comprising an elongate catheter sheath with a lumen, a proximal end, a distal end, and a distal end portion including said distal end is configured to be positioning at, or in the vicinity to, or adjacent to said target region, such as said heart valve region;
 said catheter having an elongate sheath with a distal end configured to transvascularly navigate through said vascular system upstream the aorta to a position at and/or downstream said aortic cardiac valve;   wherein said elongate sheath has an increasing flexibility towards said distal end.   
     
     
         26 . The catheter device of  claim 25 , comprising a cover sheath arranged coaxially outside of said elongate catheter sheath;
 said cover sheath including at least one or a plurality of radially expandable units proximate said distal end of said catheter sheath and at an exterior of said catheter sheath; wherein at least one of said radially expandable units is configured to be in apposition with the interior vessel wall in the ascending aorta downstream said aortic valve and upstream all side branch vessels of said aortic arch;   wherein said radially expandable units are arranged for expanding to temporarily position said distal end in relation to said cardiac valve;   whereby said expandable units are arranged to allow for blood flow outside said sheath and past lobes of said radially expandable units when in a position for delivering said artificial aortic valve; and wherein said cover sheath ends proximal of said catheter sheath distal end.   
     
     
         27 . The device of  claim 26 , wherein said cover sheath has a higher flexibility than said elongate catheter sheath. 
     
     
         28 . The device of  claim 25  comprising at least one radially expandable unit that is configured to be in apposition with the interior vessel wall in the ascending aorta downstream said aortic valve and upstream all side branch vessels of said aortic arch. 
     
     
         29 . The device of  claim 25 , including a cover sheath that has an increasing flexibility towards said distal end. 
     
     
         30 . The device of  claim 25 , including a cover sheath that is elastic and has a lesser inner lumen diameter than an outer diameter of said elongate catheter sheath, wherein said cover sheath is arranged outside said delivery catheter by stretching over said elongate catheter sheath outside and along said delivery catheter outside. 
     
     
         31 . The device of  claim 30 , wherein said cover sheath has a length shorter than a length of said elongate catheter sheath. 
     
     
         32 . The device of  claim 25 , combined with an introducer device configured to provide vascular, such as femoral access to said patients vascular system, said introducer having a shorter length than said elongate catheter sheath, and a lower flexibility than said elongate catheter sheath. 
     
     
         33 . The device of  claim 25 , including a cover sheath having a distal end with an attachment unit to the delivery catheter at the distal end of said cover sheath. 
     
     
         34 . The device of  claim 25 , including a slotted crown unit having a plurality of slots for passage of a portion of an interior inflation balloon and configured to produce lobes of said balloon through said slots and radially outside said slots. 
     
     
         35 . The device of  claim 25 , said elongate catheter sheath having a reinforcement braiding to avoid kinking. 
     
     
         36 . The device of  claim 25 , comprising multiple sets of anchoring units at a longitudinal distance from each other at said elongate catheter sheath.