Device and method for reducing cardiac valve regurgitation

Abstract

A catheter ( 4 ) based medical system ( 1 ) and medical procedure for reducing cardiac valve regurgitation are disclosed. The system comprises a resilient curvilinear shaped annuloplasty implant ( 3 ) for reducing the size of a dilated annulus ( 18 ) of said valve for reducing said regurgitation having resilient anchoring elements ( 300 ), and a delivery device ( 2 ) for said annuloplasty implant ( 3 ) having a distal curvilinear shaped portion ( 200 ) that is hollow to mount said annuloplasty implant ( 3 ) and has an annular opening ( 201 ) arranged to be in apposition against an annulus ( 18 ) of said cardiac valve. The annuloplasty implant ( 3 ) is arranged to be releasable in said hollow and has said resilient anchoring elements ( 300 ) arranged in a restrained spring loaded delivery conformation in said hollow, and wherein said resilient anchoring elements ( 300 ) when released are arranged in a tissue engaging conformation protruding out of said opening.

1 - 39 . (canceled) 
     
     
         40 . A medical device for reducing cardiac valve regurgitation,
 including a resilient curvilinear shaped annuloplasty implant for reducing the size of a dilated annulus of said valve for reducing said regurgitation, said annuloplasty implant having anchoring elements protruding radially outwards from said annuloplasty implant; wherein said anchoring elements are configured to be arranged in a first radial direction of said implant away from said annulus for delivery, and configured to anchor said annuloplasty implant to tissue at said annulus in a second radial direction of said implant, said second direction being opposite from said first direction towards said annulus,   wherein said annuloplasty implant is configured to be delivered in a compressed state and configured to be expanded before being anchored to said annulus, and   wherein said annuloplasty implant is configured to be downsized after being anchored.   
     
     
         41 . The device of  claim 40 , wherein said anchoring elements are configured to be arranged in a spring loaded first radial direction of said implant away from said annulus for delivery. 
     
     
         42 . The device of  claim 40 , wherein multiple of said anchoring elements are arranged at different radial positions around the cross section of the annuloplasty implant. 
     
     
         43 . The device of  claim 42 , wherein said anchoring elements are arranged opposite each other. 
     
     
         44 . The device of  claim 43 , wherein said anchoring elements are arranged at the same longitudinal position on the annuloplasty implant. 
     
     
         45 . A catheter based medical system for reducing cardiac valve regurgitation, including a medical device of  claim 40 , and
 a retractable delivery device for said annuloplasty implant having a distal curvilinear shaped portion that has a hollow in which to mount said annuloplasty implant with an opening of said hollow arranged to be in apposition against an annulus of said cardiac valve;   wherein said annuloplasty implant is mounted to be releasable in said hollow and has said anchoring elements arranged in said first radial direction in a restrained delivery conformation in said hollow by a restraining unit, and wherein said anchoring elements when released from said restraining unit are arranged in said second radial direction in a tissue engaging conformation protruding out of said opening.   
     
     
         46 . The system of  claim 45 , wherein said resilient curvilinear shaped annuloplasty implant has a tissue engaging conformation based on a desired downsized shape where said regurgitation of said valve is reduced, and
 said distal curvilinear shaped portion has a delivery conformation based on a shape of said dilated valve annulus shape, wherein said delivery conformation has a dimension that is larger than said tissue engaging conformation of said annuloplasty implant, such that said annuloplasty implant is resiliently kept in said hollow in said delivery conformation before release from said hollow.   
     
     
         47 . The system of  claim 46 , wherein said delivery device includes a sizing actuator, and wherein said distal curvilinear shaped portion is reducible from said delivery conformation by said actuator. 
     
     
         48 . The system of  claim 45 , wherein aid delivery device includes a first restraining unit for restraining said anchoring elements in a restrained spring-loaded delivery conformation. 
     
     
         49 . The system of  claim 45 , wherein said delivery device includes a second restraining unit for restraining said annuloplasty implant in said hollow of said distal curvilinear shaped portion. 
     
     
         50 . The system of  claim 45 , wherein said delivery device includes a third restraining unit for keeping said annuloplasty implant in said hollow of said distal curvilinear shaped portion. 
     
     
         51 . The system of  claim 45 , having a first, second and third restraining unit, wherein said third restraining unit is arranged to release said annuloplasty implant by withdrawing said delivery device when said first restraining unit has released said anchoring elements from said restrained delivery conformation and anchored said anchoring elements into said annulus tissue. 
     
     
         52 . The system of  claim 45 , wherein said cardiac valve is a mitral valve, and wherein said system is adapted for transseptal percutaneous delivery into the left atrium to said atrial side of said mitral valve, and
 wherein a delivery portion of said delivery device is distally connected to said distal curvilinear shaped portion and has a distal curvature to allow access from a septal opening towards said mitral valve.   
     
     
         53 . The system of  claim 45 , wherein said cardiac valve is a tricuspid valve, and wherein said system is adapted for percutaneous delivery into the right atrium to said atrial side of said tricuspid valve, and
 wherein a delivery portion of said delivery device is distally connected to said distal curvilinear shaped portion and has a distal curvature to allow suitable access towards said tricuspid valve.   
     
     
         54 . The system of  claim 45 , wherein said hollow of said distal curvilinear shaped portion is providable with a negative pressure for suction of said hollow to said annulus. 
     
     
         55 . The system of  claim 54 , wherein a pressure in said hollow is measured and a contact with said annulus tissue is determinable from said measured pressure or an energy consumption of a flow generator generating said pressure. 
     
     
         56 . The system of  claim 45 , wherein said distal curvilinear shaped portion has arranged thereon a sensor for indicating contact with said annulus tissue, such as a piezo transducer. 
     
     
         57 . The system of  claim 45 , wherein said distal curvilinear shaped portion has at least one fiducial marker. 
     
     
         58 . The system of  claim 57 , wherein said fiducial marker is arranged at a periphery of said distal curvilinear shaped portion; and/or wherein one of said fiducial markers is an annular fiducial marker arranged along said periphery. 
     
     
         59 . The system of  claim 57 , having a plurality of fiducial markers distributed along said distal curvilinear shaped portion for identifying said distal curvilinear shaped portion inside a body of a patient having said cardiac valve.