Heart valve implant and heart valve implant system

Abstract

A heart-valve implant, in particular for mitral-valve reconstruction, which is to be carried out on a beating heart with a minimally-invasive method where access to the heart is made between the 3rd or 4th intercostal space in the right area of the thorax, where via this access path, the heart-valve implant is inserted into the left ventricle of the heart, which heart-valve implant includes a fastener for picking up a valve leaflet, an anchor for fastening the fastener in the myocardium, and a connector, which connects the anchor to the fastener.

1 . Heart-valve implant ( 11 ) for minimally-invasive repair of a valve flap ( 6 ) in the beating heart ( 1 ) of a patient, with
 A connecting element ( 20 ), whereby the connecting element ( 20 ) is equipped with a first end ( 24 ) and a second end ( 24 ′), in general opposite one another,   An anchoring element ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), whereby the proximal end ( 51 ) is arranged on the first end ( 24 ) of the connecting element ( 20 ) and a fastening means ( 18 ) is arranged on the second end ( 24 ′) of the connecting element ( 20 ),   whereby the fastening means ( 18 ) has the following:   A tube element ( 25 );   A connecting element ( 27 ); and   A gripping element ( 60 ), whereby
 The connecting element ( 27 ) has a free end ( 30 ), which is arranged to pivot in the tube element ( 25 ), and 
 On the other end ( 54 ) of the pivotable connecting element ( 27 ) that is opposite to the longitudinal shaft ( 33 ) in the longitudinal direction ( 53 ), a leg spring ( 38 ) is arranged to pivot, on which, in turn tightly connected to the latter, two spring arms ( 50 ,  50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged; and 
   A clamping means ( 74 ), which connects the connecting element ( 20 ) to the fastening element ( 18 ).   
     
     
         2 . Heart-valve implant ( 11 ) according to  claim 1 , characterized in that the tube element ( 25 ) with the connecting element ( 27 ) form an articulated connection ( 29 ), and the connecting element ( 27 ) with the gripping element ( 60 ) form an articulated connection ( 29 ′). 
     
     
         3 . Heart-valve implant ( 11 ) according to  claims 1  to  2 , characterized in that the tube element ( 25 ) is designed as a cylindrical sleeve ( 25 ′) and has two opposite openings ( 31 ,  31 ′) in the sleeve wall ( 32 ), resting on a transverse shaft ( 35 ), whereby the transverse shaft ( 35 ) is perpendicular to the longitudinal shaft ( 33 ) of the sleeve ( 25 ′), and openings ( 31 ,  31 ′), viewed in the longitudinal direction of the sleeve ( 25 ′), are arranged in the center in the sleeve wall ( 32 ). 
     
     
         4 . Heart-valve implant ( 11 ) according to  claim 1 , characterized in that the connecting element ( 27 ) forms a strap ( 28 ), which comprises two longitudinal legs ( 34 ,  34 ′) and a transverse leg ( 36 ), whereby a pin or an eye is arranged on the free ends ( 30 ) of the longitudinal legs ( 34 ,  34 ′), and the transverse leg ( 36 ) forms a connecting rod ( 37 ) with [a] transverse shaft ( 44 ), which is separate from and parallel to the transverse shaft ( 35 ) in the sleeve ( 25 ′) and as [a] connecting rod ( 37 ) is [a] carrier of a leg spring ( 38 ). 
     
     
         5 . Heart-valve implant ( 11 ) according to  claim 1 , characterized in that the leg spring ( 38 ) of the gripping element ( 60 ) is made U-shaped from a leaf spring ( 39 ) and has at least two leaf-spring legs ( 45 ,  45 ′,  49 ,  49 ′), whereby a connecting element ( 41 ) that corresponds to the connecting rod ( 37 ) of the strap ( 28 ) and with a transverse shaft ( 55 ) is arranged in the inside crown ( 48 ) of the leg area ( 40 ). 
     
     
         6 . Heart-valve implant ( 11 ) according to  claim 5 , characterized in that the connecting element ( 41 ) is made from at least one annular eye ( 42 ,  42 ′), a cylindrical channel ( 43 ), a longitudinal groove ( 43 ) or a slot ( 72 ). 
     
     
         7 . Heart-valve implant ( 11 ) according to  claims 5  to  6 , characterized in that the connecting element ( 41 ) is arranged on the outside ( 70 ) of the leaf-spring legs ( 45 ,  45 ′,  49 ,  49 ′) in the leg area ( 48 ) of the side of the opening ( 47 ) of the leaf-spring legs ( 45 ,  45 ′,  49 ,  49 ′) that faces away. 
     
     
         8 . Heart-valve implant ( 11 ) according to  claim 5 , characterized in that the leaf spring ( 39 ) of the leg spring ( 38 ) in the surface ( 70 ) has at least one recess ( 71 ) in the leaf-spring leg ( 45 ,  49 ). 
     
     
         9 . Heart-valve implant ( 11 ) according to  claim 1 , characterized in that the gripping element ( 60 ) has a mouth part ( 56 ) that is formed by the spring arms ( 50 ,  50 ′), which mouth part is arranged resting on the fastening side ( 63 ) of the gripping element ( 60 ) and on the side of the open leg spring ( 38 ) that faces away as well as on the longitudinal shaft ( 33 ) of the pipe element ( 25 ), whereby the mouth part ( 56 ) has at least one spacer ( 88 ) that is arranged in the mouth part ( 56 ) and that creates a predetermined gap ( 89 ) between the gears ( 87 ) of the gripper jaws ( 86 ) in the mouth part ( 56 ). 
     
     
         10 . Heart-valve-implant system for minimally-invasive repair of a valve flap ( 6 ) in the beating heart ( 1 ) of a patient, with
 An outer tube spacer ( 57 ) with lumen for guiding and holding a fastening means ( 18 );   A first inner tube spacer I ( 58 ) with lumen for opening and closing a gripping element ( 60 );   A second inner tube spacer II ( 59 ) with lumen for guiding and screwing-in an anchoring element ( 13 );   A third inner tube spacer III ( 77 ) for inserting and positioning a sliding ring ( 76 ); and   A heart-valve implant ( 11 ), having:
 A connecting element ( 20 ), whereby the connecting element ( 20 ) is equipped with a first end ( 24 ) and a second end ( 24 ′), in general opposite one another; 
 An anchoring element ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), whereby the proximal end ( 51 ) is arranged on the first end ( 24 ) of the connecting element ( 20 ) and a fastening means ( 18 ) is arranged on the second end ( 24 ′) of the connecting element ( 20 ); 
 A fastening means ( 18 ) designed as a tube element ( 25 ) in the form of a cylindrical sleeve ( 25 ′); and 
 A connecting element ( 27 ) and a gripping element ( 60 ), whereby
 The connecting element ( 27 ) has a strap ( 28 ), which has a free end ( 30 ) that is arranged to pivot in the tube element ( 25 ), and 
 A gripping element ( 60 ) is arranged to pivot on the other end ( 54 ) of the pivotable connecting element ( 27 ) opposite to the longitudinal shaft ( 33 ) in the longitudinal direction ( 53 ), and 
 The gripping element ( 60 ) has a leg spring ( 38 ), on which, tightly connected with the latter, two spring arms ( 50 ,  50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged. 
 
   
     
     
         11 . Heart-valve-implant system according to  claim 10 , characterized in that the gripping element ( 60 ) has a mouth part ( 56 ) that is formed by the spring arms ( 50 ,  50 ′), which mouth part is arranged resting on the fastening side ( 63 ) of the gripping element ( 60 ) and on the side of the open leg spring ( 38 ) that faces away as well as on the longitudinal shaft ( 33 ) of the tube element ( 25 ), whereby the mouth part ( 56 ) has at least one spacer ( 88 ) that is arranged in the mouth part ( 56 ), which spacer creates a predetermined gap ( 89 ) between the gears ( 87 ) of the gripper jaws ( 86 ) in the mouth part ( 56 ).