Heart valve implant and heart valve implant system
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 3 rd or 4 th 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. A heart-valve implant ( 11 ) for minimally-invasive repair of a valve flap ( 6 ) in a beating heart ( 1 ) of a patient, comprising
a first connecting element ( 20 ) having a first end ( 24 ) and a second end ( 24 ′) opposite one another,
an anchoring element ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), wherein the proximal end ( 51 ) is arranged on the first end ( 24 ) of the first connecting element ( 20 ) and a fastening means ( 18 ) is arranged on the second end ( 24 ′) of the first connecting element ( 20 ),
wherein the fastening means ( 18 ) contains the following:
a tube element ( 25 );
a second connecting element ( 27 ); and
a gripping element ( 60 ), wherein
the second 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 second connecting element ( 27 ) along a longitudinal axis ( 33 ) in a longitudinal direction ( 53 ), a leg spring ( 38 ) is arranged to pivot, on which two spring arms ( 50 , 50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged, and the two spring arms ( 50 , 50 ′) are connected to said leg spring ( 38 ); and
a clamping means ( 74 ), which connects the first connecting element ( 20 ) to the fastening element ( 18 ).
2. The heart-valve implant ( 11 ) according to claim 1 , wherein the tube element ( 25 ) with the second connecting element ( 27 ) form a first articulated connection ( 29 ), and the second connecting element ( 27 ) with the gripping element ( 60 ) form aft a second articulated connection ( 29 ′).
3. The heart-valve implant ( 11 ) according to claim 1 , wherein the tube element ( 25 ) is a cylindrical sleeve ( 25 ′) and has two opposite openings ( 31 , 31 ′) in a sleeve wall ( 32 ), resting on a transverse axis ( 35 ), wherein the transverse axis ( 35 ) is perpendicular to the longitudinal axis ( 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. The heart-valve implant ( 11 ) according to claim 1 , wherein the second connecting element ( 27 ) forms a strap ( 28 ), which comprises two longitudinal legs ( 34 , 34 ′) and a transverse leg ( 36 ), wherein a pin or an eye is arranged on free ends ( 30 ) of the longitudinal legs ( 34 , 34 ′), and the transverse leg ( 36 ) forms a connecting rod ( 37 ) with a transverse axis ( 44 ), which is separate from and parallel to the transverse axis ( 35 ) in the sleeve ( 25 ′) and a connecting rod ( 37 ) is a carrier of a leg spring ( 38 ).
5. The heart-valve implant ( 11 ) according to claim 1 , wherein 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 ′), wherein a further connecting element ( 41 ) that corresponds to the connecting rod ( 37 ) of the strap ( 28 ) and with a transverse axis ( 55 ) is arranged in an inside crown ( 48 ) of a leg area ( 40 ).
6. The heart-valve implant ( 11 ) according to claim 5 , wherein said further 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. The heart-valve implant ( 11 ) according to claim 5 , wherein said further connecting element ( 41 ) is arranged on the outside ( 70 ) of the leaf-spring legs ( 45 , 45 ′, 49 , 49 ′) in the leg area ( 40 ) of the side of an opening ( 47 ) of the leaf-spring legs ( 45 , 45 ′, 49 , 49 ′) that faces away.
8. The heart-valve implant ( 11 ) according to claim 5 , wherein the leaf spring ( 39 ) of the leg spring ( 38 ) in a surface ( 70 ) has at least one recess ( 71 ) in the leaf-spring leg ( 45 , 49 ).
9. The heart-valve implant ( 11 ) according to claim 1 , wherein 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 a fastening side ( 63 ) of the gripping element ( 60 ) and on a side of the open leg spring ( 38 ) that faces away as well as on the longitudinal axis ( 33 ) of the tube element ( 25 ), wherein 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 gears ( 87 ) of gripper jaws ( 86 ) in the mouth part ( 56 ).
10. A heart-valve-implant system for minimally-invasive repair of a valve flap ( 6 ) in a beating heart ( 1 ) of a patient, comprising
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 ), comprising
a first connecting element ( 20 ), wherein the first connecting element ( 20 ) is equipped with a first end ( 24 ) and a second end ( 24 ′) opposite one another;
said anchoring element ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), wherein the proximal end ( 51 ) is arranged on the first end ( 24 ) of the first connecting element ( 20 ) and said fastening means ( 18 ) is arranged on the second end ( 24 ′) of the first connecting element ( 20 );
said fastening means ( 18 ) designed as a tube element ( 25 ) in the form of a cylindrical sleeve ( 25 ′); and
a second connecting element ( 27 ), wherein
the second connecting element ( 27 ) has a strap ( 28 ), which has a free end ( 30 ) that is arranged to pivot in the tube element ( 25 ), and
said gripping element ( 60 ) is arranged to pivot on the other end ( 54 ) of the pivotable second connecting element ( 27 ) along a longitudinal axis ( 33 ) in a longitudinal direction ( 53 ), and
said gripping element ( 60 ) has a leg spring ( 38 ), on which two spring arms ( 50 , 50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged, and the two spring arms ( 50 , 50 ′) are connected to said leg spring ( 38 ).
11. The heart-valve-implant system according to claim 10 , wherein 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 a fastening side ( 63 ) of the gripping element ( 60 ) and on a side of the open leg spring ( 38 ) that faces away as well as on the longitudinal axis ( 33 ) of the tube element ( 25 ), wherein 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 gears ( 87 ) of gripper jaws ( 86 ) in the mouth part ( 56 ).
12. A heart-valve implant ( 11 ) for minimally-invasive repair of a valve flap ( 6 ) in a beating heart ( 1 ) of a patient, comprising
a first connector ( 20 ) having a first end ( 24 ) and a second end ( 24 ′) opposite one another,
an anchor ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), wherein the proximal end ( 51 ) is arranged on the first end ( 24 ) of the first connector ( 20 ) and a fastener ( 18 ) is arranged on the second end ( 24 ′) of the first connector ( 20 ), wherein the fastener ( 18 ) contains the following:
a tube ( 25 );
a second connector ( 27 ); and
a gripper ( 60 ), wherein
the second connector ( 27 ) has a free end ( 30 ), which is arranged to pivot in the tube ( 25 ), and
on the other end ( 54 ) of the pivotable second connector ( 27 ) along a longitudinal axis ( 33 ) in a longitudinal direction ( 53 ), a leg spring ( 38 ) is arranged to pivot, on which two spring arms ( 50 , 50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged, and the two spring arms ( 50 , 50 ′) are connected to said leg spring ( 38 ); and
a clamp ( 74 ), which connects the first connector ( 20 ) to the fastener ( 18 ).
13. The heart-valve implant ( 11 ) according to claim 12 , wherein the tube ( 25 ) with the second connector ( 27 ) form a first articulated connection ( 29 ), and the second connector ( 27 ) with the gripper ( 60 ) form a second articulated connection ( 29 ′).
14. The heart-valve implant ( 11 ) according to claim 12 , wherein the tube ( 25 ) is a cylindrical sleeve ( 25 ′) and has two opposite openings ( 31 , 31 ′) in a sleeve wall ( 32 ), resting on a transverse axis ( 35 ), wherein the transverse axis ( 35 ) is perpendicular to the longitudinal axis ( 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 ).
15. The heart-valve implant ( 11 ) according to claim 12 , wherein the second connector ( 27 ) forms a strap ( 28 ), which comprises two longitudinal legs ( 34 , 34 ′) and a transverse leg ( 36 ), wherein a pin or an eye is arranged on free ends ( 30 ) of the longitudinal legs ( 34 , 34 ′), and the transverse leg ( 36 ) forms a connecting rod ( 37 ) with a transverse axis ( 44 ), which is separate from and parallel to the transverse axis ( 35 ) in the sleeve ( 25 ′) and a connecting rod ( 37 ) is a carrier of a leg spring ( 38 ).
16. The heart-valve implant ( 11 ) according to claim 12 , wherein the leg spring ( 38 ) of the gripper ( 60 ) is made U-shaped from a leaf spring ( 39 ) and has at least two leaf-spring legs ( 45 , 45 ′, 49 , 49 ′), wherein a further connecting element ( 41 ) that corresponds to the connecting rod ( 37 ) of the strap ( 28 ) and with a transverse axis ( 55 ) is arranged in an inside crown ( 48 ) of a leg area ( 40 ).
17. The heart-valve implant ( 11 ) according to claim 16 , wherein said further 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 ).
18. The heart-valve implant ( 11 ) according to claim 16 , wherein said further connecting element ( 41 ) is arranged on the outside ( 70 ) of the leaf-spring legs ( 45 , 45 ′, 49 , 49 ′) in the leg area ( 40 ) of the side of an opening ( 47 ) of the leaf-spring legs ( 45 , 45 ′, 49 , 49 ′) that faces away.
19. The heart-valve implant ( 11 ) according to claim 16 , wherein the leaf spring ( 39 ) of the leg spring ( 38 ) in a surface ( 70 ) has at least one recess ( 71 ) in the leaf-spring leg ( 45 , 49 ).
20. The heart-valve implant ( 11 ) according to claim 12 , wherein the gripper ( 60 ) has a mouth part ( 56 ) that is formed by the spring arms ( 50 , 50 ′), which mouth part is arranged resting on a fastening side ( 63 ) of the gripper ( 60 ) and on a side of the open leg spring ( 38 ) that faces away as well as on the longitudinal axis ( 33 ) of tube ( 25 ), wherein 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 gears ( 87 ) of gripper jaws ( 86 ) in the mouth part ( 56 ).
21. A heart-valve-implant system for minimally-invasive repair of a valve flap ( 6 ) in a beating heart ( 1 ) of a patient, comprising
an outer tube spacer ( 57 ) with lumen for guiding and holding a fastener ( 18 );
a first inner tube spacer I ( 58 ) with lumen for opening and closing a gripper ( 60 );
a second inner tube spacer II ( 59 ) with lumen for guiding and screwing-in an anchor ( 13 );
a third inner tube spacer III ( 77 ) for inserting and positioning a sliding ring ( 76 ); and
a heart-valve implant ( 11 ), comprising
a first connector ( 20 ), wherein the first connector ( 20 ) is equipped with a first end ( 24 ) and a second end ( 24 ′) opposite one another;
said anchor ( 13 ), which has a proximal end ( 51 ) and a distal end ( 52 ), wherein the proximal end ( 51 ) is arranged on the first end ( 24 ) of the first connector ( 20 ) and said fastener ( 18 ) is arranged on the second end ( 24 ′) of the first connector ( 20 );
said fastener ( 18 ) designed as a tube ( 25 ) in the form of a cylindrical sleeve ( 25 ′); and
a second connector ( 27 ), wherein
the second connector ( 27 ) has a strap ( 28 ), which has a free end ( 30 ) that is arranged to pivot in the tube ( 25 ), and
said gripper ( 60 ) is arranged to pivot on the other end ( 54 ) of the pivotable second connector ( 27 ) along a longitudinal axis ( 33 ) in a longitudinal direction ( 53 ), and
said gripper ( 60 ) has a leg spring ( 38 ), on which two spring arms ( 50 , 50 ′) that are parallel and separated by the leg spring ( 38 ) are arranged, and the two spring arms ( 50 , 50 ′) are connected to said leg spring ( 38 ).
22. The heart-valve-implant system according to claim 21 , wherein the gripper ( 60 ) has a mouth part ( 56 ) that is formed by the spring arms ( 50 , 50 ′), which mouth part is arranged resting on a fastening side ( 63 ) of the gripper ( 60 ) and on a side of the open leg spring ( 38 ) that faces away as well as on the longitudinal axis ( 33 ) of the tube ( 25 ), wherein 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 gears ( 87 ) of gripper jaws ( 86 ) in the mouth part ( 56 ).