Embolic protection device, folding method and forming device
Embolic protection device for insertion into an aortic arch, with a filter unit, a frame and a feed unit, wherein the filter unit is arranged at the frame and the frame provides a proximal area having a proximal shape, which is arranged in an inner area of the frame and is connected to the feed unit, wherein the proximal shape has a first part and a second part, wherein the second part is formed at one end of the first part.
1 . An embolic protection device for insertion into an aortic arch, comprising:
a filter unit,
a frame with a proximal end and a distal end; and
a feed unit located at the proximal end of the frame,
wherein the filter unit is arranged within the frame, the frame comprising a wire and providing a proximal area comprising a proximal shape and a distal area,
wherein the proximal shape is arranged at the proximal end of the frame and is connected to the feed unit, and
wherein the proximal shape comprises two wire ends formed to extend parallel to each other and inwards in a distal direction of the frame.
2 . The embolic protection device of claim 1 , wherein the distal area comprises a distal shape formed to extend inwards in a proximal direction of the frame.
3 . The embolic protection device of claim 1 , wherein the frame defines a generally oval two-dimensional area.
4 . The embolic protection device of claim 3 , wherein the proximal shape is formed to extend over the generally oval two-dimensional area of the frame.
5 . The embolic protection device of claim 3 , wherein a first part of the proximal shape is formed at a first angle to the generally oval two-dimensional area of the frame, and a second part of the proximal shape is formed at one end of the first part and at a second angle to the first part of the proximal shape.
6 . The embolic protection device of claim 5 , wherein the first part and the second part are arranged to each other such that they form a spring mechanism.
7 . The embolic protection device of claim 1 , wherein the proximal shape is configured to be set under tension via the feeding unit.
8 . The embolic protection device of claim 1 , wherein the filter unit is connected to the frame outside the proximal and/or the distal area of the frame.
9 . An embolic protection device for insertion into an aortic arch, comprising:
a filter unit,
a frame with a proximal end and a distal end; and
a feed unit located at the proximal end of the frame,
wherein the filter unit is arranged within the frame, the frame comprising a wire providing a proximal area comprising a proximal shape and a distal area comprising a distal shape,
wherein the proximal shape is arranged at the proximal end of the frame and is connected to the feed unit,
wherein the distal shape comprises a constriction of the wire that is formed to comprise two portions of the wire extending side-by-side and inwards in a proximal direction of the frame, wherein the distal shape extends from a distal most end of the frame.
10 . The embolic protection device of claim 9 , wherein the proximal shape is formed to extend inwards in a distal direction of the frame.
11 . The embolic protection device of claim 9 , wherein the distal shape is configured to fold outwards in a distal direction of the frame when the frame is transitioned to a folded state within a catheter.
12 . The embolic protection device of claim 9 , wherein the distal shape has an atraumatic material arranged thereon.
13 . The embolic protection device of claim 9 , wherein the filter unit is connected to the frame outside the proximal area and/or the distal area.
14 . A method of unfolding the embolic protection device of claim 11 , wherein the embolic protection device leaves the catheter, comprising:
pushing the embolic protection device out of the catheter,
wherein the distal shape folds inwards in the proximal direction of the frame when the distal area of the frame of the embolic protection device leaves the catheter.
15 . The method of claim 14 , further comprising indicating the direction of the frame by one or more markers on the distal area, wherein the distal area indicates an orientation of the frame leaving the catheter.
16 . The method of claim 14 , wherein the distal shape folds inwards due to a torsion generated in the wire of the frame towards a tip of the distal shape.
17 . The embolic protection device of claim 9 , wherein the frame defines a generally oval two-dimensional area.
18 . The embolic protection device of claim 17 , wherein the proximal shape comprises two wire ends formed to extend parallel to each other over the generally oval two-dimensional area of the frame.
19 . The embolic protection device of claim 17 , wherein a first part of the proximal shape is formed at a first angle to the generally oval two-dimensional area of the frame, and a second part of the proximal shape is formed at one end of the first part and at a second angle to the first part of the proximal shape.
20 . The embolic protection device of claim 19 , wherein the first part and the second part are arranged to each other such that they form a spring mechanism.