Embolic protection device, folding method and forming device

1. Embolic protection device ( 1 ) for insertion into an aortic arch, comprising

a filter unit ( 3 ),

a frame ( 5 ) with a proximal end and a distal end and

a feed unit ( 7 ) located at the proximal end of the frame,

wherein the filter unit ( 3 ) is arranged within the frame ( 5 ) and the frame ( 5 ) is comprised of a wire and provides a proximal area ( 9 ), comprising a proximal shape ( 11 ) and provides a distal area ( 2 ) comprising a distal shape ( 4 ),

wherein the frame ( 5 ) defines a generally oval two-dimensional area,

where the proximal shape ( 11 ) is arranged at the proximal end of the frame ( 5 ) and is connected to the feed unit ( 7 ),

wherein the proximal shape ( 11 ) comprises a first part ( 13 ) and a second part ( 15 ),

wherein the second part ( 15 ) is formed at one end of the first part ( 13 ) and the second part is connected to the feed unit,

wherein the first and second parts ( 13 , 15 ) form the proximal shape ( 11 ), wherein the proximal shape ( 11 ) extends over and under the generally oval two-dimensional area of the frame ( 5 ), and

wherein the distal shape ( 4 ) has a constriction ( 12 ) of the wire of the frame ( 5 ) into an interior of the generally oval two-dimensional area of the frame ( 5 ).

2. Embolic protection device ( 1 ) according to claim 1 , characterized in that the first part ( 13 ) of the proximal shape ( 11 ) is at a first angle (W 1 ) to the generally oval two-dimensional area of the frame ( 5 ) and the second part ( 15 ) is at a second angle (W 2 ) to the first part ( 13 ) of the proximal shape ( 11 ).

3. Embolic protection device ( 1 ) for insertion into an aortic arch, comprising

a filter unit ( 3 ),

a frame ( 5 ) with a proximal end and a distal end and

a feed unit ( 7 ) located at the proximal end of the frame,

wherein the filter unit ( 3 ) is arranged within the frame ( 5 ) and the frame ( 5 ) is comprised of a wire and has a proximal area ( 9 ), comprising a proximal shape ( 11 ) and a distal area ( 2 ) comprising a distal shape ( 4 ), wherein the frame ( 5 ) defines a generally oval two-dimensional area, where the proximal shape ( 11 ) is arranged at the proximal end of the frame ( 5 ) and is connected to the feed unit ( 7 )

wherein the proximal shape ( 11 ) comprises a first part ( 13 ) and a second part ( 15 ),

wherein the first and second parts ( 13 , 15 ) form the proximal shape ( 11 ),

wherein the proximal shape ( 11 ) extends over and/or under the generally oval two-dimensional area of the frame ( 5 ),

wherein the second part is formed at one end of the first part ( 13 ) and the second part is connected to the feed unit,

wherein the first and second parts ( 13 , 15 ) are arranged to each other such that they form a spring mechanism, and

wherein the distal shape ( 4 ) has a constriction ( 12 ) of the wire of the frame ( 5 ) into an inside of the generally oval two-dimensional area of the frame ( 5 ).

4. Embolic protection device ( 1 ) according to any one of claims 1 - 3 , characterized in that the proximal shape ( 11 ) can be set under tension via the feed unit ( 7 ).

5. Embolic protection device ( 1 ) according to claim 1 , characterized in that the proximal shape ( 11 ) comprises two ends ( 17 , 19 ) of the frame ( 5 ), which extend parallel to each other.

6. Embolic protection device ( 1 ) according to claim 1 , characterized in that the filter unit ( 3 ) is connected to the frame ( 5 ) outside the proximal and/or distal area(s) ( 9 , 2 ).

7. Forming device ( 31 ) for shaping the embolic protection device ( 1 ) according to claim 1 for insertion into a tube ( 38 ), wherein the frame ( 5 ) of the embolic protection device ( 1 ) having the filter unit ( 3 ) arranged at it, is formed from an expanded state to a stretched state, comprising a one-sided flat or round opening ( 35 ), a narrowest cross section ( 39 )′ and an opposite round opening ( 37 ).

8. Forming device ( 31 ) according to claim 7 , wherein the flat or round opening ( 35 ) of the forming device ( 31 ) is formed such that at least one of the proximal shape ( 11 ) and the distal shape ( 4 ) of the frame ( 5 ) of the embolic protection device is folded outwards.

9. Method for folding the embolic protection device by means of the forming device according to claim 7 , comprising

moving (S 1 ) the frame ( 5 ) of the embolic protection device in front of the flat or round opening ( 35 ) of the forming device ( 31 ),

wherein the feed unit ( 7 ) is fed through the forming device ( 31 ),

retracting (S 3 ) the proximal shape ( 11 ) into the forming device ( 31 ),

wherein the proximal shape ( 11 ) is folded outwards, the distal shape ( 4 ) hooks (S 4 ) over the outer edge of the forming device ( 31 ), and by pulling the distal shape ( 4 ) further is folded outwards, and is retracted into the forming device ( 31 ).

10. Method according to claim 9 , wherein the folded proximal shape ( 11 ) transfers a prestress to the frame ( 5 ), which is substantially equal to the tension resulting from straightening the folded proximal shape ( 11 ).

11. Method for unfolding the embolic protection device according to claim 1 , when the embolic protection device leaves a catheter containing it, comprising

pushing the embolic protection device out of the catheter,

folding the distal shape ( 4 ) into the distal end of the frame ( 5 ) when the distal area ( 2 ) of the frame of the embolic protection device leaves the catheter.

12. Method according to claim 11 , comprising indicating the direction of the frame ( 5 ) by a marker, when the distal area ( 2 ) leaves the catheter, wherein the distal area ( 2 ) indicates the orientation of the frame ( 5 ).

13. Method according to claim 11 , characterised in that, due to the folding of the distal shape, as well as the proximal shape, a torsion is generated in the wire of the frame ( 5 ), having a preferred direction, when leaving the catheter, from the distal area ( 2 ) towards the distal shape ( 4 ).

14. Embolic protection device ( 1 ) according to claim 1 , wherein the proximal shape ( 11 ) is defined by two ends ( 17 , 19 ) of the frame ( 5 ).

15. Embolic protection device ( 1 ) according to claim 3 , wherein the proximal shape ( 11 ) is defined by two ends ( 17 , 19 ) of the frame ( 5 ).