Device for electrotherapy and/or electrophysiology, kit and assembly
Device ( 1 ) for electrotherapy and/or electrophysiology comprising at least one lead ( 2 ) having an elongated lead body extending along a longitudinal direction (X-X) and comprising a proximal end ( 3 ) and a distal end ( 4 ); and at least one paddle ( 5 ) having a paddle body comprising two opposite major surfaces ( 6, 7 ) defining a paddle thickness ( 33 ) there between; wherein said paddle ( 5 ) comprising at least one paddle electrode ( 8 ) having an exposed surface ( 9 ) designed to come into electrical contact with a living anatomy ( 10 ) inside a patient's body ( 11 ); said paddle ( 5 ) is suitable to modify the transverse encumber ( 12 ) thereof, so that to assume at least one transport configuration and at least one operative configuration, wherein the transverse encumber ( 12 ) of the paddle ( 5 ) when in said at least one transport configuration is less than the transverse encumber ( 12 ) of the same paddle ( 5 ) when in said at least one operative configuration; wherein said lead ( 2 ) comprising a connection portion ( 13 ) near the distal end ( 4 ) thereof; said connection portion ( 13 ) of the lead ( 2 ) comprises at least one arched electrically conductive surface ( 14 ); and said paddle ( 5 ) comprises at least one counter-connection portion ( 15 ) comprising at least one arched electrically conductive counter-surface ( 16 ) in direct contact with said at least one conductive surface ( 14 ) of the connection portion ( 13 ) of the lead ( 2 ), so that said at least one counter-connection portion ( 15 ) of the paddle ( 5 ) has a transversally arched shape defining a first concavity (R 1 ) facing towards said connection portion ( 13 ) of the lead ( 2 ); said at least one conductive counter-surface ( 16 ) of the paddle ( 5 ) is in electric communication with said paddle electrode ( 8 ) through at least one conductive track ( 17 ) extending within the body of paddle ( 5 ) in such way that said proximal end ( 3 ) of the lead ( 2 ) is in electrical communication with said exposed surface ( 9 ) of the at least one paddle electrode ( 8 ).
1. A device ( 1 ) for electrotherapy and/or electrophysiology comprising:
at least one lead ( 2 ) having an elongated lead body extending along a longitudinal direction (X-X) and comprising a proximal end ( 3 ) and a distal end ( 4 ); and
at least one paddle ( 5 ) having a paddle body comprising two opposite major surfaces ( 6 , 7 ) defining a paddle thickness ( 33 ) there between;
and wherein:
said paddle ( 5 ) comprising at least one paddle electrode ( 8 ) having an exposed surface ( 9 ) designed to come into electrical contact with a living anatomy ( 10 ) inside a patient's body ( 11 );
said paddle ( 5 ) is suitable to modify the transverse encumber ( 12 ) thereof, so that to assume at least one transport configuration and at least one operative configuration, wherein the transverse encumber ( 12 ) of the paddle ( 5 ) when in said at least one transport configuration is less than the transverse encumber ( 12 ) of the same paddle ( 5 ) when in said at least one operative configuration;
and wherein:
said lead ( 2 ) comprising a connection portion ( 13 ) near the distal end ( 4 ) thereof; and characterised in that
said connection portion ( 13 ) of the lead ( 2 ) comprises at least one arched electrically conductive surface ( 14 ); and
said paddle ( 5 ) comprises at least one counter-connection portion ( 15 ) comprising at least one arched electrically conductive counter-surface ( 16 ) in direct contact with said at least one conductive surface ( 14 ) of the connection portion ( 13 ) of the lead ( 2 ), so that said at least one counter-connection portion ( 15 ) of the paddle ( 5 ) has a transversally arched shape defining a first concavity (R 1 ) facing towards said connection portion ( 13 ) of the lead ( 2 ), wherein said connection portion ( 13 ) of the lead ( 2 ) has a cylindrical shape and said counter-connection portion ( 15 ) of the paddle ( 5 ) embraces at least a portion of said cylindrical connection portion ( 13 ) of the lead ( 2 );
said at least one conductive counter-surface ( 16 ) of the paddle ( 5 ) is in electric communication with said paddle electrode ( 8 ) through at least one conductive track ( 17 ) extending within the body of paddle ( 5 ) in such way that said proximal end ( 3 ) of the lead ( 2 ) is in electrical communication with said exposed surface ( 9 ) of the at least one paddle electrode ( 8 ).
2. The device ( 1 ) according to claim 1 , wherein said paddle ( 5 ) comprises at least one paddle fold ( 19 ) defining at least one transversally folded portion ( 20 ) of the paddle ( 5 ) comprising said at least one paddle fold ( 19 ); and/or wherein
said at least one transversally folded portion ( 20 ) of the paddle ( 5 ) defines a second concavity (R 2 ) opposite to said first concavity (R 1 ).
3. The device ( 1 ) according to claim 2 , wherein said paddle ( 5 ) comprises at least one paddle transversal edge ( 22 ) delimiting the width of said major surfaces ( 6 , 7 ), and wherein said at least one paddle fold ( 19 ) is located between said counter-connection portion ( 15 ) and said transversal edge ( 22 ) of the paddle ( 5 ), defining a paddle wing ( 21 ) comprising a free end ( 23 ) and at least a portion of said at least one paddle electrode ( 8 ).
4. The device ( 1 ) according to claim 2 , wherein said at least one paddle fold ( 19 ) defining at least one transversally folded portion ( 20 ) of the paddle ( 5 ) is provided both when the paddle ( 5 ) is in the transport configuration and when the paddle ( 5 ) is in the operative configuration.
5. The device ( 1 ) according to claim 1 , wherein said paddle ( 5 ) comprises two opposite paddle folds ( 19 ) opposite with respect to said counter-connection portion ( 15 ) of the paddle ( 5 ) defining at least two opposite paddle wings ( 21 ) each having a free end.
6. The device ( 1 ) according to claim 1 , comprising at least one biasing device ( 24 ) biasing said paddle ( 5 ) towards said operative configuration; and/or wherein
said at least one biasing device ( 24 ) comprises at least one elastic element, made of elastic and/or a super-elastic material; and/or wherein
said at least one biasing device ( 24 ) comprises at least one shape memory element made of a shape memory material; and/or wherein
said at least one biasing device ( 24 ) is embedded within the paddle ( 5 ).
7. The device ( 1 ) according to claim 1 , wherein said paddle ( 5 ) has a multi-layered structure; and/or wherein
said paddle ( 5 ) is made of a polymeric substrate ( 25 ) with embedded and/or deposited thin film of metal material forming said at least one conductive track ( 17 ) and/or said paddle electrode ( 8 ); and/or wherein
said embedded metal material is in form of a plurality of nanoparticles arranged in such way to form electrical connection with said conductive surface ( 14 ) of the lead ( 2 ); and/or wherein
said embedded metal material is in form of a metal plate.
8. The device ( 1 ) according to claim 1 further comprising:
a distal free end portion ( 58 ) free from contact with said paddle ( 5 ), said free end portion ( 58 ) delimiting a distal portion of said longitudinal cavity ( 18 ) a longitudinal cavity ( 18 ) for hosting a guiding stylet.
9. A kit ( 30 ) comprising:
at least one device ( 1 ) according to claim 1 and
a percutaneous delivery system ( 27 ) comprising at least one hollow body ( 28 ), wherein said hollow body ( 28 ) houses said at least one device ( 1 ) when in transport configuration.
10. The kit ( 30 ) according to claim 9 , wherein said paddle ( 5 ) of the device ( 1 ) comprises at least one fold defining a transversally folded segment of the paddle ( 5 ) that fits inside the hollow body ( 28 ) of the percutaneous delivery system ( 27 ).
11. The kit ( 30 ) according to claim 9 , wherein said hollow body ( 28 ) acts as constraining body for the paddle ( 5 ) constraining the paddle ( 5 ) in the transport configuration.
12. An assembly ( 51 ) comprising:
at least one device ( 1 ) according to claim 1 and
at least one control unit ( 36 ), wherein said assembly ( 51 ) is a stimulator for electrotherapy and/or a recorder for electrophysiology.