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1. WO2019053600 - APPLICATEUR ET APPAREIL D'ÉLECTROPORATION

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[ EN ]

CLAIMS

1. An applicator for electroporation comprising:

a support (2), the support (2) forming a plurality of housing seats (7) distributed on a first main face (5) of it, each housing seat (7) extending transversally relative to the extension of the main face at the housing seat (7), the support (2) also comprising, on the opposite side to the first main face (5), a second main face (6), that in use is suitable for facing the subject to be treated; and

a plurality of electrodes (3) each comprising a needle (4) that is constituted of an electrically conductive material, each electrode (3) being mountable in a housing seat (7) of the support (2) in such a way that an operating end (8) of the needle (4) projects relative to the second main face (6) so that in use it can be inserted in the body of the subject to be treated;

wherein:

the support (2) also comprises, for each housing seat (7), at least one electrical conductor (9) that has a first end (10) located at the housing seat (7) and electrically connectable to an electrode (3) inserted in the housing seat (7), and a second end (11) in use connectable to an electric pulse generator; and

the support (2) comprises at least one first layer (13) that forms the first main face (5), and one second layer (14) coupled to the first layer (13),

characterised in that

the support (2) is flexible, in use suitable for covering a portion of a subject to be treated, adapting to its shape, with the second layer (14) coupled to the first layer (13) at a face of the first layer (13) that is on the opposite side to the first main face (5); the second layer (14) comprising said electrical conductors (9) and the first layer (13) comprising a sheet (15) of flexible plastic material and, at each housing seat (7), and

in that

a guiding element (16) that is rigid, is made of plastic material, is partly incorporated in the sheet (15) of flexible plastic material and projects relative to the first main face (5); the guiding element (16) having a first through hole (16) that forms the housing seat (7) and in which the needle (4) of one of the electrodes (3) can be slidably inserted and the first end (10) of each electrical conductor (9) being aligned with the respective housing seat (7) so that it is in electrical contact with a needle (4) inserted in that housing seat (7).

2. The applicator for electr op oration according to claim 1, wherein each electrode (3) also comprises a grip (23) made of electrically insulating material that incorporates a second end (11) of the needle (4), that is couplable to a guiding element (16) by means of a male-female friction coupling to ensure guided insertion of the needle (4) into the body of the subject to be treated.

3. The applicator for electroporation according to claim 1, wherein the grip (23) one or more stabilising feet (26) that extend radially outwards relative to a direction of extension of the needle (4).

4. The applicator for electroporation according to claim 3, wherein each guiding element (16) is arranged, with the support (2) laid flat, at a centre of a regular hexagon and is surrounded by other guiding elements (16) located at vertices of that regular hexagon, and

wherein the feet of each grip (23) protrude relative to said direction of extension of the needle (4) by a distance greater than half of the distance between each vertex and the centre of said regular hexagon.

5. The applicator for electroporation according to claim 3 or 4, wherein each grip (23) comprises four feet that extend along radial lines radiating out from the direction of extension which are uniformly distributed around the needle (4).

6. The applicator for electroporation according to any of the preceding claims, wherein the first end (10) of each conductor (9) is located at the related housing seat (7) and forms a second through hole (20) aligned with the first through hole (28), the second through hole (20) having a maximum width that is less than the maximum width of the needle (4) and being delimited by an intermediate portion (10) of the respective electrical conductor (9) that is plastically and/ or elastically deformable at the moment of manual insertion of the needle (4) in the second through hole (20).

7. The applicator for electroporation according to any of the preceding claims, wherein the second layer (14) comprises a plurality of base layers (17) of electrically insulating material to which respective conductive tracks (18) are fixed, each conductive track (18) forming at least one electrical conductor (9), and the base layers (17) being superposed one another.

8. The applicator for electroporation according to claim 7, wherein at least a first conductive track (18) fixed to a base layer (17), and a second conductive track (18) fixed to another support (2), are superposed, and wherein, at the first end (10) of the first conductive track (18), the second conductive track (18) extends partly differently in such a way that it does not interfere with a needle (4) electrically in contact with the first end (10) of the first conductive track (18).

9. Applicator for electroporation according to claim 8, wherein the first end (10) of each conductive track (18) of a first base layer (17) has a hexagonal shape with the second through hole (20) in its center, and wherein an intermediate portion (19) of a second conductive track (18) of a second base layer (17) overlapped on the first end (10) has a hexagonal shape similar to that of the first end (10) and a central hole (21) larger than the second through hole (20), in such a way that the needle (4) inserted in the second through hole (20) of the first end (10) of the first conductive track (18) passes through a central area of the central hole (21) of the second conductive track (18) without establishing any electrical contact with the latter.

10. The applicator for electroporation according to claim 8 or 9, wherein two or more base layers (17) have different lengths in the length direction of the conductive tracks (18).

11. The applicator for electroporation according to any of the preceding claims, wherein the support (2) also comprises a third layer (22) constituted of electrically insulating material and which forms the second main face (6), the second layer (14) being positioned between the first layer (13) and the third layer (22).

12. The applicator for electroporation according to any of claims 1 to 10, wherein the second layer (14) forms the second main face (6).

13. The applicator for electroporation according to any of the preceding claims, wherein each electrode (3) also comprises a removable protective cap (27) mounted on the needle (4) to cover its first end (10) before use.

14. The applicator for electroporation according to any of the preceding claims, also comprising adhesive means joined to the second main face (6) for in use allowing the support (2) to be attached to the subject to be treated.

15. Applicator for electroporation according to any one of the preceding

claims, wherein the guide elements (16) are integral with the sheet (15) of flexible plastic material.

16. An apparatus for electroporation comprising a pulse generator and an applicator (1) for electroporation made

in accordance with any of the preceding claims, the pulse generator being electrically connected or connectable to the second ends (11) of the electrical conductors (9) for applying a difference of potential between pairs of electrodes (3).