External end device and method for its connection to flow lines

1 . An external end device adapted to be connected, on one side, to at least one catheter, on which a subcutaneous cuff is applied, and, on the other side, to a lid, or alternatively to flow lines of a treatment apparatus, the external end device comprising:

a casing, including a base delimited by a plurality of side walls, in which there are a distal opening and a pair of proximal openings with respect to said flow lines, and a removable cover on the side walls,

a fitting housed in the casing and having at least one distal part that engages in the at least one catheter, and two proximal tracts, and

a pair of curved pipes each having a distal end inserted on the respective proximal tract of the fitting, and a proximal end,

a pair of nozzles equipped with nozzle chambers and inserted in the proximal end of the curved pipes, inside each nozzle chamber being a cap that is adapted to hermetically close the nozzle and is reversibly pierceable, and

a piercing and connecting conduit designed to reversibly pierce the cap and to connect the pair of nozzles to the flow lines of the treatment equipment,

wherein the piercing and connecting conduit comprises in parallel lines, starting from a distal end of the piercing and connecting conduit:

a pair of clamps, each clamp having a central body centrally perforated in line, a rigid pipe intended to be connected to a respective nozzle in the septum, and a joint located in the central body on the opposite side of the rigid pipe,

a pair of elastic pipes, each elastic pipe having a distal end, inserted on the joint, and a proximal end,

a pair of lock elements, each lock element being connected, on one side, to the proximal end of the elastic pipe and, on the other side, to the connection to the flow lines of the treatment equipment,

a pair of occlusion clips, each occlusion clip being positioned around each elastic pipe, and

a pair of piercing members, each piercing member having a needle and a head internally hollow to close on the lock element, the needle passing through the lock element, the elastic pipe, the clamp, to exit from the distal end of the rigid pipe.

2 . The device according to claim 1 , wherein the lid has distal projections, and the base of the casing and the removable coverage have recesses, which the distal projections of the lid are able to engage in closing the device with the interposition of an antiseptic sponge between the nozzle chambers closed with the caps and the lid.

3 . The device according to claim 1 , wherein the distal opening and the proximal openings are delimited on three sides by grooves suitable to constitute guides for inserting septa, a perforated septum for the passage of the at least one catheter and the attachment thereof to the fitting being received in the distal opening, and a pair of septa housing the pair of nozzle chambers being received in the respective proximal openings.

4 . The device according to claim 1 , wherein the base of the casing and the removable cover have recesses, and the pair of clamps has, on opposite sides to the central body, gripper arms distally equipped with respective hooks suitable for engaging said recesses for the stable connection of said piercing and connecting conduit to the casing.

5 . The device according to claim 1 , wherein the reversibly pierceable cap is made of silicone.

6 . The device according to claim 1 , wherein the fitting includes, in addition to the two proximal tracts, an access conduit to the at least one catheter, and a biosensor is partially inserted in the access conduit, the biosensor having a sensitive element capable of optically reacting with the blood lapping the at least one catheter.

7 . The device according to claim 6 , wherein the biosensor comprises a sensitive element fixed to an optical fiber received in the at least one catheter through the access conduit, an optical system connected to the optical fiber and including a light source having a variable wave length, and a detection, storage and transmission system.

8 . The device according to claim 7 , wherein the at least one catheter has a transparent window configured to face the sensitive element of the biosensor.

9 . The device according to claim 1 , in which the removable cover is fastened on the side walls by means of screws with the interposition of a gasket.

10 . A method for connecting an external end device to flow lines of a treatment equipment, the external end device comprising:

a casing, including a base and a removable cover, and a lid with the interposition of an antiseptic sponge,

a pair of nozzles equipped with nozzle chambers and connected in a distal end to at least one catheter through a fitting, inside each nozzle chamber being a cap suitable for hermetically closing the nozzle that is reversibly pierceable,

a piercing and connecting conduit adapted to reversibly pierce the cap and to connect the pair of nozzles to the flow lines of the treatment equipment, the piercing and connecting conduit comprising in parallel lines, starting from a distal end of the piercing and connecting conduit:

a pair of clamps for hooking the piercing and connecting conduit to the casing,

a pair of elastic pipes,

a pair of lock elements, connectable to the flow lines of the treatment equipment,

a pair of occlusion clips, positioned around each elastic pipe, and

a pair of piercing members, each piercing member having a needle and a head that is internally hollow to close on the lock element, the needle passing through the lock element, the elastic pipe, the clamp, to exit from the distal end of the rigid pipe, the method comprising:

removing the lid and the antiseptic sponge from the casing;

in-line assembling the piercing and connecting conduit by joining the pair of clamps, the pair of elastic pipes, the pair of occlusion clips around respective elastic pipes, the pair of lock elements, and the pair of piercing members;

approaching the mounted piercing and connecting conduit coaxially to the pair of nozzles up to the coupling of the pair of clamps to the casing with consequent reversible piercing of the caps inside the nozzle chambers;

removing the pair of piercing members from the piercing and connecting conduit with simultaneous closing of the pair of occlusion clips around the pair of elastic pipes; and

connecting the pair of lock elements to the flow lines of the treatment equipment.