Connector assembly for an implantable medical device and process for making

A modular header for making electrical connections between an array of feed-through pins extending through a wall of a hermetically sealed enclosure of an implantable medical device and lead connector receptacles within said modular header, said device comprising:

• (a) a pre-formed molded header module having paths therein to accept and incorporate a set of flexible conductors and connector blocks;
• (b) a separate set of intermediate flexible conductors each having a free end assembled into said paths in said pre-formed molded header module, said free ends being attached to corresponding connector blocks located in said molded header module;
• (c) a layer of over molding incorporating and sealing said conductors into said header structure;
• and
• (d) wherein said flexible conductors each have an end opposite the free end provided with a connecting device designed to connect with a feed-through pin in a corresponding hermetically sealed medical device enclosure and wherein one or more of said flexible conductors wrap around said pre-formed molded header module.

A method of making a connector assembly for providing electrical connections between a feed-through pattern of an implantable medical device and lead receptacles within a connector assembly coupled to said device comprising:

• (a) providing a core portion having channel guides therein to accept and incorporate a circuit member and set-screw blocks associated with lead receptacles;
• (b) providing a circuit member comprising joined deformable conductive finger elements each having a free end and a joined end, wherein the joined ends of the deformable conductive finger elements are mechanically and electrically connected via conductive traces, and coupling said circuit member into said channel guides in said core portion attaching the free ends thereof to corresponding set-screw blocks provided in said core portion;
• (c) performing an over-molding operation to encapsulate said conductive finger elements in said connector assembly;
• (d) cutting away said conductive traces to provide connector pads positioned to connect with said feedthrough pattern when said connector assembly is coupled to a compatible corresponding implantable medical device;
• (e) assembling said connector assembly to said implantable medical device and connecting said deformable conductive finger elements to said feedthrough pattern;
• and
• (f) overlaying medical adhesive on the connections between said connector assembly and said implantable medical device after connecting said deformable conductive finger elements to said feedthrough pattern.

A connector assembly for making electrical connections between a feedthrough pattern of an implantable medical device and lead receptacles within said connector assembly, said device comprising:

• (a) a core portion having channel guides therein to accept and incorporate a circuit member and set-screw blocks;
• (b) said circuit member comprising deformable conductive finger elements each having a free end assembled into said channel guides in said core portion, said free ends being coupled to corresponding set-screw blocks located in said connector assembly;
• (c) a second shot of overmolding encapsulating said finger elements in said connector assembly;
• and
• (d) wherein said deformable conductive finger elements each have an end opposite the free end provided with a connector pad designed to connect with a feedthrough pattern in a corresponding implantable medical device and wherein one or more of said deformable conductive finger elements wrap around said core portion.

An apparatus, comprising:

• a pre-molded header that is biocompatible and that defines a first channel and a second channel, the pre-molded header including a first terminal in electrical communication with a first lead terminal of the pre-molded header;
• a flex harness conformed to the pre-molded header, the flex harness including a first conductor including a first connection terminal and a second conductor including a second connection terminal, the first and second conductors being physically coupled by a common harness portion, the flex harness including a pre-formed alignment such that the first conductor is disposed in the first channel and the second conductor is disposed in the second channel, with the first conductor defining a conductive path between the first terminal and the first connection terminal;
• and
• an over-molded layer that is biocompatible and disposed over the pre-molded header and the flex harness such that the first conductor and the second conductor are disposed between the pre-molded header and the over-molding layer.

An apparatus, comprising:

• a pre-molded header that is biocompatible and that defines a plurality of lead terminals in a row, the pre-molded header defining an exterior surface with a first terminal in electrical communication with a first lead terminal of the plurality of lead terminals, and with a second terminal in electrical communication with a second lead terminal of the plurality of lead terminals;
• a harness coupled to the pre-molded header, the harness including a first conductor including a first connection terminal and a second conductor including a second connection terminal, the first and second conductors being physically coupled by a common harness portion, the harness including a pre-formed alignment such that the first conductor is aligned to the first terminal and the second conductor is aligned to the second terminal, with the first conductor defining a conductive path between the first terminal and the first connection terminal;
• and
• an over-molded layer that is biocompatible and disposed over the pre-molded header and the harness such that the first conductor and the second conductor are disposed between the pre-molded header and the over-molding layer.

An apparatus, comprising:

• a pre-molded header that is biocompatible and that defines a first channel and a second channel, the pre-molded header including a first terminal in electrical communication with a first lead terminal of the pre-molded header;
• a flex harness conformed to the pre-molded header, the flex harness including a first conductor including a first connection terminal and a second conductor including a second connection terminal, the first and second conductors being physically coupled by a common harness portion, the flex harness including a pre-formed alignment such that the first conductor is disposed in the first channel and the second conductor is disposed in the second channel, with the first conductor defining a conductive path between the first terminal and the first connection terminal;
• and
• an over-molded layer that is biocompatible and disposed over the pre-molded header and the flex harness such that the first conductor and the second conductor are disposed between the pre-molded header and the over-molding layer.

A method, comprising:

• molding a biocompatible material over an internal conductor to define a pre-molded header that includes a first channel, a second channel and a lead terminal to receive a lead, the internal conductor electrically coupling the lead terminal to a first terminal;
• pre-forming a flex conductor harness including a first conductor that includes a first connection terminal and a second conductor that includes a second connection terminal, with the first conductor and the second conductor coupled at a common portion such that the first conductor is pre-formed to conform, in alignment, to the first channel, and the second conductor is pre-formed to conform, in alignment, to the second channel;
• wrapping the flex conductor harness around the pre-molded header such that a first conductor of the flex conductor harness is disposed in the first channel and a second conductor of the flex conductor harness is disposed in the second channel;
• electrically coupling the first conductor to the first terminal;
• and
• over-molding at a first pressure an over-molded layer of biocompatible material over the first terminal, the first conductor and the second conductor, with the first connection terminal and the second connection terminal being exposed through an opening in the over-molded layer.

An apparatus, comprising:

• means for electrically and physically coupling a first lead terminal to a first terminal;
• means for coupling to a pin of an implantable device and for electrically coup the pin to the first terminal;
• and
• an over-molded layer that is biocompatible and disposed over the means for electrically and physically coupling a first lead terminal to a first terminal and the means for coupling to a pin of an implantable device.

An apparatus, comprising:

• a core portion that is biocompatible and that defines a first channel guide and a second channel guide, the core portion including a first set-screw block in electrical communication with a first lead receptacle of the core portion;
• a circuit member conformed to the core portion, the circuit member including a first conductive finger element comprising a first connector pad and a second conductive finger element comprising a second connector pad, the first and second conductive finger elements being mechanically connected via conductive traces, the circuit member comprising a pre-formed alignment such that the first conductive finger element is disposed in the first channel guide and the second conductive finger element is disposed in the second channel guide, wherein the first conductive finger element defines a conductive path between the first terminal and the first connector pad;
• and
• an overmolded layer that is biocompatible and disposed over the core portion and the circuit member such that the first conductive finger element and the second conductive finger element are disposed between the core portion and the overmolded layer.

An apparatus, comprising:

• a core portion that is biocompatible and that defines a plurality of lead receptacles in a row, the core portion defining an exterior surface with a first set-screw block in electrical communication with a first lead receptacle of the plurality of lead receptacles, and with a second set-screw block in electrical communication with a second lead receptacle of the plurality of lead receptacles;
• a circuit member coupled to the core portion, the circuit member comprising a first conductive finger element including a first connector pad and a second conductive finger element comprising a second connector pad, the first and second conductive finger elements being mechanically connected via conductive traces, the circuit member comprising a pre-formed alignment such that the first conductive finger element is aligned to the first set-screw block and the second conductive finger element is aligned to the second set-screw block, with the first conductive finger element defining a conductive path between the first set-screw block and the first connector pad;
• and
• an overmolded layer that is biocompatible and disposed over the core portion and the circuit member such that the first conductive finger element and the second conductive finger element are disposed between the core portion and the overmolded layer.

An apparatus, comprising:

• a core portion that is biocompatible and that defines a first channel guide and a second channel guide, the core portion comprising a first set-screw block in electrical communication with a first lead receptacle of the core portion;
• a circuit member conformed to the core portion, the circuit member comprising a first conductive finger element comprising a first connector pad and a second conductive finger element comprising a second connector pad, the first and second conductive finger elements being mechanically connected via conductive traces, the circuit member comprising a pre-formed alignment such that the first conductive finger element is disposed in the first channel guide and the second conductive finger element is disposed in the second channel guide, with the first conductive finger element defining a conductive path between the first set-screw block and the first connector pad;
• and
• an overmolded layer that is biocompatible and is disposed over the core portion and the circuit member such that the first conductive finger element and the second conductive finger element are disposed between the core portion and the overmolded.

A method, comprising:

• molding a biocompatible material over a jumper to define a core portion that includes a first channel guide, a second channel guide, and a lead receptacle to receive a medical electrical lead, the jumper electrically coupling the lead receptacle to a first set-screw block;
• pre-forming a circuit member comprising a first conductive finger element that comprises a first connector pad and a second conductive finger element that includes a second connector pad, wherein the first conductive finger element and the second conductive finger element are coupled via conductive traces such that the first conductive finger element is pre-formed to conform, in alignment, to the first channel guide, and the second conductive finger element is pre-formed to conform, in alignment, to the second channel guide;
• wrapping the circuit member around the core portion such that a first conductive finger element of the circuit member is disposed in the first channel guide and a second conductive finger element of the circuit member is disposed in the second channel guide;
• electrically coupling the first conductive finger element to the first set-screw block;
• and
• overmolding at a first pressure an overmolded layer of biocompatible material over the first set-screw block, the first conductive finger element, and the second conductive finger element, wherein the first connector pad and the second connector pad are exposed through an opening in the overmolded layer.

An apparatus, comprising:

• means for electrically and physically coupling a first lead receptacle to a first set-screw block;
• means for coupling to a connector of an implantable device and for electrically coupling the connector to the first set-screw block;
• and
• an overmolded layer that is biocompatible and disposed over the means for electrically and physically coupling a first lead receptacle to a first set-screw block, and the means for coupling to a connector of an implantable device.