Multi-electrode implantable systems and assemblies therefor

• US 8,639,341 B2
• Filed: 08/09/2013
• Issued: 01/28/2014
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John Louis, D'Sa, Joseph Michael, Taylor, William John, Tyler, Larry Earl, Yamamoto, Joyce K, Tischendorf, Brad C, Reinke, James D, Thom, Andrew J, Miltich, Thomas P, Gardeski, Kenneth C, York, Jeffrey O, Munns, Gordon O
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US13/962,987
• Publication Number:
  US 20130325086A1
• Time in Patent Office: 172 Days
• Field of Search: 607 36- 38
• US Class Current: 607/37
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Hermetically sealed assemblies, for example, that include IC chips, are configured for incorporation within a connector terminal of an implantable medical electrical lead, preferably within a contact member of the terminal. An assembly may include two feedthrough subassemblies, welded to either end of the contact member, to form an hermetic capsule, in which an IC chip is enclosed, and a tubular member, which allows a lumen to extend therethrough, along a length of the terminal. A multi-electrode lead may include multiplexer circuitry, preferably a switch matrix element and a communications, control and power supply element that are electrically coupled to the contact member and to another contact member of the terminal. Each pair of switch matrix switches allows for any two of the electrodes to be selected, in order to deliver a stimulation vector, via stimulation pulses from a device/pulse generator, to which the connector terminal is connected.

Claims

1. An implantable medical electrical lead including a connector terminal configured to fit within a connector port of an implantable medical device for the electrical coupling thereto, an elongate flexible insulative body extending distally from the connector terminal and including an internal and longitudinally extending channel that provides for passage of an elongate instrument therein, at least three elongate flexible conductors extending within the insulative body, distally from the connector terminal, and a plurality of electrodes mounted on a distal portion of the insulative body, each of the plurality of electrodes being coupled to a corresponding conductor of the at least three elongate flexible conductors;

and wherein the connector terminal of the lead comprises;

a first electrical contact member and a second electrical contact member, the second contact member being electrically isolated from the first contact member and spaced apart, distally from the first contact member along a length of the connector terminal;

a switching assembly mounted within the second electrical contact member, the switching assembly comprising a multiplexer mounted on an integrated circuit chip and electrically coupled to the second contact member, a proximal feedthrough subassembly including a feedthrough pin that electrically couples the first contact member to the multiplexer, and a distal feedthrough subassembly including a plurality of distal feedthrough pins, each feedthrough pin of the plurality of distal feedthrough pins being electrically coupled to the multiplexer and having a distal portion that extends distally from the distal end of the second contact member; and

an inner wall forming a lumen that extends along the length of the connector terminal and within the second contact member, the lumen having a proximal opening in proximity to the first contact member and being in fluid communication with the internal channel of the elongate flexible insulative body of the lead, to allow passage of the elongate instrument from the proximal opening and into the internal channel, and the inner wall isolating the lumen from the switching assembly and from each of the aforementioned electrical couplings to the multiplexer;

wherein each of the at least three elongate conductors includes a proximal segment coupled to the distal portion of a corresponding feedthrough pin of the plurality of distal feedthrough pins; and

the multiplexer includes a switch matrix element and a communications, control and power supply element, the switch matrix element including a plurality of pairs of switches, each pair of the plurality of pairs of switches corresponding to one of the plurality of distal feedthrough pins, a first of each pair of switches adapted to connect and disconnect the corresponding feedthrough pin to/from the first contact member and the communications, control and power supply element, and a second of each pair of switches adapted to connect and disconnect the corresponding feedthrough pin to/from the second contact member and the communications, control and power supply element.

2. The lead of claim 1, wherein the plurality of electrodes includes four electrodes and each of the four electrodes is spaced apart from the adjacent electrode by a distance of approximately 20 millimeters.

3. The lead of claim 1, wherein each of the proximal and distal feedthrough subassemblies of the connector terminal further includes a ferrule and a glass insulator, the glass insulator of each ferrule being hermetically sealed thereto and to each of the corresponding feedthrough pins, the ferrule of the proximal feedthrough subassembly being directly welded to a proximal end of the second contact member and the ferrule of distal feedthrough subassembly being directly welded to a distal end of the second contact member, and each weld extending about an entire perimeter of the second contact member in order to form an hermetic capsule enclosing the integrated circuit chip and the aforementioned electrical couplings to the multiplexer.

4. The lead of claim 3, wherein:

the connector terminal further includes a distal insulative support member;

the ferrule of the distal feedthrough subassembly includes a protrusion, which extends distally from the second contact member, and on which the distal support member is mounted; and

the proximal segment of each of the at least three elongate conductors is wrapped about the distal support member and coupled to the corresponding distal feedthrough pin thereon.

5. The lead of claim 4, wherein:

the at least three elongate flexible conductors are wound in a coil around the longitudinally extending internal channel, the coil having a diameter; and

the distal support member has a diameter, which is larger than that of the coil and about which the proximal segments of the at least three flexible conductors are wrapped.

6. The lead of claim 4, wherein:

the distal support member includes a plurality of relatively straight channels formed in an outer surface thereof and spaced apart from one another around a circumference of the distal support member; and

the distal portion of each distal feedthrough pin extends within a corresponding channel and beneath the proximal segment of the corresponding conductor of the at least three elongate conductors.

7. The lead of claim 4, wherein:

the distal support member includes helical channels formed in an outer surface thereof; and

the proximal segment of each conductor that is wrapped about the distal support member is received in a corresponding helical channel.

8. The lead of claim 3, wherein:

the connector terminal further comprises a proximal insulative support member and a conductive jumper that couples the first contact member to the proximal feedthrough pin;

the ferrule of the proximal feedthrough subassembly includes a protrusion, which extends proximally from the second contact member, and on which the proximal support member is mounted; and

the conductive jumper is wrapped about the proximal support member and coupled to the proximal feedthrough pin thereon.

9. The lead of claim 8, wherein:

the proximal support member includes a relatively straight channel formed in an outer surface thereof; and

a proximal portion of the proximal feedthrough pin extends within the channel and beneath the jumper.

10. The lead of claim 3, wherein:

a portion of the inner wall of the connector terminal that forms the lumen comprises a tubing member;

the ferrule of each of the proximal and distal feedthrough subassemblies includes a longitudinally extending thru-hole, the thru-holes being approximately longitudinally aligned with one another; and

the tubing member is mounted within each thru-hole and extends within the second contact member, between the ferrules.

11. The lead of claim 10, wherein:

the switching assembly of the connector terminal further comprises a flex circuit, the flex circuit including a plurality of contact/bond pads, a plurality of connection junctions and a pair of contoured slots, one formed in each end of the flex circuit;

the plurality of contact/bond pads being coupled to the multiplexer and to a corresponding connection junction by a conductive trace;

each of the plurality of connection junctions being coupled to a corresponding one of the plurality of distal feedthrough pins, proximal feedthrough pins and second connector contact; and

each contoured slot being fitted about the tubing member such that each end of the flex circuit is bent inward.

12. The lead of claim 1, wherein:

the proximal and distal feedthrough subassemblies each further include a ferrule end plate and together include a common ceramic insulator that extends between the ferrule end plates and is hermetically sealed to each of the ferrule end plates, the proximal ferrule end plate being coupled to the second contact member in proximity to a proximal end of the second contact member, and the distal ferrule end plate being coupled to the second contact member in proximity to a distal end of the second contact member;

each of the distal feedthrough pins and the proximal feedthrough pin extends within the ceramic insulator, being hermetically sealed thereto;

the ceramic insulator includes contact/bond pads formed on a exterior surface thereof and conductive vias formed therein, each conductive via coupling one of the contact/bond pads to a corresponding one of the feedthrough pins and second contact member; and

the integrated circuit chip is supported by the ceramic insulator and coupled to the external contact/bond pads thereof.

13. The lead of claim 1, wherein:

the switching assembly of the connector terminal further includes a package, which is contained within the second contact member and which encloses the integrated circuit chip, the package including ceramic sidewalls, conductive interconnect members formed on an exterior surface of at least one of the ceramic sidewalls, and conductive vias, each via electrically connecting the integrated circuit chip to the conductive interconnect members; and

each of the distal feedthrough pins and the proximal feedthrough pin is coupled to a corresponding one of the conductive interconnect members.

14. An implantable medical electrical stimulation system that includes an implantable device and an implantable lead configured for electrical coupling with, and decoupling from, the device;

the device including an hermetically sealed housing, a power source and electronic circuitry contained within the housing, a hermetic feedthrough assembly extending through the housing, a connector port for the coupling with the lead, and first and second electrical device contacts mounted within the connector port and spaced apart from one another along a length of the port, each of the first and second contacts being coupled to the contained circuitry of the device via the hermetic feedthrough assembly, and the contained circuitry being programmable to deliver stimulation and data pulses through the first and second device contacts;

the lead including a connector terminal configured to fit within the connector port of the device for the electrical coupling thereto, an elongate flexible insulative body extending distally from the connector terminal and including an internal and longitudinally extending channel that provides for passage of an elongate instrument therein, at least three elongate flexible conductors extending within the insulative body, distally from the connector terminal, and a plurality of electrodes mounted on a distal portion of the insulative body, each of the plurality of electrodes being coupled to a corresponding conductor of the at least three elongate flexible conductors; and

wherein the connector terminal of the lead comprises;

a first electrical connector contact;

a second electrical connector contact electrically isolated from, and spaced apart, distally, from the first electrical connector contact along a length of the connector terminal at a predetermined distance, the predetermined distance being such that, when the connector terminal is inserted within the connector port of the device with the first connector contact located to be electrical coupled to the first device contact therein, the second connector contact is located to be electrically coupled to the second device contact therein;

a switching assembly mounted within the second electrical connector contact, the switching assembly comprising a multiplexer mounted on an integrated circuit chip and electrically coupled to the second connector contact, a proximal feedthrough subassembly and a distal feedthrough subassembly, the proximal feedthrough subassembly including a conductive ferrule, a feedthrough pin and an insulator isolating the pin from the ferrule and being hermetically sealed to the pin and to the ferrule, the feedthrough pin electrically coupling the first connector contact to the multiplexer, and the distal feedthrough subassembly including a conductive ferrule, a plurality of feedthrough pins and an insulator isolating each of the pins from one another and from the corresponding ferrule, and being hermetically sealed to each of the pins and to the corresponding ferrule, each feedthrough pin of the distal feedthrough assembly electrically coupling a corresponding conductor of the at least three elongate flexible conductors to the multiplexer; and

an inner wall forming a lumen that extends along the length of the connector terminal and within the second connector contact, the lumen having a proximal opening in proximity to the first electrical connector contact and being in fluid communication with the internal channel of the elongate flexible insulative body of the lead, to allow passage of the elongate instrument from the proximal opening and into the internal channel, and the inner wall isolating the lumen from the switching assembly and from each of the aforementioned electrical couplings to the multiplexer;

wherein the multiplexer includes a switch matrix element and a communications, control and power supply element, the switch matrix element including a plurality of pairs of switches, each pair of the plurality of pairs of switches corresponding to each conductor of the at least three elongate flexible conductors, a first of each pair of switches adapted to connect and disconnect the corresponding conductor to/from the first connector contact and the communications, control and power supply element, and a second of each pair of switches adapted to connect and disconnect the corresponding conductor to/from the second connector contact and the communications, control and power supply element, such that any two of the plurality of electrodes can be selected, via programming of the contained circuitry of the device, in order to deliver a stimulation vector, via the stimulation pulses delivered through the first and second device contacts, when the lead connector terminal is inserted in the device connector port and each of the first and second connector contacts is coupled to the corresponding contact of the first and second device contacts.

15. The system of claim 14, wherein the plurality of electrodes of the lead includes four electrodes and each of the four electrodes is spaced apart from the adjacent electrode by a distance of approximately 20 millimeters.