Systems and methods for making and using contact assemblies for leads of electrical stimulation systems

• US 8,909,354 B2
• Filed: 12/10/2013
• Issued: 12/09/2014
• Est. Priority Date: 12/14/2012
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Orinski, William George
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/101,861
• Publication Number:
  US 20140172056A1
• Time in Patent Office: 364 Days
• Field of Search: 607/116
• US Class Current: 607/116
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

First contacts are disposed along a distal end portion or a proximal end portion of a lead body of an electrical stimulation lead. A contact assembly is disposed along the other of the distal end portion or the proximal end portion of the lead body. The contact assembly includes a tubular-shaped composite structure formed from multiple layered elements mechanically coupled together and rolled together into a tube. Each of the layered elements includes a first electrically-nonconductive substrate, a second electrically-nonconductive substrate, and micro-circuits laminated therebetween. Second contacts are disposed over the composite structure and electrically coupled to a first end portion of at least one of the micro-circuits. Lead-body conductors electrically couple the first contacts to the second contacts. Each of each of the lead-body conductors is attached to a second end portion of at least one of the micro-circuits.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal end portion and a proximal end portion;

a plurality of first contacts disposed along one of the distal end portion or the proximal end portion of the lead body;

a contact assembly disposed along the other of the distal end portion or the proximal end portion of the lead body, the contact assembly comprising

a tubular-shaped composite structure comprising a plurality of layered elements mechanically coupled together and rolled into a tube, each of the plurality of layered elements comprises a first electrically-nonconductive film, a second electrically-nonconductive film, and a plurality of micro-circuits laminated between the first electrically-nonconductive film and the second electrically-nonconductive film, the micro-circuits formed from a first material and each having a first end portion and an opposing second end portion, and

a plurality of second contacts disposed over the composite structure, wherein the plurality of second contacts are electrically-coupled directly to the plurality of micro-circuits; and

a plurality of lead-body conductors electrically coupling the plurality of first contacts to the plurality of second contacts, wherein each of each of the plurality of lead-body conductors is attached to the second end portion of at least one of the plurality of micro-circuits.

2. The electrical stimulation lead of claim 1, wherein the plurality of first contacts are terminals disposed along the proximal end portion of the lead body and the plurality of second contacts are electrodes disposed along the contact assembly.

3. The electrical stimulation lead of claim 1, wherein the plurality of first contacts are electrodes disposed along the distal end portion of the lead body and the plurality of second contacts are terminals disposed along the contact assembly.

4. The electrical stimulation lead of claim 1, wherein at least one of the first electrically-nonconductive films or at least one of the second electrically-nonconductive films comprises a thermoplastic material.

5. The electrical stimulation lead of claim 1, wherein the plurality of layered elements are stacked into at least two layers.

6. The electrical stimulation lead of claim 1, wherein a severed end of a conductor tie bar is attached to at least one of the plurality of micro-circuits.

7. The electrical stimulation lead of claim 1, wherein the lead is at least one of a percutaneous lead or a paddle lead.

8. The electrical stimulation lead of claim 1, wherein the contact assembly is a first contact assembly, and further comprising a second contact assembly disposed along the opposing end portion of the lead body.

9. An electrical stimulating system comprising:

the electrical stimulation lead of claim 1;

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the electrical stimulation lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end portion of at least one of the at least one lead body, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end portion of the at least one lead body of the electrical stimulation lead.

17. The electrical stimulation lead of claim 1 wherein, for each of the plurality of layered elements, the layered element comprises a first micro-circuit and a second micro-circuit, the first micro-circuit comprising a first contact interface disposed along the first end portion of the first micro-circuit and a first conductive trace coupled to the first contact interface and extending along the second end portion of the micro-circuit, the second micro-circuit comprising a second contact interface disposed along the first end portion of the second micro-circuit and a second conductive trace coupled to the second contact interface and extending along the second end portion of the micro-circuit.

18. The electrical stimulation lead of claim 17 wherein, for each of the plurality of layered elements, the layered element defines at least one first aperture defined between the first contact interface and the second contact interface, the at least one aperture extending entirely through the layered element.

19. The electrical stimulation lead of claim 17 wherein, for each of the plurality of layered elements, the layered element defines at least one second aperture defined between the first conductive trace and the second conductive trace, the at least one aperture extending entirely through the layered element.

20. The electrical stimulation system of claim 1, wherein the second contacts are formed from a second material that is different from the first material.

10. A method of forming an electrical stimulation lead, the method comprising:

extending a plurality of lead-body conductors along a lead body;

electrically coupling a plurality of first contacts to first end portions of the lead-body conductors disposed along a first end portion of the lead body;

forming a plurality of layered elements, each of the plurality of layered elements comprising a plurality of micro-circuits laminated between electrically-nonconductive films, wherein each of the micro-circuits has a first end portion and an opposing second end portion;

severing at least one conductor tie bar coupling together at least two of the plurality of micro-circuits;

coupling together the plurality of layered elements to form a composite structure;

exposing contact interfaces along the first end portions of each of the plurality of micro-circuits;

exposing conductor interfaces along the second end portions of each of the plurality of micro-circuits;

attaching each of the lead-body conductors the exposed conductor interfaces of the plurality of micro-circuits;

mechanically coupling a plurality of second contacts to the composite structure;

electrically coupling each of the second contacts to the exposed contact interfaces of the plurality of micro-circuits; and

mechanically coupling the composite structure to a second end portion of the lead body opposite to the first end portion.

11. The method of claim 10, wherein mechanically coupling a plurality of second contacts to the composite structure comprises rolling the composite structure into a tubular-shape and disposing the plurality of second contacts over the tubular-shaped composite structure.

12. The method of claim 10, wherein electrically coupling each of the second contacts to the exposed contact interfaces of the plurality of micro-circuits comprises laser welding at least one of the second contacts to at least one of the contact interfaces.

13. The method of claim 10, wherein coupling together the plurality of layered elements to form a composite structure comprises re-flowing material of at least one of the electrically-nonconductive substrates.

14. The method of claim 10, wherein mechanically coupling a plurality of second contacts to the composite structure comprises over-molding the composite structure after the second contacts are electrically coupled to the contact interfaces of the plurality of micro-circuits.

15. The method of claim 10, wherein mechanically coupling a plurality of second contacts to the composite structure comprises mechanically coupling at least one of a plurality of electrodes or a plurality of terminals to the composite structure.

16. An electrical stimulation lead, comprising:

a lead body having a distal end portion and a proximal end portion;

a plurality of first contacts disposed along one of the distal end portion or the proximal end portion of the lead body;

a contact assembly disposed along the other of the distal end portion or the proximal end portion of the lead body, the contact assembly comprising

a plurality of micro-circuits laminated between a first electrically-nonconductive film and a second electrically-nonconductive film and rolled into a tube,

the micro-circuits formed from a first material and each having a first end portion and an opposing second end portion, and

a plurality of second contacts disposed over the tube formed by the plurality of micro-circuits and the first and second electrically-nonconductive films, wherein the plurality of second contacts are electrically-coupled directly to the plurality of micro-circuits; and

a plurality of lead-body conductors electrically coupling the plurality of first contacts to the plurality of second contacts, wherein each of each of the plurality of lead-body conductors is attached to the second end portion of at least one of the plurality of micro-circuits.