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

• US 9,079,015 B2
• Filed: 11/04/2014
• Issued: 07/14/2015
• Est. Priority Date: 12/14/2012
• Status: Active Grant

• 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:
  US14/532,991
• Publication Number:
  US 20150057731A1
• Time in Patent Office: 252 Days
• US Class Current: 1/1
• 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 plurality of micro-circuits laminated to a first electrically-nonconductive substrate and rolled into a tube, the micro-circuits each having a first end portion and an opposing second end portion, wherein a plurality of through-holes are defined through the first electrically-nonconductive substrate with at least one through-hole disposed between each adjacent pair of the micro-circuits, and

a plurality of second contacts disposed over the tube formed by the plurality of micro-circuits and the first electrically-nonconductive substrate, wherein each of the second contacts is electrically coupled to the first end portion of at least one of 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 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, further comprising a second electrically-nonconductive substrate, wherein at least a portion of each of the micro-circuits is laminated between the first and second electrically-nonconductive substrates.

3. 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.

4. 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.

5. The electrical stimulation lead of claim 1, wherein each of the first electrically-nonconductive substrates comprises a thermoplastic material.

6. The electrical stimulation lead of claim 1, wherein the contact assembly further comprises a severed end of a conductor tie bar attached to at least one of the plurality of micro-circuits, wherein the severed end terminates at a one of the through-holes.

7. The electrical stimulation lead of claim 1, wherein the plurality of micro-circuits comprise MP35N.

8. The electrical stimulation lead of claim 1, wherein the lead is a percutaneous lead.

9. The electrical stimulation lead of claim 1, wherein the lead is a paddle lead.

10. 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.

11. 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 the 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 lead body of the electrical stimulation lead.

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

forming a contact assembly comprising a plurality of micro-circuits laminated to at least one electrically-nonconductive substrate, wherein each of the micro-circuits has a first end portion and an opposing second end portion and each of the micro-circuits is coupled to at least one adjacent micro-circuit by a conductor tie bar;

severing the conductor tie bars and forming a plurality of through-holes through the at least one electrically-nonconductive substrate;

exposing a contact interface along the first end portion of each of the plurality of micro-circuits;

mechanically coupling a plurality of contacts to the contact assembly; and

electrically coupling each of the contacts to the exposed contact interface of a one of the plurality of micro-circuits.

13. The method of claim 12, wherein mechanically coupling a plurality of contacts to the contact assembly comprises rolling the contact assembly into a tubular-shape and disposing the plurality of contacts over the tubular-shaped contact assembly.

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

15. The method of claim 12, wherein mechanically coupling a plurality of contacts to the contact assembly comprises over-molding the contact assembly after the contacts are electrically coupled to the contact interfaces of the plurality of micro-circuits.

16. The method of claim 12, further comprising

exposing a conductor interface along the second end portion of each of the plurality of micro-circuits;

and

attaching a plurality of lead-body conductors to the exposed conductor interfaces of the plurality of micro-circuits.

17. 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 substrate, and a plurality of micro-circuits laminated to the first electrically-nonconductive substrate, the micro-circuits each having a first end portion and an opposing second end portion, wherein a plurality of through-holes are defined through the first electrically-nonconductive substrate with at least one through-hole disposed between each adjacent pair of the micro-circuits, and

a plurality of second contacts disposed over the composite structure, wherein each of the second contacts is electrically coupled to the first end portion of at least one of 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.

18. The electrical stimulation lead of claim 17, wherein each of the layered elements further comprises a second electrically-nonconductive substrate, wherein at least a portion of each of the microcircuits is laminated between the first and second electrically-nonconductive substrates.

19. The electrical stimulation lead of claim 17, wherein the contact assembly further comprises a severed end of a conductor tie bar attached to at least one of the plurality of micro-circuits, wherein the severed end terminates at a one of the through-holes.

20. The electrical stimulation lead of claim 17, wherein the plurality of layered elements are stacked into at least two layers.