Burr hole plugs for electrical stimulation systems and methods of making and using

• US 10,232,169 B2
• Filed: 07/22/2016
• Issued: 03/19/2019
• Est. Priority Date: 07/23/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Govea, Michael X., Howard, Joshua Dale, Wechter, David Ernest
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Ghand, Jennifer L
• Application Number:
  US15/217,844
• Publication Number:
  US 20170021162A1
• Time in Patent Office: 970 Days
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

A burr hole plug includes a first plug base defining a burr hole aperture and including first grooves; a second plug base to be disposed around the first plug base and including second grooves to receive a portion of an electrical stimulation lead; a cover to be disposed on the second plug base; a cap to be disposed over the burr hole aperture and coupled to the first plug base; and an extension coupled to, and extending away from, the cover. The extension includes conductors and the second plug base and the cover include conductive elements to electrically couple the terminals of the electrical stimulation lead, when disposed in the second grooves, to the conductors of the extension. An alternative burr hole plug includes a lead connector disposed on the cap and having a connector aperture to receive the proximal end of the electrical stimulation lead.

Claims

1. A burr hole plug for use with an electrical stimulation lead comprising a proximal end and a plurality of terminals disposed along the proximal end, the burr hole plug comprising:

a first plug base defining a burr hole aperture and comprising a plurality of first grooves disposed around a circumference of the first plug base and configured and arranged to receive at least one first portion of the electrical stimulation lead;

a second plug base configured and arranged to be disposed around the first plug base and comprising a plurality of second grooves disposed around a circumference of the second plug base and configured and arranged to receive at least one second portion of the electrical stimulation lead including the plurality of terminals disposed along the proximal end of the electrical stimulation lead;

a cover configured and arranged to be disposed on, and coupled to, the second plug base and to cover the plurality of second grooves;

a cap configured and arranged to be disposed over the burr hole aperture and coupled to the first plug base; and

an extension coupled to, and extending away from, the cover, the extension comprising a plurality of conductors, wherein the second plug base and the cover comprise a plurality of conductive elements configured and arranged to electrically couple the plurality of terminals of the electrical stimulation lead, when disposed in the second grooves, to the plurality of conductors of the extension.

2. The burr hole plug of claim 1, wherein the plurality of second grooves of the second plug base are uniformly spaced around the circumference of the second plug base.

3. The burr hole plug of claim 1, wherein the conductive elements comprise a plurality of conductive contacts disposed in the second grooves of the second plug base.

4. The burr hole plug of claim 1, wherein the conductive elements comprise a plurality of contacts disposed in the cover and configured and arranged to electrically couple to the terminals of the electrical stimulation lead disposed in the second grooves of the second plug base and a plurality of conductors extending along the cover from the plurality of contacts to the extension.

5. The burr hole plug of claim 1, wherein the first plug base comprises a plurality of fastener apertures configured and arranged to receive a fastener to fasten the first plug base to a patient.

6. The burr hole plug of claim 1, wherein the second plug base comprises a plurality of fastener apertures configured and arranged to receive a fastener to fasten the second plug base to a patient.

7. The burr hole plug of claim 1, wherein the first and second plug bases form a single integral component.

8. The burr hole plug of claim 1, wherein the conductors of the extension form a single layer ribbon.

9. The burr hole plug of claim 1, wherein the second plug base comprises a body made of a non-conductive material.

10. The burr hole plug of claim 9, wherein the conductive elements are disposed in the body of the second plug base.

11. The burr hole plug of claim 1, wherein the cap forms a friction fit or compression fit with the first plug base.

12. A system for electrical stimulation, comprising:

an electrical stimulation lead comprising a proximal end and a plurality of terminals disposed along the proximal end; and

a burr hole plug for use with the electrical stimulation lead, the burr hole plug comprising;

a first plug base defining a burr hole aperture and comprising a plurality of first grooves disposed around a circumference of the first plug base and configured and arranged to receive at least one first portion of the electrical stimulation lead;

a second plug base configured and arranged to be disposed around the first plug base and comprising a plurality of second grooves disposed around a circumference of the second plug base and configured and arranged to receive at least one second portion of the electrical stimulation lead including the plurality of terminals disposed along the proximal end of the electrical stimulation lead;

a cover configured and arranged to be disposed on, and coupled to, the second plug base and to cover the plurality of second grooves;

a cap configured and arranged to be disposed over the burr hole aperture and coupled to the first plug base; and

an extension coupled to, and extending away from, the cover, the extension comprising a plurality of conductors, wherein the second plug base and the cover comprise a plurality of conductive elements configured and arranged to electrically couple the plurality of terminals of the electrical stimulation lead, when disposed in the second grooves, to the plurality of conductors of the extension.

13. The system of claim 12, wherein the proximal end of the electrical stimulation lead comprises a plurality of separable branches, each of the branches comprising at least one of the terminals.

14. The system of claim 13, wherein the first grooves of the first plug base and the separable branches of the proximal end of the electrical stimulation lead are equal in number.

15. The system of claim 13, wherein the second grooves of the second plug base and the separable branches of the proximal end of the electrical stimulation lead are equal in number.

16. The system of claim 12, wherein the conductive elements comprise a plurality of conductive contacts disposed in the second grooves of the second plug base.

17. The system of claim 12, wherein the conductive elements comprise a plurality of contacts disposed in the cover and configured and arranged to electrically couple to the terminals of the electrical stimulation lead disposed in the second grooves of the second plug base and a plurality of conductors extending along the cover from the plurality of contacts to the extension.

18. The system of claim 12, wherein the conductors of the extension form a single layer ribbon.

19. The system of claim 12 wherein a spacing between adjacent ones of the terminals of the electrical stimulation lead is equal to a spacing between adjacent ones of the conductive elements of the burr hole plug.

20. A method of implanting an electrical stimulation lead, the method comprising:

providing the system of claim 12;

inserting a distal end of the electrical stimulation lead into patient tissue;

positioning at least one first portion of the proximal end of the electrical stimulation lead in at least one of the first grooves of the first plug base of the burr hole plug;

positioning at least one second portion of the proximal end of the electrical stimulation lead in at least one of the second grooves of the second plug base of the burr hole plug, wherein each of the at least one second portion comprises at least one of the terminals of the electrical stimulation lead;

attaching the cover to the second plug base; and

attaching the cap to the first plug base.