Lead and methods for brain monitoring and modulation

• US 9,314,614 B2
• Filed: 10/31/2012
• Issued: 04/19/2016
• Est. Priority Date: 07/31/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Bedenbaugh, Purvis
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/665,533
• Publication Number:
  US 20130197424A1
• Time in Patent Office: 1,266 Days
• Field of Search: 600/373, 600/378, 600/393, 607/45, 607/46, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction

Abstract

An apparatus, a system and methods for modulating and monitoring tissue have an elongate member with proximal and distal ends and a plurality of annular stimulating electrodes axially arranged along the elongate member. The stimulating electrodes are disposed near the distal end and are adapted to pass current into tissue. At least one of the annular stimulating electrodes has at least three independent stimulation points on the electrode. The apparatus also includes a plurality of recording electrodes that are adapted to measure local tissue potentials and a plurality of conductors are coupled with the recording and stimulating electrodes. An optional multiple contact connecting terminal may be coupled with the conductors and is disposed near the proximal end of the elongate member.

Claims

1. An apparatus for stimulating tissue, the apparatus comprising:

an elongate member having a longitudinal axis, a circumference, a proximal end, a distal end, and a central lumen extending between the proximal end and the distal end of the elongate member, the central lumen sized to receive a stylet for advancement of the elongate member slidably thereover;

a plurality of stimulating regions coupled with the elongate member, the stimulating regions arranged along the elongate member and axially spaced apart along the longitudinal axis, the stimulating regions disposed near the distal end, the stimulating regions being adapted to pass current into the tissue, and wherein at least one stimulating region consists of three independent stimulation sites, each of the stimulating sites having one stimulation electrode, the stimulation sites spaced apart from one another and separated from one another by an insulating material, wherein each stimulation site may be stimulated independently of each of the other stimulation sites, wherein the three stimulation sites and the insulating material therebetween are arranged along the circumference of the elongate member to form a closed annular ring, the annular ring adapted to steer a volume of therapeutic electric current into the tissue by the stimulation of one or more of the stimulation electrodes, in order to shape a volume of stimulated tissue;

a single distal electrode disposed at a distalmost end of the elongate member;

an insulating material extending distally from the plurality of stimulating regions to the single distal electrode,

a ring electrode extending around an entirety of the circumference of the elongate member and disposed proximal to at least one of the plurality of stimulating regions;

a first plurality of conductors electrically coupled with the stimulation electrodes;

a plurality of recording electrodes disposed adjacent the stimulating regions, the plurality of recording electrodes adapted to measure local tissue potentials, wherein the ring electrode is one of the recording electrodes; and

a second plurality of conductors electrically coupled with the recording electrodes;

wherein the first plurality of conductors are arranged in one or more groups and the second plurality of conductors are arranged in one or more groups, and wherein the one or more groups of the first plurality of conductors courses separately from the one or more groups of the second plurality of electrodes.

2. The apparatus of claim 1, wherein the first plurality of conductors and the second plurality of conductors are randomly oriented.

3. The apparatus of claim 1, further comprising a multiple contact terminal with at least some of the first plurality of conductors and the second plurality of conductors electrically coupled thereto.

4. The apparatus of claim 1, wherein the first plurality of conductors and the second plurality of conductors course through two separate annular rings.

5. The apparatus of claim 1, further comprising one or more ports near the distal end of the elongate member, the ports in communication with the lumen and adapted to deliver a therapeutic agent to and/or receive a chemical substance from the tissue.

6. The apparatus of claim 5, wherein the one or more ports comprise a gating member.

7. The apparatus of claim 1, wherein the distal electrode is dome-shaped.

8. A method of treating tissue comprising:

providing a lead having at least one stimulating region and a central lumen with a stylet slidably disposed therein;

implanting the lead in tissue, wherein the at least one stimulating region consists of three stimulation sites, each stimulation site having one stimulation electrode, the three stimulation sites arranged in a broken ring separated from one another by an insulator so that each stimulation electrode may be stimulated independently of each of the other stimulation electrodes;

stimulating a volume of tissue with a therapeutic electrical current from a first group of the three stimulation sites; and

steering the therapeutic electrical current through the tissue by independently changing magnitude of the therapeutic electrical current delivered by the first group or by delivering the therapeutic electrical current from a second group of the three stimulation sites different than the first group.

9. The method of claim 8, further comprising measuring tissue responses as a result of stimulating the tissue, with one or more recording electrodes disposed adjacent the at least one stimulating region.

10. The method of claim 9, further comprising:

using a first protocol, when stimulating the volume of tissue, that results in one or more therapeutic effects in the patient; and

using a second protocol, when stimulating the volume of tissue, that provides a more conservative stimulus magnitude relative to the first protocol and just maintains the therapeutic effects, thereby conserving power during the second protocol.

11. The method of claim 10, wherein the conserved power is battery power.

12. The method of claim 10, further comprising:

tracking changes in responses to the stimulation to determine a dynamic range from threshold to saturation in the response to the stimulation as a function of stimulus magnitude.

13. The method of claim 9, wherein measuring local tissue responses comprises collecting chemical substances from the tissue with one or more ports disposed on a distal end of the lead, the ports in fluid communication with the central lumen.

14. The method of claim 13, further comprising stimulating the tissue with a therapeutic agent, the therapeutic agent delivered with at least one of the ports.

15. The method of claim 9, wherein measuring tissue responses comprise measuring local tissue potentials with one or more recording electrodes disposed adjacent the at least one stimulation region.

16. The method of claim 8, wherein the tissue is brain tissue.

17. A method of treating tissue comprising:

providing a lead having at least one stimulating region and a central lumen with a stylet slidably disposed therein;

implanting the lead in tissue, wherein the at least one stimulating region consists of three stimulation sites, each stimulation site having one stimulation electrode, the three stimulation sites arranged in a broken ring separated from one another by an insulator so that each stimulation electrode may be stimulated independently of the other stimulation electrodes;

stimulating a volume of tissue with a therapeutic electrical current from a first group of the three stimulation sites; and

steering the therapeutic electrical current through the tissue by independently changing magnitude of the therapeutic electrical current delivered by the first group or by delivering the therapeutic electrical current from a second group of the three stimulation sites different than the first group, wherein steering the electrical current comprises orienting an electric dipole in an orientation in a plane of the broken ring, thereby shaping the volume of the stimulated tissue.

18. The method of claim 17, further comprising improving a tissue modulation capability of the lead, relative to a lead having four or more electrodes, by providing the broken ring with the three independent stimulation sites, each of which is disposed in a different, non-overlapping 120°

arc around a circumference of the lead, thereby maximizing the electric dipole that can be produced in more orientations in the plane of the broken ring, as compared to an electric dipole being produced with a lead having four or more electrodes, for a given current density limit.