Devices and methods for tissue modulation and monitoring

• US 9,162,049 B2
• Filed: 10/08/2013
• Issued: 10/20/2015
• Est. Priority Date: 09/13/2010
• 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): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US14/049,072
• Publication Number:
  US 20140088672A1
• Time in Patent Office: 742 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• 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 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A tissue stimulating device has an elongate member, a proximal annular stimulating region and a distal annular stimulating region. Each of the annular stimulating regions circumscribe the elongate member, and each has a plurality of independently energizable electrodes that deliver current into tissue. Adjacent electrodes in the annular stimulating regions are separated from one another by an insulating member. The annular stimulating regions are axially separated from one another by a gap. An internal electrical connector electrically couples a first electrode in the proximal annular stimulating region with a first electrode in the distal annular stimulating region. The first internal electrical connector is disposed within the elongate member, and extends across the gap between annular stimulating regions. A recording electrode is disposed in the gap and is adapted to record local tissue potentials from the tissue.

Claims

1. A device for stimulating or modulating tissue, said device comprising:

an elongate member having a longitudinal axis, a proximal end, and a distal end;

a first pair of adjacent annular stimulating regions, the first pair of annular stimulating regions comprising a proximal annular stimulating region disposed near the distal end of the elongate member, and a distal annular stimulating region disposed near the distal end of the elongate member, the distal annular stimulating region closer to the distal end of the elongate member than the proximal annular stimulating region,

wherein the proximal annular stimulating region comprises a plurality of independently energizable electrodes adapted to deliver current into the tissue, with adjacent electrodes in the proximal annular stimulating region separated from one another by an insulating member disposed on the elongate member, the proximal annular stimulating region circumscribing the elongate member, and

wherein the distal annular stimulating region comprises a plurality of independently energizable electrodes adapted to deliver current into the tissue, with adjacent electrodes in the distal annular stimulating region separated from one another by an insulating member disposed on the elongate member, the distal annular stimulating region circumscribing the elongate member, and

wherein the distal annular stimulating region is axially separated along the longitudinal axis from the proximal annular stimulating member by a gap; and

a first internal electrical connector entirely disposed near the distal end of the elongate member and electrically coupling a first electrode in the proximal annular stimulating region with a first electrode in the distal annular stimulating region, wherein the first internal electrical connector extends across the gap between the proximal and distal annular stimulating regions.

2. The device of claim 1, wherein the first electrode in the distal annular stimulating region, the first internal electrical connector, and the first electrode in the proximal annular stimulating region form a unitary metal piece.

3. The device of claim 2, wherein the unitary metal piece comprises at least one indentation, relative to the first electrode in the distal annular stimulating region and the first electrode in the proximal annular stimulating region, corresponding to the first internal electrical connector.

4. The device of claim 3, wherein the unitary metal piece comprises a terminal indentation at at least one end of the metal piece.

5. The device of claim 1, further comprising:

a second internal electrical connector entirely disposed near the distal end of the elongate member and electrically coupling a second electrode in the proximal annular stimulating region with a second electrode in the distal annular stimulating region, wherein the second internal electrical connector extends across the gap between the proximal and distal annular stimulating regions.

6. The device of claim 5, further comprising:

a third internal electrical connector entirely disposed near the distal end of the elongate member and electrically coupling a third electrode in the proximal annular stimulating region with a third electrode in the distal annular stimulating region, wherein the third internal electrical connector extends across the gap between the proximal and distal annular stimulating regions.

7. The device of claim 1, wherein the proximal annular stimulating region completely circumscribes the elongate member.

8. The device of claim 1, further comprising a recording electrode disposed in the gap between the proximal and distal annular stimulating, regions, the recording electrode configured and arranged to record local tissue potentials from the tissue.

9. The device of claim 8, wherein the recording electrode comprises an annular recording electrode completely circumscribing the elongate member.

10. The device of claim 8, wherein the first internal electrical connector comprises a recessed region, and wherein the recording electrode is disposed over the recessed region.

11. The device of claim 1, further comprising a plurality of recording electrodes disposed in the gap between the proximal and distal annular stimulating regions, the recording electrodes configured and arranged to record local tissue potentials from the tissue.

12. The device of claim 1 further comprising a multiple contact connector disposed near the proximal end of the elongate member and electrically coupled with the annular stimulating regions.

13. The device of claim 1, wherein the proximal annular stimulating region consists of four electrodes, with adjacent electrodes separated from one another by an insulating member on the elongate member, the four electrodes disposed circumferentially around the elongate member.

14. The device of claim 1, wherein the proximal annular stimulating region consists of three electrodes, with adjacent electrodes separated from one another by an insulating member on the elongate member, the three electrodes disposed circumferentially around the elongate member.

15. The device of claim 1, further comprising

a second pair of adjacent annular stimulating regions, the second pair of annular stimulating regions adjacent, and distal to, the first pair and comprising a proximal annular stimulating region disposed near the distal end of the elongate member, and a distal annular stimulating region disposed near the distal end of the elongate member, the distal annular stimulating region closer to the distal end of the elongate member than the proximal annular stimulating region,

wherein the proximal annular stimulating region in the second pair comprises a plurality of electrodes configured and arranged to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, the proximal annular stimulating region in the second pair circumscribing the elongate member, and

wherein the distal annular stimulating region in the second pair comprises a plurality of electrodes configured and arranged to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, the distal annular stimulating region in the second pair circumscribing the elongate member, and wherein the distal annular stimulating region in the second pair is axially separated along the longitudinal axis from the proximal annular stimulating member in the second pair by a second gap;

a second internal electrical connector entirely disposed near the distal end of the elongate member and electrically coupling a first electrode in the proximal annular stimulating region of the second pair with a first electrode in the distal annular stimulating region of the second pair, wherein the second internal electrical connector extends across the second gap between the proximal and distal annular stimulating regions of the second pair.

16. The device of claim 15, further comprising a third internal electrical connector entirely disposed near the distal end of the elongate member and electrically coupling the first electrode in the distal annular stimulating region of the first pair with the first electrode in the proximal annular stimulating region of the second pair, wherein the third internal electrical connector extends across a gap between the distal annular stimulating region of the first pair and the proximal annular stimulating region of the second pair.

17. The device of claim 15, further comprising a second recording electrode disposed in the second gap between the proximal and distal annular stimulating regions of the second pair, the second recording electrode configured and arranged to record local tissue potentials from the tissue.

18. The device of claim 17, wherein the second recording electrode comprises an annular recording electrode completely circumscribing the elongate member.

19. A system for stimulating tissue, comprising:

the device for stimulating or modulating tissue as in claim 1; and

an implantable pulse generator operatively coupleable with the device for stimulating or modulating tissue.

20. The system of claim 19, further comprising an anchoring device configured and arranged to removably couple the device to a patient'"'"'s head.