Devices and methods for tissue modulation and monitoring

• US 8,583,237 B2
• Filed: 09/13/2010
• Issued: 11/12/2013
• Est. Priority Date: 09/13/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Cranial Medical Systems, Inc.
• Inventors: Bedenbaugh, Purvis
• Primary Examiner(s): Bertram, Eric D.
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US12/880,985
• Publication Number:
  US 20120065699A1
• Time in Patent Office: 1,156 Days
• Field of Search: 607/115, 607/116, 607/119, 607/122, 607/148
• US Class Current: 607/45
• 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;

only a single first internal electrical connector electrically coupled with and integral with a first electrode in the proximal annular stimulating region, and wherein the first internal electrical connector is electrically coupled with and integral with a first electrode in the distal annular stimulating region, wherein the first internal electrical connector is disposed within the elongate member, the first internal electrical connector extending across the gap between the proximal and distal annular stimulating regions, wherein the first internal electrical connector is coupled to a proximal portion of the first electrode in the distal annular stimulating region, and wherein the first internal electrical connector is coupled to a distal portion of the first electrode in the proximal annular stimulating region; and

a recording electrode disposed in the gap between the proximal and distal annular stimulating regions, the recording electrode adapted to record local tissue potentials from the tissue.

2. The device of claim 1, wherein the elongate member comprises a lumen extending between the proximal and distal ends thereof.

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

4. 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.

5. 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.

6. The device of claim 1, wherein the plurality of electrodes in the proximal annular stimulating region each have a length in the direction of the longitudinal axis, and a width transverse thereto, wherein the length is at least three times the width.

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

8. The device of claim 1, wherein the distal 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.

9. The device of claim 1, wherein the distal 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.

10. The device of claim 1, wherein the plurality of electrodes in the distal annular stimulating region each have a length in the direction of the longitudinal axis, and a width transverse thereto, wherein the length is at least three times the width.

11. The device of claim 1, further comprising:

a second internal electrical connector 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 is disposed within the elongate member, the second internal electrical connector extending across the gap between the proximal and distal annular stimulating regions; and

a third internal electrical connector 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 is disposed within the elongate member, the third internal electrical connector extending across the gap between the proximal and distal annular stimulating regions.

12. The device of claim 1, consisting of the recording electrode.

13. The device of claim 1, wherein the recording electrode comprises an annular recording electrode completely circumscribing the elongate member.

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

15. The device of claim 1, further comprising a multiple contact connector electrically coupled with the plurality of annular stimulating regions and the recording electrode.

16. The device of claim 1, further comprising a second pair of adjacent annular stimulating regions, the second pair of annular stimulating regions adjacent 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 adapted 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 adapted 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 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 is disposed within the elongate member, the second internal electrical connector extending across the second gap between the proximal and distal annular stimulating regions of the second pair; and

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 adapted to record local tissue potentials from the tissue.

17. A system for stimulating or modulating tissue, said system comprising:

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

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

18. The system of claim 17, further comprising an anchoring device, the anchoring device adapted to removably couple the device to a patient'"'"'s head.

19. The device of claim 1, wherein the single electrical connector comprises a recessed region, and wherein the recording electrode is disposed over the recessed region.

20. 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 electrodes adapted to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, wherein the electrodes of the proximal annular stimulating region have a length in the direction of the longitudinal axis and a width transverse thereto, the length being greater than the width but less than fifteen times the width, the proximal annular stimulating region circumscribing the elongate member, and wherein the distal annular stimulating region comprises a plurality of electrodes adapted to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, wherein the electrodes of the distal annular stimulating region have a length in the direction of the longitudinal axis and a width transverse thereto, the length being greater than the width but less than fifteen times the width, 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;

only a single first internal electrical connector electrically coupled with an integral with a first electrode in the proximal annular stimulating region, and wherein the first internal electrical connector is electrically coupled with and integral with a first electrode in the distal annular stimulating region, wherein the first internal electrical connector is disposed within the elongate member, the first internal electrical connector extending across the gap between the proximal and distal annular stimulating regions, and wherein the first internal electrical connector is coupled to a proximal portion of the first electrode in the distal annular stimulating region, and wherein the first internal electrical connector is coupled to a distal portion of the first electrode in the proximal annular stimulating region; and

a recording electrode disposed in the gap between the proximal and distal annular stimulating regions, the recording electrode adapted to record local tissue potentials from the tissue.

21. The device of claim 20, wherein the elongate member comprises a lumen extending between the proximal and distal ends thereof.

22. The device of claim 20, wherein the proximal annular stimulating region completely circumscribes the elongate member.

23. The device of claim 20, 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.

24. The device of claim 20, 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.

25. The device of claim 20, wherein the distal annular stimulating region completely circumscribes the elongate member.

26. The device of claim 20, wherein the distal 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.

27. The device of claim 20, wherein the distal 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.

28. The device of claim 20, further comprising:

a second internal electrical connector 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 is disposed within the elongate member, the second internal electrical connector extending across the gap between the proximal and distal annular stimulating regions; and

a third internal electrical connector 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 is disposed within the elongate member, the third internal electrical connector extending across the gap between the proximal and distal annular stimulating regions.

29. The device of claim 20, consisting of the recording electrode.

30. The device of claim 20, wherein the recording electrode comprises an annular recording electrode completely circumscribing the elongate member.

31. The device of claim 20, further comprising a second recording electrode disposed in the gap between the proximal and distal annular stimulating regions, the second recording electrode adapted to record local tissue potentials from the tissue.

32. The device of claim 20, further comprising a multiple contact connector electrically coupled with the plurality of annular stimulating regions and the recording electrode.

33. The device of claim 20, further comprising a second pair of adjacent annular stimulating regions, the second pair of annular stimulating regions adjacent 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 adapted to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, wherein the electrodes of the proximal annular stimulating region in the second pair have a length in the direction of the longitudinal axis and a width transverse thereto, the length being greater than the width but less than five times the width, 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 adapted to deliver current into the tissue, with adjacent electrodes separated from one another by an insulating member disposed on the elongate member, wherein the electrodes of the distal annular stimulating region have a length in the direction of the longitudinal axis and a width transverse thereto, the length being greater than the width but less than five times the width, 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 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 is disposed within the elongate member, the second internal electrical connector extending across the second gap between the proximal and distal annular stimulating regions of the second pair; and

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 adapted to record local tissue potentials from the tissue.

34. A system for stimulating or modulating tissue, said system comprising:

the device for stimulating or modulating tissue as in claim 20; and

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

35. The system of claim 34, further comprising an anchoring device, the anchoring device adapted to removably couple the device to a patient'"'"'s head.

36. The device of claim 20, wherein the single electrical connector comprises a recessed region, and wherein the recording electrode is disposed over the recessed region.

37. 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 annular stimulating regions, wherein the first pair of annular stimulating regions comprise a proximal stimulating region having stimulating surfaces and a distal stimulating region having stimulating surfaces, and wherein the proximal stimulating region is separated from the distal stimulating region by a gap;

a recording electrode; and

an electrical connector adjacent the proximal end of the elongate member,

wherein the stimulating surfaces in the proximal and distal stimulating regions are comprised of electrode pairs, wherein each electrode pair is comprised of one electrode in the proximal stimulating region and one electrode in the distal stimulating region,

wherein the electrodes comprising each electrode pair are internally connected so that they are always energized concurrently,

wherein the recording electrode is disposed in the gap between the proximal and distal annular stimulating regions,

wherein the electrode pairs and the recording electrode are electrically coupled to the electrical connector, and

wherein the number of conductive channels in the electrical connector is equal to the sum of the number of electrode pairs and the number of recording electrodes.