Implantable therapeutic nerve stimulator

• US 8,612,020 B2
• Filed: 09/30/2009
• Issued: 12/17/2013
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Donofrio, William T.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US12/570,774
• Publication Number:
  US 20100114260A1
• Time in Patent Office: 1,539 Days
• Field of Search: 607/2, 607/5, 607/9, 607 39- 46, 607115-118, 607126-131
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

Abstract

A medical device includes an implantable device having a processor, a pulse generator and a first lead having first and second ends. The first end of the lead is operably and conductively coupled to the implantable device. A first electrode is operably and conductively coupled to the second end of the first lead. The first electrode has a sharp tip for transmitting and focusing a stimulation signal from the pulse generator to a tissue site.

Claims

1. An implantable medical device comprising:

an implantable device including a processor and a pulse generator;

a first lead having first and second ends, the first end of the lead operably and conductively coupled to the implantable device;

a first electrode operably and conductively coupled to the second end of the first lead, the first electrode having a first sharp tip for transmitting and focusing a stimulation signal from the pulse generator to a tissue site;

a discrete nonconductive barrier not integrally formed on the first sharp tip, said barrier having a major axis extending perpendicularly from a major axis of the first electrode, wherein said barrier is positionable between the first sharp tip and tissue, the barrier having a thickness capable of protecting the tissue from mechanical damage and capable of allowing the stimulation signal therethrough,

wherein the barrier includes at least one through passage in a vicinity of the first sharp tip.

2. The medical device of claim 1, further comprising a second lead having first and second ends, the first end of the second lead operably and conductively coupled to the implantable device;

and

a second electrode operably and conductively coupled to the second end of the second lead.

3. The medical device of claim 2, wherein the second electrode has a second sharp tip.

4. The medical device of claim 1, wherein the stimulation signal is high voltage and very brief duration.

5. The medical device of claim 1, wherein the tissue site is adjacent a vagus nerve.

6. The medical device of claim 1, wherein the tissue site is adjacent a spinal cord.

7. A medical device comprising:

an implantable device including a pulse generator; and

a plurality of electrodes operably and conductively coupled to the implantable device, at least a first electrode of the plurality electrodes having a sharp tip;

a discrete nonconductive barrier not integrally formed on the sham tip, said barrier having a major axis extending perpendicularly from a major axis of the at least one electrode, wherein said barrier is positionable between the sharp tip and tissue, the barrier comprising a passage therethrough to allow direct passage of a stimulation signal from the pulse generator to a tissue site.

8. The medical device of claim 7, wherein each electrode of the plurality of electrodes includes a sharp tip and wherein the plurality of electrodes including the first electrode is arranged in a plurality of opposing pairs, each pair operably positionable on opposite sides of a nerve or tissue.

9. The medical device of claim 7, wherein the plurality of electrodes including the first electrode is arranged in a pair of opposing comb-like electrode structures.

10. The medical device of claim 7, wherein the plurality of electrodes includes a second electrode having a sharp tip.

11. The medical device of claim 10, wherein the first and second electrodes are operably positionable on opposite sides of tissue.

12. The medical device of claim 10, wherein the first and second electrodes are operably positionable on a same side of tissue.

13. The medical device of claim 10, further comprising first and second discrete nonconductive barriers not integrally formed on the sharp tips of the first and second electrodes, said barriers having a major axis extending perpendicularly from a major axis of the first and second electrodes and operably positionable respectively between the first and second electrodes and the tissue.

14. A method of delivering tissue stimulation comprising:

generating an electrical stimulation signal from a signal generator of an implantable medical device;

coupling a first electrode having a first sharp tip to the signal generator of the implantable medical device

positioning a discrete insulative barrier between the first sharp tip of the first electrode and tissue;

positioning the first sharp tip of the first electrode adjacent the discrete insulative barrier, the discrete insulative barrier not integrally formed on the first sharp tip, said barrier having a major axis extending perpendicularly from a major axis of the first electrode, wherein the barrier includes a passage therethrough; and

transmitting the electrical stimulation signal from the first sharp tip through the passage directly into tissue adjacent the insulative barrier.

15. The method of claim 14, wherein positioning the first sharp tip of the first electrode includes positioning the first sharp tip in direct contact with the discrete insulative barrier, and the barrier in direct contact with the tissue.

16. The method of claim 14, further comprising:

positioning a second sharp tip of a second electrode in contact with tissue, the second electrode conductively and operably coupled to the implantable medical device; and

transmitting the signal through the second sharp tip.

17. The method of claim 16, further comprising positioning the first and second sharp tips on opposite sides of tissue.

18. The method of claim 16, wherein the signal is a high voltage very brief duration pulse.

19. The method of claim 18, wherein the voltage is in a range of about 1 kV to about 10 kV and the duration is in a range of about 10 ns to about 1000 ns.

20. The method of claim 16, further comprising inducing an electric field in the tissue, the electric field localized in a vicinity of the first and second sharp tips.

21. The method of claim 16, wherein the signal is a transmitted through the tissue between the first and second sharp tips.

22. The method of claim 14, wherein the signal includes repeated pulses at a first therapy stimulation level characterized by one of voltage level, duration, and number of electrodes delivering stimulation and repeated pulses at a second therapy stimulation level reduced from the first therapy stimulation level.

23. The method of claim 14, wherein transmitting the signal to the tissue through the first sharp tip includes transmitting therapeutic stimulation.

24. The method of claim 14, wherein transmitting the signal to the tissue through the first sharp tip includes transmitting blocking stimulation.

25. An implantable medical device comprising:

an implantable device including a processor and a pulse generator;

a first lead having first and second ends, the first end of the lead operably and conductively coupled to the implantable device;

a first electrode operably and conductively coupled to the second end of the first lead, the first electrode having a first sharp tip for transmitting and focusing a high voltage stimulation signal from the pulse generator to a tissue site, the voltage is in a range of about 1 kV to about 10 kV and the duration is in a range of about 10 ns to about 1000 ns;

a discrete nonconductive barrier not integrally formed on the first sharp tip, said barrier having a major axis extending perpendicularly from a major axis of the first electrode, wherein said barrier is and positionable between the first sharp tip and tissue, the barrier having a thickness capable of protecting the tissue from mechanical damage and capable of allowing the stimulation signal therethrough,

wherein the barrier includes at least one through passage in a vicinity of the first sharp tip.