Nerve-branch-specific action-potential activation, inhibition, and monitoring

• US 7,295,881 B2
• Filed: 12/29/2003
• Issued: 11/13/2007
• Est. Priority Date: 12/29/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Cohen, Ehud, Ben-David, Tamir, Ayal, Shai, Ben-Ezra, Omry
• Primary Examiner(s): Evanisko; George R.
• Assistant Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/745,514
• Publication Number:
  US 20050149154A1
• Time in Patent Office: 1,415 Days
• Field of Search: 607/118, 607/148, 607/46
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

A dual electrode arrangement, is provided, wherein two, preferably unidirectional, electrode configurations flank a nerve junction from which a preselected nerve branch issues, proximally and distally to the junction, with respect to the brain. The arrangement is conducive to the following: generating efferent action-potential propagations, substantially restricted to the preselected nerve branch, inhibiting afferent action-potential propagations, from the preselected nerve branch, selectively generating action-potential propagations, in a subset of nerve fibers of a predetermined diameter range, substantially restricted to the preselected nerve branch, and selectively inhibiting action-potential propagations, in a subset of nerve fibers of a predetermined diameter range, substantially restricted to the preselected nerve branch. The dual electrode arrangement is further conducive to monitoring naturally-occurring, efferent action-potential propagations, heading towards the preselected nerve branch, and monitoring naturally-occurring, afferent action-potential propagations, from the preselected nerve branch. The unidirectional electrode configurations may be monopolar, bipolar, tripolar, or multipolar. Communication with extracorporeal stations, and closed loop operations are also provided.

Claims

1. Apparatus comprising:

a dual electrode arrangement, which comprises;

a proximal electrode configuration, adapted to be implanted on a nerve trunk, on a proximal side, with respect to the brain, of a junction of said nerve trunk with a preselected nerve branch, so as to communicate with;

i. first nerve fibers of said nerve trunk, which at said junction remain with said nerve trunk, and

ii. second nerve fibers of said nerve trunk that branch into said preselected nerve branch; and

a distal electrode configuration, adapted to be implanted on said nerve trunk, on a distal side of said junction, so as to communicate with said first nerve fibers and not with said second nerve fibers; and

an electronic unit, in signal communication with both said proximal and distal electrode configurations, said electronic unit being configured to generate efferent action-potential propagations substantially restricted to said second nerve fibers, by;

driving said proximal electrode configuration to generate distally moving action potential propagations along said first and second nerve fibers, and

driving said distal electrode configuration to generate proximally moving action potential propagations along said first nerve fibers, such that said distally and proximally moving action potential propagations along said first nerve fibers collide and block each other, while said distally moving action potential propagations along said second nerve fibers propagate into said preselected nerve branch.

2. The apparatus of claim 1, wherein said electronic unit comprises a controller.

3. The apparatus of claim 2, further comprising a sensor unit, in communication with said controller.

4. The apparatus of claim 1, wherein said electronic unit comprises a pulse generator.

5. The apparatus of claim 1, wherein said electronic unit comprises an amplification component.

6. The apparatus of claim 1, further comprising an extracorporeal station, wherein said electronic unit comprises a receiver, configured for remote communication with said extracorporeal station, for receiving instructions from said extracorporeal station.

7. The apparatus of claim 1, further comprising an extracorporeal station, wherein said electronic unit comprises a transmitter, configured for remote communication with said extracorporeal station, for sending data to said extracorporeal station.

8. The apparatus of claim 1, wherein said proximal and distal electrode configurations are configured as unidirectional electrode configurations, each adapted for generating an action-potential propagations substantially in one direction, said unidirectional electrode configurations being arranged as mirror images to each other, such that said distally and proximally moving action potentials propagate towards each other.

9. The apparatus of claim 8, wherein said unidirectional electrode configurations are configured as monopolar, unidirectional electrode configurations.

10. The apparatus of claim 8, wherein said unidirectional electrode configurations are configured as multipolar, unidirectional electrode configurations.

11. The apparatus of claim 10, wherein said unidirectional electrode configurations are configured as bipolar, unidirectional electrode configurations.

12. The apparatus of claim 10, wherein said unidirectional electrode configurations are configured as tripolar, unidirectional electrode configurations.

13. The apparatus of claim 1, wherein said proximal and distal electrode configurations comprise electrodes, having metal surfaces on a side facing said nerve trunk, and spacers, arranged between said electrodes, formed of an electrically insulating material, and having a thickness which is greater than that of the electrodes'"'"', for forming a clearance between said electrodes and said nerve trunk, and preventing direct contact between said metal surfaces and said nerve trunk.

14. The apparatus of claim 1, wherein said electronic unit is configured to drive said proximal and distal electrode configurations to generate said distally and proximally moving action potential propagations, respectively, by applying respective currents having respective amplitudes each of which is no greater than 20 mA.

15. The apparatus of claim 1, wherein said proximal and distal electrode configurations are configured as unidirectional electrode configurations, each adapted for generating action-potential propagations substantially in one direction, and wherein said proximal and distal electrode configurations are arranged such that said distally and proximally moving action potentials propagate towards each other.

16. The apparatus of claim 1, wherein:

said dual electrode arrangement further comprises a cuff, constructed for mounting on said nerve trunk; and

said proximal and distal electrode configurations are integrated into said cuff, and positioned so as to flank said preselected nerve branch from said proximal and distal sides, respectively, when said cuff is mounted on said nerve trunk.

17. The apparatus of claim 1, wherein said electronic unit is configured to drive said proximal electrode configuration to selectively generate said distally moving action-potential propagations in a first subset of said first nerve fibers and in a second subset of said second nerve fibers having a predetermined diameter range.

18. The apparatus of claim 17, wherein said electronic unit is configured to

drive said distal electrode configuration to selectively generate said proximally moving action potential propagations in said first subset of said first nerve fibers along said first nerve fibers,

such that said distally moving and proximally moving action potential propagations collide and block each other along said first subset of said first nerve fibers,

while said distally moving action potential propagations continue along said second subset of said second nerve fibers.

19. The apparatus of claim 1, further comprising a physiological sensor, in communication with said electronic unit.

20. The apparatus of claim 19, wherein said physiological sensor is selected from the group consisting of:

a heart-rate sensor, an electrocardiograph (EKG) sensor, an acid sensor, a tensile sensor, and a blood flow rate sensor.

21. The apparatus of claim 1, wherein said electronic unit is configured to drive said proximal electrode configuration to generate said distally moving action potential propagations substantially without generating action potential propagations moving in a proximal direction.

22. The apparatus of claim 1, wherein said electronic unit is configured to drive said distal electrode configuration to generate said proximally moving action potential propagations substantially without generating action potential propagations moving in a distal direction.

23. The apparatus of claim 1, wherein said electronic unit is configured to activate said proximal and distal electrode configurations simultaneously.

24. A method comprising:

providing a proximal electrode configuration, on a nerve trunk, on a proximal side, with respect to the brain, of a junction of said nerve trunk with a preselected nerve branch, so as to communicate with;

i. first nerve fibers of said nerve trunk, which at said junction remain with said nerve trunk, and

ii. second nerve fibers of said nerve trunk that branch into said preselected nerve branch;

providing a distal electrode configuration, on said nerve trunk, on a distal side of said junction, so as to communicate with said first nerve fibers and not with said second nerve fibers;

providing an electronic unit, in signal communication with said proximal and distal electrode configurations; and

generating efferent action-potential propagations, substantially restricted to said second nerve fibers, of said preselected nerve branch, by;

generating, by said proximal electrode configuration, distally moving action potential propagations along said first and second nerve fibers, and

generating, by said distal electrode configuration, proximally moving action potential propagations along said first nerve fibers, such that said distally and proximally moving action potential propagations along said first nerve fibers collide and block each other, while said distally moving action potential propagations along said second nerve fibers propagate into said preselected nerve branch.

25. The method of claim 24, wherein providing said proximal and distal electrode configurations comprises providing respective unidirectional electrode configurations, each adapted for generating an action-potential propagation substantially in one direction, and wherein providing said proximal and distal electrode configurations comprises arranging said unidirectional proximal and distal electrode configurations as mirror images to each other, such that said distally and proximally moving action potentials propagate towards each other.

26. The method of claim 25, wherein providing said proximal and distal electrode configurations comprises providing respective monopolar, unidirectional electrode configurations.

27. The method of claim 25, wherein providing said proximal and distal electrode configurations comprises providing respective bipolar, unidirectional electrode configurations.

28. The method of claim 27, wherein providing said proximal and distal electrode configurations comprises providing respective tripolar, unidirectional electrode configurations.

29. The method of claim 25, wherein providing said proximal and distal electrode configurations comprises providing respective multipolar, unidirectional electrode configurations.

30. The method of claim 24, wherein generating said distally moving action potential propagations comprises selectively generating, by said proximal electrode configuration, said distally moving action-potential propagations in a first subset of said first nerve fibers and in a second subset of said second nerve fibers having a predetermined diameter range.

31. The method of claim 24, wherein generating said efferent action-potential propagations comprises activating said proximal and distal electrode configurations in accordance with a predetermined schedule.

32. The method of claim 24, wherein generating said efferent action-potential propagations comprises activating said proximal and distal electrode configurations simultaneously.

33. The method of claim 24, wherein providing said proximal and distal electrode configurations comprises providing respective unidirectional electrode configurations, each adapted for generating action-potential propagations substantially in one direction, and wherein providing said proximal and distal electrode configurations comprises arranging said unidirectional proximal and distal electrode configurations such that said distally and proximally moving action potentials propagate towards each other.

34. The method of claim 30, wherein generating said distally moving action potential propagations comprises:

selectively generating, by said distal electrode configuration, said proximally moving action potential propagations in said first subset of said first nerve fibers along said first nerve fibers,

such that said distally moving and proximally moving action potential propagations collide and block each other along said first subset of said first nerve fibers,

while said distally moving action potential propagations continue along said second subset of said second nerve fibers.

35. The method of claim 24, wherein generating, by said proximal electrode configuration, said distally moving action potential propagations comprises generating said distally moving action potential propagations substantially without generating action potential propagations moving in a proximal direction.

36. The method of claim 24, wherein generating, by said distal electrode configuration, said proximally moving action potential propagations comprises generating said proximally moving action potential propagations substantially without generating action potential propagations moving in a distal direction.

37. The method of claim 24, wherein generating said distally and proximally moving action potential propagations comprises applying respective currents having respective amplitudes each of which is no greater than 20 mA.

38. A method for generating efferent action potential propagations substantially restricted to a preselected nerve branch that branches from a nerve trunk at a junction, said nerve trunk including first nerve fibers that do not branch into said nerve branch, and second nerve fibers that branch into said nerve branch, said method comprising:

applying first and second currents at first and second sites on proximal and distal sides, with respect to a brain, of said junction, respectively; and

generating said efferent action potential propagations substantially restricted to said nerve branch by;

configuring said first current to generate distally moving action potential propagations along said first and second nerve fibers, and

configuring said second current to generate proximally moving action potential propagations along said first nerve fibers, such that said distally and proximally moving action potential propagations along said first nerve fibers collide and block each other, while said distally moving action potential propagations along said second nerve fibers propagate into said nerve branch.

39. The method of claim 38, wherein configuring said first current comprises configuring said first current to selectively generate said distally moving action potential propagations in a first subset of said first nerve fibers and in a second subset of said second nerve fibers having a predetermined diameter range.

40. The method of claim 39, wherein configuring said second current comprises configuring said second current to generate said proximally moving action potential propagations in said first subset of said first nerve fibers along said first nerve fibers, such that said distally moving and proximally moving action potential propagations collide and block each other along said first subset of said first nerve fibers, while said distally moving action potential propagations along said second subset of said second nerve fibers propagate into said nerve branch.

41. The method of claim 38, wherein applying said first and second currents comprises applying said first and second currents simultaneously.

42. The method of claim 38, wherein configuring said first current comprises configuring said first current to generate said distally moving action potential propagations substantially without generating action potential propagations moving in a proximal direction.

43. The method of claim 38, wherein configuring said second current comprises configuring said second current to generate said proximally moving action potential propagations substantially without generating action potential propagations moving in a distal direction.

44. The method of claim 38, wherein the nerve trunk includes a vagus nerve, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said nerve branch that branches from said vagus nerve.

45. The method of claim 44, wherein said preselected nerve branch is selected from the group consisting of:

a superior cardiac branch of said vagus nerve, an inferior cardiac branch of said vagus nerve, and a thoracic cardiac branch of said vagus nerve, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said selected nerve branch.

46. The method of claim 44, wherein said preselected nerve branch is selected from the group consisting of:

a gastric branch of said vagus nerve, and an intestinal branch of said vagus nerve, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said selected nerve branch.

47. The method of claim 38, wherein the nerve trunk includes a pudendal nerve, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said nerve branch that branches from said pudendal nerve.

48. The method of claim 47, wherein said preselected nerve branch is selected from the group consisting of:

an inferior rectal branch of said pudendal nerve, and a perineal branch of said pudendal nerve, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said selected nerve branch.

49. The method of claim 48, wherein generating said efferent action potential propagations comprises treating fecal incontinence.

50. The method of claim 47, wherein said preselected nerve branch includes a dorsal nerve of a penis, and wherein generating said efferent action potential propagations comprises generating said efferent action potential propagations substantially restricted to said dorsal nerve.