Electrode assembly for nerve control

• US 7,844,346 B2
• Filed: 02/02/2006
• Issued: 11/30/2010
• Est. Priority Date: 05/23/2002
• Status: Expired due to Fees

• 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): Getzow; Scott M
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/347,120
• Publication Number:
  US 20060195170A1
• Time in Patent Office: 1,762 Days
• Field of Search: 607116-118
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

Apparatus is provided for applying current to a nerve, including a housing, that is adapted to be placed in a vicinity of the nerve. At least one electrode is fixed to the housing such that the at least one electrode does not come in direct physical contact with the nerve, and such that the electrode surrounds greater than 180 degrees of a circumference of the nerve after the placement of the housing. Two end insulating elements are fixed to the housing. The at least one electrode is between the end insulating elements. A characteristic closest end insulating element distance to a surface of the nerve is less than 0.5 mm.

Claims

1. Apparatus for applying current to a nerve, comprising:

a tubular housing, which defines and completely surrounds a space having a longitudinal central axis, and which is configured to be placed completely surrounding a longitudinal portion of the nerve;

one or more electrodes, fixed to an inner surface of the housing facing the longitudinal central axis such that the electrodes surround greater than 180 degrees of the longitudinal central axis of the housing; and

first and second end insulating elements, fixed to the housing at respective longitudinal ends of the housing, such that the end insulating elements extend toward the longitudinal central axis, and are shaped so as to define respective openings surrounding the longitudinal central axis, wherein the electrodes are longitudinally between the end insulating elements,

wherein a closest end insulating element distance between each of the end insulating elements and the longitudinal central axis is between 1 and 2 mm, such that a radius of each of the openings is between 1 and 2 mm, and

wherein a closest electrode distance between the electrodes and the longitudinal central axis is at least 1.5 times the closest end insulating element distance.

2. The apparatus according to claim 1, wherein at least one of the end insulating elements is shaped so as to define a rough surface that faces the longitudinal central axis.

3. The apparatus according to claim 1, wherein the closest electrode distance is at least 1 mm.

4. The apparatus according to claim 1, wherein the difference between the closest electrode distance and the closest end insulating element distance is at least 0.5 mm.

5. The apparatus according to claim 1, wherein the closest electrode distance is greater than 2 times the closest end insulating element distance.

6. The apparatus according to claim 1, wherein the electrodes comprise exactly one set of one or more electrodes having respective electrode surfaces that, when the housing is placed surrounding the longitudinal portion of the nerve, are in electrical contact with the nerve and are in electrical contact with each other via a path outside of the nerve.

7. The apparatus according to claim 1, wherein the housing is shaped so as to define an external surface facing away from the longitudinal central axis, which surface is configured to promote growth of fibrous connective tissue therearound.

8. The apparatus according to claim 1, wherein at least one of the end insulating elements, when the housing is placed surrounding the longitudinal portion of the nerve, is shaped so as to define a contact surface facing the longitudinal central axis, and wherein the contact surface is configured so as to promote connective tissue growth between the nerve and the contact surface.

9. The apparatus according to claim 8, wherein the contact surface comprises a mesh that is configured to promote the connective tissue growth.

10. The apparatus according to claim 1, wherein the electrodes comprise at least a first electrode and a second electrode, wherein the apparatus further comprises an internal insulating element fixed to the housing longitudinally between the first and second electrodes, so as to define a closest internal insulating element distance between the internal insulating element and the longitudinal central axis, and wherein the difference between the closest internal insulating element distance and the closest end insulating element distance is less than 0.5 mm.

11. The apparatus according to claim 10, wherein the internal insulating element distance equals the closest end insulating element distance.

12. The apparatus according to claim 1, wherein the electrodes comprise at least first, second, and third electrodes, wherein the apparatus further comprises first and second internal insulating elements fixed to the housing longitudinally between the first and the second electrodes, and longitudinally between the second and the third electrodes, respectively, so as to define respective closest internal insulating element distances between the internal insulating elements and the longitudinal central axis, and wherein the difference between each of the closest internal insulating element distances and the closest end insulating element distance is less than 0.5 mm.

13. The apparatus according to claim 12, wherein each of the internal insulating element distances equals the closest end insulating element distance.

14. The apparatus according to claim 1, wherein the electrodes comprise one or more materials selected from the list consisting of:

platinum, a platinum alloy, titanium, and a titanium alloy.

15. The apparatus according to claim 14, further comprising at least one lead coupled to the electrodes, the at least one lead comprising:

a first portion thereof within 2 cm of a surface of the electrodes closest to the longitudinal central axis, the first portion comprising substantially only the one or more materials; and

a second portion thereof greater than 2 cm from the surface of the electrodes closest to the longitudinal central axis, the second portion comprising a conductive material.

16. The apparatus according to claim 1, wherein the housing comprises an outer insulating wall that, when the housing is placed surrounding the longitudinal portion of the nerve, is not in physical contact with the nerve, and wherein at least a portion of the outer insulating wall has a hardness greater than a hardness of at least a portion of at least one of the end insulating elements.

17. The apparatus according to claim 16, wherein the at least a portion of the outer insulating wall has a Shore D hardness of between 40 and 50, and wherein the at least a portion of the at least one of the end insulating elements has a Shore D hardness of between 5 and 20.

18. The apparatus according to claim 17, wherein the at least a portion of the end insulating elements has a Shore D hardness of 10.

19. The apparatus according to claim 1,

wherein the at least one electrode comprises at least a first electrode and a second electrode,

wherein the apparatus further comprises an internal insulating element fixed to the housing longitudinally between the first and second electrodes, such that the internal insulating element extends toward the longitudinal central axis, and defines a closest internal insulating element distance between the internal insulating element and the longitudinal central axis, and

wherein the closest internal insulating element distance is less than 1.5 times the closest end insulating element distance.

20. The apparatus according to claim 19, wherein the closest internal insulating element distance is equal to the closest end insulating element distance.

21. The apparatus according to claim 1,

wherein, of all of the electrodes, a first one of the electrodes is longitudinally closest to the first end insulating element, and the first electrode is further from the longitudinal central axis than the first end insulating element is from the axis, and

wherein, of all of the electrodes, a second one of the electrodes is longitudinally closest to the second end insulating element, and the second electrode is further from the axis than the second end insulating element is from the axis.

22. The apparatus according to claim 1, wherein the first and second end insulating elements are positioned at the same distance from the longitudinal central axis.

23. Apparatus for applying current to a nerve, comprising:

a tubular housing, which defines and completely surrounds a space having a longitudinal central axis, and which is configured to be placed completely surrounding a longitudinal portion of the nerve;

first and second end insulating elements, fixed to the housing at respective first and second longitudinal ends of the housing, such that the end insulating elements extend toward the longitudinal central axis, and are shaped so as to define respective openings surrounding the longitudinal central axis, wherein respective first and second closest end insulating element distances between the end insulating elements and the longitudinal central axis are between 1 and 2 mm, such that respective radii of the openings are between 1 and 2 mm;

first and second electrodes, longitudinally closest to the first and second end insulating elements, respectively, and fixed to an inner surface of the housing facing the longitudinal central axis at respective first and second longitudinal sites of the housing longitudinally between the end insulating elements, so as to define respective first and second closest electrode distances between the electrodes and the longitudinal central axis, which first and second closest electrode distances are greater than the first and second closest end insulating element distance, respectively; and

;

an internal insulating element, fixed to the housing longitudinally between the first and second longitudinal sites, such that the internal insulating element extends toward the longitudinal central axis such that a closest internal insulating element distance between the internal insulating element and the longitudinal central axis is less than the closest electrode.

24. The apparatus according to claim 23, wherein the internal insulating element defines a closest internal insulating element distance between the internal insulating element and the longitudinal central axis, which closest internal insulating element distance is less than 1.5 times the closest end insulating element distance.

25. The apparatus according to claim 24, wherein the closest internal insulating element distance is equal to the closest end insulating element distance.

26. The apparatus according to claim 23, wherein the first and second end insulating elements are positioned at the same distance from the longitudinal central axis.

27. Apparatus for applying current to a nerve, comprising:

a tubular housing, which defines and completely surrounds a space having a longitudinal central axis, and which is configured to be placed completely surrounding a longitudinal portion of the nerve;

exactly one set of one or more electrodes fixed to an inner surface of the housing facing the longitudinal central axis, the electrodes having respective electrode surfaces that are in electrical contact with the nerve when the housing is placed in the vicinity of the nerve, and are in electrical contact with each other via a path outside of the nerve; and

first and second end insulating elements, fixed to the housing at respective longitudinal ends of the housing, such that the end insulating elements extend toward the longitudinal central axis, and are shaped so as to define respective openings surrounding the longitudinal central axis, wherein the set of electrodes are longitudinally between the end insulating elements,

wherein a closest end insulating element distance between each of the end insulating elements and the longitudinal central axis is between 1 and 2 mm, such that a radius of each of the openings is between 1 and 2 mm, and

wherein a closest electrode distance between the electrodes and the longitudinal central axis is at least 1.5 times the closest end insulating element distance.

28. The apparatus according to claim 27, wherein the closest electrode distance is at least 1 mm.

29. The apparatus according to claim 27, wherein the difference between the closest electrode distance and the closest end insulating element distance is at least 0.5 mm.

30. The apparatus according to claim 27, wherein the closest electrode distance greater than 2 times a radius of the nerve.

31. The apparatus according to claim 27, wherein the housing comprises an outer insulating wall that, when the housing is placed surrounding the longitudinal portion, is not in physical contact with the nerve, and wherein at least a portion of the outer insulating wall has a hardness greater than a hardness of at least a portion of at least one of the end insulating elements.

32. The apparatus according to claim 31, wherein the at least a portion of the outer insulating wall has a Shore D hardness of between 40 and 50, and wherein the at least a portion of the at least one of the end insulating elements has a Shore D hardness of between 5 and 20.

33. The apparatus according to claim 32, wherein the at least a portion of the end insulating elements has a Shore D hardness of 10.

34. The apparatus according to claim 27,

wherein the one or more electrodes comprise at least a first electrode and a second electrode,

wherein the apparatus further comprises an internal insulating element fixed to the housing longitudinally between the first and second electrodes, such that the internal insulating element extends toward the longitudinal central axis, and defines a closest internal insulating element distance between the internal insulating element and the longitudinal central axis, and

wherein the closest internal insulating element distance is less than 1.5 times the closest end insulating element distance.

35. The apparatus according to claim 34, wherein the closest internal insulating element distance is equal to the closest end insulating element distance.

36. The apparatus according to claim 27,

wherein, of all of the electrodes, a first one of the electrodes is longitudinally closest to the first end insulating element, and the first electrode is further from the longitudinal central axis than the first end insulating element is from the axis, and

wherein, of all of the electrodes, a second one of the electrodes is longitudinally closest to the second end insulating element, and the second electrode is further from the axis than the second end insulating element is from the axis.

37. The apparatus according to claim 27, wherein the first and second end insulating elements are positioned at the same distance from the longitudinal central axis.