ELECTRODE CUFF WITH RECESSES

• US 20120130463A1
• Filed: 11/22/2010
• Published: 05/24/2012
• Est. Priority Date: 11/22/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Ben-David, Tamir, Cohen, Ehud, Ayal, Shai, Gavish, Noam
• Granted Patent: US 8,565,896 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

An electrode assembly includes one or more electrode contact surfaces, and a cuff, to which the contact surfaces are fixed, and which comprises an electrically insulating material, is configured to assume open and closed positions, and, when in the closed position, is shaped so as to define a plurality of planar cross sections perpendicular to a longitudinal axis of the cuff, distributed continuously along an entire length of the cuff along the longitudinal axis, such that the perpendicular cross sections define respective inner closed curves that together define an inner surface that defines and completely surrounds a volume that extends along the entire length of the cuff. The inner closed curves of at least two of the perpendicular cross sections would cross, and not merely intersect, one another if superimposed while preserving orientation and position of the perpendicular cross sections with respect to the cuff. Other embodiments are also described.

Claims

1. Apparatus comprising an electrode assembly, which comprises:

one or more electrode contact surfaces; and

a cuff, to which the electrode contact surfaces are fixed, and which;

(a) comprises an electrically insulating material, (b) has a longitudinal axis, (c) is configured to assume open and closed positions, and (d) when in the closed position, is shaped so as to define;

(i) a plurality of planar cross sections perpendicular to the longitudinal axis, distributed continuously along an entire length of the cuff along the longitudinal axis, such that the perpendicular cross sections define respective inner closed curves surrounding the longitudinal axis, which inner closed curves define and enclose respective inner cross-sectional regions,

wherein an intersection of the cross-sectional regions, if the cross-sectional regions were to be superimposed while preserving orientation and position of the cross-sectional regions with respect to the cuff, would define a combined inner cross-sectional region, which, if extended along the entire length of the cuff, would define a combined innermost volume, and

(ii) a plurality of recesses that are recessed radially outwardly from the combined innermost volume, each of which recesses extends along the longitudinal axis of the cuff and has a greatest length, measured in parallel with the longitudinal axis, that is less than 50% of the entire length of the cuff,

wherein the inner closed curves enclose respective areas, each of which areas is greater than an area of the combined inner cross-sectional region.

2. The apparatus according to claim 1, wherein the entire length of the cuff is between 1 and 40 mm.

4. The apparatus according to claim 1, wherein the cuff is shaped such that the combined inner cross-sectional region is circular.

5. The apparatus according to claim 1, wherein a periphery of the combined inner cross-sectional region defines a combined innermost closed curve, and wherein each of the inner closed curves coincides with the combined innermost closed curve at a portion of, but not all, angles with respect to the longitudinal axis.

6. The apparatus according to claim 1, wherein first and second ones of the recesses overlap each other lengthwise along the cuff, and do not overlap each other anglewise with respect to the longitudinal axis.

8. The apparatus according to claim 1, wherein at least a first one of the inner closed curves extends radially outwardly from the combined innermost volume in a first radial direction, and wherein at least a second one of the inner closed curves, different from the first inner closed curve, extends radially outwardly from the combined innermost volume in a second radial direction different from the first radial direction.

11. The apparatus according to claim 1, wherein the cuff is configured to assume the open and closed positions by defining a slit therethrough that extends along the entire length of the cuff.

14. The apparatus according to claim 1,

wherein 13 sets of pluralities of the perpendicular cross sections define 13 segments of the cuff, respectively, such that the perpendicular cross sections are contiguous within each of the sets, and the sets are arranged in numerical order from a first set to a thirteenth set along the cuff, such that none of the segments overlap one other lengthwise along the cuff,

wherein the 13 segments have respective first through thirteenth lengths, measured in parallel with the longitudinal axis, each of which is at least 0.1 mm,

wherein the inner closed curves of the first, fifth, ninth, and thirteenth segments have the same shape as one another, while preserving orientation and position of the inner closed curves with respect to the cuff,

wherein the inner closed curves of the second, fourth, sixth, tenth, and twelfth segments have the same shape as one another, while preserving orientation and position of the inner closed curves with respect to the cuff,

wherein the inner closed curves of the third, seventh, and eleventh segments have the same shape as one another, while preserving orientation and position of the inner closed curves with respect to the cuff,

wherein the inner closed curve of the eighth segment has a shape that is different from the shapes of the inner closed curves of the other segments, while preserving orientation and position of the inner closed curves with respect to the cuff,

wherein respective ones of the electrode contact surfaces are fixed within the recesses defined by the second, fourth, sixth, tenth, and twelfth segments, and

wherein none of the electrode contact surfaces is fixed within the recesses defined by the first, third, fifth, seventh, eighth, ninth, eleventh, and thirteenth segments.

15. The apparatus according to claim 14, wherein the first, fifth, ninth, and thirteenth segments define respective ones of the recesses that extend generally in a first radial direction, and wherein the third, seventh, and eleventh segments define respective ones of the recesses that extend generally in a second radial direction different from the first radial direction.

16. The apparatus according to claim 14, wherein the first through thirteenth lengths are 0.8 mm, 0.7 mm, 0.8 mm, 0.7 mm, 1.6 mm, 1.1 mm, 0.8 mm, 1.4 mm, 0.8 mm, 0.7 mm, 1.2 mm, 0.7 mm, and 0.8 mm, respectively.

17. The apparatus according to claim 1,

wherein 13 sets of pluralities of the perpendicular cross sections define 13 segments of the cuff, respectively, such that the perpendicular cross sections are contiguous within each of the sets, and the sets are arranged in numerical order from a first set to a thirteenth set along the cuff, such that none of the segments overlap one other lengthwise along the cuff,

wherein the 13 segments have respective first through thirteenth lengths, measured in parallel with the longitudinal axis, each of which is at least 0.1 mm,

wherein respective ones of the electrode contact surfaces are fixed within the recesses defined of the second, fourth, sixth, tenth, and twelfth segments,

wherein none of the electrode contact surfaces is fixed within the recesses defined by the first, third, fifth, seventh, eighth, ninth, eleventh, and thirteenth segments,

wherein the apparatus further comprises a control unit, which configures the electrode contact surface fixed in the recess of the fourth segment to function as an anode, and the electrode contact surfaces fixed within the recesses of the sixth and tenth segments to function as cathodes, and

wherein the electrode contact surfaces fixed within the recesses of the second and twelfth segments are electrically device-coupled to each other, and are electrically device-coupled to neither the control unit nor an energy source.

18. The apparatus according to claim 1,

wherein 13 sets of pluralities of the perpendicular cross sections define 13 segments of the cuff, respectively, such that the perpendicular cross sections are contiguous within each of the sets, and the sets are arranged in numerical order from a first set to a thirteenth set along the cuff, such that none of the segments overlap one other lengthwise along the cuff,

wherein the 13 segments have respective first through thirteenth lengths, measured in parallel with the longitudinal axis, each of which is at least 0.1 mm,

wherein respective ones of the electrode contact surfaces are fixed within the recesses defined of the second, fourth, sixth, tenth, and twelfth segments,

wherein none of the electrode contact surfaces is fixed within the recesses defined by the first, third, fifth, seventh, eighth, ninth, eleventh, and thirteenth segments,

wherein the apparatus further comprises a control unit, which configures the electrode contact surface fixed in the recess of the fourth segment to function as an cathode, and the electrode contact surfaces fixed within the recesses of the sixth and tenth segments to function as anodes, and

wherein the electrode contact surfaces fixed within the recesses of the second and twelfth segments are electrically device-coupled to each other, and are electrically device-coupled to neither the control unit nor an energy source.

3. (canceled)

7. (canceled)

9-10. -10. (canceled)

12-13. -13. (canceled)

19. Apparatus placeable around tubular body tissue, the apparatus comprising an electrode assembly, which comprises:

one or more electrode contact surfaces; and

a cuff, to which the electrode contact surfaces are fixed, and which;

(a) comprises an electrically insulating material, (b) has a longitudinal axis, (c) is configured to assume open and closed positions, and (d) when in the closed position, is shaped so as to define a plurality of recesses that are recessed radially outwardly from the tubular body tissue if the cuff is placed therearound, such that the cuff is recessed at every longitudinal location along an entire length of the cuff along the longitudinal axis, and each of the recesses extends along the longitudinal axis of the cuff and has a greatest length, measured in parallel with the longitudinal axis, that is less than 50% of the entire length of the cuff.

20. The apparatus according to claim 19, wherein the entire length of the cuff is between 1 and 40 mm.

21. The apparatus according to claim 19, wherein the cuff is shaped so as to come in contact with the tubular body tissue at a portion of, but not all, angles with respect to the longitudinal axis, at every longitudinal location along the entire length of the cuff, if the cuff is placed around the tubular body tissue in the closed position.

22. The apparatus according to claim 19, wherein the tubular body tissue is a nerve, and wherein the cuff is configured to be applied to the nerve.

23. The apparatus according to claim 19, wherein at least one of the electrode contact surfaces is fixed within one of the recesses.

24. Apparatus placeable around an elliptical cylinder having a major axis that is between 1 and 8 mm and a minor axis that is between 0.5 and 6 mm, the apparatus comprising an electrode assembly, which comprises:

one or more electrode contact surfaces; and

a cuff, to which the electrode contact surfaces are fixed, and which;

(a) comprises an electrically insulating material, (b) has a longitudinal axis, (c) is configured to assume open and closed positions, and (d) when in the closed position, is shaped so as to define a plurality of recesses that are recessed radially outwardly from the cylinder if the cuff is placed therearound, such that the cuff is recessed at every longitudinal location along an entire length of the cuff along the longitudinal axis, and each of the recesses extends along the longitudinal axis of the cuff and has a greatest length, measured in parallel with the longitudinal axis, that is less than 50% of the entire length of the cuff.

26. The apparatus according to claim 24, wherein the cuff is shaped so as to come in contact with the cylinder at a portion of, but not all, angles with respect to the longitudinal axis, at every longitudinal location along the entire length of the cuff, if the cuff is placed around the cylinder in the closed position.

27. The apparatus according to claim 24, wherein at least one of the electrode contact surfaces is fixed within one of the recesses.

25. (canceled)

28-89. -89. (canceled)

90. A method comprising:

providing an electrode assembly that includes (1) one or more electrode contact surfaces, and (2) a cuff, to which the electrode contact surfaces are fixed, and which;

(a) includes an electrically insulating material, (b) has a longitudinal axis, and (c) is configured to assume open and closed positions, and (d) when in the closed position, is shaped so as to define a plurality of recesses that are recessed radially outwardly from the tubular body tissue, such that the cuff is recessed at every longitudinal location along an entire length of the cuff along the longitudinal axis, and each of the recesses extends along the longitudinal axis of the cuff and has a greatest length, measured in parallel with the longitudinal axis, that is less than 50% of the entire length of the cuff;

while the cuff is in the open position, placing the electrode assembly around tubular body tissue of a subject; and

coupling the cuff to the tubular body tissue by causing the cuff to assume the closed position.

91. The method according to claim 90, wherein placing comprising placing the cuff around a nerve of the subject.

92. The method according to claim 90, wherein coupling comprises coupling the cuff to the tubular body tissue such that the cuff comes in contact with the tubular body tissue at a portion of, but not all, angles with respect to the longitudinal axis, at every longitudinal location along the entire length of the cuff.

93. The method according to claim 90, wherein providing comprises providing the electrode assembly in which first and second ones of the recesses overlap each other lengthwise along the cuff, and do not overlap each other anglewise with respect to the longitudinal axis.

94. The method according to claim 90, wherein providing comprises providing the electrode assembly in which at least a first one of the inner closed curves extends radially outwardly from the combined innermost volume in a first radial direction, and at least a second one of the inner closed curves, different from the first inner closed curve, extends radially outwardly from the combined innermost volume in a second radial direction different from the first radial direction.

95. The method according to claim 90, wherein placing comprises placing the electrode assembly around the nerve such that the electrode contacts surfaces are not in physical contact with the nerve.

96-104. -104. (canceled)