Headset for treatment and assessment of medical conditions

• US 9,433,774 B2
• Filed: 09/10/2015
• Issued: 09/06/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Neurolief Ltd.
• Original Assignee: Neurolief Ltd.
• Inventors: Bar-Or, Jonathan, Belson, Ron, Dar, Amit, Cohen, Amir
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/849,868
• Publication Number:
  US 20150374971A1
• Time in Patent Office: 362 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0488 Details about the lead
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/3603 Control systems

Abstract

A circumferential headset for use in delivering electrical stimulation to the skin surface of the head.

Claims

1. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

said elastic arrangement adapted to be tensioned along said circumference;

(b) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad, and having;

(i) a housing including a floor, and a flexible circumferential member surrounding said floor, and having a flexible circumferential wall extending generally above a perimeter of said floor, said wall ending in a circumferential rim;

said floor and said flexible circumferential member forming a cavity adapted to receive an electrically conductive electrode pad; and

(ii) an electrically conductive material, disposed at least partially above, or within, said floor;

said conductive layer adapted to be electrically associated to an electrical circuit, by means of an electrical conductor, and, when said pad is inserted, to electrically communicate with said electrode pad;

said rim and said flexible circumferential wall adapted such that a pressure exerted against said electrode base, generally perpendicular to said rim, and towards a skin surface of a user, urges said rim against said skin surface, to substantially fluidly seal between said cavity and an ambient or external environment;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position.

2. The headset of claim 1, said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion.

3. The headset of claim 1, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

4. The headset of claim 1, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

5. The headset of claim 1, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

6. The headset of claim 5, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.

7. The headset of claim 1, said at least one electrode pad including:

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face.

8. The headset of claim 7, said liquid-absorbent layer including at least one material selected from the group consisting of a non-woven fabric, felt or sponge.

9. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

(b) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position;

said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion, said front section being a front mechanical element that is physically distinct from said circumferential headset body.

10. The headset of claim 9, said front mechanical element spanning at most 40% of a circumference of said circumferential headset body.

11. The headset of claim 9, said frame including a positioning system for angular and longitudinal positioning of said headset body, said positioning system including at least one at least semi-rigid side component, said side component having:

(i) a first, elongated element, forming a portion of said circumference, and adapted to fit above an ear of the user, to determine said longitudinal positioning, and

(ii) a second element disposed generally perpendicular to said elongated element, and adapted to fit behind said ear, to determine said angular positioning of said headset body.

12. The headset of claim 9, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

13. The headset of claim 9, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

14. The headset of claim 9, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

15. The headset of claim 14, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.

16. The headset of claim 9, said at least one electrode pad including:

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face.

17. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

(b) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position;

said circumferential headset body having a rear section adapted to fit around a rear portion of the head, at least one of said at least one electrode base being a rear electrode base disposed on said rear portion.

18. The headset of claim 17, said rear section being a rear mechanical element that is physically distinct from said circumferential headset body.

19. The headset of claim 18, said rear mechanical element spanning at most 40% of a circumference of said circumferential headset body.

20. The headset of claim 17, said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion.

21. The headset of claim 17, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

22. The headset of claim 17, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

23. The headset of claim 17, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

24. The headset of claim 23, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.

25. The headset of claim 17, said at least one electrode pad including:

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face.

26. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

(b) at least one electrode pad, said pad including;

(i) a liquid-absorbent layer having a biocompatible contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(ii) an electrode backing, attached to said liquid-absorbent layer, said backing containing at least one electrically conductive material or element, said conductive material or element being electrically connected with said liquid-absorbent layer, when said liquid-absorbent layer is filled with liquid;

(c) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position;

said biocompatible contact surface having;

(i) a long dimension (D_L) having a maximum length of 20 mm to 55 mm;

(ii) a narrow dimension (D_N) having a maximum length of 10 mm to 25 mm;

wherein a first side of a perimeter of said biocompatible contact surface has a generally concave contour having a concavity defined by first and second boundary points disposed at opposite ends of said concavity,

wherein;

A/L≧

0.5 mm

A being an area bounded by said line and said concavity;

L being a length of a line between said boundary points;

said length (L) being at least 10 mm;

wherein a line disposed between a first point on said concave contour and a second point on said perimeter, on a side opposite said concave contour, and aligned in perpendicular fashion with respect to said contour at said first point, has a length H, and wherein, over an entirety of said concave contour,

H_max/H_min≦

2.5,

H_max being a maximum value of H over said entirety; and

H_min being a minimum value of H over said entirety.

27. The headset of claim 26, said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion.

28. The headset of claim 26, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

29. The headset of claim 26, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

30. The headset of claim 26, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

31. The headset of claim 30, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.

32. The headset of claim 26, said at least one electrode pad including:

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face.

33. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

(b) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position;

said at least one electrode pad including;

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face;

said electrically conductive layer having, on said second face, a layer of electrically conductive paint, preferably disposed in a mesh pattern.

34. The headset of claim 33, said liquid-absorbent layer and said electrically conductive layer having said layer of electrically conductive paint forming an integral structure.

35. The headset of claim 33, said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion.

36. The headset of claim 33, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

37. The headset of claim 33, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

38. The headset of claim 33, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

39. The headset of claim 38, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.

40. A headset for use in delivering electrical stimulation to a skin surface of a head of a user, the headset comprising:

(a) a circumferential headset body, said body having a monolithic frame adapted to circumferentially fit around the head of the user, said body housing an electric circuit adapted to be connected to a power source;

said headset body including an elastic arrangement, disposed on at least a portion of a circumference of said headset body;

(b) at least one electrode base, mechanically and at least semi-rigidly connected to said headset body, and electrically associated with said electric circuit, said electrode base adapted to receive at least one electrode pad;

said headset body and said base adapted to orient an electrical stimulation surface of said pad towards the skin surface, during donning by the user;

said elastic arrangement adapted such that, during said donning, said elastic arrangement radially urges said electrode base towards the skin surface such that said electrode pad makes physical and electrical contact with the skin surface;

said elastic arrangement and said electrode base adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrode base, with respect to said frame, is fixed in a specific predetermined position;

said at least one electrode pad including;

(a) a liquid-absorbent layer having a biocompatible, conductive contact surface, said contact surface adapted to be juxtaposed against the skin surface;

(b) an electrically conductive layer having a broad first face juxtaposed against, or attached to, said liquid-absorbent layer, said conductive layer containing at least one electrically conductive material or element, said conductive layer adapted to transfer an electrical current from a broad second face, distal to said first face, to said liquid-absorbent layer, via said first face;

said electrically conductive layer containing a carbon foil.

41. The headset of claim 40, said carbon foil having a resistivity within a range of 1-180 ohm/square or 30-100 ohm/square.

42. The headset of claim 40, said circumferential headset body having a front section adapted to fit around a front portion of the head, said at least one of said at least one electrode base being a front electrode base disposed on said front portion.

43. The headset of claim 40, said frame including at least semi-rigid side components, bi-laterally disposed on said frame, and forming side portions of said circumference of said headset body.

44. The headset of claim 40, said frame including at least a first bi-lateral size adjustment mechanism adapted to fixedly adjust said circumference of said headset body.

45. The headset of claim 40, said headset body adapted to juxtapose a contact surface of an electrical device opposite or against the skin surface, said elastic arrangement adapted to radially urge said electrical device towards said skin surface such that a contact surface of said electrical device makes physical contact with said skin surface;

said elastic arrangement adapted such that for various degrees of tensioning of said elastic arrangement, a circumferential position of said electrical device is fixed in a particular device position.

46. The headset of claim 45, said electrical device including a sensor adapted to sense a body parameter associated with the head of the user.