GAIT MODULATION SYSTEM AND METHOD

• US 20090177131A1
• Filed: 11/16/2006
• Published: 07/09/2009
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Nathan, Roger, Shalev, Yossef, Bar-Or, Jonathan, Dar, Amit
• Granted Patent: US 8,209,022 B2
• Time in Patent Office: Days
• US Class Current: 602/2
• CPC Class Codes: A61B 5/1038 Measuring plantar pressure during gait
• CPC Class Codes: A61B 5/6807 Footwear
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61F 5/01 Orthopaedic devices, e.g. splints, casts or braces
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance

Abstract

An electrical stimulation orthosis and method therefor, the orthosis including: (a) an at least semi-rigid frame configured to substantially envelop a limb segment, the frame having at least one first complementary mechanical fastener associated therewith; (b) a surface electrical stimulation electrode assembly associated with, and supported by, the frame, the assembly having a surface stimulation electrode for contacting at least one stimulation point on the limb segment, the surface electrode assembly having an electrode base for electrically associating, via the frame, with a stimulator unit for providing a stimulation signal to the surface electrode, the electrode base having a top face for receiving the stimulation electrode, and a bottom face having at least one second complementary mechanical fastener, the first and second fasteners adapted for reversible attachment and detachment, at a plurality of locations on the frame, thereby enabling the electrical stimulation electrode assembly to be adjustably and reversibly positioned on the frame.

Claims

1. An apparatus, comprising:

a frame configured to substantially envelop a limb segment of a body, said frame including a retaining element disposed on a first side of the frame and a plurality of elongated members disposed on a second side of the frame, the second side of the frame spaced circumferentially apart from the first side of said frame such that a first elongated member from the plurality of elongated members is opposite said retaining element, the retaining element and at least the first elongated member from the plurality of elongated members configured to be radially spring-loaded towards a center of said frame such that when the frame is disposed about the limb segment, a position of the frame relative to the limb segment is maintained; and

at least one surface electrode supported by the frame and configured to contact at least one stimulation point on a surface of the limb segment, said at least one surface electrode configured to be electrically coupled to a stimulator unit via a conductive portion of the frame, the at least one surface electrode configured to provide electrical stimulation.

2. The apparatus, of claim 1, wherein the retaining elements and the plurality of elongated members are configured to conform to a contour of said surface in a substantially independent fashion, so as to maintain intimate contact with said contour.

3. The apparatus, of claim 2, wherein the plurality of elongated members include at least three flexible elongated members extending circumferentially from the second side of the frame.

4. The apparatus, of claim 1, further comprising:

a locking mechanism configured to lock said at least one surface electrode in contact with the stimulation point on said surface of the limb segment.

5. The apparatus of claim 4, wherein said retaining elements and at least the first elongated member from the plurality of elongated members are configured to independently move in response to changes in the surface of the limb segment such that a pressure exerted by said at least one surface electrode against the stimulation point on said surface of the limb segment is substantially uniform.

6. The apparatus, of claim 1, wherein said frame is semi-rigid and includes a housing configured to receive said stimulator unit.

7. The apparatus, of claim 6, wherein said housing is contain at least a portion of the stimulator unit against the frame.

8. The apparatus, of claim 1, further comprising:

said stimulator unit, wherein said stimulator unit is configured to;

receive a signal from a sensor, the signal associated with a physical parameter relating to the limb segment, and

deliver, based on the signal received from said sensor, a stimulation signal to said surface electrode.

9. The apparatus, of claim 8, wherein said stimulator unit includes a radio frequency transceiver configured to communicate with at least one of a stimulator control unit and said sensor.

10. The apparatus, of claim 4, wherein said locking mechanism includes at least one elastic strap configured to extend circumferentially around at least a portion of the frame and between the first side of said frame and the second side of said frame, the elastic strap configured to be reversibly fastened to a fastening element associated with said frame.

11. The apparatus, of claim 1, wherein an upper portion of the frame includes a locating surface configured to conform to an inferior border of a patella of the body.

12. The apparatus, of claim 1, wherein an upper portion of said frame includes locating surface having a three-dimensional cup shape configured to matingly abut an inferior border of a patella of the body when the frame is disposed about the limb segment.

13. The apparatus, of claim 1, wherein the frame is configured to be disposed about the limb segment with a single hand.

14. The apparatus, of claim 10, wherein said fastening element includes a protuberance associated with said frame.

15. The apparatus, of claim 14, wherein said protuberance includes a housing configured to receive said stimulator unit.

16. The apparatus, of claim 10, wherein an end portion of said at least one elastic strap includes a looped handle, said looped handle configured to be reversibly fastened to said fastening element.

17. The apparatus, of claim 1, wherein

the frame includes a housing configured to receive said stimulator unit, said housing disposed on a flexible portion of said frame, said flexible portion of the frame configured to move independently of the plurality of elongated members.

18. The apparatus, of claim 1, wherein said frame includes at least one spring-loaded strip, said strip being radially spring-loaded towards the center of said frame.

19. The apparatus, of claim 1, wherein at least one of said and retaining element or an elongated member from the plurality of elongated members has a width of between about 2 cm and about −

4.5 cm.

20. The apparatus, of claim 1, wherein at least one of said retaining element or an elongated member from the plurality of elongated members has a width within a range of 8 percent of a height of the frame and −

60 percent of the height of the frame.

21. The apparatus, of claim 1, wherein said at least one surface electrode has a surface area configured to contact said surface of the limb segment, said surface area being at least 9 cm².

22. The apparatus, of claim 21, wherein said surface area is at least 12 cm².

23. The apparatus, of claim 15, wherein an end portion of said at least one elastic strap includes a looped handle, said looped handle configured to removably engage a portion of the protuberance of said fastening element, said stimulator unit, said housing, and said looped handle collectively forming a profile of a leg of the body when the looped handle is fastened to the fastening element.

24. The apparatus, of claim 1, wherein said stimulator unit is a neuroprosthetic stimulator unit.

25. An apparatus, comprising:

a frame configured to substantially envelop a limb segment of a body;

an inner member configured to at least partially cover an inner surface of said frame, the inner member constructed from a soft material;

a first connector associated with at least one of said inner surface of said frame and the inner member; and

a stimulation electrode assembly having a stimulation electrode and an attachment mechanism, the stimulation electrode configured to be electrically coupled via the frame to a simulator unit, the stimulation electrode having a surface configured to contact at least one stimulation point on the limb segment, the attachment mechanism configured to maintain a position of said stimulation electrode with respect to said frame,

said attachment mechanism having a second connector, complementary to said first connector, the first connector and the second connector configured to reversibly attach said stimulation electrode assembly to at least one of the frame and the inner member.

26. The apparatus of claim 25, wherein said first connector and second connector are selected from the group consisting of snaps and hook and loop fasteners.

27. The apparatus of claim 25, wherein:

the first surface of the stimulation electrode is a first surface; and

said attachment mechanism includes an electrode base having a surface configured to engage a second surface of said stimulation electrode, said second surface being opposite said first surface.

28. The apparatus of claim 27, wherein said electrode base has a rim defining an opening configured to receive said stimulation electrode and maintain a position of the stimulation electrode relative to the electrode base.

29. The apparatus of claim 27, wherein said second surface of said stimulation electrode includes a hydrogel-containing surface, and said surface of said electrode base includes at least one patch of hook fasteners configured to couple said hydrogel-containing surface to said electrode base.

30. The apparatus of claim 25, wherein said soft inner member is configured to be reversibly attached to the frame.

31. The apparatus of claim 25, further comprising:

a detachable member configured to cover at least a portion of said inner member, said soft panel having a third connector complementary to a fourth connector, the fourth connector associated with at least one of said frame and said inner member, the third connector and the fourth connector configured to reversibly couple said detachable member to at least one of said frame and said inner member.

33. The apparatus of claim 27, wherein said attachment mechanism has a cover attached to said electrode base, a perimeter of said stimulation electrode configured to be disposed between the cover and a portion of the electrode base.

34. The apparatus of claim 33, wherein said cover defines an opening such that a central portion said first surface of the stimulation electrode is exposed when the perimeter of the stimulation electrode is disposed between the cover and the portion of the electrode base.

35. The apparatus of claim 33, wherein said perimeter includes hydrogel.

32. (canceled)

36. (canceled)

37. An apparatus, comprising:

a frame configured to substantially envelop a limb segment of a body, said frame having a first mechanical fastener;

a stimulation electrode assembly having a surface stimulation electrode and an electrode base, the surface stimulation electrode configured to contact at least one stimulation point on the limb segment,

said electrode base configured to be electrically coupled, via said frame, to a stimulator unit, the stimulator unit configured to provide a stimulation signal to said surface electrode, said electrode base having a top face and a bottom face, the top face configured to engage said stimulation electrode, said bottom face having a second mechanical fastener, said second fastener being complementary to said first fastener, said first fastener and said second fasteners configured to reversibly couple the stimulation electrode assembly to the frame at a plurality of locations on said frame.

38. The apparatus of claim 37, wherein said surface electrode assembly includes a conductive element configured to electrically couple said electrode base to said stimulator unit.

39. The apparatus of claim 38, wherein:

said conductive element is a first conductive mechanical fastener; and

said frame includes a second conductive mechanical fastener, said first conductive fastener being complementary to said second conductive fastener.

40. The apparatus of claim 38, wherein said electrode base is movably coupled to said first conductive fastener by a flexible wire.

42. The apparatus of claim 37, wherein said first and second fasteners include hook and loop fasteners.

41. (canceled)

43. (canceled)

44. An apparatus, comprising:

a frame configured to substantially envelop a limb segment of a body, said frame having a first fastener at an inner face of said frame;

a detachable layer having a second fastener complementary to said first fastener, the first fastener and the second fastener configured to collectively removably couple the detachable layer to the inner face of said frame, the detachable layer constructed from a soft material; and

at least one electrical stimulation electrode assembly coupled to said detachable layer such that, when the frame is disposed about the limb segment, an electrical stimulation electrode of said electrical stimulation electrode assembly is in contact with at least one stimulation point of a muscle of said user, the electrical stimulation electrode configured to be electrically coupled to a stimulator unit via the frame.

45. The apparatus of claim 44, wherein said first fastener and said second fastener include a hook and loop arrangement.

47. The apparatus of claim 44, wherein:

said second fastener includes a snap connector; and

the first fastener includes a recess defined by said frame, the snap connector and the recess collectively configured to form an interference fit.

48. The apparatus of claim 44, wherein said detachable layer defines an opening configured to receive an electrical conductor through which the electrical stimulation electrode is electrically coupled to the stimulator unit.

49. The apparatus of claim 48, wherein said electrical stimulation electrode assembly includes a connector having a portion configured to be disposed within said hole, the portion of the connector configured to be electrically coupled to a complementary connector associated with said frame.

46. (canceled)

50-62. -62. (canceled)

63. An apparatus, comprising:

a surface electrode having;

a hydrogel layer having a first face and a second face, said second face substantially opposite said first face;

an underlying surface layer, having at least a portion in contact with said first face of said hydrogel layer; and

a support layer, a first portion of the support layer disposed along said second face of the hydrogel layer, a second portion of said support layer attached to said underlying surface layer, the support layer configured to reinforce at least a portion of said hydrogel layer.

64. The apparatus of claim 63, wherein said support layer is configured to reinforce a perimeter of said hydrogel layer.

65. The apparatus of claim 63, wherein said underlying surface layer includes at least a first layer disposed directly against said hydrogel layer, and a second layer disposed against said first layer, said second layer is attached to said supporting surface layer.

66. The apparatus of claim 63, wherein at least one of said support layer and the underlying surface layer includes polypropylene.

68. The apparatus of claim 65, wherein said second layer includes hook or loop fasteners.

69. The apparatus of claim 63, wherein said supporting surface layer and said underlying surface layer are coupled together via any one of said hydrogel, a glue, a weld, or an ultrasonic weld.

74. The apparatus of claim 63, wherein at least one of said support layer and the underlying surface layer includes a non-woven material.

75. The apparatus of claim 63, wherein said support layer and said underlying surface layer are coupled together along at least a portion of a perimeter of said hydrogel layer.

76. The apparatus of claim 63, wherein said support layer is substantially ring-shaped.

67. (canceled)

70-73. -73. (canceled)

77. An apparatus, comprising:

a sensor unit having an external casing, said sensor unit configured to be disposed within a shoe of a user, said sensor unit configured to produce a change in a signal in response to a gait event;

an electronic communication unit, electrically coupled to said sensor unit, the electronic communication unit configured to receive the signal, said electronic unit having;

a microcontroller;

a transmitting unit configured to wirelessly transmit gait information based on said signal, to a unit of an orthosis external to the electronic communication unit; and

a housing configured to contain at least one of said microcontroller and said transmitting unit; and

a fastening unit configured to couple the electronic communication unit to said shoe, such that said electronic communication unit in a substantially fixed position relative to the shoe during gait of said user.

78. The apparatus of claim 77, wherein said fastening unit includes a clamp unit.

80. The apparatus of claim 78, wherein said clamp unit has at least two arms configured to cooperatively couple the fastening unit to a rim of said shoe.

81. The apparatus of claim 80, wherein said clamp unit is at least semi-rigidly associated with said housing.

82. The apparatus of claim 80, wherein said clamp unit is rigidly coupled to said housing.

83. The apparatus of claim 77, wherein said housing of said electronic unit and said casing of said sensor unit are substantially mechanically independent.

84. The apparatus of claim 80, wherein said clamp unit includes a locking lever adapted for locking said arms in position around said rim of said shoe.

85. The apparatus of claim 77, wherein a surface of said housing of the electronic communication unit is concave.

86. The apparatus of claim 80, wherein said housing and said clamp unit are attached to such that a surface of the housing and a surface of the clamp unit form an angle within a range of about 150°

to about 175°

.

87. The apparatus of claim 86, wherein said angle is in a range of about 155°

to about 175°

.

88. The apparatus of claim 86, wherein said angle is in a range of about 160°

to about 175°

.

89. The apparatus of claim 86, wherein said angle is in a range of about 160°

to about 170°

.

90. The apparatus of claim 77, wherein said transmitting unit is a transceiving unit.

92. The apparatus of claim 77, further comprising:

the shoe, said sensor unit being disposed under an inner sole of said shoe.

93. The apparatus of claim 77, wherein said fastening unit includes a clamp unit adapted to enable a hemiplegic patient to affix said clamp unit to said shoe, using a single hand.

79. (canceled)

91. (canceled)

94-110. -110. (canceled)

111. A method, comprising:

electronically coupling a stimulation electrode assembly to an inner face of a frame;

coupling a detachable layer to the inner face of the frame, the detachable layer constructed from a soft material; and

disposing the frame about a limb segment of a body such that the detachable layer is in contact with a portion of the limb segment, and an electrical stimulation electrode of the stimulation electrode assembly is in contact with at least one stimulation point on a surface of the body associated with a muscle.

112. The method of claim 111, wherein the electronically coupling includes:

disposing a connector of the stimulation electrode assembly through an opening defined by the detachable layer; and

reversibly coupling the connector of the stimulation electrode assembly to a connector disposed on the inner face of the frame.

113. The method of claim 111, wherein the coupling includes removably coupling a fastener of the detachable layer to a fastener of the frame.

114. The method of claim 111, wherein the coupling includes removably coupling a hook and loop fastener of the detachable layer to a corresponding hook and loop fastener of the frame.

115. The method of claim 111, further comprising:

adjusting a position of the electrical stimulation electrode relative to an inner surface of the detachable layer after the coupling.

116. The method of claim 111, further comprising:

removing the detachable layer from the inner face of the frame after the disposing.

117. A method, comprising:

disposing a sensor unit within a shoe, the sensor unit configured to produce a change in a signal in response to a gait event; and

coupling an electronic communication unit to a rim of the shoe, the electronic communication unit electrically coupled to the sensor unit, the electronic communications unit configured to transmit information based on the signal to an external device.

118. The method of claim 117, wherein the disposing includes disposing the sensor unit under an inner sole of the shoe.

119. The method of claim 117, wherein the disposing includes removably disposing the sensor unit within the shoe.

120. The method of claim 117, wherein the coupling includes:

disposing a first arm of a clamp of the electronic communication unit on a first side of the rim of the shoe; and

disposing a second arm of a clamp of the electronic communication unit on a second side of the rim of the shoe.

121. The method of claim 117, wherein the coupling includes lockably coupling a clamp of the electronic communication unit to the rim of the shoe.

122. The method of claim 117, wherein the coupling includes coupling the electronic communication unit to the rim of the shoe such that a surface of the electronic communications unit and a surface of a clamp of the electronic communications unit form an angle within a range of about 150°

to about 175°

.

123. A method, comprising:

electronically coupling a personal digital assistant to a stimulation electrode assembly of an orthosis, the stimulation electrode assembly configured to provide electronic stimulation to at least one stimulation point associated with a muscle of said user; and

monitoring at least one operating parameter of the stimulation electrode assembly via the personal digital assistant.

124. The method of claim 123, wherein:

the electronically coupling includes wirelessly coupling the personal digital assistant to the stimulation electrode assembly via a control unit associated with the stimulation electrode assembly.

125. The method of claim 123, wherein:

the electronically coupling includes wirelessly coupling the personal digital assistant to the stimulation electrode assembly via a docking station configured to receive the personal digital assistant and a control unit associated with the stimulation electrode assembly.

126. The method of claim 123, wherein:

The at least one operating parameter includes any one of an operating mode of the stimulation electrode assembly, an intensity of an electronic stimulation produced by the stimulation electrode assembly, a synchronization of the electronic stimulation produced by the stimulation electrode assembly or a history of the operation of the stimulation electrode assembly.

127. The method of claim 123, further comprising:

selecting an operating mode of the stimulation electrode assembly via the personal digital assistant.

128. The method of claim 123, further comprising:

adjusting an intensity of an electronic stimulation produced by the stimulation electrode assembly via the personal digital assistant.

129. The method of claim 123, further comprising:

producing an audible sound associated with the use of the stimulation electrode assembly via the personal digital assistant.