Gait modulation system and method

• US 8,209,022 B2
• Filed: 11/16/2006
• Issued: 06/26/2012
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Dar, Amit, Shalev, Yossef, Bar-Or, Jonathan, Nathan, Roger
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US12/096,077
• Publication Number:
  US 20090177131A1
• Time in Patent Office: 2,049 Days
• Field of Search: 607/144
• US Class Current: 607/48
• 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. A method, comprising:

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

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

coupling the 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.

2. The method of claim 1, wherein the coupling includes removably coupling a fastener of the detachable layer to a fastener of the frame.

3. The method of claim 1, 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.

4. The method of claim 1, further comprising:

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

5. The method of claim 1, further comprising:

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

6. A method, comprising:

positioning a surface electrode against an electrode base on an inner layer, the inner layer coupled to a frame, the frame including a retention portion and a mounting portion, the retention portion configured to retain the frame about the portion of a limb, the mounting portion coupled to an electrical stimulator;

electrically coupling the surface electrode to the electrical stimulator via a connector assembly, at least a portion of the connector assembly disposed within a connector opening defined by the frame; and

disposing the frame and the inner layer about the portion of a limb such that the electrode base is disposed at a predetermined position relative to the portion of the limb, the predetermined position being adjacent a muscle such that electrical stimulation applied at the predetermined position via the surface electrode results in dorsiflexion of a foot.

7. The method of claim 6, wherein the inner layer is reversible.

8. The method of claim 6, wherein the connector assembly includes a first connection member coupled to an intermediate layer and a second connection member coupled to the inner layer.

9. The method of claim 6, wherein:

the retention portion includes a first member and a second member, an end portion of the first member spaced apart from an end portion of the second member; and

the disposing includes disposing the frame and the inner layer about the portion of the limb such that the first member and the second member exert a force about the portion of the limb.

10. The method of claim 6, wherein:

the retention portion includes a first member and a second member, an end portion of the first member spaced apart from an end portion of the second member to define an opening; and

the disposing includes disposing the frame and the inner layer about the portion of the limb by placing a the portion of the limb through the opening.

11. The method of claim 6, wherein the retention portion includes a first member and a second member, an end portion of the first member spaced apart from an end portion of the second member to define an opening, the disposing includes disposing the frame and the inner layer about the portion of the limb by placing the portion of the limb through the opening, the method further comprising

coupling a fastening strap across the opening.

12. The method of claim 11, wherein the coupling the fastening strap includes disposing a loop member of the fastening strap about a protrusion on the frame.

13. A method, comprising:

placing a portion of a limb through a frame opening defined by a first member of a frame assembly and a second member of the frame assembly, an end portion of the first member spaced apart from an end portion of the second member to define the frame opening, the frame assembly including a surface electrode coupled to an inner surface of the frame assembly such that the surface electrode is disposed at a predetermined position relative to the portion of the limb when the frame assembly is disposed about the portion of the limb, the predetermined position being adjacent a muscle such that electrical stimulation applied at the predetermined position via the surface electrode results in dorsiflexion of a foot; and

coupling a fastening strap across the opening.

14. The method of claim 13, wherein the coupling the fastening strap includes disposing a loop member of the fastening strap about a protrusion on the frame assembly.

15. The method of claim 13, wherein the coupling the fastening strap includes disposing at least a portion of the fastening strap about a stimulator coupled to the frame assembly.

16. The method of claim 13, wherein the frame assembly includes an electronic stimulator configured to produce a current to the surface electrode, the method further comprising:

electrically coupling the surface electrode to the stimulator via a connector assembly, at least a portion of the connector assembly disposed within a connector opening defined by the frame assembly.

17. The method of claim 13, wherein the the frame assembly includes a frame member and an inner layer reversibly coupled to the frame member, the surface electrode coupled to the inner layer, the frame member including the first member and the second member.