Gait modulation system and method

• US 10,076,656 B2
• Filed: 03/03/2015
• Issued: 09/18/2018
• 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:
  US14/636,628
• Publication Number:
  US 20150273205A1
• Time in Patent Office: 1,295 Days
• 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: A61H 3/00 Appliances for aiding patients or disabled persons to walk about apparatus for helping babies to walk A47D13/04; orthopaedic devices for correcting deformities of, or supporting, limbs A61F5/0102; exercising apparatus for the feet or toes A63B23/10; stairways or ramps E04F11/00
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: G01L 1/20 by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids of piezo-resistive materials G01L1/18; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
• CPC Class Codes: H01H 3/14 adapted for operation by a part of the human body other than the hand, e.g. by foot
• CPC Class Codes: H03K 17/9625 using a force resistance transducer

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:

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 a portion of a limb, the retention portion including a first member and a second member, an end portion of the first member being spaced apart from an end portion of the second member to define an opening, the mounting portion disposed on an external surface of the frame, the mounting portion removably coupled to an electrical stimulator such that the electrical stimulator is supported by the frame, the electrical stimulator being removable from the mounting portion when the frame is retained about the portion of the limb;

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;

disposing the frame and the inner layer about the portion of the limb by placing the portion of the limb through the opening; and

coupling a fastening strap across the opening, the fastening strap coupled to and being detachable from the frame.

2. The method of claim 1, wherein the inner layer is reversibly attached to the frame.

3. The method of claim 1, wherein the connector assembly includes a first connection member coupled to an intermediate layer and a second connection member coupled to the inner layer.

4. The method of claim 1, wherein the frame and the inner layer are disposed about the portion of the limb such that the electrode base is disposed at a predetermined position relative to the portion of the limb.

5. The method of claim 4, wherein the predetermined position is adjacent at least one of a nerve or a muscle when the frame is disposed about the portion of the limb such that electrical stimulation transmitted via the surface electrode results in dorsiflexion of a foot.

6. The method of claim 1, wherein the first member of the retention portion and the second member of the retention portion are each inwardly biased such that the first member of the retention portion and the second member of the retention portion exert a force about the portion of the limb when the frame and the inner layer are disposed about the portion of the limb and before the fastening strap is coupled across the opening.

7. The method of claim 1, wherein an end portion of the fastening strap defines an opening configured to be disposed about a protrusion extending outwardly from an outer surface of the frame.

8. The method of claim 1, wherein, before the disposing, a first end of the fastening strap is coupled to the frame, and, after the coupling the fastening strap across the opening, a second end of the fastening strap is removably coupled to a fastening element of the frame.

9. The method of claim 1, further comprising:

adjusting a length of the fastening strap.

10. The method of claim 1, further comprising:

coupling the electrical stimulator to the mounting portion of the frame such that at least a portion of the electrical stimulator is removably received within a cradle of the mounting portion.

11. The method of claim 1, wherein the electrical stimulator is removable from the mounting portion of the frame when the frame and the inner layer are disposed about the portion of the limb.

12. 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; and

coupling a fastening strap across the frame opening, the fastening strap having a first end portion and a second end portion, the first end portion of the fastening strap being coupled to the frame assembly, the second end portion of the fastening strap defining an opening defined in part by an outer surface of the fastening strap and defined in part by an inner surface of the fastening strap such that the opening is extended between the outer surface of the fastening strap and the inner surface of the fastening strap, the opening of the fastening strap being disposed about a protrusion extended from an outer surface of the frame assembly when the fastening strap is coupled across the frame opening such that the protrusion is extended through the opening of the fastening strap.

13. The method of claim 12, further comprising:

adjusting a length of the fastening strap.

14. The method of claim 12, wherein at least a portion of the stimulator is disposed within the opening of the fastening strap when the fastening strap is coupled across the frame opening.

15. The method of claim 12, wherein the frame assembly includes an electrical 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.

16. The method of claim 12, wherein the predetermined position is adjacent at least one of a nerve or a muscle when the frame assembly is disposed about the portion of the limb such that electrical stimulation transmitted via the surface electrode results in dorsiflexion of a foot.

17. The method of claim 12, wherein the predetermined position overlies a peroneal nerve.

18. The method of claim 12, wherein at least a portion of the first end portion of the fastening strap is disposed within a slot defined by the frame assembly.

19. The method of claim 12, wherein at least a portion of the fastening strap between the first end portion of the fastening strap and the second end portion of the fastening strap is elastic.

20. The method of claim 12, wherein the second end portion of the fastening strap includes a handle defining the opening, the handle is constructed of an elastomeric material.

21. The method of claim 12, wherein the protrusion of the frame assembly includes at least one of (1) a cradle configured to receive at least a portion of an electrical stimulator such that the at least the portion of the electrical stimulator is disposed within the cradle or (2) the electrical stimulator coupled to the frame assembly.

22. 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, the first member of the frame assembly and the second member of the frame assembly each being radially spring-loaded towards a center 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 frame assembly including a mounting portion configured to be coupled to an electrical stimulator such that the electrical stimulator is supported by the frame assembly; and

coupling a fastening strap across the opening.

23. The method of claim 22, wherein the first member of the frame assembly and the second member of the frame assembly, in combination, are configured to retain the frame assembly on the portion of the limb before the fastening strap is coupled across the opening.