Orthosis for gait modulation

• US 8,694,110 B2
• Filed: 06/25/2012
• Issued: 04/08/2014
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Nathan, Roger H., Dar, Amit, Bar-Or, Jonathan
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/532,597
• Publication Number:
  US 20120330375A1
• Time in Patent Office: 652 Days
• Field of Search: 607/144, 607/48
• US Class Current: 607/48
• 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 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A functional electrical stimulation (FES) orthosis, including: a frame, an inner layer coupled to an inner surface of the frame, an electrode base, and a connector assembly. The frame is configured to substantially envelop a limb, and includes a retention portion configured to retain the frame about the limb, and a mounting portion configured to be coupled to an electrical stimulator. The electrode base is coupled to the inner layer, and is configured to couple a surface electrode to the inner layer. The frame and the inner layer are configured such that the electrode base is disposed at a predetermined position relative to the limb. The connector assembly is configured to electrically couple the stimulator to the electrode base. At least a portion of the connector assembly is disposed within a connector opening defined by the frame.

Claims

1. An apparatus, comprising:

a first orthosis layer configured to substantially envelop a portion of a limb, the first orthosis layer including a retention portion and a mounting portion, the retention portion configured to retain the first orthosis layer about the portion of the limb, the mounting portion configured to be coupled to an electrical stimulator;

a second orthosis layer coupled to an inner surface of the first orthosis layer, the second orthosis layer configured to be coupled to a surface electrode, the first orthosis layer and the second orthosis layer collectively configured such that the surface electrode is disposed at a predetermined position overlying a peroneal nerve of the limb when the first orthosis layer and the second orthosis layer are disposed about the portion of the limb; and

a connector assembly configured to electrically couple the electrical stimulator to the surface electrode, at least a portion of the connector assembly configured to be disposed within a connector opening defined by at least one of the first orthosis layer or the second orthosis layer.

2. The apparatus of claim 1, wherein:

the first orthosis layer includes a locator configured to identify at least one of a longitudinal position or a rotational position of the first orthosis layer relative to the portion of a limb.

3. The apparatus of claim 1, wherein the predetermined position is adjacent the peroneal nerve when the first orthosis layer is disposed about the portion of the limb such that electrical stimulation transmitted to the predetermined position via the surface electrode results in dorsiflexion of a foot.

4. The apparatus of claim 1, 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, the first member and the second member configured to exert a force about the portion of the limb when the first orthosis layer is disposed about the portion of the limb.

5. The apparatus of claim 1, wherein the retention portion is constructed from a semi-rigid material, the retention portion configured to partially surround the portion of the limb.

6. The apparatus of claim 1, 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 through which the portion of the limb is disposed when the first orthosis layer is being donned, the retention portion including a fastening strap configured to be coupled across the opening after the first orthosis layer is disposed about the portion of the limb.

7. The apparatus of claim 1, further comprising:

a fastening strap configured to removably couple the first orthosis layer to the portion of the limb, a first portion of the fastening strap fixedly coupled to the first orthosis layer, a second portion of the fastening strap configured to be disposed about the electrical stimulator.

8. The apparatus of claim 1, wherein the second orthosis layer includes an electrode base having a hook and loop fastener to reversibly couple the surface electrode to the second orthosis layer.

9. The apparatus of claim 1, wherein the mounting portion includes a connector configured to be matingly coupled to a complementary connector of the electrical stimulator to couple the mounting portion to the electrical stimulator.

10. The apparatus of claim 1, wherein the mounting portion includes a cradle defining a recess configured to receive the electrical stimulator to couple the mounting portion to the electrical stimulator.

11. An apparatus, comprising:

a frame assembly configured to substantially envelop a portion of a limb, the frame assembly including a retention portion and a cradle, the retention portion configured to retain the frame assembly about the portion of the limb, the cradle defining a recess configured to receive an electrical stimulator to couple the electrical stimulator to the frame assembly;

an electrode base coupled to an inner surface of the frame assembly, the electrode base configured to couple a surface electrode to the inner surface, the frame assembly configured such that the electrode base 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;

a connector assembly configured to electrically couple the stimulator to the electrode base, at least a portion of the connector assembly disposed within a connector opening defined by the frame assembly; and

a fastening strap configured to removably couple the frame assembly to the portion of the limb, a first portion of the fastening strap fixedly coupled to the frame assembly, a second portion of the fastening strap configured to be coupled to an outer surface of the cradle when the frame assembly is coupled to the portion of the limb.

12. The apparatus of claim 11, wherein the fastening strap includes a loop member configured to be coupled to the frame assembly.

13. The apparatus of claim 11, 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 to the predetermined position via the surface electrode results in dorsiflexion of a foot.

14. The apparatus of claim 11, wherein the predetermined position overlies a peroneal nerve.

15. The apparatus of claim 11, 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, the first member and the second member configured to exert a force about the portion of the limb when the frame is disposed about the portion of the limb.

16. The apparatus of claim 11, wherein the cradle defines a notch, a portion of the electrical stimulator being accessible via the notch when the electrical stimulator is disposed within the recess.

17. An apparatus, comprising:

a frame assembly configured to substantially envelop a portion of a limb, the frame assembly including a retention portion and a mounting portion, the retention portion including 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 through which the portion of the limb is disposed when the frame assembly is being donned, the mounting portion configured to be coupled to an electrical stimulator;

an electrode base coupled to an inner surface of the frame assembly, the electrode base configured to couple a surface electrode to the inner surface, the frame assembly configured such that the electrode base is disposed at a predetermined position overlying a peroneal nerve when the frame assembly is disposed about the portion of the limb;

a connector assembly configured to electrically couple the stimulator to the electrode base, at least a portion of the connector assembly disposed within a connector opening defined by the frame assembly; and

a fastening strap configured to be coupled across the opening to secure the frame assembly to the portion of the limb, the first member and the second member collectively configured to substantially retain the frame assembly about the portion of the limb before the fastening strap is coupled across the opening.

18. The apparatus of claim 17, wherein a first portion of the fastening strap is fixedly coupled to the frame assembly and a second portion of the fastening strap is configured to be disposed about the electrical stimulator.

19. The apparatus of claim 17, wherein the frame assembly includes a semi-rigid outer member and an inner layer coupled to an inner surface of the outer member, the electrode base coupled to an inner surface of the inner layer.

20. The apparatus of claim 17, wherein the mounting portion includes a cradle defining a recess configured to receive the electrical stimulator to couple the mounting portion to the electrical stimulator.

21. The apparatus of claim 17, wherein the mounting portion includes a cradle defining a recess and a notch, the recess configured to receive the electrical stimulator to couple the mounting portion to the electrical stimulator, a portion of the electrical stimulator being accessible via the notch when the electrical stimulator is disposed within the recess.

22. The apparatus of claim 17, wherein the frame assembly includes a semi-rigid outer member configured to maintain a C-shape to retain the frame assembly about the portion of the limb before the fastening strap is coupled across the opening.