Orthosis for a gait modulation system

• US 8,209,036 B2
• Filed: 02/28/2011
• 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, Bar-Or, Jonathan, Nathan, Roger H.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/036,256
• Publication Number:
  US 20110152968A1
• Time in Patent Office: 484 Days
• Field of Search: 607/144
• US Class Current: 607/144
• 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 for FES to a limb segment, including: (a) a semi-rigid, self-retaining C-shaped frame, the frame configured to substantially envelop the limb segment, the frame including a first flexible and elongated circumferentially retaining element and at least a first and a second opposing flexible and elongated circumferentially retaining elements disposed on the circumferentially opposite side of the frame, the first retaining element and the first opposing retaining element forming a pair of opposing retaining elements, and (b) a surface electrical stimulation electrode for contacting at least one stimulation point on a surface of the limb segment, associated with, and supported by, the frame, the surface electrode for electrically associating, via the frame, with a neuroprosthetic stimulator unit, so as to provide FES, wherein the opposing retaining elements are configured to be radially spring-loaded towards a center of the frame, such that in donning the orthosis around the limb segment, the limb segment applies a counter-pressure from within the frame, against the opposing retaining elements, such that the orthosis is firmly and fixedly self-retained in a pre-determined position on the surface.

Claims

1. An apparatus, comprising:

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

an inner layer coupled to an inner surface of the frame;

an electrode base coupled to the inner layer, the electrode base configured to couple a surface electrode to the inner layer, the frame and the inner layer of the frame collectively configured such that the electrode base is disposed at a predetermined position relative to the portion of the limb when the frame and the inner layer are 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

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.

2. The apparatus of claim 1, wherein:

the predetermined position includes at least one of a longitudinal position of the electrode base relative to the limb or a rotational position of the electrode relative to the limb; and

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

3. 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 frame is disposed about the portion of the limb.

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 to define an opening through which the portion of the limb is disposed when the frame is being donned, the apparatus further comprising:

a fastening strap configured to be coupled across the opening after the frame is disposed about the portion of the limb.

5. 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 frame is being donned, the apparatus further comprising:

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

6. The apparatus of claim 1, further comprising:

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

7. The apparatus of claim 1, wherein the electrode base includes a hook and loop fastener to reversibly couple the surface electrode to the inner layer.

8. The apparatus of claim 1, wherein the portion of the connector assembly is a first portion, a second portion of the connector assembly disposed within an opening defined by the inner layer.

9. 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.

10. 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.

11. The apparatus of claim 1, wherein the mounting portion includes a protrusion configured to be received within an opening of the electrical stimulator to couple the mounting portion to the electrical stimulator.

12. The apparatus of claim 1, wherein the predetermined position overlies a peroneal nerve.

13. 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 configured to retain the frame about the portion of the limb, 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 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;

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 disposed about the electrical stimulator.

14. The apparatus of claim 13, wherein the fastening strap includes a loop member configured to be coupled to the frame assembly.

15. The apparatus of claim 13, wherein a length of the fastening strap is adjustable.

16. The apparatus of claim 13, 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.

17. The apparatus of claim 13, 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 frame is being donned; and

the fastening strap is configured to be coupled across the opening after the frame is disposed about the portion of the limb.

18. The apparatus of claim 13, 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 frame is being donned,

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

19. The apparatus of claim 13, 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 13, wherein the retention portion is constructed from a semi-rigid material, the retention portion configured to partially surround the portion of the limb.

21. The apparatus of claim 13, wherein the predetermined position overlies a peroneal nerve.

22. 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 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 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 of the portion of the limb via the surface electrode results in dorsiflexion of a foot;

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

23. The apparatus of claim 22, 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.

24. The apparatus of claim 22, wherein the fastening strap includes a loop member configured to be coupled to the frame assembly.

25. The apparatus of claim 22, 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.

26. The apparatus of claim 22, wherein the electrode base includes a hook and loop fastener to reversibly couple the surface electrode to the inner surface.

27. The apparatus of claim 22, wherein the retention portion is constructed from a semi-rigid material, the retention portion configured to partially surround the portion of the limb.

28. The apparatus of claim 22, 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.

29. The apparatus of claim 22, wherein the mounting portion includes a protrusion configured to be received within an opening of the electrical stimulator to couple the mounting portion to the electrical stimulator.

30. The apparatus of claim 22, wherein the predetermined position overlies a peroneal nerve.

31. An apparatus, comprising:

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

an inner layer coupled to an inner surface of the frame;

an electrode base coupled to the inner layer, the electrode base including a hook and loop fastener configured to reversibly couple a surface electrode to the inner layer, the frame and the inner layer of the frame collectively configured such that the electrode base is disposed at a predetermined position relative to the portion of the limb when the frame and the inner layer are disposed about the portion of the limb; and

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.

32. The apparatus of claim 31, wherein the retention portion is constructed from a semi-rigid material, the retention portion configured to partially surround the portion of the limb.

33. The apparatus of claim 31, wherein the mounting portion includes a protrusion configured to be received within an opening of the electrical stimulator to couple the mounting portion to the electrical stimulator.