Orthosis for a gait modulation system

• US 10,080,885 B2
• Filed: 04/04/2014
• Issued: 09/25/2018
• 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:
  US14/245,597
• Publication Number:
  US 20140303705A1
• Time in Patent Office: 1,635 Days
• 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. A method, comprising:

coupling, via an electrode base, a surface electrode to an inner layer of a frame, the inner layer of the frame being coupled to an inner surface of the frame;

disposing the frame about a portion of a limb such that the frame at least partially envelops the portion of the limb, a diameter of the frame being increased during the disposing, 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, a retention portion of the frame configured to retain the frame about the portion of the limb, at least a portion of the retention portion being biased towards the portion of the limb after the disposing such that an inward force is imparted to the portion of the limb; and

coupling, via a mounting portion of the frame, an electrical stimulator to the frame such that the stimulator is electrically coupled via a connector assembly to the electrode base, at least a portion of the connector assembly disposed within a connector opening defined by the frame.

2. The method 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;

the frame including a first locator disposed on a first edge portion of the frame and configured to identify the longitudinal position and the rotational position of the frame relative to the portion of the limb, the frame including a second locator, different from the first locator, disposed on a second edge portion of the frame, different from the first edge portion, the second locator configured to identify the rotational position of the frame relative to the portion of the limb.

3. The method of claim 1, 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 to the predetermined position via the surface electrode results in flexion of a foot.

4. The method of claim 1, wherein the predetermined position overlies a motor nerve in the lower leg.

5. The method 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, the disposing the frame about the portion of the limb includes disposing the portion of the limb through the opening, further comprising:

fastening a fastening strap across the opening after the frame is disposed about the portion of the limb.

6. The method of claim 1, further comprising:

disposing a fastening strap coupled to the frame about a portion of the frame and about a portion of the electrical stimulator.

7. The method of claim 1, further comprising:

reversibly coupling the surface electrode to the inner layer via a hook and loop fastener, at least a portion of the hook and loop fastener coupled to the electrode base.

8. The method of claim 1, further comprising:

matingly coupling a connector of the mounting portion to a complementary connector of the electrical stimulator to couple the mounting portion to the electrical stimulator.

9. The method of claim 1, further comprising:

disposing a protrusion of the mounting portion within an opening of the electrical stimulator to couple the mounting portion to the electrical stimulator.

10. The method of claim 1, wherein:

the retention portion includes a first member and a second member,

before the disposing, an end portion of the first member is spaced apart from an end portion of the second member by a first distance to define an opening,

after the disposing, the end portion of the first member is spaced apart from the end portion of the second member by a second distance to define the opening, the second distance greater than the first distance,

the disposing the frame about the portion of the limb includes disposing the portion of the limb through the opening.

11. An apparatus, comprising:

a first orthosis layer configured to at least partially envelop a portion of a limb, the first orthosis layer configured to be enlarged in circumference when the first orthosis layer at least partially envelops the portion of the limb, the first orthosis layer including a semi-rigid retention portion and a mounting portion, the retention portion configured to partially surround the portion of the limb, the retention portion configured to retain the first orthosis layer about the portion of the limb, at least a portion of the retention portion being biased towards the portion of the limb when the first orthosis layer at least partially envelops the portion of the limb, the mounting portion configured to receive at least a portion of 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 target stimulation point 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.

12. 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 first orthosis layer is disposed about the portion of the limb.

13. The apparatus of claim 11, 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.

14. The apparatus of claim 11, wherein the second orthosis layer includes an electrode base having at least a portion of a hook and loop fastener to reversibly couple the surface electrode to the second orthosis layer.

15. The apparatus of claim 11, 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 when the portion of the electrical stimulator is received by the mounting portion.

16. The apparatus of claim 11, 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.

17. An apparatus, comprising:

a frame assembly configured to substantially envelop a portion of a limb, the frame assembly including a locator configured to identify the longitudinal position and the rotational position of the frame assembly during donning, the frame assembly having a first end portion and a second end portion opposite the first end portion, the locator being disposed between the first end portion of the frame assembly and the second end portion of the frame assembly, the locator having a first portion configured to conform to an anatomical protuberance of the limb and a second portion configured to conform to an anatomical recess of the limb, the frame assembly including at least one spring-loaded strip, the strip being radially spring-loaded towards a center of the frame assembly, the frame assembly including a mounting portion configured to removably couple an electrical stimulator thereto such that the electrical stimulator is supported by the frame assembly, the mounting portion being disposed between the locator and the first end portion of the frame assembly; and

an electrode base coupled to an inner surface of the frame assembly, the electrode base configured to be coupled to a surface electrode, the electrode base being disposed between the locator and the second end portion of the frame assembly, and

the frame assembly configured such that the surface electrode is disposed at a predetermined position overlying a target stimulation point of the limb when the frame assembly substantially envelops the portion of the limb.

18. The apparatus of claim 17, further comprising:

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 the frame.

19. The apparatus of claim 17, further comprising:

a fastening strap coupled to the frame assembly, the fastening strap configured to be coupled across an opening defined between the first end portion of the frame assembly and a second end portion of the frame assembly when the frame assembly is donned on the portion of the limb.

20. The apparatus of claim 17, wherein an inner layer of the frame assembly is constructed of a soft material.

21. The apparatus of claim 17, wherein the electrode base has at least a portion of a hook and loop fastener to reversibly couple the surface electrode to the frame assembly.

22. The apparatus of claim 17, wherein the mounting portion is configured to receive at least a portion of the electrical stimulator, 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 when the portion of the electrical stimulator is received by the mounting portion.

23. 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.

24. The apparatus of claim 17, wherein the frame assembly includes a first orthosis layer and a second orthosis layer.

25. The apparatus of claim 24, wherein the second orthosis layer is removably coupled to the first orthosis layer.

26. The apparatus of claim 24, wherein the first orthosis layer is semi-rigid, the second orthosis layer is constructed of a soft material.

27. The apparatus of claim 17, wherein the locator is a first locator, a first edge portion of the frame assembly between the first end portion of the frame assembly and the second end portion of the frame assembly includes the first locator, the frame assembly including a second locator, a second edge portion of the frame assembly between the first end portion of the frame assembly and the second end portion of the frame assembly includes the second locator, the second edge portion being opposite the first edge portion.

28. The apparatus of claim 17, wherein the predetermined position is adjacent a muscle of the limb such that stimulation of the limb via the surface electrode results in flexion of a foot.

29. The apparatus of claim 17, wherein the predetermined position overlies a motor nerve in the lower leg.