ORTHOSIS FOR A GAIT MODULATION SYSTEM

• US 20110152968A1
• Filed: 02/28/2011
• Published: 06/23/2011
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: NATHAN, ROGER H., Bar-Or, Jonathan, Dar, Amit
• Granted Patent: US 8,209,036 B2
• Time in Patent Office: Days
• US Class Current: 607/49
• 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 semi-rigid retaining element disposed on a first side of the frame and a plurality of semi-rigid elongated members disposed on a second side of the frame, the second side of the frame spaced circumferentially apart from the first side of the frame such that a first elongated member from the plurality of semi-rigid elongated members is substantially aligned with the retaining element and a second elongated member from the plurality of semi-rigid elongated members is offset from the retaining element, the retaining element and the plurality of semi-rigid elongated members configured to be radially spring-loaded towards a center of the frame such that when the frame is disposed about the portion of the limb, movement of the frame relative to the limb is limited, the frame including a leaf spring configured to be coupled to a stimulator, the stimulator configured to produce an electronic signal to be conveyed to a surface electrode;

an inner layer coupled to an inner surface of the frame, the inner layer configured to be coupled to the surface electrode such that a position of the surface electrode relative to the frame is maintained when the frame is disposed about the portion of the limb; and

a connector assembly configured to electrically couple the stimulator to the surface electrode, at least a portion of the connector assembly disposed within a connector opening defined by the leaf spring.

2. The apparatus of claim 1, wherein the frame defines a plurality of openings, an opening from the plurality of openings being disposed between the first elongated member from the plurality of semi-rigid elongated members and the second elongated member from the plurality of semi-rigid elongated members such that the first elongated member from the plurality of semi-rigid elongated members can move independently from the second elongated member from the plurality of semi-rigid elongated members.

3. The apparatus of claim 1, wherein each elongated member from the plurality of semi-rigid elongated members is substantially independently conformable from the other elongated member from the plurality of semi-rigid elongated members about a surface of the limb when the frame is disposed about the portion of the limb.

4. The apparatus of claim 1, wherein the plurality of semi-rigid elongated members includes between two and four distinct elongated members, each elongated member from the plurality of semi-rigid elongated members being independently movable from the other elongated members from the plurality of elongated members.

5. The apparatus of claim 1, further comprising:

a biasing strip coupled to an outer surface of the frame, the biasing strip configured to bias at least one elongated member from the plurality of elongated members towards the center of the frame.

6. The apparatus of claim 1, further comprising:

an elastic strap configured to removably couple the first side of the frame to the second side of the frame when the frame is disposed about the portion of the limb.

7. The apparatus of claim 1, wherein the frame includes a mounting portion configured to be coupled to the stimulator, the mounting portion including the leaf spring, the mounting portion substantially isolated from a remainder of the frame such that the mounting portion can move independently from any one of the retaining element or the plurality of semi-rigid elongated members.

8. The apparatus of claim 1, wherein the frame includes a mounting portion to which the stimulator and a fastener are configured to be coupled, the frame defines an opening substantially surrounding three sides of the mounting portion,

the fastener configured to removably couple the first side of the frame to the second side of the frame when the frame is disposed about the portion of the limb.

9. The apparatus of claim 1, wherein the inner layer includes a mechanical fastener configured to be removably coupled to a base of the surface electrode.

10. The apparatus of claim 1, wherein the connector assembly includes a wire, a first connector and a second connector, the first connector coupled to a first end of the wire and configured to matingly engage the stimulator, the second connector coupled to a second end of the wire and disposed on a surface of the inner layer, a portion of the wire disposed within the connector opening defined by the leaf spring.

11. An apparatus, comprising:

a semi-rigid 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 maintain a position of the frame relative to the limb when the frame is disposed about the portion of the limb, the mounting portion including a cradle configured to be coupled to a stimulator configured to produce an electronic signal, the cradle having a connector configured to matingly engage a corresponding connector of the stimulator to removably couple the stimulator within the cradle,

the frame defining an opening configured to substantially surround the mounting portion, the mounting portion substantially isolated from the remainder of the frame such that the mounting portion can move independently from the retention portion of the frame; and

an inner layer coupled to an inner surface of the frame, the inner layer configured to be coupled to a surface electrode in electronic communication with the stimulator such that a position of the surface electrode relative to the frame is maintained when the frame is disposed about the portion of the limb.

12. The apparatus of claim 11, wherein the mounting portion includes a leaf spring configured to substantially isolate the mounting portion from a remainder of the frame.

13. The apparatus of claim 11, further comprising:

a fastening strap configured to removably couple the frame to the portion of the limb, a portion of the fastening strap configured to be disposed about the cradle to maintain the fastening strap in a first position about the frame.

14. The apparatus of claim 11, wherein the inner layer is a reversibly attachable and detachable panel.

15. The apparatus of claim 11, wherein the connector of the cradle is a protrusion and the connector of the stimulator is a recess, the protrusion configured to be disposed within the recess.

16. The apparatus of claim 11, further comprising:

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

17. An apparatus, comprising:

a semi-rigid 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 maintain a position of the frame relative to the limb when the frame is disposed about the portion of the limb, the mounting portion configured to be coupled to a stimulator configured to produce an electronic signal;

an inner layer coupled to an inner surface of the frame, the inner layer configured to be coupled to a surface electrode in electronic communication with the stimulator such that a position of the surface electrode relative to the frame is maintained when the frame is disposed about the portion of the limb;

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

a fastening strap configured to removably couple the frame to the portion of the limb, a first end portion of the fastening strap fixedly coupled to the frame, a second end portion of the fastening strap having loop member configured to be removably coupled to the frame.

18. The apparatus of claim 17, wherein a portion of the loop member is configured to be disposed about a mounting protrusion of the frame when the loop member is coupled to the frame.

19. The apparatus of claim 17, further comprising:

a detachable layer configured to be reversibly coupled to an inner surface of the inner layer, the detachable layer including an electrode connector configured to couple the surface electrode to the detachable layer.

20. The apparatus of claim 17, wherein a length of the fastening strap is adjustable.