# US 2019/0167975 A1 · Orthosis for a gait modulation system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167975 A1 - Document ID: US20190167975A1 - Status: Published application - Kind: A1 - Application number: 16/139,927 - Filed: 2018-09-24 - Published: 2019-06-06 - Earliest claimed: 2005-11-16 - Assignees: Bioness Neuromodulation Ltd. - Applicants: Bioness Neuromodulation Ltd. - Inventors: Roger H. NATHAN; Amit DAR; Jonathan BAR-OR - Web page: https://patentgrep.com/patent/US20190167975A1 ## CPC - A61N 1/0484: {Garment electrodes worn by the patient} - A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]} - A61N 1/36003: {of motor muscles, e.g. for walking assistance} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/36034: {specified by the stimulation parameters} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## 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 ### Claim 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 substantially envelops the portion of the limb, 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 first 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; 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. ### Claim 2 (depends on 1) 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 locator configured to identify at least one of the longitudinal position or the rotational position of the frame relative the portion of a limb. ### Claim 3 (depends on 1) 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 dorsiflexion of a foot. ### Claim 4 (depends on 1) The method of claim 1, wherein the predetermined position overlies a peroneal nerve. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) The method of claim 1, further comprising: reversibly coupling the surface electrode to the inner layer via a hook and loop fastener of the electrode base. ### Claim 8 (depends on 1) 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. ### Claim 9 (depends on 1) 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. ### Claim 10 An apparatus, comprising: a first orthosis layer configured to substantially envelop a portion of a 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 and to retain the first orthosis layer about 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. ### Claim 11 (depends on 10) The apparatus of claim 10, 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. ### Claim 12 (depends on 10) The apparatus of claim 10, 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. ### Claim 13 (depends on 10) The apparatus of claim 10, 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. ### Claim 14 (depends on 10) The apparatus of claim 10, 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. ### Claim 15 (depends on 10) The apparatus of claim 10, 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. ### Claim 16 A method, comprising: positioning a surface electrode on a surface of a limb of a patient such that the surface electrode is disposed over a stimulation point of the limb of the patient; coupling, after the positioning, the surface electrode to an electrode base; coupling the electrode base to a frame based on the positioning, the frame configured to be disposed about a portion of the limb of the patient, the electrode base being coupled to the frame without the frame being disposed about the portion of the limb of the patient; and disposing the frame about the portion of a limb such that the frame substantially envelops the portion of the limb. ### Claim 17 (depends on 16) The method of claim 16, further comprising: coupling a stimulator assembly to the surface electrode; and actuating the stimulator assembly to transmit an electrical stimulation via the surface electrode to the stimulation point of the limb of the patient, the actuating occurring before the surface electrode is coupled to the electrode base. ### Claim 18 (depends on 16) The method of claim 16, wherein the electrode base is coupled to the frame via an internal layer of the frame, the frame and the inner layer of the frame collectively configured such that the electrode base is disposed over the stimulation point of the limb of the patient when the frame and the first layer are disposed about the portion of the limb.