# US 12,004,598 B2 · Energy return orthotic systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,598 B2 - Document ID: US12004598B2 - Status: Granted - Kind: B2 - Application number: 18/084,322 - Filed: 2022-12-19 - Published: 2023-04-20 - Granted: 2024-06-11 - Earliest claimed: 2012-06-27 - Assignees: SubioMed, Inc. - Applicants: SubioMed, Inc. - Inventors: Barry A. Butler - Web page: https://patentgrep.com/patent/US12004598B2 ## CPC - A43B 7/28: Adapting the inner sole {or the side of the upper} of the shoe to the sole of the foot - A43B 7/14: with foot-supporting parts - A43B 7/141: {having an anatomical or curved form} - A43B 7/142: situated under the medial arch, i.e. under the navicular or cuneiform bones - A43B 7/143: situated under the lateral arch, i.e. the cuboid bone - A43B 7/1445: situated under the midfoot, i.e. the second, third or fourth metatarsal - A43B 7/146: {provided with acupressure points or means for foot massage} - A43B 7/149: Pads, e.g. protruding on the foot-facing surface - A43B 7/24: Insertions or other supports preventing the foot canting to one side {, preventing supination or pronation} - A43B 13/181: {Resiliency achieved by the structure of the sole} - A43B 13/183: {Leaf springs} - A43B 13/184: {the structure protruding from the outsole} - A43B 13/386: {multilayered} - A43B 17/006: {multilayered} - A43B: CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR ## Abstract Systems and methods are disclosed including a tri-layer orthotic system having a heel portion and a forefoot portion to support respective heel and forefoot portions of a foot through at least a portion of a gait cycle. The tri-layer orthotic system can include an upper layer suspended over a mid-layer and a base layer to create a rear spring section, a mid-spring section, and a front spring section. A distal toe portion of the mid-layer can form the forefoot portion of the tri-layer orthotic system and a heel upper layer portion of the upper layer can form the heel portion of tri-layer orthotic system. ## Claims ### Claim 1 A tri-layer orthotic system having a heel portion and a forefoot portion, the tri-layer orthotic system comprising a base layer having a distal toe end and a proximal heel end; a mid-layer having a distal toe portion, a mid-portion, and a proximal heel portion, the distal toe portion of the mid-layer coupled to the distal toe end of the base layer to form the forefoot portion of the tri-layer orthotic system; and an upper layer having a front upper layer portion, an arch upper layer portion, and a heel upper layer portion, the heel upper layer portion coupled to the proximal heel portion of the mid-layer to form the heel portion of the tri-layer orthotic system, wherein the coupling of the distal toe portion of the mid-layer to the distal toe end of the base layer and the heel upper layer portion to the proximal heel portion of the mid-layer is configured such that the upper layer is suspended over the mid-layer and the heel portion is suspended over the proximal heel end of the base layer to create a rear spring section, a mid-spring section, and a front spring section, wherein the heel portion of the tri-layer orthotic system and the forefoot portion of the tri-layer orthotic system are configured to support respective heel and forefoot portions of a foot through at least a portion of a gait cycle. ### Claim 2 (depends on 1) The tri-layer orthotic system of claim 1, wherein the distal toe portion of the mid-layer extends distally beyond the front upper layer portion. ### Claim 3 (depends on 1) The tri-layer orthotic system of claim 1, wherein the distal toe portion of the mid-layer is fused to the distal toe end of the base layer, wherein the heel upper layer portion is fused to the proximal heel portion of the mid-layer. ### Claim 4 (depends on 1) The tri-layer orthotic system of claim 1, wherein the tri-layer orthotic system is configured to control foot, ankle, and body biomechanics during the gait cycle. ### Claim 5 (depends on 1) The tri-layer orthotic system of claim 1, comprising a shim positioned between at least one of the bottom layer and the mid-layer or the upper layer and the mid-layer. ### Claim 6 (depends on 1) The tri-layer orthotic system of claim 1, wherein the tri-layer orthotic system is configured to be inserted or incorporated into a footwear of an individual. ### Claim 7 (depends on 1) The tri-laver orthotic system of claim 1, wherein the front upper layer portion comprises a plurality of segmented digit rays. ### Claim 8 (depends on 7) The tri-layer orthotic system of claim 7, wherein one or more of the plurality of digit rays are configured to be deformed upwardly or downwardly by a therapeutic angle. ### Claim 9 (depends on 1) The tri-layer orthotic system of claim 1, comprising: at least one sensor positioned on or near the tri-layer orthotic system that senses movement during a gait cycle; a knowledge base configured to store data on a plurality of foot pathologies and information regarding a normal foot or a normal gait cycle; a processing device in operable communication with the at least one sensor and the knowledge base; and a non-transitory computer readable medium comprising programming instructions that are configured to, when executed by the processing device, to cause the processing device to: (a) receive, from the at least one sensor, data related to a gait cycle of an individual; (b) compare the received data with a plurality of foot pathologies in the knowledge base; (c) determine, based on at least the comparison or the information regarding the normal foot or normal gait cycle, a therapeutic correction to the tri-layer orthotic system to improve the gait cycle of the individual; and (d) output a visual representation of the therapeutic correction to the individual. ### Claim 10 (depends on 1) The tri-layer orthotic system of claim 1, comprising an arch portion configured to be deformed upwardly above the upper layer or downwardly below the upper layer to treat a high arch or a flat arch of an individual. ### Claim 11 (depends on 1) The tri-layer orthotic system of claim 1, wherein the base layer, the mid layer, and the upper layer are composed of a carbon fiber material. ### Claim 12 (depends on 1) The tri-layer orthotic system of claim 1, wherein the upper layer is composed of a material that is different than the mid-layer and the base layer. ### Claim 13 (depends on 11) The tri-layer orthotic system of claim 11, wherein the upper layer is composed of a resilient material and the mid-layer and base layer are composed of a carbon fiber material. ### Claim 14 (depends on 1) The tri-layer orthotic system of claim 1, comprising one or more cuts that extend from a medial side of the upper layer to a lateral side of the upper layer and from an upper portion of the upper layer to a lower surface of the upper layer, such that the one or more cuts divides the upper layer into a front segment, an arch segment, and a heel segment. ### Claim 15 (depends on 14) The tri-layer orthotic system of claim 14, comprising a semi-rigid spine positioned beneath the upper layer and coupled to the front segment, the arch segment, and the heel segment, wherein the semi-rigid spine is configured to allow for deflection of said segments around an axis of the spine while controlling a shape of the upper layer. ### Claim 16 (depends on 1) The tri-layer orthotic system of claim 1, wherein the distal toe portion of the mid-layer is coupled to the distal toe end of the base layer to form the forefoot portion by coupling of the mid-layer from the distal toe portion up to about a mid-arch portion to the distal toe end of the base layer to form the forefoot portion. ### Claim 17 A method of controlling biomechanics during a gait cycle, comprising: coupling a distal toe portion of a mid-layer of a tri-layer orthotic system to a distal toe end of a base layer of the tri-layer orthotic system and a heel upper layer portion of the tri-layer orthotic system to the proximal heel portion of the mid-layer to suspend the upper layer over the mid-layer and the mid-layer over the base layer to create a rear spring section, a mid-spring section, and a front spring section of the tri-layer orthotic system; and supporting respective heel and forefoot portions of a foot through at least a portion of the gait cycle using separate heel and forefoot portions of the tri-layer orthotic system, wherein the base layer comprises a distal toe end and a proximal heel end, wherein the mid-layer comprises a distal toe portion, a mid-portion, and a proximal heel portion, the distal toe portion of the mid-layer coupled to the distal toe end of the base layer to form the forefoot portion of the tri-layer orthotic system, wherein the upper layer comprises a front upper layer portion, an arch upper layer portion, and a heel upper layer portion, the heel upper layer portion coupled to the proximal heel portion of the mid-layer to form the heel portion of the tri-layer orthotic system. ### Claim 18 (depends on 17) The method of claim 17, wherein the distal toe portion of the mid-layer extends distally beyond the front upper layer portion to support the forefoot portion of the foot through at least a portion of the gait cycle. ### Claim 19 (depends on 17) The method of claim 17, wherein the distal toe portion of the mid-layer is fused to the distal toe end of the base layer, wherein the heel upper layer portion is fused to the proximal heel portion of the mid-layer. ### Claim 20 (depends on 17) The method of claim 17, wherein controlling biomechanics during the gait cycle comprises controlling foot, ankle, and body biomechanics using the rear spring section, the mid-spring section, and the front spring section of the tri-layer orthotic system.