# US 12,213,901 B2 · Non-water-activated cast > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,901 B2 - Document ID: US12213901B2 - Status: Granted - Kind: B2 - Application number: 18/083,200 - Filed: 2022-12-16 - Published: 2023-04-20 - Granted: 2025-02-04 - Earliest claimed: 2018-07-27 - Assignees: Leg Defender, LLC - Applicants: Leg Defender, LLC - Inventors: Jason R. Hanft - Web page: https://patentgrep.com/patent/US12213901B2 ## CPC - A61F 5/0111: {for the feet or ankles} - A61F 5/0109: {Sleeve-like structures} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract A non-water-activatable cast has one or more layers of sheet-like material which create a combined flexibility, stiffness, or rigidity so that the cast may be manually positioned in substantial contact with a lower extremity to be received within the cast. As such, the cast is not only readily deployable by a patient, but has predetermined flexibility located and selected to control ankle movement within a therapeutically appropriate range, whether used by itself or in association with a related orthosis, such as a CAM walker. In certain applications, the cast likewise offloads or otherwise redistributes force by virtue of the rigidity of the plantar impact surface on such cast and the rigidity of other cast portions. ## Claims ### Claim 1 A cast for a lower extremity to be treated, the cast comprising: at least two layers of sheet-like material, wherein the layers have a predetermined, combined flexibility selected to have the layers manually transformable from a first, pre-application configuration before fitting on the lower extremity, to a second, post-application configuration after the fitting on the lower extremity; wherein the first, pre-application configuration comprises a blank of the sheet-like material in a semi-rigid state extending transversely between opposite side edges by a first amount sufficient to substantially, circumferentially enclose the lower extremity by manually urging said edges toward each other, the sheet-like material extending longitudinally between upper and lower ends by a second amount sufficient to locate the leg and the foot of the lower extremity at the upper and lower ends, respectively, after fitting on the lower extremity wherein the second, post-application configuration is formed in response to manual force applied to the blank to bring the side edges relatively toward each other to define a volume into which the lower extremity is received and to define an inner surface to substantially contact opposing portions of the lower extremity when received therein; wherein the predetermined flexibility is selected to permit the inner surface of the cast to maintain the substantial contact with the lower extremity during walking on the lower extremity; and wherein the predetermined flexibility is selected to limit at least one of plantar flexion, dorsiflexion, eversion, and inversion of the ankle of the lower extremity by at least 50% compared to a corresponding, non-casted movement of said ankle. ### Claim 2 (depends on 1) The cast of claim 1, wherein each of said layers consists essentially of material that is non-water-activatable and at least one of said layers is water resistant. ### Claim 3 (depends on 1) The cast of claim 1, wherein the cast consists essentially of material that is non-heat-activatable. ### Claim 4 (depends on 1) The cast of claim 1, wherein one of the layers comprises an outer layer of semi-rigid polymeric material having a thickness ranging between 0.4 mm and 0.9 mm. ### Claim 5 (depends on 4) The cast of claim 4, wherein one of the layers comprises cushioning material. ### Claim 6 (depends on 4) The cast of claim 4, wherein the sheet-like material is characterized by a semi-rigidity selected to place the cast in a weight-bearing category in terms of therapeutic uses to offload a therapeutically significant percentage of force forward of the heel during heel strike, and to control ankle movement at therapeutic levels comparable to a CAM walker. ### Claim 7 (depends on 4) The cast of claim 4, wherein the sheet-like material is characterized by a semi-rigidity selected to place the cast in a weight-bearing category in terms of therapeutic uses to offload a therapeutically significant percentage of force of the forefoot, and to control foot movement at therapeutic levels comparable to a CAM walker. ### Claim 8 (depends on 4) The cast of claim 4, wherein one of the layers is located radially inwardly from the outer layer, and comprises knitted fabric configured to have at least one of the properties selected from the group consisting of anti-microbial properties, insulative properties, wicking properties, and anti-friction properties. ### Claim 9 (depends on 4) The cast of claim 4, further comprising at least one sensor deployed at a sensor location on the inner surface of the cast, the sensor configured to receive at least one input corresponding to at least one of force, pressure, temperature, and acceleration, the input further corresponding to a portion of the lower extremity positioned at the sensor location when the lower extremity is received in the cast. ### Claim 10 A cast for a lower extremity of a patient to be treated, the cast comprising: at least two layers of sheet-like material, wherein the layers have a predetermined, combined flexibility selected to have the layers manually transformable from a first, pre-application configuration before fitting on the lower extremity, to a second, post-application configuration after the fitting on the lower extremity; wherein the first, pre-application configuration comprises a blank of the sheet-like material in a semi-rigid state extending transversely between opposite side edges by a first amount sufficient to substantially, circumferentially enclose the lower extremity of said patient by said patient manually urging said edges toward each other, the sheet-like material extending longitudinally between upper and lower ends by a second amount sufficient to locate the leg and the foot of the lower extremity at the upper and lower ends, respectively, after fitting on the lower extremity; wherein the second, post-application configuration is formed in response to manual force applied to the blank to bring the side edges relatively toward each other to define a volume into which the lower extremity is received and to define an inner surface to substantially contact opposing portions of the lower extremity when received therein; wherein the predetermined flexibility is selected to permit the inner surface of the cast to maintain the substantial contact with the lower extremity during walking on the lower extremity; and wherein the predetermined flexibility is selected to limit at least one of plantar flexion, dorsiflexion, eversion, and inversion of the ankle of the lower extremity by at least 50% compared to a corresponding, non-casted movement of said ankle. ### Claim 11 (depends on 10) The cast of claim 10, wherein each of said layers consists essentially of material that is non-water-activatable and at least one of said layers is water resistant. ### Claim 12 (depends on 10) The cast of claim 10, wherein the cast consists essentially of material that is non-heat-activatable. ### Claim 13 (depends on 10) The cast of claim 10, wherein one of the layers comprises an outer layer of semi-rigid polymeric material having a thickness ranging between 0.4 mm and 0.9 mm. ### Claim 14 (depends on 13) The cast of claim 13, wherein one of the layers comprises cushioning material. ### Claim 15 (depends on 13) The cast of claim 13, wherein the sheet-like material is characterized by a semi-rigidity selected to place the cast in a weight-bearing category in terms of therapeutic uses to offload a therapeutically significant percentage of force forward of the heel during heel strike, and to control ankle movement at therapeutic levels comparable to a CAM walker. ### Claim 16 (depends on 13) The cast of claim 13, wherein the sheet-like material is characterized by a semi-rigidity selected to place the cast in a weight-bearing category in terms of therapeutic uses to offload a therapeutically significant percentage of force of the forefoot, and to control foot movement at therapeutic levels comparable to a CAM walker. ### Claim 17 (depends on 13) The cast of claim 13, wherein one of the layers is located radially inwardly from the outer layer, and comprises knitted fabric configured to have at least one of the properties selected from the group consisting of anti-microbial properties, insulative properties, wicking properties, and anti-friction properties. ### Claim 18 (depends on 13) The cast of claim 13, further comprising at least one sensor deployed at a sensor location on the inner surface of the cast, the sensor configured to receive at least one input corresponding to at least one of force, pressure, temperature, and acceleration, the input further corresponding to a portion of the lower extremity positioned at the sensor location when the lower extremity is received in the cast. ### Claim 19 An orthosis for a lower extremity to be treated, the orthosis comprising: a rigid frame having an inner surface; a cast comprising a plantar portion and a leg portion, the portions having respective outer surfaces; wherein the inner surface of the rigid frame engages at least one of the outer surfaces of the cast; wherein the cast is formed of at least two layers of sheet-like material, wherein the layers have a predetermined, combined flexibility selected to have the layers manually transformable from a first, pre-application configuration before fitting on the lower extremity, to a second, post-application configuration after the fitting on the lower extremity; wherein the first, pre-application configuration comprises a blank of the sheet-like material in a semi-rigid state extending transversely between opposite side edges by a first amount sufficient to substantially, circumferentially enclose the lower extremity after manipulation of the blank, the sheet-like material extending longitudinally between upper and lower ends by a second amount sufficient to locate the leg and the foot of the lower extremity at the upper and lower ends, respectively, after fitting on the lower extremity wherein the second, post-application configuration is formed in response to manual force applied to the blank to bring the side edges relatively toward each other to define a volume into which the lower extremity is received and to define an inner surface to substantially contact opposing portions of the lower extremity when received therein; wherein the predetermined flexibility is selected to permit the inner surface of the cast to maintain the substantial contact with the lower extremity during walking on the lower extremity; and wherein the predetermined flexibility is selected to limit at least one of plantar flexion, dorsiflexion, eversion, and inversion of the ankle of the lower extremity by at least 50% compared to a corresponding, non-casted movement of said ankle. ### Claim 20 (depends on 19) The orthosis of claim 19, wherein the orthosis comprises a CAM walker, and wherein the rigid frame comprises a plantar support member and a leg bracing member, the plantar support member adapted to receive thereon the plantar portion of the cast, and the leg bracing member is configured to engage the leg portion of the cast. ### Claim 21 (depends on 20) The orthosis of claim 20, wherein the cast consists essentially of material that is non-water-activatable. ### Claim 22 (depends on 20) The orthosis of claim 20, wherein the cast consists essentially of material that is non-heat-activatable. ### Claim 23 An orthosis for a lower extremity of a patient to be treated, the orthosis comprising: a rigid frame having an inner surface; a cast comprising a plantar portion and a leg portion, the portions having respective outer surfaces; wherein the inner surface of the rigid frame engages at least one of the outer surfaces of the cast; wherein the cast is formed of at least two layers of sheet-like material, wherein the layers have a predetermined, combined flexibility selected to have the layers manually transformable from a first, pre-application configuration before fitting on the lower extremity, to a second, post-application configuration after the fitting on the lower extremity; wherein the first, pre-application configuration comprises a blank of the sheet-like material in a semi-rigid state extending transversely between opposite side edges by a first amount sufficient to substantially, circumferentially enclose the lower extremity after manipulation of the blank, the sheet-like material extending longitudinally between upper and lower ends by a second amount sufficient to locate the leg and the foot of the lower extremity at the upper and lower ends, respectively, after fitting on the lower extremity wherein the second, post-application configuration is formed in response to manual force applied by said patient to the blank to bring the side edges relatively toward each other to define a volume into which the lower extremity is received and to define an inner surface to substantially contact opposing portions of the lower extremity when received therein; wherein the predetermined flexibility is selected to permit the inner surface of the cast to maintain the substantial contact with the lower extremity during walking on the lower extremity; and wherein the predetermined flexibility is selected to limit at least one of plantar flexion, dorsiflexion, eversion, and inversion of the ankle of the lower extremity by at least 50% compared to a corresponding, non-casted movement of said ankle. ### Claim 24 (depends on 23) The orthosis of claim 23, wherein the orthosis comprises a CAM walker, and wherein the rigid frame comprises a plantar support member and a leg bracing member, the plantar support member adapted to receive thereon the plantar portion of the cast, and the leg bracing member is configured to engage the leg portion of the cast. ### Claim 25 (depends on 24) The orthosis of claim 24, wherein the cast consists essentially of material that is non-water-activatable. ### Claim 26 (depends on 24) The orthosis of claim 24, wherein the cast consists essentially of material that is non-heat-activatable.