US2020405509A1PendingUtilityA1

Methods of Fabricating Skeletal Stabilization Liner System

61
Assignee: ALLEY RANDALL DPriority: Feb 11, 2015Filed: Sep 16, 2020Published: Dec 31, 2020
Est. expiryFeb 11, 2035(~8.6 yrs left)· nominal 20-yr term from priority
A61F 2002/785A61F 2240/001A61F 2/5044A61F 2/7843A61F 2/80A61F 2/7812
61
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Claims

Abstract

Methods of fabricating a liner for reducing motion between a socket and a skeletal structure in a body part are described. Methods include selecting a plurality of compression areas, lying the compression areas along the longitudinal axis of the liner, and spacing the compression areas circumferentially around the liner. The durometer, radial thickness, width, and longitudinal dimension of the compression areas are selected to compress soft tissue of the body part against the skeletal structure to reduce motion of the skeletal structure towards a wall of the socket. Methods also include selecting a plurality of attachment areas on the liner and affixing a plurality of attachment area materials to the plurality of attachment areas. The durometer, radial thickness, width, and longitudinal dimension of the attachment area materials are selected to compress soft tissue of the body part and reduce motion of the skeletal structure towards a wall of the socket.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of fabricating a liner for reducing motion between an interface and a skeletal structure in a body part, the method comprising:
 selecting a plurality of compression areas each having a durometer, a radial thickness, a width, and a longitudinal dimension;   lying the longitudinal dimension of each compression area along a longitudinal dimension of the liner, wherein the longitudinal dimension of the liner extends from a distal end to a proximal end of the liner;   spacing each compression area circumferentially around the liner; and   selecting the durometer, radial thickness, width, and longitudinal dimension of the plurality of compression areas to compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part such that motion of the skeletal structure towards a wall of the interface is reduced.   
     
     
         2 . The method of  claim 1 , wherein each compression area comprises a gel. 
     
     
         3 . The method of  claim 2 , wherein the gel is selected from the group consisting of a shear-thinning gel, a shear-thickening gel, a magneto rheological gel, an electrorheological gel, and a thermoresponsive gel. 
     
     
         4 . The method of  claim 1 , wherein each compression area extends at least approximately 10% the longitudinal dimension of the liner. 
     
     
         5 . The method of  claim 1 , wherein the plurality of compression areas have an increased thickness relative to the spaces between the compression areas. 
     
     
         6 . The method of  claim 1 , wherein a maximum radial thickness of each compression area is at least 0.4 mm greater than a minimum radial thickness of the areas between the compression areas. 
     
     
         7 . The method of  claim 1 , wherein the proximal end and distal end of the liner are both open ends. 
     
     
         8 . The method of  claim 1 , wherein at least one area between the plurality of compression areas is an open or low-compression area. 
     
     
         9 . The method of  claim 1 , further comprising the step of integrating or attaching one or more sensors with one or more compression areas. 
     
     
         10 . The method of  claim 9 , further comprising the step of sending data from the one or more sensors to a device. 
     
     
         11 . The method of  claim 10 , wherein the data includes a localized pressure. 
     
     
         12 . The method of  claim 1 , further comprising the step of adjusting a volume or durometer of at least one compression area. 
     
     
         13 . A method of fabricating a liner for reducing motion between an interface and a skeletal structure in a body part, the method comprising:
 selecting a plurality of attachment areas each having a durometer, a radial thickness, a width, and a longitudinal dimension;   lying the longitudinal dimension of each attachment area along a longitudinal dimension of the liner, wherein the longitudinal dimension of the liner extends from a distal end to a proximal end of the liner;   spacing each attachment area circumferentially around the liner;   selecting an attachment area material for each of the plurality of attachment areas, wherein each attachment area material has a durometer, a radial thickness, a width, and a longitudinal dimension;   affixing the attachment area materials to the plurality of attachment areas, respectively, such that the longitudinal dimension of each attachment area material aligns with the longitudinal dimension of the liner;   selecting the durometer, radial thickness, width, and longitudinal dimension of each attachment area material to compress soft tissue of the body part against the skeletal structure when the interface and liner are worn on the body part such that motion of the skeletal structure towards a wall of the interface is reduced.   
     
     
         14 . The method of  claim 13 , wherein at least one of the attachment areas is in a discontinuous configuration. 
     
     
         15 . The method of  claim 13 , wherein at least one of the attachment areas comprises a pocket. 
     
     
         16 . The method of  claim 15 , wherein the step of affixing the attachment area materials to the plurality of attachment areas comprises enclosing the attachment area material inside the pocket. 
     
     
         17 . The method of  claim 15 , wherein the step of affixing the attachment area materials to the plurality of attachment areas comprises inserting a shim into the pocket. 
     
     
         18 . The method of  claim 13 , wherein the step of affixing the attachment area materials to the plurality of attachment areas comprises embedding a material in the attachment areas to increase the thickness of the attachment areas. 
     
     
         19 . The method of  claim 13 , wherein the plurality of attachment areas have an increased thickness relative to the spaces between the attachment areas. 
     
     
         20 . The method of  claim 13 , wherein the step of selecting the radial thickness, width, and longitudinal dimension of the attachment area materials comprises selecting the attachment area materials from a plurality of component parts. 
     
     
         21 . The method of  claim 13 , wherein each of the attachment area materials has a durometer adapted to permit a user to don and doff the liner while the attachment area materials are attached to the attachment areas. 
     
     
         22 . The method of  claim 13 , further comprising the step of applying an alignment indicator to the liner in such a way that a user can align the alignment indicator to an anterior midline of the body part. 
     
     
         23 . The method of  claim 22 , wherein the alignment indicator represents zero degrees, and the plurality of attachment areas comprise four attachment areas circumferentially located approximately at 45, 135, 225, and 315 degrees relative to the alignment indicator. 
     
     
         24 . The method of  claim 13 , wherein the liner is integrally formed with the attachment area materials. 
     
     
         25 . The method of  claim 13 , wherein the attachment area or attachment area materials have a raised texture such that friction is increased against the socket wall to resist or prevent slippage of the liner with respect to the socket wall. 
     
     
         26 . The method of  claim 13 , further comprising the step of donning the liner and affixing the attachment area materials to the attachment areas after the liner is donned. 
     
     
         27 . The method of  claim 13 , wherein at least one of the plurality of attachment areas comprises a hook or loop fastener material. 
     
     
         28 . The method of  claim 13 , wherein the attachment area materials are selected from a plurality of attachment area materials having different durometers. 
     
     
         29 . The method of  claim 13 , wherein the proximal end and distal end of the liner are both open ends. 
     
     
         30 . The method of  claim 13 , wherein at least one area between the plurality of attachment areas is an open or low-compression area. 
     
     
         31 . A method of fabricating a socket for a limb using a liner having a plurality of compression areas, the method comprising:
 donning the liner on the limb such that the plurality of compression areas compress soft tissue of the limb at target areas, wherein the target areas (i) are longitudinally-shaped, (ii) have a longitudinal axis that is substantially parallel to a longitudinal axis of a skeletal structure within the limb, and (iii) are disposed circumferentially around the longitudinal axis of the skeletal structure; and   casting or scanning the limb while the liner is donned on the limb and the limb is in a compressed state.   
     
     
         32 . The method of  claim 31 , wherein the plurality of compression areas are spaced circumferentially around the limb and at least one area between the plurality of compression areas is an open or low-compression area. 
     
     
         33 . The method of  claim 31 , further comprising the step of creating a virtual model of the limb in the compressed state. 
     
     
         34 . The method of  claim 31 , wherein the compressed state of the limb determines an internal volume of the socket.

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