Patent Publication Number: US-11648142-B2

Title: Orthopedic device, method, and system for making an orthopedic device

Description:
FIELD OF THE DISCLOSURE 
     The disclosure generally relates to orthopedic devices, and methods and systems for making orthopedic devices. 
     BACKGROUND 
     It is well known to create digital representations of orthopedic devices, including virtual fitting of a brace to a patient, prior to fabrication of an actual device. Many of these known systems offer solutions that may involve elaborate techniques including photogrammetry, image correlation, depth mapping, or any other suitable IR and/or visible light photography based surface topography detection method. From a three-dimensional representation of the body part topography, an orthopedic device is made having an inner surface that corresponds to the three-dimensional representation of the body part. 
     These solutions require expertise for properly obtaining the digital representation, according to the methods employed. Aside from the skill required to operate the equipment associated with creating the digital representation, such equipment is expensive and not readily available across a spectrum of healthcare providers. Limited use and time required to proceed with the process for creating the digital representation may not justify the acquisition of such equipment. 
     While it is desirable to obtain such digital representations of both a body part and corresponding brace, such as a hand and a hand brace, such representations may not clearly capture a true representation of a hand since the representations may erroneously include features of the body part that are not essential or complicate proper fitting of the brace on the body part (skin folds, wrinkles, skin lines, pannus, dimples, and other anatomical features unique to the intended user of the brace). These possibly flawed digital representations may compromise or corrupt the rest of the brace manufacture process. 
     Many types of conformal orthopedic devices are known, even those customized and devised from digital representations of a body parts. These known devices, particularly in hand braces, may lack sufficient angulation according to orthopedic parameters and customizations for a pathology of a user from which the digital representation is obtained. It is difficult to know the exact position a user&#39;s body part will take from merely a three-dimensional image scan, even if the software cleans the topography of the body part according predefined parameters. 
     If in a hand the thumb has a unique shape and orientation, and requires treatment from a brace, it is difficult to know from a picture, even a three-dimensional digital representation, how the thumb should be oriented while considering the unique shape. These known methods rarely account for pathologies and orthopedic rules, as the digital representation is not taken with such pathologies and rules in mind. 
     With current technology, it is relatively simple to print a three-dimensional orthopedic device, such as a hand brace, from a digital representation of a body. The difficulty lies in creating a digital representation according to parameters related to pathologies and orthopedic rules in mind, rather than merely obtaining a digital representation having generally accurate volume of a hand based on a cloud of points. The known digital representations are simply that: digital representations. It is not known to make such digital representations driven by essential parameters for addressing the pathologies and orthopedic rules. 
     An advantage to making a custom-fitted orthopedic device is that it can be tailor-made to the specific anatomy of a user, and with improved distribution pressure over the user&#39;s anatomy, to provide superior comfort without necessarily requiring padding. The configuration of the brace may provide a comfortable surface against the user&#39;s anatomy and possess a breathable wall structure. 
     It is a challenge in orthopedic devices to maintain braces on the user, and many known custom-fitted orthopedic devices lack integrated means for securing the brace on the user. Lack of comfort of the orthopedic device is a common drawback that disincentives or deters the user from wearing the brace according to the treatment plan prescribed by a clinician. Another difficulty lies in finding clinicians able to make such braces that provide the necessary quality and effectiveness needed to treat a wound. Despite improvements in comfort, fit, retention and breathability, users may not find braces aesthetically pleasing, further deterring use of the brace. 
     The production of one-of-a-kind custom-fitted braces can be a tedious and expensive process. Many custom-fitted braces are measured according to the clinician&#39;s experience, instruments or geographical region, and there is a lack of a standardized format for such measurement. There is a lack of uniformity in fabrication of custom-fitted braces, as each clinician relies on their individual skill and experience, which may vary among clinics. Few standardized processes are used for both measuring a user&#39;s affected anatomy and fabricating custom-fitted braces on a large scale, that involves geographical centralization of the process. There tends to be a delay in fabrication of such braces due to the customization and lack of standardization and centralization of the processes used to make the braces. 
     In view of these observations, there is a need for standardization of measurement that can be handled by clinicians and users internationally in a simple manner with a minimum of instruments, and a centralized, uniform, or systematic manufacturing process that can be executed in a timely manner to yield a custom-fitted brace for treating a user&#39;s affected anatomy. 
     From the foregoing, there is a need for a method and system for creating an orthopedic device that enables a generally accurate digital representation of a body part that does not have the attendant drawbacks of known methods and systems for creating a digital representation of a body part according to parameters associated with pathologies and orthopedic rules. 
     SUMMARY 
     According to embodiments described herein, orthopedic devices are described and arranged according to parameters related to pathologies and orthopedic rules in mind, rather than merely obtaining a digital representation having generally accurate volume of a hand based on a cloud of points. These embodiments are configured to be tailor-made to the specific anatomy of a user, and with improved distribution pressure over the user&#39;s anatomy, to provide superior comfort without necessarily requiring padding. While the embodiments share common characteristics or a pattern associated with human anatomy of an affected region, the embodiments are adaptable to such parameters unique to each user to provide a comfortable surface against the user&#39;s anatomy and to possess a breathable wall structure, while supporting the affected anatomy. 
     The embodiments may include integrated means for securing the orthopedic devices on the user in a comfortable and efficient manner. The embodiments possess improvements in comfort, fit, retention, and breathability, while offering the user choices to make the orthopedic devices aesthetically pleasing, and encouraging continual wear during a treatment plan. 
     In an exemplary embodiment, an orthopedic device comprises a body having a monolithic structure and arranged to form a closed circumference in a secured configuration, the body having a predetermined shape in an unsecured configuration. The body is formed continuously without interruption from at least one polymeric material. 
     In another exemplary embodiment, an orthopedic device comprises a body having a monolithic structure and arranged to form a closed circumference in a secured configuration. The body has a predetermined shape in an unsecured configuration. The body is formed continuously without interruption from at least one polymeric material. The body forms an opening bordered by first and second sides of the body. A strap assembly includes a strap depending from the first side of the body and arranged to extend across to the second side of the body and connect thereto to form the closed circumference. The body and strap assembly are formed continuously without interruption from a single piece of at least one polymeric material forming a homogenous structure. 
     In yet another exemplary embodiment, the orthopedic device consists a body having a monolithic structure and arranged to form a closed circumference in a secured configuration. The body has a predetermined shape in an unsecured configuration, and the body is formed continuously without interruption from at least one polymeric material. The body forms at least one fenestration region having a geometrical pattern with at least two fenestrations varying in size and/or dimension relative to one another. The body defines a band disposed about a periphery of the body, and the band encloses the at least one fenestration region. The body defines at least one rib extending from the band and adjacent to the at least one fenestration region. The at least one rib is devoid of fenestrations and defining a solid portion of material forming the body. The at least one rib being more rigid than the at least one fenestration region. 
     The features of these exemplary embodiments may be modified and combined with other features as described in the following description. 
     The methods described in this disclosure offer means for standardization of measurement of a user&#39;s anatomy that can be handled by clinicians and users in a simple manner with a minimum of instruments. It acknowledged that measurement means vary according to the location of the clinician and user; the methods of the disclosure offer a solution for standardizing the measurement process and a system enabling easy entry of the measurements and eventual fabrication of the orthopedic device. 
     Once the measurements are obtained and entered, the manufacturing process is generally centralized, uniform, or systematic and can be executed in a timely manner to yield a custom-fitted brace for treating a user&#39;s affected anatomy, but is nonetheless adaptable for actual fabrication and distribution of the orthopedic device at many geographical locations from the centralized system. 
     An exemplary method for measuring and making an orthopedic device includes the steps of: providing a schematic including a model representing a body part for which the orthopedic device is intended; providing at least one array of coordinates and indicia corresponding to the coordinates proximate to the model at a plurality of locations along the model; providing a scale set corresponding to the at least one array of coordinates; and taking measurements according to the at least one array of coordinates and indicia from an actual body part, and using the measurements to make a custom-fit orthopedic device. Additional steps and features concerning the exemplary method are described below in greater detail in the accompanying drawings and associated description. 
     The disclosure offers methods and systems for creating an orthopedic device that enable a generally accurate digital representation of a body part and which do not have the attendant drawbacks of known methods and systems for creating a digital representation of a body part according to parameters associated with pathologies and orthopedic rules. 
     These and other features, aspects, and advantages of the present disclosure will become better understood regarding the following description, appended claims, and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a perspective view of an embodiment of an orthopedic device in a hand brace. 
         FIGS.  2 A- 2 C  exemplify various perspective views of the hand brace of  FIG.  1    exemplifying a frame to the hand brace. 
         FIGS.  2 D- 2 F  exemplify various perspective views of a variation of the hand brace of  FIG.  1   . 
         FIG.  3 A  is a perspective view of a strap assembly in the hand brace of  FIG.  1   . 
         FIG.  3 B  is a cross-sectional view taken along line IIIB-IIIB in  FIG.  3 A . 
         FIG.  3 C  is a perspective view of another strap assembly embodiment. 
         FIG.  4    is a perspective view showing a variation of the hand brace of  FIG.  1   . 
         FIG.  5    is a perspective view showing another variation of the hand brace of  FIG.  1   . 
         FIG.  6 A  is an exemplary view of a fenestration pattern. 
         FIG.  6 B  is an exemplary view showing apertures in the fenestration pattern of  FIG.  6 A  useable in the hand brace of  FIG.  1   . 
         FIG.  7    is a perspective view showing another variation of the hand brace of  FIG.  1    with a functional fenestration pattern. 
         FIG.  8 A  is an exemplary schematic for measuring dimensions for forming the hand brace of  FIG.  1   . 
         FIG.  8 B  is an exemplary step of entering personal information in the schematic of  FIG.  8 A . 
         FIG.  8 C  is an exemplary step of gauging the dimensions of the schematic of  FIG.  8 A  versus a ruler. 
         FIG.  8 D  is an exemplary step of marking predetermined parts of a hand against the schematic of  FIG.  8 A . 
         FIG.  8 E  is an exemplary step of measuring a thickness of a thumb against the schematic of  FIG.  8 A . 
         FIG.  8 F  is an exemplary step of measuring a wrist circumference against a scale from the schematic of  FIG.  8 A . 
         FIG.  9    is an exemplary representation on a device of a data entry system for entering dimensions obtained from the schematic of  FIG.  8 A . 
         FIG.  10 A  is an exemplary flow chart depicting a first stage of a system for making the hand brace of  FIG.  1   . 
         FIG.  10 B  is an exemplary flow chart depicting a second stage of a system for making the hand brace of  FIG.  1    for use in conjunction with the first stage of  FIG.  10 A . 
         FIG.  10 C  is an exemplary flow chart depicting a third stage of a system for making the hand brace of  FIG.  1    for use in conjunction with the first and second stages of  FIGS.  10 A and  10 B . 
     
    
    
     The drawing figures are not drawn to scale, but instead are drawn to provide a better understanding of the components, and are not intended to be limiting in scope, but to provide exemplary illustrations. 
     DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS 
     A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements. 
     While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings and described below. It should be understood, however, there is no intention to limit the disclosure to the specific embodiments disclosed, but on the contrary, the disclosure covers all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure. 
     It will be understood that, unless a term is expressly defined in this disclosure to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning. 
     The disclosure generally relates to orthopedic devices, and discusses an example of such orthopedic devices in exemplary embodiments of a hand brace for treating complications of the hand, such as arthrosis/arthritis. Orthopedic devices for other body parts and indications may be constructed with features like those in the embodiment of the hand brace. Generally, the hand brace is conformal to a user&#39;s hand by closely corresponding to a digital representation and predetermined parametric of the user&#39;s hand. The sizing and extent of coverage of the hand brace over a user&#39;s hand may be determined during measuring and fabrication of the hand brace. 
     The hand brace is intended to be removable with a strap or fastening assembly for placing the hand brace in a closed circumference or loop forming a closed or secured configuration for retention on a user&#39;s hand, or in an open configuration for removal of the user&#39;s hand from the hand brace. It will be understood that by closed circumference, it is not intended that the hand brace be closed in its entirety, but rather at least a portion of the hand brace forms a closed circumference, such as by a strap and body of the hand brace. 
     Referring to  FIG.  1   , an orthopedic device  100  is in an exemplary form of a hand brace consisting a body  102  that is preferably formed as a single integrated structure from a structural material. The body  102  may be formed by additive manufacturing, three-dimensional printing machine, injection molding from a structural or composite material, such as a polymer or fiber reinforced material, combining polymer materials that are continuously molded together to be formed preferably without adhesives or fasteners, or by other suitable manufacturing techniques. 
     If there are multiple polymeric materials, they preferably have blended interfaces so that there is a transition of a first polymeric material to a second polymeric material, to avoid using separate adhesives or fasteners, but outside of the blended interface the first and second polymeric materials are distinctly separate from one another. In this example, different regions of the orthopedic device can be constructed from different polymeric materials suitable for structural areas (for example, rigidity), comfort (soft or harder materials), and other desirable properties. 
     Many materials can be used for making the orthopedic device, particularly those commonly used to print 3D objects, including but not limited to ABS plastic, PLA, polyamide (nylon), polypropylene and other thermoplastics, glass-filled polyamide, stereolithography materials (epoxy resins), silver, titanium, steel, wax, photopolymers and polycarbonate. 
     “Additive manufacturing” is understood as building three-dimensional objects by adding material layer-upon-layer. Common to additive manufacturing is the use of a computer, 3D modeling software (Computer Aided Design or CAD), machine equipment and layering material. Once a CAD drawing is produced, the additive manufacturing equipment reads in data from the CAD file and lays downs or adds successive layers of liquid, powder, sheet material or other material, in a layer-upon-layer fashion to fabricate a 3D object. The term additive manufacturing may encompass many technologies, including but not limited to subsets like 3D Printing, Rapid Prototyping (RP), Direct Digital Manufacturing (DDM), layered manufacturing, and additive fabrication. 
     In an exemplary embodiment, the body  102  entirely consists of the structural material in a continuous manner without interruptions in a homogenous structure of the body  102  formed by the structural material. As an alternative, the body  102  may be formed from different materials such as a first material forming a first region of the body  102  and a second material forming a second region of the body  102 , however it is preferable that the first and second regions blend or are continuous with one another. 
     In yet another alternative, the structural material may be the same across the entirety or substantial entirety of the body  102 , but may have different properties such as different resiliency, hardness, flexibility, or other desirable properties for a specified region. A first region may be heat treated or geometrically or dimensionally configured different from a second region. The first and second regions are formed from the same material but possess different properties. 
     The structural material may be rigid or semi-rigid, such that the body  102  conforms to the palmar and dorsal aspects of the user&#39;s hand, but retains its structure without yielding to movement of the hand when in the closed or secured configuration. The body  102  is sufficiently flexible to be tensioned over the affected area of the user as it is secured or placed in a closed configuration. The body  102  is resilient to return to a generally predetermined shape when the tension is released, and the body  102  or orthopedic device  100  is placed in an open or unsecured configuration, particularly during or over repeated uses. Additional features may be provided in combination with the body  102 , such as straps, therapeutic elements such as heating or cooling elements, padding, and other known features in conventional orthopedic devices. 
     In the embodiment of  FIG.  1   , the body  102  preferably defines a strap assembly or enclosure device  104  adapted to place the body  102  in the secured configuration and in an open configuration. The strap assembly  104  is part of the monolithic and homogenous structure of the body  102 , and is formed integrally with the remainder of the body  102  such that the strap assembly  104  is a unitary and continuous structure with the remainder of the body  102 . 
     The body  102  defines a band  106  disposed about a periphery of the body  102 , and the band  106  encloses at least one fenestration region  108 ,  110  defining a plurality of fenestrations formed by the body  102 . The band  106  extends about an entirety of the body  102 , including all peripheral sides enclosing the at least one fenestration region  108 ,  110 , and merging with the strap assembly  104  on opposed sides of the body  102 . 
     The body  102  defines at least one rib  112  extending from the band  106  and adjacent to at the least one fenestration region  108 ,  110 . The at least one rib  112  is devoid of fenestrations and defines a solid portion of material forming the body  102 . The at least one rib  112  extends between first and second opposed peripheral sides  130 ,  132  of the body  102 . The first peripheral edge  130  may be deemed distal to or directed from or further away from the user&#39;s center of the body or torso, whereas the second peripheral edge  132  may be proximal because it may be closer to the user&#39;s center of the body than the first peripheral edge  130 . The at least one rib  112  preferably merges into the band  106  along the first and second peripheral edges  130 ,  132 . The at least one rib  112  has greater rigidity than the at least one fenestration region  108 ,  110 , and preferably has rigidity greater than the band  106 . 
     As depicted in  FIG.  1   , the at least one rib  112  preferably has a width  138  that is greater than a width  136  of the band  106 , and the width of the at least one rib  112  may be variable depending on its location and its intended proximity to features of a human hand (i.e., joint, ligament, bone, nerves, etc.). The at least one rib  112  may have a thickness greater than the band  106 . The at least one rib  112  may have a greater thickness than the at least one fenestration region  108 ,  110 . While the body  102  may have a uniform thickness, it may alternatively have different or variable thicknesses. The band  106  may have a varying width about the periphery of the body  102  or a constant width. 
     In observing  FIGS.  1 - 2 C , the band  106  and the at least one rib  112 ,  113  define a frame  154  that extends around the at least one fenestration region  108 ,  110 . The frame  154  includes a thumb column  148  for embracing and maintaining an orientation of a thumb. The frame  154  is substantially more rigid than the at least one fenestration region  108 ,  110 . The frame  154  forms strength lines for the body  102  to maintain its shape and which border the at least one fenestration region  108 ,  110 . The at least one rib  112 ,  113  includes first and second ribs  112 ,  113  merging into a joined region  156 . 
     According to the depicted exemplary embodiment, the joined region  156  defines a widened region adapted to correspond to a carpal tunnel of user. A peripheral relief portion  126  corresponds to the joined region  156 , and other peripheral relief portions may be provided according to the treatment of an individual user. 
     The at least one fenestration region  108 ,  110  defines a pattern  114  including at least one aperture or void  140 ,  142 ,  144 . The at least one fenestration region  108 ,  110 , allows air to circulate around the user&#39;s hand, while providing sufficient structural rigidity to support the user&#39;s hand. The at least one aperture  140 ,  142 ,  144  includes first and second apertures  140 ,  142  defining different shapes and/or dimensions. The at least one fenestration region  108 ,  110  defines a frame  146  separating the at least one aperture  140 ,  142 ,  144 . 
     Referring to the embodiment of  FIG.  1   , the body  102  defines an opening  116  bordered by the at least one rib  112  and/or the band  106  and formed along a wall  115  of the body  102 . The opening  116  is located outside the at least one fenestration region  108 ,  110 , and has a size substantially larger than the at least one aperture  140 ,  142 ,  144 . The opening  116  is arranged for coinciding with a metacarpal phalangeal joint. 
     For geriatric and/or arthritic users, the metacarpal phalangeal joint may be or appear pronounced over a healthy or normal joint. The joint may have an irregular shape and significantly vary from user to user, so rather than customize and measure the joint for every user, it may be expedient to provide the opening  116  to relieve the joint regardless of size variations. The rigidity of the hand brace  100 , when worn, will significantly arrest the user&#39;s thumb, so a compromise of the irregular shape of the joint may be addressed while assuring that the thumb is retained in a fixed position, eliminating or reducing pressure on the user&#39;s joint and keeping it free from pain. 
     A thumb column  148  is sized and configured for supporting the thumb and arranging the thumb in a predetermined angulation relative to the remainder of the hand. The opening  116  may be located within a length of the thumb column  148 . The body  102  may define a lip  118  about a periphery of the opening  116  and radially extending from and relative to the thumb column  148 , to keep the opening  116  from any sharp edges and to offer enhanced strength about the opening  116  to prevent flexure of the thumb column  148 . The lip  118  can have a greater thickness than the at least one rib  112  and/or the band  106 . The thumb column  148  defines an outlet  120  from which a portion of a distal phalange of the thumb extends. The thumb column  148  may define a lip  121  extending about the outlet  120 , and is bordered by the at least one rib  112  and/or band  106 . 
     The thumb column  148  defines a first region  150  arranged for supporting a thumb metacarpal, and a second region  152  arranged for supporting a thumb proximal phalange including a metacarpal phalangeal joint. The opening  116  may be within the second region  152 , or between the first and second regions  150  and  152 . The first region  150  is preferably fixedly arranged at an angle different from an angle by which the second region  152  is fixedly arranged and different from the first region  150 . The angle of the first region  150  is arranged to maintain the thumb metacarpal in a fixed position for abduction and flexion. The thumb column  148  may be fixedly arranged at an angle  128  relative to a remainder of the body  102  outside the thumb column  148 . 
     The strap assembly  104  is integrally formed from the body  102  in that the body  102  and the strap assembly  104  are one and the same with one another and preclude attachments that are subsequently secured to the body  102 . The strap assembly  104  includes a strap  122  depending from a third peripheral side  134  of the body  102 . The strap  122  continuously extends laterally relative to the third peripheral side  134  and the band  106  located thereat in that the same material forming the band  106  extends into and forms the strap  122  without seams or interruption. The strap  122  is engageable with a bracket  124  carried by a fourth peripheral side  135  laterally opposed to the third peripheral side  134 , and is generally located between the first and second peripheral sides  130 ,  132 . 
     The bracket  124  is preferably integrally and continuously formed from the same material and structure forming the body  102 . Alternatively, the bracket  124  may be adhered or otherwise connected to the body  102 . Engagement of the strap  122  to the bracket  124  places the body  102  in a closed or secured configuration because an exterior E of the body  102  forms a continuous circumference, loop, or closed shape without interruption. Disengagement of the strap  122  from the bracket  124  places the body  102  in an open configuration because access is provided into an interior or interior surface I of the body  102 . 
       FIGS.  2 D- 2 F  illustrate another exemplary embodiment of an orthopedic device  160  in the form of a forearm/wrist brace made according to the methods and principles disclosed herein, since the wrist brace  160  is selectively adapted to provide enhanced support, such as along the forearm. The wrist brace  160  includes a forearm portion  161 , a wrist portion  162 , a hand portion  163  and a thumb portion  164  having a thumb hole  164 A. The wrist brace  160  includes at least two integrally formed strap assemblies  165 ,  166 , as discussed similarly in associated with the strap assembly  104  of  FIG.  1   , arranged to move edges  162 A,  162 B of the forearm and wrist portions  161 ,  162  relative to one another, and edges  163 A,  163 B of the hand portion relative to one another. 
     The wrist brace  160  may be selectively provided with openings, aside from fenestration regions, that are adapted in areas of the wrist brace that do not require additional support. A forearm opening  167 A is provided along the forearm portion  161 , yet a forearm support  167 B is likewise provided proximate the forearm opening  167 A to assure stabilization of the forearm, while maintaining the opening  167 A. The forearm opening  167 A may be along the dorsal aspect of the forearm, and the forearm support  167 B may be along the ventral aspect, to provide enhanced support. A similar opening  169  may be located along the dorsal aspect of the hand portion  163 . The thumb portion  164  may have an opening  168  to relieve the joint or a nerve, and serves as an example of how these openings  167 A,  168 ,  169  may be selectively and optionally provided during the ordering and fabrication of the orthopedic device  160 . 
     In addition to the fenestration regions, the orthopedic device  160  may define reinforcement sections or ribs  162 C,  162 D,  163 C that extend in predetermined areas where additional reinforcement is required. During the ordering process of the orthopedic device  160 , these reinforcement sections  162 C,  162 D,  163 C may be optional and selected depending on the areas of the patient requiring reinforcement, or they may be predetermined as default areas of the wrist brace  160 . The reinforcement sections  162 C,  162 D,  163 C may be adjusted depending on the measurements once entered and fabricated for a custom-fitted orthopedic device for an individual user. 
       FIG.  2 F  exemplifies by arrows F how the body of the wrist brace  160  may be semi-rigid because the body is arranged to flexibly conform and tension about a user because of tensioning of the strap assembly  165  to place the orthopedic device  160  in the secured configuration, by drawings the edges  162 A,  162 B toward one another. When in the secured configuration, both the structure, such as by the band, ribs, and fenestrations, each imparting structure yet flexibility and breathability to the body, and the inherent qualities of the material the body, such as the material being a polymeric material that may be with or without fiber reinforcement or other reinforcement, do not yield to movement of a user over which the body extends. Once the strap assembly  165  is released, however, the tension about the user&#39;s hand is reduced and the body may resiliently return to a predetermined shape corresponding to an open and unsecured configuration, which the body was in prior to being in the closed or secured configuration. 
     The apertures of the at least one fenestration region  108 ,  110  may define different patterns that may be uniformly or irregularly defined. The frame of the at least one fenestration region  108 ,  110  maintains sufficient rigidity throughout the at least one fenestration region  108 ,  110 , and enhances the overall rigidity and support of the hand brace  160  in combination with the at least one rib  113  and band  106 . While the at least one fenestration region  108 ,  110  depicted in the illustrated embodiments are shown the same in each region, the orthopedic device  160  may be provided with differently shaped or sized fenestration regions with apertures differently shaped according to the region, to modify ventilation and breathability characteristics and biomechanical features of the orthopedic device  160 . The at least one fenestration region  108 ,  110  lightens the orthopedic device  160  by providing ventilation and breathability to provide enhanced comfort for the user. Further, the user may have an option to select among different patterns to allow for aesthetic options, which may encourage the user to wear the orthopedic device throughout the duration of treatment by allowing for personalization of orthopedic device  160 . 
     Referring to  FIGS.  3 A and  3 B , the strap  122  includes a base  170  having an elongate form, a plurality of teeth  172  formed transversely along the base  170 , with each tooth of the plurality of teeth  172  having a tip  174 . The bracket  124  includes upper and lower portions  176 ,  184  between which a latch  178  is flexibly suspended and biased for engagement with at least one of tooth of the plurality of teeth  172 . The bracket  124  further defines a rear portion  186  extending between and connected to the upper and lower portions  176 ,  184  and from which an arm of the latch  178  extends. The latch  178  is biased from the rear portion  186  and towards the lower portion  184 . 
     The latch  178  is movable between the upper and lower portions  176 ,  184 . The latch  178  defines a tab  180  having an arcuately recessed profile and attached to a latch arm  182 . The tab  180  is shaped to accommodate a thumb for lifting the tab  180  upwardly toward the upper portion  176  away from the strap  122 . The latch  178  forms a detent profile  188  having a pair of teeth  190  adapted to engage one tooth of the plurality of teeth  172 , the detent profile  188  arranged to surround opposed sides of the tip  174  of the corresponding tooth of the plurality of teeth  172 . The plurality of teeth  172  defines a serrated profile, and the detent profile  188  corresponds in shape to the serrated profile of the plurality of teeth  172 . The bracket  124  may be monolithic and formed from the same material without interruptions or seams, or may be separately formed and adhered or otherwise connected to the body of the orthopedic device  100 . 
       FIG.  3 C  exemplifies another exemplary embodiment of a strap assembly  192  that may be similarly formed with and/or connected to the orthopedic device  100 . The strap assembly  192  includes a strap  194  that slides within a bracket  196 . The strap  194  has a cross-sectional profile  198  forming opposed ribs  201  alongside portions of the strap  194 . The bracket  196  defines opposed side portions  203  which form channels  205  into which the ribs  201  slide for stabilizing and directing movement of the strap  194  relative to the bracket  196 . The bracket  196  defines a tab  209  depending from a rear portion  207  and arranged for engaging a plurality of teeth  211  carried by the strap  194  that may be arranged in a manner like the strap assembly of  FIGS.  3 A and  3 B . Like the latch  178  of  FIGS.  3 A and  3 B , the tab  209  may have an arcuately recessed profile configured for receiving a user&#39;s thumb or finger. 
       FIG.  4    exemplifies another exemplary embodiment  171  of a hand brace including first and second sets of locking tabs  173  located on opposed sides of a frame of the hand brace  171 , and a strap  179  is engageable with the first and second sets of locking tabs  173  to bridge a distance between the first and second sets of locking tabs  173 . Each of the locking tabs  173  defines a stem  175  and a head  177  for engagement with corresponding structure on the strap  179 , such as openings adapted to receive and engage the head  177 . 
       FIG.  4    shows a variation of a fenestration region having a geometrical pattern  193  with apertures varying in size and/or dimension depending on their location at the body, exemplifying an irregular geometrical pattern (such as a Voronoi pattern or diagram) of apertures.  FIG.  5    shows a fenestration region having a geometrical pattern  191  with apertures a uniform size and/or dimension regardless on their location at the body. 
       FIG.  5    depicts another exemplary embodiment of the hand brace  181  wherein the body defines strap loops  187 ,  189  formed from the body for receiving a strap.  FIG.  5    exemplifies how any of the embodiments of the orthopedic device may have an exterior or interior surface for receiving therapeutic elements. The hand brace  181  defines a recess  183  adapted to receive a therapeutic element  185  and is configured for being located generally flush with the body of the device  181 . 
     Referring to  FIGS.  6 A and  6 B , a sample of a fenestration region  500  has a geometrical pattern forming first and second cube sets  502 ,  504  having alternating orientations relative to one another. Each of the first and second cube sets  502 ,  504  forms a frame  506 ,  514  surrounding at least three apertures  508 ,  510 ,  512 ,  516 ,  518 ,  520 , respectively, having varying sizes. The frame  506 ,  514  has a width that is generally the same although the at least three apertures  508 ,  510 ,  512 ,  516 ,  518 ,  520  vary in size. In this manner, the frame  506 ,  514  provides generally uniform support despite the at least three apertures  508 ,  510 ,  512 ,  516 ,  518 ,  520  being different in size and location. The frame  506 ,  514  may have varying widths to achieve biomechanical, functional and aesthetic purposes. 
     For example, a first width w 1  comprises the entire width of a pair of first and second cube sets  502 ,  504 . A second width w 2  represents the width of cube  504 , which comprises a fourth width w 4  of a frame element of frame  514  and a third width w 3  of aperture  516 . The fourth width w 4  may vary from fifth and sixth widths w 5 , w 6  corresponding to the cube set  502 , as necessary to achieve desired functions and dimensions. First and second heights H 1 , H 2  of frame  514  similarly may be chosen based on the dimensions of widths w 1 , w 2 , w 3 , w 4 , w 5 , w 6  and to achieve desired functions and dimensions. Likewise, a seventh width w 7  of aperture  510  relates to an eighth width w 8  of a frame element of frame  506  and a ninth width w 9 , which may be varied to achieve desired functions and dimensions. 
     The fenestration region  500  of  FIGS.  6 A and  6 B  offers a visual aspect or appearance of three dimensional cubes that enhances a three-dimensional impression, and offers a desirable balance between material and vacuity. The balance is achieved in that if there is too much vacuity and air, the fenestration region  500  will become fragile. If there is too much material in the pattern, the fenestration region  500  may fail to provide significant advantages as being insufficiently flexible. 
       FIG.  7    depicts how a hand brace  522  has at least one fenestration region  524  offering functionality by facilitating movement or fitting of the hand brace  522 . Fenestration region  524  defines elongate apertures  526  generally arranged laterally relative to the hand to improve flexibility and tightening of the hand brace  522  about the hand, as evidenced by arrows about the hand brace  522 . Further, a strap  528  includes the elongate apertures  526  in a fenestration region along its length to improve its flexibility when wrapping about the user&#39;s hand. The fenestration region  524  along the strap  528  may be used in combination with other fenestration regions having the same or differing geometrical patterns, each having functionality selected based on where the fenestration region is located on the hand brace  522 . 
     The fenestration region  524  is arranged to lay flat on the interior side or surface corresponding to the palmar and dorsal surfaces of the user. However, a variation of the fenestration region  524  may include an exterior side or side that may define various heights protruding or extending from the flat interior side or surface of the hand brace  522 , such as in the fenestration pattern  500  in the exemplary embodiment of  FIGS.  6 A and  6 B . Such varying heights may further enhance the strength of the hand brace  522  and offer additional functionality such as enabling discrete regions of enhanced flexibility, stiffness, or other desired frame properties imparted into the monolithic body of the hand brace  522 . 
       FIG.  8 A  illustrates a schematic or measurement form  200  that may be used for measuring anatomical portions to create an accurately dimensioned orthopedic device, such as the embodiments of the hand brace. Unlike prior art methods for creating a digital representation of a user&#39;s body part based on the methods discussed above, the schematic  200  offers a device, methodology, and system that is easy to use, less complex, and cost effective. The schematic  200  relies on taking measurements at predefined locations of a model  202 , such as one generalized as a hand in  FIG.  8 A . The measurements are used to create a parametric model of the user&#39;s hand while advantageously accounting for the irregularities and pathologies unique to the individual user in fabricating the orthopedic device. 
     The schematic  200  may be printed on paper, displayed on a suitable electronic display, or shown via any other suitable medium. If printed on paper, then a clinician or user needs only a writing implement, a ruler, and scissors. 
     The schematic  200  includes the model  202  representing a body part for which the orthopedic device is intended. The schematic  200  further includes at least one array of coordinates  210  and indicia  212 ,  214  corresponding to the coordinates proximate to the model  202  at a plurality of locations along the model  202 . A scale set  204  corresponds to the at least one array of coordinates  210 . Each of the coordinates  210  includes at least one locator  216  comparable to an actual body part relative to the model  202  for which the custom-fit orthopedic device is intended to treat and be worn. When using the schematic  200 , the at least one locator  216  may be marked on the schematic  200  based on a location of the actual body part relative to the model  202  in the array of coordinates  210 . 
     The size and shape of the at least one array of coordinates  210  may vary according to the location in the schematic  200 . For example, the array of coordinates  210  for measuring the thumb is both longer and wider than the array of coordinates  230 ,  232  for measuring between the thumb and index finger, or where the thumb transitions to the wrist. The array of coordinates  210  for measuring the thumb is likewise a different dimension than the array of coordinates for measuring the hand proximate the little finger  244  and the base of the hand  248 . As with the difference in size of the array of coordinates  210 , the indicia  212 ,  214  may be designated along horizontal and vertical axes, respectively, however sometimes only the vertical axis is needed, as in the array of coordinates  230 ,  232 . 
     As the scale of the schematic may vary depending on how a clinician receives the schematic  200 , the scale set  204  is provided to approximate the actual size of the user&#39;s hand. The scale set  204 , upon receipt for fabrication of the orthopedic device, can be compared to actual dimensions of an actual ruler to ascertain according to the indicia  208 , among the at least one scale  206 , to which scale the measurements can be indexed. The at least one scale  206  may be set to roughly five centimeters, and when fabrication is desired, the actual dimension of a ruler is measured against the at least one scale  206  and the correct indicia is chosen to scale up the schematic  200 . In this manner, a clinician can print the schematic  200  on different sized media, anywhere in the world. Essentially, the locators  216  are not tied specifically to a dimension, rather they are provided relative to the scale set  204 . 
     The schematic  200  displays at least one alignment target  218 ,  220 ,  226 ,  228 ,  240 ,  242 ,  246 ,  250  corresponding to a feature common to body parts such as an index finger of a hand. When comparing a user&#39;s hand to the model  202 , the clinician may align the actual hand to the at least one alignment target  218 ,  220 ,  226 ,  228 ,  240 ,  242 ,  246 ,  250 . At least one of the locators  216  corresponding to the at least one alignment target  218 ,  220 ,  226 ,  228 ,  240 ,  242 ,  246 ,  250  is marked according to the location of the actual body part. The schematic  200  displays at least one reference line  222 ,  224  over the model  202  for locating/placing the actual body part relative to the reference line  222 ,  224 . The at least one alignment target  218 ,  220 ,  226 ,  228 ,  240 ,  242 ,  246 ,  250  corresponds to the at least one reference line  222 ,  224 . 
     The schematic  200  defines a region  262  for measuring the thickness of the hand, finger(s), and thumb. The region  262  is defined by cut boundary  237  and baseline  236 , and includes a generally diagonal cut-line  239  along which at least one positioning line  238  is formed. A triangle, shown as  257  in  FIG.  8 E , is removed from the region  262 , and essentially from the schematic  200 , by cutting along the cut-line  239  and at least a baseline  236 . The hand, finger(s), or thumb can be inserted into the removed triangle void. The baseline  236  is aligned with a dorsal side of an actual hand and the thickness of the hand, finger(s) and thumb is obtained according to where at least one of the alignment targets  240 ,  242  intersects one of the plurality of sizing lines  234 . The baseline  236  and at least one positioning line  238  may be used for comparing at least two portions of the body part relative to one another, as noted above. The at least one positioning line  238  is arranged obliquely relative to the baseline  236 , and the at least one alignment target  240 ,  242  is located along the at least one positioning line  238 . 
     The schematic  200  displays at plurality of sizing lines  234  indexed incrementally away from the baseline  236 . The baseline  236  corresponds to the dorsal side of a hand, and the plurality of sizing lines  234  enable measurement of a thickness  258  of a thumb and a thickness  260  of a hand, such that the plurality of sizing lines  234  extends toward the palmar side of a hand. 
     The schematic  200  defines a region  251  having an elongate scale  256  for measuring a circumference or distance about a portion of a body part. The region  251  includes at least one cutting line  254  for removing the region  251  from the schematic  200 . The elongate scale  256  includes a slit or baseline  252  for measuring a length of the circumference or distance about the portion of the body part. The slit  252  enables the elongate scale  256  to extend therethrough for measuring a circumference of a wrist. 
     The schematic  200  may be provided on a single sheet of paper or similar medium. The schematic  200  can be provided on differently sized mediums without impeding its usability. A clinician in the U.S.A. can print the schematic  200  on a standard sheet of paper of 8.5×11 inches (216×279 millimeters), and a clinician in Europe can obtain the schematic  200  on an A4 sized medium 210×297 millimeters (8.27×11.69 inches). The scale set  204  enables a determination of an approximation of how the locators  216  should be measured in actual dimensions. 
     The schematic  200  may be printed or formed so it is non-language specific. This is advantageous in that the schematic  200  can be used in different countries without the necessity of printing different languages thereon. 
       FIGS.  8 B- 8 F  exemplify possible steps for making measurements of a wrist and hand in view of the schematic  200 , considering the features provided by the schematic  200 . 
       FIG.  8 B  shows a step of filling out at least one field with the user information. The field  215  may also specify the type of orthopedic device desired for fabrication. While the schematic  200  is directed to measuring a hand, different wrist or hand braces may be obtained by the schematic  200 . This may include a brace for supporting a thumb while permitting wrist movement, and the thumb and wrist support, or only wrist support. The field  215  may be useable if it is scanned for entry into a system for ordering the orthopedic device. 
       FIG.  8 C  shows a step of measuring or gauging the scale of the schematic  200  versus a ruler  217  for determining relative dimensions. Since the schematic  200  may deviate from the actual size or length in which it was published, it is necessary to determine the scale of the schematic  200  versus actual dimensions of a ruler  217 , establishing the relative dimension of the schematic  200  to actual dimensions of a ruler  217 . In this step, the ruler  217  is compared to a scale set  219  representing the dimension of a ruler that must be compared to the schematic  200 . The scale set  219  resembles 5 cm which is compared to alignment locators  221  on the schematic  200 . Once the scale target dimension  225  of 5 cm is compared to the alignment locators  221 , the appropriate box  223  of the locators is selected as a comparison of what the schematic  200  considers the dimension versus the actual linear measurement of the ruler  217  at the target dimension  225 . 
       FIG.  8 D  shows measuring a hand H aligned to the at least one alignment target  218 ,  220 ,  226 ,  228 ,  240 ,  242 ,  246 ,  250  in  FIG.  8 A . The hand H is aligned with the reference line  222  and the reference line  224 . Markings  227 A- 227 F are placed in the arrays of coordinates  210  at corresponding locators  216  by a writing implement  229 . Each of the locators  216  is indexed to coordinates  210 , such that locators  216  can be entered by the clinician when ordering the orthopedic device. This process enables the ordering of the orthopedic device to easily determine where strategic locations of the measured hand are found, without the necessity of numerous measurements, but rather simply by transposing the hand of the schematic according to the reference line  222  and reference line  224 . 
       FIG.  8 E  shows measuring the thumb T of the user according to region  262 . The thumb T is placed within the triangle  257  and placed against the base line  236 . The thickness T W  of the thumb T is determined between the base line  236  against the sizing lines  234  along the at least one positioning line  238 . The thickness of the thumb T is placed in a measurement field  241  on the schematic  200 . The triangle  257  is advantageous because it allows for measurements of different portions of the hand including the thickness of the thumb, any of the fingers, the hand, and the thenar of the thumb (the rounded fleshy part of the hand at the base of the thumb). The schematic  200  in the measurement field may require the thickness of the thumb at a predetermined location, a thickness of the hand such as at the inter-phalangeal joint, and a thickness of the thenar of the thumb. 
       FIG.  8 F  shows how the region  251  is removed from the schematic  200  and used to measure the circumferences of the wrist W. The region  251  is slipped through a slit  252  about the wrist W, so the relative dimension or circumference of the wrist W can be determined by aligning the circumference on the elongate scale  256  to the target  253 . The relative dimension according to the elongate scale  256  is entered in a field  259  on the schematic  200 . 
     In an alternative, the schematic  200  is provided by a portable digital device or computer. The portable digital device, such as a tablet, can sense the dimensions of the body part as it is placed on the screen. In yet another alternative, a computer may have a camera that measures the predefined locations on a comparable schematic for entering the measurements. 
       FIG.  9    exemplifies how the measurements may be entered in an ordering system. In the example of  FIG.  9   , the measurements are entered by software on a portable digital device  300 . The coordinates obtained from the schematic  200  are entered onto a form  302 , such as a measurement page by prompting a user to enter a measurement  304  according to one of the at least one array of coordinates in at least one field  312 ,  314 . The body part  306  is depicted to prompt the user where the measurement  304  is found. The form  302  exemplifies a guidance  310  at a location  308  of the measurement on the depicted body part  306 . The form  302  specifies the status  316  of the entry of measurements obtained from the schematic  200 . 
       FIGS.  10 A- 10 C  illustrate an exemplary method for fabricating an orthopedic device. The method involves obtaining at least one measurement  422  of a body part from a user in a step  400 A, the step entering the at least one measurement  422  of the body part in an order request  400 B, and the step of fabricating the orthopedic device based on the at least one measurement  422  entered into the order request step  400 C. A virtual model or digital representation of the user&#39;s body part is created 436 upon importing  416  the at least one measurement  422 . 
     According to the step  400 A in  FIG.  10 A , the schematic  200  discussed above is used to measure the dimensions of a user  402 . A help system  404  is provided if a clinician has questions on how to proceed with measurement and ordering of the orthopedic device, and there may be live support  406  enabled through various communication means. The ordering system  408  of the orthopedic device may be conducted through a website or other electronic portal based on many known platforms  421  and with client contact  423 . The ordering system  408  may include a tutorial  424  for showing how to obtain the at least one measurement  42  from the user  402 , and it will be understood that the step  400 A is not limited to measuring according to using the schematic  200  discussed above. The ordering system  408  may require a set up process  410 . The ordering system  408  may include a catalog  426  showing different orthopedic devices that may be used according to the method for fabricating the orthopedic device. 
     Referring to  FIG.  10 B  showing order request step  400 B, appropriate login information  428  may be required for making the order. At login, various inquiries  412  may be required for answering to establish the user&#39;s information for the orthopedic device. The patient/clinic type  430  may be requested. After login, the measurements are entered  414  for customizing the orthopedic device in measurement form  432 , according to the measurements obtained in the step  400 A. Once the measurements are entered  414 , appropriate purchasing information may be required to complete an order  434 . After such information is entered into the ordering system, the information is imported  416  into the manufacturing system according to the step  400 C. 
       FIG.  10 C  exemplifies step  400 C, in that the imported information is used to manufacturing the orthopedic device. The manufacturing process preferably employs additive manufacturing, however the method may be used for other manufacturing processes of an orthopedic device. For sake of this explanation, additive manufacturing will be assumed as the means for manufacturing the orthopedic device. 
     A virtual model of the orthopedic device is developed from the imported information and prepared for manufacturing an actual orthopedic device  436 . The virtual file is sent  438  to a facility or printing mechanism, and the printing mechanism forms the orthopedic device  436  by additive manufacturing  440 . Once the orthopedic device  436  is prepared, it is inspected  442 . If the orthopedic device  436  passes inspection, there may be post assembly  444  including adding strap, belts, fasteners, and other suitable connectivity features, and therapeutic elements such as heating or cooling patches, padding, packs with analgesics, or other known therapeutic elements. Once completed, the orthopedic device  436  is sent to the clinician or user  446 . During the manufacturing process, the clinician or user may check the status of the process to determine when the orthopedic device  436  will be finished  420 . 
     During or when the virtual model of the orthopedic device  436  is created, a quality control feedback  448  is provided for determining whether the measurements are correct according to a virtual model  450  and predetermined criteria  452 . The inspection may be done manually by an individual reviewing the virtual model  450  or automatically by software according to the predetermined criteria  452 . A decision is made  454  whether any defects in the virtual model  450  are reparable  456  or not  458 . If the defects are reparable  456 , adjustments are made  460  to the virtual model prior to manufacturing. If the defects are not reparable  458 , the clinician and/or user is contacted and new measurements or further consultation is conducted. 
     The orthopedic device, method and system for making the orthopedic device provide an improvement by more accurately capturing the dimensions and features of a user via a standardized format for measuring a user&#39;s affected limb or body part. By obtaining more accurate measurements than existing virtual fittings, the orthopedic device advantageously provides an aesthetically pleasing orthosis with improved pressure distribution, comfort, breathability, and support, enhancing user compliance during treatment and overall treatment outcomes. The system and method further provide an efficient and systematic manufacturing process for fabricating the orthopedic device. 
     While the foregoing embodiments have been described and shown, alternatives, reversal of parts, and modifications of these embodiments, such as those suggested by others may be made to fall within the scope of the disclosure. Reference characters are provided in the claims for explanatory purposes only and are not intended to limit the scope of the claims or restrict each claim limitation to the element shown in the drawings and identified by the reference character. 
     The constructions described above and illustrated in the drawings are presented for example only and are not intended to limit the concepts and principles of the present disclosure. As is evident from the foregoing description, certain aspects of the present disclosure are not limited by the details of the examples illustrated, and other modifications and applications, or equivalents thereof, will occur to those skilled in the art. The terms “having” and “including” and similar terms as used in the foregoing specification are used in the sense of “optional” or “may include” and not as “required.” 
     Many changes, modifications, variations and other uses and applications of the present construction will, however, become apparent to those skilled in the art after considering the specification and the accompanying drawings. All such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the disclosure are deemed covered by the disclosure limited only by the claims which follow.