US20220183871A1

US20220183871A1 - Additive manufacturing techniques for orthotics

Info

Publication number: US20220183871A1
Application number: US17/547,502
Authority: US
Inventors: Aaron FLORES; Antonio Dias; Justin Mieth
Original assignee: Hanger Inc
Current assignee: Hanger Inc
Priority date: 2020-12-11
Filing date: 2021-12-10
Publication date: 2022-06-16
Also published as: US20220183861A1; US20220183860A1

Abstract

An orthotic device for a patient's foot includes a shell that is configured to structurally support the patient's foot. The shell has a variable thickness along a dimension of the shell. The shell is configured to undergo flexion throughout the shell. The variable thickness of the shell targets areas of increased stress.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATION

This application claims the benefit of and priority to U.S. Provisional Application No. 63/124,230, filed Dec. 11, 2020, the entire disclosure of which is incorporated by reference herein.

BACKGROUND

The present disclosure relates generally to prosthetics and orthotics. More particularly, the present disclosure relates to additive manufacturing or protective devices, prosthetics and/or orthotics.

SUMMARY

One embodiment of the present disclosure is an orthotic device for a patient's foot, according to some embodiments. In some embodiments, the orthotic device includes a shell that is configured to structurally support the patient's foot. In some embodiments, the shell has a variable thickness along a dimension of the shell. In some embodiments, the shell is configured to undergo flexion throughout the shell. In some embodiments, the variable thickness of the shell targets areas of increased stress.
In some embodiments, the orthotic device is a shoe insert configured to be worn on the patient's foot. In some embodiments, the shell is configured to completely contain a heel of the patient's foot. In some embodiments, the shell is configured to provide medial support for the patient's foot.
In some embodiments, the shell is configured to provide lateral support for the patient's foot. In some embodiments, the shell is configured to undergo deformation without sustaining structural damage.
In some embodiments, a thickness of the shell at a first longitudinal position of the shell is different than a thickness of the shell at a second longitudinal position of the shell. In some embodiments, the variable thickness is configured to accommodate for differences in an anatomical structure of the patient's foot.
In some embodiments, the orthotic device is configured for use with a patient having valgus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot. In some embodiments, the orthotic device is configured for use with a patient having varus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot. In some embodiments, a geometric shape and the variable thickness of the shell are configured to account for unique anatomical structure of the patient's foot to relieve stress along edges, sides, and a bottom of the patient's foot.
Another implementation of the present disclosure is a method for manufacturing an orthotic device for a patient's foot, according to some embodiments. In some embodiments, the method includes using a digital scanner to capture an anatomical structure of the patient's foot and generate a patient scan file. In some embodiments, the method also includes modifying the patient scan file into a device shape, creating a printer-compatible file for an additive manufacturing device, and additively manufacturing the printer-compatible file using the additive manufacturing device to generate the orthotic device.
In some embodiments, the device shape is a schematic of the orthotic device. In some embodiments, the method further includes converting the schematic of the orthotic device that captures the anatomical structure of the patient's foot to a computer assisted design (CAD) file or a computer assisted manufacturing (CAM) file.
In some embodiments, modifying the patient scan file includes using at least one of a buildup technique or a reduction technique to generate the printer-compatible file so that the printer-compatible file accommodates the anatomical structure of the patient's foot. In some embodiments, additively manufacturing the printer-compatible file includes providing layers of material on top of each other in succession to produce the orthotic device.
Another embodiment of the present disclosure is an orthotic device for a patient's foot manufactured using additive manufacturing, according to some embodiments. In some embodiments, the orthotic device includes a shell configured to structurally support the patient's foot, the shell having a variable thickness along a dimension of the shell. In some embodiments, the variable thickness of the shell increases at areas of increased stress.
In some embodiments, the shell is configured to undergo flexion throughout the shell. In some embodiments, the orthotic device is configured for use with a patient having valgus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot. In some embodiments, the orthotic device is configured for use with a patient having varus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements, in which:

FIG. 1 is a front view of a foot orthotic device, according to some embodiments.

FIG. 2 is a side view of the foot orthotic device of FIG. 1, according to some embodiments.

FIG. 3 is a top view of the foot orthotic device of FIG. 1, according to some embodiments.

FIG. 4 is a flow diagram of a process for manufacturing the foot orthotic device of FIGS. 1-3, according to some embodiments.

FIG. 5 is a system for additive manufacturing that can be used to manufacture the foot orthotic device of FIGS. 1-3, according to some embodiments.

DETAILED DESCRIPTION

Before turning to the FIGURES, which illustrate the exemplary embodiments in detail, it should be understood that the present application is not limited to the details or methodology set forth in the description or illustrated in the FIGURES. It should also be understood that the terminology is for the purpose of description only and should not be regarded as limiting.

Overview

Referring generally to the FIGURES, additive manufacturing is used to produce orthotic devices with variable wall thickness. The variable wall thickness facilitates improved fit and comfort, and can facilitate distribution of stresses. The foot orthotic device is a shoe insert designed to stabilize and support the foot to give to the wearer increased gait and general movement control, according to some embodiments.
In some embodiments, the orthotic device has a variable cross section thickness. The differing thickness of the orthotic device is based on an anatomical foot structure of the patient, according to some embodiments. In some embodiments, the varying thickness provides flexibility in needed areas and increased structural support in others.
In some embodiments, the orthotic device is produced using additive manufacturing. The method of producing the device includes taking a three dimensional file of the wearer's foot and applying buildups and modifications to create a new computer assisted design (CAD)/computer assisted manufacturing (CAM) schematic of the device, according to some embodiments. The CAD/CAM schematic is uploaded to the 3D printer where the device is constructed layer by layer in accordance to the previously mentioned buildups and modifications, according to some embodiments. The end result is a foot orthotic with variable thickness that is configured to conform to the anatomical structure of the patient, according to some embodiments.
The techniques described herein for additive manufacturing can additionally be used to manufacture the prosthetic, orthotic, connection insert, or related medical devices as described in U.S. Patent Application Pub. No.: 2018/0353308 A1, filed Jul. 31, 2018, the entire disclosure of which is incorporated by reference herein. Further, any of the additive manufacturing techniques as described in U.S. Patent Application Pub. No.: 2018/0353308 A1 may be used to manufacture any of the devices described herein.
In some embodiments, the prosthetic, orthotic, connection insert, protective device, etc., as described herein are manufactured using any of the techniques as described in U.S. Pat. No.: 10,766,246 B2, filed Dec. 15, 2014, the entire disclosure of which is incorporated by reference herein.

Orthotic Device

Referring particularly to FIGS. 1-3, an orthotic device, a foot insert, a shoe insert, a foot orthotic device, etc., shown as orthotic device 200 is shown, according to some embodiments. Orthotic device 200 may be configured to stabilize and support a patient's food to give the patient improved gait and movement control. The orthotic device 200 can have a variable thickness throughout. The variable or differing thickness of orthotic device 200 can be based on anatomical foot structure of the patient to provide differing flexibility in required areas and improve structural support in other areas. Orthotic device 200 can be manufactured, fabricated, or constructed using additive manufacturing techniques such as 3d printing.
Referring still to FIGS. 1-3, orthotic device 200 includes a shell, a structural member, a sidewall, etc., shown as shell 201. Shell 201 can be flexible throughout. In some embodiments, shell 201 has differing thicknesses or elasticities throughout. In some embodiments, shell 201 is configured to receive a patient's foot so that the patient's foot rests on top of the shell 201 with contours of shell 201 aligning with contours of the patient's foot. For example, shell 201 can include a heel portion 202 that is configured to receive a patient's heel. Shell 201 can also include a distal medial contour 206 that matches or corresponds to a distal medial contour of the patient's foot. Shell 201 can also include a distal lateral contour 204 that matches or corresponds to a distal lateral contour of the patient's foot. Shell 201 can have an overall length 208 that matches or corresponds to an overall length of the patient's foot.
As shown in FIG. 3, shell 201 can also include flaring 214 on a front edge of a medial side 210 of shell 201. In some embodiments, the flaring 214 is configured to conform to the first metatarsal head of the patient's foot. The flaring 214 can be adjusted or deformed plastically by applying heat and a force to the shell 201.
Shell 201 can also include flaring 216 on a front edge of a lateral side 212 of shell 201. In some embodiments, the flaring 216 is configured to conform to the fifth metatarsal head of the patient's foot. The flaring 216 can be adjusted or deformed plastically by applying heat and a force to the shell 201.
Shell 201 can also include a medial side arch portion 218 and a lateral side arch portion 220. In some embodiments, thickness of shell 201 is targeted or adjusted (e.g., increased or decreased) at the medial side arch portion 218 or the lateral side arch portion 220 during design or manufacturing of shell 201. In this way, shell 201 can have thickness at the medial side arch portion 218 or the lateral side arch portion 220 to provide a desired amount of flexibility or support at these areas.
Referring particularly to FIG. 3, shell 201 can include a thickness 222. The thickness 222 can be measured between an outer periphery or an outer edge of shell 201 and an inner periphery or an inner edge of shell 201 at a particular point. Shell 201 can have a variable thickness 222 throughout. For example, the medial side arch portion 218 and the lateral side arch portion 220 can have increased thickness relative to the flaring 216, the flaring 214, etc. In some embodiments, the thickness 222 of different areas or portions of shell 201 results in additional support or flexibility of shell 201. For example, increased thickness of shell 201 may correspond to improved support, whereas areas with decreased or lower thickness may undergo higher amounts of flexion. The amount of flexion or deformation may be inversely proportional to thickness 222.
In some embodiments, a geometry or thickness of shell 201 is configured to target areas of high stress of the patient's foot. For example, areas with higher stress may require additional support and can therefore have added thickness. In some embodiments, the geometry and/or thickness of shell 201 is configured to distribute forces applied to shell 201 by the patient's foot across an increased surface, thereby reducing pressure at a single point. In some embodiments, the thickness can be increased or decreased at different portions or areas of the shell 201 during the design of shell 201 to target areas of increased stress on the patient's foot. For example, the thickness 222 of the medial side 210 or the lateral side 212 of shell 201 may be greater than other areas of shell 201 based on requirements of the patient's foot. Similarly, contouring of the medial side 210 and/or the lateral side 212 can be configured based on requirements of the patient's foot.
In some embodiments, different supporting portions of shell 201 have thickness 222 that is proportional to corresponding anatomy of the patient's foot to relieve stress across the patient's foot. The variable thickness 222 of shell 201 can provide variable flexibility throughout shell 201. The shell 201 of orthotic device 200 can be adjusted by applying heat and a force to shell 201. For example, the overall length 208 of shell 201 can be adjusted to fit the requirements of the patient's foot. Similarly, dimensions of the heel portion 202 can be modified to fit the requirements of the patient's foot. Similarly, any of a first metatarsal head cutout or contour, a length from an apex of the heel to the first metatarsal head cutout or contour, a fifth metatarsal head cutout or contour, a length from the apex of the heel to the fifth metatarsal head cutout or contour, a medial arch cutout or contour, a lateral arch cutout or contour, a distal medial contour, a distal lateral contour, a tapering amount of a medial supporting vertical wall, or a tapering amount of a lateral supporting vertical wall of shell 201 can correspond to, or be adjusted (during design of shell 201) based on requirements of the patient's foot.
In some embodiments, shell 201 is configured to provide structural support to the patient's foot to supplement anatomical structures of the patient's foot. In some embodiments, shell 201 is configured to improve or increase support for the patient's foot by relieving pressure from high stress areas of the patient's foot using targeted increase and reductions in the thickness 222 of shell 201. In some embodiments, shell 201 is configured for use with a patient that has valgus of the foot by providing gradual offset to account for excessive leaning of the patient's foot. Similarly, shell 201 can be configured for use with a patient that has varus of the foot by providing gradual offset to account for excessive leaning of the patient's foot.
The shell 201 has thickness 222 that may transition between different spatial locations along the shell 201. The thickness 222 of the shell 201 may be uniform or may vary spatially at different positions. For example, areas of the shell 201 that are anticipated or expected to undergo higher stress may have an increased thickness relative to other areas that are expected to undergo lower stress during use of the orthotic device 200 (or vice versa). In some embodiments, different areas of the shell 201 that should deform to a shape of the user's residual limb have a decreased thickness to facilitate controlled flexing or bending of the shell 201 to facilitate comfort and proper fit of the shell 201. In some embodiments, the thickness of the shell 201 increases from one end to another end of the shell 201 so that the thickness of the shell 201 proximate the one end is greater than thickness of the shell 201 at the other end. In some embodiments, variation of the thickness of the shell 201 is configured based on patient activity level, weight, etc.
Referring now to FIG. 4, a process 800 for producing or manufacturing the orthotic device 200 of FIGS. 1-3 is shown, according to some embodiments. Process 800 includes steps 802-812 and can be performed using an additive manufacturing system (e.g., system 1300 as described in greater detail below with reference to FIG. 5).
Process 800 includes scanning a patient's foot (step 802), according to some embodiments. In some embodiments, step 802 is performed using a scan device or a 3d scanner (e.g., scan device 1312 as described in greater detail below with reference to FIG. 5). In some embodiments, performing step 802 results in the generation of a scan file.
Process 800 includes modifying a patient scan file into a device shape (step 804), according to some embodiments. In some embodiments, the device shape is a schematic of the orthotic device. For example, step 804 can include receiving one or more user inputs (e.g., from a health care provider) to adjust the thickness (e.g., increase or decrease the thickness) of a CAD file at different areas or locations (e.g., at any of a first metatarsal head cutout or contour, a length from an apex of the heel to the first metatarsal head cutout or contour, a fifth metatarsal head cutout or contour, a length from the apex of the heel to the fifth metatarsal head cutout or contour, a medial arch cutout or contour, a lateral arch cutout or contour, a distal medial contour, a distal lateral contour, etc., of the CAD file or the patient scan file). In some embodiments, step 804 includes adding or removing material at any of the different areas to achieve a desired thickness. Step 804 can be performed by computer system 1302 of system 1300, described in greater detail below with reference to FIG. 5.
Process 800 includes creating a printer-compatible file for a device (e.g., the orthotic device 200) (step 806), according to some embodiments. Process 800 also includes uploading the printer-compatible file for the device to a printer (step 808), according to some embodiments.
In some embodiments, steps 806 and 808 are performed by computer system 1302 and 3d printer 1314 of system 1300 as described in greater detail below with reference to FIG. 5.
Process 800 includes printing the printer-compatible file for the device to generate a 3d printed device (e.g., orthotic device 200) (step 810), according to some embodiments. Step 810 can be performed by an additive manufacturing machine or 3d printer 1314 of system 1300 as described in greater detail below with reference to FIG. 5. In some embodiments, step 810 includes performing additive manufacturing (e.g., dispensing or outputting layers consecutively on top of each other) to produce the device. In some embodiments, the additive manufacturing is performed using a single uniform material such as a thermoplastic (e.g., nylon). The resulting device or 3d printed component can have variable thickness as defined by the printer-compatible file.
Process 800 incudes performing post-processing of the 3d printed device (step 812), according to some embodiments. For example, step 812 can include removing excess material that is dispensed during step 810 (e.g., during fabrication of the device). Step 812 can include applying heat to plastically deform the 3d printed device. Step 812 can be performed by a technician. Additional post-processing can be performed based on anatomy or needs of the patient.

Additive Manufacturing System Architecture

Referring now to FIG. 5, a system 1300 for additive manufacturing of prosthetic, orthotic, or protective devices is shown, according to some embodiments. System 1300 includes a user device 1310, a display device 1316, a computer system 1302, a scan device 1312, and a 3d printer or additive manufacturing machine 1314.
Computer system 1302 is configured to receive scan data from scan device 1312, according to some embodiments. Computer system 1302 can be a desktop computer, a laptop, a remote computing system, a smart phone, a tablet, a personal computing device, etc. Computer system 1302 includes a processing circuit 1304 having memory 1308 and a processor 1306. Processor 1306 can be implemented as a general-purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a group of processing components, or other suitable electronic processing components.
Memory 1308 (e.g., memory, memory unit, storage device, etc.) may include one or more devices (e.g., RAM, ROM, Flash memory, hard disk storage, etc.) for storing data and/or computer code for completing or facilitating the various processes, layers and modules described in the present application. Memory 1308 may be or include volatile memory or non-volatile memory. Memory 1308 may include database components, object code components, script components, or any other type of information structure for supporting the various activities and information structures described in the present application. According to an exemplary embodiment, memory 1308 is communicably connected to processor 1306 via processing circuit 1304 and includes computer code for executing (e.g., by processing circuit 1304 and/or processor 1306) one or more processes described herein.
Computer system 1302 can be configured to run CAD computer software to facilitate the design and production of any of prosthetic socket 100, orthotic device 200, and/or protective device 300. Computer system 1302 is configured to receive scan data from scan device 1312, according to some embodiments. In some embodiments, the scan data is a scan file obtained from scan device 1312. In some embodiments, a technician may scan device 1312 to scan a patient's residual limb or a cast of the patient's residual limb, thereby generating the scan data.
When the scan data is provided to computer system 1302, computer system 1302 can generate a CAD or CAM file. A user (e.g., a health care provider) can then provide inputs (e.g., via user device 1310) to adjust geometry, thickness, etc., of the CAD or CAM file. More generally, computer system 1302 may use the scan data to generate a digital representation of a device to be manufactured for the patient's residual limb. Computer system 1302 can provide display data to display device 1316 (e.g., a computer screen, a display screen, etc.) so that the digital representation is visually displayed in real-time. The user or health care provider can then view real-time changes or updates as the user changes or adjusts the CAD or CAM file.
For example, the user may adjust the CAD or the CAM file so that the design gradually tapers or thickens in different areas. In some embodiments, the user or the health care provider may use data from different experiments to identify areas where a patient may experience high stress. The user may decrease thickness of the CAD or CAM file at areas where high stress is experienced so that the 3d printed device may flex or deform. This can allow the 3d printed device to be more comfortable for the patient. In some embodiments, thickness of the 3d printed devices is maintained above a minimum thickness value. The user can also use knowledge regarding different weight lines of the patient to determine which areas of the CAD or CAM file/model should have decreased or increased thickness. The user may also use historical data to determine which areas or portions of the 3d printed device or the CAD/CAM file/model should have increased or decreased thickness (e.g., wall thickness).
Once the user (e.g., the health care provider) has adjusted or manipulated the CAD/CAM file/model, the user can prompt computer system 1302 to export the file/model to 3d printer 1314 as print data. Computer system 1302 can convert the adjusted, manipulated, or updated CAD/CAM file/model to a file type that is compatible with 3d printer 1314 (e.g., a Standard Tessellation Language (STL) file). Computer system 1302 then provides the print data to 3d printer 1314.
The 3d printer 1314 can be any additive manufacturing machine or device that is configured to successively provide or discharge layers of material onto each other to form or construct a part. 3d printer 1314 may be configured to dispense material (e.g., one or more powder materials that can form nylon when combined with fusing/detailing agents and exposed to fusing light, or any other dispensable materials) in layers to fabricate the CAD/CAM file.
Advantageously, the systems and methods described herein can be used to produce 3d printed prosthetics, orthotics, or protective devices. Traditional molding methods do not offer the same flexibility of variable wall thickness as does additive manufacturing. The variable wall thickness is achieved using additive manufacturing (e.g., 3d printing) and can facilitate improved fit, comfort, and stress distribution.

Configuration of Exemplary Embodiments

As utilized herein, the terms “approximately”, “about”, “substantially”, and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the invention as recited in the appended claim.
It should be noted that the terms “exemplary” and “example” as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such term is not intended to connote that such embodiments are necessarily extraordinary or superlative examples).
The terms “coupled,” “connected,” and the like, as used herein, mean the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent, etc.) or moveable (e.g., removable, releasable, etc.). Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another.
References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below,” “between,” etc.) are merely used to describe the orientation of various elements in the figures. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.
Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, Z, X and Y, X and Z, Y and Z, or X, Y, and Z (i.e., any combination of X, Y, and Z). Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present, unless otherwise indicated.
It is important to note that the construction and arrangement of the systems as shown in the exemplary embodiments is illustrative only. Although only a few embodiments of the present disclosure have been described in detail, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements. It should be noted that the elements and/or assemblies of the components described herein may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present inventions. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the preferred and other exemplary embodiments without departing from scope of the present disclosure or from the spirit of the appended claim.

Claims

What is claimed is:

1. An orthotic device for a patient's foot, the orthotic device comprising:

a shell configured to structurally support the patient's foot, the shell having a variable thickness along a dimension of the shell;

wherein the shell is configured to undergo flexion throughout the shell;

wherein the variable thickness of the shell targets areas of increased stress.

2. The orthotic device of claim 1, wherein the orthotic device is a shoe insert configured to be worn on the patient's foot.

3. The orthotic device of claim 1, wherein the shell is configured to completely contain a heel of the patient's foot.

4. The orthotic device of claim 1, wherein the shell is configured to provide medial support for the patient's foot.

5. The orthotic device of claim 1, wherein the shell is configured to provide lateral support for the patient's foot.

6. The orthotic device of claim 1, wherein the shell is configured to undergo deformation without sustaining structural damage.

7. The orthotic device of claim 1, wherein a thickness of the shell at a first longitudinal position of the shell is different than a thickness of the shell at a second longitudinal position of the shell.

8. The orthotic device of claim 1, wherein the variable thickness is configured to accommodate for differences in an anatomical structure of the patient's foot.

9. The orthotic device of claim 1, wherein the orthotic device is configured for use with a patient having valgus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot.

10. The orthotic device of claim 1, wherein the orthotic device is configured for use with a patient having varus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot.

11. The orthotic device of claim 1, wherein a geometric shape and the variable thickness of the shell are configured to account for unique anatomical structure of the patient's foot to relieve stress along edges, sides, and a bottom of the patient's foot.

12. A method for manufacturing an orthotic device for a patient's foot, the method comprising:

using a digital scanner to capture an anatomical structure of the patient's foot and generate a patient scan file;

modifying the patient scan file into a device shape;

creating a printer-compatible file for an additive manufacturing device; and

additively manufacturing the printer-compatible file using the additive manufacturing device to generate the orthotic device.

13. The method of claim 12, wherein the device shape is a schematic of the orthotic device.

14. The method of claim 13, further comprising:

converting the schematic of the orthotic device that captures the anatomical structure of the patient's foot to a computer assisted design (CAD) file or a computer assisted manufacturing (CAM) file.

15. The method of claim 12, wherein modifying the patient scan file comprises:

using at least one of a buildup technique or a reduction technique to generate the printer-compatible file so that the printer-compatible file accommodates the anatomical structure of the patient's foot.

16. The method of claim 12, wherein additively manufacturing the printer-compatible file comprises:

providing layers of material on top of each other in succession to produce the orthotic device.

17. An orthotic device for a patient's foot manufactured using additive manufacturing, the orthotic device comprising:

wherein the variable thickness of the shell increases at areas of increased stress.

18. The orthotic device of claim 17, wherein the shell is configured to undergo flexion throughout the shell.

19. The orthotic device of claim 17, wherein the orthotic device is configured for use with a patient having valgus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot.

20. The orthotic device of claim 17, wherein the orthotic device is configured for use with a patient having varus of the patient's foot, the shell configured to provide gradual offset to an anatomy of the patient's foot.