WO2018148039A1

WO2018148039A1 - Methods and systems for designing and customizing wearable and/or implantable devices

Info

Publication number: WO2018148039A1
Application number: PCT/US2018/015611
Authority: WO
Inventors: Dean E. Cropper; Joseph T. Zachariasen
Original assignee: 3D Promed, Llc
Priority date: 2017-01-26
Filing date: 2018-01-26
Publication date: 2018-08-16

Abstract

Systems and methods and for designing and ordering customized devices that are to be worn by or implanted into a particular individual are capable of obtaining information about a body part with which a device is to be used, incorporating that information into a digital model for the device to create a custom digital model for the device, optionally modifying the custom digital model based on additional information, and transmitting the custom digital model to additive manufacturing equipment (which may be local or at a remote location) for fabrication of the device. Information about the body part with which a custom device is to be used may be obtained by scanning the body part and generating a digital model of the body part.

Description

METHODS AND SYSTEMS FOR DESIGNING AND CUSTOMIZING WEARABLE AND/OR IMPLANTABLE DEVICES

A claim for priority is hereby made to the January 26, 2017 filing date of U.S. Provisional Patent Application No. 62/451,035, titled METHODS AND SYSTEMS FOR DESIGNING AND CUSTOMIZING WEARABLE AND/OR IMPLANTABLE DEVICES ("the '035 Provisional Application"). For purposes of the United States, the application is also a continuation-in-part of U.S. Patent Application No. 15/297,092, filed on October 18, 2016 and titled USE OF ADDITIVE MANUFACTURING PROCESSES IN THE MANUFACTURE OF CUSTOM WEARABLE AND/OR IMPLANTABLE

MEDICAL DEVICES ("the '092 Application"), pending, which is a continuation of U.S. Patent Application No. 14/808,203, filed on July 24, 2015 and titled USE OF ADDITIVE MANUFACTURING PROCESSES IN THE MANUFACTURE OF CUSTOM WEARABLE AND/OR IMPLANTABLE MEDICAL DEVICES ("the '203

Application"), now U.S. Patent 9,469,075, issued on October 18, 2016, which is a continuation-in-part of U.S. Patent Application No. 14/139,489, filed on

December 23, 2013 and titled USE OF ADDITIVE MANUFACTURING PROCESSES IN THE MANUFACTURE OF CUSTOM ORTHOSES ("the '489 Application"), now U.S. Patent 9,610,731, issued April 24, 2017. The '489 Application included claims for priority under 35 U.S.C. § 119(e) to the December 22, 2012 filing date of U.S.

Provisional Patent Application No. 61/745,557, titled USE OF ADDITIVE

MANUFACTURING PROCESSES IN THE MANUFACTURE OF CUSTOM ORTHOSES, ("the '557 Provisional Application") and to the March 15, 2013 filing date of U.S. Provisional Patent Application No. 61/800,582, also titled USE OF ADDITIVE MANUFACTURING PROCESSES IN THE MANUFACTURE OF CUSTOM

ORTHOSES, ("the '582 Provisional Application"). The entire disclosures of the '035 Provisional Application, the '092 Application, the '203 Application,

the '489 Application, the '557 Provisional Application, and the '582 Provisional Application are hereby incorporated herein.

TECHNICAL FIELD

This disclosure relates to methods for designing and ordering customized devices that are to be worn by or implanted into a particular individual. More specifically, this disclosure relates to a method for obtaining information about a body part with which a device is to be used, incorporating that information into a digital model for the device to create a custom digital model for the device, optionally modifying the custom digital model based on additional information, and transmitting the custom digital model to additive manufacturing equipment (which may be local or at a remote location) for fabrication of the device. Information about the body part with which a custom device is to be used may be obtained by scanning the body part and generating a digital model of the body part. Systems for enabling healthcare providers to design custom wearable and/or implantable medical devices are also disclosed. RELATED ART

Custom orthoses, such as braces (e.g., knee braces, ankle braces, etc.), and custom prosthetic devices are typically designed to specifically fit the individual for whom they are customized. Customization of an orthosis may optimize the support that the orthosis provides to a body part, such as a joint, to which the orthosis has been fitted. In addition, custom orthoses are typically more comfortable than and provide for increased function and therapy over standard versions of the same types of orthoses, including sized orthoses. Customization of a wearable prosthesis may ensure that the prosthesis properly fits a residual limb (i.e., a stump) or other residual body part next to which the prosthesis is to be secured, which may ensure that the prosthesis may be securely coupled to a subject's body, minimize injury to the subject's body and make the prosthesis as comfortable as possible for the subject to wear.

Conventionally, custom orthoses have been made by casting a negative mold of the part of an individual's body that an orthosis is supposed to support. The negative mold is then sent to the orthosis manufacturer, who uses the negative mold to make a positive mold, which generally serves as an accurate replica of the individual' s body part. Depending at least partially upon the type of orthosis being made, the material may be added to or removed from the positive mold. One or more customized features of the orthosis may then be made on the positive mold, often by hand. From the forgoing, it should be apparent that conventional processes for making custom orthoses are labor intensive and time consuming.

The interface (e.g., socket, cup, etc.) of a custom prosthesis may also be molded to the part of a subject' s body (e.g., a residual limb, etc.) to which the interface is to be secured. Such molding may be conducted in a manner similar to the way in which conventional custom orthoses have been have been made. Additionally, custom prostheses may be fabricated to match an opposite body part (e.g., the other limb, etc.) to balance function and aesthetics.

U.S. Patent 6, 155,997 to Castro (hereinafter "Castro") discloses an improvement upon the conventional process for making custom orthoses. Specifically, Castro discloses processes for making custom ankle braces. According to Castro, once enhancement to the conventional process for making custom orthoses includes the application of instructions, in the form of readily recognizable symbols, to an inner surface of a negative mold. The instructions may be placed on the inner surface of the negative mold by a person, such as a health care professional, who is prescribing the custom ankle brace. When the brace maker receives the negative mold and uses it to create a positive mold, the instructive symbols that were placed on the inner surface of the negative mold are transferred to corresponding locations on an outer surface of the positive mold. The brace maker may then follow the instructions conveyed by the symbols to define features of (e.g., build them up on, remove material from, etc.) the positive mold. Once the brace maker has modified the positive mold in accordance with the instructions conveyed by the symbols, he or she may use the positive mold to make a custom ankle brace. Like other parts of the process, custom ankle braces are also usually made by hand.

Because conventional processes for making custom orthoses (e.g. , custom ankle braces, customized portions of knee braces, etc.) and custom interfaces for externally worn prostheses may be very labor-intensive, such processes, from casting of a negative mold to completion of the custom orthosis or custom prosthesis, typically take an inordinate amount of time (e.g., weeks, a month, etc.) to complete. Thus, an individual for whom the orthosis or prosthesis is being made, and who may rely on that orthosis or prosthesis, may have to live without the orthosis or the prosthesis for the same amount of time.

DISCLOSURE

In one aspect, a system for designing custom wearable and/or implantable medical devices for subjects (e.g., individuals, patients, etc.) is disclosed. For the sake of simplicity, a wearable and/or implantable medical device may also be referred to hereinafter as a "custom device" and even more simply as a "device." A system for designing such a custom device may be configured to enable evaluation of a body part the custom device is intended to fit, and for which the custom device is to be tailored. Such a system includes a portable scanner and a processing element, both of which may be used at the site where the subject is evaluated or examined (e.g., an examination room at a healthcare provider' s office, a treatment room at a healthcare provider's office or a hospital, an operating room, etc.).

The portable scanner of such a system may comprise a three-dimensional scanner that may provide data that may be used to generate a three-dimensional model of the body part. Alternatively, the portable scanner may be capable of obtaining a plurality of two-dimensional images or a two-dimensional panoramic image that may then be used to generate a three-dimensional model of the body part. Such a portable scanner may comprise a portable electronic device, such as a camera of a tablet computer, a camera of a smart phone, or the like. The portable scanner may operate under control of a so-called "app" or other programming to execute a method according to this disclosure.

The processing element of a system for designing custom wearable and/or implantable medical devices may also be capable of use at the site where the subject is evaluated. In various embodiments, the processing element may comprise the processor of a laptop computer, a tablet computer, a smart phone, or any of a variety of other portable electronic devices (including those devices which may function as the portable scanner). The processing element may be capable of facilitating proper image capture, for example, by providing an individual operating the portable scanner with instructions and/or directions on proper orientation of the body part, the image views that are to be obtained, the size of each image, etc.). The processing element may be capable of generating (e.g., programmed to generate) a digital image of the body part from data provided by the portable scanner. The processing element may also be capable of generating (e.g., programmed to generate) a negative digital model of the body part for incorporation into, transposition to, or superimposition with a digital model for a custom device that is to be fitted, or tailored, for use with the body part. The result of incorporating such a digital negative model into a model for a device is a custom digital model of a custom device tailored to fit the subject. The processing element may also be capable of transmitting (e.g., programmed to transmit) the custom digital model to additive manufacturing equipment.

A method for designing a custom digital model for making a custom wearable and/or implantable medical device may include scanning the body part with a portable scanner, generating a digital image of the body part, generating a negative digital model of the body part, selecting a type (and, optionally, size) of device to be customized for use with the body part, applying the negative digital model to digital model for the selected type (and, optionally, size) of device to provide a custom digital model of the custom device, and optionally modifying, or further customizing, the custom digital model.

Scanning of the body part may comprise a three-dimensional scan, from which a three-dimensional digital model of the body part may be generated. Alternatively, a three-dimensional digital model of the body part may be generated from a plurality of two-dimensional images. Two-dimensional images may be obtained in any suitable manner, including by use of a camera of a portable electronic device, such as a tablet computer or a smart phone. Instructions and/or directions may be provided to an individual while he or she obtains two-dimensional images. The instructions and/or directions may include, but are not limited to, directions and/or instructions regarding proper orientation of the body part being scanned, instructions and/or directions on the views of the body part of which images are to be obtained (e.g., lateral side, medial side, front, rear, bottom, top, orthogonal, etc.), and instructions and/or directions on the size of each image. A digital template of an appropriate body part may be used in providing such instructions and/or directions. Once the two-dimensional images have been obtained, they may then be processed and compiled in a manner known in the art to generate the three-dimensional digital model of the body part.

Once a three-dimensional digital model of the body part has been generated, that digital model may be evaluated. Evaluation of the digital model may include comparing the digital model to the actual body part. Evaluation of the digital model may be conducted by an individual who is tailoring the custom device for use with or by the subject. Alternatively, a processing element (e.g., a processor of a laptop computer, a tablet computer, a smart phone, etc.) may compare two or more different

three-dimensional models of the same body part to confirm their accuracy.

The type of device that is to be used with the scanned body part may be selected. In some embodiments, an appropriate size for the device may also be selected, based on the size of the body part for which the device is to be customized. A negative of the three-dimensional model of the body part or of a portion of the three-dimensional body part may then be generated. Such a negative model may be applied to a digital model of the selected device to generate a custom digital model for a custom wearable and/or implantable medical device. The custom digital model may be manipulated thereafter. For example, the custom digital model may be compared with the three-dimensional model of the body part to digitally model how the custom wearable and/or implantable medical device will interact with the body part. Such a comparison may be carried out visually (e.g., on a computer model by an individual who is designing the custom wearable and/or implantable medical device, by another individual, etc.) and/or with a processing element (e.g., a processor of a laptop computer, a tablet computer, a smart phone, etc.). The information obtained from such a comparison may be used to further modify the custom digital model.

Other methods for modifying, or further customizing, digital models for custom devices are also disclosed. Such a method may include modifying a custom digital model for a custom device based on information known to an individual (e.g., a healthcare provider, such as a physician, a surgeon, a therapist, a prosthetist, etc.) who is designing the device. Any modifications to the custom digital model may be based on information that is known to the individual who is designing the custom device (e.g., range of motion, conditions or sensitivities of the subject that may not be apparent from structural and/or topographical information obtained by scanning, etc.). Modifications to the digital model may be made while an individual evaluates, or examines, the subject for whom the custom device is being made.

Once a custom digital model of a custom device to be manufactured for use with a particular body part of a certain individual is designed, the custom digital model may be transmitted to additive manufacturing equipment. The additive manufacturing equipment may then be used to fabricate the custom device in a manner known in the art (e.g., as disclosed by U.S. Patent 9,469,075 and by U.S. Patent 9,610,731.

Other aspects, as well as features and advantages of various aspects, of the disclosed subject matter will become apparent to those of ordinary skill in the art through consideration of the ensuing disclosure, the accompanying drawings, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a schematic representation of an embodiment of a system and a method for generating a digital model of a body part, which includes three-dimensionally scanning the body part and using the three-dimensional scan to generate the digital model of the body part;

FIG. 2 is a schematic representation of another embodiment of a system and a method for generating a digital model of a body part, which includes obtaining a plurality of two-dimensional images of the body part and compiling the two-dimensional images to generate the digital model of the body part;

FIGs. 3A-3C depict instruction and/or direction of an individual while scanning the body part;

FIG. 4 provides a representation of application of a digital body model to a device model to generate a digital custom device model;

FIG. 5 illustrates an embodiment of a process in which a custom digital device model provides a pattern for fabrication of a custom wearable and/or implantable medical device, such as the depicted orthosis or a prosthesis, in which an additive manufacturing process is used to make a custom wearable and/or implantable medical device; and

FIG. 6 shows an embodiment of a custom wearable and/or implantable medical device that includes a standardized part and an at least partially customized part.

DETAILED DESCRIPTION

A system that is capable of use in facilitating the design of a custom wearable and/or implantable medical device for use with a specific body part of a certain individual may include a scanner and a processing element.

The scanner of the system is capable of being used at the location where the particular body part of the certain individual is evaluated (e.g., an examination room, a treatment room, an operating room, etc.). In some embodiments, the scanner may be a portable scanner. The scanner may obtain images of the body part. The scanner may include one or more cameras and a processing element, which may output the images and, in some embodiments, generate a digital model (not shown) of the body part. That digital model may comprise a three-dimensional digital model of the body part.

In some embodiments, such as that represented by FIG. 1, the scanner 10 of an imaging system 1 according to this disclosure may comprise a three-dimensional scanner. The scanner 10 may be positioned at a location where it can obtain one or more sufficient images of the body part P and, in some embodiments, it may have dimensions that enable it to receive the body part P. A variety of suitable three-dimensional scanners, including portable three-dimensional scanners, are known in the art. As an example, the scanner 10 may comprise a portable three-dimensional scanner, such as that available from 3D Systems, Inc., of Rock Hill, South Carolina, as the iSense™ three-dimensional scanner.

In other embodiments, such as that represented by FIG. 2, the scanner 20 of an image capture system 1 ' according to this disclosure may comprise a two-dimensional scanner, which may be capable of obtaining one or more two-dimensional images of an object, such as a body part P. A two-dimensional scanner 20 may be capable of obtaining a plurality of images of the body part P with conventional aspect ratios (e.g., 3:2, 16:9, etc.), or it may be capable of obtaining one or more panoramic images of the body part P. As FIG. 2 illustrates, one or more two-dimensional scanners 20 may be positioned at a plurality of different locations A, B, C, and D around the body part P to be imaged.

Without limitation, one or more portable electronic devices, such as tablet computing devices, a smart phones, or digital cameras may function as the scanner 20 of an image capture system 1 '.

Image capture by one or more scanners 10, 20 may be facilitated by programming of each scanner 10, 20. FIGs. 3A-3C illustrate a few of a wide variety of options for providing an individual with instructions and/or directions on use of a scanner 10, 20 to obtain appropriate images of an object, such as a body part P. Such instruction and/or direction may be facilitated by programming of a processing element of the scanner 10, 20, as well as by a camera and image detection functionality of the scanner 10, 20. As depicted by FIG. 3 A, instruction and/or direction as to a proper orientation of an object, such as a body part P, may be provided in the form of an image 24 shown on a display 22 of the scanner 10, 20. FIG. 3B illustrates instruction and/or direction, in the form of arrows 26 and 28, on movement of the scanner 10, 20 to a location and/or orientation that will enable the scanner 10, 20 to obtain an image of an appropriate view of the object, such as the depicted body part P. FIG. 3C shows an embodiment in which the scanner 10, 20 may provide instruction and/or direction on the size of the image of the object (e.g., the body part P, etc.) that is to be obtained.

With returned reference to FIGs. 1 and 2, once one or more images of an object, such as a body part P have been obtained by the scanner 10, 20, each image may be communicated to the processing element 14 of the image capture system 1, 1' wirelessly or by wired connection, as known in the art. The processing element 14, like the scanner 10, 20, is capable of being used at the location where the object (e.g., the body part P of a subject, etc.) is evaluated or examined. The processing element 14 of the image capture system 1, 1 ' may be portable.

In some embodiments, the processing element 14 may comprise a processing element of the scanner 10, 20. Some examples of integrated three-dimensional scanners 10 and processing elements 14 include the three-dimensional digital laser scanner available from Nikon Metrology, Inc., of Leuven, Belgium, under the

ModelMaker™ MMCx trademark and the HDI 120 three-dimensional digital scanner available from LMI Technologies Inc. of Vancouver, Canada. Some examples of integrated two-dimensional scanners 20 and processing elements 14 include portable electronic devices, such as tablet computers or smart phones, with the two-dimensional scanner 20 comprising the rear-facing camera of the tablet computer or the smart phone and the processing element comprising the processor of the tablet computer or the smart phone. Some digital cameras also include processors that may be capable of functioning as the processing element 14 of an image capture system 1, 1 ' according to this disclosure.

In other embodiments, the processing element 14 may be separate from the scanner 10, 20. Examples of separate processing elements include the processors of notebook computers and/or tablet computers.

The processing element 14 may process each image of the object (e.g., the body part P (FIGs. 1 and 2), etc.) to generate a digital model 16 of the object. More

specifically, the processing element 14, operating under control of, or while executing, a suitable program, or application (i.e., "app"), may generate a digital model 16 of the object. The digital model 16 may include a positive digital model, as depicted by FIGs. 1, 2, and 4, or it may comprise a negative digital model.

In addition, as depicted by FIG. 4, when the image capture system 1, is used to create a custom digital model for a custom wearable and/or implantable medical device for use with a particular body part P (FIGs. 1 and 2), the processing element 14 may enable selection of a type (and, optionally, size) of device to be used with the body part P, and apply the digital model 16 (e.g., a negative digital model of the body part P or of a portion of the body part P) to a digital model 30 of a selected type (and, optionally, size) of device to generate a custom digital model of the device 40. In a specific embodiment, the digital model 16 of the body part P may be applied to the digital device model 30 by identifying two or more features 17 on the digital model 16 that correspond to predetermined reference features 32 on a digital device model 30. The corresponding features 17 and 32 may then be aligned with one another, effectively superimposing the digital model 16 over at least a customizable portion 34 of the digital device model 30. In some embodiments, any data from the digital model 16 located outside the customizable portion 34 of the digital device model 30 may be discarded. The remaining data from the digital model 16, including data representative the of one or more surfaces 18 that complement, or are negatives, of surfaces of the body part P for which a custom orthosis is being manufactured, may be applied to a customizable portion 34 of the digital device model 30 (i.e., such data from the digital model 16) may be incorporated into the digital device model 30 to define a customized digital model 40.

The processing element 14 of an image capture system 1, and its programming may also enable evaluation of the digital model 16 of the body part P and/or of the custom digital model 40 of the device. The processing element 14 and its programming may enable an individual who is designing the custom device to modify, or further customize, the custom digital model 40 of the device.

Additionally, the processing element 14 may be capable of transmitting the custom digital model 40 to additive manufacturing equipment 60 (FIG. 5), which may then fabricate a device 50 from the custom digital model 40. Once a custom digital model 40 has been generated, it may be processed and used to form a custom wearable and/or implantable medical device 50 (FIGs. 5 and 6), or at least a portion of a custom wearable and/or implantable medical device 50. FIG. 5 schematically illustrates an embodiment of a method for manufacturing, or fabricating, a custom wearable and/or implantable medical device 50 from a customized digital model 40. As an example of such a method, an additive manufacturing process, such as that effected by the systems available from Objet Geometries, Ltd., of Rehovot, Israel, may be used to fabricate some or all of the custom wearable and/or implantable medical device 50 as a series of layers. When such a process is used, the custom digital model 40 may be separated into a plurality of sections 42, such as slices or layers (e.g., the custom digital model 40 may be converted from a CAD (Computer Aided Design) format to any suitable format, such as an STL

(STereoLithography) format, etc.).

Each of the sections 42 of the custom digital model 40 may be used by the additive manufacturing system 60 to define a corresponding section 52 of a custom wearable and/or implantable medical device 50. More specifically, the additive manufacturing system 60 may be used to fabricate the custom wearable and/or implantable medical device 50, as well as any contoured surfaces that are intended to fit to the form, or contour, of a body part P (FIGs. 1 and 2), one section 52 (e.g., layer, etc.) at a time. As each section 52 is formed, the material from which it is formed may cure or otherwise solidify. Once a section 52 has at least partially solidified (e.g., before that section 52 has fully cured, etc.), a subsequent section 52' may be formed adjacent to it (e.g., at least partially superimposed over it, etc.). The subsequent section 52' may be formed before the previously formed, adjacent section 52 has fully cured, enabling at least some integration between the adjacent sections 52 and 52', which may impart a custom wearable and/or implantable medical device 50 that results from such a process with substantially smooth surfaces, increase the fracture resistance (and, optionally, the flexibility) of the custom wearable and/or implantable medical device 50, increase the strength of the custom wearable and/or implantable medical device 50, otherwise improve the custom orthosis, or provide any combination of the foregoing. Alternatively, one section 52 may substantially cure or fully cure before the subsequent section 52' is formed, resulting in a structure with a discernable, discrete boundary between the adjacent sections 52 and 52'. In either event, the resulting structure includes a plurality of adjacent, mutually adhered sections 52 (e.g., a plurality of at least partially superimposed, mutually adhered layers, etc.). Such a process may be used to form a customized portion of the custom wearable and/or implantable medical device 50, an entire part of the custom wearable and/or implantable medical device 50, or the entire custom wearable and/or implantable medical device 50.

When the additive manufacturing system 60 includes a so called "3D printer," such as that manufactured by Objet, and a polypropylene like material, such as the Durus White™ material available from Objet, is used to form at least a portion of the custom wearable and/or implantable medical device 50, each section 52 (e.g., layer, etc.), may have a thickness of about 0.005 inch to about 0.001 inch or less. The smoothness of the surfaces of the custom wearable and/or implantable medical device 50 corresponds, at least in part, to the thinness of the sections 52 from which the custom wearable and/or implantable medical device 50 is formed, with thinner sections 52 forming smoother surfaces.

In some embodiments, such as that depicted by FIG. 6, the custom wearable and/or implantable medical device 50 may comprise a tailored part of a partially tailored medical device 55 that also includes a standardized part 56. The standardized part 56 may comprise an off-the-shelf component that may have a standard shape and one of a limited number of (e.g., one, three, five, etc.) standard sizes. The use of one or more standard components in the manufacture of a partially tailored medical device 55 may decrease the amount of time required to make the partially tailored medical device 55 and minimize the cost of a custom medical device. In other embodiments, however, the disclosed processes may be used to fabricate two or more components of a fully tailored wearable and/or implantable medical device, such as both the upper element and the lower element of the depicted ankle brace.

The use of a system to collect data and design a custom digital model during evaluation of a subject, as well as its ability to transmit the custom digital model to additive manufacturing equipment, may enable each of the foregoing acts and others to be conducted without delay, improving the manner in which subjects and their conditions are treated.

While this disclosure focuses on methods and systems for designing custom digital models for devices that are configured to be worn by and/or implanted into subjects (e.g., individuals, patients, etc.), it should be understood that the disclosed methods and systems may be used to create custom digital models for a device that is customized or tailored for use with any suitable substrate.

Although the foregoing description sets forth many specifics, these should not be construed as limiting the scope of any of the claims, but merely as providing illustrations of some embodiments and variations of elements or features of the disclosed subject matter. Other embodiments of the disclosed subject matter may be devised which do not depart from the spirit or scope of any of the claims. Features from different embodiments may be employed in combination. Accordingly, the scope of each claim is limited only by its plain language and the legal equivalents thereto.

Claims

CLAIMS What is claimed:

1. A method for designing a custom digital model for a wearable and/or implantable device, comprising:

scanning a body part with which the wearable and/or implantable device is to be used; generating a digital model of the body part;

enabling selection of a type of wearable and/or implantable device to be used with the body part;

providing a digital model for the wearable and/or implantable device to be used with the body part; and

applying the digital model of the body part to the digital model for the wearable and/or implantable device to provide a custom digital model for the wearable and/or implantable device.

2. The method of claim 1, wherein generating the digital model of the body part comprises generating the digital model of the body part from data obtained during scanning the body part.

3. The method of claim 1, wherein generating the digital model for the body part comprises generating a three-dimensional model of the body part from data obtained during scanning the body part.

4. The method of any of claims 1-3, further comprising:

evaluating the digital model of the body part, including comparing the digital model of the body part to the body part.

5. The method of any of claims 1-4, further comprising:

evaluating at least one of the digital model of the body part and the custom digital model for the wearable and/or implantable device.

6. The method of claim 5, wherein evaluating at least one of the digital model of the body part and the custom digital model for the wearable and/or implantable device comprises comparing the digital model for the wearable and/or implantable device to the digital model of the body part.

7. The method of claim 6, further comprising:

modifying the custom digital model based on comparing the digital model for the

wearable and/or implantable device to the digital model of the body part.

8. The method of any of claims 1-7, further comprising:

modifying the custom digital model based on additional information obtained by an individual who is designing the custom digital model for the wearable and/or implantable device.

9. The method of any of claims 1-8, wherein scanning, generating, enabling selection, providing, and applying occur at the same location.

10. The method of claim 9, wherein scanning, generating, enabling selection, providing, and applying occur in an examination room, a treatment room, or an operating room.

11. The method of any of claims 1-10, further comprising:

transmitting the custom digital model to additive manufacturing equipment.

12. A system for designing a custom digital model for a wearable and/or implantable device, comprising:

a portable scanner capable of scanning a body part with which the wearable and/or

implantable device is to be used;

at least one processing element capable of:

generating a digital model of the body part based on data provided by the digital scanner;

enabling a user to select a type of wearable and/or implantable device to be used with the body part;

providing or obtaining a digital model of the type of wearable and/or implantable device selected by the user; and applying the digital model of the body part to the digital model of the type of wearable and/or implantable device selected by the user to generate a custom digital model of the wearable and/or implantable device.

13. The system of claim 12, wherein the at least one processing element is further capable of executing a method including a process according to any of claims 2-6.

14. The system of claim 12, further comprising:

a wireless communication element in communication with additive manufacturing

equipment for transmitting the custom digital model to the additive manufacturing equipment.

15. The system of any of claims 12-14, further comprising:

additive manufacturing equipment in communication with the at least one processing element, the additive manufacturing equipment capable of receiving the custom digital model and of fabricating the wearable and/or implantable device from the custom digital model.

16. The system of any of claims 12-15, wherein the portable scanner comprises a camera of a portable electronic device.

17. The system of claim 16, wherein the at least one processing element comprises a processing element of the portable electronic device.

18. The system of claim 17, wherein the portable electronic device comprises a tablet computing device or a smart phone.