**Abstract**

The aim of this study was to design, manufacture and verify orthoses using innovative methods. 3D scanning, additive manufacturing and CAD/CAM software are applied during the development process. Target group of the study are subjects with insufficient gripping and manipulating functions of the arm and forearm. Positives are obtained using a hand-held 3D scanner Artec Eva. Specific 3D scanning methodology is applied during this process. Individual orthoses are designed in an open-source CAD software Meshmixer and manufactured by FDM (Fused Deposition Modeling) additive technology from a biocompatible plastic material. All models are inspected and verified in an analysis software VGStudio MAX. Given methodology can be used not only for this specific purpose, but also for orthosis development in general.

**Keywords:** orthosis, additive manufacturing, 3D scanning, CAD/CAM, fused filament fabrication

## **1. Introduction**

An orthosis or orthotic device is a device applied to the body to replace lost function of locomotor systems or to help restore lost or damaged function, to stabilize or immobilize a part of the body, to improve alignment, prevent deformation, protect against injury or assist in movement, or function [1].

Orthoses are used, to:


These are orthopedic devices that affect the function of the musculoskeletal system: they keep body parts in the desired positions or bring them into the necessary positions, sometimes replacing lost functions, or bringing the disability to a tolerable condition. Furthermore, they are devices attached to the patient's body, which affect the condition and operation of the musculoskeletal system. This means that they do not compensate for the anatomical loss of the limb, but partially compensate for the lost function. The Committee for Prosthetic Research and Development (CPRD) categorized orthoses with respect to anatomical segments and joints. It created, firmly established and implemented a system of abbreviations derived from the first letters of the name of the orthosis in English for each category. Within the international Standards By ISO, the technical committee TC 168 has introduced the mentioned terminology, which is accepted worldwide [1, 3–5].

These devices are manufactured individually or in series production, from different materials and in different sizes according to the expected length of use and the burden also related to the patient's lifestyle. When using mass-produced orthopedic-prosthetic devices (in a sufficient size range based on the anthropometrically determined dimensions of healthy people), the choice and application of a suitable device does not pose a problem. In some cases, this device may require only minimal adjustments (e.g. adjustment of the fastening strap) during the test by a qualified person (orthopedic technician, doctor). Another case is an orthosis made to measure according to the individual requirements of the individual. The traditional production process consists of the phase of taking the necessary measurements, the phase of production of the model (gypsum positive, which is made by casting gypsum) and then the creation of an orthotic device from the required materials [1, 3].

In the final phase, it is necessary to take into account the specific physiological, kinesiological and biomechanical properties that will be placed on the orthosis, structural and material characteristics, use of joints, locks and other biomechanical elements, so that the orthosis fulfills its purpose [1, 5, 6].

The goal of an orthotic device is to help a person with a disability achieve the highest level of functional independence and integration into the community. The design, manufacture and installation of orthoses and ancillary equipment is an important part of the treatment regimen [1, 4, 7].

Of course, an orthopedic device must always be prescribed by a specialist. Because, it is an aid that acts and influences the function of the locomotor system, it can harm the patient can lead to progression of the damage. It is therefore necessary that the technician who equips the patient with orthopedic aids understands the work well and is sufficiently prepared in the field of craftsmanship.

For the technician to be able to determine the correct functional type of orthosis and its optimal design, he needs to be able to assess the overall physical condition of the patient, or the affected segment. Basic examination methods, which include manual muscle testing (MMT), range test (ROM) and sensory testing, thus provide the technician with important information for an individual design of the structure and structure of the device [1, 8–10]. This knowledge, combined with the technical skills required in the manufacturing process and installation of these devices, lead to successful outcomes for patients [1, 4, 7].
