The manufacturer-ready design of the customized foot orthosis made from ABS/PC is engineered to provide optimal support and comfort for patients with flat feet. This design incorporates specific measurements and features aimed at correcting plantar foot pressure distribution, ensuring it meets relevant international standards for safety and efficacy.
Design Specifications
- Materials: The orthosis is constructed from a combination of Acrylonitrile Butadiene Styrene (ABS) and Polycarbonate (PC), chosen for their strength, durability, and biocompatibility.
- Foot Length: 278 mm
- Arch Length: 19 mm
- Heel Width: 8 mm
- Ball Width: 11 mm
- Arch Height: 39.5 mm
- Heel Height: 30 mm
- Forefoot thickness : 10mm
- Rear Foot Angle: 8 degrees
These dimensions are specifically designed to accommodate patients weighing between 75 kg and 85 kg, with foot lengths ranging from 250 mm to 280mm.The significant arch height of 39.5 mm is a critical feature of this design. It effectively prevents the center of mass from shifting medially, which is essential for maintaining proper alignment and stability in patients with flat feet. The design aims to redistribute plantar pressure effectively, alleviating discomfort associated with flat feet.
Foam Padding Integration
To enhance comfort, especially in high-pressure areas such as the metatarsal head region ,midfoot and hallux in flatfoot patients, a layer of high density foam padding will be integrated into the orthosis during assembly. This padding not only provides cushioning but also helps in preventing the center of mass from shifting medially, absorbing shock, further reducing peak plantar pressures.
Compliance with ISO Standards
- ISO 10993 - Biocompatibility:
- The materials used in the orthosis are compliant with ISO 10993, which evaluates the biocompatibility of medical devices. This standard ensures that the materials do not elicit adverse biological responses when in contact with skin. The ABS/PC combination has been tested for cytotoxicity, sensitization, and irritation, confirming its safety for prolonged skin contact.
- The design process includes a thorough chemical characterization to identify any extractables or leachables that may pose risks during clinical use. This compliance is crucial to ensure patient safety and device effectiveness.
- ISO 22675 - Load Bearing Capacity:
- The orthosis is designed to support patients within the weight range of 75 kg to 85 kg, adhering to ISO 22675, which specifies requirements for the load-bearing capacity of orthotic devices. This standard ensures that the device can withstand the mechanical stresses encountered during regular use without failure.
- ISO 10328 - Custom Fit Geometry:
- The orthosis respects ISO 10328, which outlines testing methods for custom-fitted orthopedic devices. The geometry of this orthosis is tailored specifically for patients within the specified weight and foot length ranges, ensuring a snug fit that enhances comfort and functionality.