This invention introduces novel iron-based alloys designed to safely degrade within the body, offering a groundbreaking solution for medical implants. These alloys overcome the limitations of traditional materials by eliminating the need for removal surgeries and promoting natural healing, significantly improving patient outcomes in orthopedic, craniofacial, and cardiovascular applications.
Description
The invention centers on novel iron-based alloys developed using advanced theoretical and scientific understanding of biodegradability and phase diagrams. These compositions are precisely engineered by selecting alloying elements such as manganese, magnesium, zirconium, zinc, and calcium, which are thermodynamically stable and exhibit significant corrosive response in physiological environments. This controlled degradation ensures biocompatibility and allows the implant to dissolve harmlessly as the surrounding tissue heals, eliminating the need for secondary removal surgeries.
The alloys can be prepared using methods such as high energy mechanical alloying (HEMA) or melting and casting processes. HEMA involves milling elemental powders of iron and selected alloying elements, potentially followed by compaction and sintering. This innovative approach allows for the incorporation of elements like magnesium and calcium, which are typically incompatible with iron, and enables the creation of complex architectures, enhancing the versatility and application of the materials.
Applications
- Orthopedic devices (e.g., plates, screws, pins, rods, bone-fracture healing devices, bone replacement devices, joint replacement devices)
- Craniofacial devices (e.g., temporo-mandibular joints)
- Cardiovascular stents
- Dental implants
- Nerve guides
- Surgical implants and wires
Advantages
- Biodegradability: The alloys degrade harmlessly within the body, eliminating the need for implant removal surgeries.
- Biocompatibility: Initial characterization studies confirm these systems are both biodegradable and biocompatible.
- Controlled Degradation Rate: The corrosion rate can be controlled to match the healing time of surrounding tissue, ensuring optimal support during recovery.
- Improved Mechanical Properties: The presence of iron contributes to enhanced mechanical strength and controlled corrosion.
- Novel Composition: Allows for the incorporation of elements like magnesium and calcium, otherwise incompatible with iron, leading to superior material properties.
- Versatile Fabrication: The ability to print and generate novel complex architectures expands potential applications.
Invention Readiness
Initial characterization studies, including XRD, potentiodynamic measurements, and in vitro cell culture tests, have validated the biodegradability and biocompatibility of these novel iron-based alloys. Three new classes of degradable iron-based alloys (Fe-Zr; Fe-Zn, and Fe-Mn) have been identified, along with novel compositions containing magnesium, calcium, silver, and strontium.
IP Status
https://patents.google.com/patent/US20230211053A1