Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof
Inventors
Preiss-Bloom, Orahn • LINDNER, Taly Pnina
Assignees
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Publication Number
US-11678923-B2
Publication Date
2023-06-20
Expiration Date
Abstract
Reinforced biocomposite materials. According to at least some embodiments, medical implants are provided that incorporate novel structures, alignments, orientations and forms comprised of such reinforced bioabsorbable materials, as well as methods of treatment thereof.
Core Innovation
The invention relates to an orthopedic implant comprising a biodegradable composite with a reinforcement filler that includes a plurality of reinforcing fibers and a biodegradable polymer. The biodegradable composite has an average density in a range of 1.3-3.0 g/cm3, and the biodegradable polymer has an inherent viscosity (IV) in a range of 1.0 to 3.0 dl/g. A percentage of reinforcing fibers is in a range of 40% to 50% weight per weight.
The reinforcing fibers are arranged in parallel to a longitudinal axis of the implant, establishing direction-dependent mechanical behavior. In certain embodiments, unidirectionally aligned continuous reinforcing fibers provide improved stiffness and strength along selected mechanical axes relative to amorphous or non-aligned structures. The reinforced biocomposite implant architecture is configured to maintain mechanical performance under simulated body fluid exposure.
The disclosed systems include embodiments where mechanical properties are evaluated after simulated body fluid (SBF) exposure, including retention of elastic modulus and flexural strength. The patent further describes biodegradable polymers and biodegradable reinforcement fiber materials with specified composition ranges, together with reinforcement parameters that relate to resulting mechanical performance. The described approach also includes simulations indicating improved buckling loads through layer stacking and angle optimization.
Claims Coverage
The independent claim provides an orthopedic implant definition based on an anisotropic biodegradable composite reinforced by fibers arranged in parallel to the implant’s longitudinal axis, with specified quantitative ranges for density, polymer inherent viscosity, fiber weight fraction, and fiber arrangement. Dependent claims refine performance thresholds, reinforcement geometry parameters, and include polymer/fiber composition constraints and additional orthopedic device categories.
Orthopedic implant with parallel reinforcing fibers in biodegradable composite
An orthopedic implant comprising a biodegradable composite comprising a reinforcement filler with a plurality of reinforcing fibers, the biodegradable composite further comprising a biodegradable polymer, wherein an average density is 1.3-3.0 g/cm3, an inherent viscosity (IV) of the biodegradable polymer alone is 1.0 to 3.0 dl/g, and a percentage of reinforcing fibers is 40% to 50% weight per weight, wherein a plurality of said reinforcement fibers are arranged in parallel to a longitudinal axis of the implant.
Maximum flexural modulus and flexural strength ranges
The implant includes a biodegradable composite whose maximum flexural modulus is 6 to 30 GPa and whose flexural strength is 100 to 1000 MPa.
Elastic modulus retention after simulated body fluid exposure
The implant retains at least 50% elastic modulus after exposure to simulated body fluid (SBF) at 50°C for 3 days.
Orthopedic device types for fixation and repair
The implant is selected from orthopedic implant device types used for fracture fixation, tendon reattachment, spinal fixation, and spinal cages, including bone fixation plates, intramedullary nails, joint implants, spine implants, and other similar devices.
Reinforcing fiber diameter ranges
The implant includes a reinforcing fiber having a diameter within 2-40 μm, 8-20 μm, or 12-18 μm.
Overall, the claim coverage centers on a biodegradable composite orthopedic implant with parallel-arranged reinforcing fibers and specified density, polymer inherent viscosity, and fiber weight fraction, with dependent claims narrowing to flexural mechanical property ranges, elastic modulus retention after SBF exposure conditions, fiber diameter ranges, and specific orthopedic device categories.
Stated Advantages
Improved stiffness and strength in selected mechanical axes due to unidirectionally aligned continuous reinforcing fibers arranged in parallel to the implant longitudinal axis.
Sustained mechanical retention after simulated body fluid exposure, including retained elastic modulus and flexural strength.
Durability under accelerated degradation conditions.
Improved buckling loads indicated by finite-element simulation through layer stacking/angle optimization.
Documented Applications
Orthopedic fracture fixation using orthopedic implant device types including bone fixation plates and intramedullary nails.
Tendon reattachment using orthopedic implant device types.
Spinal fixation and spinal cages using orthopedic implant device types including spine implants.
Joint implants including hip, knee, and elbow implants.
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