Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
Inventors
D'Agostino, Jeffrey A. • Whitehouse, Robert S. • Watterson, Arthur • Blank, Werner • Hegedus, Charles • Agarwal, Sandip • Nelson, Elizabeth
Assignees
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Publication Number
US-11207109-B2
Publication Date
2021-12-28
Expiration Date
Abstract
A composite comprising: a barrier, said barrier being configured to selectively pass water, and said barrier being degradable in the presence of water; a matrix material for disposition within said barrier, wherein said matrix material has a flowable state and a set state, and wherein said matrix material is degradable in the presence of water; and at least one reinforcing element for disposition within said barrier and integration with said matrix material, wherein said at least one reinforcing element is degradable in the presence of water, and further wherein, upon the degradation of said at least one reinforcing element in the presence of water, provides an agent for modulating the degradation rate of said matrix material in the presence of water.
Core Innovation
The invention provides a layered structure configured to selectively pass water. The layered structure includes a core structure and at least one outer region formed on the core structure, and the core structure comprises at least one reinforcement element including a degradable matrix and at least one filament disposed within the degradable matrix. The reinforcement element core structure further includes an outer region formed on the reinforcement element core structure, where the outer region comprises at least one layer.
The at least one filament comprises between 5% and 85% by volume of the reinforcement element, and in the composite the filament volume is between 5% and 65% by volume. In certain embodiments, a plurality of filaments are twisted together at a rate of up to 2.0 twists per inch to form fibers, with some fibers arranged substantially parallel and others substantially transverse.
The outer region on the core structure provides a desired porosity, and surface features include at least one of barbs and threads. The degradable matrix and the outer region materials are selected from polylactic acid homopolymer or copolymer, polycaprolactone, polyglycolide (PGA), glycolide copolymers, glycolide/lactide copolymers, polylactic acid cocaprolactone copolymers, stereoisomers or copolymer of polylactide, polyhydroxyalkanoate (PHA) homopolymer or copolymer, poly-β-hydroxybutyrate (PHB), poly-4-hydroxybutyrate (P4HB), citric acid polymer, and polyurethane.
Claims Coverage
The independent claims are directed to a layered composite configured to selectively pass water, with a core structure containing a reinforcement element formed from a degradable matrix and filaments, and with outer regions formed on both the reinforcement element core structure and the core structure. Across the independent claims, the main inventive features include the water-selectively passing layered structure, filament volume constraints, polymer material selections, fiber formation by twisting filaments, and outer-region porosity and surface features.
Water-selectively passing layered composite with core reinforcement and outer regions
A layered structure configured to selectively pass water, including a core structure with at least one reinforcement element comprising a degradable matrix and at least one filament disposed within the degradable matrix, and an outer region formed on the reinforcement element core structure and on the core structure, each comprising at least one layer.
Filament volume fraction within the reinforcement element
The at least one filament comprises between 5% and 85% by volume of the reinforcement element.
Filament volume fraction narrowed for the composite
The at least one filament comprises between 5% and 65% by volume of the composite.
Degradable matrix and outer region polymer material selection
The degradable matrix and the outer region comprise one of the listed polymers and related compositions, including polylactic acid homopolymer or copolymer, polycaprolactone, polyglycolide (PGA), glycolide copolymers, glycolide/lactide copolymers, polylactic acid cocaprolactone copolymers, stereoisomers or copolymer of polylactide, polyhydroxyalkanoate (PHA) homopolymer or copolymer, poly-β-hydroxybutyrate (PHB), poly-4-hydroxybutyrate (P4HB), citric acid polymer, and polyurethane.
Fiber formation by twisting filaments at a limited rate
A plurality of filaments are twisted together at a rate of up to 2.0 twists per inch to form at least one fiber, with some fibers disposed substantially parallel and others substantially transverse.
Surface features and desired porosity via outer region
The outer region formed on the core structure provides a desired porosity, and surface features comprise at least one of barbs and threads.
The claims cover a layered composite configured to selectively pass water with a core reinforcement element formed from a degradable matrix containing filaments and outer layered regions. The coverage further recites filament volume limits, polymer material selections, filament twisting to form fibers with substantially parallel and substantially transverse orientations, and outer-region porosity with barbs or threads.
Stated Advantages
Provides a water-selective, water-degradable barrier structure.
Reinforcement degradation in water releases an agent to modulate matrix hydrolysis/degradation rate.
Outer region provides desired porosity.
Surface features include barbs and threads.
Documented Applications
Bone-fracture treatment composite implant for intramedullary canal internal splint.
Bone fracture healing/internal splint.
Composite implant can take orthopedic fastening component forms including screws, rods, pins, nails, and bone anchor types.
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