Dynamic bioactive bone graft material having an engineered porosity
Inventors
Bagga, Charanpreet S. • Bae, Hyun W. • Day, Thomas E.
Assignees
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Publication Number
US-11338061-B2
Publication Date
2022-05-24
Expiration Date
Abstract
The present disclosure relates to a dynamic bioactive bone graft material having an engineered porosity. In one embodiment, a bone graft material is provided having bioactive glass fibers arranged in a porous matrix that is moldable into a desired shape for implantation. The material can be substantially without additives and can include at least one nanofiber. The porous matrix may include a combination of one or more pore sizes including nanopores, macropores, mesopores, and micropores. In another embodiment, a bone graft implant is provided having a matrix comprising a plurality of overlapping and interlocking bioactive glass fibers, and having a distributed porosity based on a range of pores provided in the bioactive glass fibers. The distributed porosity can comprise a combination of macropores, mesopores, and micropores, and the matrix can be formable into a desired shape for implantation into a patient.
Core Innovation
The invention provides a bone graft material that includes a porous matrix comprising a plurality of overlapping and interlocking bioactive glass fibers and bioactive glass particulates distributed throughout the fibers. The fibers and particulates each have varying diameters, and pores having a range of sizes are defined by the spaces between the fibers and particulates. The varying diameters of the fibers and particulates control pore size and distribution, and thereby control overall porosity of the matrix.
The matrix further has a distributed porosity based on the range of sizes of the pores such that the matrix is configured for staged resorption. The pores comprise micropores and macropores, where the distribution of pore sizes provides interconnected porosity and a staged/differential resorption behavior. The structure is described as a dynamic, non-fused fiber network that remains flexible and is configured to mimic aspects of a fibrin clot architecture.
An implant is formed from the bone graft material by shaping the material into a shape and size for insertion into the bone defect, and the formed implant is implanted into the bone defect. The material is described as optionally including nanofibers and bioactive glass particulates, and may further include carrier materials and enhancements such as radiopacity and antimicrobial function, while maintaining the engineered multi-scale porosity from nano to macro and improved fluid wicking and sustained release.
Claims Coverage
The independent claim provides a treatment method for a bone defect using a shaped implant formed from a porous bioactive-glass composite matrix with overlapping and interlocking fibers and distributed particulates. The coverage includes multiple inventive refinements in dependent claims, primarily focused on explicit pore-size ranges, pore-size distribution/gradient, porosity thresholds, and optional carrier and composition features, including micropores and macropores and staged resorption.
Overlapping and interlocking bioactive glass fiber and particulates porous matrix with varying diameters
A porous matrix comprising a plurality of overlapping and interlocking bioactive glass fibers and bioactive glass particulates distributed throughout the fibers, where the fibers and particulates each have varying diameters.
Pore size and distribution defined by spaces between fibers and particulates
Pores having a range of sizes defined by the spaces between said fibers and particulates, where the varying diameters of the fibers and particulates control pore size and distribution of the range of pores and overall porosity of the matrix.
Distributed porosity configured for staged resorption with micropores and macropores
The matrix having a distributed porosity based on said range of sizes of the pores such that the matrix is configured for staged resorption, where the pores comprise micropores and macropores.
Shaped implant formed from the porous bone graft material
Forming an implant from the bone graft material by shaping the material into a shape and size for insertion into the bone defect.
Implanting the shaped implant into the bone defect
Implanting the formed implant into the bone defect.
Micropore diameter range
Micropores having diameters ranging from about 1 micron to about 10 microns.
Gradient pore-size distribution across the matrix
Pore sizes distributed according to a gradient across the matrix.
Collagen carrier material
A carrier material where the carrier material comprises collagen.
Molding in a mold tray to form the implant
The implant is formed by molding the material in a mold tray.
Overall, the claim set centers on a porous matrix with overlapping and interlocking bioactive glass fibers and distributed bioactive glass particulates having varying diameters to define pores whose range and distribution yield distributed porosity configured for staged resorption with micropores and macropores, followed by shaping the material into an implant and implanting it into a bone defect. Dependent refinements include micropore diameter ranges, gradient pore-size distribution, collagen as a carrier, and forming the implant by molding in a mold tray.
Stated Advantages
Staged resorption behavior configured by distributed porosity based on a pore-size range.
Porosity distribution across micropores and macropores based on spaces between overlapping/interlocking fibers and particulates.
Documented Applications
Treating a bone defect by providing a bone graft material, forming an implant, and implanting the formed implant into the bone defect.
In vitro cell growth/culture observations and an animal comparative study in a rabbit distal femoral defect, reporting physiologic bone healing/remodeling and greater base material resorption by 6 months versus a commercial silicate-substituted graft.
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