Packable ceramic beads for bone repair

Abstract

Adherent packed beds of ceramic beads, each comprising a ceramic body coated with a biodegradable polymer, and fabric bags containing such beads in a packed, self-supporting configuration. The polymeric coating provides some resilience to a packed bed of the ceramic beads, and prevents the beads from moving with respect to each other when placed under stress, leading to reduced breakage. The ceramic beads desirably are osteoconductive, and preferably are formed of a ceramic material that is resorbed during bone growth, such as hydroxyapatite, tricalcium phosphate, or mixtures of these materials. The beads may contain, either internally or on their surfaces or both, a bone morphogenic protein, and the latter may also be included in the biodegradable polymer coatings on the beads.

Description

FIELD OF THE INVENTION[0001]The invention relates to coated ceramic beads that are packable to form a bone substitute material.BACKGROUND OF THE INVENTION[0002]Proper bone healing and subsequent favorable bone remodeling are dependent on maintaining stability between bone fragments, and on maintaining physiologic strain levels. Successful bone graft procedures commonly require an osteoconductive matrix providing a scaffold for bone in-growth, osteoinductive factors providing chemical agents that induce bone regeneration and repair, osteogenic cells providing the basic building blocks for bone regeneration by their ability to differentiate into osteoblasts and osteoclasts, and a substantially stable implant site. Current bone graft materials include autografts, allografts, and a variety of artificial or synthetic bone substitute materials.[0003]For structural bone repair materials to be conveniently used, they must be capable of being formed into complex shapes that are designed to f...

AI Technical Summary

Benefits of technology

[0007]We have found that ceramic beads each comprising a ceramic body coated with a biodegradable polymer can be particularly useful when employed in the surgery referred to above. The polymeric coating provides some resilience to a packed bed of the ceramic beads, and also helps to render the beads less friable when moved over m one another under stress. The ceramic beads desirably are osteoconductive, and preferably are formed of a ceramic material that is resorbed during bone growth, such as hydroxyapatite, tricalcium phosphate, or mixtures of these materials. The beads may contain, either internally or on their surfaces or both, a bone morphogenic protein, and the latter may also be included in the biodegradable polymer coatings on the beads.

[0008]Structurally, the beads may be solid and dense, or may be porous. Solid, dense beads provide a higher modulus of elasticity and exhibit greater strength than do porous beads. However, the lower modulus of elasticity of porous beads more closely approaches the modulus of elasticity of natural bone. Porous beads useful in the present invention may have a continuous, strong supportive framework of struts providing a plurality of interconnecting interstices forming pores that extend through their volumes and open onto their surfaces. Bone morphogenic protein may be received in and carried by the pores, so as to be available for encouraging bone growth.

[0009]Thus, in one embodiment, the invention provides ceramic beads that are useful, when packed or clumped together, as a bone substitute material. The beads each comprise a ceramic body having an outer surface defining a shape having a bulk volume. The outer surfaces of the beads bear a substantially continuous coating of a biodegradable polymer, the coating providing a surface enabling the beads to pack together into a coherent, load-supporting mass when subjected to compressive forces to avoid bead breakage due to rubbing together of adjacent beads, but enabling the beads to flow freely past each other when uncompressed. The polymeric coatings provide the packed beads with a measure of resiliency to harmlessly absorb impact forces that otherwise might lead to brittle failure of beads.

[0010]In another embodiment, the invention relates to an article useful for replacing or stabilizing bone. The article comprises a fabric bag formed of a fabric having openings sized to enable bone growth therethrough. Packed within the bag is a plurality of in ceramic beads of the type described above. At points of contact between the beads, the biodegradable polymer coatings on the outer surfaces of the beads restrain the beads from sliding past one another when in their packed orientation in the bag. The coatings also provide a thin, resilient cover to lessen the effects of sudden forces such as compression impact forces. The bag packed with polymer-coated ceramic beads, as thus described, provides a stable implant structure useful in spinal and other orthopedic procedures.

Problems solved by technology

Moreover, the beads themselves may actually break when subjected to packing forces.

It is desirable to inhibit such movement also, inasmuch as such movement may create local configurations of high stress, leading to bead fracture.

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