Guided bone regeneration membrane and manufacturing method thereof

Inventors

Kasuga, Toshihiro • Ota, Yoshio • Wakita, Takashi

Assignees

Yabashi Industries Co Ltd • Nagoya Institute of Technology NUC • Orthorebirth Co Ltd • Yamahachi Dental Mfg Co

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Publication Number

US-10159737-B1

Patent

Publication Date

2018-12-25

Expiration Date


Abstract

A guided bone regeneration material is disclosed. The guided bone regeneration material includes biodegradable fibers produced by an electrospinning method. The biodegradable fibers produced by the method include a silicon-releasing calcium carbonate and a biodegradable polymer. The silicon-releasing calcium carbonate is a composite of siloxane and calcium carbonate of vaterite phase. The biodegradable fibers may be coated with apatite. When the guided bone regeneration material is immersed in a neutral aqueous solution, silicon species ions are eluted from the calcium carbonate. The guided bone regeneration material excels in bone reconstruction ability.

Core Innovation

Disclosed is a fibrous biodegradable bone regeneration material in the form of a guided bone regeneration (GBR) membrane made of electrospun biodegradable fibers. The material comprises a biodegradable polymer and silicon-releasing calcium carbonate particles, described as a vaterite-phase calcium carbonate composite with siloxane that releases silicon species in neutral aqueous solution.

The silicon-releasing calcium carbonate particles elute silicon species, and the fibers may be coated with apatite using simulated body fluid (SBF) or 1.5SBF soaking. A bi-layer nonwoven structure is described, including a silicon-containing calcium carbonate/PLA layer and a PLA layer, and the silicon-containing layer promotes apatite nucleation and deposition selectively to improve osteoblastic cell adhesion and growth and to enhance bone reconstruction ability.

Electrospun fabrication is described by incorporating the silicon-releasing calcium carbonate particles with the biodegradable polymer to form the composite fibers. Characterization is described by SEM and XRD evidence of apatite formation, and biological evaluation is described by enhanced MC3T3-E1 cell proliferation on apatite-coated Si–CaCO3/PLA compared with PLA/control.

Claims Coverage

The document provides one independent claim directed to a fibrous biodegradable bone regeneration material having specific components, a biodegradable polymer and silicon-releasing calcium carbonate particles, and a defined electrospinning-based production process. Dependent claims specify particular biodegradable polymer identities and a quantitative constraint for the silicon-releasing calcium carbonate content.

Biodegradable polymer with silicon-releasing calcium carbonate particles for fibrous bone regeneration

A fibrous biodegradable bone regeneration material comprising a biodegradable polymer and silicon-releasing calcium carbonate particles.

Kneading, chloroform dissolution, and electrospinning to produce biodegradable fibers

Production by kneading a mixture of the biodegradable polymer and the silicon-releasing calcium carbonate particles to produce a composite; dissolving the composite in chloroform of 99% or more purity to produce a spinning solution with polymer content of 4 to 12 wt %; feeding to a nozzle of an electrospinning apparatus; applying high voltage to convert the spinning solution into biodegradable fiber; and collecting the biodegradable fiber deposited on the collector.

Biodegradable polymer as poly(lactic-acid)

The biodegradable polymer is poly(lactic-acid).

Biodegradable polymer as a poly(lactic-acid)/poly(glycolic acid) copolymer

The biodegradable polymer is a copolymer of poly(lactic-acid) and poly(glycolic acid).

Silicon-releasing calcium carbonate content of 40–60 wt%

The silicon-releasing calcium carbonate content in the composite is 40–60 wt%.

Overall claim coverage centers on a fibrous biodegradable bone regeneration material formed from biodegradable polymer and silicon-releasing calcium carbonate particles, produced via kneading, chloroform dissolution into a specified polymer-content spinning solution, and electrospinning into biodegradable fibers, with dependent claims specifying polymer type and a 40–60 wt% range for the silicon-releasing calcium carbonate.

Stated Advantages

Improved osteoblastic cell adhesion and growth.

Enhanced bone reconstruction ability.

Documented Applications

Guided bone regeneration (GBR) membrane use.

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