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-10092650-B2

Patent

Publication Date

2018-10-09

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

The invention relates to a fibrous biodegradable bone regeneration material and a bioresorbable guided bone regeneration (GBR) membrane made of biodegradable electrospun fibers. The membrane includes silicon-releasing calcium carbonate and a biodegradable polymer, and the silicon-releasing calcium carbonate is described as a composite of siloxane and calcium carbonate in the vaterite phase. The membrane is configured to enable silicon species ion elution and subsequent apatite coating after soaking.

The membrane can be bi-layered, including a Si–CaCO3/PLA nonwoven layer and a PLA-only nonwoven barrier layer. During soaking in a neutral aqueous solution, silicon species ions elute from the Si–CaCO3/PLA layer to enable apatite deposition. The disclosed examples include forming the silicon-releasing calcium carbonate composite, manufacturing the electrospun membrane, and using neutral aqueous solution soaking to achieve apatite coating.

The invention reports selective apatite formation after simulated body fluid soaking, including 1.5 SBF, with apatite coating or deposition occurring after elution of silicon species ions. The apatite-coated Si–CaCO3/PLA layer is reported to show improved osteoblast cell affinity and proliferation compared with PLA-only and control.

Claims Coverage

The provided material includes one independent claim directed to a method for producing a fibrous biodegradable bone regeneration material via electrospinning. The claim includes three key constraints on the inventive concept: composition of the silicon-releasing calcium carbonate in the composite, preparation of a polymer spinning solution by dissolving in chloroform, and forming electrospun biodegradable fibers while evaporating chloroform and collecting the fibers. Dependent claims further refine the silicon particle composition, silicon content, elution conditions, and a carbonation route for preparing the silicon-releasing particles.

Electrospinning a composite of biodegradable polymer and silicon-releasing calcium carbonate

A method for producing a fibrous biodegradable bone regeneration material by electrospinning, wherein a composite mixture comprises a biodegradable polymer and silicon-releasing calcium carbonate particles, and the silicon-releasing calcium carbonate particles are present at 40 to 60 wt % in the composite.

Dissolving in high-purity chloroform to form a polymer spinning solution

The composite is dissolved in chloroform having a purity of 99% or more to produce a spinning solution having a polymer content of 4 to 12 wt %.

Electrospinning while evaporating chloroform and collecting deposited fibers

The spinning solution is fed to a nozzle of an electrospinning apparatus at a predetermined rate; a biodegradable fiber is spun toward a collector by applying a high voltage while evaporating the chloroform; and the fiber deposited on the collector is collected.

Silicon content constraint for silicon-releasing calcium carbonate particles

The silicon-releasing calcium carbonate particles have a silicon content of 0.5 to 5 wt %.

Siloxane and vaterite-phase CaCO3 particle composite

The silicon-releasing calcium carbonate particles are a composite of siloxane and calcium carbonate in the vaterite phase.

Eluting silicon species ions using a neutral aqueous solution

Silicon species ions are eluted from the silicon-releasing calcium carbonate particles by immersing the particles in a neutral aqueous solution.

Producing silicon-releasing calcium carbonate particles via carbonation with specified components

Silicon-releasing calcium carbonate particles are produced via carbonation by blowing carbon dioxide into a suspension of methanol, slaked lime, and an organic silicon compound, and stirring to gel the suspension.

Biodegradable polymer comprises poly(lactic-acid)

The biodegradable polymer comprises poly(lactic-acid).

Across the independent claim and dependent refinements provided, the invention centers on producing a fibrous biodegradable bone regeneration material by electrospinning a biodegradable polymer composite containing 40 to 60 wt % silicon-releasing calcium carbonate, dissolved in 99%+ purity chloroform to a 4 to 12 wt % polymer spinning solution, and forming fibers by electrospinning with chloroform evaporation and collection. Refinements further specify the silicon particle structure, silicon content range, and a neutral aqueous elution approach, and include a carbonation route for preparing the particles, with poly(lactic-acid) as the biodegradable polymer.

Stated Advantages

Improved osteoblast cell affinity/proliferation for the apatite-coated Si–CaCO3/PLA layer versus PLA-only and control.

Documented Applications

Bioresorbable guided bone regeneration (GBR) using a fibrous biodegradable membrane made of silicon-releasing electrospun fibers and capable of apatite coating after neutral aqueous soaking or simulated body fluid soaking.

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