Two-paste cement-forming compositions
Inventors
Luo, Jun • Engqvist, Håkan • PERSSON, Cecilia
Assignees
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Publication Number
US-11260144-B2
Publication Date
2022-03-01
Expiration Date
Abstract
Injectable, ready-to-use two-paste cement-forming compositions comprise a first paste and a second paste. The first paste comprises a non-aqueous oil-based suspension of monocalcium phosphate monohydrate (MCPM) powder, at least one surfactant effective to improve compatibility of the oil and the MCPM, and an organic acid, with an oil to MCMP powder weight ratio of about 0.2 to about 0.5. The second paste comprises an aqueous suspension of β-tricalcium phosphate (β-TCP) powder and a gel-forming polymer, with a water to β-TCP powder weight ratio of about 0.3 to about 0.5. The molar ratio of β-TCP powder to MCPM powder is greater than 1. An article of manufacture comprises a first compartment in which the first paste is contained, and a second compartment in which the second paste is contained. The compositions are useful for bone repair or replacement.
Core Innovation
The invention relates to an injectable, ready-to-use two paste cement-forming composition for bone repair or bone replacement. The composition includes a first paste comprising a non-aqueous oil-based suspension of monocalcium phosphate monohydrate (MCPM) powder, at least one surfactant effective to improve compatibility of the oil and the MCPM, and an organic acid.
The composition further includes a second paste comprising an aqueous suspension of β-tricalcium phosphate (β-TCP) powder and a gel-forming polymer. The first paste has an oil to MCPM powder weight ratio of about 0.2 to about 0.5, the second paste has a water to β-TCP powder weight ratio of about 0.3 to about 0.5, and the molar ratio of β-TCP powder to MCPM powder is greater than 1.
The invention also describes an article of manufacture with dual compartments for delivering the two pastes, including a mixing chamber configured to combine the first paste and the second paste. The reported context indicates improved injectability without filter pressing, improved cohesion compared to chronOS™ Inject, an increase in compressive strength, stable injectability and strength after shelf-life storage, and phase transformation to brushite.
Claims Coverage
The partial content identifies one independent claim, centered on the structure of an injectable, ready-to-use two-paste cement-forming composition. The inventive features are tied to the specific MCPM-containing non-aqueous first paste, the β-TCP-containing aqueous second paste with gel-forming polymer, and a β-TCP:MCPM molar ratio greater than 1.
Injectable ready-to-use two paste cement-forming composition
An injectable, ready-to-use two paste cement-forming composition comprising a first paste and a second paste, wherein the first paste comprises a non-aqueous oil-based suspension of monocalcium phosphate monohydrate (MCPM) powder, at least one surfactant effective to improve compatibility of the oil and the MCPM, and an organic acid, and the second paste comprises an aqueous suspension of β-tricalcium phosphate (β-TCP) powder and a gel-forming polymer.
Non-aqueous oil-based MCPM first paste with surfactant and organic acid
The first paste has an oil to MCPM powder weight ratio of about 0.2 to about 0.5, and includes at least one surfactant effective to improve compatibility of the oil and the MCPM, and an organic acid.
Aqueous β-TCP second paste with gel-forming polymer
The second paste has a water to β-TCP powder weight ratio of about 0.3 to about 0.5 and includes a gel-forming polymer.
β-TCP to MCPM molar ratio greater than 1
The molar ratio of β-TCP powder to MCPM powder is greater than 1.
The independent claim is directed to a two-paste cement-forming system combining a non-aqueous MCPM oil-based suspension with surfactant and organic acid, an aqueous β-TCP suspension with gel-forming polymer, and a β-TCP:MCPM molar ratio greater than 1.
Stated Advantages
Improved cohesion compared to chronOS™ Inject.
Injectability without filter pressing.
Compressive strength increases.
Stable injectability and strength after shelf-life storage.
Phase transformation to brushite.
Documented Applications
Bone repair or bone replacement using the injectable, ready-to-use two paste cement-forming composition.
Delivery using a compartmentalized, dual-paste article of manufacture with first and second paste compartments and a mixing chamber that combines the first and second pastes for dispensed delivery.
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