Preshearing method and apparatus for the control of the rheology and the injectability of aqueous cement suspensions for bone repair and regeneration

Abstract

The invention provides a system for the preshearing based control of the flow and deformation behavior, i.e., the setting kinetics, and the time dependent shear viscosity, elasticity of aqueous cementitious suspensions that can be used for bone repair and regeneration. The dynamic cement microstructure is tailored to the demands of the surgical tasks (faster / slower setting) or additive manufacturing tasks (lower / higher viscosity) by application of various preshearing conditions. The relationships between the preshearing and pressurization conditions and the setting kinetics and the time dependent changes in elasticity and viscosity are complex and characterization of viscoelastic properties using advanced rheological characterization techniques including small-amplitude oscillatory and steady torsional rheometry is needed a priori to enable such tailoring. The preshearing system is intended to give control on the injectability and setting time of any calcium phosphate cement formulation to the surgeon during an orthopedic surgery where a batch of bone cement is processed. Other possible utilizations of the system include controlling the setting kinetics, shear viscosity and facilitating the resultant flow stability of cementitious ceramic suspensions processed in direct ink writing assemblies for additive manufacturing of cement constructs, in injection systems for restoration and fracking.

Description

BACKGROUND OF THE INVENTIONTechnical field[0001]The present invention relates to ceramic cements used in bone repair and regeneration, and more particularly to methods and devices for mixing, pressurization, and preshearing based in situ treatment for the control of the flowability, setting kinetics, and injectability / extrudability during manual or robotic deposition of such cementitious suspensions.Prior art[0002]Cementitious materials are the materials of choice in design and manufacturing of structural, monolithic or injectable components due to their abundancy in nature, and by virtue of their flowability before setting. The latter is exploited most commonly in biomedical applications for bone repair and regeneration using calcium phosphate based cements (driven by the exceptional osteoconductivity of calcium phosphates) as injectable biomaterials (bone cement pastes) especially following cancerous bone removal and for minimally invasive surgeries. The minimally invasive clinica...

AI Technical Summary

Benefits of technology

The present patent is about a method and apparatus for tailoring the flow behavior, setting time, and injectability / extrudability of ceramic cement suspensions made by orthopedic surgeons or robotic additive manufacturing systems. This is achieved by preshearing the cement suspensions using steady or oscillatory torsional deformations, pressurization, or both. The method allows for specific tailoring of the flow properties and setting kinetics, which can control the injectability / extrudability of the ceramic paste and the physical properties of the set cement. The surgeon can choose the appropriate preshearing mode and parameters to determine the best fit for the application. The invention also facilitates extrusion of cementitious suspensions for construction, structural restoration, and additive manufacturing applications.

Problems solved by technology

However additive manufacturing of relatively slow setting cementitious suspensions have been realized by pressurization through hoses of relatively large diameters (>10 mm) due to the propensity of such dynamically evolving suspensions for flow instabilities and related clogging issues during pressure-driven flows through narrow capillaries with diameters in the micronmeter scale.

Once the ceramic suspension attains certain upper thresholds of viscosity and elasticity the injection of the cement paste to the treatment site via the pressure applied on the ram by the surgeon is no longer possible.

Currently in clinical practice, the setting time and flowability of the cementitious suspension are not adjustable parameters for a given formulation.

The major problem that is faced is that every time there is a formulation change that involves the use of ingredients that are not approved by US Food and Drug Administration, FDA, for in vivo usage, new and very costly FDA approvals may be necessary for implementation of these ingredients and formulations.

Furthermore, the problem associated with the development of many choices for the surgeon is that the cement needs to be tailored via changes in composition to the specific application at hand.

The surgeon currently has no recourse but to switch formulations depending on the requirements of the specific surgery since there are typically no adjustable parameters available during the injection of the bone cements to allow their tailoring for specific applications at the surgery site.

The mixing, conveying and delivery of the bone cement are time consuming in practice when done manually and separately.

These US patents and applications lack method and control on the flow behavior, setting time and kinetics of the ceramic bone cements.

Overall, none of these methods and devices can control the rheology (flow and deformation behavior), the setting kinetics and the injectability / extrudability window of the bone cement paste to accommodate the specific demands of a particular task that is being undertaken.

Images