The present invention provides a negative pressure guided bone cement injection system comprising a negative pressure system, comprising a negative pressure introduction device, a pushing system for implant bone cement to the target area, a control system for regulating the negative pressure system and the pushing system, and at least one sensing device disposed at any position of the negative pressure system, which can sense at least one environmental parameter for observing the physiological condition of a patient's spinal vertebral body can be monitored immediately, and the result is actively or passively sent back to the system or the operator for adjusting the injection parameters.

A method for planning the insertion of bone cement into an orthopedic void of a vertebra. A three dimensional preoperative image of the vertebra is used and the voxels are analyzed to provide the voxel absorption levels. The absorption levels are transformed into mechanical properties of regions of the vertebra, such that a three dimensional mesh of the mechanical properties of the vertebra is generated. An entry point and an entry angle are selected on the vertebra, through which to inject bone cement into the void. Then, using the known viscosity of the bone cement, and using the entry point and entry angle, a finite elements analysis may be performed on the mesh to simulate the propagation of the bone cement into the orthopedic void. The simulation is repeated using different operational parameters until said propagation of said bone cement is deemed satisfactory.

Systems and methods for treating vertebral compression fractures are discussed. In an embodiment, a method includes mixing bone cement precursors thereby causing a first chemical curing reaction characterized by a first time-viscosity profile, controllably applying energy to the bone cement from an external source to modify the first time-viscosity profile to a second time-viscosity profile, and injecting the cement into bone at a substantially constant viscosity greater than about 1000 Pa.Math.s to greater than about 5000 Pa.Math.s over an extended working time. In another embodiment, a bone cement injector system is provided that includes a first handle component that is detachably coupled to a second sleeve component having a distal end for positioning in bone and a flow channel extending through the first and second components. The system includes first and second thermal energy emitters for delivering energy to bone cement flows in a flow channel portion in the first and second components, respectively.

The invention comprises a system which determines the cure status of bone cement which is then used in making surgical decisions on the cement use and further comprises a system for aiding in securing an implant to a bone using a cured grout or bone cement. The system includes a device which comprises a frequency sensor joined to a circuit to monitor one or more frequency signals, and to an indicator that emits a signal in response to a current emitted to the circuit by the system while monitoring the state of cure. The invention also relates to surgical methods using the system.

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. Since the relationships between the preshearing and pressurization conditions and the setting kinetics and the time dependent changes in elasticity and viscosity are complex, a priori characterization of viscoelastic properties using the advanced rheological characterization technique of small-amplitude oscillatory rheometry is needed 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 oil wells, restoration and fracking.

The present invention provides a negative pressure guided bone cement injection systme comprising a negative pressure system, comprising a negative pressure introduction device, a pushing system for implant bone cement to the target area, a control systmem for regulating the negative pressure system and the pushing system, and at least one sensing device disposed at any position of the negative pressure system, which can sense at least one environmental paramtere for observing the physiological condition of a patient's spinal vertebral body can be monitored immediately, and the result is actively or passively sent back to the system or the operator for adjusting the injection parameters.

A bone cement delivery system including a mixer, a reservoir for holding bone cement, a cannula that is connected to the reservoir and through which the bone cement is delivered into living tissue. A plunger that is advanced by a drive assembly, pushes the bone cement out of the delivery tube into the cannula for discharge from the cannula. A valve is located upstream of the cannula. A control unit regulates both drive assembly and the setting of the valve. The control unit is configured to, when deactivating the valve so as to stop the advancement of the plunger, close the valve. The closing of the valve reduces the extent to which the bone cement, which is under pressure continues to flow into and be discharged out of the cannula.

A method for planning the insertion of bone cement into an orthopedic void of a vertebra. A three dimensional preoperative image of the vertebra is used and the voxels are analyzed to provide the voxel absorption levels. The absorption levels are transformed into mechanical properties of regions of the vertebra, such that a three dimensional mesh of the mechanical properties of the vertebra is generated. An entry point and an entry angle are selected on the vertebra, through which to inject bone cement into the void. Then, using the known viscosity of the bone cement, and using the entry point and entry angle, a finite elements analysis may be performed on the mesh to simulate the propagation of the bone cement into the orthopedic void. The simulation is repeated using different operational parameters until said propagation of said bone cement is deemed satisfactory.

Systems and methods for treating vertebral compression fractures are discussed. In an embodiment, a method includes mixing bone cement precursors thereby causing a first chemical curing reaction characterized by a first time-viscosity profile, controllably applying energy to the bone cement from an external source to modify the first time-viscosity profile to a second time-viscosity profile, and injecting the cement into bone at a substantially constant viscosity greater than about 1000 Pa.Math.s to greater than about 5000 Pa.Math.s over an extended working time. In another embodiment, a bone cement injector system is provided that includes a first handle component that is detachably coupled to a second sleeve component having a distal end for positioning in bone and a flow channel extending through the first and second components. The system includes first and second thermal energy emitters for delivering energy to bone cement flows in a flow channel portion in the first and second components, respectively.

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.