Method and apparatus for regulating and controlling poly-methylmethacrylate injection by using pressure
The present invention provides a pressure-guided bone cement injection method and device, comprising an algorithm capable of sensing at least one environmental parameter. It dynamically monitors saturation level of bone cement within the vertebral body of a patient in real-time and actively provides feedback to the device to modify injection conditions.
1 . A pressure-guided bone cement injection device, comprising:
a pressure unit for introducing pressure;
a propulsion unit for driving bone cement injection into a vertebral body;
at least one sensing unit for detecting at least one environmental parameter; and
a control unit connecting the pressure unit, the propulsion unit, and the sensing unit,
wherein the environmental parameter comprises a monitored pressure value, wherein the control unit comprises an algorithm module,
wherein the algorithm module is configured to perform the following steps:
(a) setting an initial pressure output value;
(b) receiving at least one environmental parameter sensed by the sensing unit;
(c) obtaining data through a computational process based on the at least one environmental parameter;
(d) continuing or halting the injection of bone cement and modifying the pressure output value of the pressure during continuing the injection of bone cement according to a data comparison process;
wherein the computational process includes defining a saturation range of bone cement within the vertebral body through subtracting the pressure output value from the pressure output value multiplied by a manually set parameter, calculating a pressure change rate using a differential or derivative method, and calculating a saturation level of bone cement through dividing the monitored pressure value by the pressure output value,
wherein the data comparison process includes comparing the pressure change rate with a default pressure change threshold, and if the pressure change rate is less than the default pressure change threshold, commanding the control system to increase the pressure output value, then comparing the monitored pressure value with the saturation range of bone cement, and if the monitored pressure value is less than the saturation range of bone cement, commanding the sensing unit to re-monitor the monitored pressure value and repeating steps (a) to (d) until the monitored pressure value reaches a maximum output value, and if the pressure change rate exceeds the default pressure change threshold or the monitored pressure value exceeds the saturation range, commanding the propulsion unit to stop the injection of the bone cement.
2 . A method for pressure-guided bone cement injection, comprising:
(a) setting an initial pressure output value;
(b) receiving at least one environmental parameter sensed by a sensing unit;
(c) obtaining data through a computational process based on the at least one environmental parameter;
(d) continuing or halting the injection of bone cement and adjusting the pressure output value of the pressure during continuing the injection of bone cement according to a data comparison process,
wherein the computational process includes defining a saturation range of bone cement within the vertebral body through subtracting the pressure output value from the pressure output value multiplied by a manually set parameter, calculating a pressure change rate using a differential or derivative method, and calculating a saturation level of bone cement through dividing the monitored pressure value by the pressure output value,
wherein the data comparison process includes comparing the pressure change rate with a default pressure change threshold, and if the pressure change rate is less than the default pressure change threshold, commanding the control system to increase the pressure output value, then comparing the monitored pressure value with the saturation range of bone cement, and if the monitored pressure value is less than the saturation range of bone cement, commanding the sensing unit to re-monitor the monitored pressure value and repeating steps (a) to (d) until the monitored pressure value reaches a maximum output value, and if the pressure change rate exceeds the default pressure change threshold or the monitored pressure value exceeds the saturation range, commanding the propulsion unit to stop the injection of the bone cement.
3 . The method for pressure-guided bone cement injection according to claim 2 , wherein the monitored pressure value comprises pressure value within the pressure introduction device, pressure value within the pressure unit, and pressure value within the vertebral body.
4 . The method for pressure-guided bone cement injection according to claim 2 , wherein the algorithm module determines that the pressure output value should not exceed the maximum pressure output value.
5 . The method for pressure-guided bone cement injection according to claim 2 , wherein the initial pressure output value is not allowed to be less than 0 mmHg.