Lumber puncture is a meticulous procedure used to collect ...
Lumber puncture is a meticulous procedure used to collect cerebrospinal fluid (CSF). The procedure is risky and is particularly difficult to perform in obese and young patients.
Lumbar puncture frequently includes measurement of the CSF pressure. The existing kit for lumbar punctures includes a u-tube manometer used to measure CSF pressure that is bulky, cumbersome, time consuming and drains unnecessary CSF volume, resulting in a painful procedure for the patient.
Our solution is to create pressure measurement system using a microelectronics contained in a handheld casing that can be operated easily in one hand. The innovative idea is that the pressure is measured by a pressure transducer and displayed on an LCD screen instead of a U-tube manometer.
Our prototype demonstrates the measurement of pressures using a pressure transducer.
Our product offers vast advantages over the existing instrument such as convenience to patient and physician, faster procedures, accuracy, ease of use, and safety. The invention has a total cost that will be low compared to the total cost of a conventional lumbar puncture kit, and will add substantial value to the package.
The 510(k) will allow us to bypass extensive and costly pre-market approval (PMA). The novel parts of our invention do not impair the conventional lumbar puncture procedure.
The product will be welcomed by neurologists for its fast operation and ease of use. Transitioning to this device does not require significant modification to the lumbar puncture procedure, and strong sales are expected within five years of inception. f
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