The Epidural Injection Instrument has been developed to transform the administration of epidurals and improve the safety of epidural procedures, lower costs, and significantly reduce malpractice risk. The CompuFlo's pressure sensing technology embedded in the epidural instrument provides an objective tool that consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the extraligamentary tissue. In studies using our epidural instrument the epidural space has been correctly and consistently identified. Knowing the precise location of a needle during an epidural injection procedure provides a measure of safety not presently available to doctors using conventional syringes, who identify the epidural space by relying on the subjective perception of loss of resistance to saline.
The overall epidural market is significant, with approximately $1 billion in annual sales in the U.S. alone, and approximately 2.5 million U.S. women giving birth each year who receive epidurals. Epidural injections are typically performed blindly or, occasionally, with fluoroscopic guidance, guidance not always available to the anesthetist or unsuitable because of the exposure of the patient to excess radiation. The insertion of an epidural needle in a blind procedure requires anesthetists to assess whether or not the needle has entered the epidural space, a space of only 2-8 mm in depth. Since the methods for determining correct placement, other than through fluoroscopy, are largely subjective they are associated with mistakes. If the epidural needle is placed in too shallow a position no epidural anesthesia is accomplished. If it is placed too deep the dural membrane may be punctured and the patient subjected to possible leakage of spinal fluid. Complications from conventional epidurals include wet tap, dural membrane puncture, catheter misplacement into a vein, neurological injury and, rarely, even death.
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