EPIA(Epidural Anesthesia device)

Introduction

EPIA is the device that finds out the epidural space automatically based on the results of an analysis of the reaction forces received as the needle advances.

Identification of the epidural space during injection is critical, yet epidural injection is considered the most difficult technique to acquire since a success rate of it is as low as 80%. Side effects or complications include nausea, spinal cavity, low blood pressure headaches (also known as post-dural puncture headache) at the range of 0.5-3% incidence rates, and even paralysis or nerve damage in very rare cases.

Epidural anesthesia also called as regional anesthesia, blocks pain in an area of the body by blocking nerve impulses into the epidural space. Epidural space, which is right outside of the membrane that protects the spinal cord. This aids in reducing the sensation of the lower part of the body. The epidural anesthetic is the most common method to reduce pain during normal or C-section delivery.

  • EPIA is equipped with a sensor to detect the reaction force of the needle as the needle advances steadily and mechanically.
  • As the needle progress through skin, subcutaneous tissue, ligamentum flavum, and epidural space, EPIA gives a real-time measurement of reaction force, which is then useful to detect an epidural space
  • Designed to make an auto-stop at the epidural space and administer anesthetic drugs (administration of anesthetic can be done manually)
  • EPIA gives a better identification of the epidural space than the LOR technique.
  • Compared to other epidural injection equipment such as CompuFlo® or Epidrum®, EPIA does not rely on pressure or LOR. Instead, it measures the change of reaction force, providing more accurate detection of epidural space.
  • EPIA’s software can be applied to various needle injection practices in the fields of urology, gynecology, or catheter insertions.
  • Global Epidural Anesthesia Disposable Devices Market is estimated to reach USD 16.51 billion by 2027, growing at a CAGR of 6.3 % between 2019 and 2027.
    (https://www.profsharemarketresearch.com/epidural-anaesthesia-disposable-devices-market/)
  • The estimated global needle market size is USD 5.97 billion in 2017 and is expected to reach USD 9.96 billion in 2025 with a CAGR of 6.6% over the period. (https://www.grandviewresearch.com/press-release/global-needles-market).
  • PCT/KR2012/007774 INTELLIGENT SURGERY SYSTEM
    The patent is currently registered in the USA, China, Australia, Europe and pending in Japan and Thailand.

R&D status

  • EPIA has received ISO13485 certification in March 2021.
  • EPIA has been approved of an investigator-initiated exploratory trial by KFDA in March 2021.
  • Pre-clinical experiments collaborated with Seoul National University have been concluded in March 2021.
  • Animal test of EPIA was conducted by KNOTUS in April 2020.
  • -The non-clinical test for the EPIA was tested by using an 18G needle on 56kg porcine model with the 4th generation of EPIA device. Neurosurgeon, anesthesiologist and orthopedist’s faculty members participated in the experiment. As a result of analyzing the X-ray and the reaction force graph results, we confirmed that the various sections of the reaction force detected by the EPIA coincide with the actual epidural space. Detection of the epidural space and auto-stop function were both successful.

  • Medical Device Conformity Assessment has been conducted with Seoul National University Hospital.