A surgical anastomosis is a frequently used surgical technique to make a new connection between two body structures that carry fluid, such as blood vessels or bowel. It is complex and time-consuming, but above all a crucial step in a surgical operation. After surgical anastomosis during bowel resections, the most frequent complication is Anastomotic Leakage (AL; prevalence on average 10%, depending upon the tissue that is being anastomosed). Currently, there is no tool or technology that can serve as a predictive instrument for AL during surgery and this poses a high unmet need. One, which this OP-Zuid project aims to resolve by developing an Anastomotic Perfusion Measurement Device (APM), which simultaneously measures systolic blood pressure on organs and arm blood pressure during surgery and translates this into a risk Index. This technology predicts during surgery the risk of ischemic tissue and subsequently anastomotic leakage (AL) after surgery. Therefore the surgeon can take action during surgery to circumvent such a leakage.
In Europe and the United States alone there are more than 1.5 million bowel surgeries performed yearly, resulting in 150.000 patients suffering an AL.
This project focuses on the development and validation of a market ready APM device, from TRL 5 to 8. This integrated medical device can be used in (small and large) bowel surgery. It will consist of:
- A sterile plastic disposable probe that measures the blood pressure on the tissue organ wall. The probe contains a micro-sensor set that is put together from a pressure sensor and a miniature optical blood flow sensor in one probe. The probe dimension should allow use with common trocar-ports of as small as 12 mm.
- A non-disposable, universal module in which an off the shelf arm-cuff and the developed probe can be inserted. Both are connected to a Non-Invasive Blood Pressure (NIBP) device, to which a specific read-out display is connected (includes software with dedicated algorithms). The integrated module processes measurements and read-outs within 1 minute in a user interface.
The APM device will change the surgical field by improving safety and efficacy, whilst reducing complications and costs. As such (yet only for bowel surgeries) APM will:
- Prevent AL: aim to prevent the currently 150.000 yearly ALs.
- Reduce AL-related deaths: currently 12.000 deaths per year.
- Save healthcare costs: currently € 2.87 billion AL associated costs per year in Europe and US alone.
The following partners are participating in this project:
- Project Leader: Health Value Creation (HVC) BV- hereafter under the tradename Corporis Medical – Innovative start-up focusing on surgical devices for laparoscopic surgery.
- Project Partner: AIM BV (Advanced Instruments Manufacturing)– Contract Equipment Manufacturer for electro-mechanical medical devices.
- Project partner Medanco Rubber & Plastic Solutions BV – high-end engineering and injection moulding specialist with clean room facilities.