Highlighted project: Safer keyhole surgery thanks to new mechanism

Name: VeressPLUS; Innovative decoupling mechanism for the Veress needle
Aim: To validate a prototype needle mechanism for the Veress needle, a needle used for keyhole surgery.
Intended result: To analyse whether the new needle mechanism 'VeressPLUS' for the Veress needle can actually cause less damage for patients
Partners: Pro Vinci MedTech, Van Straten Medical, TU Delft Sustainable Surgery & Translational technology, Living Lab Medical Delta Instruments, Province of Utrecht
Status: Pilot study prototype completed; conclusions published; preclinical study completed

One of the instruments used for keyhole surgery in the abdomen is the Veress needle. The surgeon uses this needle to make a small hole in the abdominal cavity in order to introduce CO2 and thus create viewing and working space. In some cases, the needle may be inserted too deeply and damage underlying tissue. Especially in patients with a higher BMI, it becomes more difficult to position and stabilise the needle properly, increasing the risk of "overshoot". When this happens, it often results in serious medical complications.

A consortium including Medical Delta scientists led by Tim Horeman (TU Delft) developed a prototype of a mechanism that should prevent the Veress needles from slipping after puncturing the abdominal wall. A small test series of the 'VeressPLUS' needle (or 'VN+') was tested from the Medical Delta Instruments Living Lab at the LUMC and the University of Malta; the first results were published recently.

Fifteen million operations per year

Although the literature reports complication rates for the Veress needle of 0.31% and 0.23%, there are indications that the actual number of incidents is much higher for certain patient groups and certain abdominal insertion sites. In a 2010 national survey of laparoscopic access techniques in Canadian general surgery practice, 57% of respondents had experienced or witnessed a serious laparoscopic access complication, such as bowel perforation and vascular injury. These complications are potentially life-threatening. Around 15 million operations are performed globally each year using a Veress needle, with each complication being one too many.

To prevent this, Pro Vinci MedTech and Van Straten Medical, in cooperation with Delft University of Technology, have developed a disconnection safety mechanism. A production series of the Veress needle, the VeressPLUS, has been equipped with this new safety mechanism.

Promising test results

After the new mechanism had been successfully integrated into a standard Veress needle, the first prototypes were tested on an ex vivo porcine abdominal wall tissue model in a standardised set-up. This was followed by a series of preclinical studies from the Living Lab Medical Delta Instruments at the anatomy department of the University of Malta. This was done on special 'Thiel' embalmed human bodies. A team of twenty novice and experienced surgeons systematically punctured the bodies hundreds of times with the VeressPLUS.

It became clear that the preclinical data corresponded to the data from the ex-vivo experiments, and the researchers found a significant difference between the attempts with a standard, conventionally working Veress needle and a Veress needle with the release mechanism. The results of both the ex vivo and preclinical studies indicate that these VeressPLUS needles reduce overshoot by at least 50%.

Basis for further development

"These results provide a good basis for further development," says Tim Horeman, assistant professor at TU Delft. "A lot of health benefits can be achieved with a relatively small adjustment. If further clinical studies also turn out positive, we will bring it to the market in various versions."

"By also involving other surgeons and nurses from other regions and countries in the development and testing, we will know first-hand what the target group needs," says Roelf Postema, PhD student and involved surgeon from MC Spijkenisse MC and Amsterdam UMC.

The consortium expects to have enough funding by mid-2022 to start clinical follow-up research and hopes to submit a CE certification application that same year. After that, the implementation of the mechanism in other so-called 'first-acces' instruments will be further investigated.

Read the scientific publication about the test results here.