For patients with cancer of the gastrointestinal tract, tumours are most commonly removed surgically, and the ends of the intestines are reconnected. Currently, up to 10 per cent of these patients endure serious complications caused by leaks from this surgical join. Scientists from St. Olavs Hospital have developed a safer solution in the form of a surgical stapler called Koppler. The objective is to land a licensing agreement with the help of the Research Council’s Proof-Of-Concept Project.
The invention is the work of two experienced surgeons, Lars Cato Rekstad and Brynjulf Ystgaard, from the Department of Gastrointestinal Surgery at St. Olavs hospital. They have long experience of gastrosurgery and have experienced the limitations of the instruments currently available firsthand.
- Koppler is lighter and easier to manoeuvre during operations than the technology currently available. With its new functionality, we believe that Koppler will help to reduce the problems associated with this kind of operation, says project manager at NTNU Technology Transfer Tonje Steigedal.
Success criteria
Steigedal underlines that Research Council funding for the Proof-Of-Concept Project has been crucial, and that the combination of the Pre-project and Proof-Of-Concept Project has enabled vital verification work in a demanding MedTech case.
Steigedal also emphasises some of the project’s characteristics that have been decisive to the specific results of the Proof-Of-Concept Project:
- A good concept
- A strong team
- Thorough work on securing intellectual property rights (IPR) related to the invention
- A clear need, i.e. the concept addresses an actual problem
- The market situation, industry actors seeking to take market shares
“With its new functionality, we believe that Koppler will help to reduce the problems related to this kind of operation.
Prosjektleder ved NTNU Technology Transfer Tonje Steigedal
Early industry contact is essential
Steigedal explains that the main objective of the Pre-project was to start a dialogue with potential licensees to verify that the concept had real commercial potential and interest from industry actors.
- The Pre-project was used to develop prototypes that could be presented to industry actors through dialogue and meetings with potential licensees. The positive results of the Pre-project led to the decision being made to follow up with a Proof-of-Concept Project. The goal here was to develop a final and functional prototype of a circular surgical stapler with the ability to staple tissue in accordance with applicable industry actor requirements, Steigedal explains.
- The early industry contact and their detailed feedback on the concept has been essential to the results and the progress of the Proof-Of-Concept Project. It is not necessarily the case that similar results are possible for all Commercialisation Projects, but in this case, the team attained highly valuable market insight and important feedback, says Steigedal.
The market for this kind of surgical instrument is dominated by major stakeholders.
- For this reason, we think the best commercialisation strategy is to enter into partnerships and licence agreements with existing industry actors. These can then finalise the product, ensure regulatory approval and sell it to the end users through well-established sales channels.
Anastomotic leak is among the most dreaded complications of gastrointestinal surgery. Koppler represents a novel technology for reducing the risk of leaks after stapling.
Existing equipment for stapling with a fixed anvil has obvious limitations, and leaks can occur when the two ends of the intestines become detached after being connected with staples. Gastrointestinal content may then leak out into the chest or abdominal cavity with a potentially fatal outcome for the patient.
Koppler is a novel surgical stapler with a foldable anvil causing less stress on the anastomosis, thereby reducing the risk of leaks after stapling.
The Inventors behind Koppler are gastro surgeons Brynjulf Ystgaard and Lars Cato Rekstad from St. Olavs Hospital in Trondheim. An application for a patent for the invention was submitted in June 2016 and Koppler is now in the extensive testing phase, in dialogue with potential commercial partners. The design agency Inventas, fronted by Rolf Sellesbakk and Lars Vartdal, has played an important role in developing a prototype. The product has been developed and commercialised through NTNU Technology Transfer.