French pharmaceutical company Gecko has developed an innovative medical adhesive for use in revascularization surgery and has invited IDC to develop a Setalum light source device for it to help achieve rapid gels.
In this project, the UK IDC team started with the most basic product requirements, continuously overcoming a series of user and technical challenges, and delivered the product in a short 12 months to make it available for clinical trials.
In collaboration with the Gecko Biomedical (now known as Tissium) team, the Setalum light source developed by IDC in the UK is the first curing device of its kind.
This product is a new type of Setalum adhesive used to assist Tissium during revascularization surgery to achieve high-quality bonding, I .e., a suturing aid in revascularization surgery.
Since no similar products exist at present, the initial direction of the project is defined as: a pen-shaped, portable and rechargeable 405nm light source device for curing its adhesive in the surgical environment. The device will be used in complex heart surgery and needs to be completely sterile.
The IDC team in the UK is made up of mechanical and electronic engineers, industrial designers and prototype manufacturers, making it possible to move products from initial demand to clinical trials in a short 12 months.
IDC UK spends a lot of time observing surgery, interviewing clinicians to study and understand user needs. Clinicians are involved in the completion of the questionnaire and prototype testing process, providing valuable information on user needs and product operation.
The desktop research helped the team provide valuable insight into the available technology and also showed that there is no similar sterile light source product in the market today.
The team took the lead in testing and evaluating various LED products to find the best LED lighting solution.
One of the biggest challenges found in clinical observation is that when the device is fixed at different heights, it needs to emit parallel beams to provide the correct light intensity. The IDC design team in the UK developed a solution that uses a collimating lens configuration and a custom prism to adjust the angle of the beam at the 405nm wavelength to make it easier to locate.
Another key issue relates to the sterility of the device.
The UK IDC team conceived and designed a disposable sterile sleeve for covering the device and a failsafe procedure between the surgical team to ensure sterility when the sterile sleeve is nested on the device, thereby overcoming this problem.
As a complement to the safety features, the UK IDC has added an infrared sensor to the design, which prevents the light source device from being used when it has not yet been placed in a sterile cannula.
The form of the device is a long and narrow pen. How to properly embed electronic components in such a small physical space is also one of the challenges for the team's development work. Using a simplified strategy in design development, the UK IDC team reduces risk and unnecessary costs with the least number of components.
Another strategy to reduce risk is to set up programming logic for electronic devices to ensure a clear certification process (in compliance with ISO 60601 standards).
The device is powered by a rechargeable battery, and the dual device charging base is provided to prevent the risk of insufficient power of the device during the operation.
The overall design is simple and intuitive to achieve the best curing performance. If the device only has an "on" button on the top to start the curing time of 30 seconds, and a simple LED charging indicator, which can clearly indicate whether the device is ready, these details show the relevant characteristics.
Finally, the system is defined as a multi-class product in the EU, in which the reusable electronic light source is Class I and the sterile disposable sleeve is Class IIa.
The system has also been approved by the US FDA.
Related reading link: https://www.idcdesigncn.com/medical/surgical-adhesive-device/