The German medical device systems provider has developed a laparoscope control and holding device that enables operating room clinicians to obtain a precise, stable, sharp image during laparoscopies.
The device was developed in close cooperation with Mofixx and INDES. The initial idea for the system was sparked during practices applied during surgeries at the University Medical Centre in Utrecht (UMC), The Netherlands. Since 2006, Dr. Joris Jaspers, head of medical technical development at the hospital, has been involved in the optimization and validation of working processes during surgery. “During keyhole surgery, assistants frequently have to stand for hours in awkward positions and, at the same time, hold and guide their instruments accurately. This should change,” he said.
Indeed, Mofixx changes the way O.R. assistants work during micro-invasive procedures. Complex instructions to position the trocar— equipped with a micro-camera—no longer are necessary. Direct activation results in short reaction times of the optical device by simply pressing a single button. Only that way an absolutely precise, stable and sharp image during laparoscopies can be obtained. This result is achieved with the use of a stabilizing swivel arm equipped with a ball-and socket joint (sphere), enhanced with a spindle motor and base. Single-handedly operated, the device can be manipulated as long, easy and as seamlessly intuitive as it is required for the operator to be able to lock the apparatus into the desired optimal image position or documentation. The device is also available for 3D documentation where a stable image is of particularly importance. Mofixx is firmly fixed to the operating table and can be applied flexibly not just using laparoscopes but also with a variety of other instruments required for keyhole surgery, according to Spang & Brands.
Spang & Brands adopted a "move and fix" motto in November 2014 to develop the Mofixx system. Development challenges involved:
- Establishing a definitive solution to guarantee the stability of the base at the locking point to the sphere. Simultaneously, the company also worked to ensure clean guidance of the camera system without the base causing an unacceptably high resistance at the sphere. Other considerations included ease of operation, mobility, and a stable fixing mechanism.
- Selecting the most appropriate polymers—in this case predominantly polycarbonate—capable of handling the forces exerted. At the same time, functionality was not to be impeded or restricted. Moreover, the components had to withstand high biocompatible standards (also taking into consideration the Mofixx corporate colours), as well as international control criteria and certification requirements, such as CE (European Conformity) guidelines.
- The provision of optimized precision molds for the construction phase so the production of Mofixx trocar components (predominantly PC) is assured following manufacturing and quality assurance standards.
- Developing user-ready packaging for the single-use components of the Mofixx laparoscope control and fixing device.
“Our know-how was in demand. The system comprises 12 separate components. They had to be functionally matched to one another and had to comply with the requirements of Move and Fix,” said Friedrich Echterdiek, managing director at Spang & Brands. The competence of Spang & Brands developers and their injection molding expertise helped lead to a quick realization of the Mofixx system. With this camera system surgical assistants are free to carry out other important and crucial tasks.
The Mofixx laparoscope control and holding device was successfully used for the first time this year by urologist Dr. Arto Boeken during a kidney operation at the UMC Utrecht.
Spang & Brands is a specialist in the field of precision and cleanroom injection molding technology for the medical and pharmaceutical industries. The company is ISO 13485 certified.