The ‘all-seeing’ Hand of the Operator…

The ‘all-seeing’ Hand of the Operator…

is just one of the highlights of Spang & Brands GmbH, Friedrichsdorf, Germany, at this year’s COMPAMED in Dusseldorf. On its stand, M33 in Hall 8a, the systems provider for medical devices presents the innovative Mofixx laparoscope control and holding device.

The device is the result of close cooperation between Mofixx, INDES and Spang & Brands. The initial idea for this system was sparked during practices applied in operating theatres 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.”

The resulting developments were taken on board by Mofixx BV and INDES BV in order to create user-specific workable solutions. Previously, Spang & Brands had been at the top of the shortlist of the two Dutch partner companies: at the forefront were functionality and a holistic approach in the design of medical devices and components as well as complete ready-for-use systems, not forgetting their comprehensive plastics production technologies, the crucial criteria in favour of Spang & Brands as systems partner.

The result was truly remarkable: Mofixx, the ‘all-seeing’ hand of the operator during micro-invasive surgery. No more complex instructions to assistants to position the trocar equipped with a micro-camera. 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 3-D 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.

Move and Fix was the motto of the complex challenge and task in hand for Spang & Brands in November 2014 to accomplish the transformation of the Mofixx system. The remit involved:

  1. … the establishment of a definitive solution to guarantee the stability of the base at the locking point to the sphere. Simultaneously, to ensure clean guidance of the camera system without the base causing an unacceptably high resistance at the sphere. Ease of operation and mobility on the one hand and, on the other, the absolutely stable fixing mechanism had to be achieved. This may sound contradictory yet the objective was, indeed, accomplished!
  1. … the selection of the most appropriate polymers – in this case predominantly polycarbonate – capable of taking into account the forces exerted. At the same time, functionality was not to be impeded or restricted. What’s more, 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 (Conformité Européenne which means European Conformity)
  1. … the provision of optimized precision moulds for the construction phase so that the production of Mofixx trocar components (predominantly PC) is assured following state-of-the-art manufacturing and quality assurance standards.
  1. … the development of user-ready packaging for the single-use components of the Mofixx laparoscope control and fixing device.

Friedrich Echterdiek, managing director at Spang & Brands GmbH: “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.” The high professional competence of the Spang & Brands developers and their injection moulding expertise in the implementation led to a speedy realization of the Mofixx system. With this camera system surgical assistants are free to carry out other important and crucial tasks.

The innovative Mofixx laparoscope control and holding device was successfully used for the first time in 2016 by urologist Dr Arto Boeken during a kidney operation at the UMC Utrecht.

 

Spang & Brands GmbH, Friedrichsdorf: For the past 30 years the systems provider for medical devices has been a specialist in the field of precision and cleanroom injection moulding technology for medical and pharmaceutical industries – supported by continuous growth in engineering knowhow, aided by CAD-3D developments, MoldFlow analysis, in-house mould making, not forgetting over 60 fully electric as well as hydraulic single and multi-component injection moulding machines operating in-house. Cleanrooms with differing specifications accommodate fully automatic and manual assembly, including packaging of components and systems, starting with pilot productions and just-in-time manufactured batch production – from the smallest series to manufacture of millions of units. Conformity to the latest domestic and international legislation relating to medical devices is guaranteed right across the entire product cycle – from prototype to arrival at the user. The company is, among others, certified ISO 13.485.

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