Targetted approach

Prostate cancer is one of the most common forms of cancer in men, accounting for around 10% of all male cancer deaths.

One treatment option is radiotherapy. The challenge here is to hit the prostate - it can move significantly during the treatment - with a focused dose that will kill the tumour and a low dose to the surrounding healthy tissue. Because organ motion is normally not detectable from the outside, a margin around the tumour is applied in order to make sure that the cancer is treated - the motion and the margin increases the risk that the patient will suffer from side effects like impotence, incontinence and rectal bleeding.

To counteract these risks, Raumedic was commissioned by Micropos Medical to develop a localisation probe to be placed in the organ to be treated. This, in combination with an external antenna system, can continuously position and track the prostate throughout all treatment sessions to increase precision and make a better treatment available.

Aided by ultrasound, the probe is accurately placed directly at the tumour and is easily removed after the final treatment (two-12 weeks after implantation). The implantation of this probe enables the physician to quickly and accurately localise the cancer in real-time and allows for radiation to be focussed on the affected area. The implant will also allow the physician to continuously record and monitor the strength of the radiation dose.

When selecting a suitable material for the probe tubing, we chose polyurethane. This possesses excellent biotoxicological characteristics as well as blood compatibility and flexibility and is therefore well-suited for application in implants. Based on its long-term extrusion experience, Raumedic used a radiopaque polyurethane that is suitable for implantation in this newly developed device. In addition to the extrusion, this material is also suitable for the encapsulation of the electronic components that are located in the catheter tip. The micro-cables are pulled into the tubing before the encapsulation. At the proximal catheter tip, a connection is established with an electronic element and at the distal end with a plug element. During these manufacturing steps, various processes are used such as glueing or soldering. A secure connection can be ensured in a variety of ways. Epoxy-based or UV-curing adhesives have proven to be a good solution. Well-trained personnel use microscope-equipped work stations for the soldering of wires with tiny diameters. An alternative to the insertion of wires into one of the lumens of the tubing is to embed the wires into the tubing wall during the extrusion process. Raumedic develops optimal manufacturing concepts depending on the product and the required quantities.

We were able to use our experience in processing plastic materials along with our manufacturing expertise for the integration of electronics such as microchips, storage elements or cameras into medical technology products. In the case outlined above, we developed the RayPilot Transmitter catheter system in cooperation with the customer.

As a system supplier possessing the manufacturing skills extrusion, injection moulding and assembly, Raumedic can provide everything from one source – from the development process to serial production. We can also develop and produce proprietary pressure measurement catheters for neuromonitoring, urology, gastroenterology and traumatology for clinical and practical applications.

Author:

Katja Thierschmidt is product manager business unit assembly/catheters