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Testing and improvement of a long-term monitoring system for hypertension patients

: Cleven, N.; Woitok, A.; Görtz, M.; Göttsche, T.; Steinseifer, U.; Schmitz-Rode, T.

Deutsche Gesellschaft für Biomedizinische Technik -DGBMT-; Univ. Freiburg/Brsg., Institut für Mikrosystemtechnik -IMTEK-:
BMT 2011, Biomedizinische Technik. Proceedings 45. DGBMT Jahrestagung : 27. - 30. September 2011, Freiburg
Berlin: De Gruyter, 2011 (Biomedizinische Technik 56.2011, Supplement 1)
ISSN: 0939-4990
Deutsche Gesellschaft für Biomedizinische Technik (Jahrestagung) <45, 2011, Freiburg>
Fraunhofer IMS ()
intelligente Implantate; implantierbarer Drucksensor; Blutdruckmessung

Approximately ten million patients in Germany suffer from hypertension, 10% of these patients are difficult to medicate, whereas 1% requires long-term blood pressure monitoring. The purpose of our study is the empirical evaluation of a novel monitoring system recording blood pressure, pulse rate and body temperature of hypertensive patients which is designed for minimally-invasive implantation into the femoral artery.
The device is tested in twelve chronic animal trials (sheep) for a period of three to six months. Implantation of the sensor is accomplished by means of a dedicated sheath (PASIS) in the femoral artery under X-ray-control. A reference sensor positioned contra laterally is used to counter-check the measurement quality and validity of each sensor after implantation. Position and proper functioning of the sensor are controlled via regular readout measurements and CTs. Pathologic evaluation are made to investigate possible ingrowth of sensor tip and sensor cable at the end of each trial.
Although the project is still in process, several interesting findings can already be reported. The pressure sensors in general deliver stable pressure history. However, the stiffness of the micro-cable as well as the implantation technique and position have an important impact on stable positioning of the sensor in the artery and thus on the validity of the pressure curves. Cables with low stability tend to slip out of the artery easily whereas high stiffness may injure the vessel.
Achieved findings are promising and support the feasibility of a stable long-term blood pressure implant to monitor
hypertensive patients. However, there are still some challenges to overcome. Future work encompasses to analyze the influence of different cable designs and implantation techniques as well as the validation of ingrowth and explantability