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Results from long-term in-vivo tests of a wireless, intravascular blood-pressure monitoring system for hypertension patients

: Cleven, Nina J.; Woitok, Anna; Penzkofer, T.; Isfort, P.; Görtz, Michael; Göttsche, Thorsten; Steinseifer, Ulrich; Schmitz-Rode, Thomas

Abstract ()

Deutsche Gesellschaft für Biomedizinische Technik -DGBMT-; Univ. Freiburg/Brsg., Institut für Mikrosystemtechnik -IMTEK-:
BMT 2012, Biomedizinische Technik. Proceedings 46. DGBMT Jahrestagung : Jena, September 16 - 19, 2012
Berlin: De Gruyter, 2012 (Biomedizinische Technik 57, 2012, Supplement 1)
Deutsche Gesellschaft für Biomedizinische Technik (DGBMT Jahrestagung) <46, 2012, Jena>
Abstract, Elektronische Publikation
Fraunhofer IMS ()
intelligente Implantate; implantierbarer Drucksensor; Blutdruckmessung; implantable biomedical devices; hypertension; biomedical monitoring; blood-pressure measurement

Long-term monitoring of malign hypertension patients is important for physicians to prescribe appropriate medical treatment in order to reduce the incidence of secondary consequences such as stroke, kidney failure or heart insufficiency. However, current devices are not suited for long-term blood-pressure measurement. In order to address this need, we developed and conducted in-vivo tests on a novel, fully-implantable, wireless blood-pressure monitoring system.
The monitoring system was tested for six months in 12 chronic ovine models. The sensor was implanted with X-raycontrol in the femoral artery by means of a dedicated sheath (PASIS). Reference measurements were recorded with industry standard pressure sensors post implantation. Position and proper functioning of the sensor were controlled via regular readout measurements and CTs. At the end of each trial, a histological examination was conducted.
Chronic in-vivo studies revealed that blood pressure measurement over a period of six months was possible with the novel implantable sensor system. Stable pressure histories were recorded. However, the mechanical resilience of the sensor system requires improvement. The in-vivo tests in the femoral artery of sheep produced high stress on the sensors system. Several implanted systems became inoperative despite efforts to stiffen the sensor-cable. The histological analysis detected no thrombi, however mild ingrowth was observed in several cases.
The results of the chronic in-vivo tests on the novel implantable blood-pressure monitoring system were encouraging. Improvements need to be made regarding the mechanical resilience of the system and the coating needs to investigated to reduce ingrowth-behavior. Additional trials at a modified implantation spot will be conducted in order to reveal further insights regarding system performance.