Design of a multi-axis implantable MEMS sensor for intraosseous bone stress monitoring

The capability to assess the biomechanical properties of living bone is important for basic research as well as the clinical management of skeletal trauma and disease. Even though radiodensitometric imaging is commonly used to infer bone quality, bone strength does not necessarily correlate well with these non-invasive measurements. This paper reports on the design, fabrication and initial testing of an implantable ultra-miniature multi-axis sensor for directly measuring bone stresses at a micro-scale. The device, which is fabricated with CMOS-MEMS processes, is intended to be permanently implanted within open fractures, or embedded in bone grafts, or placed on implants at the interfaces between bone and prosthetics. The stress sensor comprises an array of piezoresistive pixels to detect a stress tensor at the interfacial area between the MEMS chip and bone, with a resolution to 100 Pa, in 1 s averaging. The sensor system design and manufacture is also compatible with the integration of wireless RF telemetry, for power and data retrieval, all within a 3 mm × 3 mm × 0.3 mm footprint. The piezoresistive elements are integrated within a textured surface to enhance sensor integration with bone. Finite element analysis led to a sensor design for normal and shear stress detection. A wired sensor was fabricated in the Jazz 0.35 μm BiCMOS process and then embedded in mock bone material to characterize its response to tensile and bending loads up to 250 kPa. (Some figures in this article are in colour only in the electronic version)