Encapsulation of Capacitive Micromachined Ultrasonic Transducers (CMUTs) for the Acoustic Communication between Medical Implants.

The aim of this work was to extend conventional medical implants by the possibility of communication between them. For reasons of data security and transmitting distances, this communication should be realized using ultrasound, which is generated and detected by capacitive micromachined ultrasonic transducers (CMUTs). These offer the advantage of an inherent high bandwidth and a high integration capability. To protect the surrounding tissue, it has to be encapsulated. In contrast to previous results of other research groups dealing with the encapsulation of CMUTs, the goal here is to integrate the CMUT into the housing of a medical implant. In this work, CMUTs were designed and fabricated for a center frequency of 2 MHz in water and experimentally tested on their characteristics for operation behind layers of Polyether ether ketone (PEEK) and titanium, two typical materials for the housings of medical implants. It could be shown that with silicone as a coupling layer it is possible to operate a CMUT behind the housing of an implant. Although it changes the characteristics of the CMUT, the setup is found to be well suited for communication between two transducers over a distance of at least 8 cm.

A Novel Matrix-Array-Based MR-Conditional Ultrasound System for Local Hyperthermia of Small Animals.

OBJECTIVE: The goal of this work was to develop a novel modular focused ultrasound hyperthermia (FUS-HT) system for preclinical applications with the following characteristics: MR-compatible, compact probe for integration into a PET/MR small animal scanner, 3D-beam steering capabilities, high resolution focusing for generation of spatially confined FUS-HT effects. METHODS: For 3D-beam steering capabilities, a matrix array approach with 11 × 11 elements was chosen. For reaching the required level of integration, the array was mounted with a conductive backing directly on the interconnection PCB. The array is driven by a modified version of our 128 channel ultrasound research platform DiPhAS. The system was characterized using sound field measurements and validated using tissue-mimicking phantoms. Preliminary MR-compatibility tests were performed using a 7T Bruker MRI scanner. RESULTS: Four 11 × 11 arrays between 0.5 and 2 MHz were developed and characterized with respect to sound field properties and HT generation. Focus sizes between 1 and 4 mm were reached depending on depth and frequency. We showed heating by 4 °C within 60 s in phantoms. The integration concept allows a probe thickness of less than 12 mm. CONCLUSION: We demonstrated FUS-HT capabilities of our modular system based on matrix arrays and a 128 channel electronics system within a 3D-steering range of up to ±30°. The suitability for integration into a small animal MR could be demonstrated in basic MR-compatibility tests. SIGNIFICANCE: The developed system presents a new generation of FUS-HT for preclinical and translational work providing safe, reversible, localized, and controlled HT.

A Novel Quantitative 500-MHz Acoustic Microscopy System for Ophthalmologic Tissues.

OBJECTIVE: This paper describes development of a novel 500-MHz scanning acoustic microscope (SAM) for assessing the mechanical properties of ocular tissues at fine resolution. The mechanical properties of some ocular tissues, such as lamina cribrosa (LC) in the optic nerve head, are believed to play a pivotal role in eye pathogenesis. METHODS: A novel etching technology was used to fabricate silicon-based lens for a 500-MHz transducer. The transducer was tested in a custom-designed scanning system on human eyes. Two-dimensional (2-D) maps of bulk modulus (K) and mass density (ρ) were derived using improved versions of current state-of-the-art signal processing approaches. RESULTS: The transducer employed a lens radius of 125 µm and had a center frequency of 479 MHz with a -6-dB bandwidth of 264 MHz and a lateral resolution of 4 µm. The LC, Bruch's membrane (BM) at the interface of the retina and choroid, and Bowman's layer (BL) at the interface of the corneal epithelium and stroma, were successfully imaged and resolved. Analysis of the 2-D parameter maps revealed average values of LC, BM, and BL with KLC = 2.81 ±0.17; GPa, KBM = 2.89 ±0.18; GPa, KBL = 2.6 ±0.09 ; GPa, ρ LC = 0.96 ±0.03 g/cm3; ρ BM = 0.97 ±0.04 g/cm3; ρ BL = 0.98 ±0.04 g/cm3. SIGNIFICANCE: This novel SAM was shown to be capable of measuring mechanical properties of soft biological tissues at microscopic resolution; it is currently the only system that allows simultaneous measurement of K, ρ, and attenuation in large lateral scales (field area >9 mm2) and at fine resolutions.

Measurement of skull bone thickness for bone-anchored hearing aids: an experimental study comparing both a novel ultrasound system (SonoPointer) and computed tomographic scanning to mechanical measurements.

HYPOTHESIS: A-mode ultrasound scanning with coded signals allows bone thickness measurements at the site of bone-anchored hearing aid surgery as compared to computed tomographic scanning and mechanical measurements. BACKGROUND: Adequate bone thickness is a prerequisite for successful, long-lasting osseointegration of titanium fixtures for bone-anchored hearing aids. Computed tomography can be used to measure bone thickness but has several drawbacks. MATERIAL: Bone thickness was measured at the site of bone-anchored hearing aids surgery in 28 formaldehyde-preserved human cadaver temporoparietal bones. Four blinded investigators used a hand-held, A-mode ultrasound system with direct coupling at 2.25 MHz transducer using coded signals (SonoPointer) and repeated the measurements twice. Comparisons were made with high-resolution computed tomographic scanning and mechanical micrometer caliper measurements. RESULTS: There was significant anatomical variation in the temporoparietal bones. Computed tomography was in good agreement with the mechanical reference. All specimens could be measured by the SonoPointer. The mean difference between the mechanical control and ultrasound scanning averaged for all measurements by all investigators was 0.3 mm (standard deviation, 1.2 mm). Trained ultrasound experts yielded better results (mean difference, 0.3 mm; standard deviation, 1.0 mm). Agreement was best for bone thickness up to 5 mm. Outliers occurred in bones thicker than 7.5 mm. CONCLUSION: The SonoPointer is a promising, noninvasive, hand-held tool for real-time measurement of bone thickness in bone-anchored hearing aid surgery, especially for children. Even disregarding the absolute thickness reading, the SonoPointer could be used to search intraoperatively for a local maximum of bone thickness.

Accuracy of ultrasound measurements for skull bone thickness using coded signals.

The knowledge of skull bone thickness would be helpful for a great variety of surgical interventions of the head. Ultrasound (US) can offer this information intraoperatively in real time. A-mode US measurements of skull bone thickness were performed with different pulse characteristics: 1) in water and 2) by directly coupling a 2.25-MHz US transducer integrated in a handpiece with a soft delay line using coded excitation (CE) (SonoPointer). Mechanical measurements by calipers served as controls. The specimen were 16 nonselected human cadaveric skull bones preserved with formaldehyde. The average difference between the bone thickness measured by the SonoPointer and the mechanical control measurements was 0.04 +/- 0.62 mm. The 95% limits of agreement between the two methods were -1.18 and 1.25 mm. However, even the gold standard of two repeated caliper measurements had limits of agreement of -0.4 and 0.42 mm. Using a standard US pulse in water, only 62.5% sample points were measurable, whereas the SonoPointer produced the thickness measurement in 97.9% of points. CE proved to be superior to single burst or needle US pulses. A-mode US measurements of skull bone thickness using the SonoPointer are feasible. It may provide valuable information on skull bone thickness, e.g., for osteosynthesis, calvarial split bone harvesting, implantation of hearing devices, osseointegrated titanium fixtures, and skull base surgery.

First 3D ultrasound scanning, planning, and execution of CT-free milling interventions with a surgical robot.

Surgical procedures with navigation or robot system support usually require pre-operative planning data. This data can be acquired with imaging techniques such as computed tomography (CT), the current gold standard due to its high precision. With such planning data, access trajectories, implant positions, individual milling paths etc. can be computed. We present a novel ultrasound-based method to generate equivalent 3D image data which is well-suited for many interventions, but less costly than the CT-based method. The method is demonstrated for robot-based implant bed milling in the lateral skull base, in a complete process consisting of infrared navigation registration, manual ultrasound scan path delineation, path smoothing and checking, robot-based ultrasound scan execution, 3D ultrasound volume reconstruction, implant position optimization, robot milling path planning, and intervention execution. This represents, to the best of our knowledge, the first time such a CT-free, 3D-ultrasound-based intervention has been demonstrated in the laboratory.