Novel Fabrication Technology for Clamped Micron-Thick Titanium Diaphragms Used for the Packaging of an Implantable MEMS Acoustic Transducer

Micro-Electro-Mechanical Systems (MEMS) acoustic transducers are highly sophisticated devices with high sensing performance, small size, and low power consumption. To be applied in an implantable medical device, they require a customized packaging solution with a protecting shell, usually made from titanium (Ti), to fulfill biocompatibility and hermeticity requirements. To allow acoustic sound to be transferred between the surroundings and the hermetically sealed MEMS transducer, a compliant diaphragm element needs to be integrated into the protecting enclosure. In this paper, we present a novel fabrication technology for clamped micron-thick Ti diaphragms that can be applied on arbitrary 3D substrate geometry and hence directly integrated into the packaging structure. Stiffness measurements on various diaphragm samples illustrate that the technology enables a significant reduction of residual stress in the diaphragm developed during its deposition on a polymer sacrificial material.

An Ultra-Low Power Implantable Medical Devices: An Engineering Perspective

Implantable Medical Devices (IMDs) reside within human bodies either temporarily or permanently, for diagnostic, monitoring, or therapeutic purposes. IMDs have a history of outstanding success in the treatment of many diseases, including heart diseases, neurological disorders, and deafness etc.,With the ever-increasing clinical need for implantable devices comes along with the continuous flow of technical challenges. Comparing with the commercial portable products, implantable devices share the same need to reduce size, weight and power. Thus, the need for device integration becomes very much imperative. There are many challenges faced when creating an implantable medical device. While this paper focuses on various techniques adapted to design a reliable device and also focus on the key electronic features of designing an ultra-low power implantable medical circuits for devices and systems.

Surface Coating with Hyaluronic Acid-Gelatin-Crosslinked Hydrogel on Gelatin-Conjugated Poly(dimethylsiloxane) for Implantable Medical Device-Induced Fibrosis

Polydimethylsiloxane (PDMS) is a biocompatible polymer that has been applied in many fields. However, the surface hydrophobicity of PDMS can limit successful implementation, and this must be reduced by surface modification to improve biocompatibility. In this study, we modified the PDMS surface with a hydrogel and investigated the effect of this on hydrophilicity, bacterial adhesion, cell viability, immune response, and biocompatibility of PDMS. Hydrogels were created from hyaluronic acid and gelatin using a Schiff-base reaction. The PDMS surface and hydrogel were characterized using nuclear magnetic resonance, X-ray photoelectron spectroscopy, attenuated total reflection Fourier-transform infrared spectroscopy, and scanning electron microscopy. The hydrophilicity of the surface was confirmed via a decrease in the water contact angle. Bacterial anti-adhesion was demonstrated for Pseudomonas aeruginosa, Ralstonia pickettii, and Staphylococcus epidermidis, and viability and improved distribution of human-derived adipose stem cells were also confirmed. Decreased capsular tissue responses were observed in vivo with looser collagen distribution and reduced cytokine expression on the hydrogel-coated surface. Hydrogel coating on treated PDMS is a promising method to improve the surface hydrophilicity and biocompatibility for surface modification of biomedical applications.

Development, validation, and pilot MRI safety study of a high-resolution, open source, whole body pediatric numerical simulation model

Numerical body models of children are used for designing medical devices, including but not limited to optical imaging, ultrasound, CT, EEG/MEG, and MRI. These models are used in many clinical and neuroscience research applications, such as radiation safety dosimetric studies and source localization. Although several such adult models have been reported, there are few reports of full-body pediatric models, and those described have several limitations. Some, for example, are either morphed from older children or do not have detailed segmentations. Here, we introduce a 29-month-old male whole-body native numerical model, “MARTIN”, that includes 28 head and 86 body tissue compartments, segmented directly from the high spatial resolution MRI and CT images. An advanced auto-segmentation tool was used for the deep-brain structures, whereas 3D Slicer was used to segment the non-brain structures and to refine the segmentation for all of the tissue compartments. Our MARTIN model was developed and validated using three separate approaches, through an iterative process, as follows. First, the calculated volumes, weights, and dimensions of selected structures were adjusted and confirmed to be within 6% of the literature values for the 2-3-year-old age-range. Second, all structural segmentations were adjusted and confirmed by two experienced, sub-specialty certified neuro-radiologists, also through an interactive process. Third, an additional validation was performed with a Bloch simulator to create synthetic MR image from our MARTIN model and compare the image contrast of the resulting synthetic image with that of the original MRI data; this resulted in a “structural resemblance” index of 0.97. Finally, we used our model to perform pilot MRI safety simulations of an Active Implantable Medical Device (AIMD) using a commercially available software platform (Sim4Life), incorporating the latest International Standards Organization guidelines. This model will be made available on the Athinoula A. Martinos Center for Biomedical Imaging website.

Application of 3D Printing in Implantable Medical Devices

3D printing technology is widely used in the field of implantable medical device in recent decades because of its advantages in high precision, complex structure, and high material utilization. Based on the characteristics of 3D printing technology, this paper reviews the manufacturing process, materials, and some typical products of 3D printing implantable medical devices and analyzes and summarizes the development trend of 3D printed implantable medical devices.