Kyou Sik Min

Monolithic Encapsulation of Implantable Neuroprosthetic Devices Using Liquid Crystal Polymers

Flexible polymers have gained much attention in the development of low cost, magnetic resonance compatible, and nonfragile implantable medical devices. However, efficacy of the conventional polymer encapsulations containing hybrid interfaces is limited due to their relatively high moisture absorption and unstable interfacial adhesion in aqueous environments. As an alternative, we report on a monolithic encapsulation platform for neuroprosthetic devices using liquid crystal polymers (LCPs), which have a very low degree of moisture absorption (<;0.04%) and a fusion bondable interface. This platform offers monolithic encapsulation by fusion bonding of the hemispherical LCP package lids and LCP-based microelectrode arrays. The package lids were fabricated by thermoforming of the LCP films to provide the desired shape and size for encasing the electronic components and wireless telemetry coils. Fusion-bonded LCP encapsulations were evaluated using electrical leakage current measurements during in vitro soak tests. The measurements were done in both 37°C and 75°C phosphate-buffered saline (PBS) solution and showed that LCP encapsulation was superior and more reliable in PBS than polyimide and parylene-C encapsulations. In addition, LCP-based monolithic encapsulation provided reliable electrical insulation for more than 300 days in both 37°C and 75°C PBS solution.

A Miniaturized, Eye-Conformable, and Long-Term Reliable Retinal Prosthesis Using Monolithic Fabrication of Liquid Crystal Polymer (LCP)

A novel retinal prosthetic device was developed using biocompatible liquid crystal polymer (LCP) to address the problems associated with conventional metal- and polymer-based devices: the hermetic metal package is bulky, heavy, and labor-intensive, whereas a thin, flexible, and MEMS-compatible polymer-based system is not durable enough for chronic implantation. Exploiting the advantageous properties of LCP such as a low moisture absorption rate, thermobonding, and thermoforming, we fabricate a small, light-weight, long-term reliable retinal prosthesis that can be conformally attached on the eye-surface. A LCP fabrication process using monolithic integration and conformal deformation was established enabling miniaturization and a batch manufacturing process as well as eliminating the need for feed-through technology. The functionality of the fabricated device was tested through wireless operation in saline solution. Its efficacy and implantation stability were verified through in vivo animal tests by measuring the cortical potential and monitoring implanted dummy devices for more than a year, respectively.

A Liquid Crystal Polymer-Based Neuromodulation System: An Application on Animal Model of Neuropathic Pain

We developed a custom‐made miniaturized neural stimulation system with a liquid crystal polymer (LCP)‐based electrode array for animal experiments. In order to verify the feasibility of the system, motor cortex stimulation (MCS) was applied on the rat pain model induced by sciatic nerve injury.

Magnetic Resonance Imaging Compatibility of the Polymer-based Cochlear Implant

Objectives In this study, we compared the magnetic resonance (MR) image artifacts caused by a conventional metal-based cochlear implant and a newly developed liquid crystal polymer (LCP)-based device. Methods The metal-based cochlear implant system (Nurobiosys Co.) was attached to side of the head of a subject and the LCP-based device was attached to opposite side. In both devices, alignment magnets were removed for safety. Magnetic resonance imaging (MRI) was performed on a widely used 3.0 T and an ultra-high 7.0 T MRI machine. 3.0 and 7.0 T MR images were acquired using T1- and T2*-weighted gradient echo sequences, respectively. Results In the 3.0 T images, the metal-based device on the left side generated the significant amount of artifacts. The MR images in the proximity of the metal package were obscured by the artifacts in both axial and sagittal views. On the other hand, the MR images near the LCP-based device were relatively free from the artifacts and clearly showed the brain structures. 7.0 T MR images showed the more severe distortion in the both sides but the metal-based cochlear implant system caused a much larger obscure area than the LCP-based system. Conclusion The novel LCP-based cochlear implant provides a good MRI compatibility beyond present-day cochlear implants. Thus, MR images can be obtained from the subjects even with the implanted LCP-based neural prosthetic systems providing useful diagnostic information. Furthermore, it will be also useful for functional MRI studies of the auditory perception mechanism after cochlear implantations as well as for positron emission tomography-MRI hybrid imaging.

A polymer-based multichannel cochlear electrode array.

Objective Compared with conventional cochlear electrode arrays, which are hand assembled and wire-based, polymer-based implants have several advantages. They are very precise, and their fabrication is inexpensive because of the use of thin-film processes. In the present study, a cochlear electrode array based on a high-performance liquid crystal polymer material is devised. Furthermore, the device is encapsulated in silicone elastomer. Methods The fabrication steps introduced here include thin-film processes with liquid crystal polymer (LCP) films and customized self-aligning molding processes for the electrode array. To assess the feasibility of the proposed electrode array, the charge storage capacitance and impedance were measured using a potentiostat. Vertical and horizontal deflection forces were measured using a customized fixture and a force sensor. Insertion and extraction forces were also measured using a transparent human cochlear plastic model, and five cases involving human temporal insertion trials were undertaken to assess the level of safety during the insertion process. Results The charge storage capacity and impedance at 1 kHz were 33.26 mC/cm2 and 1.02 k&OHgr;, respectively. Likewise, the vertical force and horizontal force of the electrode array were 3.15 g and 1.07 g. The insertion force into a transparent plastic cochlear model with displacement of 8 mm from a round window was 8.2 mN, and the maximum extraction force was 110.4 mN. Two cases of human temporal bone insertion showed no observable trauma, whereas 3 cases showed a rupture of the basilar membrane. Conclusion An LCP-based intracochlear electrode array was fabricated, and its electrical and mechanical properties were found to be suitable for clinical use.

Ventral posterolateral deep brain stimulation treatment for neuropathic pain shortens pain response after cold stimuli

Neuropathic pain is often severe. Deep brain stimulation (DBS) is a treatment method for neuropathic pain, but its mechanism of action remains unclear. Patients with neuropathic pain are affected by various stimulations, such as mechanical and cold stimuli, but studies of cold allodynia showed the associated pain to be less than that caused by mechanical stimuli. This study focused on the effects of DBS on cold allodynia in rats. To observe the effects of DBS, we established three groups: a normal group (normal), a neuropathic pain group (pain), and a DBS with neuropathic pain group (DBS). The stimulation target was the ventral posterolateral nucleus (VPL). We observed differences in the degree of cold allodynia elicited between a conventional method that measured the number of pain responses and our altered novel method that measured the duration of pain responses. Cold allodynia after DBS did not differ when conventional analysis was applied, but the pain response duration was decreased. We suggest that VPL DBS was partially effective in cold allodynia, implicating complex pathways of pain signaling.