Po-Jui Chen

Microfabricated Implantable Parylene-Based Wireless Passive Intraocular Pressure Sensors

This paper presents an implantable parylene-based wireless pressure sensor for biomedical pressure sensing applications specifically designed for continuous intraocular pressure (IOP) monitoring in glaucoma patients. It has an electrical LC tank resonant circuit formed by an integrated capacitor and an inductor coil to facilitate passive wireless sensing using an external interrogating coil connected to a readout unit. Two surface-micromachined sensor designs incorporating variable capacitor and variable capacitor/inductor resonant circuits have been implemented to realize the pressure-sensitive components. The sensor is monolithically microfabricated by exploiting parylene as a biocompatible structural material in a suitable form factor for minimally invasive intraocular implantation. Pressure responses of the microsensor have been characterized to demonstrate its high pressure sensitivity ( > 7000 ppm/mmHg) in both sensor designs, which confirms the feasibility of pressure sensing with smaller than 1 mmHg of resolution for practical biomedical applications. A six-month animal study verifies the in vivo bioefficacy and biostability of the implant in the intraocular environment with no surgical or postoperative complications. Preliminary ex vivo experimental results verify the IOP sensing feasibility of such device. This sensor will ultimately be implanted at the pars plana or on the iris of the eye to fulfill continuous, convenient, direct, and faithful IOP monitoring.[2008-0111].

Wireless Intraocular Pressure Sensing Using Microfabricated Minimally Invasive Flexible-Coiled LC Sensor Implant

This paper presents an implant-based wireless pressure sensing paradigm for long-range continuous intraocular pressure (IOP) monitoring of glaucoma patients. An implantable parylene-based pressure sensor has been developed, featuring an electrical LC-tank resonant circuit for passive wireless sensing without power consumption on the implanted site. The sensor is microfabricated with the use of parylene C (poly-chloro-p-xylylene) to create a flexible coil substrate that can be folded for smaller physical form factor so as to achieve minimally invasive implantation, while stretched back without damage for enhanced inductive sensor-reader coil coupling so as to achieve strong sensing signal. A data-processed external readout method has also been developed to support pressure measurements. By incorporating the LC sensor and the readout method, wireless pressure sensing with 1-mmHg resolution in longer than 2-cm distance is successfully demonstrated. Other than extensive on-bench characterization, device testing through six-month chronic in vivo and acute ex vivo animal studies has verified the feasibility and efficacy of the sensor implant in the surgical aspect, including robust fixation and long-term biocompatibility in the intraocular environment. With meeting specifications of practical wireless pressure sensing and further reader development, this sensing methodology is promising for continuous, convenient, direct, and faithful IOP monitoring.

Surface-Micromachined Parylene Dual Valves for On-Chip Unpowered Microflow Regulation

This paper presents the worlds first surface-micromachined parylene dual-valved microfluidic system for on-chip unpowered microflow regulation. Incorporating a normally closed and a normally open passive check valve in a back-to-back configuration inside a microchannel, the dual-valved system has successfully regulated the pressure/flow rate of air and liquid without power consumption or electronic/magnetic/thermal transduction. By exclusively using parylene C (poly-para-xylylene C) as the structural material, the fabricated valves have higher flexibility to shunt flows in comparison to other conventional thin-film valves. A state-of-the-art multilayer polymer surface-micromachining technology is applied here to fabricate parylene microvalves of various designs. The parylene-based devices are completely biocompatible/implantable and provide an economical paradigm for fluidic control in integrated lab-on-a-chip systems. Design, fabrication, and characterization of the parylene dual valves are discussed in this paper. Testing results have successfully demonstrated that the microflow regulation of the on-chip dual-valved system can achieve a bandpass profile in which the pressure control range is 0-50 mmHg with corresponding flow rates up to 2 mL/min for air flow and 1 muL/min flow rate for water flow. This regulation range is suitable for controlling biological conditions in human health care, with potential applications including drug delivery and regulation of elevated intraocular pressure (IOP) in glaucoma patients

Implantable micromechanical parylene-based pressure sensors for unpowered intraocular pressure sensing

This paper presents the first implantable, unpowered, parylene-based microelectromechanical system (MEMS) pressure sensor for intraocular pressure (IOP) sensing. From in situ mechanical deformation of the compliant spiral-tube structures, this sensor registers pressure variations without electrical or powered signal transduction of any kind. Micromachined high-aspect-ratio polymeric hollow tubes with different geometric layouts are implemented to obtain high-sensitivity pressure responses. An integrated device packaging method has been developed toward enabling minimally invasive suture-less needle-based implantation of the device. Both in vitro and ex vivo device characterizations have successfully demonstrated mmHg resolution of the pressure responses. In vivo animal experiments have also been conducted to verify the biocompatibility and functionality of the implant fixation method inside the eye. Using the proposed implantation scheme, the pressure response of the implant can be directly observed from outside the eye under visible light, with the goal of realizing convenient, direct and faithful IOP monitoring in glaucoma patients.

Implantable parylene-based wireless intraocular pressure sensor

This paper presents a novel implantable, wireless, passive pressure sensor for ophthalmic applications. Two sensor designs incorporating surface-micromachined variable capacitor and variable capacitor/inductor are implemented to realize the pressure sensitive components. The sensor is monolithically microfabricated using parylene as a biocompatible structural material in a suitable form factor for increased ease of intraocular implantation. Pressure responses of the microsensor are characterized on-chip to demonstrate its high pressure sensitivity (> 7000 ppm/mmHg) with mmHg level resolution. An in vivo animal study verifies the biostability of the sensor implant in the intraocular environment after more than 150 days. This sensor will ultimately be implanted at the pars plana or iris of the eye to fulfill continuous intraocular pressure (IOP) monitoring in glaucoma patients.

Implantable parylene MEMS for glaucoma therapy

An implantable glaucoma management system is presented for the first time. Glaucoma is an incurable disease characterized by gradual visual field loss that eventually results in blindness. Studies indicate that reduction of intraocular pressure reduces the rate of disease progress. A passive parylene MEMS pressure sensor and drainage shunt comprise a complete system for the detection and alleviation of elevated intraocular pressure. Tissue anchors for securing the pressure sensor to the iris have been developed to facilitate direct and convenient optical monitoring of intraocular pressure.

Floating-disk parylene microvalve for self-regulating biomedical flow controls

A novel self-regulating parylene micro valve is presented in this paper with potential applications for biomedical flow controls. Featuring a free-floating bendable valve disk and two-level valve seat, this surface-micromachined polymeric valve accomplishes miniature pressure/flow rate regulation in a band-pass profile stand-alone without the need of power sources or active actuation. Experimental data of underwater testing results have successfully demonstrated that the microfabricated in-channel valve can regulate water flow at 0-80 mmHg and 0-10 muL/min pressure/flow rate level, which is perfectly suitable for biomedical and lab-on-a-chip applications. For example, such biocompatible microvalve can be incorporated in ocular implants for control of eye fluid drainage to fulfill intraocular pressure (IOP) regulation in glaucoma patients.

Minimally Invasive Parylene Dual-Valved Flow Drainage Shunt for Glaucoma Implant

A parylene-enabled microvalved shunt implant for glaucoma drainage is presented in this paper. Enabled by the dual-checkvalve operation, this device can physically drain the extra intraocular fluid and regulate the intraocular pressure (IOP) within the normal range (15-20 mmHg). Improved surgical features, in addition to the functional/microfluidic components, such as parylene-tube carrier and anchors, are also incorporated in such device to realize minimally invasive suture-less implantation, suitable for practical in vivo use. With the optimized micromachining and post-fabrication process procedures, the developed implant is the first checkvalved glaucoma drainage device (GDD), which is passive, consumes no additional power, and functions without any circuit involved to pursue its medical application.

Implantable Flexible-Coiled Wireless Intraocular Pressure Sensor

This work presents an implantable wireless passive pressure sensor for long-range continuous intraocular pressure (IOP) monitoring of glaucoma patients. The sensor is microfabricated with use of parylene C (poly-chloro-p-xylylene) to create a flexible coil substrate that can be folded during implantation for suture-less minimally invasive surgery, while stretched back without damage for enhanced inductive sensor-reader coil coupling and the corresponding sensing signal. Extensive device characterizations including on-bench testing and in vivo and ex vivo animal studies verify the device feasibility in both engineering (1 mmHg pressure sensing accuracy and 2 cm sensing distance) and surgical (robust fixation to the iris and long-term biocompatibility in the intraocular environment) aspects, all meeting specifications for future practical implementation of such IOP sensing technology.

Floating-Disk Parylene Microvalves for Self-Pressure-Regulating Flow Controls

This paper presents the first parylene-based floating-disk microvalve with self-pressure-regulating characteristics for various microfluidic applications. By incorporating a free-floating disk diaphragm with no anchoring/tethering structures to constrain its movement, the microvalve realizes configurable pressure-based flow-shunting functions in a stand-alone fashion. Its passive operation eliminates the need for power sources or the external actuation of the device. A multilayer polymer surface-micromachining technology is utilized for device fabrication by exploiting parylene C (poly-chloro-p-xylylene) as the biocompatible structural material for high mechanical compliance as compared with other conventional thin-film materials. Experimental results successfully demonstrate that the in-channel microvalves control water flows in the following two different shunt designs: 1) a nearly ideal regular check valve with zero forward-cracking pressure, zero reverse leakage, and 1.25 times1013 - 2.09 times 1013 Nldrs/m5 (0.03-0.05 psildrmin/muL, 1.55-2.59 mmHgldrmin/muL) of fluidic resistance; and 2) a pressure-bandpass check valve with 0-100 mmHg and 0-10 muL/min of pressure and flow rate regulation ranges, respectively, as well as 4.88 ×1013 Nldrs/m5 (0.12 psi middotmin/muL, 6.08 mmHg middotmin/muL) of fluidic resistance in the forward conductive region. Such a biocompatible and implantable microvalve has the great potential of being integrated in microfluidic systems to facilitate effective microflow control for lab-on-a-chip and biomedical applications. [2008-0055].