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Fig. 13.16 Capsule ring device prototype compared to a penny showing valve assembly with a 27-gauge cannula in the valve access port. Reprinted from Molokhia et al. (2010a, b). Copyright 2010, with permission from Elsevier
13.4.5 Lens Capsule Delivery
Traditionally, the lens capsule has not been thought of as a primary location for delivery devices if other more accessible sites prove successful. The issue of repetitive surgical replacement of devices in this location has historically been a roadblock. Therefore, the concept of being able to refill a one-time implanted capsule device offers greater attractiveness. That being said, the target population that can accommodate a device in this anatomical location may be more limited to cataract patients who require therapy for the IOL surgery itself or who have other concurrent ophthalmic disease. Despite the possible caveats, studies continue to progress on a refillable capsule ring device which has been reported on recently (Molokhia et al. 2009, 2010a, b; Bishop et al. 2010). This device contains two small ports made of polyimide with a polydimethylsiloxane plug acting as a one-way valve (Fig. 13.16). Using noncoring needles, the valve continued to seal and hold 40 mm pressure up to 30 punctures. Prepuncturing the other valve allowed for release of pressure upon fill. The reservoir accommodates up to 80 mL and studies evaluating Avastin® release through the semi-permeable membrane demonstrated zero-order type rates over 2 months.
13.5 Conclusions
It is clear that significant development is still needed to advance various refillable ophthalmic device designs to a commercial level. There appear to be only a limited handful where theoretical designs have actually been reduced to practice, fabricated
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by an approvable manufacturing process, implanted in preclinical or clinical studies, and evaluated sufficiently to show validated safety or efficacy. What can be said, however, is that the sophistication of the designs and understanding of the necessary engineering to achieve the above goals has advanced greatly. With better comprehension and utilization of available compatible biomaterials, evolution of microand nano-fabrication techniques and application of more minimally invasive design elements, there is great hope for the future that more convenient therapeutic regimens will emerge as a result of new devices offering capabilities to conduct safer refill procedures instead of surgical interventions.
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