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Development of a micro-mechanical valve in a novel glaucoma implant

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Abstract

This paper describes methods for design, manufacturing and characterization of a micro-mechanical valve for a novel glaucoma implant. The implant is designed to drain aqueous humour from the anterior chamber of the eye into the suprachoroidal space in case of an elevated intraocular pressure (IOP). In contrast to any existing glaucoma drainage device (GDD), the valve mechanism is located in the anterior chamber and there, surrounded by aqueous humour, immune to fibrosis induced failure. For the prevention of hypotony the micro-mechanical valve is designed to open if the physiological pressure difference between the anterior chamber and the suprachoroidal space in the range of 0.8 mmHg to 3.7 mmHg is exceeded. In particular the work includes: (i) manufacturing and morphological characterization of polymer tubing, (ii) mechanical material testing as basis for (iii) the design of micro-mechanical valves using finite element analysis (FEA), (iv) manufacturing of microstent prototypes including micro-mechanical valves by femtosecond laser micromachining and (v) the experimental fluid-mechanical characterization of the manufactured microstent prototypes with regard to valve opening pressure. The considered materials polyurethane (PUR) and silicone (SIL) exhibit low elastic modulus and high extensibility. The unique valve design enables a low opening pressure of micro-mechanical valves. An ideal valve design for PUR and SIL with an experimentally determined opening pressure of 2 mmHg and 3.7 mmHg is identified. The presented valve approach is suitable for the inhibition of hypotony as a major limitation of today’s GDD and will potentially improve the minimally invasive treatment of glaucoma.

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Acknowledgement

This work is supported by the German Research Foundation (DFG) as a part of the Special Research Program Transregio 37 “Micro- and Nanosystems in Medicine – Reconstruction of Biological Functions”.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Institute for Biomedical Engineering, University of Rostock, Friedrich-Barnewitz-Straße 4, 18119, Rostock, Germany

    Stefan Siewert, Christine Schultze, Wolfram Schmidt, Katrin Sternberg & Klaus-Peter Schmitz

  2. Laser Zentrum Hannover e. V., Hollerithallee 8, 30419, Hannover, Germany

    Ulf Hinze & Boris Chichkov

  3. Department of Anatomy, University of Rostock, Gertrudenstraße 9, 18057, Rostock, Germany

    Andreas Wree

  4. Department of Ophthalmology, University of Rostock, Doberaner Straße 140, 18057, Rostock, Germany

    Reto Allemann & Rudolf Guthoff

Authors
  1. Stefan Siewert
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  2. Christine Schultze
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  3. Wolfram Schmidt
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  4. Ulf Hinze
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  5. Boris Chichkov
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  6. Andreas Wree
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  7. Katrin Sternberg
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  8. Reto Allemann
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  9. Rudolf Guthoff
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  10. Klaus-Peter Schmitz
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Correspondence to Stefan Siewert.

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Siewert, S., Schultze, C., Schmidt, W. et al. Development of a micro-mechanical valve in a novel glaucoma implant. Biomed Microdevices 14, 907–920 (2012). https://doi.org/10.1007/s10544-012-9670-7

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  • DOI: https://doi.org/10.1007/s10544-012-9670-7

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