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Research Papers

Tissue Translocation Device for Surgical Correction of Age-Related Macular Degeneration

[+] Author and Article Information
Shreyes Melkote

George W. Woodruff
School of Mechanical Engineering,
Georgia Institute of Technology,
813, Ferst Drive NW,
Atlanta, GA 30332

Timothy Olsen

Emory Eye Center,
1365-B Clifton Road NE,
Atlanta GA 30322

Manuscript received July 23, 2012; final manuscript received July 19, 2013; published online September 24, 2013. Assoc. Editor: William K. Durfee.

J. Med. Devices 7(4), 041006 (Sep 24, 2013) (8 pages) Paper No: MED-12-1091; doi: 10.1115/1.4025184 History: Received July 23, 2012; Revised July 19, 2013

Age-related macular degeneration (AMD) is the leading cause of blindness in the western world in those over age 60. While this disorder is complex, the origin of injury appears to be at the level of the retinal pigment epithelium (RPE), Bruchs membrane, and inner choroid. A potential method to replace damaged tissue in AMD is to harvest healthy donor tissue (RPE-Bruchs-Choroid) from an eye and translocate it to the injured subretinal region. Such an autograft avoids immune mediated rejection and can theoretically restore function to the neurosensory retina (light sensitive part of the retina) by restoring the damaged tissue. Such a procedure requires the design of a device that mechanically supports the integrity of the graft while inside the eye, without injuring or disrupting the tissue. This paper presents the systematic design and manufacture of a thin shape memory foil-based tissue translocation device. The selected embodiment of the design uses thermal adhesion of the tissue to the foil surfaces for tissue support. The shape memory effect enables insertion of the device into the eye via a small incision. The device is manufactured using micromachining techniques and has been tested both ex vivo and in vivo with acceptable anatomic results.

Copyright © 2013 by ASME
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Figures

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Fig. 1

Cross-sectional view of macular tissue (a) normal eye (b) dry AMD or aAMD (c) wet AMD or eAMD

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Fig. 2

Function diagram for tissue translocation device

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Fig. 3

Selected working principle for device

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Fig. 4

Embodiment 2: Shape memory foil based structure (a) open configuration (b) closed configuration

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Fig. 5

Foil hinge (a) tab bent with zero radius (b) tab bent with 150 μm bend diameter

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Fig. 6

Electrical heat sources used in ophthalmic surgery (a) bipolar pencil cautery and (b) monopolar electrified probes

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Fig. 7

Modifications to prevent flow of current through saline (a) insulated tips (b) use of perfluoro-octane

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Fig. 8

Micromilling of tissue support structure

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Fig. 9

Micromilled foil support structures (a) unrolled and closed (b) rolled

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Fig. 10

SEM images of tissue translocation device (a) surface with burrs (b) surface without burrs

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Fig. 11

Ex vivo tests of wire-based ring design in pig model (a) before extraction of graft (b) after extraction of graft

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Fig. 12

Animal studies to evaluate designed device (a) in vivo (b) ex vivo tests of foil based structure

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Fig. 13

Pulling force measurement apparatus

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Fig. 14

Pulling force for devices with and without burrs

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Fig. 15

Support structure after the tissue was adhered to it and then pulled out of it (a) device with burrs (b) deburred device

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