A novel orbital tissue expander (OTE): Design, in-vitro and in-vivo studies

Elizabete Lee, David Tse, Leonard Pinchuk, Ana C. Acosta, John B. Martin, Stewart B. Davis, Eleut Hernandez, Hideo Yamamoto, David B. Denham, Sander Dubovy, Jean-Marie A Parel

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Abstract

Purpose: To assess the efficacy of a novel orbital tissue expander (OTE) in treating congenital anophthalmic and microphthalmic infants. Methods: The OTE implant is an inflatable (0.5 to >6cc) silicone rubber globe sliding on a titanium T-shaped bone plate secured to the temporal bone with 1mm titanium screws. In vitro testing was performed to assess injection volume versus diameter measurements to determine consistency between devices, flex fatigue for durability of the implants when compressed, weight change in isotonic saline at 37°C to mimic human body temperature, seal durability by puncturing the globe numerous times while inflating, capacity before rupture to determine the maximum amount of saline it is able to contain, and effective sterilization. Ex-vivo testing was performed for adjustments prior to in vivo study. An OTE was then implanted in five 2-week old kittens (OS only) and inflated in 0.5cc increments. Three control animals received enucleation alone. All 8 animals were followed for 18 weeks and underwent euthanasia for morphological and histopathological analysis. Results: In vitro testing confirmed a <5% diameter variance between different OTEs inflated in 0.5cc increments up to 5.0cc, <5% weight change in isotonic saline at 37°C over 7 weeks, <3% weight change over 14 months in the fatigue tester, and no quantifiable leakage (<1mg) after 65 consecutive 30ga needle punctures. The OTEs were successfully sterilized by autoclave and easily secured in the orbit of postmortem kittens. The in vivo study demonstrated biocompatibility of the implant which stimulates orbital bone growth resulting in almost no difference between the implanted socket and the control eye of the cat. There were no adverse effects in the normal maturation, weight gain, and food intake of the cats. Light microscopy showed no signs of foreign body reaction. Pictures of the implants were obtained by using a shadow-photogrammetry system to compare the explanted OTE with the OD control eye. Conclusion: In vitro and in vivo studies show the implant's potential to safely treat anophthalmic and microphthalmic infants.

Original languageEnglish
Title of host publicationProgress in Biomedical Optics and Imaging - Proceedings of SPIE
Volume6138
DOIs
StatePublished - Jun 30 2006
EventOphthalmic Technologies XVI - San Jose, CA, United States
Duration: Jan 21 2006Jan 24 2006

Other

OtherOphthalmic Technologies XVI
CountryUnited States
CitySan Jose, CA
Period1/21/061/24/06

Fingerprint

Tissue
Bone
Animals
Testing
Durability
Titanium
Fatigue of materials
Piercing
Photogrammetry
Autoclaves
Biocompatibility
Silicones
Needles
Optical microscopy
Seals
Rubber
Orbits
Temperature

Keywords

  • Bony growth
  • Congential anophthalmos
  • Microphthalmos
  • Orbit

ASJC Scopus subject areas

  • Engineering(all)

Cite this

Lee, E., Tse, D., Pinchuk, L., Acosta, A. C., Martin, J. B., Davis, S. B., ... Parel, J-M. A. (2006). A novel orbital tissue expander (OTE): Design, in-vitro and in-vivo studies. In Progress in Biomedical Optics and Imaging - Proceedings of SPIE (Vol. 6138). [61380T] https://doi.org/10.1117/12.652497

A novel orbital tissue expander (OTE) : Design, in-vitro and in-vivo studies. / Lee, Elizabete; Tse, David; Pinchuk, Leonard; Acosta, Ana C.; Martin, John B.; Davis, Stewart B.; Hernandez, Eleut; Yamamoto, Hideo; Denham, David B.; Dubovy, Sander; Parel, Jean-Marie A.

Progress in Biomedical Optics and Imaging - Proceedings of SPIE. Vol. 6138 2006. 61380T.

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Lee, E, Tse, D, Pinchuk, L, Acosta, AC, Martin, JB, Davis, SB, Hernandez, E, Yamamoto, H, Denham, DB, Dubovy, S & Parel, J-MA 2006, A novel orbital tissue expander (OTE): Design, in-vitro and in-vivo studies. in Progress in Biomedical Optics and Imaging - Proceedings of SPIE. vol. 6138, 61380T, Ophthalmic Technologies XVI, San Jose, CA, United States, 1/21/06. https://doi.org/10.1117/12.652497
Lee E, Tse D, Pinchuk L, Acosta AC, Martin JB, Davis SB et al. A novel orbital tissue expander (OTE): Design, in-vitro and in-vivo studies. In Progress in Biomedical Optics and Imaging - Proceedings of SPIE. Vol. 6138. 2006. 61380T https://doi.org/10.1117/12.652497
Lee, Elizabete ; Tse, David ; Pinchuk, Leonard ; Acosta, Ana C. ; Martin, John B. ; Davis, Stewart B. ; Hernandez, Eleut ; Yamamoto, Hideo ; Denham, David B. ; Dubovy, Sander ; Parel, Jean-Marie A. / A novel orbital tissue expander (OTE) : Design, in-vitro and in-vivo studies. Progress in Biomedical Optics and Imaging - Proceedings of SPIE. Vol. 6138 2006.
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abstract = "Purpose: To assess the efficacy of a novel orbital tissue expander (OTE) in treating congenital anophthalmic and microphthalmic infants. Methods: The OTE implant is an inflatable (0.5 to >6cc) silicone rubber globe sliding on a titanium T-shaped bone plate secured to the temporal bone with 1mm titanium screws. In vitro testing was performed to assess injection volume versus diameter measurements to determine consistency between devices, flex fatigue for durability of the implants when compressed, weight change in isotonic saline at 37°C to mimic human body temperature, seal durability by puncturing the globe numerous times while inflating, capacity before rupture to determine the maximum amount of saline it is able to contain, and effective sterilization. Ex-vivo testing was performed for adjustments prior to in vivo study. An OTE was then implanted in five 2-week old kittens (OS only) and inflated in 0.5cc increments. Three control animals received enucleation alone. All 8 animals were followed for 18 weeks and underwent euthanasia for morphological and histopathological analysis. Results: In vitro testing confirmed a <5{\%} diameter variance between different OTEs inflated in 0.5cc increments up to 5.0cc, <5{\%} weight change in isotonic saline at 37°C over 7 weeks, <3{\%} weight change over 14 months in the fatigue tester, and no quantifiable leakage (<1mg) after 65 consecutive 30ga needle punctures. The OTEs were successfully sterilized by autoclave and easily secured in the orbit of postmortem kittens. The in vivo study demonstrated biocompatibility of the implant which stimulates orbital bone growth resulting in almost no difference between the implanted socket and the control eye of the cat. There were no adverse effects in the normal maturation, weight gain, and food intake of the cats. Light microscopy showed no signs of foreign body reaction. Pictures of the implants were obtained by using a shadow-photogrammetry system to compare the explanted OTE with the OD control eye. Conclusion: In vitro and in vivo studies show the implant's potential to safely treat anophthalmic and microphthalmic infants.",
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