The Measurement of 2D Curvature of In-Vivo Human Ear Canal
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risk for marsupialization and infection at the device-skin interface. METHODS: TACA phantoms, coated with a fibrous titanium mesh biomaterial, w...
risk for marsupialization and infection at the device-skin interface. METHODS: TACA phantoms, coated with a fibrous titanium mesh biomaterial, were tested in long-term preclinical implantation studies. Histomorphometric comparison of mesh coated and uncoated TACA phantoms was performed in 3 rabbits at 90 and 180 days. A follow-up study in 7 rabbits was performed to temporally characterize wound healing around the mesh coated implants from 1-13 weeks. Based on promising animal results, a phase I FDA human trial was conducted lasting 6 months. RESULTS: Preliminary histomorphometric studies (N⫽18 phantoms with mesh, 6 without mesh) in 3 rabbits demonstrated that the titanium mesh biomaterial prevented marsupialization and infection at 90 and 180 days. The follow-up study of 42 mesh-coated phantoms in 7 rabbits demonstrated that the epidermal seal was reestablished around the percutaneous projection at 3 weeks, with supporting vascularized connective tissue ingrowth complete at 6 weeks. The human phase I data demonstrated connective tissue ingrowth and epidermal sealing with no evidence of marsupialization or infection. CONCLUSION: The TACA may offer an alternative for patients with sensorineural mild-to-moderate sloping high frequency hearing loss. Percutaneous implant studies in rabbits and man demonstrated the safety of this novel percutaneous device. SIGNIFICANCE: Preclinical and clinical demonstration of feasibility and safety. SUPPORT: This work was supported by Implanted Acoustics, Santa Clarita, California.
bend were 246 degrees and -0.1102; of superior wall of second bend were 227.8 degrees and -0.0332; of inferior wall of second bend were 143.1 degrees and 0.0130 respectively. 2D curvature of superior and inferior wall of first and second bends was diagrammed. CONCLUSION: The 2D curvature of ear canal at first and second bends could be measured and produce the ear impression non-invasively. The geometry of canal changed by tumors is a common syndrome in ear disease. Therefore, the geometry of ear canal can be tracked after the otoplasty. SIGNIFICANCE: The 3D geometry of canal can help physicians diagnose the syndrome of external canal before otoplasty. Moreover, the hearing aid earmold can be made by non-invasive ear impression instead of invasive ear impression.
The Measurement of 2D Curvature of In-Vivo Human Ear Canal Jen-Fang Yu, PhD, FE (presenter); Chung-chieh Fan; Chin-Kuo Chen, MD PROBLEM: To non-invasively measure the 2D curvature of human ear canal and produce the earmold by the non-invasive 3D ear impression. METHODS: The images of external ear were scanned by high-resolution computed tomography (HRCT). The resolution for each slice was 512⫻512 pixels. The pixel size was 0.188⫻0.188mm and the slice thickness was 0.625mm. The boundary between tympanic membrane and external auditory meatus was enhanced by image processing. Additionally, 3D model of ear canal was reconstructed by 2D images. The length and angle of first and second bends of canal were measured based on the 3D model. 2D curvature of first and second bends of canal was then computed by sine and cosine laws. RESULTS: The volume of ear canal was 862.0 cubic mm. The angle and curvature of superior wall of first bend at axial view were 121.5 degrees and 0.0685; of inferior wall of first
Volumetric Rendering of Human Inner Ear by MR Imaging Jen-Fang Yu, PhD, FE (presenter); Wei-Chung Chin MD; Che-Ming Wu, MD; Shu-Hang Ng, MD PROBLEM: To non-invasively measure in-vivo human inner ear by MRI and measure the geometry of vestibule by the reconstructed 3D model of inner ear for further diagnosis of large vestibular aqueduct syndrome (LVAS). METHODS: 3-T MR scanner, MAGNETOM Trio made by Siemens, was utilized. The TR/TE for MR imaging of 7 patients was 5.65/2.6 ms and the voxel size was 0.5 mm ⫻ 0.5 mm ⫻ 0.5 mm for single slice of 48 slices. The configuration of semicircular canals, vestibule and cochlea could be detected by threshold. The 3D geometry of inner ear was then computed based on the thickness of slice. RESULTS: The surface area and volume of semicircular canals for 7 normal ears were 217.85 square mm and 63.56 cubic mm; of vestibule were 105.88 square mm and 56.36 cubic mm; of cochlea were 171.84 square mm and 81.29 cubic mm respectively. The variation of volumes of vestibule and cochlea could be quantified non-invasively. The correlation between the volume and the level of LVAS will be analyzed once the number of volunteer reaches a statistically significant level. CONCLUSION: The variation for the geometry of vestibule could be measured non-invasively. The grade of LVAS can be assessed by the obtained 3D model of semi-circular canal, vestibule and cochlea. SIGNIFICANCE: According to the 3D model, the geometry of inner ear can be measured, and the syndrome can be revealed directly to help clinical diagnosis of LVAS more accurately.