磁電式骨整合穩固度評估系統之探頭配件設計及功能驗證

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题名:	磁電式骨整合穩固度評估系統之探頭配件設計及功能驗證
作者:	蔡昆燁;Tsai, Kuen-Yeh
贡献者:	機械工程學系在職專班
关键词:	骨整合評估;共振頻率分析;檢測評估裝置;截肢植體;霍爾效應;Osseointegration;Resonance Frequency Analysis;Detection and Evaluation Device;Amputation Implant;Hall Effect
日期:	2024-11-29
上传时间:	2025-04-09 18:24:39 (UTC+8)
出版者:	國立中央大學
摘要:	近年來隨著植體植入技術發展，植體植入手術已由牙科植體擴展至四肢截肢、顏面五官等植體植入，而在臨床方面普遍以手術後的骨整合(植體穩固度) 好壞作為評估手術成功與否的依據。本研究運用磁激振之非接觸式的共振頻率法檢測法，將柱狀植體鎖附至模擬患者義肢之骨整合模型，模擬三種骨整合狀態 (1) 植體植入手術後初始穩固度 (2) 復健期緻密骨骨細胞增長狀況 (3) 植體植入後6個月時，骨整合接近完成狀況藉由裝置量測其穩固度趨勢變化並進行客觀量化，以建立骨整合評估方式，提供醫師更詳盡的術後診斷，以利醫師在適當時機予以治療。　　柱狀植體植入後，可視為懸臂樑結構，當骨整合癒合狀況越好，其植體周圍結構剛性越強，則共振頻率越高；反之，癒合狀況越差時，其植體周圍結構剛性越弱，則共振頻率越低。本檢測裝置將交流掃頻訊號輸入電感，使之產生磁力激振植體上方的永久磁鐵產生振動，並以接收電感及霍爾元件偵測其磁場變化，並轉換為訊號輸出，再透過頻率響應函數計算檢測組及參考組電壓，獲得懸臂樑結構之共振頻率，來評估骨整合癒合狀況。　　研究中將激振電感、偵測電感與霍爾元件以不同配置與及安裝位置，分別製作出四種型式探頭，以市售檢測裝置Osstell®生產的標準結構物驗證探頭能力，雙電感對型探頭之靈敏度以及於最佳量測位置、量測角度所得之訊雜比均優於雙電感-霍爾IC探頭。NCU_TPeg建立選用與探頭吸斥力較大之NCUpeg-2搭配塑膠製標準結構物，共振頻率為2114±83 Hz，及鋁製標準結構物，共振頻率為3846±75 Hz，提供日後骨整合探頭功能確認使用。激振端安裝於前端之雙電感對型探頭搭配NCUpeg-2量測效果最佳，量測模擬骨整合三階段之山羊骨截肢模型時，頻率響應圖之訊雜比高達18.26 dB。;In recent years, implantation surgery has been widely used from dental implants to implantation of limbs, amputations, facial features, etc. Clinically, it is generally believed that the postoperative osseointegration (implant stability) is the basis for judging the success of the operation. This study utilizes a non-contact resonance frequency detection method based on magnetic excitation, attaching cylindrical implants to a simulated osseointegration model of a patient′s prosthesis. Three osseointegration states were simulated: (1) initial stability after implant surgery; (2) bone cell growth during the rehabilitation period; and (3) near-complete osseointegration at six months post-implant. The device measures changes in implant stability over time and quantifies these trends objectively, aiming to establish a method for evaluating osseointegration. This provides physicians with more detailed postoperative diagnostics, facilitating timely treatment when needed. 　　Lower limb implant knocks into femur, can be considered as cantilever structure. The better the rigidity of the cantilever beam, the stronger the rigidity around it, the higher the resonance frequency; otherwise, the lower the resonance frequency. The detection device inputs an alternating sweep frequency signal into an inductor, generating magnetic excitation that causes the permanent magnet mounted above the implant to vibrate. A receiving inductor and Hall sensor are used to detect the changes in the magnetic field, converting them into signal output. The frequency response function is then applied to calculate the voltages of both the test group and the reference group, obtaining the resonance frequency of the cantilever beam structure. This resonance frequency is used to assess the state of osseointegration and healing progress. 　　In this study, four types of probes were developed by varying the configurations and mounting positions of the excitation inductor, detection inductor, and Hall sensor. The performance of these probes was validated using standard structures produced by the commercially available Osstell® detection device. The dual-inductor probes exhibited superior sensitivity and signal-to-noise ratio (SNR) at optimal measurement positions and angles compared to the dual-inductor-Hall IC probes. The NCU_TPeg was developed using NCUpeg-2, which has stronger magnetic attraction and repulsion forces, paired with a plastic standard structure with a resonance frequency of 2114 ± 83 Hz and an aluminum standard structure with a resonance frequency of 3846 ± 75 Hz. This setup will be used for future functional verification of osseointegration probes. The dual-inductor probe, with the excitation element installed at the front end and paired with NCUpeg-2, demonstrated the best measurement performance. When measuring a goat femur amputation model simulating three stages of osseointegration, the frequency response graph yielded a maximum SNR of 18.26 dB.
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