乳癌是女性最常見的癌症之一，其早期診斷對於提高患者存活率具有關鍵意義。超音波引導核心針活檢作為乳癌診斷的金標準技術，雖具有高準確性和低侵入性，但現有徒手操作方式在保持針軸於超音波平面內方面存在挑戰，需依賴高度的手眼協調能力，增加學習曲線並影響操作精度。
本研究透過文獻回顧分析各種導引裝置的優缺點，選擇最接近目標需求的機構進行改良，設計並驗證了一種創新的導引機構。該機構結合電腦輔助設計、3D列印技術及精選零件的應用，解決了過去導引裝置在固定上的不便，包括固定力道、固定位置及拆卸操作等方面，旨在提升活檢操作的效能與使用便利性。
測試結果顯示，新型導引機構顯著提高了活檢成功率，平均提高23.17%；減少了退針次數，平均減少0.896次；並縮短了操作時間，平均縮短6.63秒。同時，其改良的固定設計展現出高穩定性與操作便利性，能有效降低學習曲線並優化整體操作體驗。
結論指出，本研究提出之創新導引機構成功克服了現有徒手操作的技術瓶頸，為提升乳癌活檢診斷技術效能提供了有效解決方案。未來可結合臨床測試，進一步推廣應用於實際醫療場景，從而改善患者診斷體驗並提高醫療效率。

Breast cancer remains one of the most prevalent cancers among women, and early detection plays a vital role in improving survival rates. Ultrasound-guided core needle biopsy (CNB) is recognized as the gold standard for breast cancer diagnosis due to its high accuracy and minimally invasive nature. However, the current freehand operation presents significant challenges, including maintaining needle alignment within the ultrasound plane and requiring substantial hand-eye coordination, leading to a steep learning curve and reduced procedural precision. This study aimed to design and validate a novel needle guidance device that addresses these limitations. By integrating computer-aided design (CAD), 3D printing technology, and ergonomic refinements, the new device improves usability, procedural stability, and operational efficiency. Experimental results revealed a 23.17% improvement in biopsy success rates, a reduction in average needle withdrawals by 0.896 times, and a decrease in operation time by 6.63 seconds. The findings demonstrate the device’s potential to overcome the shortcomings of traditional freehand techniques, thereby enhancing breast cancer diagnostic outcomes.

[1] 衛生福利部國民健康署, "中華民國110年癌症登記報告." [Online]. Available: https://www.hpa.gov.tw/File/Attach/17639/File_23506.pdf
[2] 衛生福利部國民健康署, "乳癌防治," ed, 2023.
[3] S. M. Willems, C. Van Deurzen, and P. Van Diest, "Diagnosis of breast lesions: fine-needle aspiration cytology or core needle biopsy? A review," J. Clin. Pathol., vol. 65, no. 4, pp. 287-292, 2012.
[4] J. H. Youk, E. K. Kim, M. J. Kim, J. Y. Lee, and K. K. Oh, "Missed breast cancers at US-guided core needle biopsy: How to reduce them," Radiographics, vol. 27, no. 1, pp. 79-U9, 2007.
[5] C. Clinic, "Breast biopsy," ed, 2022.
[6] P. M. Phal, D. M. Brooks, and R. Wolfe, "Sonographically guided biopsy of focal lesions: A comparison of freehand and probe-guided techniques using a phantom," Am. J. Roentgenol., Article vol. 184, no. 5, pp. 1652-1656, 2005.
[7] W. Shabana, A. Kielar, V. Vermani, D. Fernandez, R. Antoniscu, and M. Schweitzer, "Accuracy of sonographically guided biopsy using a freehand versus needle-guided technique computed tomographic correlation study," J. Ultrasound Med., Article vol. 32, no. 3, pp. 535-540, 2013. [Online]. Available: <Go to ISI>://WOS:000315835900019.
[8] A. Vydyanathan, P. Agrawal, N. Shetty, S. Nair, N. Shilian, and N. Shaparin, "The use of a new device-assisted needle guidance versus conventional approach to perform ultrasound guided brachial plexus blockade: A randomized controlled study," Local and regional anesthesia, vol. 15, pp. 61-69, 2022.
[9] R. Li et al., "AngleNav: MEMS tracker to facilitate CT-guided puncture," Ann. Biomed. Eng., Article vol. 46, no. 3, pp. 452-463, 2018.
[10] N. Bluvol, A. Kornecki, A. Shaikh, D. D. R. Fernandez, D. H. Taves, and A. Fenster, "Freehand versus guided breast biopsy: comparison of accuracy, needle motion, and biopsy time in a tissue model," Am. J. Roentgenol., Article vol. 192, no. 6, pp. 1720-1725, 2009.
[11] N. Bluvol, A. Sheikh, A. Kornecki, D. D. R. Fernandez, D. Downey, and A. Fenster, "A needle guidance system for biopsy and therapy using two-dimensional ultrasound," Med. Phys., Article vol. 35, no. 2, pp. 617-628, 2008.
[12] J. Suthakorn, N. Tanaiutchawoot, C. Wiratkapan, and S. Ongwattanakul, "Breast biopsy navigation system with an assisted needle holder tool and 2D graphical user interface," Eur. J. Radiol. Open, vol. 5, pp. 93-101, 2018.
[13] K. Ma, A. Kornecki, J. Bax, Y. Mundt, and A. Fenster, "Development and validation of a new guidance device for lateral approach stereotactic breast biopsy," Phys., Article vol. 36, no. 6, pp. 2118-2129, 2009.
[14] D. Han et al., "A steerable guiding device - The new method in ultrasound guidance," Invest. Radiol., vol. 37, no. 11, pp. 626-631, 2002.
[15] D. Lee, "Tool insertion guidance device for use with a medical imaging system," United States Patent Patent US20050267373A1, 2005.
[16] G. S. Findlay, J Schlitt, "Needle guides for catheter delivery," United States Patent Patent US20100041990A1, 2010.
[17] 林悅生, "用於徒手超音波引導組織切片術之針導引機構," 碩士, 機械工程學系, 國立成功大學, 台南市, 2021.
[18] 顏鴻森, 機械裝置的創意性設計, 台灣東華, 台北市, 2006.
[19] S. Y. Ng, Y. L. Kuo, and C. L. Lin, "Low-cost and easily fabricated ultrasound-guided breast phantom for breast biopsy training," Applied Sciences-Basel, vol. 11, no. 16, 2021.
[20] R. L. McCornack, "Extended tables of the wilcoxon matched pair signed rank-statistic," Journal of the American Statistical Association, vol. 60, no. 311, pp. 864-871, 1965.
[21] X. Q. Wang, C. Joyce, and J. Kuipers, "Making a convenient, low-cost phantom with a previously unreported material for practicing ultrasound-guided procedures," J. Clin. Ultrasound, vol. 49, no. 9, pp. 987-991, 2021.
[22] 伍思縈, "可調節物理特性之乳房活檢訓練專用超音波導引乳房假體," 碩士, 機械工程學系, 國立成功大學, 台南市, 2019.