2020-11-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/709429"低劑量斷層掃描是現行臨床篩檢早期肺部腫瘤的最佳利器，但微小的毛玻璃樣結節以微創的胸腔內視鏡手術切除時，腫瘤定位是一大挑戰，目前國內醫院常用的定位方式為附有倒鉤的細鋼針和拍得藍，針對目前術前定位之缺失，本計畫提出一種新的定位方法，設計前端附有倒鉤之可降解縫線，以同軸針將倒鉤線送至病灶處下錨，提供安全、有效、人性化的精準定位。 設計原理是以同軸針的外針穿刺皮膚和肺臟，在低劑量斷層掃描下確認位置後，內針可將裝置在其內之倒鉤線送至同軸針外下錨。倒鉤線頭之設計會有較大之倒鉤，約大於內針，卡在內針前端外、外針內，故內針前進穿出外針後，線頭自然進入體內，退針後，因為有倒鉤設計，線則留在原位。此外，較大的倒鉤線頭設計可強化定位功能，也可避免在未完成定位前，倒鉤線即自內針後移，無法在退針時，使倒鉤線順利進入體內。術中則以線頭的位置，進行手術切除病灶，同時切除縫線前端附有倒鉤之部份，縫線後端為無倒鉤平滑區，故可輕易從體外抽出移除，基本上倒鉤縫線定位後24小時內可自身體完全移除，符合ISO 10993 短期接觸身體醫材之需求，降低醫材的風險等級，有利縮短上市申請查驗登記之時間，若有剩餘部份線段術中未能移除而殘留身體，因線材設計為可吸收醫療級材料，亦無安全上之疑慮。本研究預計以臨床上已廣泛使用的可吸收polydioxane (PDO)作為定位倒鉤線材料。" "Low-dose computed tomography (CT) has been demonstrated to increase the detection rate for small pulmonary nodules in lung cancer screening. The main challenge of minimally invasive thoracoscopic surgery is in locating the nodules. Although different localization methods such as hookwires and dyes have been used in Taiwan hospital, an optimal localization method has not yet been established. The purpose of this proposal is to study the feasibility of a new localization technique by designing a suture with barbs at the front end and coaxial needles, and to meet guidance for pre-clinical testing of absorbable surgical suture. The principal of the proposal is to use the outer needle of coaxial needles to puncture skin and lung. After confirming the localization site by low-dose CT, the barbed suture is transported to anchor around the nodule by injecting the inner needle. The barb at the suture tip will be designed to be larger than the inner needle and located outside the inner needle, so the barbed suture enters naturally into the body after the inner needle forward through the outer needle. In addition to enhancing the location function of the larger barb design, the barbed suture can be always kept left in the original position to avoid the overall suture sliding into the inner needle. Based on the site of barbed suture, surgical removal of lesions becomes easy. Simultaneously, surgeon can cut all the barbs at the front end of the suture, so the residual smooth suture with no barbs can be easily removed out of the body. Basically, the barbed suture is designed to be completely removed from the body within 24 hours, which meets the standard of the limited contact duration (< 24 h) of medical devices of ISO 10993 to reduce risks, evaluation tests for consideration, and time for marketing application. If there is a remaining part of the suture failed to be removed form the body, there are no safety concerns because the suture is made of a medical and biodegradable biomaterial. Polydioxane (PDO) will be the suture material in this project, which has been extensively used in various clinical applications."