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研究生：	宋儼惠 Sung, Yen-Hui
論文名稱：	設計一個新的硬脊膜外腔偵測器來協助麻醉醫師施行硬脊膜外麻醉 Design a Novel Epidural Space Detector to Assist the Anesthesiologists in Performing Epidural Anesthesia
指導教授：	林宙晴 Ling, Chou-Ching
學位類別：	碩士 Master
系所名稱：	工學院 - 生物醫學工程學系 Department of BioMedical Engineering
論文出版年：	2018
畢業學年度：	106
語文別：	英文
論文頁數：	56
中文關鍵詞：	硬脊膜外麻醉、硬脊膜外腔、「阻力消失法」
外文關鍵詞：	Epidural anesthesia, Epidural space, Loss of resistance technique
相關次數：	點閱：57 下載：0
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硬脊膜外麻醉是將麻醉藥注入硬脊膜外腔的麻醉方式，屬於半身麻醉的一種，目前被廣泛應用於產婦的減痛分娩，可以達到良好的疼痛緩解又保有部分的知覺及肌張力，使產婦不受產痛之苦但又可隨產程進展配合用力娩出寶寶。硬脊膜外腔為介於黃韌帶及脊膜之間的腔室，它的特性為跟其他組織相比阻力明顯降低。1921年西班牙的軍醫Fidel Pãges發展為現在的硬脊膜外麻醉技術，即所謂的「阻力消失法」-持續施加壓力於接在硬脊膜外針的空針，當阻力消失即表示硬脊膜外針到達硬脊膜外腔，即可施打麻醉藥物或置放導管完成硬脊膜外麻醉。若沒有發現已到達硬脊膜外腔，硬脊膜外針繼續深入，則可能穿破脊膜而致腦脊髓液流出甚至傷害到神經。故如何辨識硬脊膜外腔是非常重要的。但直到現在硬脊膜外麻醉還是使用1921年的「阻力消失法」去辨識硬脊膜外腔。難道沒有更客觀的方法去辨識硬脊膜外腔? 直到2012年有英國團隊發明了Epidrum，Epidrum有一可打氣膨出的薄膜，在硬脊膜外針與空針間加裝上Epidrum，一旦硬脊膜外針進入硬脊膜外腔，薄膜即塌陷顯示壓力變化。但因仍須接上空針，故Epidrum增加了整體長度而有操作困難的缺點；2014年台大團隊研發了EpiFaith，聲稱有簧片可偵測硬脊膜外腔並有煞車功能，但設計複雜，可性度不足。我們設計出一種可明確顯示出硬脊膜外腔的阻力變化的工具，希望能提高硬脊膜外麻醉的成功率並縮短施打時尋找確認硬脊膜外腔的時間。

Epidural anesthesia is one form of regional anesthesia. The anesthesiologist injects local anesthetics into epidural space that results in regional block. It is widely used in painless labor for excellent pain relief with minimal effect of motor block. In 1921, a Spanish military surgeon, Fidel Pãges, developed the modern technique of epidural anesthesia which is known by “loss of resistance” (LOR) technique. “LOR” technique involves constant application of pressure to the plunger of a syringe to identify the epidural space while advancing the epidural needle. Epidural space is between ligamentum flavum and dura matter. The resistance within epidural space is relatively lower than adjacent tissue. Therefore “LOR” happens when epidural needle enters the epidural space. It’s very important to identify the epidural space when the anesthesiologist performs epidural anesthesia. However, till now, the anesthesiologist still depends on “LOR” technique to detect epidural space. Is there any better way to identify epidural space? We design a novel device to assist the anesthesiologists in finding epidural space. We hope this device could increase the success rate of epidural anesthesia and shorten the procedure time.

Contents
List of Figures	VII
List of Tables	IX
Chapter 1 introduction	1
1	 Background and Motivation	1
1.1	Epidural anesthesia	1
1.2	Modern technique of epidural anesthesia	3
1.3	Shortcomings of modern technique of epidural anesthesia	6
2	Comparison of current devices	7
2.1	Ultrasound-guided epidural blockade	7
2.2	Epidrum	8
2.3	Fiberoptic-guided epidural needle	9
2.4	EpiFaith	11
Chapter 2 Materials and Methods	12
1 Design a novel device as a visual detector of the	12
1.1 The aim of our design	12
1.2 Design processes	12
2 Check the physical property of the device	14
2.1 Measure the volume-pressure relationship of	14
2.2 Measure the time-pressure relationship of the device	15
2.3 Measure Young’s modulus of the material	16
3 Efficacy tests	16
4 Functional tests	16
5 Substantial equivalence tests	18
5.1 The materials of experimental model	19
5.2 The subgroups of the operators	20
5.3 The substantial equivalence tests of our device	20
6 Statistical analysis	21
Chapter 3 Results	22
1 The design of our device	22
2 The first prototype	24
3 The second prototype	25
4 The third prototype	26
4.1 The volume-pressure relationship of the third prototype	27
4.2 The time-pressure relationship of the third prototype	28
4.3 Functional tests of the third prototype	28
4.4 Substantial equivalence tests	30
5 The fourth prototype	32
5.1 The volume-pressure relationship of the fourth prototype	33
5.2 The time-pressure relationship of the fourth prototype	34
5.3 Young’s modulus of the material of the fourth prototype	34
5.4 Functional tests of the fourth prototype	36
5.5 Substantial equivalence tests of the fourth 　prototype	37
Chapter 4 Discussion and Prospect	44
1 The differences between our third and fourth prototype	44
2 The contribution of the project and future work	51
References	53


                                    

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