臺灣博碩士論文加值系統

臨床上，神經傳導速度 (nerve conduction velocity, NCV) 和肌電圖 (electromyography, EMG) 量測為目前神經和肌肉功能檢測的標準工具。然而，由近年來的研究顯示，微血管的收縮與疼痛感受器(nociceptor)的活化有高度相關性，因此雷射都卜勒血流儀 (laser Doppler flowmetry, LDF) 也可以用來作為檢測疼痛的工具。有別於神經傳導速度和肌電圖，雷射都卜勒血流儀以微循環的角度做檢測，這是一個新的研究方法。但是，目前這一類的研究仍以視覺觀察信號的強弱為主，欠缺客觀的量化指標，因此，在相關的議題中，雷射都卜勒血流信號的量化方法仍然是一個亟待解決的問題。本計畫的目的是希望開發一個可以用來作為慢性肩頸痠痛檢測用的雷射都卜勒血流與光體積變化描記圖(photoplethysmography, PPG)信號量測裝置，除了裝置的實體以及基於平板電腦的圖形使用者界面 (graphical user interface, GUI) 應用程式，亦預期規劃兩種臨床試驗，分別以市售以及本專案所開發的雷射都卜勒血流儀測量信號，藉以測試量化演算法對於痠痛檢測的靈敏程度，並完成與市售器材之間的實質比對。量化指標目前預計將針對雷射都卜勒血流信號的 0.0095Hz ~ 1.6 Hz 頻帶採用小波分析，以及計算血流信號的灌流指標。全程擬定以一年的時間執行完成，期望本計畫所開發的裝置將來可以提升疼痛處理的醫療品質。本計畫的研發過程，將依照 ISO 13485 (醫療器材品質管理)、ISO 14971 (醫療器材風險分析) 以及 IEC 62304 (醫療器材軟體生命週期) 所建議的設計開發流程，所開發的裝置並需符合 IEC 60601-1 (醫療器材電氣安全性) 以及 IEC 60825-1 (雷射安全性) 等規範的要求。

In clinical setting, nerve conduction velocity (NCV) measures and electromyography (EMG) have been accepted to be the gold standard in the evaluation of nerve and muscle function before pain management. Apart from the conventional NCV and EMG measures, laser Doppler flowmetry (LDF) provides a new perspective on pain from the microcirculatory point of view. Recent researches have revealed that the interaction between the blood vessels and nociceptors is important to the activation of muscle nociceptors, and LDF is expected to play an important role in the assessment of chronic pain. However, most of these studies were only conducted by visual interpretation on the LDF flux signal. It is not easy to obtain the consensus without the quantification indices for scientific studies. As an alternative tool, there still lacks common quantification measures for the LDF flux signal for the assessment of pain. To solve the quantification issue thus become the prerequisite for any further studies in this field.

The objective of this project is to develop the LDF device that can be utilized for the quantification of chronic shoulder and neck pain in a non-invasive way for the office workers. Due to the miscellaneous terms in pain, this project will be dedicated to the technology development for the occurrence assessment of pain, but not the level of pain, for the office workers in a two-year duration. In the first year, the clinical trials will be conducted by the commercial LDF equipment. Two kinds of experiment will be performed to determine what quantification indices are sensitive to the evaluation of chronic shoulder and neck pain. The preliminary plan for the quantization of flux signal is the analysis by wavelet transform in the frequency range of 0.0095 ~ 1.6 Hz and by the computation of perfusion index (PI). The development of LDF and photoplethysmography (PPG) device, which includes the system design and the graphical user interface (GUI) application program on tablet PC platform, will finished in the first year. The verification and validation process will be performed for the developed LDF device during the development period to assure the substantial equivalence to the commercial LDF equipment. In this issue, the data will be collected and compared by both the commercial LDF system and the developed device for all of the subjects in the clinical trials under well-controlled situations. It is expected such technology can improve the quality of pain treatments by the medical staff in the future.

This LDF device will be developed under the process regulated by ISO 13485 (quality management for the medical devices), ISO 14971 (application of risk analysis to medical analysis) and IEC 62304 (software life cycle processes of medical device). The design will also satisfy the requirements regulated by IEC 60601-1 (for electrical safety of medical device) and IEC 60825-1 (safety of laser products).

目錄
致謝 I
摘要 III
ABSTRACT IV
圖目錄 IX
表目錄 XIII
第一章 緒論 1
1.1前言 1
1.2研究動機與目的 1
1.3文獻回顧 2
第二章 研究背景 4
2.1微循環 4
2.2肩頸痠痛之定義 5
2.3光體積變化描記圖 6
2.4雷射都卜勒血流儀 7
2.4.1都卜勒現象 8
2.4.2 First Weighted Moment 演算法 11
第三章 研究方法 13
3.1 微循環量測儀系統架構 13
3.2探頭 14
3.2.1光源 14
3.2.2雷射驅動電路 17
3.2.3探頭光接收器製作 18
3.3前置電路設計 21
3.3.1電流轉電壓電路 21
3.3.2 濾波電路及放大電路 22
3.4獨立電源 26
3.5訊號擷取卡 27
3.6軟體功能開發環境與工具 28
3.6.1開發平台 28
3.6.2主要搭配軟體 28
3.6.3整合型開發環境(IDE)工具 29
3.6.4 UI設計工具 30
3.7程式功能架構 30
3.8 驗證方法一 34
3.9驗證方法二 35
第四章實驗結果 36
4.1電路驗證 37
4.1.1 PPG及LDF電路頻譜訊號驗證 37
4.1.2雷射光源驗證 44
4.1.3光接收二極體驗證 46
4.1.4 驗證結果方法一 46
4.1.5驗證結果方法二 49
4.2軟體驗證 52
4.2.1軟體功能呈現 52
4.2.2軟體對NI-DAQ card 6211取樣頻率驗證 55
4.2.3訊號分析結果 56
第五章結論與討論 58
5.1結論 58
5.2討論 58
5.2.1探頭 58
5.2.2類比電路及機殼設計 59
5.2.3使用者介面GUI 59
參考文獻 61
附錄 63
 
圖目錄
圖 2-1、微循環之構造 5
圖 2-2、微血管之構造 5
圖2-3、手指的光體積變化描記圖 7
圖2-4、光訊號入射紅血球的散射現象 8
圖2-5、麥克森干涉儀裝置 9
圖2-6、頻域訊號分佈 11
圖3-1、微循環系統架構圖 13
圖3-2、雷射探頭量測架構圖 14
圖3-3、雷射二極體實體圖 15
圖3-4、光纖連接FC接頭 15
圖3-5、雷射二極體光譜圖 16
圖3-6、元件封裝結構圖與連接腳位圖 16
圖3-7、ADAFC2連接器 17
圖3-8、光纖線材 17
圖3-9、雷射驅動IC電路圖 18
圖3-10、光接收器實體圖 19
圖3-11、探頭所切割之塑膠形狀 19
圖3-12、光接收器由MICRO USB連接圖 20
圖3-13、挖去光接收器所放置位置 20
圖3-14、探頭完成俯視圖 20
圖3-15、探頭完成側視圖 21
圖3-16、光接收器電流轉電壓電路 22
圖3-17、PPG二階主動高通濾波器 23
圖3-18、PPG二階主動低通濾波器 23
圖3-19、PPG NOTCH濾波器 24
圖3-20、LDF高通濾波器 24
圖3-21、LDF低通濾波器 25
圖3-22、放大電路 25
圖3-23、12 V電源供應器 26
圖3-24、總開關電路 27
圖3-25、電路變壓器 27
圖3-26、類比數位訊號轉換流程圖 28
圖3-27、主功能架構圖 31
圖3-28、BIOPAC多通道生理量測系統MP150 34
圖3-29、本研究PPG與MP150同步量測架構 35
圖3-30、微循環阻塞實驗示意圖 35
圖4-1、微循環量測儀 36
圖4-2微循環量測儀內部配置 36
圖4-3、微循環量測儀軟體量測介面 37
圖4-4、PPG電路測試示意圖 38
圖4-5、PPG帶通濾波器波德圖 38
圖4-6、PPG帶通濾波器波德圖及相位圖 38
圖4-7、NOTCH 濾波器波德圖 39
圖4-8、實際輸入頻率為0.5 HZ之旋波結果圖 39
圖4-9、實際輸入頻率為8 HZ之旋波結果圖 40
圖4-10、實際輸入頻率為18 HZ之旋波結果圖 40
圖4-11、實際輸入頻率為25 HZ之旋波結果圖 41
圖4-12、LDF電路測試示意圖 42
圖4-13、LDF帶通濾波器波德圖 42
圖4-14、LDF帶通濾波器波德圖及相位圖 42
圖4-15、實際輸入頻率為20 HZ之旋波結果圖 43
圖4-16、實際輸入頻率為1K HZ之旋波結果圖 43
圖4-17、實際輸入頻率為22.5K HZ之旋波結果圖 44
圖4-18、光功率驗證示意圖 44
圖4-19、光譜儀量測示意圖 45
圖4-20、光譜儀量測結果 45
圖4-21、光接受器驗證電路 46
圖4-22、光源和接收器的距離關係圖 46
圖4-23、量測部位示意圖 47
圖4-24、量測實際情況 47
圖4-25、量測結果圖 47
圖4-26、穿戴示意圖 48
圖4-27、量測實際情況 48
圖4-28、為量測結果圖 49
圖4-29、微循環阻塞實驗實際圖 49
圖4-30、微循環阻塞實驗局部放大圖 50
圖4-31、量測之原始訊號 50
圖4-32、原始訊號計算過後之結果 51
圖4-33、原始訊號計算過後之局部放大結果 51
圖4-34、登入介面圖 52
圖4-35、使用者資料編輯介面 52
圖4-36、量測初始介面 53
圖4-37、訊號預覽介面 53
圖4-38、擷取過程 54
圖4-39、擷取完成提示訊息 54
圖4-40、計算結果圖一 55
圖4-41、計算結果圖二 55
圖4-42、取樣率為50 KHZ擷取1 HZ SIN波 56
圖4-43、取樣率為50 KHZ擷取1 KHZ SIN波 56
圖4-44、左手食指訊號分析結果 56
圖4-45、左手中指訊號分析結果 57

 
表目錄
表3-1 LP785-SF20規格表 16
表3-2 軟體模組列表 32

參考文獻
[1]J. Anddersen, A. Kaergaard, S. Mikkelsen, U. F. Jensen, P. Frost, J. P. Bonde, N. Fallentin, J. F. Thomsen, “Risk factors in the onset of neck/shoulder pain in a prospective study of workers in industrial and service companies”, Occupational and Environmental Medicine, Vol.60, No.9, pp.649-654, 2003.
[2]梁蕙雯、徐擏暉、彭淑美，電腦工作者頸肩上之疼痛之危險因子及職場運動之效果，行政院勞工委員會勞工安全衛生研究所委託研究報告，2004。
[3]K. M. S. Ayers, W. M. Thomson, J. T. Newton, “Morgaine, K.C., Rich, A.M.,Self-reported occupational health of general dental practitioners”, Occupational Medicine, Vol.59, No.3, pp.142-148, 2009.
[4]A. Yamashina, “Validity, reproducibility, and clinical significance of noninvasive brachial-ankle pulse wave velocity measurement”, Hypertens Research, Vol.25, No.3, pp.359-364, 2002.
[5]S. Loukogeorgakis, “Validation of a device to measure arterial pulse wave velocity by a photoplethysmographic method”, Physiological Measurement., Vol.23, No.3, pp.581–596, 2002.
[6]A. Granelli, I. Östman-Smith, “Noninvasive peripheral perfusion index as a possible tool for screening for critical left heart obstruction” Acta Paediatrica, Vol.96, No.10, pp.1455-1459, 2007.
[7]W. Perl, R. L. Hirsch, “Local blood flow in kidney tissue by heat clearance measurement”, Journal of Theoretical Biology, Vol.10, No.2, pp.251-280, 1966.
[8]M. D. Stern, ”In vivo evaluation of microcirculation by coherent light scattering”, Nature, Vol.254, No.5495, pp.56-58, 1975.
[9]D. W. Watkins, G. A. Holloway, “An instrument to measure cutaneous blood flow using the Doppler shift of laser light”, IEEE Transactions on Bio-medical Engineering, Vol.25, No.1, pp.28-33, 1978.
[10]Gert E. Nillson, Torsten Tenland, and P. Ake Oberg, “A new instrument for continuous measurement of tissue blood flow by light beating spectroscopy”, IEEE Transactions on Bio-medical Engineering, Vol.27, No.1, pp.12-19, 1980.
[11]Gert E. Nillson, Torsten Tenland, and P. Ake Oberg, “Evaluation of a laser Doppler flowmeter for measurement of tissue blood flow”, IEEE Transactions on Bio-medical Engineering, Vol.27, No.10, pp.597-604, 1980.
[12]R. F. Bonner, R. Nossal, “Model for laser Doppler measurements of blood flow in tissue”, Applied Optics, Vol.20, No.12, pp.2097-2107, 1981.
[13]I. Fredriksson, C. fors, J. Johansson, “Laser Doppler Flowmetry – a Theoretical Framework”, Department of Biomedical Engineering, Linkoping University, 2007.
[14]Ana Isabel Leitão Ferreira,“Laser Doppler Flowmetry”, Departamento de Física da Universidade de Coimbra, Biomedical Engineering, September 2007.
[15]微血管National Cancer Institute網站 (http://www.cancer.gov) cited on June, 2014.
[16]微循環網站 (http://www.baike.com/ipadwiki) cited on June, 2014.
[17]郭育良，職業病概論(二版)，華杏出版有限公司，臺北，第99-104頁，2005。
[18]A. Stefanovska, M. Bracic, H. D. Kvernmo, “Wavelet analysis of oscillations in the peripheral blood circulation measured by laser Doppler technique”, IEEE Transactions on Bio-medical Engineering, Vol.46, No.10, pp.1230-1239, 1999.
[19]R. Bonner, R. Nossal, “Model for laser Doppler measurements of blood flow in tissue”, Applied Optics, Vol.20, No.12, pp.2097-2107, 1981.
[20]王昱昇，近紅外光系統之設計於糖尿病患足部血管病變之研究，國立成功大學，醫學工程研究所，2007。
[21]Moor instruments Ltd moorVMS-LDF網站 (www.moor.co.uk) cited on March, 2014.