| 研究生: |
何正宇 Hoe, Zheng-Yu |
|---|---|
| 論文名稱: |
手持式乳癌相關淋巴水腫監測器材設計 Handheld Measurement Device Design for Breast Cancer-related Lymphedema |
| 指導教授: |
陳家進
Chen, Jia-Jin Jason |
| 學位類別: |
博士 Doctor |
| 系所名稱: |
工學院 - 生物醫學工程學系 Department of BioMedical Engineering |
| 論文出版年: | 2020 |
| 畢業學年度: | 109 |
| 語文別: | 英文 |
| 論文頁數: | 71 |
| 中文關鍵詞: | 生物醫學工程 、醫療器材設計 、乳癌 、淋巴水腫 、肢體周徑 、順應性 |
| 外文關鍵詞: | Biomedical Engineering, Medical Device Design, Breast Cancer, Lymphedema, Limb Circumference, Compliance |
| 相關次數: | 點閱:94 下載:0 |
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根據統計,乳癌為美國目前女性發生率極高的癌症種類之一,每8位女性就有一位會罹患乳癌,但可透過臨床治療達很高的存活率,但在治療過程中,經常伴隨副作用產生,例如淋巴水腫,在前瞻性研究的數據統計中,乳癌患者發生上肢淋巴水腫發生率高達21.4%,其也隨著患者存活率提高變得越來越普遍。床上發現,乳癌相關淋巴水腫若無及時治療,會導致最終不可逆的腫脹及纖維化,對患者的生活品質造成嚴重負面影響。
本研究提出了兩種用於檢測乳癌相關淋巴水腫器材的設計。該設計易於操作且價格合理,使大多數患者都可使用,希望能經由增加量測器材的易用性和可及性,確保乳癌患者未來可針對淋巴水腫進行更好的長期追蹤,以達成早期診斷和更有效的治療。
要追蹤乳癌相關淋巴水腫的發生可經由偵測臂圍以及肢體順應性的長期變化來達成。本研究以直接近場電紡技術製造出已極化完成之聚偏二氟乙烯壓電纖維,以此壓電纖維製造出具有動態感測特性且較壓阻式感測器更為靈敏的力感應器,並應用三個力感測器構成順應性量測裝置。利用此順應性量測裝置對有單側淋巴水腫的受試者測量了兩側上肢多個固定點後,發現淋巴水腫患側的順應性較正常側肢體差。
測量臂圍是目前監測淋巴水腫發作及程度的常用方法,需經常量測肢體周徑數據變化,並藉由比較兩側肢體周徑差異及變化分析嚴重度,理論上測量臂圍可有效進行監測,但現有以皮尺量測之方式相當耗時且操作不易,若使用3D掃描器則有量測器材昂貴之問題。上述限制使得患者無法經常量測,因此目前實務上測量臂圍不易達成長期監測淋巴水腫發生之目標。為此本研究開發了便攜式、可連續測量肢體周徑的測量裝置,它可以藉由兩個安裝在裝置上的光學傳感器連續且同時測量待測肢體的徑向位置和周長,經由裝置主控制板接收後傳輸到行動裝置或電腦儲存並顯示肢體各部位周徑及其歷史變化。研究中針對有單側淋巴水腫的受試者進行測試,比較捲尺、3D掃描器與本裝置的操作時間及量測準確度。結果發現本裝置所需的總時間遠少於其他兩種方法,而數據再現性較其他方法更佳。更進一步分析本裝置與皮尺的測量差異與順應性感測裝置所測量的結果可知,本裝置與皮尺之量測數據差異係由組織順應性造成。未來的設計應可解決此量測差異。
該兩項器材均具操作方便,量測快速準確且價格合理之特性,使大多數患者都可以使用。由於該兩項量測器材的易用性和可用性,將有助於對乳癌相關淋巴水腫進行長期的追踪。未來需更多臨床研究來確定乳癌相關淋巴水腫發生前後肢體周徑和順應性的變化模式。以協助患者儘早發現和治療淋巴水腫,並減少乳癌相關淋巴水腫對日常生活品質的影響。
Breast cancer is one of the most common types of cancer to afflict women in the United States, with a lifetime prevalence rate of one in every eight women. Treatment is often accompanied by various side effects, such as lymphedema, whose incidence rate is as high as 21.4%. If breast cancer-related lymphedema (BCRL) is not treated in a timely manner, then accumulated proteins in the lymph will eventually cause irreversible swelling and fibrosis, negatively affecting patients’ quality of life. This study explores two device designs for the detection of breast cancer-related lymphedema (BCRL). The design features for the devices are convenient, fast, and affordable, making them useable by the majority of patients. Increasing the ease of use and availability of such equipment will ensure better long-term lymphedema tracking in breast-cancer patients and allow for early diagnosis and more effective treatment.
The onset of BCRL can often be detected by measuring the degree of tissue deformation in response to an external force, a.k.a. tissue compliance. In this study, three piezoelectric fiber force sensors (PF force sensor) were incorporated into the design of a tissue compliance measuring device (CpMD). The PF force sensors used polyvinylidene fluoride (PVDF) piezoelectric fibers, which were manufactured using a direct-write near-field electrospinning (DW-NFES) and repolarized to align the fibers’ dipoles in sequence and increase their activity. The design of the CpMD leveraged the dynamic force sensor properties of the PVDF PF force fibers, which are more highly sensitive than piezoresistive force sensors. The CpMD was tested on one subject with BCRL in one arm (the “Affected” side, vs. the “Sound” side). Multiple points between the wrist crease and armpit were measured, and the data demonstrated that the Affected side showed worse compliance than the Sound side.
This study adopted another common method for detecting the onset and degree of BCRL by measuring arm circumference or upper limb volume. This process involves periodically tracking and comparing collected data against measurements of normal limbs and analyzing the severity of the illness. However, these conventional measurements are time-consuming and difficult to perform by the patient and are often costly, making regular measurement and comparison impractical. Thus, a portable, home-based, continuous limb circumference measurement device (CLCMD) that could simultaneously measure the lateral length and circumference of the patient’s limbs (upper or lower) was also developed. The CLCMD used two optical sensors built onto a measuring loop, one of which measured lateral movement, the other measuring changes in circumference. Data was received by the device’s main control board and then transmitted to a mobile device or computer, where a custom app processed, stored, and displayed a data curve (circumference against distance from wrist). The CLCMD was tested on five subjects, each with BCRL in one arm, against two conventional methods of measuring limb circumference, a tape measure and a 3D scanning gun. The CLCMD required far less total operating time than the other two methods when preparation and post-measurement times were factored in. All three methods were able to successfully detect lymphedema in the Affected limbs. All three methods produced similar data on the Affected side, but the device’s data differed from the other two methods on the Sound side. This was attributed to better tissue compliance on the Sound side, and future design iterations of the CLCMD may address this issue.
The proposed CLCMD with app can be used to monitor the circumferential changes of the limbs and is expected to help breast cancer paints detect and treat lymphedema early, thereby reducing damage to limb function and appearance problems. Future studies can establish the change pattern(s) of limb circumference and compliance before and after the occurrence of breast cancer-related lymphedema. More clinical studies of CLCMD and CpMD could early detect or even predict the occurrence of breast cancer-related lymphedema, so that patients can receive treatment in its early stages, thus increase the effectiveness of treatment and control the effects of BCRL.
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