M428452 五、新型說明： . 【新型所屬之技術領域】 本創作係為一種人工材質黏膜病灶之模型，尤其是一種用 於訓練内視鏡黏膜下剝離術之人工材質黏膜病灶之模型。 【先前技術】 内視鏡黏膜下剝離術(end〇sc〇pic submucosai dissection; ESD)之發展乃是針對傳統内視鏡黏膜切除術無法整體切除之 φ 較大病灶，提供完整之整體病灶切除，對於病灶侵犯程度提供 更詳細之病理判斷，以期達到早期消化道癌症得免除傳統開刀 而各又得’口療。自1995年’ Hosokawa及Yoshida兩位學者，利 用經内視針二指腸乳頭括約肌爛朗狀針刀(needle tofe) ’前端加上—絕緣的小圓球，發展成汀杨（丨細㈣d ϋρ-knife)。其後日本G〇t〇da及〇n〇醫師首先用於大腸息肉之 切除。現在，隨著新器械的發展及技術的普及，在日本，内視 • 鏡黏膜下剝離術已經成為早期食道癌、胃癌、大腸癌之標準治 療0 σ 二Γ 仍侷限於原有器官，尚未擴散 遂u s ’右此日禮被魏，將癌細胞彳_除乾淨，〜 將無法有再發之機會。而在評估—次手術的好壞 能在對病^生最小的傷σ、保存最多的H官功㈣狀態下; 成手術即是完美的手術。當早 田 ^ > 肌肉層以上時，鮮少有淋巴結的^道=瘤侵犯舰於軸 轉❼故_喊鏡在不產4 外在傷口的狀態下完成腸胃道腫瘤的完整切除，是對病人最有 利的。因此以内視鏡黏膜下剝離術（ESD)作局部的腫瘤切除， 不僅可以完全切除腫瘤，免開刀並且完整地保留腸胃道的功 能。 内視鏡黏膜下剝離術是一個高度内視鏡技術的治療方 式，它至少包含以下幾個基本步驟㈠識別病灶並訂出範圍、 在病灶外做-環狀記號。㈡於病灶外注射生理食鹽水(内加無 菌之染色劑）’使病灶周圍隆起。（三)利用ΙΤ1]α1ί^電刀等進行 病灶周圍之環狀切開，使病灶與周圍正常組織分離。（四)再利 用IT-knife電刀等逐步進行黏膜下剝離，將病灶與其下層之組 織完整剝賴來。㈤湘止血夾或電燒^進行進行止血及裸 露血管之處理，最後病灶成功剝離並量度大小。 内視鏡黏膜下剝離術必須在有經驗的醫師操作下方得施 行° 一般學f内視鏡顧下_術的技術必麵序漸進、但也 耗費人力、物力甚鉅。第一階段須觀摩專家操作的教學影片、 白待刼作之步驟與概念。但内視鏡黏膜下剝離術須要精巧的内 視鏡#作、這些技巧光是觀摩影片無法習得精髓。在第二階段 必須在離體的動物器官(如豬的胃）中模擬内視鏡黏膜下剝離 術的各項内視鏡技巧如在腫瘤下方注射液體、腫瘤周圍環狀切 '于'腫瘤下剝離、止血夾進行止血。此項模擬已具備擬真性與 達到邛分甽練步驟(二、三、四）。第三階段進階到活體的動物 貫驗(活豬在全身麻醉下接受内視鏡手術）。此階段的練習可達 以下優點。（-)擬真有效.直視下就可識別病灶。可練習先前 所述^基本轉。㈡树：將人工材_膜病灶模型貼上 人政裔4賴如胃體模魏可操作、可省下製備離體的動物 器官(如豬的胃)與活體的動物實驗的時間。㈢方便：將人工 材質黏膜病灶模型貼上人造器官模型就可以接幼視鏡與光 源主機操作。《獅_祕”(域的胃)與活體動物實 驗時尚需具有的充氣設備撐開胃體，所以操作時不—定限於胃 鏡室’故本創作使職無場地限制。㈣人坤_膜病灶模 型費用低廉而且能重複使賴次。㈤人1材_膜病灶模 型乾淨無H官異味、丟棄時不用由醫療廢棄㈣纽不需犧牲 動物故無倫理考量。 兹配合所關示、實關之私說明及中請專利範圍，將 上述及本創作之其他目的與優點詳述於後。然而，當可了解所 附圖式純係為魄本_之精神岐，不#_糊作範鳴之 定義。有關本創作齡之定義，請參照所附之申請專利範圍。 【實施方式】 晴1考第-圖’顧係為本創作人坤質_紐模型使 用於-器官模型上第—實施例的示意圖。在本_之第一 ;施^人造議型1包含—具有複朗π 12之殼體11 數盍子13，該殼體11可為一胃體模型，每一蓋子13、尚 於盖合於對應之開σ 12。該人工材f _雜模型1G具有一 夕層體14 ’該多層體14適於設置在蓋子13的一側表面而保 持賴殼體11 _壁，該多層體14包含—仿細層141以及 至少-具有重複撕貼表面之内層143，内層143之另—面黏附 於器官模盤子的-絲面而轉_殼體_壁，其中仿黏 膜層141為一人工皮並標示有病灶特徵145，内㉟143之表面 設有仿裸露血管144之構造，而於⑽143之重複撕貼表^塗 佈-離形膠’雜轉適於無該仿細層，使仿軸層⑷ 與内層143之間可重複撕貼，達到環保、重複使用的目的。 創作之第二貫施例係為人工材質黏膜病灶模型⑺之 ，體Μ進-步包含—中間層142 ;多層體&結構如第二圖 不’中間層142的-側以膠合或黏附的方式固定於 ⑷’而中間層142的另一側具有重複撕貼表面，中間 之重硬撕絲©與⑽143可分別域鬼&⑽之公、母 成，其中魔鬼亶色146之母面與仿裸露血管m _，故進行内 視鏡手術練習時，將仿黏膜層141、中間層142之病灶特徵⑷ 2時，可見内層143之仿裸露血f 144，進而練習裸露血管 =理，該仿裸露血管144可肢色的縫線表示，或以 式呈現。 之人工材質黏膜病灶模财達到學習内視鏡 黏膜下剝綠術時之訓練目標，包含： ㈠在病灶外作-環狀記號可朗病灶並訂出範圍。 ㈡==電卿亍病灶周圍之環狀切開，使病灶與 周圍JE吊組織分離。 ㈢再利断-knife電刀於病灶與下層正常組織間水平物理施 力’可桓擬病灶與下層正常組織分離，將病灶與其下層 之組織完整剝離開來。 、/'曰 (四）利用止血夾或電燒H進行進行止血及裸露血管之處理， 以及病灶成功剝離並量度大小。 ，為達成以上目標’請參考第一至二圖，本創作之人工材質 f膜病灶麵1G用於—練習内視鏡雜下獅術之人造器官 杈型時’在這裡以胃體模型例示，該人工材質黏膜病灶模型適 於附著在該蓋子的一側表面而保持於該殼體的内壁，將内視鏡 伸入殼體1!中’首先可確定病灶位置，係由多層體14之仿黏 膜=41絲之病灶特徵145識別病灶，並於病灶特徵⑷外 作裒狀。己號以5丁出切除範圍，並進行病灶特徵⑷周圍之環 狀切開’便可達卿丨練目標㈠與㈡··識顧灶並訂出範圍、 病灶外做-環狀記號並進行病灶周圍之環狀切開，使病灶與周 圍正常組織分離。另外，亦可於仿黏膜層141以及中間層142 依病灶特徵145之輪廓贱切開，增加練f方便性。 接下來欲使模擬病灶與正常組織剝離 例的仿黏膜層⑷固定於第靖142上，於操二二 T-kmfe深入中間層142與内層143之間，並水平施力，使魔 鬼乾146之公、母面分離’可模擬病灶與下層正常組織分離的 狀況。或於本創作在内層143之重複撕貼表面塗佈一離形膠之 貫施例中’操作時使用了杨深入仿黏臈層⑷與内層143 ，間，並水平施力’使離形膠塗佈處分離，以上皆可模擬病灶 與:層正常組織分離的狀況，如此可達到訓練目標㈢：病灶 與其下層之組織完整剝離開來。將病灶_後，露出多層體 M428452 14之内層143裸露血管部分，進而練習裸露企管的處理，達 到訓練目標㈣··利用止J^進行裸露企管之處理與止血，以 及病灶成功剝離並量度大小。 【圖式簡單說明】 第一圖係為本創作人工材質黏膜病灶模型使用於一器官模型 上之第一實施例的示意圖。 第二圖係為本創作人工材質黏膜病灶模型第二實施例中之多 層體結構示意圖。 【主要元件符號說明】 1 人造器宫模型 10人工材質黏膜病灶模型 11殼體 12 開口 13蓋子 14多層體 141仿黏膜層 142中間層 143内層 144仿裸露血管 145病灶待徵 146魔鬼氈M428452 V. New description: . [New technical field] This creation is a model of artificial material mucosal lesions, especially a model of artificial material mucosal lesions used to train endoscopic submucosal dissection. [Previous technique] The development of endoscopic submucosal dissection (ESD) is to provide a complete overall lesion resection for large lesions that cannot be removed by conventional endoscopic mucosal resection. Provide more detailed pathological judgment on the extent of lesion invasion, in order to achieve early digestive tract cancer, which is exempted from traditional surgery and each has its own 'oral therapy. Since 1995, two scholars, Hosokawa and Yoshida, have developed the Ting Yang (丨细(四)d ϋρ by using the needle-feet of the endoscopic nipple sphincter scabbard (needle tofe) -knife). Later, Japanese doctors G〇t〇da and 〇n〇 were first used for the removal of colorectal polyps. Now, with the development of new devices and the popularization of technology, in Japan, endoscopic and microscopic submucosal dissection has become the standard treatment for early esophageal cancer, gastric cancer and colorectal cancer. 0 σ Dioxins are still confined to the original organs and have not spread.遂us 'Right this day is Wei, the cancer cells 彳 _ clean, ~ will not have a chance to re-issue. In the assessment, the quality of the surgery can be in the state of the smallest injury to the disease, the most preserved H official function (four) state; surgery is the perfect surgery. When the early field ^ > muscle layer above, there are few lymph nodes ^ road = tumor invasion ship in the axis of rotation 喊 喊 在 在 在 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不 不Most beneficial. Therefore, endoscopic submucosal dissection (ESD) for local tumor resection can not only completely remove the tumor, but also avoid the function of the gastrointestinal tract. Endoscopic submucosal dissection is a highly endoscopic technique that involves at least the following basic steps: (1) Identifying the lesion and setting the range, making a ring-mark outside the lesion. (B) Injecting physiological saline (with a sterile stain) into the lesions to make the lesions bulge around. (3) Using a ΙΤ1]α1ί^ electrosurgical knife to perform a circular incision around the lesion to separate the lesion from the surrounding normal tissue. (4) Gradually perform submucosal dissection with an IT-knife electrosurgical knife, etc., and completely decoy the lesion and its underlying tissue. (5) Hunan hemostasis or electrocautery ^ to carry out the treatment of hemostasis and bare blood vessels, and finally the lesion was successfully stripped and measured. Endoscopic submucosal dissection must be performed under the experience of an experienced physician. The technique of the endoscope is gradual, but it is also labor-intensive and labor-intensive. In the first stage, it is necessary to observe the teaching films and the steps and concepts of the expert operation. However, endoscopic submucosal dissection requires a delicate endoscope #, these techniques are not able to learn the essence of the film. In the second stage, endoscopic submucosal dissection techniques must be simulated in isolated animal organs (such as the stomach of pigs), such as injection of fluid under the tumor, annular resection around the tumor. Peeling and hemostasis clips to stop bleeding. This simulation has the practical and achievable steps (2, 3, 4). The third stage is advanced to live animals (live pigs under endoscopic surgery under general anesthesia). The exercises at this stage can achieve the following advantages. (-) It is effective and effective. The lesion can be identified under direct vision. You can practice the basic transfer described previously. (2) Tree: The artificial material _ membrane lesion model is affixed to the human ethics 4 Lai, the stomach phantom Wei can operate, can save the time of preparation of isolated animal organs (such as pig's stomach) and living animal experiments. (3) Convenience: The artificial material mucosal lesion model can be attached to the artificial organ model to connect the goggles and the light source host. "Lion _ secret" (the stomach of the domain) and the inflatable animal equipment required for the live animal experiment fashion to open the corpus, so the operation is not limited to the gastroscope room, so the creation does not have a site limitation. (4) Ren Kun _ membrane lesion model The cost is low and can be repeated. (5) The person's material _ membrane lesion model is clean and has no H odor, and it is not discarded by medical treatment when discarded. (4) New Zealand does not need to sacrifice animals, so there is no ethical consideration. The scope of the patent application and the other purposes and advantages of the present invention are detailed below. However, when it can be understood that the pure form of the drawing is the spirit of 魄本_, not the definition of Fan Ming. For the definition of this creation age, please refer to the attached patent application scope. [Embodiment] Qing 1 test - Figure 'Gu is the creator of the creator _ New model used on the - organ model - the first embodiment Schematic. In the first of the present; the artificial type 1 includes - a casing 11 having a complex π 12 number, the casing 11 can be a corpuscle model, and each cover 13 is still covered Combined with the corresponding opening σ 12. The artificial material f _ hybrid model 1G has an eve layer 1 4' The multilayer body 14 is adapted to be disposed on one side surface of the cover 13 to retain the housing 11-wall, the multilayer body 14 comprising a --like layer 141 and at least - an inner layer 143 having a repeating tearing surface, the inner layer 143 In addition, the surface adheres to the silk surface of the organ mold plate, and the shell layer 141 is an artificial skin and is marked with a lesion feature 145, and the surface of the inner 35143 is provided with a structure resembling the bare blood vessel 144. Repeated tearing sheet (10) 143 ^ coating - release rubber 'missing is suitable for the absence of the imitation layer, so that the imitation shaft layer (4) and the inner layer 143 can be repeatedly peeled, to achieve environmental protection, reuse purposes. The second embodiment is an artificial material mucosal lesion model (7), the body enthalpy step includes - the intermediate layer 142; the multilayer body & structure is as shown in the second figure, and the side of the intermediate layer 142 is fixed by gluing or adhesion. In (4)', the other side of the intermediate layer 142 has a repeating tearing surface, and the middle hard hard tearing wire © and (10) 143 can be made separately from the male and female of the ghost & (10), wherein the mother face and the bare nude of the devil color 146 The blood vessel m _, so when performing endoscopic surgery, the imitation mucosa layer 141, the middle 142 lesion features (4) 2, the inner layer 143 can be seen naked blood f 144, and then practice naked blood vessels = rational, the imitation bare blood vessels 144 can be expressed by the color of the suture, or in the form of artificial material mucosal lesions To achieve the training objectives of learning endoscopic submucosal dehearning, including: (1) in the external appearance of the lesion - ring mark can be a lesion and set the scope. (2) == electric ring sputum around the ring incision, so that the lesion and Separation of the surrounding JE hanging tissue. (3) Re-breaking-knife electric knife horizontal physical interaction between the lesion and the underlying normal tissue 'can be used to separate the normal lesion from the underlying normal tissue, and separate the lesion from the underlying tissue.四 (4) Use hemostasis clips or electric burning H to perform hemostasis and bare blood vessels treatment, and the lesions were successfully stripped and measured. In order to achieve the above objectives, please refer to the first to second figures. The artificial material f-membrane surface 1G of this creation is used for the practice of the artificial organ type of the endoscopic lion lion technique. The artificial material mucosal lesion model is adapted to be attached to one side surface of the cover and is retained on the inner wall of the housing, and the endoscope is inserted into the housing 1! 'Firstly, the position of the lesion can be determined, which is simulated by the multilayer body 14. Mucosa = 41 filament lesion features 145 identify lesions and lesions outside the lesion features (4). The number has been cut out by 5, and the lesion is characterized by (4) the circular incision around the 'can reach the goal of (1) and (2)········································· The surrounding ring is cut open to separate the lesion from the surrounding normal tissue. In addition, the pseudo-mucosa layer 141 and the intermediate layer 142 may also be cut according to the contour of the lesion feature 145, thereby increasing the convenience of training. Next, the simulated mucosa layer (4) of the simulated lesion and the normal tissue exfoliation example is fixed on the Yajing 142, and the T-kmfe is deeped between the intermediate layer 142 and the inner layer 143, and horizontally exerted force to make the devil dry 146 The separation of the male and female faces can simulate the separation of the lesion from the normal tissue in the lower layer. Or in the case of applying a release gel to the repeated tearing surface of the inner layer 143, the operation is carried out using a deep imitation adhesive layer (4) and an inner layer 143, and horizontally applying force to make the release glue The coating is separated, and the above can simulate the condition of the lesion and the normal tissue separation of the layer, so that the training target can be achieved (3): the lesion and the tissue of the lower layer are completely separated. After the lesion _, the exposed vascular portion of the inner layer 143 of the multi-layered body M428452 14 is exposed, and then the treatment of the bare enterprise is practiced, and the training target is achieved (4). The treatment and hemostasis of the bare enterprise management are performed by using the J^, and the lesion is successfully peeled off and measured. BRIEF DESCRIPTION OF THE DRAWINGS The first figure is a schematic view of a first embodiment of the artificial material mucosal lesion model used in an organ model. The second figure is a schematic diagram of the multi-layer structure in the second embodiment of the artificial material mucosal lesion model. [Main component symbol description] 1 Artificial artifact model 10 Artificial material mucosal lesion model 11 housing 12 opening 13 cover 14 multilayer body 141 imitation mucosa layer 142 middle layer 143 inner layer 144 imitation bare blood vessels 145 lesions to be sought 146 devil felt