AU^^478 四、指定代表圖： (一) 本案指定代表圖為：第（1 )圖。 (二) 本代表圖之元件符號簡單說明： 本體支架1 上迴圈端2 下迴圈端3 第二股支架4 上端孔5 下端孔6 側孔7 五、新型說明： 【新型所屬之技術領域】 本案係有關一種雙股輸尿管引流支架，目的在於改善因惡性腫瘤所導 致的輸尿管阻塞，以避免腎衰竭及改善癌症病患的存活率，進而提高其生 活品質。 【先前技術】 惡性腫瘤長期以來位居國人十大死因之首，且發生率仍在逐年升高當 中。輸屎管阻塞是惡性腫瘤病程中常見的併發症，可能導因於腫瘤的直接 侵犯/壓迫或淋巴結轉移。輸尿管阻塞會造成病患的腎衰竭，間接導致病 况惡化甚至壯。輸尿f支架（ure1;eral stent)最初如在輸尿管破損或 斷裂的病患，其基本功能為維持輸尿管徑的通暢以及幫助管壁癒合。破損 的輸尿管需要尿液流動，以刺激肌肉生長，但尿液會抑制内皮增生，且漏 至後腹腔之尿液會導致輸尿管周圍纖維化。有鑑於此，安置輸尿管支架於 輸尿官不但可以維持管腔暢通，且幫助内皮細胞癒合，還可以暫時性的引 叫3478 流尿液’使之不由破洞外漏。1%4年货啊便證實細支架即可幫助輪尿 管瘡合。近年來也廣泛的應用於輪尿管阻塞的情況。其原始的設計為以榜 胱鏡自尿道逆行性置放，上端在腎盂，下端則順著驗〇導尿管連出體 和但这種管子容㈣激尿道造成病人的不適^觀年，設計出 下端留置在膀助的完全内置型核，其管身有凸出的雜續止管子往 上移行㈤咖㈣。但該支架無法使用在輸尿管接合(咖伽。初或有 破損的航，辟子的Μ訪齡妙口獻。現今輸料於臨床問題 包括··⑴_造成輸尿管高度财，支架與輸尿管之财有多於的空隙 供尿液引流，絲支架内部空間不心巧流；⑵尿液㈣流另一個重要 的機制是輸鍋卿㈣stalsis)，嗎騎失去此功 能；⑻雜腫_組_由支架的測洞(他㈣侵人核内部；上 逑問題不僅造麟人對於m與謂觸層_大的影響，亦降低癌 症病患之存活率。 【新型内容】AU^^478 IV. Designated representative map: (1) The representative representative of the case is: (1). (2) Simple description of the symbol of the representative figure: Main body bracket 1 Upper loop end 2 Lower loop end 3 Second strand bracket 4 Upper end hole 5 Lower end hole 6 Side hole 7 V. New description: [New technical field This case is a double-strand ureteral drainage stent, which aims to improve ureteral obstruction caused by malignant tumors, to avoid renal failure and improve the survival rate of cancer patients, thereby improving their quality of life. [Prior Art] Malignant tumors have long been among the top ten causes of death among Chinese people, and the incidence is still rising year by year. Obstruction of the fistula is a common complication in the course of malignancy and may result from direct invasion/compression or lymph node metastasis of the tumor. Obstruction of the ureter can cause kidney failure in the patient, which indirectly leads to worsening or even worsening of the condition. The urethral stent (ure1; eral stent) is initially used in patients with broken or broken ureters. Its basic function is to maintain the patency of the ureter and help the wall to heal. A broken ureter requires urine flow to stimulate muscle growth, but urine can inhibit endothelial proliferation, and leakage of urine into the posterior abdominal cavity can cause fibrosis around the ureter. In view of this, placement of the ureteral stent in the ureter can not only maintain the lumen of the lumen, but also help the endothelial cells to heal, and can also temporarily introduce 3478 urine to make it leak out. 1% 4 years of goods, it is confirmed that the thin stent can help the urethral tube. In recent years, it has also been widely used in the case of urethral obstruction. The original design is retrograde placement from the urethra by the cystoscope, the upper end is in the renal pelvis, and the lower end is followed by the urinary catheter continuation and the tube capacity (4) the urinary tract causes the patient's discomfort. The lower end is left in the fully built-in type core of the arm, and the tube body has a protruding and continuous tube to move upward (5) coffee (4). However, the stent can not be used in the ureteral junction (Caga gamma. The initial or damaged voyage, the 子 Μ Μ 妙 妙 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 There are more gaps for urine drainage, the internal space of the silk stent is not dexterous; (2) Another important mechanism for the flow of urine (four) is the potty (four) stalsis), the ride loses this function; (8) the swollen _ group _ by the bracket The hole (he (4) invades the inside of the nucleus; the problem of the scorpion is not only the influence of the arsenal on the m and the stalk, but also reduces the survival rate of cancer patients. [New content]
期能克服 且該第二 有鑑於此，本創作提供一種新構造的雙股輸尿管引流支架 現今輪尿管支架之缺失β 卞 本創作之目的在於提供—種雙股輸尿料流支架其包含： 本體支架，·其中該上端點以及下端點分別設有迴圈蠕； 一第-股支架；其中上端點以及下端點分別設有至少—個端孔 股支架之長度至少應短於本體支架之長度； 而 其中4第二股支架黏合於該本體支架。 根據本創作之-實施例，其中該本體支架上端點 之迴圈端 (稱上迴圈 3 M413478 端）與下端點之迴圈端（稱下迴圈端）在不同側。 根據本創作’該雙股輸尿管引流支架的第二股支架長度應短於該本體 支架，係平行黏合於本體支架，可依一般習用技術藉由熔接接合加工技術 黏合。該第二股支架的目的在於增加輸尿管與支架之縫隙，以改良引流功 月匕’亦不增加患者因膀胱刺激產生之不適感。 根據本創作，該雙股輸尿管引流支架的本體支架之表面係採無側孔設 計，以減低因腫瘤入侵本體支架造成感染與堵塞機會；其雙股輸尿管引流 支架之長度視病人體型而定，例如一般可介於2〇cm〜30cm。其該本體支架 之表面可設有深度量測標記（深度標記），以清楚獲知深入人體内之深度（例 如以公分為單位）。 本創作之本體支架，兩端分別設計有一迴圈端。依病人情況，上迴圈 端置放於病人之腎盂，下迴圈端置放於病人之膀胱。藉由置放於腎盂之上 迴圈端與置放於膀胱之下迴圈端，將本體支架順利固定於輸尿管，形成引 流功效並防止位移，同時改善以膀胱鏡置換進行順行性或逆行性輸尿管支 架置放之方便性。根據本創作，迴圈端設有規則間距或不規則間距之一個 以上的側孔。根據本創作之一實施例，本創作雙股輸尿管引流支架之迴圈 端設有規則間距。 本創作之第二股支架表面亦採無側孔設計且上下端亦無迴圈端，以減 低因腫瘤人侵造成感_堵塞賴會。而其上、下端分別設有至少一個端 孔’目的在於因本體支架及第二股支架採無側孔設計，必須改善尿液引流 之功能’以加強雙股輸尿管引流支架絲引流之功能。 根據本創作，任何適用於製作人體器官或血管支架之材質具一定程 M413478 度柔軟性者，均適合用於製備本創作雙股輸尿管引流支架，包括例如一般 常用的聚合物(co-polys)，或記憶金屬（例如錄一鈦合金> 其中以具高 強度與勒性以及-定程度之錄性的聚合物材f為佳，可助於雜尿管引 流支架順進於輸尿管，以餘病患之獨。此外，㈣於現今多以金 屬材質之輸尿管支架’價格較為低廉，可有效減輕絲之經濟負擔。 為便利順行性或逆行性置放本創作雙股輪尿管引流支架於輸尿管中， 例如’可於該雙股輸尿管引流支架營 又木ig身塗佈—層親水性物質In the light of this and the second, in view of this, the present invention provides a newly constructed double-strand ureteral drainage stent. The current urethral stent is missing. The purpose of the creation is to provide a double-strand urinary flow stent comprising: The body bracket, wherein the upper end point and the lower end point respectively have a loop creep; a first-strand bracket; wherein the upper end point and the lower end point are respectively provided with at least one end hole strand bracket length of at least shorter than the length of the body bracket And 4 of the second strands of the bracket are bonded to the body bracket. According to the present invention, the loop end of the end of the body bracket (referred to as the upper loop 3 M413478 end) and the loop end of the lower end (referred to the lower loop end) are on different sides. According to the present invention, the second stent of the double-tube ureteral drainage stent should be shorter than the body stent and adhered to the body stent in parallel, and can be bonded by a fusion bonding technique according to a conventional technique. The purpose of the second stent is to increase the gap between the ureter and the stent to improve the drainage function and not to increase the patient's discomfort due to bladder irritation. According to the present invention, the surface of the body stent of the double-tube ureteral drainage stent adopts no side hole design to reduce the chance of infection and blockage caused by tumor invasion of the body stent; the length of the double-tube ureteral drainage stent depends on the patient's body shape, for example, Generally it can be between 2〇cm~30cm. The surface of the body support may be provided with a depth measurement mark (depth mark) to clearly understand the depth (for example, in centimeters) deep into the human body. The body bracket of the present invention is designed with a loop end at each end. According to the patient's condition, the upper loop is placed on the patient's renal pelvis and the lower loop is placed on the patient's bladder. The stent is smoothly fixed to the ureter by placing it on the loop end of the renal pelvis and placed under the bladder, forming a drainage effect and preventing displacement, and improving antegrade or retrograde with cystoscopy. The convenience of placement of the ureteral stent. According to the present creation, the loop end is provided with one or more side holes of a regular pitch or an irregular pitch. According to one embodiment of the present creation, the loop end of the double-tube ureteral drainage stent of the present invention is provided with a regular spacing. The second stent surface of this creation also has no side hole design and no loop end at the upper and lower ends, so as to reduce the feeling caused by tumor invasion. The upper and lower ends are respectively provided with at least one end hole. The purpose is to improve the function of the urine drainage because the body support and the second support have no side hole design to enhance the function of the double-strand ureteral drainage wire drainage. According to this creation, any material suitable for making human organs or vascular stents with a certain degree of M413478 softness is suitable for the preparation of the double-tube ureteral drainage stent, including, for example, commonly used polymers (co-polys). Or memory metal (for example, recording a titanium alloy), which is preferably a polymer material f with high strength and linearity, and a degree of visibility, which can help the drainage catheter of the urinary catheter to advance into the ureter. In addition, (4) in today's many ureteral stents made of metal material, the price is relatively low, which can effectively reduce the economic burden of silk. To facilitate the antegrade or retrograde placement of the double-tube ureteral drainage stent in the ureter In the middle, for example, 'the double-sided ureteral drainage stent camp and the wooden ig body coating-layer of hydrophilic substances
(hydrophilwting)，使該輸尿管引流支架之·度提高，以有助於通 過極緊密而狹窄、堅硬的纖維化組織或是軸，再配合辅助置放工具，無 論是順行性或逆行性，可較制地將雙赌尿管服核置放於輸尿管中。 本創作可應用於各種原因所造成的輸尿管阻塞，包括腫瘤、發炎、後 腹腔纖維化(retroperitoneal flbr〇s；is)、術後結症而狹窄、子宮内膜異 位（endometriosis)等。 在下列的描述帽細謂本創作的—或多項具體實施例。從下列圖式 和實施例的制，以及從帽專概圍將可更觸鑛的特色及優點。 【實施方式】 «己合下狀圖式制本創作之結構，及其連、纟綱係，収實施態樣，以 利於瞭解梢叙内容，為賴魅稀贿_式麻的實施態樣。 請參晒i所示，其為-雙股輸尿利流支架之構造示賴，該雙股 輸尿管狀支架之整職造包括—本體妓丨及―^股支架心其中該本 體支架1係採用無側孔之設計，目的在於降低因腫瘤入侵本體支架造成感 染與堵塞機會所造成病患的腎衰竭。而在本體支架丨之上、下端，其上端 5 M413478 點設有上迴圈端2以及下端點設有下迴圈端3 ;其中上迴圈端係置放於患者 之腎盂，下迴圈端係置放於患者之膀胱，透過上、下迴圈端之設計可順利 固定雙股輸尿管引流支架於輸尿管，形成引流功效及防止位移；並提供醫 生便於進行順行性或逆行性輸尿管支架置放手術。在上迴圈端2及下迴圈 端3有規則間距之一個以上的側孔7 ’目的在於提供尿液引流。該第二股支 架4係採無雙J端設計，且於第二股支架4之上端點設有一上端孔5，以及 第二股支架4之下端點設有一下端孔6,其目的在於增加輸尿管與支架之缝 . 隙以及改善因本體支架1採無側孔設計之尿液引流之功能，亦不增加患者 _ 因膀胱刺激產生之不適感。該第二股支架4長度至少應短於本體支架j，且 平行黏合於本體支架1上。 實施本創作雙股輸尿管引流支架於輸尿管中橫切面實施的示意圖如圖 2所示’其為將本創作雙股輸尿管引流置於輸尿管中，該本體支架1及第二 股支架4撐起輸尿管10造成可供尿液引流的空間，利用支架管腔内部以及 支架與輸尿管間之間隙20引流屎液。 本創作雙股輸尿管引流支架至少提供下六優點及改良之處： 鲁 (1) 因有第一股支架之設計，增加輸尿管與支架之缝隙，以改良引流功能， 亦不增加患者因膀胱刺激產生之不適感； (2) 因該雙股輸尿管引流支架的本體支架及第二股支架之表面係採無侧孔 設計’可減低因腫瘤入侵本體支架造成感染與堵塞機會。 (3) 本體支架兩端分別設計有一迴圈端，藉由置放於腎盂與膀胱遂可將本 體支架順利固定於輸尿管，形成引流功效並防止位移，同時改善以膀胱 鏡置換進行順行性或逆行性輸尿管支架置放手術。 6(hydrophilwting), the degree of ureteral drainage stent is increased to facilitate the passage of extremely tight, narrow, rigid fibrotic tissue or shaft, together with an auxiliary placement tool, whether antegrade or retrograde The double gamma catheter is placed in the ureter. This creation can be applied to ureteral obstruction caused by various reasons, including tumor, inflammation, retroperitoneal flbrss (is), postoperative syndrome and stenosis, endometriosis and so on. In the following description, the present invention is described in detail as one or more specific embodiments. Features and advantages from the following figures and examples, as well as from the caps, will be more accessible. [Embodiment] The structure of the original creation of the original pattern, and the structure of the company, and the series, in order to facilitate the understanding of the content of the story, is the implementation of the Lama. Please refer to the sun as shown in the figure, which is the structure of the double-strand urinary tract stent. The whole job of the double-strand urinary tubular stent includes: the body 妓丨 and the ― 股 bracket heart, wherein the body bracket 1 is used The design of the side hole is not intended to reduce the renal failure of the patient caused by the infection and blockage caused by the tumor invading the body stent. On the upper and lower ends of the body bracket ,, the upper end 5 M413478 points are provided with the upper loop end 2 and the lower end is provided with the lower loop end 3; wherein the upper loop end is placed on the patient's renal pelvis, the lower loop end The system is placed in the bladder of the patient, and the design of the upper and lower loops can smoothly fix the double ureteral drainage stent to the ureter to form drainage effect and prevent displacement; and provide doctors to facilitate antegrade or retrograde ureteral stent placement. surgery. One or more side holes 7' having a regular spacing at the upper loop end 2 and the lower loop end 3 are intended to provide urine drainage. The second stent 4 adopts a double-end J-end design, and has an upper end hole 5 at an upper end of the second strand bracket 4, and a lower end hole 6 at a lower end of the second strand bracket 4, the purpose of which is to increase the ureter and The gap between the stent and the function of improving the urine drainage caused by the side hole design of the body stent 1 does not increase the patient's discomfort due to bladder stimulation. The second support 4 is at least shorter than the body support j and is bonded to the body support 1 in parallel. The schematic diagram of the implementation of the double-tube ureteral drainage stent in the transverse section of the ureter is shown in Fig. 2, which is to place the double-tube ureter drainage in the ureter, and the body stent 1 and the second stent 4 support the ureter 10 The space for draining urine is used to drain the sputum by using the inside of the stent lumen and the gap 20 between the stent and the ureter. The creation of the double-strand ureteral drainage stent provides at least the following six advantages and improvements: Lu (1) because of the design of the first stent, increase the gap between the ureter and the stent to improve the drainage function, and does not increase the patient's bladder stimulation Discomfort; (2) Because the surface of the double-tube ureteral drainage stent and the surface of the second stent are not designed with side holes, the chance of infection and blockage caused by tumor invasion of the body stent can be reduced. (3) The two ends of the body bracket are respectively designed with a loop end. The stent can be smoothly fixed to the ureter by placing it on the renal pelvis and the bladder, forming drainage effect and preventing displacement, and improving antegrade or cystoplasty replacement. Retrograde ureteral stent placement. 6