45^ 45^ 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明（1 ) 本發明係關於引入病人氣管內之插管，其內含有中心 內腔供通氣或呼吸之用，並包括至少一個位於插管外之膨 脹式環套以供密封插管外圍與氣管管壁之間隙。 此插管可作爲氣管切開術插管，其係以經氣管切口或 係經口或鼻引入之氣管內插管來爲麻醉中的病人或昏迷中 之病人呼吸。 此插管常用於加護治療。特定的問題包括感染肺炎， 尤其是在長期使用插管呼吸下其較之一般加護病房之病人 更易發生感染，顯然係與此類呼吸方式有關。 如上文中所提及，此插管係用於引入病人氣管內，其 放置方式係將插管外圍具有膨脹式環套之區域置於氣管部 位，通常位於喉頭正下方。然後經由獨立的軟管或管線（ 一 - 其係與插管管壁合倂）使環套充氣膨脹，理想之環套壓力 爲數十個毫巴。環套膨脹之結果會使其外壁貼緊氣管之內 表面。但是，此裝置會阻礙了沿著氣管管壁規律運送的分 泌物（由下往上），且此外來物可強烈激發分泌物形成。 此分泌物之形成及凝集處，例如環套上插管周圍之區域， 能提供許多供細菌及其他病源生長之絕佳溫度條件、水分 及營養素。雖然有人認爲由於環套能緊貼著氣管管壁防止 分泌物（其內病源充斥，並集中在面朝外之環套末端）繼 續穿透到其下游之支氣管內而可預防肺部感染’不過肺炎 仍頻頻發生，歸究其原因即在於使用此種插管。 尤其是經過硏究後結果顯示，此環套--雖然具有彈 性及活動性，雖然可在相當高壓力（可達數十毫巴）下膨 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） 11--------if、------!—訂 if------轉 (請先閱讀背面之注意事項再填寫本頁) 4 B7_ 五、發明說明（2 ) (請先閲讀背面之注意事項再填寫本頁> 脹——卻未必都能緊貼著氣管管壁上任何部位且/或易於 產生皺摺1此類皴摺會形成一條供分泌物及致病菌通過的 甬道，導致嚴重的肺部感染。 爲了避免此種皺摺，有人提議使用超薄管壁及/或特 別是彈性環套，但此類環套之問題是其相當易碎且非常容 易受損，進而失去其密封性及留滞功能。 此外亦可增加此類環套之壓力，不過如此一來在某些 情況下會造成氣管負載過度，承受高壓之黏膜表面細胞會 遭到破壞1甚而造成壞死，包括環狀軟骨。 環視目前之技藝，構成本發明目的之基礎是在硏究出 一種具有膨脹式環套之適用的插管，該插管能排除密封不 當的問題且並不脆弱，同時也不需要使用高膨脹壓力。 此目的係以使用環套外圍表面上可膨脹的及/或可（ 有限度）流動的塗層達成。 經濟部智慧財產局員工消費合作社印*'Λ 若環套在病人氣管內充氣或脹大後能使此塗層發脹， 則此發脹材料便能將任何尙存之空隙予以封閉。特定言之 ，若此塗層材料係位在任何皺摺部位且當其膨賬之後，此 類皺摺即不再具有供物質通過環套的甬道=即使此塗層無 法膨脹，但至少能有限度的流動下則仍可造成相似的效果 *因爲塗層材料會在使用機械力的部位（例如扭結上或與 形成皺摺或之類部位互相緊壓之外表面）移位並分配到其 他空檔區域。同時在此情況下，其形成的駿摺會充滿著塗 層材料，因而可避免在此類環套縱向形成任何運送甬道。 無庸置疑的，塗層材料與環套材料必須黏著性良好， 本紙張尺度適用中國國家標準（CNS)A4規格（21CU297公釐) ~~ 經濟部智慧財產局員工消费合作社印製 A7 ___B7__ 五、發明說明（3 ) 以免因小小的壓力差異（來自氣管中環套兩端）使其由密 封面移至環套的正面區域而喪失密封功能。 基於相同理由，材料之流動性亦不可太好，且在使用 時黏性宜類似於（例如）凝膠或乳膏，或其它更黏的油。 在體溫（3 7 °C )下材料之黏性至少1 〇 p a . 5 ( Pascal 秒），較佳者大於4〇Pa.s。 塗層材料可藉由（例如）擴散或引發部份塗層材料擴 散進入環套壁內或由其與環套材料形成化學組合而使塗層 材料與環套材料呈一體狀。此外’亦可視需要選擇地在環 套材料上施用一層薄結合層，進而與環套材料緊密黏結， 並同時作爲密封層的一層良好膠黏底質。環套材料（具有 彈性但足以承受撕裂並且不具流動.性）轉變成爲狀似液體 之塗層材料後可改善塗層材料與環套材料之間的黏著力。 塗層材料亦可爲貯藏在室溫下既不會發脹亦不具流動性（ 大小介於1至l〇Pa . s)的物質。此種發脹性或流動 性可由（例如）水分及熱、尤其是以任何與氣管內情況相 關之水分及溫度狀況引發，不過同樣地，其亦可由試劑、 催化劑，、X _射線、u v輻射線、光線或甚至超音波照射 或其他機械處理引發。另一方面，使用試劑、催化劑及以 輻射線照射或以上述機械型態處理亦可使塗層與細胞膜底 質材料達到良好的附著效果。 本發明的特佳具體實施例中，塗層材料能在水中發脹 ，發脹的塗層材料亦可有限度的流動。較佳之環套壁係由 聚合物組成，且須儘可能薄，即環套壁厚度以不超出 本紙張尺度適用t國國家標準（CNS)A4規格（210 x 297公a ) „ _ K _ (請先閲讀背面之;i意事項再填寫本頁) 訂---------% > 煙濟部智慧財產局_工消費合作社印*·1^ A7 B7______ 五、發明說明（4 ) 5 Ο ΟμίΏ較佳’更佳者不超出2 Ο Ομη〗及，尤佳者不超 出 3 0 μΐΏ。 許多物質可被視爲塗層材料，尤其是黏液物質及黏液 形成劑或凝膠形成劑等，以及泡沫劑。特定言之，此類物 質可爲非電離性黏液物質，例如：蘭莖粉聯聚甘露糖、關 華豆膠、角豆素、源自小麥、玉米等之澱粉、黃原膠、聚 乙酿殼多醣、藤原蛋白、carmellose、hypromellose、 macrogots等；同樣的，亦可考慮使用具陰離子活性的黏液 形成劑，例如：阿拉伯膠、特拉加康斯膠樹膠、刺梧桐膠 、果膠、藻膠酸、紅藻膠、瓊脂、瓊脂糖，特別是可再水 化的瓊脂糖凝膠，B型明膠及羧甲基纖維素。具陽離子活 性的黏液物質（A型明膠）亦可作爲塗層材料。此外，亦 可考慮源自藥物之黏液物質，例如：木槿根、semen ]ini、 semen psy 1!i、semen foenugreci 、 semen isphaghulae、源自 plantago ovata之種子外皮、無機凝膠形成劑以及源自合成 凝膠形成劑之水膨脹式凝膠、其衍生物及所有上述物質的 組合。此外，尙有聚甲基丙烯酸及其鹽類、聚丙烯酸及其 鹽類、聚二甲基矽氧烷及彼與甘油、蠟、脂肪或石油膠以 及乳化劑之混合物。另一群適用於本發明的重要塗覆劑係 由聚乙二醇組成。 此外，塗層可由輔助物質組成，例如：膠微粒膠體（ 具兩性、非電離性、陰離子性或陽離子性者）及助溶劑（ 具電離性或非電離性）。亦可將不同塗層交互層疊使用， 其中各塗層本身並不具有所欲求之密封性，但雙塗層在以 本纸張尺度適用中國园家標準（CNS)A4規格（210 X 297公釐） ----------- -------訂·----*綠 (請先閱讀背面之注意事項再填寫本頁) 458789 A7 _;__B7 _ 五、發明說明（5 ) 機械方式混合或反應後即形成具有所欲求之性質的塗層。 原則上’所有具水膨脹性的凝膠.天然的或合成的物 質、聚合物或波之組合均可列入考慮。尤其適用的是觸變 性物質，即其流動行爲在負載後會改變之材料，即在較高 負載下及當其負載剪力提高時其流動性會優於較低負載。 上述之泡沫劑可改善塗層之密封性。 有關此類上述的泡沬劑，値得一提的是在環套及氣管 壁間塗層上所形成小氣泡對於運送任何液體會造成某種阻 礙。此係與其毛細引力或表面張力（來自泡沫氣泡表面） 較大有關，由於此類黏著力會使液體分泌物〔s i c〕與 泡沫適當的結合在一起，因而阻擾〔s丨c〕了分泌物進 —步流動。 經濟部智慧財產局員工消費合作社印製 (請先閱讀背面之注咅？事項再填寫本頁) 特別適用於本發明塗層的是聚合泡沫*因此，泡沫之 材料最好儘量與膜壁本身的材料相同，或爲非常相似的材 料。意即一方面可由泡沫材料組成附著性非常良好之塗層 ，另一方面（如上述）此泡沫塗層可防止（尤爲有效的方 法）任何分泌物在膜壁及氣管管壁間（就如同膜皺摺形成 之甬道.）之流動。總之，在此一考量下*開孔泡沫或泡沫 塗層都極爲適用》泡沫塗層的另一優點係其能被強烈的壓 縮，因而極適於充塡在皺摺上形成之孔洞；雖泡沫在某些 皴摺部位被強烈壓縮及壓緊，不過彼在其它橫切面相當大 之部位（通常在各皺摺底部）仍可擴張而完整的充塡所形 成之孔洞。 除了具水膨脹性的凝膠之外，亦可使用具有適當疏水 本紙張又度適用中國國家標準（CNS)A4規格（210 * 297公釐） A7 458789 B7_ 五、發明說明（6 ) (請先閱讀背面之注意事項再填寫本頁) 性、塗抹性、具適當黏度的製劑，例如：烴凝膠，例如脂 凝膠，或於溶液、懸浮液、乳狀液形態的矽酮凝膠，或懸 浮液-乳狀液形式的脂凝膠。硬脂酸酯油膏或乳膏亦可爲 適用的塗層。若塗層在室溫下呈固體狀、僅略具流動性、 而在體溫下能熔化或軟化則較佳。 環套在充氣膨脹時應儘可能無皺摺並緊附在氣管管壁 上，在此考量下以薄壁的環套尤佳。其使用之壓力應小於 1 b a r ° 亦可考慮使用其玻璃態轉變溫度大於3 0 °C之聚合材 料作爲塗層材料》 本發明進一步的較佳具體實施例說明由彈性材料組成 的環套，在非膨脹的狀況下其大小係緊密的套在插管外壁 而不會產生皺摺，而在膨脹壓力介於2 0及3 0毫巴下膨 脹時，其直徑（與插管軸線垂直處之長度）至少較插管外 徑或非膨脹狀況下之環套直徑擴大5 0%，在膨脹狀況下 其直徑亦可擴大1 0 0%。 經濟部智慧財產局員工消費合作社印5找 若使用適當的彈性材料（在數十毫巴之較低膨脹壓力 下環套半徑可擴大50%或以上），則可確保環套在膨脹 狀況下爲無皺摺狀況，因爲在未膨脹時環套實質上已幾無 皺摺。以此方式亦可避免產生上述之甬道（因發生皺摺而 產生*會使分泌物從環套上方區域穿過進入環套下方之區 域）。在特殊狀況下，此一具體實施例可完全不須在環套 外表面上使用其它種塗覆劑即可緊密的密封住。 由聚合材料組成之環套*及由凝膠形成劑與非共價聯 各紙張尺度適用中國圉家標準（CNS)A4規格（210 X 297公釐） -9- Α7 Β7 五、發明說明（7) 結聚合鏈所形成之具水膨脹性的凝膠（同極半價（ homeopolar half-valency)凝膠、次價（secondary-valency) 凝膠或透過庫侖引力交聯之物質等）組成之塗層組合已經 証實極爲適用。 內含無水、具塗抹性製劑的塗層能先吸水再發脹 > 其 係由天然或合成物質或聚合物及/或此類物質之組合組成 ，經証實其亦極爲適用。另一適當的塗層乃由疏水性的、 具塗抹性製劑組成，其黏度爲2 P a . s及更高（例如， 烴凝膠，例如：脂凝膠，或溶液、懸浮液、乳狀液形式的 矽酮凝膠或懸浮液-乳狀液脂凝膠及硬脂酸酯油膏或乳膏 形式）。 一般而言，可考慮使用之大多數塗層至少可分成以下 各組，應考慮其是否能永久存放在氣管內： a )塗層之黏度（在引入氣管內時及於其內之溫度及 /或水分狀況下）至少爲2 P a . s ，較佳者至少1 〇 Pa . s ，例如：4〇Pa · s或更多， b )塗層材料與環套材料之黏著力相當高，此黏著力 之高甚而在（例如）2 0 0寬密封溝槽之兩端壓差達（例 如）30毫巴時塗層材料亦不會從溝槽流出， c )可高度膨脹的材料（體積至少增加5倍）， d )此材料可施用於泡沬塗層（最小厚度爲例如 2 0 〇μ)內，並可在數十毫巴低表面壓力下至少壓縮3倍 〇 經由以下較佳具體實施例的描述及相關圖示說明可進 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） --------------』η-κ--- (請先閱璜背面之注意事項再填寫本頁) 訂： 經濟部智慧財產局員工消費合作社印*'1衣 -10- A7 B7 五、發明說明（8 ) 一步的閲明本發明的優點、特色及可能之用途。圖示說明 爲： 圖1 ’依據本發明具有可膨脹式環套之插管的簡圖， 圖2以圖1中沿著Π - Π畫出之點虛線定出的切平面 橫切插管軸線之管線切面圖及 圖3圖2中以m〔 s i c〕代表之圓圈的放大詳圖。 主要元件對照表 1 插管 1 導管 2 環套 3 皺摺 4 中心內腔 5 甬道 6 塗層 於圖1中，可看出氣管內或氣管切開術插管1實質上 含有軟管或導管1 ，其外圍有一個中心貫穿的膨脹式環套 2。環套2可視需要以熱永久密封在軟管或導管1上，但 亦可以黏著方式與插管1結合或製成一體。此處在插管1 管壁上無法目識之甬道則在環套2部位上插管1之外壁上 有開孔，使得環套2可經由此插管1管壁上之甬道出口充 氣膨脹，但亦可視需要排氣。呼吸或通氣便是經由此插管 1的中心內腔4進行。 本紙張尺度適用中國酉家標準（CNSM4規格（210 X 297公t) (請先閱讀背面之注意事項再填寫本頁) 訂---------铲！ 經濟部智莛財產局員工消f合作社印製 -n I n n tt n ϋ I il· ϋ ϋ n - -11 - 經濟部智慧財產局員工消費合作社印製 ο 9 Α7 __Β7 五、發明說明（9 ) 圖1至3顯示本發明主題之簡圖，同時三圖中可目識 的皺摺3亦僅以簡圖繪出，當然，皺摺無需以固定的曲線 形狀遍佈在環套縱軸範圍。 圖2中，插管顯現在環套2區域°可看出插管1管壁 (斜線區）、中心內腔4及插管1管壁中的兩條甬道5 1 其可用以膨脹、排氣或亦可用以供應或萃取抽取液或分泌 物，視此類甬道5之下方排放端而定，在插管上端可排放 到適當的萃取液抽取或沖洗裝置。 甬道5亦可在環套2區域插管1外管壁上排放。 在圖中顯示膨脹的環套可以各種程度套在氣管管壁上 ，其上有數條縱走的皺摺3 此類皺摺3顯然不須互相平 行，同時皺摺也無須橫跨整個環套2的長度。不過，這些 簡圖意在展示皺摺3可爲任何種類，且由於此類皺摺3的 存在而形成甬道，即使其橫切面非常小，分泌物仍可從環 套2上方區域藉以流入環套_2下方區域，使得病源（在分 泌物中尋求極有利之生長之條件|尤其是在環套上方）滲 透到下呼吸道而造成肺炎症。 依據本發明此係以環套2外表面上之塗層6防止，可 明顯的從圖3之放大圖中看出。如上述，圖3展示在圖2 中圈起的部位並再予以放大，此處仍然僅以簡圖代表，特 別是塗覆層6之厚度對照於環套2之壁厚（僅以線條代表 )可能過於誇張，不過，並不排除各個對應的厚度比例。 圖3之放大區域中有兩個皺摺31圖3左方之皺摺3 略淺，而圖3右方則有較深的皺摺3。另外以斜線代表者 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） (請先閱讀背面之注意事項再填寫本頁) --I I I I 訂---------^ i -12- 經濟部智慧財產局員工消费合作社印製45 ^ 45 ^ Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (1) The invention relates to an intubation tube introduced into a patient's trachea, which contains a central lumen for ventilation or breathing, and includes At least one inflatable ring outside the cannula is used to seal the gap between the periphery of the cannula and the wall of the trachea. This cannula can be used as a tracheostomy tube, which uses an endotracheal tube introduced through the tracheostomy or through the mouth or nose to breathe a patient under anaesthesia or a patient in a coma. This intubation is often used for intensive care. Specific problems include infection with pneumonia, especially when chronically intubated, which is more susceptible to infection than patients in general intensive care units, is clearly related to this type of breathing. As mentioned above, this cannula is used to introduce into the trachea of a patient. It is placed by placing the area with an expandable collar around the intubation at the trachea, usually just below the throat. The cuff is then inflated through a separate hose or line (one-which fits into the wall of the intubation tube). The ideal cuff pressure is tens of mbar. As a result of the expansion of the cuff, the outer wall of the cuff closes against the inner surface of the trachea. However, this device obstructs secretions (bottom-to-up) that are regularly transported along the tracheal tube wall, and in addition the secretions can strongly stimulate secretion formation. The formation and agglutination of this secretion, such as the area around the cannula on the ring, can provide many excellent temperature conditions, moisture and nutrients for the growth of bacteria and other pathogens. Although some people think that because the cuff can be close to the tracheal tube wall to prevent secretions (the internal source is flooded and concentrated at the end of the cuff that faces outward) and continue to penetrate into the bronchus downstream, it can prevent lung infections' However, pneumonia still occurs frequently, and the reason is due to the use of such intubation. In particular, after research, the results show that although this loop is flexible and mobile, it can be expanded under relatively high pressure (up to tens of mbar). The paper size is applicable to the Chinese National Standard (CNS) A4 specification ( 210 X 297 mm) 11 -------- if, ------! — Order if ------ Go (Please read the notes on the back before filling this page) 4 B7_ Five 、 Explanation (2) (Please read the precautions on the back before filling in this page> Bloat-but not necessarily close to any part of the tracheal tube wall and / or prone to wrinkles A sacral passage through which secretions and pathogenic bacteria pass, causing severe lung infections. To avoid such wrinkles, it has been proposed to use ultra-thin tube walls and / or elastic sleeves, but the problem with such sleeves is that It is quite fragile and very easy to be damaged, thus losing its sealing and retention function. In addition, it can increase the pressure of such sleeves, but in this case, it may cause excessive tracheal load and high pressure mucosa Surface cells can be damaged1 and even cause necrosis, including circular cartilage. The foundation of the purpose of the present invention is to find a suitable cannula with an expanding collar, which can eliminate the problem of improper sealing and is not fragile, and does not need to use high expansion pressure. This is achieved by using an expandable and / or (limited) flow coating on the peripheral surface of the cuff. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs * 'Λ If the cuff is inflated or inflated in the patient's trachea, it can The coating is swelled so that the swollen material can seal any entrapped voids. In particular, if the coating material is located in any wrinkled area and when it swells, such wrinkles That is, there is no longer a channel for the substance to pass through the ring = even if the coating cannot expand, at least a limited amount of flow can still cause a similar effect * because the coating material will be used in areas where mechanical force is used (such as kink Or pressed against the outer surface with the formation of wrinkles or the like) and shifted to other neutral areas. At the same time, the formed folds will be filled with coating material, so it can be avoided in such cases ring Form any vertical conveyance. Undoubtedly, the coating material and the ring material must have good adhesion. This paper size applies to the Chinese National Standard (CNS) A4 specification (21CU297 mm) ~~ Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs System A7 ___B7__ 5. Description of the invention (3) To avoid the loss of sealing function due to small pressure difference (from both ends of the ring in the trachea) from the sealing surface to the front area of the ring. For the same reason, the fluidity of the material It should not be too good, and the viscosity should be similar to, for example, gel or cream, or other more viscous oil. The viscosity of the material should be at least 10 MPa at body temperature (37 ° C). 5 ( Pascal seconds), preferably greater than 40 Pa.s. The coating material can be applied by, for example, diffusing or inducing the diffusion of a portion of the coating material into the wall of the collar or by forming a chemical combination with the collar material. The layer material and the ring material are integrated. In addition, you can also optionally apply a thin bonding layer on the ring material to further tightly bond with the ring material, and at the same time serve as a good adhesive substrate for the sealing layer. The ring material (which is elastic but sufficient to withstand tearing and does not have fluidity) is transformed into a liquid-like coating material to improve the adhesion between the coating material and the ring material. The coating material can also be a substance that does not swell or flow at room temperature (the size ranges from 1 to 10 Pa · s). This swelling or fluidity can be caused by, for example, moisture and heat, especially any moisture and temperature conditions related to the situation in the trachea, but it can also be caused by reagents, catalysts, X-rays, UV radiation Caused by radiation, light, or even ultrasound or other mechanical processing. On the other hand, the use of reagents, catalysts, and irradiation with radiation or the above-mentioned mechanical treatment can also achieve a good adhesion effect between the coating and the cell membrane substrate material. In a particularly preferred embodiment of the present invention, the coating material can swell in water, and the swollen coating material can also flow to a limited extent. The preferred ring sleeve wall is made of polymer and must be as thin as possible, that is, the thickness of the ring sleeve wall does not exceed the size of this paper. The national standard (CNS) A4 specification (210 x 297 male a) is used. _ _ K _ ( (Please read the back of the page; I will fill out this page before filling in this page) Order ---------% > Intellectual Property Bureau of the Ministry of tobacco industry_Industrial and Consumer Cooperatives' Seal * · 1 ^ A7 B7______ V. Description of Invention (4 ) 5 Ο ΟμίΏ is better, the better is not more than 2 Ο Ομη〗, and the more preferably is not more than 30 μΐΏ. Many materials can be regarded as coating materials, especially mucus substances and slime forming agents or gel forming agents And foaming agents. In particular, such substances can be non-ionizing mucus substances, such as: blue stem powder-linked polymannose, guanhua bean gum, carobene, starch derived from wheat, corn, etc., yellow Gum, Polyethylene Chitosan, Fujiwara, carmellose, hypromellose, macrogots, etc. Similarly, the use of anion-active mucus-forming agents can also be considered, such as gum arabic, tragacons gum, gum gum , Pectin, alginic acid, red algae, agar, agarose, especially Rehydratable agarose gel, type B gelatin and carboxymethyl cellulose. Cationic active mucus (type A gelatin) can also be used as a coating material. In addition, drug-derived mucus , Such as: hibiscus root, semen] ini, semen psy 1! I, semen foenugreci, semen isphaghulae, seed skins derived from plantago ovata, inorganic gel formers, and water-swellable gels derived from synthetic gel formers, Derivatives and combinations of all the above. In addition, there are polymethacrylic acid and its salts, polyacrylic acid and its salts, polydimethylsiloxane and glycerol, wax, fat or petroleum gum, and emulsification. Mixtures of agents. Another important coating agent suitable for the present invention is composed of polyethylene glycol. In addition, the coating can be composed of auxiliary substances, such as colloidal particles, colloids (amphoteric, non-ionizing, anionic or cationic) Or) and co-solvents (with or without ionization). Different coatings can also be used alternately. The coatings themselves do not have the desired sealing properties, but the double coatings are used in Paper size applies to Chinese Gardener's Standard (CNS) A4 specification (210 X 297 mm) ----------- ------- Order · ---- * Green (Please read first Note on the back, please fill out this page again) 458789 A7 _; __ B7 _ 5. Description of the invention (5) After mixing or reacting mechanically, a coating with the desired properties will be formed. In principle, 'all water-swellable gels Combinations of natural or synthetic substances, polymers, or waves can be considered. Especially suitable are thixotropic substances, that is, materials whose flow behavior changes after loading, that is, under higher loads and when they are loaded When the shear force is increased, its fluidity is better than lower loads. The above-mentioned foaming agent can improve the sealability of the coating. Regarding such foaming tinctures mentioned above, it is noted that the formation of small air bubbles on the coating between the cuff and the trachea wall can cause some kind of hindrance to the transportation of any liquid. This is related to its greater capillary gravity or surface tension (from the surface of the foam bubbles). Because of this type of adhesion, the liquid secretion [sic] and the foam are properly combined, thus blocking [s 丨 c] the secretion Further flow. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs (please read the note on the back? Matters before filling out this page) Particularly suitable for the coating of the present invention is polymer foam * Therefore, the material of the foam should preferably be as close to The materials are the same or very similar. This means that, on the one hand, it can be composed of a foam material with a very good adhesion, and on the other hand (as mentioned above) this foam coating can prevent (especially effective) any secretions between the membrane wall and the tracheal tube wall (like Membrane creases form the channel.) Flow. In short, under this consideration * open-cell foam or foam coating is very suitable. Another advantage of foam coating is that it can be strongly compressed, so it is very suitable for filling the holes formed on the creases; although foam It is strongly compressed and compacted in some creases, but it can still expand and complete the holes formed by the creases in other parts with large cross-sections (usually at the bottom of each crease). In addition to water-swellable gels, it is also possible to use paper with proper hydrophobicity that is also suitable for China National Standard (CNS) A4 (210 * 297 mm) A7 458789 B7_ V. Description of Invention (6) (please first Read the notes on the back and fill in this page). Preparations with good viscosity, smearability, and appropriate viscosity, such as: hydrocarbon gels, such as lipogels, or silicone gels in the form of solutions, suspensions, or emulsions, or Lipid gel in the form of a suspension-emulsion. A stearic acid ointment or cream may also be a suitable coating. It is better if the coating is solid at room temperature, only slightly fluid, and melts or softens at body temperature. The cuff should be as wrinkle-free and tightly attached to the wall of the tracheal tube as possible when inflated and expanded, and a thin-walled cuff is preferred in this regard. The use pressure should be less than 1 bar °. It is also possible to consider using a polymer material with a glass transition temperature greater than 30 ° C as a coating material. "A further preferred embodiment of the present invention illustrates a ring composed of an elastic material. In the non-inflated condition, the size is tightly sleeved on the outer wall of the cannula without wrinkling. When the expansion pressure is between 20 and 30 mbar, its diameter (the length perpendicular to the intubation axis) ) At least 50% larger than the diameter of the ferrule in the intubation or non-expanded condition, and the diameter can also be increased by 100% in the expanded condition. The Ministry of Economic Affairs ’Intellectual Property Bureau ’s Consumer Cooperatives’ Cooperative Association 5 finds that if an appropriate elastic material is used (the collar radius can be expanded by 50% or more under a low expansion pressure of tens of mbar), it can be ensured that No wrinkle, because the cuff is virtually wrinkle-free when it is not inflated. In this way, the above-mentioned path can also be avoided (caused by the occurrence of wrinkles * will cause the secretion to pass from the area above the loop into the area below the loop). Under special circumstances, this embodiment can be tightly sealed without using other coating agents on the outer surface of the collar. Rings made of polymeric materials * and gel-forming agents and non-covalent associations. Paper sizes are applicable to Chinese Standard (CNS) A4 (210 X 297 mm) -9- Α7 Β7 V. Description of the invention (7 ) A coating consisting of water-swellable gels (homeopolar half-valency gels, secondary-valency gels, or substances crosslinked by Coulomb gravity) formed by the formation of polymer chains. The combination has proven extremely useful. A coating containing an anhydrous, smearable formulation that absorbs water before it swells > consists of natural or synthetic substances or polymers and / or combinations of such substances, which have proven to be extremely useful. Another suitable coating is a hydrophobic, smearable formulation with a viscosity of 2 P a. S and higher (for example, hydrocarbon gels, such as lipogels, or solutions, suspensions, emulsions Silicone gels or suspensions in liquid form-emulsion lipid gels and stearate ointments or creams). In general, most coatings that can be considered for use can be divided into at least the following groups, and whether they can be permanently stored in the trachea should be considered: a) the viscosity of the coating (the temperature at and when introduced into the trachea and / (Or under water conditions) is at least 2 P a. S, preferably at least 10 Pa. S, for example: 40 Pa · s or more, b) the adhesion between the coating material and the ring material is quite high, this The adhesion is so high that the coating material will not flow out of the groove even when the pressure difference between the two ends of the wide sealing groove (for example) is 200 mbar, for example, 30 mbar. C) Highly expandable material (volume at least Increase by 5 times), d) this material can be applied in foam coating (minimum thickness is, for example, 200 μ), and can be compressed at least 3 times at a low surface pressure of tens of millibars. The description of the example and related illustrations can be entered into this paper. The size of the paper is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) -------------- 『η-κ --- (Please read the precautions on the back of the card before filling out this page) Order: Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs * '1-10-10-A7 B7 Explanatory note (8) Read the advantages, features and possible uses of the invention one step further. The illustration is as follows: Fig. 1 'A simplified diagram of an intubation tube with an expandable collar according to the present invention, and Fig. 2 cross the intubation axis with a tangent plane defined by a dotted line along the points Π-Π in Fig. 1 A cross-sectional view of the pipeline and an enlarged detailed view of the circle represented by m [sic] in Figs. Comparison of main components 1 Intubation 1 Catheter 2 Sleeve 3 Wrinkle 4 Central lumen 5 Sacral canal 6 Coating In Figure 1, it can be seen that the endotracheal or tracheostomy cannula 1 essentially contains a tube or catheter 1, Its periphery has a centrally extending expansion collar 2. The ferrule 2 can be permanently sealed on the hose or catheter 1 with heat as required, but it can also be combined with the cannula 1 or made in one piece in an adhesive manner. Here, the invisible channel on the tube wall of intubation 1 has an opening in the outer wall of intubation 1 at the position of the ring sleeve 2 so that the ring sleeve 2 can be inflated and expanded through the channel outlet on the tube wall of this intubation 1. However, venting may be required. Breathing or ventilation is performed through the central lumen 4 of the cannula 1. This paper size applies to China's family standards (CNSM4 specification (210 X 297 g)) (Please read the precautions on the back before filling out this page) Order --------- Shovel! Staff of the Intellectual Property Office of the Ministry of Economic Affairs Printed by the Consumer Cooperative -n I nn tt n ϋ I il · ϋ ϋ n--11-Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 9 Α7 __Β7 V. Description of the invention (9) Figures 1 to 3 show the invention The schematic diagram of the subject, and the visible folds 3 in the three figures are only drawn as a schematic diagram. Of course, the creases do not need to be fixed in the shape of a curve all over the longitudinal axis of the collar. In Figure 2, the intubation appears in The area of the loop 2 can be seen in the tube wall (slanted area) of the intubation 1, the central lumen 4 and the two canals 5 in the tube wall of the intubation 1. It can be used to expand, vent, or supply or extract. The liquid or secretion depends on the discharge end below such a canal 5. The upper end of the cannula can be discharged to an appropriate extraction liquid extraction or flushing device. The canal 5 can also be discharged on the outer tube wall of the cannula 1 in the area of the collar 2. The figure shows that the inflated cuff can be placed on the wall of the trachea tube at various degrees, and there are several longitudinal wrinkles on it. 3 Such wrinkles 3 obviously does not need to be parallel to each other, and the folds need not span the entire length of the ring 2. However, these diagrams are intended to show that the folds 3 can be of any kind, and due to the existence of such folds 3, a martyrdom is formed. Even if its cross section is very small, the secretions can still flow from the area above the loop 2 into the area below the loop _2, so that the disease source (seeking extremely favorable growth conditions in the secretion | especially above the loop) penetrates to Pulmonary inflammation caused by the lower respiratory tract. According to the present invention, this is prevented by the coating 6 on the outer surface of the collar 2, which can be clearly seen from the enlarged view of FIG. 3. As mentioned above, FIG. 3 is circled in FIG. 2. And the part is enlarged again, here is still only represented by a schematic diagram, especially the thickness of the coating layer 6 compared to the wall thickness of the ring 2 (represented by lines only) may be too exaggerated, but it does not exclude the corresponding Thickness ratio. There are two wrinkles in the enlarged area of Fig. 31. The wrinkles 3 on the left of Fig. 3 are slightly shallow, while the wrinkles on the right of Fig. 3 are deeper. National Standard (CNS) A4 (210 X 297 mm) ( (Please read the precautions on the back before filling this page) --I I I I Order --------- ^ i -12- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs
KI ___B7__ 五、發明說明（10) 爲塗層6，其中內含，例如，具水膨脹性的凝膠。 若將插管1與環套2 (開始時並未以充氣膨脹1而是 緊套在插管1或鬆掛在其上）引入病人氣管內’而塗層6 仍然非常薄而幾乎無法辦識，即在圖3中僅能看到塗層之 厚度，其與環套2之壁則僅能以較粗之線代表。 此塗層材料一旦在病人氣管內與含水之分泌物接觸後 便開始發脹而形成塗層6 (在圖3中以虛線代表）。各個 皺摺3 (多分佈在鄰近底部區域，此處之環套材料壁具有 最強的曲率）形成具有微滴橫切面之腔或甬道。換言之， 在此皺摺底部附近之皺摺3部位其環套2上的兩個對面壁 段彼此並未套牢、緊密，據推測可能是由於作用在環套2 材料上之彈性回力所致以及在形成甬道時皺摺3底部之扭 呼· 結並不陡峭、卻具有小彎曲而造成的結果。若在此一會受 水分或（例如）及熱影響而膨脹之區域施用塗層，再由於 此種能膨脹及隨心可塑式變彤或甚而具流動性之塗層材料 6所致，便可將甬道緊密封閉。此外，在一些皺摺區域與 其外表面互相套牢之環套2壁段區域、及在可能將該外表 面略向外推開之處塗層材料6亦可膨脹，使得塗層材料6 在所有皺摺上連續形成，並將可能在某些部位上或其他形 成皺摺的甬道予以緊密封閉。同理亦可用於外圍轉角區域 中環套類似筒狀之外圍的此類皺摺3。同樣地，此發脹塗 層6能擴張並形成連續而均質的塗層，其係介於氣管內表 面及環套材料2之間。其效果亦相似，在環套2外表面上 刷上一層薄薄的塗層，以形成某種乳膏或凝膠形式的可流 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公藿） 丨 I ------— — — — — — ---------*5^ ‘ (請先閲讀背面之注意事項再填寫本頁) -13 - A7 B7 五、發明說明（11) 動塗層。藉由這些由互套之皺摺3壁段對可流動的塗層材 料6施加壓力，則一部份塗層材料6會被擠出皺摺區域， 同時一部份也被推入已形成上述甬道之皺摺3底部。結果 ，阻隔或阻塞了對應的甬道。在氣管表面及環套壁2之間 ，塗層材料係依據其空間條件分佈。 除了具體實施例之外，在室溫下及在乾燥狀態下貯藏 時，塗層6 〔 s i c〕狀似固體，而尤其能耐磨損，而此 類塗層在經某種形式照射、及水分、熱、試劑或亦倂合催 化劑下能呈現所欲求之流動性質及密封性，塗層亦可具有 狀似凝膠之永久流動性，而爲求貯藏及運送之便，彼可蓋 上（例如）金屬薄片保護層或保護鞘，涵蓋住環套並可能 達整條插管。在任何情況下此種鞘或蓋子之組成材料對塗 覆劑之膠黏性或黏著力以小於環套材料較佳。後者較佳者 係由聚合材料組成。另一方面，若環套2之壁材料能盡可 能薄’便能確保其以皺摺3形式存在的任何甬道之橫切面 在一開始即非常小，因而此類微小的橫切面便能輕而易舉 的被少量塗層材料充塡。 -------------,4--------訂---------參 (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印*'J< 本纸張尺度適用中國國家標準（CNS)A4蜆格（210 X 297公釐） * 14 -KI ___B7__ 5. Description of the invention (10) is coating 6, which contains, for example, a water-swellable gel. If the intubation 1 and the sleeve 2 are introduced into the patient's trachea instead of being inflated 1 at the beginning but tightly placed on the cannula 1 or loosely attached to it ', the coating 6 is still very thin and almost unrecognizable That is, in FIG. 3, only the thickness of the coating can be seen, and its wall with the collar 2 can only be represented by a thicker line. Once the coating material comes into contact with the water-containing secretions in the patient's trachea, it begins to swell to form a coating 6 (represented by a dashed line in Figure 3). Each fold 3 (mostly distributed in the vicinity of the bottom area, where the wall of the loop material has the strongest curvature) forms a cavity or tunnel with a droplet cross-section. In other words, the two opposite wall segments on the loop 2 at the wrinkle 3 near the bottom of the wrinkle are not fastened and tight to each other. It is speculated that this may be due to the elastic return force acting on the material of the loop 2 and the When the martyrdom is formed, the wrinkles and knots at the bottom of the wrinkle 3 are not steep, but have the result of small bends. If the coating is applied in an area that will expand under the influence of moisture or, for example, heat, and then due to such a coating material 6 which can expand and become plastic or even fluid, it can be applied The tunnel is tightly closed. In addition, the coating material 6 can also swell in the area of the wall 2 of the collar 2 where the crease area and its outer surface are fastened to each other, and where the outer surface may be pushed slightly outward, so that the coating material 6 can Folds are formed continuously, and the palate, which may form creases in some places, is tightly closed. The same can be applied to this kind of wrinkle in the peripheral corner area of the ring-like sleeve 3. Similarly, the swelled coating 6 can expand and form a continuous and homogeneous coating, which is interposed between the inner surface of the trachea and the cuff material 2. The effect is similar. Brush a thin coating on the outer surface of the sleeve 2 to form a kind of cream or gel. The size of this paper is applicable to China National Standard (CNS) A4 (210 X 297).藿） 丨 I ------— — — — — — —-------- * 5 ^ '(Please read the precautions on the back before filling this page) -13-A7 B7 V. Description of the invention (11) Dynamic coating. By applying pressure to the flowable coating material 6 by the interfolded folds 3 wall sections, a part of the coating material 6 will be squeezed out of the crease area, and a part of it will also be pushed into the above-mentioned formation. Martyrs wrinkle 3 bottom. As a result, the corresponding martyrdom is blocked or blocked. Between the surface of the trachea and the wall of the annulus 2, the coating material is distributed according to its spatial conditions. Except for specific examples, when stored at room temperature and in a dry state, the coating 6 [sic] looks like a solid, and is particularly resistant to abrasion. Such coatings are exposed to water and heat in some form , Reagent or catalyst can show the desired flow properties and sealing properties. The coating can also have permanent fluidity like a gel. For storage and transportation, it can be covered with (for example) metal A thin protective layer or sheath that covers the cuff and may reach the entire cannula. In any case, the material of the sheath or cap is preferably less adhesive or adhesive to the coating material than the loop material. The latter is preferably composed of a polymeric material. On the other hand, if the wall material of the sleeve 2 can be as thin as possible, it can ensure that the cross section of any gangway existing in the form of folds 3 is very small at the beginning, so such a small cross section can be easily done. Filled with a small amount of coating material. -------------, 4 -------- Order --------- Refer to (Please read the notes on the back before filling this page) Printed by the Consumer Affairs Cooperative of the Property Bureau * 'J < This paper size applies the Chinese National Standard (CNS) A4 grid (210 X 297 mm) * 14-