200911312 九、發明說明： 【發明所屬之技術領域】 本發明係關於從在氣管前壁切開之氣管切開孔插入到 氣管內的氣切插管。 【先前技術】 爲了預防呼吸道堵塞、或對於下部呼吸道（氣管、支氣 管）之分泌物等（痰、唾液、食物殘液）之貯留的處置及預防、 或呼吸不全時的加壓呼吸等，氣管前壁被切開並從此氣管 切開孔插入氣切插管到氣管內（例如，專利文獻1)。第5圖 係表示以往的氣切插管之一種形態，第3圖、第4圖係表 示從氣管切開孔插入到氣管內之狀態的氣切插管。 [專利文獻1]特開2007-50020號公報 如第5圖所示，在以往的氣切插管11中，曲管狀的插 管1 2從氣管切開孔插入到氣管內的狀態下，一對凸緣1 3、 1 4係設置在位於體外的插管1 2之一方的端部，框架1 5位 於這些凸緣13、14彼此之間。在框架15設有用以插入插 管1 2的貫通孔1 6以及此貫通孔1 6兩側之一對貫通孔1 7、 18 ° 因爲一對凸緣1 3、1 4彼此的間隔係僅比框架1 5的厚 度還要大一點而已，所以藉由一對凸緣13、14而在貫通孔 1 6之假想的軸芯方向上將插管1 2進行定位。插管1 2係以 聚四氟乙烯等之比較硬質的材料所形成，但框架1 5係以矽 膠等的軟質材料所形成。因此，即使貫通孔1 6的內徑比凸 緣1 3、1 4的外徑還要小，也能藉由使框架1 5彈性變形而 200911312 越過凸緣13、14之一方，而使框架15位於一對凸緣13、 1 4彼此之間。 如同第4圖所示，氣切插管11從氣管切開孔插入到氣 管內時，藉由插通於貫通孔17、18的條帶21或鈕繩等而 將框架15固定於頸部。然後，如同上述，因爲藉由一對凸 緣13' 14而將插管12定位在框架15之貫通孔16的軸芯 方向上，所以結果如同第3圖所示，插管12被定位在氣管 內。在框架1 5和頸部之間插入具有Y字狀等之切入部的紗 布22，以膠帶23來固定此切入部。 【發明內容】 [本發明欲解決的課題] 不過，如第5圖所示之以往的氣切插管11中，因爲只 是將插管12插入貫通孔16內，所以當施加旋轉力超過插 管12之外周面和貫通孔16之內周面之間的摩擦力時，插 管12和框架15就會繞著貫通孔16的軸芯而相對地旋轉。 不過，如同上述，因爲藉由插通於貫通孔17、18的條帶21 或鈕繩等來固定框架15於頸部，所以當插管12和框架15 因爲任何原因而相對地旋轉時，在框架15固定於頸部的狀 態下，插管12會從對於氣管而言爲正常的角度位置而旋 轉。 因爲插管12是曲管，所以當插管12從對於氣管而言 爲正常的角度位置旋轉時，位於氣管內的插管12之前端部 會接觸氣管內壁並壓迫此氣管內壁，氣管粘膜會壞死或者 出血’或在氣管粘膜形成肉芽。在氣管粘膜形成肉芽時， 200911312 除了來自氣管的出血以外，也成爲氣管狹窄的原因。因此， 本發明之目的在於提供一種安全性高的氣切插管’其能防 止插管和框架的相對旋轉，且位於氣管內的插管之前端部 不會因旋轉而接觸到氣管內壁。 [解決課題的手段] 在申請專利範圍第1項之氣切插管方面，具備旋轉防 止機構，用於防止插管和框架的相對旋轉。因此，即使由 於任何原因而使插管和框架相對旋轉的力發生作用，也能 防止插管和框架的相對旋轉，插管不會從對氣管而言爲正 常的角度位置旋轉。 在申請專利範圍第2項之氣切插管方面，在插管之凸 緣設置穿孔、以及在此穿孔內通過框架之貫通孔內以及框 架之外緣而兩個端部彼此被結合的條帶，會成爲旋轉防止 機構。因此，即使插管、框架是由成形性不佳的材料或黏 著性不佳的材料所組成而很難作爲微細的構造或黏著於其 他構件，也能輕易地實現旋轉防止機構。 在申請專利範圍第3項之氣切插管方面，條帶之兩個 端部彼此係藉由條帶之兩個端部彼此的卡入（snap _in)而結 合。因此’能使條帶之兩個端部彼此輕易地結合，且條帶 之兩個端部的結合不容易被解除。 [發明的效果] 在申請專利範圍第1項之氣切插管方面，即使由於任 何原因而使插管和框架相對旋轉的力發生作用，也能防止 插管和框架的相對旋轉，插管不會從對氣管而言爲正常的 200911312 角度位置旋轉。因此，位於氣管內的插管之前端部不會因 旋轉而接觸到氣管內壁，安全性高。 在申請專利範圍第2項之氣切插管方面，即使插管、 框架是由成形性不佳的材料或黏著性不佳的材料所組成而 很難作爲微細的構造或黏著於其他構件，也能輕易地實現 旋轉防止機構。因此’能用低成本來實現安全性高的氣切 插管。 在申請專利範圍第3項之氣切插管方面，能使條帶之 兩個端部彼此輕易地結合’且條帶之兩個端部的結合不容 易被解除。因此’能以用更低的成本來實現安全性更高的 氣切插管。 【實施方式】 以下’參照第1圖、第2圖’說明適用於單管式的氣 切插管且用以實施本發明之最佳的一種形態。在本形態的 氣切插管11中具備用以將插管12與框架15結合之聚丙烯 製的條帶24。如第2圖所示，在這條帶24中，帶狀的中間 部25以直線狀延伸r此中間部25的雙方端部26、27係朝 著相對於此中間部25之縱長方向呈直角的方向而屈曲。 在中間部2 5之一方的端部2 6之前端部3 1當中，在與 端部27相反的面上形成鉤部32。在鉤部32的下端面33 當中，以與端部27相反側的部分隔離端部26之前端側的 方式，而下端面3 3相對於中間部25呈傾斜。另一個端部 27的軸芯部會成爲空洞部34，在包圍空洞部34之端部27 的壁面當中，與端部26相反側的壁面35只有存在於端部 200911312 27的前端部。換言之，壁面35的基端側成爲開口部36， 壁面35的下端面37面對開口部36。在下端面37當中，以 與端部2 6相反側的部分會接近端部2 7之前端側的方式， 使下端面3 7相對於中間部2 5呈傾斜。 如第1圖所示，在本形態之氣切插管1 1中，在一對凸 緣13、14當中，於插管12從氣管切開孔插入到氣管內的 狀態下’離氣管較遠的凸緣13之外徑稍微大於離氣管較近 的凸緣14之外徑，在外徑大的凸緣13上設置穿孔38。另 外’條帶24之端部27係在一對凸緣13、14彼此之間，被 包夾於插管12之外周面和貫通孔16之內周面之間。 條帶24之中間部25會彎曲而通過框架1 5的外緣，由 於中間部25會更加彎曲，所以條帶24之端部26通過穿孔 3 8且被壓入至端部27之空洞部34內。換言之，如同第2 圖中以箭頭A所示’中間部25會彎曲，端部26被壓入至 端部27之空洞部34內。被壓入至空洞部34內的端部27 會通過空洞部34內’端部27之前端部31會從開口部36 脫出。 因爲前端部31的鉤部32之下端面33和壁面35之下 端面3 7係如同上述而傾斜，所以前端部3 1朝向開口部3 6 脫出的同時，這些下端面33、37彼此會嵌合。換言之，端 部26 ’ 27彼此藉由卡入（snap-in)而結合。藉由下端面33、 3 7彼此的嵌合，端部2 6，2 7會彼此結合，使得僅在朝向從 穿孔3 8拔出之方向上拉拔條帶2 4之端部2 6，也不會使此 條帶24從氣切插管11脫離。 200911312 除了以上所述，本形態的氣切插管1 1亦具有與第 所示之以往的氣切插管11實質相同的構成。如同以上 形態之氣切插管1 1係因爲條帶24使插管1 2和框架 合，所以不管是什麼原因，即便使插管12和框架15 框架15之貫通孔16的軸芯而相對地旋轉的力發生作 也能防止插管1 2和框架1 5的相對旋轉。 此外，本形態的氣切插管11係單管式，但本發明 切插管能適用於複管式、附有袖套式、附有側孔式、 發聲線（speech line)式、附有吸引線式等的各種的氣 管。換言之，藉由防止最外側之管的旋轉，能防止各 切插管的旋轉。另外，在本形態的氣切插管11中，插 係聚四氟乙烯製，框架15係矽膠製，條帶24係聚丙舞 但這些材料也可以是其他材料。 此外，也能採用第2圖所示之形狀以外的形狀來 條帶24的形狀。例如，端部26、27之形狀以及高度 鉤部3 2之形狀以及下端面3 3的傾斜角度、或壁面3 5 端面37的傾斜角度等也可以與第2圖不同。例如，在第 圖中’端部26的前端部31的截面係山形，中間部25 面和與中間部2 5相反側的面的兩者相對於中間部2 5 斜，但也可以是中間部25側的面相對於中間部25爲i 只有與中間部25相反側的面相對於中間部25爲傾斜 [產業利用性] 本發明能利用於提供插管的前端部不會因旋轉而 到氣管內壁而安全性高的氣切插管。另外，針對可能 5圖 的本 15結 繞著 用， 的氣 附有 切插 種氣 管12 ^製， 作爲 、或 之下 2(b) 側的 爲傾 妄直， 接觸 會旋 -10- 200911312 轉之以往的氣切插管而抑制成本的增加，且容易具備旋轉 防止機構。 【圖式簡單說明】 第1圖係表示用於實施本發明的一個形態，（a)爲側截 面圖，（b)爲平面圖。 第2圖係表示用於實施本發明之一形態的條帶，（a)爲 平面圖，（b)爲正面圖，（c)爲底面圖，（d)爲左側面圖，（e) 爲右側側面圖。 第3圖係從氣管切開孔插入到氣管內之狀態的氣切插 管的側面圖。 第4圖係從氣管切開孔插入到氣管內之狀態的氣切插 管的正面圖。 第5圖係表示本發明之以往的一種形態，（a)爲側截面 圖，（b)爲平面圖。 【主要元件符號說明】 11 氣切插管 12 插管 13 凸緣 15 框架 16 貫通孔 24 條帶（旋轉防止機構） 26 端部 27 端部 38 穿孔（旋轉防止機構） -11-200911312 IX. Description of the Invention: [Technical Field of the Invention] The present invention relates to a gas-cut cannula inserted from a tracheostomy incision in the anterior wall of a trachea into a trachea. [Prior Art] In order to prevent obstruction of the respiratory tract, or to treat and prevent the storage of the lower respiratory tract (tracheal, bronchial) secretions (sputum, saliva, food residue), or the pressurized breathing when the breathing is incomplete, the trachea The wall is cut and inserted into the trachea from the tracheostomy hole (for example, Patent Document 1). Fig. 5 shows a form of a conventional gas-cut cannula, and Figs. 3 and 4 show a gas-cut cannula in a state in which a tracheo incision hole is inserted into a trachea. [Patent Document 1] JP-A-2007-50020 As shown in Fig. 5, in the conventional gas-cut cannula 11, a pair of curved tubular cannulas 12 are inserted into the trachea from the tracheostomy hole, and a pair The flanges 13 3, 14 are disposed at one end of the cannula 12 outside the body, and the frame 15 is located between the flanges 13, 14. The frame 15 is provided with a through hole 16 for inserting the cannula 1 2 and a pair of through holes 17 and 18 on both sides of the through hole 16 because the spacing between the pair of flanges 1 3, 1 4 is only Since the thickness of the frame 15 is also larger, the cannula 12 is positioned in the imaginary axis direction of the through hole 16 by the pair of flanges 13, 14. The cannula 1 2 is formed of a relatively hard material such as polytetrafluoroethylene, but the frame 15 is formed of a soft material such as silicone. Therefore, even if the inner diameter of the through hole 16 is smaller than the outer diameter of the flanges 13 and 14, it is possible to make the frame 15 by elastically deforming the frame 15 and 200911312 over one of the flanges 13, 14. Located between a pair of flanges 13, 14 between each other. As shown in Fig. 4, when the gas-cut cannula 11 is inserted into the trachea from the tracheostomy hole, the frame 15 is fixed to the neck by the strip 21 or the button wire inserted through the through-holes 17, 18. Then, as described above, since the cannula 12 is positioned in the axial direction of the through hole 16 of the frame 15 by the pair of flanges 13' 14, as a result, as shown in Fig. 3, the cannula 12 is positioned in the trachea. Inside. A gauze 22 having a cut portion such as a Y-shape is inserted between the frame 15 and the neck portion, and the cut portion is fixed by a tape 23. [Problem to be Solved by the Invention] However, in the conventional gas-cut cannula 11 shown in Fig. 5, since the insertion tube 12 is inserted into the through-hole 16, the rotational force is applied beyond the cannula. When the friction between the outer circumferential surface and the inner circumferential surface of the through hole 16 is 12, the insertion tube 12 and the frame 15 relatively rotate around the axial center of the through hole 16. However, as described above, since the frame 15 is fixed to the neck by the strap 21 or the button wire or the like inserted through the through holes 17, 18, when the insertion tube 12 and the frame 15 are relatively rotated for any reason, With the frame 15 fixed to the neck, the cannula 12 will rotate from a normal angular position for the trachea. Because the cannula 12 is a curved tube, when the cannula 12 is rotated from a normal angular position for the trachea, the front end of the cannula 12 located in the trachea contacts the inner wall of the trachea and compresses the inner wall of the trachea, the tracheal mucosa Will be necrotic or bleeding ' or form a granulation in the tracheal mucosa. When granulation is formed in the tracheal mucosa, 200911312 is also the cause of tracheal stenosis in addition to bleeding from the trachea. Accordingly, it is an object of the present invention to provide a highly safe gas-cut cannula which prevents relative rotation of the cannula and the frame, and which does not contact the inner wall of the trachea due to rotation before the cannula located in the trachea. [Means for Solving the Problem] In the gas-cut cannula of the first application of the patent scope, there is provided a rotation preventing mechanism for preventing relative rotation of the cannula and the frame. Therefore, even if the force of relative rotation of the cannula and the frame acts for any reason, the relative rotation of the cannula and the frame can be prevented, and the cannula does not rotate from a normal angular position to the air tube. In the case of the gas-cut cannula of claim 2, a perforation is provided in the flange of the cannula, and a strip is formed in the perforation through the through-hole of the frame and the outer edge of the frame, and the two ends are joined to each other. It will become a rotation prevention mechanism. Therefore, even if the cannula or the frame is composed of a material having poor formability or a material having poor adhesion, it is difficult to realize a rotation preventing mechanism as a fine structure or adhesion to other members. In the case of the gas-cut cannula of claim 3, the two ends of the strip are joined to each other by the snap-in of the two ends of the strip. Therefore, the two ends of the strip can be easily joined to each other, and the combination of the two ends of the strip is not easily released. [Effect of the Invention] In the gas-cut cannula of the first application of the patent scope, even if the force of relative rotation of the cannula and the frame acts for any reason, the relative rotation of the cannula and the frame can be prevented, and the cannula is not It will rotate from the 200911312 angular position that is normal for the trachea. Therefore, the end portion of the cannula located in the trachea does not come into contact with the inner wall of the trachea due to the rotation, and the safety is high. In the case of the gas-cut intubation of the second paragraph of the patent application, even if the cannula or the frame is composed of a poorly formable material or a poorly adhesive material, it is difficult to be a fine structure or adhere to other members. The rotation preventing mechanism can be easily realized. Therefore, a highly safe gas-cut cannula can be realized at low cost. In the case of the gas-cut cannula of the third application of the patent application, the two ends of the strip can be easily joined to each other' and the combination of the two ends of the strip is not easily released. Therefore, it is possible to achieve a more safe gas-cut cannula at a lower cost. [Embodiment] Hereinafter, a preferred embodiment of the present invention for applying a single-tube gas cutting cannula will be described with reference to Figs. 1 and 2 . In the gas cut tube 11 of the present embodiment, a strip 24 made of polypropylene for joining the cannula 12 to the frame 15 is provided. As shown in Fig. 2, in the strip 24, the strip-shaped intermediate portion 25 extends linearly, and both end portions 26 and 27 of the intermediate portion 25 are oriented in the longitudinal direction with respect to the intermediate portion 25. Flexing in the direction of the right angle. In the end portion 3 1 of the end portion 26 of one of the intermediate portions 25, a hook portion 32 is formed on a surface opposite to the end portion 27. In the lower end surface 33 of the hook portion 32, the portion on the opposite side to the end portion 27 isolates the front end side of the end portion 26, and the lower end surface 33 is inclined with respect to the intermediate portion 25. The other end portion 27 has a hollow portion 34, and among the wall surfaces surrounding the end portion 27 of the hollow portion 34, the wall surface 35 on the opposite side to the end portion 26 exists only at the front end portion of the end portion 200911312. In other words, the base end side of the wall surface 35 serves as the opening portion 36, and the lower end surface 37 of the wall surface 35 faces the opening portion 36. In the lower end surface 37, the lower end surface 37 is inclined with respect to the intermediate portion 25 such that the portion on the opposite side to the end portion 26 approaches the front end side of the end portion 27. As shown in Fig. 1, in the gas-cut cannula 1 of the present embodiment, among the pair of flanges 13, 14, in the state in which the cannula 12 is inserted into the trachea from the tracheo incision hole, it is far from the trachea. The outer diameter of the flange 13 is slightly larger than the outer diameter of the flange 14 which is closer to the air tube, and the through hole 38 is provided on the flange 13 having a large outer diameter. Further, the end portion 27 of the strip 24 is interposed between the pair of flanges 13, 14 and sandwiched between the outer peripheral surface of the insertion tube 12 and the inner peripheral surface of the through hole 16. The intermediate portion 25 of the strip 24 is bent to pass through the outer edge of the frame 15. Since the intermediate portion 25 is more curved, the end portion 26 of the strip 24 passes through the perforations 38 and is pressed into the hollow portion 34 of the end portion 27. Inside. In other words, as shown by the arrow A in Fig. 2, the intermediate portion 25 is bent, and the end portion 26 is pressed into the hollow portion 34 of the end portion 27. The end portion 27 that is pressed into the hollow portion 34 will pass through the opening portion 36 from the front end portion 31 of the end portion 27 of the hollow portion 34. Since the lower end surface 33 of the hook portion 32 of the front end portion 31 and the lower end surface 33 of the wall surface 35 are inclined as described above, the front end portions 31 are disengaged toward the opening portion 36, and the lower end surfaces 33, 37 are embedded with each other. Hehe. In other words, the ends 26' 27 are joined to each other by snap-in. By the fitting of the lower end faces 33, 37 to each other, the ends 2 6, 27 are joined to each other such that the end portion 2 of the strip 24 is drawn only in the direction of being pulled out from the perforation 38. This strip 24 is not detached from the gas incision cannula 11. 200911312 In addition to the above, the gas-cut cannula 11 of the present embodiment has substantially the same configuration as the conventional gas-cut cannula 11 shown in the above. The gas-cut cannula 11 of the above embodiment is such that the cannula 12 and the frame are joined by the strip 24, so that the stem 12 and the core of the through-hole 16 of the frame 15 of the frame 15 are oppositely opposed for whatever reason. The rotation of the force also prevents relative rotation of the cannula 1 2 and the frame 15 . In addition, the gas-cut cannula 11 of the present embodiment is a single-tube type, but the incision cannula of the present invention can be applied to a double-tube type, with a sleeve type, a side hole type, a speech line type, and a A variety of air pipes such as wire type are attracted. In other words, by preventing the rotation of the outermost tube, the rotation of each of the cannulas can be prevented. Further, in the gas cut tube 11 of the present embodiment, the insert is made of polytetrafluoroethylene, the frame 15 is made of silicone, and the strip 24 is made of polypropylene. However, these materials may be other materials. Further, the shape of the strip 24 can be adopted in a shape other than the shape shown in Fig. 2 . For example, the shape of the end portions 26, 27 and the shape of the height hook portion 32 and the inclination angle of the lower end surface 33, or the inclination angle of the end surface 37 of the wall surface 35 may be different from those of Fig. 2. For example, in the drawing, the end portion 31 of the end portion 26 has a mountain shape, and both the intermediate portion 25 surface and the surface opposite to the intermediate portion 25 are inclined with respect to the intermediate portion 25, but may be the intermediate portion. The surface on the 25 side is i with respect to the intermediate portion 25, and only the surface on the opposite side to the intermediate portion 25 is inclined with respect to the intermediate portion 25. [Industrial Applicability] The present invention can be utilized in that the front end portion of the cannula is provided without being rotated to the inner wall of the trachea A highly safe gas-cut cannula. In addition, for the 15 knots of the possible 5 diagrams, the gas is attached with the cut-in seed tube 12^, as the bottom or the bottom 2(b) side is tilted straight, and the contact will be rotated-10-200911312 The conventional gas-cut cannula suppresses an increase in cost and is easy to provide a rotation preventing mechanism. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows an embodiment for carrying out the invention, wherein (a) is a side cross-sectional view and (b) is a plan view. Fig. 2 is a view showing a strip for carrying out one embodiment of the present invention, wherein (a) is a plan view, (b) is a front view, (c) is a bottom view, (d) is a left side view, and (e) is a right side; side view. Fig. 3 is a side view of the gas-cut cannula in a state in which the tracheo incision hole is inserted into the trachea. Fig. 4 is a front view of the gas-cut cannula in a state in which the tracheo incision hole is inserted into the trachea. Fig. 5 is a view showing a conventional form of the present invention, wherein (a) is a side sectional view and (b) is a plan view. [Main component symbol description] 11 Gas-cut cannula 12 Cannula 13 Flange 15 Frame 16 Through-hole 24 Strip (rotation prevention mechanism) 26 End 27 End 38 Perforation (rotation prevention mechanism) -11-