506843 A7 __B7 " s 五、發明說明（丨） 4 【技術領域】 本發明係一種附翼之醫療用針裝置，特別有關一種將 針管使用後可安全地收容之具誤刺防止用附翼護套之醫療 用針裝置。 【背景技術】 先前，在醫療機構中，注射針或穿刺針之誤穿刺已造 成污染•感染之問題。特別是最近因B型肝炎、C型肝炎 、HIV(人類免疫不全病毒)等已構成整個社會上的問題，故 期待著有方法來積極防止誤穿刺等偶發事故之發生。 防止誤穿刺之方法中，有各種在收容使用後之注射針 或穿刺針時，將針管以覆蓋物覆蓋之注射針裝置。該等防 止誤穿刺之方法中多數具有爲防止使用後誤穿刺之圓筒狀 保護蓋（以下稱護套），該護套可相對於注射針作滑動。亦 即，其構成係藉著護套之滑動，使注射針處於露出之狀態 及被護套覆蓋之狀態。 另一方面，在進行輸液或輸血、體外血液循環等處置 時，附翼注射針裝置係被廣爲使用。附翼注射針裝置有一 針基，其前端掘定著注射針而後端連接於輸液軟管上，該 針基上具裝設有翼之構造。因此，附翼注射針裝置之誤穿 刺防止方法須有特殊構造。亦即其構造必須是，翼片對於 護套之滑動不能造成阻礙。若將習知技術分類，可分爲翼 安裝於注射針或針基之構造及翼安裝於護套之構造。 就後者之構造之例子而言，有記載於日本特公平第6- ____ 3_ 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） -----------—-----—訂·----—線 (請先閱讀背面之注意事項再填寫本頁) 506843 A7 ^_____B7_________ 五、發明說明（，） ’ 7861號公報、國際公開WO91/04761號公報，或美國專利 第5,088,982號說明書者。在該等習知例中，因翼被安裝 於可滑動之圓筒狀護套外周面，故翼會和護套一起在注射 針之外側滑動。注射針使用後，爲防止誤穿刺，可使護套 滑動以覆蓋注射針之前端。 如上述之有翼片安裝在護套上之注射針裝置在使用時 ，須具有一機構來將注射針暫時保持在護套上之既定位置 ，並使兩者成爲一體。特別是於穿刺操作時，注射針須確 實地保持在護套內。否則，穿刺操作中，注射針在護套內 移動恐怕會對穿刺操作造成很大的影響。亦即，注射針由 於穿刺時之按壓被壓回基端側，而有可能使露出護套之針 管縮進去。 ‘ 又，穿刺後將針滯留於患者期間，須將注射針保持於 護套既定位置。而且，穿刺時及進行爲防止誤穿刺而將注 射針收納於護套之收納操作時，希望針保持於護套之作用 兩者有如以下之不同。 穿刺時因爲係握持護套進行操作，故須使針確實地保 持在護套內。相對於此，收納時將針保持於護套之保持力 較小爲佳。若保持力過強，則針在護套內之滑動會變得困 難，恐怕會導致意外之事故。另一方面，將針滯留在患者 時，因護套被固定在患者之穿刺部，在該狀態下針一旦在 護套內容易地滑動，則針恐怕會從患者身上脫落。因此， 針滯留時保持力過弱亦不適當。結果，希望穿刺後比起穿 刺時有較弱而適當的保持力作用於注射針或針基。 __ 4 表紙張尺度適用中國國家標準（CNS)A4規格（210>< 297公釐) '一 ~ ------------—------訂 *-------I (請先閱讀背面之注意事項再填寫本頁) 506843 A7 _______B7__ 五、發明說明（）） 但是，習知之具有附翼護套之注射針裝置在穿刺時不 一定能確實地將注射針保持於護套。亦即，機構上恐怕無 法保持注射針。 再者因穿刺時及穿刺後（滯留時及拔去時）注射針之保 持係藉由同一機構進行，故對於穿刺及收納兩者注射針均 無法得到最佳之保持力。 【發明之揭示】 本發明之目的爲提供一種醫療用針裝置，其注射針於 穿刺時可確實地被保持。 另一目的爲提供一種醫療用針裝置，其於穿刺時及穿 刺後，可分別以最佳保持力將醫療用針保持於附翼護套’ 並且於使用後可以安全且容易地進行將醫療用針收納於護 套內之操作。 本發明之醫療用針裝置基本構造係具誤穿刺防止用附 翼護套之醫療用針裝置，其具備：附翼護套，有大致呈圓 间狀之護套筒和與前述護套筒前端側相結合之一對翼部； 針基，以軸方向上可移動之方式***於前述護套筒內腔； 及針管，裝設於前述針基之前端部；並且可將前述針管以 被覆前端之方式收納於前述護套筒之內腔。前述各翼部具 有翼突起，該翼突起突出各翼部基端側區之翼面；而前述 護套筒則具有貫通孔，該貫通孔形成於側部圓筒壁，供前 述各翼突起***。使前述兩翼部沿前述護套筒側面疊合， 以經由前述貫通孔可將前述各翼突起***於前述護套筒內 ____ 5 T、紙爪尺度適^中國0家標準（CNS)A4規格（210 X 297公一""" --—- --------訂---------線 (請先閱讀背面之注意事項再填寫本頁) 506843 A7 ———___B7___ 五、發明說明（女） 腔。藉此讓前述各翼突起阻止前述針基於前述護套筒內軸 方向移動，使得前述針基在前述針管突出前述護套筒前端 既定長度之狀態下保持於前述護套筒。 根據這種構造，進行穿刺時由於將翼部突起之部分予 以夾住按壓來握持翼部，故使翼部突起所造成之對針基之 保持牢固而確實，而可提高穿刺之安全性。再者，因穿刺 時僅須以與一般的附翼針同樣地操作即可，並不需要特別 的操作，就可提高針基之保持力，故操作簡便。 在上述之構成中，前述各翼突起，係經由前述貫通孔 ***於前述護套筒內腔，而抵接於前述針基，並藉由其抵 接所造成之摩擦力，使前述針基在前述針管突出前述護套 筒前端既定長度之狀態下保持於前述護套筒。 又，較佳爲各對應於前述一對翼突起之一對前述貫通 孔分別於前述護套筒之兩側壁上形成。 前述貫通孔在前述護套筒兩側面上相連而呈1條槽狀。 又，較佳爲前述各翼部基端側區之厚度比前端側爲薄。 又，較佳爲前述護套筒之底部外表面爲平坦的。 上述基本結構中較佳爲，前述針基，係具有主管部及 位於前述主管部前端附近之保持部，前述保持部具有直徑 比前述主管部爲大之徑大部，在該徑大部之後部外表面形 成段差部；使前述兩翼部沿前述護套筒側面疊合，可使前 述各翼突起經由前述貫通孔卡合於前述針基之段差部；讓 前述各翼突起卡合於前述針基之段差部，使得前述針基在 前述針管突出前述護套筒前端既定長度之狀態下保持成在 __ 6 本纸張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） *........... 1 n H 11 1—-1 J i i-i n n · n n n n n It I— 『 · I m ---1 i SI n Hi I (請先閱讀背面之注意事項再填寫本頁) 506843 A7 ____B7 ________ 五、發明說明（< ) 前述護套筒內不往基端側移動。 藉此結構，對針基之保持變得更確實而牢固。 該結構中較佳爲，前述護套筒進一步具有形成於其後 端部內周面上之後端卡止部，前述後端卡止部係其內徑比 前述針基保持部之徑大部爲小，且其軸方向中間部上形成 環狀槽；使前述針基相對於前述護套筒往軸方向基端側移 動，可使前述針基保持部之徑大部卡合於前述護套筒後端 卡止部之環狀槽，藉由該卡合，使前述針基在將前述針管 於收納於前述護套筒內腔之狀態下保持於前述護套筒。 再者，較佳爲前述針基之保持部進一步在前述徑大部 之後部具有外方環狀突起，且於前述徑大部與前述外方環 狀突起之間之外表面上形成有環狀槽；前述各翼突起係經 由前述貫通孔而***於前述護套筒內腔並可卡合於前述針 基之環狀槽，藉由該卡合，使前述針基在前述針管突出前 述護套筒前端既定長度之狀態下保持於前述護套筒。 該結構中較佳爲，前述護套筒進一步具有形成於其後 端部內周面上之後端卡止部，前述後端卡止部係包含內方 環狀突起，使前述針基相對於前述護套筒往軸方向基端側 移動，可使前述內方環狀突起可卡合於前述針基之環狀槽 ，藉由該卡合，使前述針基在將前述針管收納於前述護套 筒內腔之狀態下保持於前述護套筒。 較佳爲前述護套筒進一步具有前端部突起，該前端部 突起形成在與前述貫通孔大致一致之軸方向位置之內周面 上；前述護套筒之前端部突起可卡合於前述針基之段差部 ____ 7 本纸張尺度適用由國國家標準（CNS)A4規格（210 X 297公釐） —-----------------—訂·-------- (請先閱讀背面之注意事項再填寫本頁) 506843 A7 _____B7__ 五、發明說明（t ) (請先閲讀背面之注意事項再填寫本頁) ，於該卡合狀態下，使前述兩翼部沿前述護套筒側面疊合 ，可經由前述貫通孔將前述各翼突起卡合於前述針基之段 差部；使前述前端部突起或前述各翼突起卡合於前述針基 之段差部，使前述針基在前述針管突出前述護套筒前端既 疋長度之狀態下保持成在刖述遵套同內不往基端側移動。 依該結構，穿刺時及穿刺後，用來把醫療用針保持於 附翼護套之保持力會分別被設定成最佳。 該結構中較佳爲，前述針基之保持部，係在前述徑大 部之後部上進一步具有外方環狀突起，且在前述徑大部與 前述外方環狀突起之間之外表面上形成環狀槽；使前述護 套筒之前端部突起或前述各翼突起卡合於前述針基之環狀 槽，可得到與以前述段差部所得到之保持功能同樣之功能。 -線 再者，較佳爲使前述兩翼部沿著前述護套筒側面疊合 ，並在前述針基之段差部與前述各翼突起相卡合之狀態下 ，將前述兩翼部在前述各翼突起之位置予以夾住按壓，而 可使對前述針基之保持力比前述針基段差部與前述前端突 起部間之卡合所造成之保持力爲大。 上述基本結構中，較佳爲前述護套筒的上面形成保持 桿。施行醫療的人藉著將手指抵接於保持桿’使得操作中 容易地防止護套筒移動。 再者，較佳爲進一步具有設於前述護套筒基端部之輔 助保持機構及形成於前述針基後部之輔助保持部；前述輔 助保持機構包括旋動片，安裝於前述護套筒之基端部外表 面；設於旋動片上之輔助突起；及貫通孔’設於前述護套 8 ____ 由國國家標準（CNS)A4規格(210 >< 297公釐Γ 506843 A7 __ _ B7___ 五、發明說明（？） 筒壁上，使前述輔助突起藉由前述旋動片之旋動可***前 述護套筒內腔；前述輔助保持部包括於前述針基外表面形 成之輔助環狀槽或輔助環狀突起；將前述輔助突起經由前 述貫通孔而卡合於前述針基之輔助環狀槽或輔助環狀突起 ，在前述針管僅突出前述護套筒前述既定長度之狀態下， 可產生將前述針基保持於前述護套筒之輔助保持力。 【發明之最佳實施形態】 (實施形態1) 圖1爲本發明實施形態1中醫療用針裝置之俯視圖。1 爲針管並被固定於樹脂製針基2之前端部。針基2之後端 部連接有軟管3。4爲附翼護套，包含大致呈圓筒狀之樹脂 製護套筒4a及左右翼部5、6。針管1及針基2被***護 套筒4a之內腔，且可於軸方向移動。左右翼部5、6均設 於護套筒4a之前端部，亦即針管1突出之一側之端部。翼 部5、6分別結合於護套筒4a之外周面兩側部，且以護套 筒4a之軸爲中心具有彼此對稱之形狀。針基2之前端部上 裝設有針套18，並覆蓋著針管1。 異邰5、6分成前端側區5a、6a及基端側區(與護套筒 4a之結合區）5b、6b。基端側區5b、6b上分別形成有翼突 起7、8。對應於翼突起7、8之護套筒4a之左右側部壁上 有貫通孔9、10形成。前端區5a、6a上形成有凸條u、 12及條形槽13、14形成。506843 A7 __B7 " s V. Description of the invention (丨) 4 [Technical Field] The present invention relates to a medical needle device with a wing, and more particularly to a wing protection with a stab prevention that can be safely contained after a needle tube is used. Set of medical needle devices. [Background Art] Previously, in medical institutions, incorrect puncture of injection needles or puncture needles has caused problems of contamination and infection. Especially recently, hepatitis B, hepatitis C, and HIV (Human Immunodeficiency Virus) have become a problem in the whole society. Therefore, we are looking forward to ways to actively prevent accidents such as accidental puncture. Various methods for preventing accidental puncture include various types of injection needle devices that cover the needle tube with a covering material when the injection needle or puncture needle is stored and used. Most of these methods to prevent accidental puncture have a cylindrical protective cap (hereinafter referred to as a sheath) to prevent accidental puncture after use, and the sheath can slide relative to the injection needle. That is, its structure is such that the injection needle is exposed and covered with the sheath by sliding the sheath. On the other hand, the epiphyseal needle device is widely used for treatments such as infusion, blood transfusion, and extracorporeal blood circulation. The winged injection needle device has a needle base, the front end of which has an injection needle and the rear end is connected to an infusion tube. The needle base is provided with a wing structure. Therefore, the erroneous puncture prevention method of the winged injection needle device must have a special structure. That is, its structure must be such that the flaps cannot hinder the sliding of the sheath. If the conventional technology is classified, it can be divided into a structure in which a wing is mounted on an injection needle or a needle base and a structure in which a wing is mounted on a sheath. As for the example of the latter structure, it is described in Japan's special fair No. 6 ____ 3_ This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ----------- —-----— Order · ----— Line (Please read the precautions on the back before filling out this page) 506843 A7 ^ _____ B7_________ V. Description of the Invention (,) No. 7861, International Publication No. WO91 / 04761 Gazette, or US Patent No. 5,088,982. In these conventional examples, since the wing is mounted on the outer peripheral surface of the slidable cylindrical sheath, the wing and the sheath slide along the outer side of the injection needle. After use of the needle, to prevent accidental puncture, the sheath can be slid to cover the front end of the needle. When the above-mentioned injection needle device with the wing mounted on the sheath is used, it must have a mechanism to temporarily maintain the injection needle in a predetermined position on the sheath and make the two into one. Especially during puncture, the needle must be kept firmly in the sheath. Otherwise, the movement of the injection needle in the sheath during the puncture operation may have a great impact on the puncture operation. That is, the injection needle is pushed back to the proximal end side due to the pressing force during puncture, and it is possible to retract the needle tube exposing the sheath. ‘Also, after the needle is held in the patient after puncture, the injection needle must be held in the predetermined position of the sheath. In addition, it is desirable that the function of the needle to be held in the sheath during puncture and the operation of storing the injection needle in the sheath to prevent accidental puncture is different from the following. Since the sheath is operated during puncture, the needle must be held in the sheath securely. On the other hand, it is preferable that the holding force for holding the needle to the sheath during storage is small. If the holding force is too strong, the sliding of the needle in the sheath becomes difficult, which may cause accidents. On the other hand, when the needle is held in the patient, the sheath is fixed to the puncture portion of the patient. In this state, once the needle easily slides in the sheath, the needle may fall out of the patient. Therefore, it is not appropriate that the holding force is too weak during needle retention. As a result, it is desirable that a weaker and appropriate holding force is applied to the injection needle or needle base after the puncture than when the puncture is performed. __ 4 The paper size of the table applies the Chinese National Standard (CNS) A4 specification (210 > < 297 mm) '一 ~ ------------------ Order * --- ---- I (Please read the precautions on the back before filling out this page) 506843 A7 _______B7__ 5. Description of the Invention ()) However, the conventional needle device with a winged sheath may not be able to reliably The injection needle is held in the sheath. That is, the injection needle may not be maintained at the institution. Furthermore, because the needles are held at the time of puncture and after puncture (during stay and removal) by the same mechanism, the best retention force cannot be obtained for both the puncture and storage of the needles. [Disclosure of the invention] An object of the present invention is to provide a medical needle device whose injection needle can be reliably held during puncture. Another object is to provide a medical needle device that can hold the medical needle to the winged sheath with the best holding force during and after the puncture, and can safely and easily perform medical use after use. The needle is stored in the sheath. The basic structure of the medical needle device of the present invention is a medical needle device with a winged sheath for preventing erroneous puncture, which includes a winged sheath, a protective sleeve having a substantially circular shape, and a front end of the protective sleeve. A pair of wings combined with the side; a needle base that is inserted into the cavity of the aforementioned protective sleeve in a movable manner in the axial direction; and a needle tube that is installed at the front end of the needle base; and the needle tube can cover the front end This way is stored in the inner cavity of the aforementioned protective sleeve. Each of the wing portions has a wing protrusion that protrudes from the wing surface of the base end side region of each wing portion; and the protective sleeve has a through hole formed in the side cylindrical wall for the insertion of the wing protrusions . The two wings are overlapped along the side of the protective sleeve, so that the wing protrusions can be inserted into the protective sleeve through the through hole ____ 5 T, the size of the paper claw is suitable ^ China 0 standard (CNS) A4 specifications (210 X 297 public one " " " ------- -------- Order --------- line (Please read the precautions on the back before filling this page) 506843 A7 ———___ B7___ V. Description of the invention (female) cavity. This allows the wing protrusions to prevent the needle from moving based on the inner axis of the protective sleeve, so that the needle base protrudes from the front end of the protective sleeve by a predetermined length. According to this structure, since the wing portion is clamped and pressed to hold the wing portion during puncture, the wing portion is held firmly and securely by the needle base, It can improve the safety of puncture. Moreover, it is only necessary to operate the same as a general winged needle during puncture, and no special operation is required to increase the holding force of the needle base, so the operation is simple. In the above configuration, each of the wing protrusions is inserted through the through hole. Into the inner cavity of the protective sleeve and abut the needle base, and the friction force caused by the abutment keeps the needle base in the state where the needle tube protrudes a predetermined length from the front end of the protective sleeve It is also preferable that the pair of through holes corresponding to one of the pair of wing protrusions is formed on two side walls of the protective sleeve respectively. The through holes are connected on both sides of the protective sleeve to form 1 It is preferable that the thickness of the base end side region of each wing part is thinner than the front end side. It is also preferable that the outer surface of the bottom of the protective sleeve is flat. In the basic structure described above, The needle base is provided with a main pipe portion and a holding portion located near the front end of the main pipe portion. The holding portion has a large diameter portion having a larger diameter than the main tube portion, and a stepped portion is formed on the outer surface of the rear portion of the large diameter portion; The two wing portions are overlapped along the side of the protective sleeve, so that the wing protrusions can be engaged with the stepped portion of the needle base through the through hole; the wing protrusions can be engaged with the stepped portion of the needle base, so that the needle base On the aforementioned needle Protruding the predetermined length of the front end of the protective sleeve to keep it at __ 6 This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) * ........... 1 n H 11 1—-1 J i ii nn · nnnnn It I— 『· I m --- 1 i SI n Hi I (Please read the precautions on the back before filling this page) 506843 A7 ____B7 ________ V. Description of the invention (≪) The inside of the protective sleeve does not move toward the base end side. With this structure, the needle base can be held more reliably and firmly. In this structure, it is preferable that the protective sleeve further has a rear end formed on the protective sleeve. The rear end locking portion on the inner peripheral surface of the inner portion, the inner diameter of the rear end locking portion is smaller than that of the needle base holding portion, and an annular groove is formed on the middle portion in the axial direction; When the protective sleeve is moved toward the base end side in the axial direction, a large portion of the diameter of the needle base holding portion can be engaged with the annular groove of the locking portion at the rear end of the protective sleeve, and the needle can be caused by the engagement. The needle tube is held in the protective sleeve in a state where the needle tube is stored in the inner cavity of the protective sleeve. Furthermore, it is preferable that the holding portion of the needle base further has an outer annular protrusion at a rear portion of the large-diameter portion, and an annular shape is formed on an outer surface between the large-diameter portion and the outer annular protrusion. Each wing protrusion is inserted into the inner cavity of the protective sleeve through the through hole and can be engaged with the annular groove of the needle base, and the needle base projects from the sheath through the needle tube by the engagement The front end of the cylinder is kept in the aforementioned protective sleeve under a predetermined length. In this structure, it is preferable that the protective sleeve further has a rear end locking portion formed on an inner peripheral surface of a rear end portion thereof, and the rear end locking portion includes an inner annular protrusion, so that the needle base is opposite to the protection portion. The sleeve is moved toward the proximal end side in the axial direction, so that the inner annular protrusion can be engaged with the annular groove of the needle base, and through the engagement, the needle base can store the needle tube in the protective sleeve. The inner cavity is held in the aforementioned protective sleeve. Preferably, the protective sleeve further has a front end protrusion, which is formed on an inner peripheral surface of an axial position substantially consistent with the through hole; the front end protrusion of the protective sleeve may be engaged with the needle base. The segment difference ____ 7 This paper size is applicable to the national standard (CNS) A4 specification (210 X 297 mm) ----------- order --- ------ (Please read the precautions on the back before filling this page) 506843 A7 _____B7__ V. Description of the invention (t) (Please read the precautions on the back before filling out this page). Under this state of engagement, The two wing portions are overlapped along the side of the protective sleeve, and the wing protrusions can be engaged with the stepped portion of the needle base through the through hole; the front end protrusions or the wing protrusions can be engaged with the needle base. The stepped portion keeps the aforesaid needle base in a state where the needle tube protrudes from the length of the front end of the protective sleeve so that the needle base does not move toward the base end side. According to this structure, the holding force for holding the medical needle to the winged sheath at the time of puncturing and after the puncturing is set to be optimal, respectively. In this structure, it is preferable that the holding portion of the needle base further has an external annular protrusion on a rear portion of the large diameter portion, and on an outer surface between the large diameter portion and the external circular protrusion. Forming an annular groove; engaging the front end protrusion of the protective sleeve or the aforementioned wing protrusion with the annular groove of the needle base can obtain the same function as the retaining function obtained by the aforementioned stepped portion. -The line is further preferably such that the two wing portions are overlapped along the side of the protective sleeve, and the two wing portions are placed on the respective wings in a state where the step portion of the needle base is engaged with the wing protrusions. The position of the protrusion is clamped and pressed, so that the holding force on the needle base is greater than the holding force caused by the engagement between the difference between the needle base segment and the front end protrusion. In the above-mentioned basic structure, it is preferable that a retaining rod is formed on the upper surface of the protective sleeve. The person performing the medical treatment can easily prevent the protective sleeve from moving during the operation by abutting a finger on the holding lever '. Furthermore, it is preferable to further include an auxiliary holding mechanism provided at the base end portion of the protective sleeve and an auxiliary holding portion formed at the rear portion of the needle base; the auxiliary holding mechanism includes a rotating piece and is mounted on the base of the protective sleeve. The outer surface of the end; the auxiliary protrusion provided on the rotating blade; and the through hole 'provided in the aforementioned sheath 8 ____ by the national standard (CNS) A4 specification (210 > < 297 mm Γ 506843 A7 __ _ B7___ 5 2. Description of the invention (?) On the cylinder wall, the auxiliary protrusion can be inserted into the inner cavity of the protective sleeve by the rotation of the rotating piece; the auxiliary holding portion includes an auxiliary annular groove formed on the outer surface of the needle base or Auxiliary annular protrusion; the auxiliary protrusion is engaged with the auxiliary annular groove or auxiliary annular protrusion of the needle base through the through hole, and the state in which the needle tube protrudes only the predetermined length of the protective sleeve can be generated [The best embodiment of the invention] (Embodiment 1) FIG. 1 is a plan view of a medical needle device according to Embodiment 1 of the present invention. 1 is a needle tube and is fixed. A hose 3 is connected to the front end of the resin-based needle base 2. The rear end of the needle base 2 is connected with a hose 3, which is a winged sheath, and includes a substantially cylindrical resin-made protective sleeve 4a, and left and right wings 5, 6. The needle tube 1 and the needle base 2 are inserted into the inner cavity of the protective sleeve 4a and can be moved in the axial direction. Both the left and right wings 5 and 6 are provided at the front end of the protective sleeve 4a, that is, the end of the protruding side of the needle tube 1. The wings 5 and 6 are respectively connected to both sides of the outer peripheral surface of the protective sleeve 4a, and have symmetrical shapes with respect to the axis of the protective sleeve 4a. A needle cover 18 is mounted on the front end of the needle base 2. And is covered with the needle tube 1. The different ridges 5 and 6 are divided into front-end side regions 5a, 6a and base-end side regions (combination regions with the protective sleeve 4a) 5b, 6b. The base-end side regions 5b, 6b are respectively formed with wings Protrusions 7, 8. The left and right side walls of the protective sleeve 4a corresponding to the wing protrusions 7, 8 are formed with through holes 9, 10. The front ends 5a, 6a are formed with convex ribs u, 12 and strip grooves 13, 14formation.
圖2A表示附翼護套4之剖面形狀。圖2B表示圖2A 適用中國國家標準（CNsGTi^ _(iI〇_x 29f公釐_)~ ^ — ---------------------訂-----—線 (請先閱讀背面之注意事項再填寫本頁) 506843 A7 ^___B7_____ 五、發明說明（2 ) 於A-A方向上之剖面。翼部5、6之基端側區5b、6b之厚 度比起前端側區5a、6a之厚度爲薄。因此翼部5、6於基 端側區5b、6b處容易彎曲。 圖2A於B-B方向上沿護套筒4a之軸方向剖面係以圖 3表示。護套筒4a前端側內周面之上下有前端部突起15、 16形成。前端部突起15、16於軸方向之位置大致上與貫 通孔9、10之位置爲一致。護套筒4a之後端部內周面上有 後端卡止部17形成。後端卡止部17包括徑小邰17a及形 成於周方向之內方環狀突起..17b。對於徑小部17a ’內方環 狀突起17b以既定之間隔被安置並藉此形成環狀槽17c ° 圖4A表示針基2之外觀形狀。圖4B爲其軸方向上之 剖面圖。針基2具有軸方向中央部之主管部2a及形成於其 前端部之保持部2b及形成於後端部之規制部2c。主管部 2a之外徑比起護套筒4a之徑小部17a及內方環狀突起 之內徑爲小。因此，在主管部2a對向徑小部17a及內方環 狀突起17b之範圍內，可使護套筒4a對針基2於軸方向上 自由移動。保持部2b之更前端側及規制部2c之更後端側 部分係與主管部2a同徑。 針基2之規制部2c之外徑比起護套筒4a之徑小部 17a之內徑爲大。因此，於規制部2c與主管部2a交接處 所形成之段差部若與徑小部17a，亦即護套筒4a之後端相 抵接，可阻止針基2往護套筒4a之前端方向再移動。藉此 ，可防止針管1突出護套筒4a既定之長度以上。 針基2之保持部2b由徑大部2d、環狀槽及外方環 _ 10 __ $纟氏張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） --------------------訂·------11 (請先閱讀背面之注意事項再填寫本頁) 506843 A7 ____B7____-- 五、發明說明（^ ) 狀突起2f形成。徑大部2d及外方環狀突起2f之外徑比起 護套筒4a前端部突起15、16於徑方向之間隔稍大。 將針基2裝於護套4時係將針基2***護套筒4之前 端使向基端側移動。首先規制部2c會與後端卡止部17抵 接。因爲規制部2c之後端側如圖所示裝有膠帶’因樹脂之 柔軟性使可容易通過後端卡止部。大致同時’針基2之外 方環狀突起2f會與前端部突起15、16抵接。再者藉使針 基2強制向基端側移動，前端部突起15、16會越過外方環 狀突起2f，且前端部突起15、16會卡合於環狀槽2e上。 由以上之結果，形成了如圖1所示之狀態。圖1中針 基2在使用位置，而可得到針管1以既定長度由護套筒4a 前端突出之狀態。藉前端部突起15、16與環狀槽2e之卡 合，可阻止針基2在護套筒4a內往軸方向移動，使針基2 可保持於護套筒4a內。如上所述圖1所示之狀態中針管1 要再往軸方向前端側之移動會被規制部2c與徑小部17a之 卡合所阻止。因此，前端部突起15、16與環狀槽之卡 合對使針基2不向護套筒4a基端側移動並能保持具有主要 作用。 將該針基2保持於使用位置具有於針管1穿刺患者後 被滯留時，防止針管丨在附翼護套4中向基端側移動並從 患者身上脫落等未料到事故發生之功能。另一方面，使用 後廢棄醫療用針裝置時，爲防止誤穿刺會將針管1收納於 護套筒4a內。此時，因會使針基2往護套筒4a之後端側 移動’於使用位置上之上述保持力會過強不易操作。因此 --------- 11 本紙張尺度適用由國國家標準（CNS^i^i巧11111x 297公爱）-- --------------------訂--------- (請先閱讀背面之注意事項再填寫本頁) 506843 A7 _J7_____ 五、發明說明（L0) 於使用位置之保持力要設定於不會很簡單的脫離保持且不 會使收納針管1造成困難之範圍內。 本實施形態中，卡合於針基2環狀槽2e之護套筒4a 前端部突起15、16僅於內周之上下部分形成。藉此，藉卡 合使保持力被調整至較弱些。惟並非因此對前端部突起15 、16之形成範圍設限，亦可以用改變前端部突起15、16 之突起量等之藉其他結構來調整保持力。 徑大部2d及外方環狀突起2f之外徑比起護套筒4a之 徑小部17a及內方環狀突起17b之內徑爲大。因此’由圖 1之狀態使針基2向護套筒4a之後端方向移動’解除前端 部突起15、16與環狀槽2e之卡合’再使針基2往後端方 向移動時，首先外方環狀突起2f會與內方環狀突起17b抵 接。外方環狀突起2f如圖4所示在後部具有膠帶，且其外 徑比內方環狀突起17b之內徑只稍大，因此藉再將針基2 強制移動，可以容易的通過內方環狀突起17b。外方環狀 突起2f—旦通過內方環狀突起17b，則外方環狀突起2f會 卡合於環狀槽17c。又，藉由該等卡合，可阻止針基2在 護套筒4a內往軸方向移動，使針基2可於護套筒4a內保 持於收納位置。該收納位置係針管1被收納於護套筒4a內 ’爲防止誤穿刺之狀態。 該收納位置上針基2之保持力必須很強。其原因爲’ 通常希望由防止誤穿刺之狀態不必再使針管1往突出方向 移動針基2，就可使針基2確實保持於收納位置。依上述 結構，於收納位置上針基2之保持力較使用位置上之保持 . _ 12_—_____ .私.紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ϋ «n H ϋ H ϋ ϋ —i n n u 0 i I i ft I— n n 一^^ fl n flu n n n Is n K (請先閲讀背面之注意事項再填寫本頁) 506843 A7 __ ___B7 _;______ 五、發明說明（U ) ' 力大很多。其原因是，與前端部突起15、16不同處在於針 基2保持部2b與護套筒4a後端卡止部Π之卡合是由瓌繞 全內周所形成之環狀突起所形成的。 後端卡止部17亦可將徑小部17a置換爲內方環狀突起 17b來構成。亦即，護套筒4a之後端僅由內方環狀突起 17b形成，並沒有形成環狀槽17c之結構。此種情形下， 針基2保持部2b與護套筒4a後端卡止部17之卡合僅由內 方環狀突起17b與環狀槽2e之卡合所進行。 圖5A〜5C表示裝於翼部5、6之翼突起7 ' 8之作用。 同圖亦表示圖1於C-C方向上之剖面。惟，考量圖之易看 性，針基2以外之剖面線被省略。該使用翼部5、6之操作 係於穿刺時進行。該情形下，必須將針基置於圖1所示之 使用位置，使針基2之環狀槽2e對向貫通孔9、10。因爲 通常醫療用針裝置係以圖1之狀態下被提供使用’針管1 ,對於附翼護套4已在穿刺時之適當位置上，故使用時不必 決定其位置。又，若依本實施型態，因圖1之狀態係以環 狀槽2e與前端部突起15、16之卡合來保持，故可防止穿 刺前產生位置之滑動。 如圖5A所示，若將翼部5、6沿護套筒4a之外表面 往上提，則翼突起7、8會對向貫通孔9、10。如圖5B所 示，將翼部5、6再往上提，則翼突起7、8會***貫通孔 9、10，並貫通護套筒4a之內壁突出至內腔。其結果爲， 針基2之環狀槽2e會與翼突起7、8之前端部卡合。藉此 ，針基2，亦即，針管1會保持於附翼護套4內。 ________ 13 本纸m尺度適用中國國家標準（CNS)i4規i"(2l〇 X 297公爱1 ^^ --------------------•訂·--------線 (請先閲讀背面之注意事項再填寫本頁) 506843 A7 _____B7__ 五、發明說明（（>) 再者，如圖5C所示，若將兩翼部5、6疊合，則凸條 ’ 11、12會分別與條形槽13、14嵌合。藉此，兩翼部5、6 之相互位置會以既定之關係被疊合。因此，圖5Β所示之 步驟中即使翼突起7、8未適切的被***貫通孔9、10，其 相互位置關係仍會修正使上述之卡合可確實進行。 再者’穿刺時之保持力亦可不使用環狀槽2e與翼突起 7、8之卡合，而由摩擦力得到。亦即，結構亦可爲在針基 2之外表面按壓翼突起7、8之前端，藉此由按壓力所產生 之摩擦力會阻止針基2移動_。 爲使該翼突起7、8之***圓滑，必須精確設定翼突起 7、8與貫通孔9、10之相互位置關係。又，如上述，藉將 基端側區5b、6b之厚度變薄，可使翼部5、6在上提時， 沿護套筒4a外面容易滑動。 上述操作因在穿刺時進行，故藉翼突起7、8與針基2 之卡合產生之針基2保持力必須足夠牢固。亦即，比起上 述前端部突起15、16與環狀槽2e之卡合產生之保持，必 須要有可作用之更強保持力。穿刺操作因係以手指夾住兩 翼部5、6進行按壓，故很容易得到足夠之保持力。但是必 須留意確實設定翼突起7、8之形狀或尺寸。特別是，不使 用與環狀槽2e之卡合，而僅使用針基2與翼突起7、.8之 摩擦卡合之情形下，翼突起7、8之長度必須足夠長。例如 ’如圖5(c)所示翼突起7、8之長度L1希望是比貫通孔9 、1〇縱向之L2爲大。具體而言，希望是在1<l1/L2£2.5 之範圍。 ____ 14 本中國國家標準（CNS)A4^iir(210 x 297公爱) (請先閱讀背面之注意事項再填寫本頁)FIG. 2A shows a cross-sectional shape of the winged sheath 4. Figure 2B shows that Figure 2A applies the Chinese National Standard (CNsGTi ^ _ (iI〇_x 29fmm_) ~ ^---------------------- Order- ----- Line (please read the notes on the back before filling this page) 506843 A7 ^ ___ B7_____ V. Description of the invention (2) Section in the AA direction. The base end side areas 5b, 6b of the wings 5 and 6 The thickness is thinner than the thicknesses of the front end side regions 5a, 6a. Therefore, the wings 5 and 6 are easily bent at the base end side regions 5b, 6b. Fig. 2A is a diagram along the BB direction along the axial direction of the protective sleeve 4a Indicated by 3. The protective sleeve 4a is formed with front end protrusions 15 and 16 above and below the inner peripheral surface of the front end side. The positions of the front end protrusions 15 and 16 in the axial direction substantially coincide with the positions of the through holes 9 and 10. The protective sleeve After the 4a, the rear end locking portion 17 is formed on the inner peripheral surface of the end portion. The rear end locking portion 17 includes a small diameter ridge 17a and an inner annular protrusion formed in the circumferential direction .. 17b. For the small diameter portion 17a 内 内The ring-shaped protrusions 17b are arranged at predetermined intervals, thereby forming the ring-shaped groove 17c. Fig. 4A shows the external shape of the needle base 2. Fig. 4B is a sectional view in the axial direction. The needle base 2 has a central portion in the axial direction. 2a and The holding portion 2b formed at the front end portion and the regulation portion 2c formed at the rear end portion. The outer diameter of the main pipe portion 2a is smaller than the inner diameter of the small diameter portion 17a of the protective sleeve 4a and the inner annular protrusion. Therefore, The protective sleeve 4a can move freely in the axial direction with respect to the needle base 2 within the range of the small diameter portion 17a and the inner annular protrusion 17b of the main portion 2a. The front end side of the holding portion 2b and the regulation portion 2c The rear-end side portion has the same diameter as the main pipe portion 2a. The outer diameter of the regulation portion 2c of the needle base 2 is larger than the inner diameter of the small portion 17a of the protective sleeve 4a. If the step formed at the junction of 2a is in contact with the small diameter portion 17a, that is, the rear end of the protective sleeve 4a, the needle base 2 can be prevented from moving toward the front end of the protective sleeve 4a. This can prevent the needle tube 1 from protruding and protecting The sleeve 4a has a predetermined length or more. The holding portion 2b of the needle base 2 is composed of a large diameter portion 2d, an annular groove and an outer ring. _ 10 __ $ Zhang's scale is applicable to China National Standard (CNS) A4 (210 X 297 male) Li) -------------------- Order · ------ 11 (Please read the notes on the back before filling this page) 506843 A7 ____ B7 ____-- 5 Invention description (^) Shaped protrusions 2f are formed. The outer diameter of the large diameter portion 2d and the outer annular protrusion 2f is slightly larger than the radial distance between the protrusions 15 and 16 of the front end of the protective sleeve 4a. The needle base 2 is attached to the sheath At 4 o'clock, the needle base 2 is inserted into the front end of the protective sleeve 4 and moved toward the base end side. First, the regulation portion 2c will abut against the rear end locking portion 17. Because the regulation end 2c is provided with tape as shown in the figure 'Because of the softness of the resin, it can easily pass through the rear end locking portion. At about the same time, the outer ring-shaped protrusion 2f outside the needle base 2 comes into contact with the tip protrusions 15 and 16. Furthermore, if the needle base 2 is forcibly moved toward the proximal end side, the front end protrusions 15 and 16 will pass over the outer ring-shaped protrusion 2f, and the front end protrusions 15 and 16 will be engaged with the annular groove 2e. As a result, the state shown in FIG. 1 is formed. In Fig. 1, the needle base 2 is in the use position, and a state where the needle tube 1 protrudes from the front end of the protective sleeve 4a with a predetermined length can be obtained. By engaging the front end protrusions 15 and 16 with the annular groove 2e, the needle base 2 can be prevented from moving in the axial direction in the protective sleeve 4a, and the needle base 2 can be held in the protective sleeve 4a. In the state shown in FIG. 1 as described above, further movement of the needle tube 1 toward the front end side in the axial direction is prevented by the engagement of the regulation portion 2c and the small diameter portion 17a. Therefore, the engagement of the front end protrusions 15 and 16 with the annular groove has a major effect on preventing the needle base 2 from moving toward the base end side of the protective sleeve 4a. Holding the needle base 2 in the use position has the function of preventing the needle tube 丨 from moving toward the proximal end side in the winged sheath 4 and falling off the patient when the needle tube 1 is detained after being punctured by the patient. On the other hand, when the medical needle device is discarded after use, the needle tube 1 is stored in the protective sleeve 4a to prevent accidental puncture. At this time, since the needle base 2 is moved toward the rear end side of the protective sleeve 4a 'at the use position, the above-mentioned holding force is too strong and difficult to operate. Therefore --------- 11 this paper size applies to national standards (CNS ^ i ^ i 巧 11111x 297 public love) --------------------- --- Order --------- (Please read the precautions on the back before filling this page) 506843 A7 _J7_____ V. Description of the invention (L0) It is not easy to set the holding force in the use position It is within a range that does not cause difficulty in storing the needle tube 1. In this embodiment, the protrusions 15 and 16 at the front end of the protective sleeve 4a engaged with the annular groove 2e of the needle base 2 are formed only on the upper and lower portions of the inner periphery. With this, the holding force is adjusted to be weaker by the engagement. However, instead of limiting the forming range of the front end protrusions 15 and 16, the holding force may be adjusted by other structures such as changing the protrusion amount of the front end protrusions 15 and 16. The outer diameters of the large-diameter portion 2d and the outer annular protrusion 2f are larger than the inner diameters of the small-diameter portion 17a and the inner annular protrusion 17b of the protective sleeve 4a. Therefore, when "the needle base 2 is moved toward the rear end of the protective sleeve 4a from the state shown in Fig. 1", the engagement of the front end protrusions 15, 16 and the annular groove 2e is released, and then the needle base 2 is moved toward the rear end. The outer annular protrusion 2f comes into contact with the inner annular protrusion 17b. As shown in Fig. 4, the outer annular protrusion 2f has tape at the rear portion, and its outer diameter is only slightly larger than the inner diameter of the inner annular protrusion 17b. Therefore, by forcibly moving the needle base 2, it can easily pass through the inner side. Ring-shaped protrusion 17b. Outer annular protrusion 2f-Once the inner annular protrusion 17b passes, the outer annular protrusion 2f is engaged with the annular groove 17c. In addition, by such engagement, the needle base 2 can be prevented from moving in the axial direction in the protective sleeve 4a, and the needle base 2 can be held in the storage position in the protective sleeve 4a. This storage position is a state where the needle tube 1 is stored in the protective sleeve 4a 'to prevent accidental puncture. The holding force of the needle base 2 in this storage position must be strong. The reason is that it is generally desirable that the needle base 2 can be reliably held in the storage position without moving the needle base 2 in the protruding direction from the state of preventing accidental puncture. According to the above structure, the holding force of the needle base 2 in the storage position is better than that in the use position. _ 12 _—_____. Private. The paper size applies the Chinese National Standard (CNS) A4 (210 X 297 mm) ϋ «n H ϋ H ϋ ϋ —innu 0 i I i ft I— nn ^^ fl n flu nnn Is n K (Please read the precautions on the back before filling out this page) 506843 A7 __ ___B7 _; ______ 5. Description of the invention (U ) 'Much more powerful. The reason is that the difference from the front end protrusions 15 and 16 is that the engagement between the needle base 2 holding portion 2b and the rear end locking portion Π of the protective sleeve 4a is formed by a ring-shaped protrusion formed around the entire inner periphery. . The rear end locking portion 17 may be configured by replacing the small-diameter portion 17a with an inner annular projection 17b. That is, the rear end of the protective sleeve 4a is formed only by the inner annular protrusion 17b, and there is no structure in which the annular groove 17c is formed. In this case, the engagement of the needle base 2 holding portion 2b and the rear end locking portion 17 of the protective sleeve 4a is performed only by the engagement of the inner annular protrusion 17b and the annular groove 2e. 5A to 5C show the effects of the wing protrusions 7'8 attached to the wing portions 5,6. The same figure also shows the cross section of FIG. 1 in the C-C direction. However, in consideration of the ease of view of the figure, the section lines other than the base 2 are omitted. The operation using the wings 5 and 6 is performed during puncture. In this case, the needle base must be placed in the use position shown in Fig. 1 so that the annular groove 2e of the needle base 2 faces the through holes 9, 10. Since the medical needle device is usually provided and used in the state shown in FIG. 1, the needle tube 1 is already in a proper position for the winged sheath 4 at the time of puncture, so it is not necessary to determine its position during use. In addition, according to this embodiment, the state shown in Fig. 1 is held by the engagement of the annular groove 2e and the front end protrusions 15 and 16, so that it is possible to prevent the position from slipping before puncturing. As shown in FIG. 5A, if the wing portions 5, 6 are lifted up along the outer surface of the protective sleeve 4a, the wing protrusions 7, 8 face the through holes 9, 10. As shown in FIG. 5B, if the wings 5 and 6 are lifted up again, the wing protrusions 7, 8 are inserted into the through holes 9, 10, and penetrate through the inner wall of the protective sleeve 4a to protrude to the inner cavity. As a result, the annular groove 2e of the needle base 2 is engaged with the front end portions of the wing protrusions 7 and 8. Thereby, the needle base 2, that is, the needle tube 1 will be kept in the winged sheath 4. ________ 13 The m scale of this paper applies the Chinese National Standard (CNS) i4 Regulations (2l0X 297 Public Love 1 ^^ -------------------- • Order · -------- Line (Please read the notes on the back before filling this page) 506843 A7 _____B7__ V. Description of the invention (>) Furthermore, as shown in Figure 5C, if the two wings 5, 6 When superimposed, the convex strips 11 and 12 are respectively fitted with the strip grooves 13 and 14. Thus, the mutual positions of the two wings 5 and 6 are superimposed in a predetermined relationship. Therefore, the step shown in FIG. 5B Even if the wing protrusions 7 and 8 are not properly inserted into the through-holes 9 and 10, their positional relationship will still be corrected so that the above-mentioned engagement can be performed reliably. Furthermore, the retaining force during puncturing can be eliminated without using the annular groove 2e and The engagement of the wing protrusions 7 and 8 is obtained by the friction force. That is, the structure can also be that the front end of the wing protrusions 7 and 8 is pressed on the outer surface of the needle base 2, so that the frictional force generated by the pressing force will be prevented. Needle base 2 moves _. In order to make the insertion of the wing protrusions 7 and 8 smooth, the positional relationship between the wing protrusions 7 and 8 and the through holes 9 and 10 must be accurately set. Also, as described above, the base end side regions 5b, 6b of The thickness becomes thinner, so that the wings 5 and 6 can easily slide along the outside of the protective sleeve 4a when being lifted up. The above operation is performed during puncture, so the needles generated by the engagement of the wing protrusions 7, 8 and the needle base 2 The holding force of the base 2 must be sufficiently strong. That is, it must have a stronger holding force than the holding caused by the engagement of the front end protrusions 15, 16 and the annular groove 2e. The puncture operation is performed by a finger clamp It is easy to obtain sufficient holding force by pressing the two wing portions 5 and 6. However, care must be taken to ensure that the shape or size of the wing protrusions 7 and 8 is set. In particular, the engagement with the annular groove 2e is not used but only used. In the case of the frictional engagement between the needle base 2 and the wing protrusions 7, 8.8, the length of the wing protrusions 7, 8 must be sufficiently long. For example, 'as shown in FIG. 5 (c), the length L1 of the wing protrusions 7, 8 is preferably longer than The longitudinal L2 of the through holes 9 and 10 is large. Specifically, it is hoped that it is in the range of 1 < l1 / L2 £ 2.5. ____ 14 This Chinese National Standard (CNS) A4 ^ iir (210 x 297 public love) (Please (Read the notes on the back before filling out this page)
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五、發明說明（丨々） 異突起7、8希望是易***貫通孔9、1〇之形狀及尺 寸。又，解除按壓時，爲直接將翼突起7、8由貫通孔9、 1〇拔出，相對於貫通孔9、10之內徑，翼突起7、8之外 徑稍小些會較易使用。 如上述之例中，翼部5上凸條U及條形槽13，及翼 部6上凸條12及條形槽14被形成，且凸條u及條形槽 13，及凸條12及條形槽14分別卡合，但並不須特別限定 此種組合。例如，一邊之翼部上形成丨條凸條，另—邊之 翼部上形成對應條形槽亦可，一邊之翼部上形成2條凸條 ’另一邊之翼部上形成對應之2條條形槽亦可。 護套筒4a之內腔形狀較佳爲使對應於針基2之外表面 形狀。例如，若針基2之軸上垂直剖面爲圓形，則護套筒 4a之內腔形狀希望亦同樣爲圓形，或至少內腔有一部分爲 圓形。本實施形態中護套筒4a之內腔形狀爲圓形，但內腔 上側對應於針基2之外表面形狀形成曲面，內腔面底部爲 平坦者亦可。又，護套筒4a之外表面底部亦爲平坦的。特 別是，護套筒4a之外表面底部爲了可穩定的配置於患者之 皮膚上，以平坦者爲較佳。 g蒦套同之尺寸當然一定要有可完全收納針管前端之長 度，但其他則不特別限定。較佳爲護套筒內腔徑比起針基 之最大外徑稍大。例如，其結構爲使針基之最大外徑部處 於剛可接觸護套筒內腔面之程度，藉滑動使針基及針管在 護套筒內腔往軸方向移動。 其次，說明關於上述實施形態之醫療用針裝置之使用 15 --------tr---------$· (請先閱讀背面之注意事項再填寫本頁) 本纸張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） 506843 A7 _________ __B7 五、發明說明（丨今） 方法。使用時，如圖1所示，醫療用針裝置係以，安裝有 針管1之針基2上裝設有附翼護套4，且針管丨上被覆有 針套18之狀態下被提供。 施行醫療的人一手將兩翼部5、6疊合握持，而另一手 將針套18從針管1處拔去。接著，如圖5B及c所示，將 兩翼部往上提，利用翼突起7、8之部分握持翼部5、6。 於此狀態下，翼突起7、8會貫通貫通孔9、10，並與針基 2之環狀槽2e卡合。因此，使針管丨與針基2保持成不能 於護套筒4a內自由移動。於此狀態下，針管1被穿刺入患 者體內。 針管1被穿刺入患者後，把疊合之兩翼部5、6予以分 開’藉由黏著膠帶將翼部5、6固定於患者之皮膚上。於此 狀態下，翼突起7、8雖然不卡合於針基2，但護套筒4a 之前端突起15、16會卡合於針基2之環狀槽2e，其保持 力雖較使用翼部5、6時爲弱，但針基2仍可保持於護套筒 .4a內。因此，可以防止針管1在護套筒4a內往軸方向基 端側移動以致針管從患者體內被拔出。 對患者體內之藥液注入完畢後，於翼部5、6固定著之 狀態下，或邊將翼部5、6以手押住，邊將軟管3往護套筒 4a之基端側拉動。藉此，保持力弱之前端突起15、16與 針基2之環狀槽2e間之卡合會分離，使針基2可移動。再 者，若進一步將軟管3往護套筒4a之基端側拉動，到前端 部爲止之整支針管均會完全收納於護套筒4a內，而得到防 止誤穿刺之狀態。同時，針基2之保持部2b與護套筒4a 16_ 本紙張尺度適用中國國家標準（CNS)A4規格（210 χ 297公釐） ——--------— ------訂---------線 (請先閒讀背面之注意事項再填寫本頁) 506843 A7 ___B7____ 五、發明說明（ 之後端卡止部17會卡合’而形成針基2牢固地保持於護套 筒4a內收納位置之狀態。 (實施形態2) 圖6表示實施形態2中構成醫療用針裝置之附翼護套 。該附翼護套係除了在實施形態1之結構，尙在護套筒4a 上面加設保持桿2〇。如上述’醫療用針裝置使用後係將連 接於針基之軟管向護套筒4a之基端側拉動，於誤穿刺防止 狀態下將針基保持於護套筒-4a內。保持桿20係爲了於此 時將護套筒固定使不會移動所使用。亦即，將手指置於保 持桿上，藉抵抗軟管之拉動力，使將針基往護套筒4a基端 側拉動之操作變得容易。 (實施形態3) 圖7係表示實施形態3中構成醫療用針裝置之附翼護 套。該附翼護套係除了在實施形態1之結構，尙在護套筒 4a之基端部上面加設包括旋動片21之輔助保持結構。圖 7A爲其俯視圖，圖7B爲圖7A於D-D方向上之剖面圖。 旋動片21於其長手方向單側被固定於護套筒4a。另一側 具有可在護套筒4a之軸周圍旋動之突起22。被固定之部 分形成貫通孔23。護套筒4a之圓筒壁上設有與貫通孔23 連接之貫通孔。 圖8表τκ圖7中所不與護套筒4a組合使用之針基2。 該針基2之後部設有環狀突起24與環狀槽25所形成之輔 _ 17 I纸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) r 訂i —線- 506843 B7 五、發明說明（（ 助保持部。該針基2***於圖7之附翼護套’且規制部2C 於與護套筒4a基端抵接之狀態，亦即，於上述使用狀態下 ，輔助保持部之環狀槽25之位置與旋動片21之貫通孔23 位置爲一致的。 於該狀態下’藉使旋動片旋動將突起22***於貫通孔 23，突起22之前端會卡合於環狀槽25。藉此’可賦予針 基2對於護套筒4 a保持之保持力° g亥保持力相Μ於藉護套 筒4a前端部突起15、16與針基2環狀槽2e之卡合所得到 之保持力，爲輔助性之加成。不須要輔助性保持力時，或 使用後將針基2收納於護套筒4a時，則將旋動片21之突 起22由貫通孔23拔出。 若適當設定突起22與貫通孔23之徑，並使突起22 壓入貫通孔23 ’則亦可於該狀態下固定。又’環狀突起24 與環狀槽25中’僅靠一個亦可得到同樣之保持作用。 藉上述實施形態，補強了穿刺後相對較弱之保持力， 使針滯留時與針收納時之保持力不同，可設定爲兩段式之 保持力。 (實施形態4) 圖9表示實施形態4之醫療用針裝置。該裝置中針基 2之保持部僅以徑大部2d所構成。護套筒4a之後端部僅 由徑小部17a所形成。其他之結構與實施形態1相同。 該結構中，藉針基2之徑大部2d與其後部交接處形成 之段差部26，可達到使用時之保持作用。亦即，藉翼突起 18 適用中國國家(CNS)A4 規格（210 X 297 公t ) ' — ---- ------------------—訂---------線 (請先閱讀背面之注意事項再填寫本頁) 506843 A7 __ B7_______ 五、發明說明 7、8或護套筒4a前端部突起(圖9未圖示)卡合於段差部 26，可防止針基2由圖示位置向護套筒4a後端側移動。藉 此，與實施形態1同樣的，藉翼突起7、8使針基2在穿刺 時之保持，及藉護套筒4a前端部突起，使針基可在穿刺後 之保持可進行。 圖9中雖未圖示針基2於收納狀態下保持之構造，但 只要以任一種周知之構造可得到該種保持之作用即可。 (實施形態5) 圖10表示實施形態5之醫療用針裝置。該裝置中，針 基2之保持部僅以外方環狀突起2f所構成。外方環狀突起 2f係將圖1之徑大部2d替換而配置。其他之結構與實施 形態1相同。 該構成中，藉針基2之外方環狀突起與其後部交接處 所形成之段差部27，可得到保持作用。亦即，藉翼突起7 、8或護套筒4a前端部突起(圖1〇未圖示)卡合於段差部 27，可防止針基2由圖示位置向護套筒4a後端側移動。藉 此，與實施形態1同樣的，藉翼突起7、8使針基2在穿刺 時之保持，及藉護套筒4a前端部突起，使針基在穿刺後之 保持可以進行。 再者，針基2於收納狀態時，外方環狀突起2f係卡合 於護套筒4a後端卡止部17處形成之環狀槽l7c。藉此， 使針基2保持於收納狀態。 ____ 19 ^紙張尺度適甩中國國家標準(CNS)A4規格（210 X 297公爱) ' ^ - -----------------—訂 *-----— (請先閱讀背面之注意事項再填寫本頁) 506843 A7 B7 _ 五、發明說明（（容） 【產業上之可利用性】 依本發明，進行穿刺時對針基之保持會牢固而確實， 而可提高穿刺之安全性。又，因爲穿刺時僅須進行與一般 附翼針相同之操作，故不需要特別之操作，保持針基之保 持力就會提高而使操作簡便。 【圖式之簡單說明】 圖1係表示本發明之實施形態1中具有誤穿刺防止裝 置之附翼醫療用針裝置之俯視形狀剖面圖。 圖2A係表示構成圖1之附翼醫療用針裝置之附翼護 套之俯視形狀剖面圖。 圖2B係圖2A之A-A方向剖面圖。 圖3係圖2A之B-B方向剖面圖。 圖4A係圖1附翼醫療用針裝置之針基前視圖。 圖4B係圖4A針基之軸方向剖面圖。 圖5係表示圖1附翼醫療用針裝置動作之剖面圖。 圖6係表示本發明實施形態2中附翼醫療用針裝置之 附翼護套側視圖。 圖7A係表示本發明實施形態3中附翼醫療用針裝置 之附翼護套俯視圖。 圖7B係圖7A之D-D方向剖面圖。 、 圖8係本發明實施形態3附翼醫療用針裝置之針其 視圖。 、’土 圖9係表示本發明實施形態4附翼醫療用針裝置之俯 I----1----------------訂 - --------* 線 (請先閱讀背面之注意事項再填寫本頁) 20 506843 A7 _ B7_^_ 五、發明說明) 視形狀剖面圖。 . 圖10係表示本發明實施形態5附翼醫療用針裝置之俯 視形狀剖面圖。 【符號說明】 n ί -- - HI 1— n m —1 1— HI m n m i m 1— in 1 · n Hi Ha n i— n -1— I (請先閱讀背面之注意事項再填寫本頁) 1 針管 2 針基 2a 主管部 2b ..保持部 2c 規制部 2d 徑大部 . 2e ^環狀槽 2f 外方環狀突起 3 軟管 4 附翼護套 4a 護套筒 5、6 翼部 5a 〜6a 前端側區 5b、6b 基端側區 7、8 翼突起 9、10 貫通孔 11、12 凸條 13、14 條形槽 15、16 前端部突起 21 1紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐) 506843 A7 _B7 五、發明說明（户） 17 後端卡止部 17a 徑小部 17b 內方環狀突起 17c 環狀槽 18 針套 20 保持桿 21 旋動片 22 突起 23 .....貫通孔 24 環狀突起 25 環狀槽 26 段差部 (請先閱讀背面之注意事項再填寫本頁) C---- 訂----------線一 22 ^纸張尺度適用中國國家標準（CNS)A4規格（210 X 297公爱iV. Description of the invention (丨 々) The different protrusions 7 and 8 are desirably of a shape and size that can be easily inserted into the through holes 9 and 10. In addition, when the wing protrusions 7 and 8 are directly pulled out from the through holes 9 and 10 when the pressing is released, the outer diameters of the wing protrusions 7 and 8 are easier to use than the inner diameter of the through holes 9 and 10. . As in the above example, the convex strip U and the strip groove 13 on the wing portion 5 and the convex strip 12 and the strip groove 14 on the wing portion 6 are formed, and the convex strip u and the strip groove 13 and the convex strip 12 and The strip-shaped grooves 14 are respectively engaged, but the combination is not particularly limited. For example, 丨 ribs can be formed on one side of the wings, and corresponding grooves can be formed on the wings of one side, and 2 ribs can be formed on the wings of one side, and 2 corresponding ones can be formed on the wings of the other side. Strip grooves are also available. The shape of the inner cavity of the protective sleeve 4a preferably corresponds to the shape of the outer surface of the needle base 2. For example, if the vertical section on the axis of the needle base 2 is circular, the shape of the inner cavity of the protective sleeve 4a is desirably also circular, or at least a part of the inner cavity is circular. In this embodiment, the shape of the inner cavity of the protective sleeve 4a is circular, but the upper side of the inner cavity forms a curved surface corresponding to the shape of the outer surface of the needle base 2. The bottom of the inner cavity surface may be flat. The bottom of the outer surface of the protective sleeve 4a is also flat. In particular, the bottom surface of the outer surface of the protective sleeve 4a can be stably placed on the skin of the patient, and it is preferable that it is flat. Of course, the same size of g sleeve must have a length that can fully accommodate the front end of the needle tube, but the other is not particularly limited. Preferably, the inner diameter of the protective sleeve is slightly larger than the maximum outer diameter of the needle base. For example, its structure is such that the maximum outer diameter of the needle base is just close to the surface of the inner cavity of the protective sleeve, and the needle base and the needle tube are moved in the axial direction of the internal cavity of the protective sleeve by sliding. Next, the use of the medical needle device in the above embodiment will be described. 15 -------- tr --------- $ · (Please read the precautions on the back before filling this page) Zhang scale is applicable to China National Standard (CNS) A4 specification (210 X 297 mm) 506843 A7 _________ __B7 V. Description of the invention (丨 present) method. In use, as shown in FIG. 1, the medical needle device is provided with a winged sheath 4 on the needle base 2 on which the needle tube 1 is mounted, and the needle tube 丨 is covered with the needle cover 18. The person performing the medical treatment holds the two wings 5 and 6 in one hand, and pulls the needle cover 18 from the needle tube 1 with the other hand. Next, as shown in FIGS. 5B and c, the two wing portions are lifted up, and the wing portions 5 and 6 are held by the wing protrusions 7 and 8. In this state, the wing protrusions 7 and 8 pass through the through holes 9 and 10 and engage with the annular groove 2e of the needle base 2. Therefore, the needle tube 丨 and the needle base 2 are held so that they cannot move freely within the protective sleeve 4a. In this state, the needle tube 1 is punctured into the patient. After the needle tube 1 is punctured into the patient, the overlapping two wings 5 and 6 are separated 'and the wings 5 and 6 are fixed to the skin of the patient with an adhesive tape. In this state, although the wing projections 7 and 8 are not engaged with the needle base 2, the front end projections 15 and 16 of the protective sleeve 4a are engaged with the annular groove 2e of the needle base 2. The parts 5 and 6 are weak, but the needle base 2 can still be held in the protective sleeve .4a. Therefore, the needle tube 1 can be prevented from moving toward the base end side in the axial direction within the protective sleeve 4a so that the needle tube is pulled out of the patient. After the injection of the medicinal solution into the patient's body, with the wings 5 and 6 fixed, or while holding the wings 5 and 6 by hand, pull the hose 3 toward the base end of the protective sleeve 4a. . Thereby, the engagement between the front end protrusions 15 and 16 and the annular groove 2e of the needle base 2 with weak holding force is separated, so that the needle base 2 can be moved. Furthermore, if the hose 3 is further pulled toward the base end side of the protective sleeve 4a, the entire needle tube up to the front end portion will be completely accommodated in the protective sleeve 4a, and a state of preventing accidental puncture will be obtained. At the same time, the holding part 2b of the needle base 2 and the protective sleeve 4a 16_ This paper size applies the Chinese National Standard (CNS) A4 specification (210 x 297 mm) ------------ ----- -Order --------- Thread (please read the precautions on the back before filling this page) 506843 A7 ___B7____ 5. Description of the invention (the rear end locking portion 17 will be engaged 'to form the needle base 2 firmly It is held in the storage position in the protective sleeve 4a. (Embodiment 2) FIG. 6 shows a winged sheath constituting a medical needle device in Embodiment 2. This winged sheath is in addition to the structure of Embodiment 1,加 A retaining rod 20 is provided on the protective sleeve 4a. As described above, after the medical needle device is used, the hose connected to the needle base is pulled toward the proximal end side of the protective sleeve 4a, and in the state of preventing accidental puncture The needle base is held in the protective sleeve-4a. The holding rod 20 is used to fix the protective sleeve at this time so that it will not move. That is, by placing a finger on the holding rod and resisting the pulling force of the hose, The operation of pulling the needle base toward the proximal end side of the protective sleeve 4a is facilitated. (Embodiment 3) FIG. 7 shows a configuration of a medical needle device in Embodiment 3. With a wing sheath. In addition to the structure of the first embodiment, the auxiliary wing sheath is provided with an auxiliary holding structure including a rotating piece 21 on the base end portion of the protective sleeve 4a. Fig. 7A is a plan view and Fig. 7B 7A is a sectional view in the DD direction. The rotating piece 21 is fixed to the protective sleeve 4a on one side in the long-hand direction. The other side has a protrusion 22 that can be rotated around the axis of the protective sleeve 4a. A through-hole 23 is formed in the part. The cylindrical wall of the protective sleeve 4a is provided with a through-hole connected to the through-hole 23. Fig. 8 shows a needle base 2 which is not used in combination with the protective sleeve 4a in Fig. 7. The needle The rear part of the base 2 is provided with a ring-shaped protrusion 24 and a ring-shaped groove 25. _ 17 I Paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) * --- (Please read the back first Note for refilling this page) r Order i — thread-506843 B7 V. Description of the invention ((Assisting holding part. The needle base 2 is inserted into the winged sheath of FIG. 7) and the regulatory part 2C is connected with the protective sleeve 4a. The state where the base end abuts, that is, in the above-mentioned use state, the position of the annular groove 25 of the auxiliary holding portion and the position of the through hole 23 of the rotating piece 21 are In this state, 'the protrusion 22 is inserted into the through hole 23 by the rotation of the rotating piece, and the front end of the protrusion 22 will be engaged with the annular groove 25. This can give the needle base 2 to the protective sleeve 4 a holding force of holding ° g holding force is a supplementary holding force obtained by engaging the protrusions 15 and 16 of the front end portion of the protective sleeve 4a with the annular groove 2e of the needle base 2 as an auxiliary bonus. When the auxiliary holding force is used, or when the needle base 2 is stored in the protective sleeve 4a after use, the protrusion 22 of the rotating piece 21 is pulled out from the through hole 23. If the diameter of the protrusion 22 and the through hole 23 is appropriately set, and Pressing the protrusion 22 into the through hole 23 'can also be fixed in this state. The same retaining effect can be obtained by using only one of the "ring-shaped protrusion 24 and the ring-shaped groove 25". According to the above-mentioned embodiment, the relatively weak holding force after puncture is reinforced, so that the holding force when the needle stays and when the needle is stored are different, and can be set to a two-stage holding force. (Embodiment 4) Figure 9 shows a medical needle device according to Embodiment 4. The holding portion of the needle base 2 in this device is constituted only by a large diameter portion 2d. The rear end portion of the protective sleeve 4a is formed only by the small diameter portion 17a. The other structures are the same as those of the first embodiment. In this structure, the step portion 26 formed at the junction of the large-diameter portion 2d of the needle base 2 and its rear portion can achieve the retaining effect during use. That is, the wing protrusion 18 is applicable to China National (CNS) A4 specifications (210 X 297 mm t) '— ---- ------------------— order- ------- Thread (please read the precautions on the back before filling this page) 506843 A7 __ B7_______ V. Description of the invention 7, 8 or the protrusion of the front end of the protective sleeve 4a (not shown in Figure 9) is engaged with The step portion 26 prevents the needle base 2 from moving toward the rear end side of the protective sleeve 4a from the position shown in the figure. Thus, as in the first embodiment, the needle base 2 is retained during puncture by the wing projections 7 and 8 and the front end portion of the protective sleeve 4a is protruded, so that the needle base can be retained after the puncture. Although the structure in which the needle base 2 is held in the storage state is not shown in FIG. 9, any kind of well-known structure can be used to obtain such a holding effect. (Embodiment 5) Figure 10 shows a medical needle device according to Embodiment 5. In this device, the holding portion of the needle base 2 is composed of only the outer annular projection 2f. The outer annular protrusion 2f is arranged by replacing the large-diameter portion 2d of FIG. 1. The other structures are the same as those of the first embodiment. In this configuration, the step portion 27 formed by the intersection of the outer ring-shaped protrusion of the needle base 2 and the rear portion thereof can obtain a holding effect. That is, the wing protrusions 7 and 8 or the front end protrusion of the protective sleeve 4a (not shown in FIG. 10) are engaged with the step portion 27 to prevent the needle base 2 from moving from the position shown to the rear end side of the protective sleeve 4a . Thus, as in the first embodiment, the needle base 2 can be held during puncture by the wing protrusions 7, 8 and the front end portion of the protective sleeve 4a can be protruded to allow the needle base to be held after the puncture. When the needle base 2 is in the stored state, the outer annular protrusion 2f is engaged with an annular groove 17c formed at the locking portion 17 at the rear end of the protective sleeve 4a. Thereby, the needle base 2 is maintained in the storage state. ____ 19 ^ The paper size is suitable for the Chinese National Standard (CNS) A4 specification (210 X 297 public love) '^------------------— Order * ----- — (Please read the precautions on the back before filling this page) 506843 A7 B7 _ V. Description of the invention ((capacity) [Industrial applicability] According to the present invention, the needle base will be firmly and reliably maintained during puncture. It can improve the safety of puncture. Also, because only the same operation as that of a general winged needle is required during puncture, no special operation is required, and the holding force of the needle base will be improved, making the operation simple. [Schematic Brief description] Fig. 1 is a plan sectional view showing a winged medical needle device having an erroneous puncture prevention device according to a first embodiment of the present invention. Fig. 2A is a view showing the wing of the winged medical needle device of Fig. 1 2B is a cross-sectional view taken along the line AA in FIG. 2A. FIG. 3 is a cross-sectional view taken along the line BB in FIG. 2A. FIG. 4A is a front view of the needle base of the medical needle device with wings in FIG. Fig. 4A Axial sectional view of the needle base. Fig. 5 is a sectional view showing the operation of the medical needle device with wings in Fig. 1. Fig. 6 Fig. 7A is a plan view of a winged sheath of a winged medical needle device according to a second embodiment of the present invention. Fig. 7A is a plan view of a winged sheath of a winged medical needle device according to a third embodiment of the present invention. Sectional view in the direction of DD. FIG. 8 is a view of the needle of the winged medical needle device according to the third embodiment of the present invention. 'Earth view 9 shows the top view of the winged medical needle device according to the fourth embodiment of the present invention. 1 ---------------- Order--------- * Line (Please read the precautions on the back before filling this page) 20 506843 A7 _ B7 _ ^ _ 5 2. Description of the invention) Cross-sectional view of shape. Fig. 10 is a sectional view showing the shape of a medical needle device with a wing according to a fifth embodiment of the present invention in a plan view. [Symbol description] n ί--HI 1— nm —1 1— HI mnmim 1—in 1 · n Hi Ha ni— n -1— I (Please read the precautions on the back before filling this page) 1 Needle tube 2 Needle base 2a Main part 2b. Holding part 2c Regulatory part 2d Large diameter part. 2e ^ Circular groove 2f Outer annular protrusion 3 Hose 4 Wing sheath 4a Protective sleeve 5, 6 Wing part 5a ~ 6a Front end Side area 5b, 6b Base end side area 7, 8 Wing protrusions 9, 10 Through holes 11, 12 Convex strips 13, 14 Strip grooves 15, 16 Front end protrusions 21 1 Paper size applies Chinese National Standard (CNS) A4 specifications ( 210 X 297 mm) 506843 A7 _B7 V. Description of the invention (household) 17 Rear end locking portion 17a Small diameter portion 17b Inner ring protrusion 17c Ring groove 18 Needle sleeve 20 Retaining lever 21 Rotating piece 22 Protrusion 23. .... through hole 24 annular protrusion 25 annular groove 26 step difference (please read the precautions on the back before filling this page) C ---- order ---------- line one 22 ^ Paper size applies to China National Standard (CNS) A4 (210 X 297 Public Love i