200810801 (1) 九、發明說明 【發明所屬之技術領域】 本發明關於一種導管和引入針組件，更具體地說，關 於一種用於導管和引入針組件的安全裝置。 【先前技術】 血管內導管，特別是靜脈導管 （IV導管），通常被 用於給病人輸入液體，比如通常的鹽液、各種藥物以及注 射營養品等，或者用來從病人體內抽取血液。末梢靜脈導 管通常比較短，尺寸大槪在兩英寸或更短。最常見類型的 導管是套在一個引入針上的末梢靜脈導管。這種套在引入 針上的末梢靜脈導管是裝配在一根帶有尖銳針尖的引入針 上。導管和引入針被組裝成，引入針的針尖延伸超過導管 的尖端，並且引入針針尖部的傾斜面朝上。 導管和引入針組件被以一個淺的角度刺穿病人的皮膚 而進入到末梢血管中，所述的末梢血管不與心臟直接相連 ，而是與與心臟直接相連的中央血管分支之一相連。在其 中一種技術中，引入針和導管一起被完全刺入到血管中。 而在另外一種技術中，引入針在開始的靜脈穿刺之後被部 分地從導管抽出。然後，導管被完全插入到血管中。 在導管和引入針組件插入到血管中之後，比較重要的 是需要確認該組件是否在血管中處於正確的定位。爲了確 認所述組件是否正確定位，醫務人員需要確認是否在引入 針和位於引入針近端處的回流腔中有回流血存在。通常該 -4 - (2) 200810801 回腔構成導管座的一部分。作爲另外一種方案，引入針可 以在其遠端部分上設有一個凹槽或開口，這樣，當導管由 透明或半透明材料製成時，可以在引入針和導管之間的環 形空間中觀察血液回流。一旦正確的定位可以確認，醫務 人員將通過在引入針和導管組件的尖端部位向下壓患者的 皮膚而對血管施加壓力。手指的壓力將閉塞進一步的血液 流動通過引入針。也可以通過一個隔離塞來實現血液流動 的閉塞。醫務人員抽出引入針而將導管留在原地，然後將 液體輸送裝置比如普通肝素帽或者將頭蓋連接到導管。一 旦引入針從導管抽出，其將會帶有、、沾染血液的針尖〃， 必須要正確處置。 近年來，對於醫務人員可能沾染到患者的血液已經有 了非常大的關注，已經認識到、、沾染血液的針尖〃必須要 立即處置。這種關注越來越大，因爲出現了目前還不能治 療的致命疾病，比如，愛滋病 （AIDS)，這些病病可能 通過體液的交換而從一個被感染者傳遞到另外一個人。因 此，與愛滋病感染者的體液接觸必須要避免。正如上面所 述的那樣，如果引入針已經被用於將一個導管放置到愛滋 病感染者的血管中，那麼這個引入針就是傳遞疾病的一個 媒介。儘管醫務人員已經知道需要正確處理、、沾染血液的 針尖〃，但是不幸的是在某些醫療環境下，比如緊急情況 下或者由於沒留意或疏忽，依然存在著被沾染的引入針戳 到醫務人員的情形。 爲了解決上述被、、血液沾染的針尖〃意外刺到的問題 -5- (3) 200810801 ，已經開發了各種引入針安全裝置。 美國專利文獻US 62 8 7278公開7 該IV導管組件沒有一個用來保護使 ，該IV導管組件並不設有外罩或者 罩。儘管所述彈簧夾可以防止使用者 ，但是它並不能防止使用者接觸到位 ，特別是，當引入針上設有一些圓周 是如此。所以，US62 8 7278中的IV 來說依然是不安全的。 美國專利文獻US5215528中公開 組件，該組件中具有一個金屬夾，該 血管中並且從導管中抽出引入針後防 傷。如U S 5 2 1 5 5 2 8的附圖中所示，導 多個從凸緣4 8伸出的弧形凸起5 0， 成一個容納座5 3，在該容納座5 3中 38的一端限定形成一個凸起部38a延 凸起5 0的端部包括一些向內延伸的J 釋放地保持著導管座的凸緣5 6。弧形 設計成能接合凸緣5 6並且使得與從宅 5 2相比，使用者借助於突出部4 8 b更 退下針罩。然而，上述的配合關係並 於製造公差。這樣，在導管座和引入 不可預料的，可能在針尖被安全保護 這種不穩定的行爲在一些需要精確性 一種IV導管組件， 用者的彈簧夾。然而 包圍所述彈簧夾的外 接觸到引入針的針尖 於針尖上的殘留血液 孔比如回流凹槽時更 導管組件對於使用者 了一種導管和引入針 金屬夾在導管插入到 止使用者被引入針刺 管和引入針組件具有 這些弧形凸起限定形 保持導管座52。管體 伸到導管座中。弧形 5部54，這些唇部可 凸起50和唇部54被 ?納座5 3去掉導管座 容易從引入針針座上 不可靠，因爲其依賴 針針罩之間的脫離是 起來之前就脫離了。 和可靠性的環境中是 -6 - (4) (4)200810801 不合適的。 因此，在現有技術中’依然需要對用於導管和引入針 組件的安全裝置進行改進以便克服上述的缺點。 【發明內容】 本發明的一個目的是提供一種用於導管和引入針組件 的安全裝置，其在導管插入到血管中並將引入針抽出導管 之後，不但能夠防止使用者接觸到引入針的針尖而且能夠 防止使用者接觸到針尖上的黏接物。 本發明的另外一個目的是提供一種用於導管和引入針 組件的安全裝置，該安全裝置使得導管座和針罩之間的脫 離更加精確和可靠。 本發明的目的通過一種用於導管和引入針組件的安全 裝置來實現’所述導管和引入針組件包括· 導管組件，該導管組件包括：導管，具有近端和遠端 ;導管座，固定到導管的近端； 引入針組件，該引入針組件包括：引入針，其具有遠 端的針尖，近端，和位於針尖和近端之間的增大部分；針 座，固定到引入針的近端； 所述安全裝置，其滑動連接在所述導管組件和引入針 組件之間，所述安全裝置包括：針罩’該針罩限定形成縱 向延伸通道，該縱向延伸通道設有縱長的開口；至少一個 彈簧夾，其通過縱長的開口安裝在所述縱向延伸通道中； 以及止擋裝置，用於阻擋引入針的增大部分，其中所述，縱 (5) (5)200810801 向延伸通道能容許引入針縱向延伸穿過針罩，所述至少一 個彈簧夾設置有第一卡接部用於與導管座嚙合，所述至少 一個彈簧夾的至少一部分的形狀被製成爲在引入針從導管 組件中抽出之前被該引入針壓縮，而在該引入針從導管組 件抽出之後，該所述至少一部分被釋放彈起並捕獲所述引 入針的尖銳遠端針尖。 本發明還提供了一種導管和引入針組件，所述導管和 引入針組件包括： 導管組件，該導管組件包括：導管，具有近端和遠端 ;導管座，固定到導管的近端； 引入針組件，該引入針組件包括：引入針，其具有遠 端的針尖，近端，和位於針尖和近端之間的增大部分；針 座，固定到引入針的近端； 安全裝置，其滑動連接在所述導管組件和引入針組件 之間，所述安全裝置包括：針罩’該針罩限定形成縱向延 伸通道，該縱向延伸通道設有縱長的開口；至少一個彈簧 夾，其通過縱長的開口安裝在所述縱向延伸通道中；以及 止擋裝置，用於阻擋引入針的增大部分，其中所述縱向延 伸通道能容許引入針縱向延伸穿過針罩，所述至少一個彈 簧夾設置有第一卡接部用於與導管座嚙合，所述至少一個 彈簧夾的至少一部分的形狀被製成爲在引入針從導管組件 中抽出之前被該引入針壓縮’而在該引入針從導管組件抽 出之後，該所述至少一部分被釋放彈起並捕獲所述引入針 的尖銳遠端針尖。 -8 - 200810801200810801 (1) Description of the Invention [Technical Field] The present invention relates to a catheter and introducer needle assembly, and more particularly to a safety device for a catheter and an introducer needle assembly. [Prior Art] Intravascular catheters, particularly intravenous catheters (IV catheters), are commonly used to deliver fluids to patients, such as normal salines, various medications, and injecting nutrients, or to extract blood from a patient. The peripheral venous catheter is usually shorter and larger than two inches or less. The most common type of catheter is a peripheral venous catheter that is placed over an introducer needle. The distal venous catheter that is placed over the introducer needle is fitted to an introducer needle with a sharp needle tip. The catheter and the introducer needle are assembled such that the tip of the introducer needle extends beyond the tip end of the catheter and the inclined face of the introducen needle tip faces upward. The catheter and introducer needle assembly is pierced into the peripheral blood vessel at a shallow angle to the patient's skin, and the peripheral blood vessel is not directly connected to the heart but is connected to one of the central vessel branches directly connected to the heart. In one of the techniques, the introducer needle and the catheter are fully inserted into the blood vessel. In yet another technique, the introducer needle is partially withdrawn from the catheter after the initial venipuncture. The catheter is then fully inserted into the blood vessel. After the catheter and introducer needle assembly are inserted into the blood vessel, it is important to confirm that the component is properly positioned in the blood vessel. In order to confirm that the component is properly positioned, the medical professional needs to confirm if there is a returning blood present in the introduction needle and the return chamber located at the proximal end of the introduction needle. Usually the -4 - (2) 200810801 back cavity forms part of the catheter adapter. Alternatively, the introducer needle may be provided with a recess or opening in its distal portion such that when the catheter is made of a transparent or translucent material, the blood may be viewed in an annular space between the introducer needle and the catheter. Reflux. Once the correct positioning is confirmed, the medical professional will apply pressure to the blood vessel by pressing down on the patient's skin at the tip end of the introducer needle and catheter assembly. The pressure of the finger will occlude further blood flow through the introducer needle. Occlusion of blood flow can also be achieved by a spacer plug. The medical staff pulls the introducer needle to leave the catheter in place and then attaches the fluid delivery device, such as a plain heparin cap, or attaches the head cover to the catheter. Once the introducer needle is withdrawn from the catheter, it will carry the needle tip of the blood and must be disposed of properly. In recent years, there has been a great deal of concern for medical personnel who may be contaminated with the blood of patients. It has been recognized that blood-stained needle tips must be disposed of immediately. This concern is growing because of the deadly diseases that are currently incurable, such as AIDS, which can be passed from one infected person to another through the exchange of body fluids. Therefore, contact with body fluids of people living with AIDS must be avoided. As mentioned above, if the introducer needle has been used to place a catheter into the blood vessels of an AIDS-infected person, the introducer needle is a medium for transmitting the disease. Although medical staff already know the tip of the needle that needs to be properly treated and contaminated with blood, unfortunately in some medical settings, such as in an emergency or because of inadvertent or negligent, there is still a contaminated introduction needle to the medical staff. The situation. In order to solve the problem that the above-mentioned, blood-stained needle tip is accidentally stabbed -5- (3) 200810801, various needle safety devices have been developed. U.S. Patent No. 6,628,278 discloses that the IV conduit assembly is not provided for protection. The IV conduit assembly is not provided with a cover or cover. Although the spring clip can prevent the user, it does not prevent the user from coming into contact with the position, in particular, when the introduction needle is provided with some circumference. Therefore, the IV in US62 8 7278 is still unsafe. An assembly is disclosed in U.S. Patent No. 5,215,528, which has a metal clip in which the needle is removed from the catheter and the needle is prevented from injury. As shown in the drawings of US 5 2 1 5 5 2 8 , a plurality of arcuate projections 50 extending from the flanges 4 8 are guided into a receptacle 5 3 in which 38 of the receptacles 3 3 An end portion defining one projection 38a extending the projection 50 includes a plurality of inwardly extending flanges 61 that releasably retain the catheter hub. The arc is designed to engage the flange 56 and such that the user retracts the needle shield by means of the projection 4 8 b as compared to the housing 52. However, the above-mentioned mating relationship is also related to manufacturing tolerances. In this way, the catheter seat and the introduction are unpredictable and may be safely protected at the tip of the needle. This unstable behavior requires some precision in an IV catheter assembly, the user's spring clip. However, when the outer contact of the spring clip contacts the residual blood hole of the needle tip on the needle tip, such as the return groove, the catheter assembly is for the user to have a catheter and the introduction needle metal clip is inserted into the catheter and the user is introduced into the needle. The spine and introducer needle assembly has these arcuate projection defining retaining catheter hubs 52. The tube extends into the catheter hub. Curved 5 portions 54, these lips can be raised 50 and the lip 54 is removed by the seat 53. The catheter holder is easily unreliable from the introduction of the needle hub because it relies on the separation between the needle shields before it is up Departed. And the environment of reliability is -6 - (4) (4) 200810801 is not suitable. Accordingly, there is still a need in the prior art to improve the safety devices for catheters and introducer needle assemblies in order to overcome the above disadvantages. SUMMARY OF THE INVENTION It is an object of the present invention to provide a safety device for a catheter and an introducer needle assembly that not only prevents the user from contacting the tip of the introducer needle but also after the catheter is inserted into the blood vessel and the introducer needle is withdrawn from the catheter. It prevents the user from coming into contact with the glue on the needle tip. Another object of the present invention is to provide a safety device for a catheter and introducer needle assembly that provides for more precise and reliable separation between the catheter hub and the needle shield. The object of the present invention is achieved by a safety device for a catheter and an introducer needle assembly. The catheter and introducer needle assembly comprises a catheter assembly comprising: a catheter having a proximal end and a distal end; a catheter hub fixed to a proximal end of the catheter; an introducer needle assembly comprising: an introducer needle having a distal tip, a proximal end, and an enlarged portion between the needle tip and the proximal end; the needle hub secured to the introducer needle The safety device is slidably coupled between the catheter assembly and the introducer needle assembly, the safety device comprising: a needle shield 'the needle shield defining a longitudinally extending passageway, the longitudinally extending passageway being provided with an elongated opening At least one spring clip mounted in the longitudinally extending passage through an elongated opening; and a stop means for blocking an enlarged portion of the introduction needle, wherein said longitudinal (5) (5) 200810801 extension The passageway can allow the introducer needle to extend longitudinally through the needle shield, the at least one spring clip being provided with a first snap portion for engaging the catheter hub, at least a portion of the at least one spring clip The shape is made to be compressed by the introducer needle before the introducer needle is withdrawn from the catheter assembly, and after the introducer needle is withdrawn from the catheter assembly, the at least a portion is released to bounce and capture the sharp distal end of the introducer needle Needle tip. The present invention also provides a catheter and introducer needle assembly, the catheter and introducer needle assembly comprising: a catheter assembly comprising: a catheter having a proximal end and a distal end; a catheter hub secured to the proximal end of the catheter; An introducer needle assembly comprising: an introducer needle having a distal tip, a proximal end, and an enlarged portion between the needle tip and the proximal end; a needle hub secured to the proximal end of the introducer needle; a safety device that slides Connected between the catheter assembly and the introducer needle assembly, the safety device comprising: a needle shield 'the needle shield defining a longitudinally extending channel, the longitudinally extending channel being provided with an elongated opening; at least one spring clip passing longitudinally a long opening is mounted in the longitudinally extending channel; and a stop means for blocking an enlarged portion of the introducer needle, wherein the longitudinally extending channel is adapted to allow the introducer needle to extend longitudinally through the needle shield, the at least one spring clip a first snap portion is provided for engaging the catheter hub, at least a portion of the at least one spring clip being shaped to be withdrawn from the catheter assembly at the introducer needle Previously compressed by the introducer needle', after the introducer needle is withdrawn from the catheter assembly, the at least a portion is released to bounce and capture the sharp distal tip of the introducer needle. -8 - 200810801
【實施方式】 在本文中，術語〜近〃和、遠〃是相對於引入針針座 3 4而言來描述位於導管和引入針組件上的位置。 如圖1，2，8，和9所示，帶有本發明的安全裝置的 導管和引入針組件總體上由標號1 0標識。其包括導管組 件20，引入針組件30和安全裝置40。 導管組件20包括具有近端和遠端的導管2 1，以及固 定到導管21近端上的導管座24。用於導管21的合適材料 包括’但並不侷限於，熱塑性樹脂諸如聚四氟乙烯 (PTFE)，聚亞安酯等等。更優選地，導管21由透明材料 或者至少半透明材料製成以便於從引入針3 1的回流凹槽 (如果有）觀察回流。用於導管座2 4的合適材料包括，但 不限於，熱塑性聚合物樹脂比如聚碳酸酯，聚苯乙烯，聚 丙烯，等等。 引入針組件30包括引入針31，該引入針31具有尖銳 的末端針尖，該針尖由一個斜面限定形成，近端與引入針 針座34相連。引入針31優選由不銹鋼形成。優選地，在 引入針3 1上可以設置一個回流凹槽3 3。作爲一種備選方 案，可以在引入針組件3 0中設置一個回流腔來代替所述 的回流凹槽3 3。引入針針座3 4可以包括一個徑向向外延 伸的延伸片3 6供握持使用。引入針針座3 4的材料可以與 導管座24相同，也可以不同。 如圖3a-3d所示，安全裝置40包括針罩41，該針罩 41優選由塑料製成。如圖2所示，一旦導管21被插入到 -9 - (7) (7)200810801 血管中並且引入針21被抽出導管21，安全裝置40將會握 持在引入針的針尖上，從而保護使用者不被針刺傷。針罩 4 1限定形成縱向延伸通道，該延伸通道具有近端部分43 ，遠端部分44和中間槽部45。縱向延伸通道能容許引入 針31縱向延伸穿過針罩41。近端部分43、遠端部分44 和中間槽部45的直徑至少稍大於引入針3丨的桿部的直徑 。這樣能容許引入針3 1的桿部容易地穿過近端部分43、 遠端部分44和中間槽部45。如圖3a和3b所示，縱長開 口 6 0沿著針罩4 1的縱向方向開設在至少部分所述中間槽 部45上。 安全裝置40還包括彈簧夾50，其優選由彈簧片製成 。該彈簧夾50通過開口 60安裝在所述中間槽部45中。 如圖4a-4g所示，彈簧夾50包括：近端壁51，中間壁54 和遠端壁53，在近端壁51上限定形成有孔52。在圖4b ( 彈簧夾5 0的正視圖）很好地示出，近端壁5 1與中間壁 54的一端相連，且近端壁51大體上垂直於中間壁54。遠 端壁5 3與中間壁5 4的另外一端相連，並且在遠端壁5 3 和中間壁5 4之間設有彎曲5 5，該彎曲5 5向著中間壁5 4 的與近端壁5 1和遠端壁5 3相反的一側突出。優選地，彎 曲5 5可以爲倒V形彎曲。該彎曲5 5被用作一個卡接部與 導管座24相連。遠端壁53的形狀被製成爲其在彈簧夾觸 發之前由引入針31壓縮，而在彈簧夾觸發之後被引入針 3 1釋放彈起。這將會在下文中詳細描述。 優選地，遠端壁53在其自由端具有一個部分，該部 -10- 200810801 (8) 分的寬度優選比遠端壁的其它部分寬度窄。該寬度減小的 部分在彈簧觸發之前可以被引入針3 1壓縮和彎曲。 優選地，近端壁5 1在其自由端上設有第二卡接部57 。例如，該第二卡接部5 7可以通過將近端壁5 1的自由端 彎折形成U形卡接部。該U形卡接部將與形成於針罩內 壁上的相應部分卡扣在一起。所述相應部分可以爲設置在 中間槽部45中的齒部47。 優選地，孔5 2在其周邊上具有加強唇，用於卡住位 於引入針針桿上的直徑增大部分（例如一個凸起）。作爲 一種備選方案，引入針針桿的直徑增大部分可以比孔5 2 小但是大於延伸通道的近端部分4 3的直徑，這樣，當抽 出引入針時，該近端部分43將卡住引入針針桿的直徑增 大部分。 如圖3a-3d，彈簧夾50通過開口 60配合在針罩41中 ，並且由彈簧夾5〇的第二卡接部57卡在位置上，位於近 端壁5 1上的孔52與針罩41近端部分上的開口對準。如 圖3 b最好地示出，彈簧夾的倒V形彎曲5 5突出於針罩 4 1的外壁之外。當引入針從導管抽出之後（也就是彈簧 觸發之後），遠端壁53將會介於針罩主體41的延伸通道 中近端部分43的開口和遠端部分44的開口之間。 圖5a-5e示出了本發明第一實施例中針罩41的結構 。針罩4 1由塑料或者其它材料模製而成，沿著引入針3 i 的通過軸線具有一個通孔。在針罩4 1中優選設置一個齒 狀被卡接部47，該齒狀被卡接部4 7用於與彈簧夾5 0的所 -11 - 200810801 (9) 述U形卡接部5 7卡合，防止彈簧夾5 0從針罩41中脫離 〇 圖6示出在引入針31從導管中抽出之後，針罩41和 彈簧夾5 0封閉在引入針遠端的針尖處。引入針3 1的近端 部固定到引入針針座3 0。而在圖1所示的情形中，引入針 針座34包圍著安全裝置40，從而從外面看不見。 如圖7所不’在針罩41的外表面上可以設置一個或 更多個滑軌4 9。由於所述滑軌4 9減小了針罩4 1和針座 3 4之間的接觸面積，所以有利於針罩4 1滑出針座3 4內。 圖8爲一個剖視圖，其示出了在引入針3 1從導管21 中抽出之前導管和引入針組件1 0的狀態，其中安全裝置 40被包圍在引入針針座34和導管座24中。安全裝置40 的近端部分被引入針針座34所包圍，而安全裝置40的遠 端部分被導管座24包圍。在導管座24上設有一個凹口 25 。彈簧夾5 0上的倒V形卡接部5 5與該凹口 2 5嚙合。圖 9示出圖8中所示狀態下，導管和引入針組件1 0的放大剖 視圖，其中引入針3 1被稍微抽出一點。 儘管對本發明的描述是參照一個帶有隔離塞 29 (septum)的導管組件20進行的，但是本發明的安全裝置 40也可以與其它類型的導管組件一起使用，例如，沒有所 述的隔離塞2 9。 在正常使用中，一旦導管21被正確插入到血管中， 將會把引入針31抽出導管21，所述引入針31優選地設有 血液回流凹槽33 (參見圖13和I4)。圖10-12示出了引 •12- (10) (10)200810801 入針3 1從導管組件20中抽出時的幾個階段。 圖1 〇示出的階段中，引入針31的回流凹槽3 3移入 到隔離塞29的頭部中並被該隔離塞29所包圍，此時，彈 簧夾50的遠端壁53依然被引入針31壓縮。 圖1 1示出的階段中，彈簧夾5 0的遠端壁5 3由於引 入針3 1不再妨礙它，所以從壓縮狀態彈起來，從而，遠 端壁5 3將引入針3 1的針尖捕獲而防止其向著遠端方向往 回運動。 圖12示出了另外一個階段，其中，引入針3 1的針尖 被彈簧夾50的遠端壁53捕獲而不能向著遠端方向往回滑 動’引入針31的增大部分38防止了引入針31向著近端 方向滑動。位於針罩4 1上的延伸凸起4 6防止血液從針尖 或者回流凹槽33 (如果有）漏出。隨著進〜步向著近端方 向抽引入針3 1，倒V形卡接部5 5將會與導管座2 4的凹 口 25脫離嚙合。因此，針罩41被導管座24釋放。 在上述實施例中，位於引入針3 1上的增大部分3 8可 以爲一個凸起。如圖13中所示，該凸起38可以爲擠壓凸 起’優選地，該擠壓凸起之後設有回流凹槽33。優選地， 該擠壓凸起可以通過擠壓或者捏引入針31上的兩點而形 成。所述的兩點之間的連線必需與引入針3 1的縱軸線交 叉。 如圖14所示，引入針31上的增大部分38還可以採 用其它形式的結構。例如，該增大部分3 8可以爲一個直 &增大的部分38，該直徑增大的部分38可以採用美國專 -13- (11) (11)200810801 利US5215528中所公開的凸起形式，該文獻在這裏被引入 作爲參考。所述直徑增大的部分3 8具有一個中間部分， 該中間部分的外徑大於引入針3 1桿部的外徑，從所述中 間部分向著引入針3 1的近端部分延伸有一漸細的近端部 分，從所述中間部分向著引入針3 1的遠端部分延伸有一 漸細的遠端部分。儘管增大的直徑部分3 8設爲對稱結構 ，但是這並不是必須的。 增大的直徑部分3 8的直徑應當大於引入針3 1的桿部 外徑，但是應當小於縱向延伸通道的遠端部分44的內徑 。這樣就確保了引入針3 1可以沿著近端方向拉入到安全 裝置40中。爲了防止引入針3 1沿著近端方向徹底地拉出 到安全裝置40之外，縱向延伸通道的近端部分43應當比 大直徑部分3 8小，從而阻擋引入針3 1運動通過近端部分 43 ° 作爲一種備選方案，也是優選方案，彈簧夾50的近 端壁5 1的孔5 2的直徑稍大於引入針3 1的桿部的直徑， 但是小於增大的直徑部分3 8的直徑。這樣，當引入針3 1 相對於安全裝置40向著近端方向抽出時，增大的直徑部 分38將會卡在近端壁51的孔52處，而不是卡在針罩41 的近端部分43處。這防止了引入針31沿著近端方向徹底 抽出到針罩41之外。 爲了將導管2 1放入到患者的血管內，醫務人員將引 入針3 1和導管21大體上縱向地與目標血管對準。引入針 針尖的斜面在穿刺過程中應當背離患者的皮膚表面。醫務 -14- (12) (12)200810801 人員將引入針31和導管21以一個淺的角度優選小於35 度刺入到患者皮膚中，從而引入針的針尖3 2進入到目標 血管中。醫務人員然後優選地觀察位於引入針針座3 *中 的回流腔中的血液回流或者位於引入針3 1的回流凹槽3 3 中的回流血。 在確認了引入針3 1和導管2 1處於目標血管中的定位 之後，醫務人員將導管2 1在血管中軸向沿著引入針3 1向 者速端則進。在某些技術中，引入針3 1可以在導管2 1完 全前進到血管中恰當位置之前部分地在導管2 1中回撤。 在實現導管2 1的正確定位後’醫務人員將另一個手的手 指壓在導管2 1的遠端所處血管處的患者皮膚上。通過將 其手指壓在患者皮膚上並施加足夠的壓力，醫務人員將有 效地阻塞通過導管2 1的血液流動，或者如果導管組件2〇 中如果設有隔離塞29的話，血液的流動也可以被該隔離 塞29所阻擋。然後醫務人員通過向著近端移動引入針針 罩座34而將引入針31徹底抽出導管21中。這種運動使 得引入針31的針尖32向著近端方向進入到安全裝置40 中。然而，至少在引入針3 1開始的近端運動期間，彈簧 夾5 0的倒V形彎曲5 5作爲一個卡接部與導管座上的凹口 卡合，使得針罩41依然與導管座2 4接合。一旦針尖3 2 位於安全裝置40中並且引入針31被彈簧夾50鎖定在其 中時，作用在針座34上的持續的近端方向作用力將使得 倒V形彎曲與導管座24的凹口脫離嚙合。在引入針3 1和 安全裝置40從導管座24中移出之後，醫務人員可以將液 -15- (13) (13)200810801 體輸送裝置、普通肝素帽 （PRN)或者將頭蓋連接到導管 組件20 ’而開始計劃好的治療。然後，引入針3 1和針罩 4 1可以按照簡單的處理規程進行處理。 圖15a-e示出了本發明第二實施例的安全裝置40，圖 1 6-h示出了在第二實施例的安全裝置40中使用的彈簧夾 50。在這裏僅僅描述其與第一實施例不同之處。第一實施 例與第二實施例不同之處在於第一實施例中的彈簧夾5 0 在第二實施例中被分爲兩個部分，即，第一彈簧夾50a和 第二彈簧夾50b。第一彈簧夾50a包括中間壁54和遠端壁 5 3，以及位於它們之間的彎曲5 5。第二彈簧夾5 Ob包括近 端壁51，其限定形成有孔52，近端壁51通過彎折其自由 端形成有U形卡接部5 7。在第二實施例中，第一彈簧夾 5 0a通過將中間壁54的自由端黏接到針罩41的相應部分 上而安裝到針罩41中，而第二彈簧夾50b通過U形卡接 部57與針罩41中設置的齒狀被卡接部47卡扣而安裝到 針罩41中。作爲一種備選方案，在該第二實施例中，第 二彈簧夾5 Ob也可以由一個帶有孔的墊圈取代，墊圈的孔 的直徑應當大於引入針3 1的桿部的直徑，而小於引入針 3 1的增大部分3 8。 應當指出，本發明中，彈簧夾5 0的第一卡接部5 5可 以採用不同於第一和第二實施例的形式。例如’彈簧夾上 可以設置一個球形孔來代替所述倒v形彎曲，而所述球形 孔可以與設置在導管座2 4中的球形軸承嚙合。 本發明的彈簧夾50具有兩個功能。其中一個功能是 -16- (14) (14)200810801 保護使用者不會接觸到引入針的針尖。而另外一個功能是 提供一個卡接部例如所述倒V形彎曲或球形孔來與導管座 24相嚙合。如果這兩個功能被分開的話，需要兩個不同的 彈簧夾來實現該功能，從而使成本增加。 儘管在上文中參照具體實施例對本發明進行了說明， 但是應當明白，這些具體實施例不應當被理解爲是對本發 明的限制，本領域技術人員可以在不脫離本發明範圍的情 況下對具體實施例進行一些變化，而本發明的範圍由所附 的權利要求書限定。 【圖式簡單說明】 在下文中將參照附圖中所示的優選實施例對本發明進 行描述。 圖1示出了其中帶有本發明安全裝置的導管和引入針 組件。 圖2示出在抽出引入針之後，引入針的針尖被封閉在 本發明的安全裝置中。 圖3a-d示出本發明的安全裝置，該安全裝置包括彈 簧夾，該彈簧夾從安全裝置的頂部安裝到針罩中，並且通 過彈簧夾的U形結構卡在位置上，彈簧夾上的孔與針罩上 的通道對準。其中圖3a爲安全裝置的頂視圖，圖3b爲安 全裝置的正視圖，圖3c爲安全裝置的透視圖，以及圖3d 爲安全裝置的側視圖。 圖4a-4g示出了第一實施例中彈簧夾的形狀，其中圖 -17- (15) (15)200810801 4a爲底視圖，圖4b爲正視圖，圖4c爲彈簧夾的頂視圖， 圖4e和圖4g爲兩個透視圖，圖4f爲彈簧夾的側視圖。 圖5 a-e示出了本發明針罩的結構。其中圖5a爲針罩 的一個透視圖，圖5 B爲針罩的一個側視圖，圖5 c爲針罩 的一個底視圖，圖5d爲針罩的一個正視圖，圖5e爲針罩 的一個頂視圖。 圖6的放大視圖示出了封閉在引入針遠端的針尖上的 針罩和彈簧夾。 圖7示出了針罩和彈簧夾。在該針罩主體的外周上設 有一個或者更多個滑軌，從而由於減小了接觸點而使針罩 容易滑動。 圖8爲一個剖視圖，示出了本發明的安全裝置包圍在 引入針針座和導管座內。 圖9示出了引入針和導管組件的一個放大剖視圖，其 中’針罩被包圍在引入針針座和導管座內，彈簧夾的V彎 曲嚙合在導管座上的凹槽中。 圖1 〇示出了在抽出引入針時的一個階段，在該階段 ’引入針上的凹槽被隔離塞的頭部所包圍，而彈簧夾的遠 端壁依然被引入針作用而處於壓縮狀態，而倒V形彎曲嚙 合在導管座上的凹槽中。 圖11示出了在抽出引入針時的一個階段，在該階段 ’引入針的針尖移動通過了彈簧夾的遠端壁，該遠端壁被 引入針釋放彈起而捕獲引入針的針尖，防止該針尖向著遠 端方向運動，而倒v形彎曲依然嚙合在導管座的凹口中。 -18- (16) (16)200810801 圖1 2示出了抽出引入針時的一個階段，其中彈簧夾 的V彎曲與導管座的凹口脫離嚙合，針罩與導管座分開， 而位於引入針上的凸起阻止了引入針向著近端方向移動， 在針罩的近端上延伸出來的凸起部防止了血液從引入針的 凹槽內露出來。 圖13示出了引入針的一種結構，其中凹槽位於擠壓 凸起之後。 圖1 4示出了引入針的一種結構，其中凹槽位於一個 三維凸起之後。 圖15 a-e示出了本發明第二實施例的安全裝置。其中 圖15a爲該安全裝置的頂視圖，圖15b爲該安全裝置的正 視圖，圖15c爲該安全裝置的底視圖，圖15d爲該安全裝 置的透視圖，圖15e爲該安全裝置的側視圖。 圖16a-h示出了用在第二實施例安全裝置中的彈簧夾 。圖1 6a爲第二彈簧夾的左側視圖，圖1 6b爲第二彈簧夾 的正視圖，圖1 6 c爲第二彈簧夾的透視圖，圖1 6 d爲第二 彈簧夾的右側視圖，圖1 6e爲第一彈簧夾的透視圖，圖 1 6f爲第一彈簧夾的左側視圖，圖丨6g爲第一彈簧夾的正 視圖，圖1 6 h爲第一彈簧夾的右側視圖。 【主要元件符號說明】 10 :導管和引入針組件 20 :導管組件 21 :導管 -19- (17) 200810801 2 4 ： 25 ： 29 ： 30 ： 3 1: 32 ： 33 ： 34 ： 35 ： 36 ： 38 ： 40 ： 4 1: 43 ： 44 ： 45 ： 46 ： 47 ： 50 ： 50a ： 50b ： 5 1 ： 52 : 53 : 導管座 凹口 隔離塞 引入針組件 引入針 針尖 回流凹槽 引入針針座 回流凹槽 延伸片 凸起、增大部分 安全裝置 針罩 近端部分 遠端部分 中間槽部 孔 齒部、齒狀被卡接部 彈簧夾 第一彈簧夾 第二彈簧夾 近端壁 孔 遠端壁 -20 (18) 200810801 54 ： 55 : 5 7 ： 60 ： 中間壁 彎曲、卡接部 卡接部 開口 -21[Embodiment] Herein, the terms 〃 〃 and 〃 are described relative to the introduction needle hub 34 to describe the position on the catheter and the introduction needle assembly. As shown in Figures 1, 2, 8, and 9, the catheter and introducer needle assembly with the security device of the present invention is generally identified by the numeral 10. It includes a catheter assembly 20, a needle assembly 30 and a safety device 40. The catheter assembly 20 includes a catheter 21 having a proximal end and a distal end, and a catheter hub 24 secured to the proximal end of the catheter 21. Suitable materials for the conduit 21 include, but are not limited to, thermoplastic resins such as polytetrafluoroethylene (PTFE), polyurethane, and the like. More preferably, the conduit 21 is made of a transparent material or at least a translucent material to facilitate viewing of the backflow from the return groove (if any) of the introduction needle 31. Suitable materials for the catheter hub 24 include, but are not limited to, thermoplastic polymer resins such as polycarbonate, polystyrene, polypropylene, and the like. The introducer needle assembly 30 includes an introducer needle 31 having a sharpened distal tip formed by a beveled surface that is coupled to the introducer needle hub 34. The introduction needle 31 is preferably formed of stainless steel. Preferably, a recirculation groove 3 3 may be provided on the introduction needle 3 1 . As an alternative, a recirculation chamber may be provided in the introduction needle assembly 30 in place of the recirculation groove 3 3 . The introduction needle hub 34 can include a radially extending extension tab 36 for gripping use. The material introduced into the needle hub 34 may be the same as or different from the catheter hub 24. As shown in Figures 3a-3d, the safety device 40 includes a needle shield 41 which is preferably made of plastic. As shown in Figure 2, once the catheter 21 is inserted into the -9 - (7) (7) 200810801 blood vessel and the introducer needle 21 is withdrawn from the catheter 21, the safety device 40 will be held on the tip of the introducer needle, thereby protecting the use The person is not stabbed by a needle. Needle cover 4 1 defines a longitudinally extending channel having a proximal end portion 43, a distal end portion 44 and an intermediate groove portion 45. The longitudinally extending passages allow the introduction needle 31 to extend longitudinally through the needle shield 41. The diameter of the proximal portion 43, the distal portion 44 and the intermediate groove portion 45 is at least slightly larger than the diameter of the stem portion of the introduction needle 3''''''' This allows the stem portion of the introducer needle 3 1 to easily pass through the proximal end portion 43, the distal end portion 44 and the intermediate groove portion 45. As shown in Figs. 3a and 3b, the elongated opening 60 is opened in at least a part of the intermediate groove portion 45 along the longitudinal direction of the needle cover 4 1. The safety device 40 also includes a spring clip 50 that is preferably made of a spring leaf. The spring clip 50 is mounted in the intermediate groove portion 45 through the opening 60. As shown in Figures 4a-4g, the spring clip 50 includes a proximal wall 51, an intermediate wall 54 and a distal wall 53 defining a bore 52 formed therein. In Figure 4b (front view of the spring clip 50) is well shown, the proximal wall 51 is connected to one end of the intermediate wall 54, and the proximal wall 51 is substantially perpendicular to the intermediate wall 54. The distal wall 53 is connected to the other end of the intermediate wall 534, and a bend 5 5 is provided between the distal wall 53 and the intermediate wall 504, the bend 5 5 facing the intermediate wall 5 4 and the proximal wall 5 1 protrudes from the opposite side of the distal wall 533. Preferably, the bend 5 5 may be an inverted V-shaped bend. The bend 5 5 is used as a snap portion to connect to the catheter hub 24. The distal wall 53 is shaped to be compressed by the introducer needle 31 before the spring clip is triggered, and is released by the introducer needle 3 1 after the spring clip is triggered. This will be described in detail below. Preferably, the distal wall 53 has a portion at its free end, the width of the portion -10- 2008 10801 (8) is preferably narrower than the width of other portions of the distal wall. The reduced width portion can be compressed and bent by the introduction needle 3 1 before the spring is triggered. Preferably, the proximal wall 51 is provided with a second snap 57 on its free end. For example, the second latching portion 57 can form a U-shaped snap portion by bending the free end of the proximal wall 51. The U-shaped snap portion will snap together with a corresponding portion formed on the inner wall of the needle shield. The corresponding portion may be a tooth portion 47 provided in the intermediate groove portion 45. Preferably, the aperture 5 2 has a reinforcing lip on its periphery for catching an enlarged diameter portion (e.g., a projection) on the introduction needle bar. As an alternative, the enlarged diameter portion of the introduction needle bar may be smaller than the aperture 5 2 but larger than the diameter of the proximal portion 43 of the extension channel such that when the introduction needle is withdrawn, the proximal portion 43 will become stuck Introduce the enlarged diameter portion of the needle bar. 3a-3d, the spring clip 50 is fitted into the needle shield 41 through the opening 60, and the second snap portion 57 of the spring clip 5 is snapped into position, the hole 52 on the proximal wall 51 and the needle shield. The openings on the proximal portion of 41 are aligned. As best shown in Fig. 3b, the inverted V-shaped bend 5 5 of the spring clip projects beyond the outer wall of the needle shield 4 1 . After the introduction needle is withdrawn from the catheter (i.e., after the spring is triggered), the distal wall 53 will be interposed between the opening of the proximal portion 43 and the opening of the distal portion 44 in the extension channel of the needle shield body 41. Figures 5a-5e show the structure of the needle shield 41 in the first embodiment of the present invention. The needle cover 4 1 is molded of plastic or other material and has a through hole along the axis of the introduction needle 3 i . Preferably, a tooth-shaped engaged portion 47 is provided in the needle cover 4 1 , and the toothed-shaped snap-fit portion 47 is used for the y-shaped latching portion 57 of the spring clip 50 - 9 - 200810801 (9) Engagement prevents the spring clip 50 from disengaging from the needle shield 41. Figure 6 shows that after the introducer needle 31 is withdrawn from the catheter, the needle shield 41 and the spring clip 50 are closed at the needle tip of the distal end of the introducer needle. The proximal end of the introduction needle 3 1 is fixed to the introduction needle hub 30. In the case shown in Fig. 1, the introduction needle hub 34 surrounds the safety device 40 so as to be invisible from the outside. One or more slide rails 49 may be provided on the outer surface of the needle shield 41 as shown in Fig. 7. Since the slide rail 49 reduces the contact area between the needle cover 4 1 and the needle holder 34, it is advantageous for the needle cover 4 1 to slide out of the needle holder 34. Fig. 8 is a cross-sectional view showing the state of the catheter and the introduction needle assembly 10 before the introduction needle 31 is withdrawn from the catheter 21, in which the safety device 40 is enclosed in the introduction needle hub 34 and the catheter hub 24. The proximal portion of the safety device 40 is surrounded by the needle hub 34, while the distal portion of the safety device 40 is surrounded by the catheter hub 24. A recess 25 is provided in the catheter hub 24. The inverted V-shaped catching portion 5 5 on the spring clip 50 engages the notch 25. Fig. 9 is an enlarged cross-sectional view showing the catheter and the introducer needle assembly 10 in the state shown in Fig. 8, in which the introduction needle 31 is slightly pulled out. Although the description of the invention has been made with reference to a catheter assembly 20 with a septum 29, the safety device 40 of the present invention can also be used with other types of catheter assemblies, for example, without the isolation plug 2 described. 9. In normal use, once the catheter 21 is properly inserted into the blood vessel, the introducer needle 31 will be withdrawn from the catheter 21, which is preferably provided with a blood return groove 33 (see Figures 13 and I4). Figures 10-12 illustrate several stages of the introduction of the 12-(10) (10) 200810801 needle 3 1 from the catheter assembly 20. In the stage shown in Fig. 1, the return groove 3 3 of the introduction needle 31 is moved into and surrounded by the isolation plug 29, at which time the distal wall 53 of the spring clip 50 is still introduced. The needle 31 is compressed. In the stage shown in Fig. 11, the distal end wall 53 of the spring clip 50 is bounced from the compressed state because the introduction needle 3 1 no longer interferes with it, so that the distal wall 53 will introduce the needle tip of the needle 3 1 Capture to prevent it from moving back towards the distal direction. Figure 12 shows another stage in which the needle tip of the introduction needle 3 1 is captured by the distal wall 53 of the spring clip 50 and cannot slide back toward the distal direction. The enlarged portion 38 of the introduction needle 31 prevents the introduction needle 31. Slide in the proximal direction. An extension projection 46 on the needle shield 4 1 prevents blood from leaking out of the needle tip or return groove 33 (if any). As the advancement step pulls the needle 3 toward the proximal end, the inverted V-shaped snap portion 5 5 will disengage from the recess 25 of the catheter hub 24. Therefore, the needle shield 41 is released by the catheter hub 24. In the above embodiment, the enlarged portion 38 located on the introduction needle 31 may be a projection. As shown in Fig. 13, the projection 38 may be a pressing projection. Preferably, the pressing projection is provided with a reflow groove 33. Preferably, the pressing projections can be formed by pressing or pinching two points on the needle 31. The line between the two points must intersect the longitudinal axis of the introduction needle 31. As shown in Fig. 14, the enlarged portion 38 on the introduction needle 31 can also adopt other forms of construction. For example, the enlarged portion 38 can be a straight &lified enlarged portion 38 that can be in the form of a projection disclosed in U.S. Patent No. 3,215,528. This document is hereby incorporated by reference. The enlarged diameter portion 38 has an intermediate portion having an outer diameter greater than an outer diameter of the stem of the introducer needle 31, and a tapered portion extending from the intermediate portion toward the proximal end portion of the introducer needle 31. The proximal portion extends from the intermediate portion toward the distal end portion of the introducer needle 31 with a tapered distal portion. Although the enlarged diameter portion 38 is set to a symmetrical structure, this is not essential. The diameter of the enlarged diameter portion 38 should be greater than the outer diameter of the stem portion of the introducer needle 3 1 , but should be smaller than the inner diameter of the distal end portion 44 of the longitudinally extending passage. This ensures that the introducer needle 3 1 can be pulled into the safety device 40 in the proximal direction. In order to prevent the introduction needle 3 1 from being completely pulled out of the safety device 40 in the proximal direction, the proximal end portion 43 of the longitudinally extending channel should be smaller than the large diameter portion 38, thereby blocking the movement of the introduction needle 3 1 through the proximal portion 43 ° As an alternative, it is also preferred that the diameter of the bore 5 2 of the proximal wall 51 of the spring clip 50 is slightly larger than the diameter of the stem of the introducer needle 31, but smaller than the diameter of the enlarged diameter section 38. . Thus, when the introducer needle 3 1 is withdrawn toward the proximal direction relative to the safety device 40, the enlarged diameter portion 38 will become caught at the aperture 52 of the proximal wall 51 rather than being caught at the proximal end portion 43 of the needle shield 41. At the office. This prevents the introduction needle 31 from being completely withdrawn to the outside of the needle shield 41 in the proximal direction. In order to place the catheter 21 into the blood vessel of the patient, the medical professional will introduce the needle 31 and the catheter 21 substantially longitudinally aligned with the target vessel. The bevel that introduces the needle tip should face away from the patient's skin surface during the puncture. Medical -14- (12) (12) 200810801 The person introduces the needle 31 and the catheter 21 into the patient's skin at a shallow angle, preferably less than 35 degrees, so that the needle tip 3 2 of the introduction needle enters the target blood vessel. The medical staff then preferably observes the return of blood in the return chamber introduced into the needle hub 3* or the return blood located in the return groove 3 3 of the introduction needle 31. After confirming the positioning of the introducer needle 3 1 and the catheter 2 1 in the target vessel, the medical staff advances the catheter 21 in the blood vessel axially along the introducer needle 3 1 toward the distal end of the vessel. In some techniques, the introducer needle 3 1 can be partially withdrawn in the catheter 21 before the catheter 21 is fully advanced into the proper position in the blood vessel. After the correct positioning of the catheter 21 is achieved, the medical professional presses the finger of the other hand against the patient's skin at the blood vessel where the distal end of the catheter 21 is located. By pressing their fingers against the patient's skin and applying sufficient pressure, the medical staff will effectively block the flow of blood through the catheter 21, or if the isolation plug 29 is provided in the catheter assembly 2, the flow of blood can also be The isolation plug 29 is blocked. The medical staff then completely withdraws the introducer needle 31 out of the catheter 21 by introducing the needle hub 34 toward the proximal end. This movement causes the needle tip 32 of the introduction needle 31 to enter the safety device 40 in the proximal direction. However, at least during the proximal movement in which the introduction of the needle 3 1 begins, the inverted V-shaped bend 5 5 of the spring clip 50 acts as a snap-fit engagement with the recess on the catheter hub, so that the needle shield 41 remains with the catheter hub 2 4 joints. Once the needle tip 3 2 is in the safety device 40 and the introducer needle 31 is locked therein by the spring clip 50, the sustained proximal directional force acting on the needle hub 34 will cause the inverted V-shaped bend to disengage from the recess of the catheter hub 24. Engage. After the introducer needle 31 and the safety device 40 are removed from the catheter hub 24, the medical staff can connect the fluid -15-(13) (13) 200810801 body delivery device, a common heparin cap (PRN), or connect the head cover to the catheter assembly 20 'And start planning the treatment. Then, the introduction needle 3 1 and the needle cover 4 1 can be processed in accordance with a simple processing procedure. Figures 15a-e illustrate a safety device 40 in accordance with a second embodiment of the present invention, and Figures 16-h illustrate a spring clip 50 for use in the safety device 40 of the second embodiment. Only the differences from the first embodiment will be described here. The first embodiment is different from the second embodiment in that the spring clip 50 in the first embodiment is divided into two parts in the second embodiment, i.e., the first spring clip 50a and the second spring clip 50b. The first spring clip 50a includes an intermediate wall 54 and a distal wall 53, and a bend 5 5 therebetween. The second spring clip 5 Ob includes a proximal end wall 51 defining a bore 52 formed therein, the proximal end wall 51 being formed with a U-shaped snap portion 57 by bending the free end thereof. In the second embodiment, the first spring clip 50a is mounted into the needle shield 41 by adhering the free end of the intermediate wall 54 to the corresponding portion of the needle shield 41, and the second spring clip 50b is snapped by the U-shape. The portion 57 is engaged with the tooth-shaped engaged portion 47 provided in the needle cover 41 and attached to the needle cover 41. As an alternative, in the second embodiment, the second spring clip 5 Ob may also be replaced by a gasket with a hole whose diameter should be larger than the diameter of the stem of the introduction needle 31, and smaller than The enlarged portion 38 of the needle 3 1 is introduced. It should be noted that in the present invention, the first engaging portion 55 of the spring clip 50 may take a form different from the first and second embodiments. For example, a spring hole may be provided in the spring clip instead of the inverted v-shaped bend, and the spherical hole may be engaged with a spherical bearing provided in the catheter holder 24. The spring clip 50 of the present invention has two functions. One of the functions is -16- (14) (14)200810801 to protect the user from touching the tip of the needle. Yet another function is to provide a snap portion, such as the inverted V-shaped curved or spherical aperture, for engaging the catheter hub 24. If these two functions are separated, two different spring clips are required to achieve this function, resulting in increased costs. While the invention has been described hereinabove with reference to the specific embodiments thereof, it should be understood that the invention should not be construed as Some variations are made, and the scope of the invention is defined by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described hereinafter with reference to preferred embodiments shown in the drawings. Figure 1 shows a catheter and introducer needle assembly with a safety device of the present invention. Figure 2 shows that after the introduction of the introducer needle, the tip of the introducer needle is enclosed in the safety device of the present invention. Figures 3a-d illustrate a security device of the present invention comprising a spring clip mounted from the top of the security device into the needle shield and snapped in place by the U-shaped structure of the spring clip, on the spring clip The holes are aligned with the channels on the needle shield. 3a is a top view of the security device, FIG. 3b is a front view of the security device, FIG. 3c is a perspective view of the security device, and FIG. 3d is a side view of the security device. Figures 4a-4g show the shape of the spring clip in the first embodiment, wherein Figure -17-(15) (15) 200810801 4a is a bottom view, Figure 4b is a front view, and Figure 4c is a top view of the spring clip, Figure 4a 4e and 4g are two perspective views, and Fig. 4f is a side view of the spring clip. Figure 5 a-e shows the structure of the needle shield of the present invention. 5a is a perspective view of the needle shield, FIG. 5B is a side view of the needle shield, FIG. 5c is a bottom view of the needle shield, FIG. 5d is a front view of the needle shield, and FIG. 5e is a needle cover top view. Figure 6 is an enlarged view showing the needle shield and spring clip enclosed on the tip of the distal end of the introducer needle. Figure 7 shows the needle shield and spring clip. One or more slide rails are provided on the outer circumference of the needle cover main body, so that the needle cover is easily slid due to the reduction of the contact point. Figure 8 is a cross-sectional view showing the safety device of the present invention enclosed within the introducer needle hub and catheter hub. Figure 9 shows an enlarged cross-sectional view of the introducer needle and catheter assembly with the needle shield enclosed within the introducer needle hub and catheter hub with the V-bend of the spring clip engaged in a recess in the catheter hub. Figure 1 shows a stage in the extraction of the introduction needle, in which the groove on the introduction needle is surrounded by the head of the isolation plug, while the distal wall of the spring clip is still compressed by the introduction of the needle. And the inverted V-shaped bend engages in the groove on the catheter hub. Figure 11 shows a stage in the withdrawal of the introducer needle, at which the tip of the introducer needle moves past the distal end wall of the spring clip, which is released by the introducer needle to capture the tip of the introducer needle, preventing The needle tip moves in the distal direction and the inverted v-bend remains engaged in the recess of the catheter hub. -18- (16) (16) 200810801 Figure 1 2 shows a stage in which the introducer needle is withdrawn, wherein the V-bend of the spring clip disengages from the recess of the catheter hub, the needle shield is separated from the catheter hub, and the needle is placed The upper projection prevents the introduction needle from moving in the proximal direction, and the raised portion extending over the proximal end of the needle shield prevents blood from being exposed from the recess of the introduction needle. Fig. 13 shows a structure of the introduction needle in which the groove is located after the extrusion projection. Fig. 14 shows a structure of the introduction needle in which the groove is located after a three-dimensional projection. Figure 15 a-e shows a security device in accordance with a second embodiment of the present invention. 15a is a top view of the safety device, FIG. 15b is a front view of the safety device, FIG. 15c is a bottom view of the safety device, FIG. 15d is a perspective view of the safety device, and FIG. 15e is a side view of the safety device . Figures 16a-h show the spring clips used in the safety device of the second embodiment. Figure 1 is a left side view of the second spring clip, Figure 16b is a front view of the second spring clip, Figure 16c is a perspective view of the second spring clip, and Figure 16d is a right side view of the second spring clip, Fig. 1e is a perspective view of the first spring clip, Fig. 16f is a left side view of the first spring clip, Fig. 6g is a front view of the first spring clip, and Fig. 16h is a right side view of the first spring clip. [Description of main component symbols] 10: Catheter and introducer needle assembly 20: Catheter assembly 21: Catheter-19- (17) 200810801 2 4 : 25 : 29 : 30 : 3 1: 32 : 33 : 34 : 35 : 36 : 38 : 40 : 4 1: 43 : 44 : 45 : 46 : 47 : 50 : 50a : 50b : 5 1 : 52 : 53 : Catheter socket notch isolation needle introduction needle assembly introduction needle tip recirculation groove introduction needle needle retraction concave Slot extension piece protrusion, enlarged part safety device needle needle proximal end part distal part intermediate groove part hole tooth part, toothed snap-fit part spring clip first spring clip second spring clip proximal end wall hole distal end wall - 20 (18) 200810801 54 : 55 : 5 7 : 60 : The middle wall is bent, the snap-in part is open - 21