TWI426936B - Catheter and introducer needle assembly with safety device - Google Patents

Catheter and introducer needle assembly with safety device Download PDF

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TWI426936B
TWI426936B TW095130080A TW95130080A TWI426936B TW I426936 B TWI426936 B TW I426936B TW 095130080 A TW095130080 A TW 095130080A TW 95130080 A TW95130080 A TW 95130080A TW I426936 B TWI426936 B TW I426936B
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catheter
needle
introducer needle
safety device
assembly
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TW095130080A
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TW200810801A (en
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Neville Chia
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Becton Dickinson Co
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Description

帶有安全裝置的導管和引入針組件Catheter and introducer needle assembly with safety device

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。This invention relates to a catheter and introducer needle assembly, and more particularly to a safety device for a catheter and introducer needle assembly.

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,尺寸大概在兩英寸或更短。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。Intravascular catheters, particularly intravenous catheters (IV catheters), are commonly used to deliver fluids to patients, such as normal salines, various medications, and injectable nutrients, or to extract blood from a patient. The peripheral venous catheter is usually relatively short and measures approximately 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 mounted on 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 of the catheter and the inclined face of the introducen needle tip faces upward.

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。The catheter and introducer needle assembly is pierced through the patient's skin at a shallow angle into the peripheral blood vessel, which is not directly connected to the heart but is connected to one of the central vessel branches directly connected to the heart. In one technique, the introducer needle and catheter are fully inserted into the blood vessel together. 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.

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。為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。通常該回腔構成導管座的一部分。作為另外一種方案,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。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 assembly is properly positioned, the medical staff needs to confirm if there is a return blood in the introduction needle and the return chamber at the proximal end of the introduction needle. Typically the return 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 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 a needle tip that is contaminated with blood and must be disposed of properly.

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,因為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。In recent years, there has been a great deal of concern for medical personnel who may be contaminated with the patient's blood. It has been recognized that sputum contaminated with blood must be disposed of immediately. This concern is growing because of the emergence of deadly diseases that are currently not treatable, 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 described 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 that it is necessary to properly treat sputum-stained sputum, it is unfortunate that in some medical settings, such as in an emergency or because of inadvertent or negligent, there is still a contaminated introduction needle that pokes to the medical staff. situation.

為了解決上述被〝血液沾染的針尖〞意外刺到的問題,已經開發了各種引入針安全裝置。In order to solve the above problem of accidental puncture of the needle tip contaminated by the blood, various needle safety devices have been developed.

美國專利文獻US6287278公開了一種IV導管組件,該IV導管組件沒有一個用來保護使用者的彈簧夾。然而,該IV導管組件並不設有外罩或者包圍所述彈簧夾的外罩。儘管所述彈簧夾可以防止使用者接觸到引入針的針尖,但是它並不能防止使用者接觸到位於針尖上的殘留血液,特別是,當引入針上設有一些圓周孔比如回流凹槽時更是如此。所以,US6287278中的IV導管組件對於使用者來說依然是不安全的。U.S. Patent No. 6,287,278 discloses an IV catheter assembly which does not have a spring clip for protecting the user. However, the IV catheter assembly is not provided with a housing or a housing surrounding the spring clip. Although the spring clip prevents the user from contacting the needle tip of the introduction needle, it does not prevent the user from contacting the residual blood on the needle tip, in particular, when the introduction needle is provided with some circumferential holes such as a recirculation groove. This is the case. Therefore, the IV catheter assembly of US 6,287,278 is still unsafe for the user.

美國專利文獻US5215528中公開了一種導管和引入針組件,該組件中具有一個金屬夾,該金屬夾在導管插入到血管中並且從導管中抽出引入針後防止使用者被引入針刺傷。如US5215528的附圖中所示,導管和引入針組件具有多個從凸緣48伸出的弧形凸起50,這些弧形凸起限定形成一個容納座53,在該容納座53中保持導管座52。管體38的一端限定形成一個凸起部38a延伸到導管座中。弧形凸起50的端部包括一些向內延伸的唇部54,這些唇部可釋放地保持著導管座的凸緣56。弧形凸起50和唇部54被設計成能接合凸緣56並且使得與從容納座53去掉導管座52相比,使用者借助於突出部48b更容易從引入針針座上退下針罩。然而,上述的配合關係並不可靠,因為其依賴於製造公差。這樣,在導管座和引入針針罩之間的脫離是不可預料的,可能在針尖被安全保護起來之前就脫離了。這種不穩定的行為在一些需要精確性和可靠性的環境中是不合適的。A catheter and introducer needle assembly is disclosed in U.S. Patent No. 5,215,528, which has a metal clip that prevents the user from being introduced into the needle after the catheter is inserted into the blood vessel and the introducer needle is withdrawn from the catheter. As shown in the drawings of US 5,215,528, the catheter and introducer needle assembly has a plurality of arcuate projections 50 extending from the flanges 48, the arcuate projections defining a receptacle 53 in which the conduit is retained Block 52. One end of the tubular body 38 defines a projection 38a that extends into the catheter hub. The ends of the curved projections 50 include inwardly extending lips 54 that releasably retain the flange 56 of the catheter adapter. The curved projections 50 and lips 54 are designed to engage the flange 56 and make it easier for the user to retract the needle shield from the introduction needle hub by means of the projection 48b as compared to the removal of the catheter hub 52 from the receptacle 53. . However, the above-described mating relationship is not reliable because it depends on manufacturing tolerances. Thus, the detachment between the catheter hub and the introducer needle cover is unpredictable and may be disengaged before the needle tip is safely secured. This unstable behavior is not suitable in some environments where accuracy and reliability are required.

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。Accordingly, there is still a need in the art for improvements in safety devices for catheters and introducer needle assemblies to overcome the above-discussed shortcomings.

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。It is an object of the present invention to provide a safety device for a catheter and an introducer needle assembly that prevents the user from contacting the tip of the introducer needle and prevents the user from being inserted after the catheter is inserted into the blood vessel and the introducer needle is withdrawn from the catheter. Touch the glue on the tip of the needle.

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。It is a further object of the present invention to provide a safety device for a catheter and introducer needle assembly that provides for more precise and reliable detachment between the catheter hub and the needle shield.

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為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。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 comprising: a catheter assembly comprising: a catheter having a proximal end and a distal end; a catheter hub secured to a proximal end of the catheter; an introducer needle assembly, the 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 defining a longitudinally extending channel, the longitudinally extending channel being provided with an elongated opening At least one spring clip mounted in the longitudinally extending passageway through an elongated opening; and a stop means for blocking an enlarged portion of the introduction needle, wherein the longitudinally extending passageway allows the insertion needle to extend longitudinally through a needle cover, the at least one spring clip being provided with a first snap portion for engaging with the catheter seat, at least a portion of the at least one spring clip being shaped to be introduced Withdrawn from the catheter assembly before the needle is introduced into the compressed, while the introduction of the catheter assembly after the needle withdrawn from the at least a portion of the bounce is released and capture the sharp distal tip of the introducer needle.

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為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。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; the introducer needle 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 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, and at least a portion of the at least one spring clip is shaped to be drawn before the introducer needle is withdrawn from the catheter assembly Compressed into the needle, and the needle is introduced withdrawn from the catheter assembly after the release of at least a portion of the bounce and capture the sharp distal tip of the introducer needle.

在本文中,術語〝近〞和〝遠〞是相對於引入針針座34而言來描述位於導管和引入針組件上的位置。As used herein, the terms 〝 and 〝 are described relative to the introducer hub 34 to describe the location on the catheter and introducer needle assembly.

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10標識。其包括導管組件20,引入針組件30和安全裝置40。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, an introducer needle assembly 30, and a safety device 40.

導管組件20包括具有近端和遠端的導管21,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31的回流凹槽(如果有)觀察回流。用於導管座24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。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.

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31上可以設置一個回流凹槽33。作為一種備選方案,可以在引入針組件30中設置一個回流腔來代替所述的回流凹槽33。引入針針座34可以包括一個徑向向外延伸的延伸片36供握持使用。引入針針座34的材料可以與導管座24相同,也可以不同。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 return groove 33 may be provided on the introduction needle 31. As an alternative, a recirculation chamber may be provided in the introduction needle assembly 30 instead of the recirculation recess 33. The introducer hub 34 can include a radially outwardly extending 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.

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41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31的桿部的直徑。這樣能容許引入針31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60沿著針罩41的縱向方向開設在至少部分所述中間槽部45上。As shown in Figures 3a-3d, the safety device 40 includes a needle shield 41, which is preferably made of plastic. As shown in Fig. 2, once the catheter 21 is inserted into the blood vessel and the introducer needle 21 is withdrawn from the catheter 21, the safety device 40 will be held on the needle tip of the introducer needle, thereby protecting the user from needle stick injuries. The needle shield 41 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 of the introducer needle 31. This allows the stem portion of the introducer needle 31 to easily pass through the proximal end portion 43, the distal end portion 44, and the intermediate groove portion 45. As shown in Figures 3a and 3b, the elongated opening 60 is formed in at least a portion of the intermediate groove portion 45 along the longitudinal direction of the needle shield 41.

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50的正視圖)很好地示出,近端壁51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53與中間壁54的另外一端相連,並且在遠端壁53和中間壁54之間設有彎曲55,該彎曲55向著中間壁54的與近端壁51和遠端壁53相反的一側突出。優選地,彎曲55可以為倒V形彎曲。該彎曲55被用作一個卡接部與導管座24相連。遠端壁53的形狀被製成為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31釋放彈起。這將會在下文中詳細描述。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 an 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. 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 54, and a bend 55 is provided between the distal wall 53 and the intermediate wall 54, which is opposite the proximal wall 51 and the distal wall 53 of the intermediate wall 54. One side stands out. Preferably, the bend 55 can be an inverted V-bend. This bend 55 is used as a snap-on connection to the catheter hub 24. The distal wall 53 is shaped to be compressed by the introducer needle 31 prior to triggering of the spring clip, and is released by the introducer needle 31 after the spring clip is triggered. This will be described in detail below.

優選地,遠端壁53在其自由端具有一個部分,該部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31壓縮和彎曲。Preferably, the distal wall 53 has a portion at its free end, the width of which 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 31 before the spring is triggered.

優選地,近端壁51在其自由端上設有第二卡接部57。例如,該第二卡接部57可以通過將近端壁51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。所述相應部分可以為設置在中間槽部45中的齒部47。Preferably, the proximal wall 51 is provided with a second snap portion 57 on its free end. For example, the second catching portion 57 can form a U-shaped snap portion by bending the free end of the proximal end 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.

優選地,孔52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)。作為一種備選方案,引入針針桿的直徑增大部分可以比孔52小但是大於延伸通道的近端部分43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。Preferably, the aperture 52 has a reinforcing lip on its periphery for catching an enlarged diameter portion (e.g., a projection) located on the introduction needle bar. As an alternative, the enlarged diameter portion of the introducer needle bar may be smaller than the aperture 52 but larger than the diameter of the proximal portion 43 of the extension channel such that when the introducer needle is withdrawn, the proximal portion 43 will catch the introducer needle The diameter of the needle bar is increased.

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50的第二卡接部57卡在位置上,位於近端壁51上的孔52與針罩41近端部分上的開口對準。如圖3b最好地示出,彈簧夾的倒V形彎曲55突出於針罩41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。As shown in Figures 3a-3d, the spring clip 50 fits within the needle shield 41 through the opening 60 and is captured by the second snap portion 57 of the spring clip 50. The aperture 52 on the proximal wall 51 is adjacent to the needle shield 41. The openings on the end portions are aligned. As best shown in Figure 3b, the inverted V-shaped bend 55 of the spring clip projects beyond the outer wall of the needle shield 41. 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.

圖5a-5e示出了本發明第一實施例中針罩41的結構。針罩41由塑料或者其它材料模製而成,沿著引入針31的通過軸線具有一個通孔。在針罩41中優選設置一個齒狀被卡接部47,該齒狀被卡接部47用於與彈簧夾50的所述U形卡接部57卡合,防止彈簧夾50從針罩41中脫離。5a-5e show the structure of the needle shield 41 in the first embodiment of the present invention. The needle cover 41 is molded of plastic or other material and has a through hole along the passing axis of the introduction needle 31. Preferably, a toothed engaged portion 47 is provided in the needle cover 41 for engaging with the U-shaped engaging portion 57 of the spring clip 50 to prevent the spring clip 50 from the needle cover 41. In the middle.

圖6示出在引入針31從導管中抽出之後,針罩41和彈簧夾50封閉在引入針遠端的針尖處。引入針31的近端部固定到引入針針座30。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。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 31 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 that it is not visible from the outside.

如圖7所示,在針罩41的外表面上可以設置一個或更多個滑軌49。由於所述滑軌49減小了針罩41和針座34之間的接觸面積,所以有利於針罩41滑出針座34內。As shown in FIG. 7, one or more slide rails 49 may be disposed on the outer surface of the needle shield 41. Since the slide rail 49 reduces the contact area between the needle cover 41 and the needle holder 34, it is advantageous for the needle cover 41 to slide out of the needle holder 34.

圖8為一個剖視圖,其示出了在引入針31從導管21中抽出之前導管和引入針組件10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50上的倒V形卡接部55與該凹口25嚙合。圖9示出圖8中所示狀態下,導管和引入針組件10的放大剖視圖,其中引入針31被稍微抽出一點。FIG. 8 is a cross-sectional view showing the state of the catheter and the introducer needle assembly 10 before the introducer needle 31 is withdrawn from the catheter 21, wherein the safety device 40 is enclosed in the introduce 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 55 on the spring clip 50 engages with the recess 25. Fig. 9 shows an enlarged cross-sectional view of the catheter and introducer needle assembly 10 in the state shown in Fig. 8, in which the introducer needle 31 is slightly pulled out.

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29。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 29 described. .

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14)。圖10-12示出了引入針31從導管組件20中抽出時的幾個階段。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 14). Figures 10-12 illustrate several stages when the introducer needle 31 is withdrawn from the catheter assembly 20.

圖10示出的階段中,引入針31的回流凹槽33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。In the stage shown in Fig. 10, the return groove 33 of the introduction needle 31 is moved into and surrounded by the isolation plug 29, at which time the distal end wall 53 of the spring clip 50 is still introduced into the needle 31. compression.

圖11示出的階段中,彈簧夾50的遠端壁53由於引入針31不再妨礙它,所以從壓縮狀態彈起來,從而,遠端壁53將引入針31的針尖捕獲而防止其向著遠端方向往回運動。In the stage shown in Fig. 11, the distal end wall 53 of the spring clip 50 bounces from the compressed state because the introduction needle 31 no longer obstructs it, so that the distal end wall 53 captures the needle tip of the introduction needle 31 to prevent it from being directed toward the distal end. The direction of the end moves back.

圖12示出了另外一個階段,其中,引入針31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41上的延伸凸起46防止血液從針尖或者回流凹槽33(如果有)漏出。隨著進一步向著近端方向抽引入針31,倒V形卡接部55將會與導管座24的凹口25脫離嚙合。因此,針罩41被導管座24釋放。Figure 12 shows another stage in which the needle tip of the introducer needle 31 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 introducer needle 31 prevents the introducer needle 31 from facing Slide in the proximal direction. An extension projection 46 on the needle shield 41 prevents blood from escaping from the needle tip or return groove 33, if any. As the needle 31 is further drawn toward the proximal end, the inverted V-shaped catch 55 will disengage from the recess 25 of the catheter hub 24. Therefore, the needle shield 41 is released by the catheter hub 24.

在上述實施例中,位於引入針31上的增大部分38可以為一個凸起。如圖13中所示,該凸起38可以為擠壓凸起,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31的縱軸線交叉。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, and preferably, the pressing projection is provided with a reflow groove 33. Preferably, the pressing projection 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.

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38可以為一個直徑增大的部分38,該直徑增大的部分38可以採用美國專利US5215528中所公開的凸起形式,該文獻在這裏被引入作為參考。所述直徑增大的部分38具有一個中間部分,該中間部分的外徑大於引入針31桿部的外徑,從所述中間部分向著引入針31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31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38設為對稱結構,但是這並不是必須的。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 an enlarged diameter portion 38 that can be used in the form of a projection as disclosed in U.S. Patent No. 5,215,528, the disclosure of which is incorporated herein by reference. The enlarged diameter portion 38 has an intermediate portion having an outer diameter greater than the outer diameter of the stem of the introducer needle 31, and a tapered proximal portion extending from the intermediate portion toward the proximal end portion of the introducer needle 31. A tapered distal end portion extends from the intermediate portion toward the distal end portion of the introducer needle 31. Although the enlarged diameter portion 38 is set to a symmetrical structure, this is not essential.

增大的直徑部分38的直徑應當大於引入針31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31可以沿著近端方向拉入到安全裝置40中。為了防止引入針31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38小,從而阻擋引入針31運動通過近端部分43。The diameter of the enlarged diameter portion 38 should be greater than the outer diameter of the stem of the introducer needle 31, 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 31 can be pulled into the safety device 40 in the proximal direction. In order to prevent the introducer needle 31 from being pulled out completely 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 preventing the introduction needle 31 from moving through the proximal portion 43.

作為一種備選方案,也是優選方案,彈簧夾50的近端壁51的孔52的直徑稍大於引入針31的桿部的直徑,但是小於增大的直徑部分38的直徑。這樣,當引入針31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。As an alternative, and preferably, the diameter of the bore 52 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 portion 38. Thus, when the introducer needle 31 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. . This prevents the introduction needle 31 from being completely withdrawn to the outside of the needle shield 41 in the proximal direction.

為了將導管21放入到患者的血管內,醫務人員將引入針31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32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34中的回流腔中的血液回流或者位於引入針31的回流凹槽33中的回流血。To place the catheter 21 into the blood vessel of the patient, the medical professional will introduce the needle 31 and 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. The medical staff will introduce 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 32 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 34 or the return blood located in the return groove 33 of the introducer needle 31.

在確認了引入針31和導管21處於目標血管中的定位之後,醫務人員將導管21在血管中軸向沿著引入針31向著遠端前進。在某些技術中,引入針31可以在導管21完全前進到血管中恰當位置之前部分地在導管21中回撤。在實現導管21的正確定位後,醫務人員將另一個手的手指壓在導管21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21的血液流動,或者如果導管組件20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31開始的近端運動期間,彈簧夾50的倒V形彎曲55作為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24接合。一旦針尖32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31和安全裝置40從導管座24中移出之後,醫務人員可以將液體輸送裝置、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31和針罩41可以按照簡單的處理規程進行處理。After confirming the positioning of the introducer needle 31 and the catheter 21 in the target vessel, the medical professional advances the catheter 21 axially along the introducer needle 31 in the blood vessel. In some techniques, the introducer needle 31 can be partially withdrawn in the catheter 21 before the catheter 21 is fully advanced into 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 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 20, the flow of blood can also be isolated. The plug 29 blocks. 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 introducer needle 31 to enter the safety device 40 in a proximal direction. However, at least during the proximal movement of the introduction needle 31, the inverted V-shaped bend 55 of the spring clip 50 engages as a snap on the recess on the catheter hub such that the needle shield 41 remains engaged with the catheter hub 24. Once the needle tip 32 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. . After the introducer needle 31 and the safety device 40 are removed from the catheter hub 24, the medical professional can initiate a planned treatment by attaching a fluid delivery device, a common heparin cap (PRN), or attaching the head cover to the catheter assembly 20. Then, the introduction needle 31 and the needle cover 41 can be processed in accordance with a simple processing procedure.

圖15a-e示出了本發明第二實施例的安全裝置40,圖16-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50在第二實施例中被分為兩個部分,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53,以及位於它們之間的彎曲55。第二彈簧夾50b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57。在第二實施例中,第一彈簧夾50a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。作為一種備選方案,在該第二實施例中,第二彈簧夾50b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31的桿部的直徑,而小於引入針31的增大部分38。Figures 15a-e show a safety device 40 of a second embodiment of the invention, and Figure 16-h shows 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, namely, a first spring clip 50a and a second spring clip 50b. The first spring clip 50a includes an intermediate wall 54 and a distal wall 53, and a bend 55 therebetween. The second spring clip 50b 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 bonding the free end of the intermediate wall 54 to the corresponding portion of the needle shield 41, and the second spring clip 50b passes through the U-shaped snap portion. The snap-fit portion 47 provided in the needle cover 41 is snap-fitted to the needle cover 41. As an alternative, in the second embodiment, the second spring clip 50b 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 introduction needle. The enlarged portion 38 of 31.

應當指出,本發明中,彈簧夾50的第一卡接部55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24中的球形軸承嚙合。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 spherical 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 disposed in the catheter hub 24.

本發明的彈簧夾50具有兩個功能。其中一個功能是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。The spring clip 50 of the present invention has two functions. One of the functions is to protect the user from touching the tip of the introducer needle. Yet another function is to provide a snap, such as the inverted V-shaped curved or spherical aperture, for engagement with the catheter hub 24. If these two functions are separated, two different spring clips are needed to achieve this function, resulting in increased costs.

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為是對本發明的限制,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。Although the present invention has been described above with reference to the specific embodiments thereof, it should be understood that these embodiments are not to be construed as limiting the scope of the invention. Some variations are made, and the scope of the invention is defined by the appended claims.

10...導管和引入針組件10. . . Catheter and introducer needle assembly

20...導管組件20. . . Catheter assembly

21...導管twenty one. . . catheter

24...導管座twenty four. . . Catheter seat

25...凹口25. . . Notch

29...隔離塞29. . . Isolation plug

30...引入針組件30. . . Introduction needle assembly

31...引入針31. . . Introduction needle

32...針尖32. . . Tip

33...回流凹槽33. . . Reflow groove

34...引入針針座34. . . Introduction needle seat

35...回流凹槽35. . . Reflow groove

36...延伸片36. . . Extension piece

38...凸起、增大部分38. . . Raised, enlarged part

40...安全裝置40. . . safety equipment

41...針罩41. . . Needle cover

43...近端部分43. . . Proximal part

44...遠端部分44. . . Remote part

45...中間槽部45. . . Intermediate groove

46...孔46. . . hole

47...齒部、齒狀被卡接部47. . . Toothed, toothed snap-fit

50...彈簧夾50. . . Spring clip

50a...第一彈簧夾50a. . . First spring clip

50b...第二彈簧夾50b. . . Second spring clip

51...近端壁51. . . Proximal wall

52...孔52. . . hole

53...遠端壁53. . . Distal wall

54...中間壁54. . . Intermediate wall

55...彎曲、卡接部55. . . Bending, snap-in

57...卡接部57. . . Card joint

60...開口60. . . Opening

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。The invention will be described hereinafter with reference to the preferred embodiments shown in the drawings.

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。Figure 1 shows a catheter and introducer needle assembly with a safety device of the invention therein.

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。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.

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為安全裝置的頂視圖,圖3b為安全裝置的正視圖,圖3c為安全裝置的透視圖,以及圖3d為安全裝置的側視圖。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.

圖4a-4g示出了第一實施例中彈簧夾的形狀,其中圖4a為底視圖,圖4b為正視圖,圖4c為彈簧夾的頂視圖,圖4e和圖4g為兩個透視圖,圖4f為彈簧夾的側視圖。4a-4g show the shape of the spring clip in the first embodiment, wherein Fig. 4a is a bottom view, Fig. 4b is a front view, Fig. 4c is a top view of the spring clip, and Fig. 4e and Fig. 4g are two perspective views, Figure 4f is a side view of the spring clip.

圖5a-e示出了本發明針罩的結構。其中圖5a為針罩的一個透視圖,圖5B為針罩的一個側視圖,圖5c為針罩的一個底視圖,圖5d為針罩的一個正視圖,圖5e為針罩的一個頂視圖。Figures 5a-e illustrate the construction of a 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 top view of the needle shield .

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。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.

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。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.

圖8為一個剖視圖,示出了本發明的安全裝置包圍在引入針針座和導管座內。Figure 8 is a cross-sectional view showing the safety device of the present invention enclosed within the introducer needle hub and catheter hub.

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。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.

圖10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。Figure 10 shows a stage when the introduction needle is withdrawn, at which the groove on the introduction needle is surrounded by the head of the isolation plug, and the distal wall of the spring clip is still compressed by the introduction of the needle, The inverted V-shaped bend engages in a groove in the catheter hub.

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。Figure 11 shows a stage in the withdrawal of the introducer needle, at which the tip of the introducer needle moves past the distal wall of the spring clip, which is released by the introducer to release the tip of the introducer needle, preventing the tip of the introducer needle from being caught The needle tip moves in the distal direction while the inverted V-shaped bend still engages in the recess of the catheter hub.

圖12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。Figure 12 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 projection on the introducer needle prevents the introducer needle from approaching the proximal end The direction of movement, the raised portion extending over the proximal end of the needle shield prevents blood from exposing from the recess of the introducer needle.

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。Figure 13 shows a structure of the introduction needle in which the groove is located after the extrusion projection.

圖14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。Figure 14 shows a structure of the introducer needle in which the groove is located behind a three-dimensional projection.

圖15a-e示出了本發明第二實施例的安全裝置。其中圖15a為該安全裝置的頂視圖,圖15b為該安全裝置的正視圖,圖15c為該安全裝置的底視圖,圖15d為該安全裝置的透視圖,圖15e為該安全裝置的側視圖。Figures 15a-e illustrate 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 .

圖16a-h示出了用在第二實施例安全裝置中的彈簧夾。圖16a為第二彈簧夾的左側視圖,圖16b為第二彈簧夾的正視圖,圖16c為第二彈簧夾的透視圖,圖16d為第二彈簧夾的右側視圖,圖16e為第一彈簧夾的透視圖,圖16f為第一彈簧夾的左側視圖,圖16g為第一彈簧夾的正視圖,圖16h為第一彈簧夾的右側視圖。Figures 16a-h illustrate a spring clip for use in the safety device of the second embodiment. Figure 16a 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, Figure 16d is a right side view of the second spring clip, Figure 16e is a first spring A perspective view of the clip, Fig. 16f is a left side view of the first spring clip, Fig. 16g is a front view of the first spring clip, and Fig. 16h is a right side view of the first spring clip.

10...導管和引入針組件10. . . Catheter and introducer needle assembly

21...導管twenty one. . . catheter

24...導管座twenty four. . . Catheter seat

25...凹口25. . . Notch

31...引入針31. . . Introduction needle

34...引入針針座34. . . Introduction needle seat

41...針罩41. . . Needle cover

50...彈簧夾50. . . Spring clip

53...遠端壁53. . . Distal wall

55...彎曲、卡接部55. . . Bending, snap-in

57...卡接部57. . . Card joint

Claims (18)

一種用於導管和引入針組件(10)的安全裝置,所述導管和引入針組件(10)包括:導管組件(20),該導管組件包括:導管(21),具有近端和遠端;導管座(24),固定到導管(21)的近端;引入針組件(30),該引入針組件包括:引入針(31),其具有遠端的針尖(32),近端,和位於針尖和近端之間的增大部分(38);針座(34),固定到引入針(31)的近端;所述安全裝置(40),其滑動連接在所述導管組件(20)和引入針組件(30)之間,所述安全裝置(40)包括:針罩(41),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(60);至少一個彈簧夾(50),其通過縱長的開口(60)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(31)的增大部分(38),其中所述縱向延伸通道能容許引入針(31)縱向延伸穿過針罩(41),所述至少一個彈簧夾(50)設置有第一卡接部(55)用於與導管座(24)嚙合,所述至少一個彈簧夾(50)的至少一部分的形狀被製成為在引入針從導管組件(20)中抽出之前被該引入針壓縮,而在該引入針從導管組件(20)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(32),其中所述至少一個彈簧夾(50)包括:近端壁(51) 、中間壁(54)、和遠端壁(53),近端壁與中間壁的一端相連,而遠端壁與中間壁的另外一端相連,而所述第一卡接部為位於所述中間壁和所述遠端壁之間的彎曲(55),該彎曲(55)與導管座(24)嚙合,所述遠端壁(53)作為所述彈簧夾(50)的所述至少一部分。 A safety device for a catheter and introducer needle assembly (10), the catheter and introducer needle assembly (10) comprising: a catheter assembly (20), the catheter assembly comprising: a catheter (21) having a proximal end and a distal end; a catheter hub (24) secured to the proximal end of the catheter (21); an introducer needle assembly (30) including: an introducer needle (31) having a distal tip (32), a proximal end, and a An enlarged portion (38) between the needle tip and the proximal end; a needle hub (34) secured to the proximal end of the introducer needle (31); the safety device (40) slidably coupled to the catheter assembly (20) And between the introduction needle assembly (30), the safety device (40) includes a needle shield (41) defining a longitudinally extending channel, the longitudinally extending channel being provided with an elongated opening (60); at least one a spring clip (50) mounted in the longitudinally extending passageway through an elongated opening (60); and a stop means for blocking an enlarged portion (38) of the introducer needle (31), wherein the longitudinal extension The passageway can allow the introduction needle (31) to extend longitudinally through the needle shield (41), the at least one spring clip (50) being provided with a first snap portion (55) for engaging the catheter hub (24), At least a portion of at least one of the spring clips (50) is shaped to be compressed by the introducer needle before it is withdrawn from the catheter assembly (20), and after the introducer needle is withdrawn from the catheter assembly (20), the At least a portion is released to pop up and capture a sharp distal tip (32) of the introducer needle, wherein the at least one spring clip (50) comprises: a proximal wall (51) , the intermediate wall (54), and the distal wall (53), the proximal wall is connected to one end of the intermediate wall, and the distal wall is connected to the other end of the intermediate wall, and the first engaging portion is located in the middle A bend (55) between the wall and the distal wall, the bend (55) engaging the catheter hub (24), the distal wall (53) acting as the at least a portion of the spring clip (50). 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述遠端壁(53)在其自由端處具有一部分,該部分的寬度比遠端壁的其它部分寬度小,該寬度減小的部分就充當彈簧夾(50)的所述至少一部分。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 1, wherein the distal wall (53) has a portion at its free end, the width ratio of the portion The other portion of the distal wall is small in width and the reduced width portion acts as the at least a portion of the spring clip (50). 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中,在所述近端壁(51)的自由端處形成一個U形結構,該U形結構用來與位於針罩(41)上的齒部(47)卡合。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 1, wherein a U-shaped structure is formed at the free end of the proximal wall (51), the U The configuration is used to engage the teeth (47) on the needle shield (41). 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中所述近端壁(51)具有一個孔(52),引入針(31)的桿部從該孔中可以穿過,該孔的內徑小於引入針的所述增大部分(38)。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 1, wherein the proximal wall (51) has a hole (52) for introducing a needle (31) A portion can pass through the bore, the inner diameter of the bore being smaller than the enlarged portion (38) of the introducer needle. 如申請專利範圍第4項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述孔(52)在其周邊上具有增強唇部,該增強唇部用於卡住引入針上的增大部分(38)。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 4, wherein the aperture (52) has a reinforcing lip on its periphery, the reinforcing lip being used for The enlarged portion (38) of the introduction needle is caught. 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述增大部分(38) 可以為位於引入針(31)上的擠壓凸起、三維凸起、滾壓凸起或鐵環之一。 A safety device (40) for a catheter and an introducer needle assembly (10) according to claim 1, wherein the enlarged portion (38) It may be one of a pressing projection, a three-dimensional projection, a rolling projection or an iron ring located on the introduction needle (31). 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中一個凹口設置在導管座(24)上,所述彎曲與所述凹口嚙合。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 1, wherein a recess is provided in the catheter hub (24), the bend engaging the recess. 如申請專利範圍第1項所述之用於導管和引入針組件(10)的安全裝置(40),其中所述第一卡接部為一個位於彈簧夾頂部的球形孔,所述球形孔與設置在導管座中的球形軸承嚙合。 A safety device (40) for a catheter and an introducer needle assembly (10) according to claim 1, wherein the first snap portion is a spherical hole at the top of the spring clip, the spherical hole and The spherical bearing disposed in the catheter hub is engaged. 如申請專利範圍第1至8項中任一項所述之用於導管和引入針組件(10)的安全裝置(40),其中,在針罩的外周上設置了一個或者更多個導軌(49)。 A safety device (40) for a catheter and an introducer needle assembly (10) according to any one of claims 1 to 8, wherein one or more guide rails are provided on the outer circumference of the needle shield ( 49). 一種導管和引入針組件(10),包括:導管組件(20),該導管組件包括:導管(21),具有近端和遠端;導管座(24),固定到導管(21)的近端;引入針組件(30),該引入針組件包括:引入針(31),其具有遠端的針尖(32),近端,和位於針尖和近端之間的增大部分(38);針座(34),固定到引入針(31)的近端;安全裝置(40),其滑動連接在所述導管組件(20)和引入針組件(30)之間,所述安全裝置(40)包括:針罩(41),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(60);至少一個彈簧夾(50),其通 過縱長的開口(60)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(31)的增大部分(38),其中所述縱向延伸通道能容許引入針(31)縱向延伸穿過針罩(41),所述至少一個彈簧夾(50)設置有第一卡接部(55)用於與導管座(24)嚙合,所述至少一個彈簧夾(50)的至少一部分的形狀被製成為在引入針從導管組件(20)中抽出之前被該引入針壓縮,而在該引入針從導管組件(20)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(32),其中所述至少一個彈簧夾(50)包括:近端壁(51)、中間壁(54)、和遠端壁(53),近端壁與中間壁的一端相連,而遠端壁與中間壁的另外一端相連,而所述第一卡接部為位於所述中間壁和所述遠端壁之間的彎曲(55),該彎曲(55)與導管座(24)嚙合,所述遠端壁(53)作為所述彈簧夾(50)的所述至少一部分。 A catheter and introducer needle assembly (10) comprising: a catheter assembly (20) comprising: 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) Introducing a needle assembly (30), the introducer needle assembly comprising: an introducer needle (31) having a distal tip (32), a proximal end, and an enlarged portion (38) between the needle tip and the proximal end; the needle a seat (34) fixed to the proximal end of the introducer needle (31); a safety device (40) slidably coupled between the catheter assembly (20) and the introducer needle assembly (30), the safety device (40) Included is a needle shield (41) defining a longitudinally extending channel, the longitudinally extending channel being provided with an elongated opening (60); at least one spring clip (50) An overlength opening (60) is mounted in the longitudinally extending passage; and a stop means for blocking the enlarged portion (38) of the introduction needle (31), wherein the longitudinally extending passage can accommodate the introduction needle (31) Longitudinally extending through the needle shield (41), the at least one spring clip (50) being provided with a first snap portion (55) for engaging the catheter hub (24), the at least one spring clip (50) At least a portion of the shape is made to be compressed by the introducer needle before the introducer needle is withdrawn from the catheter assembly (20), and after the introducer needle is withdrawn from the catheter assembly (20), the at least a portion is released and bounced a sharp distal tip (32) of the introducer needle, wherein the at least one spring clip (50) comprises a proximal wall (51), an intermediate wall (54), and a distal wall (53), the proximal wall and One end of the intermediate wall is connected, and the distal wall is connected to the other end of the intermediate wall, and the first engaging portion is a bend (55) between the intermediate wall and the distal wall, the bending (55) ) engaging the catheter hub (24) as the at least a portion of the spring clip (50). 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述遠端壁(53)在其自由端處具有一部分,該部分的寬度比遠端壁的其它部分寬度小,該寬度減小的部分就充當彈簧夾(50)的所述至少一部分。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 10, wherein the distal wall (53) has a portion at its free end, the width ratio of the portion The other portion of the distal wall is small in width and the reduced width portion acts as the at least a portion of the spring clip (50). 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中,在所述近端壁(51)的自由端處形成一個U形結構,該U形結構用來與位於針罩(41)上的齒部(47)卡合。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 10, wherein a U-shaped structure is formed at the free end of the proximal wall (51), the U The configuration is used to engage the teeth (47) on the needle shield (41). 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中所述近端壁(51)具有一個孔(52),引入針(31)的桿部從該孔中可以穿過,該孔的內徑小於引入針的所述增大部分(38)。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 10, wherein the proximal wall (51) has a hole (52) into which the needle of the needle (31) is introduced. A portion can pass through the bore, the inner diameter of the bore being smaller than the enlarged portion (38) of the introducer needle. 如申請專利範圍第13項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述孔(52)在其周邊上具有增強唇部,該增強唇部用於卡住引入針上的增大部分(38)。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 13 wherein the aperture (52) has a reinforcing lip on its periphery for use with the reinforcing lip The enlarged portion (38) of the introduction needle is caught. 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中,所述增大部分(38)可以為位於引入針(31)上的擠壓凸起、三維凸起、滾壓凸起或鐵環之一。 A safety device (40) for a catheter and an introducer needle assembly (10) according to claim 10, wherein the enlarged portion (38) may be an extruded convex located on the introducer needle (31) One of three, three-dimensional protrusions, rolling protrusions or iron rings. 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中一個凹口設置在導管座(24)上,所述彎曲與所述凹口嚙合。 A safety device (40) for a catheter and introducer needle assembly (10) according to claim 10, wherein a recess is provided in the catheter hub (24), the bend engaging the recess. 如申請專利範圍第10項所述之用於導管和引入針組件(10)的安全裝置(40),其中所述第一卡接部為一個位於彈簧夾頂部的球形孔,所述球形孔與設置在導管座中的球形軸承嚙合。 A safety device (40) for a catheter and an introducer needle assembly (10) according to claim 10, wherein the first snap portion is a spherical hole at the top of the spring clip, the spherical hole and The spherical bearing disposed in the catheter hub is engaged. 如申請專利範圍第10至17項中任一項所述之用於導管和引入針組件(10)的安全裝置(40),其中,在針罩的外周上設置了一個或者更多個導軌(49)。A safety device (40) for a catheter and an introducer needle assembly (10) according to any one of claims 10 to 17, wherein one or more guide rails are provided on the outer circumference of the needle shield ( 49).
TW095130080A 2006-07-27 2006-08-16 Catheter and introducer needle assembly with safety device TWI426936B (en)

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CN2006101080738A CN101112639B (en) 2006-07-27 2006-07-27 Vessel having a safeguard device and introducing needle component
IN1834DE2006 2006-08-14

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6749588B1 (en) * 1998-04-09 2004-06-15 Becton Dickinson And Company Catheter and introducer needle assembly with needle shield
US20040133167A1 (en) * 2001-03-15 2004-07-08 Ferguson F. Mark Safety shield for medical needles
US20040243061A1 (en) * 2003-04-08 2004-12-02 Mcgurk Joseph P. Safety needle and catheter assembly
TWI249434B (en) * 2005-04-13 2006-02-21 Jia-Lung Guo Detachable probe kit

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6749588B1 (en) * 1998-04-09 2004-06-15 Becton Dickinson And Company Catheter and introducer needle assembly with needle shield
US20040133167A1 (en) * 2001-03-15 2004-07-08 Ferguson F. Mark Safety shield for medical needles
US20040243061A1 (en) * 2003-04-08 2004-12-02 Mcgurk Joseph P. Safety needle and catheter assembly
TWI249434B (en) * 2005-04-13 2006-02-21 Jia-Lung Guo Detachable probe kit

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