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TW202434323A - Injection device with an improved needle guard lockout mechanism - Google Patents

Injection device with an improved needle guard lockout mechanism Download PDF

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Publication number
TW202434323A
TW202434323A TW113106099A TW113106099A TW202434323A TW 202434323 A TW202434323 A TW 202434323A TW 113106099 A TW113106099 A TW 113106099A TW 113106099 A TW113106099 A TW 113106099A TW 202434323 A TW202434323 A TW 202434323A
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TW
Taiwan
Prior art keywords
needle guard
injection device
trigger member
injection
housing
Prior art date
Application number
TW113106099A
Other languages
Chinese (zh)
Inventor
克里斯多夫 朱迪克
班傑明 拉許
山姆 立查克
Original Assignee
美商輝瑞股份有限公司
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Application filed by 美商輝瑞股份有限公司 filed Critical 美商輝瑞股份有限公司
Publication of TW202434323A publication Critical patent/TW202434323A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/2013Having specific accessories triggering of discharging means by contact of injector with patient body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8275Mechanical
    • A61M2205/8281Mechanical spring operated

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to an injection device comprising a housing (3), a needle guard (20), an injection drive mechanism for driving a plunger within a medicament container (5) and thus expelling the medicament, the drive mechanism including o a plunger rod (31) biased by an injection spring (34); o a retaining member (33) for initially retaining the plunger rod (31) in its proximal position; and o a trigger member (35), mounted onto the retaining member (33). The retraction of the needle guard (20) causes the trigger member (35) to move proximally and thus causes the release of the plunger rod (31). The device (1) further comprises a lockout mechanism for preventing retraction of the needle guard (20) after use of the device, the lockout mechanism comprising a cam system provided on the trigger member (35) and the retaining member (33), that prevents the trigger member from rotating as the needle guard (20) is retracted and that is caused to rotate into a blocking position when the needle guard (20) is returned to its extended position after firing of the device.

Description

具有改良針保護閉鎖機制的注射裝置Injection device with improved needle protection locking mechanism

本發明有關注射裝置,尤其是所謂的「針保護件起動式」自動注射器,其可藉由使用者將裝置按壓在注射部位上來啟動。The present invention relates to injection devices, in particular to so-called "needle guard activated" auto-injectors which can be activated by the user pressing the device onto an injection site.

此類型之裝置通常對於在緊急條件下注射待施用藥物係較佳的。尤其是,緊急裝置不僅需要堅固並可靠,而且易於使用,具有最少步驟。This type of device is usually preferred for injecting a drug to be administered in an emergency situation. In particular, the emergency device needs to be not only strong and reliable, but also easy to use with a minimum of steps.

在由現有技術已知之一些裝置中,例如WO 2009/114542提供可拆卸的安全構件,其防止在於裝置之操縱期間意外啟動此裝置。為此目的,當裝置壓抵靠著注射部位時,安全構件阻擋在針保護件縮回時可致動之觸發器構件。於致動此裝置用於施行注射之前,需要藉由使用者移除安全構件。此類型的裝置亦包括可拆卸地配置在裝置外殼之遠側端的帽蓋,用於覆蓋針保護件並將其維持在延伸位置中,由而防止於運送期間例如由於震動而意外啟動。帽蓋亦設有夾緊典型保護藥物容器之針的鞘套之特徵,由此鞘套係與帽蓋同時被移除。In some devices known from the prior art, such as WO 2009/114542, a removable safety member is provided, which prevents accidental activation of the device during handling of the device. For this purpose, when the device is pressed against the injection site, the safety member blocks the trigger member that can be activated when the needle guard is retracted. Before activating the device for performing an injection, the safety member needs to be removed by the user. Devices of this type also include a cap that is detachably arranged at the distal end of the device housing, which is used to cover the needle guard and maintain it in an extended position, thereby preventing accidental activation during transportation, for example due to vibrations. The cap is also provided with the feature of clamping a sheath that typically protects the needle of a drug container, whereby the sheath is removed simultaneously with the cap.

提供另一安全特徵,其在使用裝置之後(注射之後)將針保護件閉鎖於延伸位置中,且由而防止針保護件的任何另一縮回。這是為了防止重複使用此裝置及用針造成之潛在傷害。Another safety feature is provided which locks the needle guard in the extended position after use of the device (after an injection) and thereby prevents any further retraction of the needle guard. This is to prevent repeated use of the device and potential injuries with the needle.

此安全特徵係藉由裝置中的額外安全部件來達成,此額外安全部件係可於裝置外殼內運動及可變形。此附加部件增加此裝置之複雜性及製造成本。它亦可能增加缺陷的風險。This safety feature is achieved by an additional safety component in the device that is movable and deformable within the device housing. This additional component increases the complexity and manufacturing cost of the device. It may also increase the risk of defects.

因此,本發明之目的是減少部件之數量,同時以穩健且可靠的方式達成此閉鎖安全功能。Therefore, the object of the present invention is to reduce the number of components while achieving this locking safety function in a robust and reliable manner.

根據本發明,其提供一種注射裝置,包含: -細長外殼,沿著縱向軸線(X)延伸並建構來收納藥物容器,此藥物容器設有含有藥物之筒件、附接至其上的針、及可在筒件內位移以經過此針排出藥物之柱塞; -針保護件,其可伸縮地安裝於外殼中並能在延伸位置與縮回位置之間軸向地運動,而於延伸位置中,針保護件由外殼朝遠側地突出並圍繞此針,且縮回位置從延伸位置朝近側地隔開,對應於將裝置壓抵靠著注射部位用以啟動注射裝置的條件; -針保護件彈簧,使針保護件在遠側方向中偏向; -注射驅動機制,用於在筒件內驅動柱塞,並因此排出藥物,此注射驅動機制包括: 柱塞桿,可於外殼內軸向地運動在近側位置與遠側位置之間,用於在筒件內驅動柱塞; 注射彈簧,配置用於使柱塞桿偏向至其遠側位置; 保持構件,固定在外殼內,用於在注射裝置的初始狀態中抵抗注射彈簧之偏向作用將柱塞桿保持於其近側位置中,保持構件及柱塞桿具有對應的閂鎖特徵,閂鎖特徵包括止動表面及形成有突出部之對應可徑向偏轉的彈性支臂,由此柱塞桿係藉由突出部與止動表面之嚙合而保持在其近側位置中;及 觸發器構件,包含阻擋特徵,並藉由當使針保護件從其延伸位置運動至其縮回位置時,阻擋特徵能由阻擋位置軸向地移位至釋放位置,於阻擋位置中,阻擋特徵防止彈性支臂的徑向偏轉,因此防止突出部由對應之止動表面脫離,而在釋放位置中,彈性支臂係自由徑向地偏轉,由此突出部係於注射彈簧的偏向作用之下由對應之止動表面脫離; 其中針保護件的縮回造成觸發器構件朝近側地運動,並因此造成閂鎖特徵之釋放且因此造成注射裝置的啟動, 注射裝置更包含閉鎖機制,用於一旦裝置已被啟動及一旦針保護件已藉由針保護件彈簧返回至其延伸位置,則防止針保護件縮回, 其中觸發器構件能夠取決於針保護件之軸向位移及位置相對保持構件旋轉,且閉鎖機制包含: -凸輪系統,設在觸發器構件及保持構件上,其防止觸發器構件於針保護件縮回時旋轉,並當針保護件係在啟動裝置之後返回其延伸位置時造成旋轉進入一阻擋角位置;及 止動特徵,配置於觸發器構件上,使得止動特徵在用於啟動裝置的縮回期間處於針保護件之軸向路徑以外,且在觸發器構件的阻擋角位置中與針保護件干涉。 According to the present invention, an injection device is provided, comprising: - an elongated housing extending along a longitudinal axis (X) and constructed to accommodate a drug container, the drug container being provided with a barrel containing a drug, a needle attached thereto, and a plunger displaceable in the barrel to discharge the drug through the needle; - a needle guard telescopically mounted in the housing and axially movable between an extended position and a retracted position, wherein in the extended position the needle guard protrudes distally from the housing and surrounds the needle, and the retracted position is proximally spaced from the extended position, corresponding to the condition of pressing the device against an injection site for activating the injection device; - a needle guard spring to bias the needle guard in a distal direction; - an injection drive mechanism for driving the plunger in the barrel and thereby expelling the drug, the injection drive mechanism comprising: a plunger rod axially movable within the housing between a proximal position and a distal position for driving the plunger in the barrel; an injection spring configured to bias the plunger rod to its distal position; A retaining member fixed in the housing, used to hold the plunger rod in its proximal position against the biasing action of the injection spring in the initial state of the injection device, the retaining member and the plunger rod having corresponding latching features, the latching features including a stop surface and a corresponding radially deflectable elastic arm formed with a protrusion, whereby the plunger rod is held in its proximal position by the engagement of the protrusion with the stop surface; and A trigger member comprising a blocking feature, and the blocking feature can be axially displaced from the blocking position to a release position when the needle guard is moved from its extended position to its retracted position, in which the blocking feature prevents radial deflection of the elastic arm, thereby preventing the protrusion from disengaging from the corresponding stop surface, and in the release position, the elastic arm is free to deflect radially, thereby the protrusion is disengaged from the corresponding stop surface under the biasing action of the injection spring; wherein the retraction of the needle guard causes the trigger member to move proximally, thereby causing the release of the latch feature and thereby causing the activation of the injection device, The injection device further comprises a locking mechanism for preventing the needle guard from retracting once the device has been activated and once the needle guard has returned to its extended position by the needle guard spring, wherein the trigger member is capable of rotating relative to the retaining member depending on the axial displacement and position of the needle guard, and the locking mechanism comprises: - a cam system, provided on the trigger member and the retaining member, which prevents the trigger member from rotating when the needle guard is retracted and causes the needle guard to rotate into a blocking angular position when it returns to its extended position after activating the device; and The stop feature is disposed on the trigger member such that the stop feature is outside the axial path of the needle guard during retraction of the trigger device and interferes with the needle guard in the blocking angle position of the trigger member.

以此設計,於閂鎖特徵被提供在觸發器構件上之意義上,閉鎖安全功能係與觸發功能結合,由此不需要專用於閉鎖功能的額外部件。此設計以簡單可靠之方式達成閉鎖功能,而允許減少部件的數量。With this design, the latching safety function is combined with the triggering function in the sense that the latching feature is provided on the trigger member, thereby eliminating the need for an additional component dedicated to the latching function. This design achieves the latching function in a simple and reliable manner, allowing the number of components to be reduced.

較佳實施例可包括以下特徵之一或數個: -針保護件具有用於圍繞處於延伸位置中的針之鞘套部分,鞘套部分具有在遠側端的通孔,用於當針保護件縮回時使此針通過,及由鞘套部分軸向地且朝近側地突出之腿部,所述腿部具有用於當針保護件縮回時嚙合及移位觸發器構件的自由端; -凸輪系統包括設在觸發器構件上之凸輪軌道、及設於保持構件上並界定凸輪隨動件的尖頭,此尖頭用於嚙合在凸輪軌道中; -保持構件具有實質上圓柱形之中空本體,且觸發器構件具有裝配於所述圓柱形中空本體上方之套筒本體,使套筒本體能夠取決於針保護件的軸向位移及位置而相對於圓柱形中空本體滑動或旋轉; -套筒本體係設有第一肋條,用於當針保護件縮回時與腿部之自由端嚙合,由此造成觸發器構件朝近側地移位; -套筒本體係在其內表面上設有收納尖頭之凸輪軌道,此尖頭由圓柱形中空本體徑向地及朝內地突出,此凸輪軌道具有與於近側方向中延伸的軸向通道連接之橫向地定向的終端通道,此軸向通道具有一開放之遠側端; -止動特徵包括由套筒本體徑向地突出之第二肋條,此第二肋條用於與針保護件選擇性嚙合,用以防止針保護件朝近側地縮回; -第二肋條從第一肋條朝遠側地隔開; -腿部具有由腿部之自由端朝遠側地隔開並形成一橫向邊緣的凹口,此橫向邊緣界定一止動表面,用於在注射裝置於注射之後的最終狀態中防止針保護件朝近側地縮回; -尖頭被偏向朝此終端通道,由此當針防護件在針防護彈簧的作用之下移回對應於注射後的裝置之最終狀態的延伸位置時,造成觸發器構件旋轉並使第二肋條嚙合腿部之橫向邊緣; -觸發器構件及外殼包含處於相互可釋放之嚙合的對應鎖定特徵,用於將觸發器構件維持在其阻擋位置中,且其中所述鎖定特徵被設計成當針保護件由其延伸位置運動至其縮回位置時釋放,由此針保護件之縮回造成鎖定特徵的釋放、閂鎖特徵之釋放、及因此注射裝置的啟動; -腿部具有一軸向邊緣,此軸向邊緣具有一於鞘套部分與凹口之間延伸的區段,其界定一在針保護件(20)之軸向位移期間與保持構件(33)的對應導引元件(113)滑動地配合的導引元件; -第二肋條係配置於套筒本體上,用於在注射裝置注射之後的最終狀態中嚙合腿部之橫向邊緣,並因此防止針保護件朝近側地縮回; -閂鎖特徵包括一對形成在柱塞桿之近側端上的彈性支臂,及形成於每一彈性支臂之自由端的軸向地延伸、各自突出部; -保持構件包含具有軸向孔之徑向壁,此軸向孔具有界定此等閂鎖特徵的止動表面之周向邊緣; -突出部係由各自之彈性支臂徑向地及往外地突出,此等彈性支臂由徑向壁軸向地突出經過此孔,而當柱塞桿處於其近側位置中時,使此等突出部與止動表面相互嚙合; -阻擋特徵包括軸向栓銷,此軸向栓銷在觸發器構件之阻擋位置中防止此等彈性支臂的朝內偏轉,並因此防止此等突出部由止動表面脫離; -外殼包含至少一凹部,且觸發器構件包含套筒本體,及由套筒本體往外地突出之至少一懸臂式撓性支臂,此懸臂式撓性支臂於其自由端設有用於與外殼的凹部可釋放地嚙合之徑向耳片,此等鎖定特徵包括所述耳片及對應的凹部; -耳片係藉由懸臂式撓性支臂偏向成嚙合在凹部內,且懸臂式撓性支臂係能藉由針保護件朝內地偏轉,用於由凹部釋放耳片; -懸臂式撓性支臂包含用於與針保護件嚙合之斜面,當針保護件在近側方向中運動時,此斜面的輪廓決定藉由針保護件之軸向位移所造成的懸臂式撓性支臂之朝內偏轉; -外殼及觸發器構件分別具有一對於直徑方向中相對之凹部及對應的懸臂式撓性支臂; -此裝置更包含配置在外殼與觸發器構件之間的觸發器彈簧,用於朝遠側地偏向此觸發器構件,由此觸發器構件在注射裝置之初始狀態中被偏向至其阻擋位置;及 -注射彈簧被設計成於其近側位置中向柱塞桿賦予一克服與閂鎖特徵相互嚙合之保持力的力量,由此阻擋特徵之釋放造成此等閂鎖特徵脫離並造成注射彈簧將柱塞桿驅動至其遠側位置。 Preferred embodiments may include one or more of the following features: -The needle guard has a sheath portion for surrounding the needle in the extended position, the sheath portion having a through hole at the distal end for passing the needle when the needle guard is retracted, and a leg protruding axially and proximally from the sheath portion, the leg having a free end for engaging and displacing the trigger member when the needle guard is retracted; -The cam system includes a cam track provided on the trigger member, and a tip provided on the retaining member and defining a cam follower, the tip being used to engage in the cam track; - the retaining member has a substantially cylindrical hollow body, and the trigger member has a sleeve body mounted on the cylindrical hollow body, so that the sleeve body can slide or rotate relative to the cylindrical hollow body depending on the axial displacement and position of the needle guard; - the sleeve body is provided with a first rib for engaging with the free end of the leg when the needle guard is retracted, thereby causing the trigger member to shift proximally; - the sleeve body is provided with a cam track on its inner surface for receiving a tip, which protrudes radially and inwardly from the cylindrical hollow body, and the cam track has a transversely oriented terminal channel connected to an axial channel extending in the proximal direction, and the axial channel has an open distal end; - the stop feature comprises a second rib radially projecting from the sleeve body, the second rib being adapted to selectively engage with the needle guard to prevent the needle guard from retracting proximally; - the second rib being distally spaced from the first rib; - the leg having a recess distally spaced from the free end of the leg and forming a transverse edge, the transverse edge defining a stop surface for preventing the needle guard from retracting proximally in the final state of the injection device after injection; - the tip is biased towards this terminal passage, thereby causing the trigger member to rotate and the second rib to engage the lateral edge of the leg when the needle guard moves back to the extended position corresponding to the final state of the device after injection under the action of the needle guard spring; - the trigger member and the housing include corresponding locking features in a mutually releasable engagement for maintaining the trigger member in its blocking position, and wherein the locking features are designed to be released when the needle guard moves from its extended position to its retracted position, whereby the retraction of the needle guard causes the release of the locking features, the release of the latching features, and thus the activation of the injection device; - the leg has an axial edge having a section extending between the sheath portion and the recess, defining a guide element that slidably engages with a corresponding guide element (113) of the retaining member (33) during axial displacement of the needle guard (20); - a second rib is arranged on the sleeve body for engaging the transverse edge of the leg in the final state of the injection device after injection and thereby preventing the needle guard from retracting proximally; - the latching feature comprises a pair of elastic arms formed on the proximal end of the plunger rod and an axially extending, respective projection formed at the free end of each elastic arm; - the retaining member comprises a radial wall with an axial hole having a peripheral edge defining a stop surface of the latching features; - the projections project radially and outwardly from respective resilient arms which project axially from the radial wall through the hole so as to engage the projections with the stop surface when the plunger rod is in its proximal position; - the blocking feature comprises an axial latch which, in the blocking position of the trigger member, prevents inward deflection of the resilient arms and thus prevents the projections from disengaging from the stop surface; -The housing includes at least one recess, and the trigger member includes a sleeve body and at least one cantilevered flexible arm protruding outward from the sleeve body, the cantilevered flexible arm having a radial ear piece at its free end for releasably engaging with the recess of the housing, and the locking features include the ear piece and the corresponding recess; -The ear piece is biased to engage in the recess by the cantilevered flexible arm, and the cantilevered flexible arm can be deflected inwardly by the needle guard to release the ear piece from the recess; -The cantilevered flexible arm includes a slope for engaging with the needle guard, and when the needle guard moves in the proximal direction, the profile of the slope determines the inward deflection of the cantilevered flexible arm caused by the axial displacement of the needle guard; -The housing and the trigger member respectively have a pair of recesses relative to each other in the radial direction and corresponding cantilevered flexible arms; -The device further includes a trigger spring disposed between the housing and the trigger member, for biasing the trigger member distally, whereby the trigger member is biased to its blocking position in the initial state of the injection device; and -The injection spring is designed to impart a force to the plunger rod in its proximal position that overcomes the retaining force of the interengaging latching features, whereby release of the blocking features causes these latching features to disengage and cause the injection spring to drive the plunger rod to its distal position.

定義Definition

以下定義將在本說明書及請求項中使用: -自動注射器一詞指明注射裝置,其中用於從藥物容器排出藥物之力量係藉由裝置的能量源所提供,此裝置係藉由使用者所觸發,如與使用來自使用者之手動力量來排出藥物的裝置相反。在本說明書中,自動注射器一詞涵蓋具有固定針之注射器以及那些具有自動穿透特徵者,其中此針於排出藥物之前藉由裝置的能量源被運動並插入此注射部位; -「遠側」一詞意指當藥筒被收納在注射裝置中時接近、或定向朝藥筒內容物之出口通孔的位置或方向。「遠側」位置及方向亦可分別被稱為「前方」位置及「向前」方向;及 -「近側」一詞意指與遠側位置或方向相反之位置或方向,及/或接近、或定向朝注射裝置的抓握部分。「近側」位置及方向亦可分別被稱為「後方」位置及「向後」方向。 The following definitions will be used in this specification and claim: -The term autoinjector refers to an injection device in which the force used to expel medication from a medication container is provided by an energy source of the device, which is triggered by the user, as opposed to a device that uses manual force from the user to expel medication. In this specification, the term autoinjector covers syringes with fixed needles and those with automatic penetration features, in which the needle is moved and inserted into the injection site by the energy source of the device before the medication is expelled; -The term "distal" means a position or direction close to, or oriented toward, the exit opening of the cartridge contents when the cartridge is received in the injection device. The term "distal" position and direction may also be referred to as the "forward" position and the "forward" direction, respectively; and - The term "proximal" means a position or direction opposite to the distal position or direction and/or close to or directed toward the grip of the injection device. The term "proximal" position and direction may also be referred to as the "rearward" position and the "rearward" direction, respectively.

現在將藉由圖(圖1-10)上所顯示之以下較佳實施例進一步說明本發明。The present invention will now be further described by the following preferred embodiments shown in the drawings (FIGS. 1-10).

圖上所描述的注射裝置係一次性自動注射器。The injection device depicted in the figure is a disposable autoinjector.

參考圖1、2及2A,注射裝置1包含細長外殼3,其沿著縱向軸線X延伸並建構來收納藥物容器5。於所說明之實施例中,外殼3係由兩個零件製成,包括同軸且固定地附接的前外殼3a及後外殼3b。然而,在其他實施例中,外殼3可一體地製成為一件式部件。1, 2 and 2A, the injection device 1 comprises an elongated housing 3 extending along a longitudinal axis X and configured to receive a drug container 5. In the illustrated embodiment, the housing 3 is made of two parts, including a front housing 3a and a rear housing 3b coaxially and fixedly attached. However, in other embodiments, the housing 3 may be integrally made as a one-piece component.

於所說明之實施例中,藥物容器5係預填充注射器,其設有含有藥物7的筒件6、附接至其上之針8、及可在筒件6內位移以經過此針排出藥物的柱塞9。筒件6係於其近側端形成有凸緣10、在其遠側端連接至針8之尖端,此尖端呈現一減小的直徑且由而形成前肩部11。筒件6係由玻璃製成,但於其他實施例中,可由塑膠材料製成。注射器5更設有圍繞針8並在其近側端包含一放大之基底部分17的可移除保護鞘套15。鞘套15典型至少部分地由諸如橡膠之彈性體材料製成。如下文將詳細地敘述,注射器5係固定地安裝於前外殼3a內。In the illustrated embodiment, the drug container 5 is a prefilled syringe having a barrel 6 containing a drug 7, a needle 8 attached thereto, and a plunger 9 displaceable within the barrel 6 to expel the drug through the needle. The barrel 6 is formed with a flange 10 at its proximal end, connected to the tip of the needle 8 at its distal end, the tip presenting a reduced diameter and thereby forming a front shoulder 11. The barrel 6 is made of glass, but in other embodiments it may be made of a plastic material. The syringe 5 is further provided with a removable protective sheath 15 surrounding the needle 8 and including an enlarged base portion 17 at its proximal end. The sheath 15 is typically at least partially made of an elastomeric material such as rubber. As will be described in detail below, the syringe 5 is fixedly mounted in the front housing 3a.

裝置1更包含針保護件20,其可伸縮地安裝於外殼3中並能在延伸位置與縮回位置之間軸向地運動。於延伸位置中,針保護件20由外殼3的遠側端朝遠側地突出並圍繞此針8,由此針被隱藏在使用者之視線外並受到保護。此縮回位置從延伸位置朝近側地隔開,並對應於將裝置壓抵靠著注射部位用以啟動此裝置的條件。The device 1 further comprises a needle guard 20 which is telescopically mounted in the housing 3 and can move axially between an extended position and a retracted position. In the extended position, the needle guard 20 protrudes distally from the distal end of the housing 3 and surrounds the needle 8, whereby the needle is hidden from the user's sight and protected. The retracted position is proximally spaced from the extended position and corresponds to the condition in which the device is pressed against an injection site for activation of the device.

與針保護件20相關聯,此裝置包括針保護件彈簧21,其在本實施例中係螺旋壓縮彈簧,並軸向地配置於外殼3與針保護件20之間,用於在遠側方向中偏向此針保護件。In association with the needle guard 20, the device comprises a needle guard spring 21, which in the present embodiment is a helical compression spring and is axially arranged between the housing 3 and the needle guard 20 for biasing the needle guard in a distal direction.

裝置1更包含可拆卸地安裝至外殼3的遠側部分上之帽蓋22,用於覆蓋針保護件20並限制其軸向運動。如下文中將看到,帽蓋22亦設有抓握特徵,用於當帽蓋22由外殼3拆卸時移除針鞘套15。The device 1 further comprises a cap 22 detachably mounted on the distal portion of the housing 3 for covering the needle guard 20 and limiting its axial movement. As will be seen below, the cap 22 is also provided with a grip feature for removing the needle sheath 15 when the cap 22 is removed from the housing 3.

為了在筒件6內驅動柱塞9並因此經過針8排出藥物7,裝置1更包含配置於外殼3內的注射驅動機制25。In order to drive the plunger 9 in the barrel 6 and thus expel the drug 7 through the needle 8, the device 1 further comprises an injection drive mechanism 25 arranged in the housing 3.

注射驅動機制25包括可在外殼3內軸向地運動用以於筒件6內驅動柱塞9之柱塞桿31、固定在外殼3內的保持構件33、軸向地配置在保持構件33與柱塞桿31之間用於向前偏向柱塞桿31的呈螺旋壓縮彈簧形式之注射彈簧34、及可在外殼3內軸向地運動用於當向後運動時觸發注射階段的觸發器構件35。The injection drive mechanism 25 includes a plunger rod 31 that can move axially in the housing 3 to drive the plunger 9 in the barrel 6, a retaining member 33 fixed in the housing 3, an injection spring 34 in the form of a spiral compression spring axially arranged between the retaining member 33 and the plunger rod 31 to bias the plunger rod 31 forward, and a trigger member 35 that can move axially in the housing 3 to trigger the injection stage when moving backward.

再者,裝置1包含軸向地配置在外殼3與觸發器構件35之間用於朝遠側地偏向觸發器構件35的呈螺旋壓縮彈簧形式之觸發器彈簧37。Furthermore, the device 1 comprises a trigger spring 37 in the form of a helical compression spring arranged axially between the housing 3 and the trigger member 35 for biasing the trigger member 35 distally.

參考圖3、3A及3B,將可看出,前外殼3a具有細長的圓柱形外壁41、形成用於注射器筒件6之容納部的同軸圓柱形內壁42、及用於與帽蓋22可拆卸地連接之同軸前端套筒43。前外殼更設有徑向連接肋條44,在所說明實施例中的數量為四個,將外壁41牢牢地連接至內壁42,且繞著縱向軸線X規則地分佈。3, 3A and 3B, it will be seen that the front housing 3a has an elongated cylindrical outer wall 41, a coaxial cylindrical inner wall 42 forming a housing for the syringe barrel 6, and a coaxial front sleeve 43 for detachably connecting to the cap 22. The front housing is further provided with radial connecting ribs 44, four in number in the illustrated embodiment, which firmly connect the outer wall 41 to the inner wall 42 and are regularly distributed around the longitudinal axis X.

於所表示之實施例中,外壁41的橫截面為整體橢圓形狀,由此防止裝置在平坦表面上滾動。它於後方部分中包含一對相向之孔口45,用於將後外殼3b牢牢地附接至前外殼3a。在其內表面上,外壁41係形成有止動表面46,用於與針保護件20的互補特徵嚙合,由而限制針保護件20在遠側方向中之位移。外壁41係亦於其前方部分的外表面上設有用以增強使用者之操作性的脊部47或槽紋。In the embodiment shown, the outer wall 41 is generally elliptical in cross section, thereby preventing the device from rolling on a flat surface. It includes a pair of facing apertures 45 in the rear portion for firmly attaching the rear housing 3b to the front housing 3a. On its inner surface, the outer wall 41 is formed with a stop surface 46 for engaging with a complementary feature of the needle guard 20, thereby limiting the displacement of the needle guard 20 in the distal direction. The outer wall 41 is also provided with ridges 47 or grooves on the outer surface of its front portion for enhancing the operability of the user.

內壁42之橫截面大致上為圓形,其尺寸設計成與注射器筒件6的外部尺寸相匹配,且在前方設有較小直徑之止動部分48。設有止動部分48以用於嚙合注射器筒件6的肩部11,由此注射器5可被同軸地插入前外殼41,收納在藉由內壁42所界定之孔腔中並藉由止動部分48固持於軸向位置中而防止向前運動。The inner wall 42 is generally circular in cross section, sized to match the outer dimensions of the syringe barrel 6, and provided with a smaller diameter stop portion 48 at the front. The stop portion 48 is provided to engage the shoulder 11 of the syringe barrel 6, whereby the syringe 5 can be coaxially inserted into the front housing 41, received in the cavity defined by the inner wall 42 and held in an axial position by the stop portion 48 to prevent forward movement.

界定外殼3的遠側端之前端套筒43具有一用於與帽蓋22的互補特徵配合之肋條螺紋區段49,設計那些連接特徵,使得帽蓋22可藉由旋轉此帽蓋達幾分之一圈且接著軸向地移除它而由前外殼41拆卸。The front sleeve 43 defining the distal end of the housing 3 has a ribbed thread section 49 for cooperating with complementary features of the cap 22, those connecting features being designed so that the cap 22 can be removed from the front housing 41 by rotating the cap a fraction of a turn and then removing it axially.

較佳地係,前外殼41係藉由合成材料的成形而一體製成。Preferably, the front housing 41 is integrally formed by forming a synthetic material.

現在更具體地參考圖1及4,針保護件20具有鞘套部分50,其帶有用於在其延伸位置中圍繞針8之前環形邊緣51;及一對相對的腿部52,其由鞘套部分50軸向地且朝近側地突出。1 and 4, the needle guard 20 has a sheath portion 50 with a front annular edge 51 for surrounding the needle 8 in its extended position, and a pair of opposed legs 52 projecting axially and proximally from the sheath portion 50.

鞘套部分50被形成為圓柱體,於其遠側端具有藉由邊緣51所限定之通孔53,用於當針保護件20縮回進入外殼3時使針8通過。鞘套部分50係在其遠側端亦設有一對於直徑方向中相對的徑向突出部54,此等徑向突出部被設計用於與帽蓋22之互補特徵嚙合,用以當帽蓋22附接至外殼3時限制針保護件20的軸向運動。此配置旨在防止裝置之意外觸發,例如於震動的情況案例中。The sheath portion 50 is formed as a cylinder and has a through hole 53 defined by an edge 51 at its distal end for the needle 8 to pass through when the needle guard 20 is retracted into the housing 3. The sheath portion 50 is also provided at its distal end with a pair of radial projections 54 that are opposite in the radial direction and are designed to engage with complementary features of the cap 22 to limit axial movement of the needle guard 20 when the cap 22 is attached to the housing 3. This configuration is intended to prevent accidental triggering of the device, for example in the event of a shock.

每一腿部52具有一自由端55,用於如下文將敘述,當針保護件20縮回進入外殼3時嚙合並移位此觸發器構件35。每一腿部52係形成有從自由端55朝遠側地隔開並形成橫向邊緣56之凹口,及具有延伸在鞘套部分50與凹口之間的區段57之軸向邊緣。Each leg 52 has a free end 55 for engaging and displacing the trigger member 35 when the needle guard 20 is retracted into the housing 3 as will be described below. Each leg 52 is formed with a notch spaced distally from the free end 55 and forming a transverse edge 56, and an axial edge having a section 57 extending between the sheath portion 50 and the notch.

橫向邊緣56界定一止動表面,用於在注射之後的注射裝置之最終狀態中防止針保護件20朝近側地縮回。軸向邊緣的區段57界定一導引元件,用於在針保護件20之軸向移位期間與保持構件33的對應特徵嚙合。The transverse edge 56 defines a stop surface for preventing the needle guard 20 from retracting proximally in the final state of the injection device after injection. The section 57 of the axial edge defines a guide element for engaging with a corresponding feature of the retaining member 33 during the axial displacement of the needle guard 20.

每一腿部52係更設有撓性可偏轉翼片58,其具有用於與外壁41之對應止動表面46嚙合的徑向突出之前翼片邊緣59,如圖2上可見。翼片58與止動表面46的嚙合界定針保護件20相對於外殼3之延伸位置,而防止針保護件20進一步的遠側相對移位。Each leg 52 is further provided with a flexible deflectable wing 58 having a radially protruding front wing edge 59 for engaging with a corresponding stop surface 46 of the outer wall 41, as can be seen in Figure 2. The engagement of the wing 58 with the stop surface 46 defines the extended position of the needle guard 20 relative to the housing 3 and prevents further distal relative displacement of the needle guard 20.

如圖2及2A上可見,配置在針防護件20與外殼3之間的針防護彈簧21於近側端支承在前外殼3a之止動部分48上,且於遠側端支承在環形邊緣51上。As can be seen in FIGS. 2 and 2A , the needle guard spring 21 disposed between the needle guard 20 and the housing 3 is supported at the proximal end on the stop portion 48 of the front housing 3 a and at the distal end on the annular edge 51 .

現在更具體參考圖1、2及2A,帽蓋22包括一實質上圓柱形壁61,其設計成裝配於前外殼2a的前端套筒43上方、及在前面部分地封閉此圓柱形壁61之前端環形壁63。圓柱形壁61的內表面係形成有凹部64,形成用於與肋條螺紋區段49之互補特徵以螺紋連接。1, 2 and 2A, the cap 22 includes a substantially cylindrical wall 61 designed to fit over the front sleeve 43 of the front housing 2a and partially close the front end annular wall 63 of the cylindrical wall 61. The inner surface of the cylindrical wall 61 is formed with a recess 64, which is formed for threaded connection with the complementary features of the rib thread section 49.

帽蓋22更包含由前端壁61向後延伸的同軸抓握套筒65,用於嚙合針鞘套15。在自由端(近側端),抓握套筒65係形成有一對相向之鉗爪67,當帽蓋22被附接至外殼3時(圖2),此對鉗爪嚙合針鞘套15的放大基底17之後方環形表面,由此當帽蓋22係由外殼3拆卸時,此鞘套15係由注射器5移除。The cap 22 further comprises a coaxial gripping sleeve 65 extending rearwardly from the front end wall 61 for engaging the needle sheath 15. At the free end (proximal end), the gripping sleeve 65 is formed with a pair of opposing clamping claws 67, which engage the rear annular surface of the enlarged base 17 of the needle sheath 15 when the cap 22 is attached to the housing 3 (FIG. 2), so that when the cap 22 is removed from the housing 3, the sheath 15 is removed from the syringe 5.

於圓柱形壁61的外表面上,帽蓋22係設有由圓柱形壁61之前端延伸至後端的主肋條68、及脊狀表面69,所述肋條68係連續地形成有實質上軸向部分及實質上螺旋狀部分。主肋條68及脊狀表面69被設計成增強使用者之操作,尤其是讓使用者更輕易地對應於帽蓋22與外殼3之間的螺紋式連接而將帽蓋22旋轉幾分之一圈(例如1/4圈),且接著軸向地拉動帽蓋22,用於將帽蓋由外殼拆卸。連同前外殼3a的脊部47,脊狀表面69亦可界定帽蓋22相對於外殼3之角度位置的視覺指示器。On the outer surface of the cylindrical wall 61, the cap 22 is provided with a main rib 68 extending from the front end to the rear end of the cylindrical wall 61, and a ridge surface 69, wherein the rib 68 is continuously formed with a substantially axial portion and a substantially spiral portion. The main rib 68 and the ridge surface 69 are designed to enhance the user's operation, in particular to make it easier for the user to rotate the cap 22 a fraction of a turn (e.g., 1/4 turn) corresponding to the threaded connection between the cap 22 and the housing 3, and then axially pull the cap 22 for removing the cap from the housing. Together with the ridge 47 of the front housing 3a, the ridge surface 69 can also define a visual indicator of the angular position of the cap 22 relative to the housing 3.

在所說明之實施例中,帽蓋22係由合成材料製成為一體成形件。尤其是,抓握套筒65係與帽蓋22的其餘部分一體製成。然而,於其他實施例中,抓握套筒65可為與帽蓋之其餘部分分開的部件並附接至其上。抓握套筒亦可為以不同材料、諸如金屬製成。In the illustrated embodiment, the cap 22 is formed as a one-piece piece of synthetic material. In particular, the grip sleeve 65 is formed as a one-piece piece with the rest of the cap 22. However, in other embodiments, the grip sleeve 65 may be a separate component from the rest of the cap and attached thereto. The grip sleeve may also be formed of a different material, such as metal.

圓柱體61之內表面係形成有收縮部70,此收縮部70界定一用於與針保護件的徑向突出部54嚙合之止動表面,用以當帽蓋22被附接至外殼3時防止針保護件20縮回。在此組構中,針保護件的軸向移位因此被限制至收縮部70與前端環形壁63之間的小距離(圖2A)。The inner surface of the cylinder 61 is formed with a constriction 70 defining a stop surface for engaging with the radial protrusion 54 of the needle guard to prevent the needle guard 20 from retracting when the cap 22 is attached to the housing 3. In this configuration, the axial displacement of the needle guard is therefore limited to a small distance between the constriction 70 and the front annular wall 63 (FIG. 2A).

仍參考圖1、2及2A,後外殼3b係形成為塞子,用於在其後端封閉藉由前外殼3a所界定之內部容積。它主要包含裝配於前外殼3a的外壁41中之大致上圓柱形本體71、及在其近側端的徑向封閉壁73。圓柱形本體71之外表面係形成有一對相向的徑向閂鎖75,用於與各自之孔45嚙合並將後外殼3b牢牢地附接至前外殼3a。Still referring to Figures 1, 2 and 2A, the rear housing 3b is formed as a plug for closing the internal volume defined by the front housing 3a at its rear end. It mainly comprises a substantially cylindrical body 71 fitted in the outer wall 41 of the front housing 3a, and a radial closing wall 73 at its proximal end. The outer surface of the cylindrical body 71 is formed with a pair of radial latches 75 facing each other, which are used to engage with the respective holes 45 and firmly attach the rear housing 3b to the front housing 3a.

後外殼3b的圓柱形本體71之內表面係形成有相向的凹部77,此等凹部77被提供成與保持構件33之互補特徵嚙合,用於將其牢牢地附接至後外殼3b。後外殼3b的本體71之內表面更形成有於直徑方向中相向的凹部,此等凹部界定用於與觸發器構件35之特徵嚙合的徑向止動部79,如將在下文中看到。The inner surface of the cylindrical body 71 of the rear housing 3b is formed with facing recesses 77, which are provided to engage with complementary features of the retaining member 33 for firmly attaching it to the rear housing 3b. The inner surface of the body 71 of the rear housing 3b is further formed with facing recesses in the radial direction, which define radial stops 79 for engaging with features of the trigger member 35, as will be seen below.

仍參考圖1、2及2A,柱塞桿31係形成為一體式零件,其具有一於其遠側端設有徑向板塊83之主要細長實心本體81、及由實心本體81軸向地且朝近側地延伸的一對平行之彈性支臂85。板塊85被設計成嚙合柱塞9並將注射彈簧34的排出力量傳送至柱塞9。Still referring to Figures 1, 2 and 2A, the plunger rod 31 is formed as a one-piece part having a main elongated solid body 81 with a radial plate 83 at its distal end, and a pair of parallel elastic arms 85 extending axially and proximally from the solid body 81. The plate 85 is designed to engage the plunger 9 and transmit the expelling force of the injection spring 34 to the plunger 9.

支臂85係彼此隔開,由而界定一間隙87,且係可撓的,使得它們可在徑向方向中朝內地偏轉。每一支臂85係於其自由近側端形成有用於與保持構件33之止動表面嚙合的突出部89。突出部89由各自之彈性支臂85徑向且朝外地突出。彈性支臂85界定用於軸向地保持柱塞桿31抵抗注射彈簧34的偏向作用之閂鎖特徵。The arms 85 are spaced apart from one another to define a gap 87 and are flexible so that they can deflect inwardly in a radial direction. Each arm 85 is formed at its free proximal end with a projection 89 for engaging with a stop surface of the retaining member 33. The projection 89 projects radially and outwardly from the respective resilient arm 85. The resilient arms 85 define a latching feature for axially retaining the plunger rod 31 against the biasing action of the injection spring 34.

現在具體參考圖1、2、2A及5。保持構件33包含一實質上圓柱形的中空本體101及於其近側端之徑向壁,此徑向壁形成有一具有周向邊緣103的中心軸向孔102。邊緣103界定用於與突出部89嚙合之止動表面(如圖2上可見),且因此界定一對應的閂鎖特徵。1, 2, 2A and 5. The retaining member 33 comprises a substantially cylindrical hollow body 101 and a radial wall at its proximal end which forms a central axial hole 102 having a peripheral edge 103. The edge 103 defines a stop surface for engaging the projection 89 (as can be seen in FIG. 2) and thus defines a corresponding latching feature.

圓柱形中空本體101係設計用於容納注射彈簧34,徑向壁界定用於注射彈簧34之承座。如圖2上可見,在此圖上所說明的初始狀態中被壓縮之注射彈簧34於其遠側端支承在柱塞桿31的板塊83上,且於其近側端支承在中空本體101之徑向壁上。The cylindrical hollow body 101 is designed to accommodate the injection spring 34, and the radial wall defines a seat for the injection spring 34. As can be seen in FIG. 2, in the initial state illustrated in this figure, the compressed injection spring 34 is supported at its distal end on the plate 83 of the plunger rod 31 and at its proximal end on the radial wall of the hollow body 101.

一方面藉由彈性支臂85及突出部89所界定且另一方面藉由邊緣103所界定的注射彈簧34及閂鎖特徵被設計,使得當相互嚙合時,如果未阻止彈性支臂85朝內地偏轉,藉由注射彈簧34於其近側位置(與圖2相同之位置)中賦予至柱塞桿31的力量克服閂鎖特徵之保持力量。The injection spring 34 and the latching feature defined by the resilient arm 85 and the protrusion 89 on the one hand and by the edge 103 on the other hand are designed so that when engaged with each other, if the resilient arm 85 is not prevented from deflecting inwardly, the force imparted to the plunger rod 31 by the injection spring 34 in its proximal position (the same position as in FIG. 2 ) overcomes the retaining force of the latching feature.

圓柱形中空本體101係形成有由其徑向且往外突出的尖頭105,此尖頭105界定一用於與觸發器構件35之對應特徵嚙合的凸輪隨動件。The cylindrical hollow body 101 is formed with a tip 105 protruding radially and outwardly therefrom, and the tip 105 defines a cam follower for engaging with a corresponding feature of the trigger member 35.

保持構件33更包含一對相反之固定扣合部107,其由中空本體101徑向地延伸並及與對應凹部77嚙合(如圖2A上所顯示),用於將保持構件33鎖固至後外殼3a。The retaining member 33 further includes a pair of opposite fixing buckles 107, which extend radially from the hollow body 101 and engage with the corresponding recesses 77 (as shown in FIG. 2A ) for locking the retaining member 33 to the rear housing 3 a.

保持構件33亦包括一對平行的分支108,其在遠側方向中由中空本體101軸向地突出並由中心軸線X對稱地隔開。每一分支係於其自由遠側端設有傾斜邊緣109,其設計來支承並壓在注射器凸緣10上。分支108及各自之傾斜邊緣109提供一定程度的彈性,其吸收注射器與裝置部件之間由於製造公差而可能殘餘的遊隙。分支108及邊緣109亦被設計成在裝置以「針向上」之定向掉落的情況下吸收震動,並最小化對構成注射器筒件6之玻璃上的衝擊力量。The retaining member 33 also comprises a pair of parallel branches 108 which protrude axially from the hollow body 101 in the distal direction and are symmetrically spaced by the central axis X. Each branch is provided at its free distal end with a beveled edge 109 designed to bear against and press against the syringe flange 10. The branches 108 and the respective beveled edge 109 provide a degree of elasticity which absorbs possible residual play between the syringe and the device components due to manufacturing tolerances. The branches 108 and the edge 109 are also designed to absorb shocks in the event that the device is dropped in a "needle-up" orientation and to minimize the impact forces on the glass constituting the syringe barrel 6.

再者,保持構件33具有由中空本體101徑向地延伸之環形支承凸緣111,用於可滑動地支承此針保護件20的腿部52,及進一步由支承凸緣111往外地突出之兩對相反之導引壁113,每對導引壁113界定一用於各自腿部52的通道。導引壁113被建構成與對應腿部52滑動地配合,以便允許針保護件20軸向地滑動並防止相對旋轉。Furthermore, the retaining member 33 has an annular support flange 111 extending radially from the hollow body 101 for slidably supporting the leg 52 of the needle guard 20, and two pairs of opposite guide walls 113 further protruding outward from the support flange 111, each pair of guide walls 113 defining a passage for a respective leg 52. The guide walls 113 are constructed to slidably cooperate with the corresponding leg 52 so as to allow the needle guard 20 to slide axially and prevent relative rotation.

現在參考圖1、2、2A、6及6A,將看出的是,觸發器構件35包含一中空套筒本體131,此中空套筒本體131係於其遠側端開放且在其近側端藉由近側封閉壁133所封閉。套筒本體131裝配於保持構件33之圓柱形中空本體101上方,使套筒本體131能夠取決於針保護件20的軸向移位及位置而相對於圓柱形中空本體101滑動或旋轉。下面將解釋此觸發器構件35相對此保持構件33之運動。Referring now to FIGS. 1, 2, 2A, 6 and 6A, it will be seen that the trigger member 35 comprises a hollow sleeve body 131 which is open at its distal end and closed at its proximal end by a proximal closing wall 133. The sleeve body 131 is fitted over the cylindrical hollow body 101 of the retaining member 33 so that the sleeve body 131 can slide or rotate relative to the cylindrical hollow body 101 depending on the axial displacement and position of the needle guard 20. The movement of the trigger member 35 relative to the retaining member 33 will be explained below.

觸發器構件35包括由閉合壁133朝遠側地突出的軸向栓銷135,使得在圖2及2A上所說明之初始組構中,栓銷135被插入柱塞桿31的彈性支臂85之間的間隙87中,由而防止彈性支臂85朝內徑向偏轉,並因此防止突出部由邊緣103之止動表面脫離。The trigger member 35 includes an axial pin 135 protruding distally from the closing wall 133, so that in the initial configuration illustrated in Figures 2 and 2A, the pin 135 is inserted into the gap 87 between the elastic arms 85 of the plunger rod 31, thereby preventing the elastic arms 85 from deflecting radially inward and thus preventing the protrusion from disengaging from the stop surface of the edge 103.

因此,栓銷135界定一阻擋特徵,當由其延伸位置運動至其縮回位置時,此阻擋特徵係可藉由針保護件20與觸發器構件35一起軸向地移位。當觸發器構件35係由其中栓銷135阻擋支臂85的朝內偏轉之阻擋位置朝近側地運動時,栓銷135係由間隙87移除,由此其不再干涉支臂85且不再阻擋支臂的偏轉。這對應於觸發器構件35之釋放位置,其中彈性支臂85係自由地徑向偏轉。因此,在注射彈簧34的偏向作用之下,突出部係由藉由邊緣103所形成的對應止動表面脫離。The latch 135 thus defines a blocking feature which can be displaced axially together with the trigger member 35 by the needle guard 20 when moving from its extended position to its retracted position. When the trigger member 35 is moved proximally from the blocking position in which the latch 135 blocks the inward deflection of the arm 85, the latch 135 is removed from the gap 87, whereby it no longer interferes with the arm 85 and no longer blocks the deflection of the arm. This corresponds to a released position of the trigger member 35 in which the elastic arm 85 is free to deflect radially. Thus, under the biasing action of the injection spring 34, the projection is disengaged from the corresponding stop surface formed by the edge 103.

觸發器構件35更包含由套筒本體131往外地突出之一對相向的懸臂式撓性支臂137,每一懸臂式撓性支臂於其自由端設有徑向耳片139。耳片139被提供用於與藉由後外殼3b之凹部形成的各自之徑向止動部79可釋放地嚙合(圖2)。The trigger member 35 further comprises a pair of opposing cantilevered flexible arms 137 projecting outwardly from the sleeve body 131, each cantilevered flexible arm being provided with a radial tab 139 at its free end. The tabs 139 are provided for releasably engaging respective radial stops 79 formed by recesses of the rear housing 3b (Fig. 2).

每一耳片139係藉由各自的撓性支臂137偏向進入嚙合在對應凹部內,支臂137係可藉由針保護件20朝內地偏轉,用於由凹部釋放耳片139。每一懸臂式撓性支臂137包含一用於與針保護件20之對應腿部52嚙合的斜面141。當針保護件係在近側方向中運動時,斜面141之輪廓決定藉由針保護件20的軸向移位所造成之懸臂式撓性支臂137的朝內偏轉。Each tab 139 is biased into engagement in a corresponding recess by a respective flexible arm 137, which can be deflected inwardly by the needle guard 20 for releasing the tab 139 from the recess. Each cantilevered flexible arm 137 includes a ramp 141 for engaging with a corresponding leg 52 of the needle guard 20. The profile of the ramp 141 determines the inward deflection of the cantilevered flexible arm 137 caused by axial displacement of the needle guard 20 when the needle guard is moved in the proximal direction.

耳片139及對應之徑向止動部79界定相互可釋放嚙合的鎖定特徵。這些鎖定特徵被設計成將觸發器構件35維持於其阻擋位置中,且當針保護件20由其延伸位置運動至其縮回位置時可藉由針保護件20釋放。針保護件20之縮回造成鎖定特徵79、139的釋放、閂鎖特徵89、103之釋放、並因此造成注射裝置的啟動。The tabs 139 and the corresponding radial stops 79 define mutually releasably engaging locking features. These locking features are designed to maintain the trigger member 35 in its blocking position and can be released by the needle guard 20 when the needle guard 20 moves from its extended position to its retracted position. The retraction of the needle guard 20 causes the release of the locking features 79, 139, the release of the latching features 89, 103, and thus the activation of the injection device.

觸發器構件35更包括由套筒本體131徑向且朝外地突出之第一肋條143、及由其朝遠側地隔開的第二肋條145。在所說明之實施例中,觸發器構件35包括一對此等於直徑方向中相對的第一肋條143、及一對此等同樣於直徑方向中相對之第二肋條145。The trigger member 35 further includes a first rib 143 radially and outwardly protruding from the sleeve body 131, and a second rib 145 spaced apart from it. In the illustrated embodiment, the trigger member 35 includes a pair of first ribs 143 that are opposite in the radial direction, and a pair of second ribs 145 that are also opposite in the radial direction.

第一肋條143被提供用於當針保護件20縮回時與腿部52的對應自由端55嚙合,由此造成此觸發器構件35朝近側地移位。The first rib 143 is provided for engaging with the corresponding free end 55 of the leg 52 when the needle protector 20 is retracted, thereby causing the trigger member 35 to be displaced proximally.

第一肋條具有一從耳片139稍微朝遠側地隔開之止動表面,用於與腿部52的自由端55在對應於斜面141之頂點的軸向位置嚙合,使得針保護件20的縮回依序地造成懸臂137之偏轉及腿部52的自由端55之嚙合,而無需接觸耳片139。The first rib has a stop surface slightly spaced distally from the ear 139 for engaging with the free end 55 of the leg 52 at an axial position corresponding to the apex of the ramp 141, so that retraction of the needle guard 20 sequentially causes deflection of the cantilever 137 and engagement of the free end 55 of the leg 52 without contacting the ear 139.

設有第二肋條145,用於在針保護件20朝向其縮回位置的縮回期間嚙合藉由腿部52之軸向邊緣57所界定的對應導引元件,且於注射裝置注射之後的最終狀態中,嚙合對應腿部52之橫向邊緣56並因此防止針保護件20朝近側地縮回。A second rib 145 is provided for engaging a corresponding guide element defined by the axial edge 57 of the leg 52 during retraction of the needle guard 20 towards its retracted position and, in the final state of the injection device after injection, for engaging a corresponding transverse edge 56 of the leg 52 and thereby preventing the needle guard 20 from retracting proximally.

因此,第二肋條145提供一選擇性嚙合此針保護件20的止動特徵,用於在此裝置之操作的第一階段中允許針保護件20之軸向移位,且於此裝置的最終狀態中防止針保護件20朝近側地縮回。這將在下文中進一步解釋。Thus, the second rib 145 provides a stop feature that selectively engages the needle guard 20, allowing axial displacement of the needle guard 20 in the first stage of operation of the device, and preventing the needle guard 20 from retracting proximally in the final state of the device. This will be further explained below.

觸發器構件35之套筒本體131係亦於其內表面上設有凸輪軌道150,用於收納保持構件33的尖頭105。凸輪軌道150具有由開放之遠側端151朝近側地延伸的軸向通道151及與軸向通道151連接之橫向地定向的終端通道155。如圖6A中可見,此終端通道155之內部後壁係相對於主軸線X傾斜,而內部前壁係垂直於主軸線X。The sleeve body 131 of the trigger member 35 is also provided with a cam track 150 on its inner surface for receiving the tip 105 of the retaining member 33. The cam track 150 has an axial channel 151 extending proximally from the open distal end 151 and a transversely oriented terminal channel 155 connected to the axial channel 151. As can be seen in FIG. 6A, the inner rear wall of the terminal channel 155 is inclined relative to the main axis X, while the inner front wall is perpendicular to the main axis X.

藉由尖頭105及凸輪軌道150所構成的凸輪系統界定閉鎖機制之閉鎖特徵,用於將針保護件20鎖定在對應於此裝置在注射之後的最終狀態之延伸位置中,亦即用於一旦此裝置已啟動且一旦針保護件20已藉由針保護件彈簧21返回至其延伸位置,防止針保護件20縮回。The locking feature of the locking mechanism defined by the cam system formed by the tip 105 and the cam track 150 is used to lock the needle guard 20 in an extended position corresponding to the final state of the device after injection, that is, to prevent the needle guard 20 from retracting once the device has been activated and once the needle guard 20 has returned to its extended position by the needle guard spring 21.

再者,套筒本體131係於近側區域中設有由其徑向地突出的呈軸環160形式之止動構件,此軸環160界定用於觸發器彈簧37的承座。Furthermore, the sleeve body 131 is provided in the proximal region with a stop member in the form of a shaft ring 160 protruding radially therefrom, which shaft ring 160 defines a seat for the trigger spring 37.

如圖2及2A上可見,配置在針保護件20與外殼3之間的觸發器彈簧37於近側端支承在後外殼3b之封閉壁73上且於遠側端支承在軸環160上。As can be seen in Figures 2 and 2A, the trigger spring 37 disposed between the needle guard 20 and the housing 3 is supported on the closing wall 73 of the rear housing 3b at the proximal end and on the shaft ring 160 at the distal end.

由圖2及2A上所說明的注射裝置10(如所儲存之裝置)的初始組構開始,現在將參考圖7-11敘述用於操作此裝置之主要步驟。Beginning with the initial configuration of the injection device 10 (as stored) illustrated in FIGS. 2 and 2A , the major steps for operating the device will now be described with reference to FIGS. 7-11 .

在圖2、2A的初始組構中,將指出的是,柱塞桿31係藉由突出部89與邊緣103之止動表面的嚙合而抵抗預壓縮注射彈簧34之偏向作用而保持於其近側位置中。彈性支臂85軸向地突出穿過孔102,使突出部89及邊緣103的止動表面係相互嚙合,並與彈性支臂85之間的栓銷135嚙合來防止朝內地偏轉。2, 2A, it will be noted that the plunger rod 31 is held in its proximal position by engagement of the stop surfaces of the projection 89 and the edge 103 against the biasing action of the pre-compression injection spring 34. The resilient arms 85 protrude axially through the holes 102 so that the stop surfaces of the projection 89 and the edge 103 engage each other and engage the latch 135 between the resilient arms 85 to prevent inward deflection.

在此初始組構中,觸發器彈簧37被壓縮於後外殼3b與觸發器構件35之間,由此觸發器構件35被偏向至其阻擋位置,其中栓銷135嚙合彈性支臂85之間的間隙87。In this initial configuration, the trigger spring 37 is compressed between the rear housing 3 b and the trigger member 35 , whereby the trigger member 35 is biased to its blocking position, wherein the latch 135 engages the gap 87 between the resilient arms 85 .

觸發器構件35係藉由用耳片139及徑向止動部79所構成之鎖定特徵的相互可釋放嚙合而保持於此阻擋位置中,其在此位置中防止觸發器構件35於近側方向中之軸向移位。顯然,亦藉由止動此觸發器構件35的壁73支臂85來防止觸發器構件35朝遠側地運動。The trigger member 35 is held in this blocking position by the releasable engagement of the locking features formed by the tabs 139 and the radial stop 79, which prevents the axial displacement of the trigger member 35 in the proximal direction in this position. Obviously, the trigger member 35 is also prevented from moving distally by the wall 73 arm 85 that stops the trigger member 35.

在此初始組構中,藉由嚙合此止動表面46之翼片邊緣59來防止針保護件20朝遠側地運動。由於突出部54與帽蓋22的收縮部70之相互作用,針保護件20亦具有抵抗針保護件彈簧21的偏向作用之近側移位的有限能力。In this initial configuration, the needle guard 20 is prevented from moving distally by the wing edge 59 engaging the stop surface 46. Due to the interaction of the projection 54 and the constriction 70 of the cap 22, the needle guard 20 also has a limited ability to resist the proximal displacement of the biasing action of the needle guard spring 21.

在使用此裝置1之前,使用者需要藉由扭轉帽蓋22來移除帽蓋22,用於釋放帽蓋22與前外殼3a之間的螺紋式連接49、64,且接著將帽蓋22由前外殼3a軸向地拆卸。這樣做時,使用者由針8移除鞘套15,此鞘套15被保持在帽蓋之握柄套筒65中。針8仍然藉由針保護件20所保護,其接著處於其完全延伸位置中,且不暴露。Before using the device 1, the user needs to remove the cap 22 by twisting it, for releasing the threaded connection 49, 64 between the cap 22 and the front housing 3a, and then axially disassemble the cap 22 from the front housing 3a. In doing so, the user removes the sheath 15 from the needle 8, which is retained in the grip sleeve 65 of the cap. The needle 8 is still protected by the needle guard 20, which is then in its fully extended position and is not exposed.

接著此裝置製備好進行注射。當未加帽蓋時,此裝置係處於與圖2、2A所顯示者相同的組構中,而僅只移除帽蓋22及鞘套15,且針防護件20自由進一步朝近側地運動。The device is then ready for injection. When uncapped, the device is in the same configuration as shown in Fig. 2, 2A, with only the cap 22 and sheath 15 removed and the needle guard 20 free to move further proximally.

為了觸發此裝置1並注射藥物容器5(注射器)中所含有之藥物7,使用者需要將此裝置的遠側端、亦即藉由針保護件20之環形邊緣51所構成之尖端按壓在注射部位上。當抵抗針保護件彈簧21的作用而按壓時,針保護件20開始部分地縮回外殼3內。In order to trigger the device 1 and inject the medicine 7 contained in the medicine container 5 (syringe), the user needs to press the distal end of the device, i.e. the tip formed by the annular edge 51 of the needle guard 20, against the injection site. When pressed against the action of the needle guard spring 21, the needle guard 20 begins to partially retract into the housing 3.

於圖7、7A、7B上所說明之組構中,針保護件部分地縮回外殼3中,因而露出刺入使用者的組織之針8的尖端。In the configuration illustrated in FIGS. 7, 7A, and 7B, the needle guard is partially retracted into the housing 3, thereby exposing the tip of the needle 8 that penetrates the user's tissue.

腿部52係軸向地導引在導引壁113之間,使軸向邊緣57滑動於觸發器構件35的各自第二肋條145上。在此階段期間,腿部52滑動於懸臂137之各自斜面141上方,因此朝內地偏轉支臂37並由外殼3的對應徑向止動部79釋放耳片139。在此組構中,觸發器構件35未相對於初始組構軸向或旋轉地運動。尖頭105嚙合在凸輪軌道150中,並定位於軸向通道153之最後面部分中。The legs 52 are axially guided between the guide walls 113 so that the axial edges 57 slide on the respective second ribs 145 of the trigger member 35. During this phase, the legs 52 slide over the respective inclined surfaces 141 of the cantilever arms 137, thus deflecting the cantilever arms 37 inwardly and releasing the tabs 139 from the corresponding radial stops 79 of the housing 3. In this configuration, the trigger member 35 does not move axially or rotationally relative to the initial configuration. The prongs 105 are engaged in the cam track 150 and are positioned in the rearmost portion of the axial channel 153.

在此部分縮回的組構中,將參考圖7注意的是,當釋放此等鎖定特徵79、139時,觸發器構件35仍處於其軸向阻擋位置中,其中栓銷135被插入間隙87中並防止彈性支臂85之朝內偏轉,由而防止突出部89由邊緣103的止動表面脫離。觸發器構件35係在觸發器彈簧37之偏向作用下維持於其阻擋位置中。In this partially retracted configuration, it will be noted with reference to FIG. 7 that when these locking features 79, 139 are released, the trigger member 35 remains in its axial blocking position, wherein the latch 135 is inserted into the gap 87 and prevents the inward deflection of the resilient arm 85, thereby preventing the projection 89 from disengaging from the stop surface of the edge 103. The trigger member 35 is maintained in its blocking position under the bias of the trigger spring 37.

藉由對著注射部位持續向裝置1施加壓力,針保護件進一步縮回進入外殼,直至其抵達其完全縮回位置,藉此暴露待插入使用者的組織之針的整個長度。此組構被表示在圖8、8A、8B上。By continuing to apply pressure to the device 1 against the injection site, the needle guard is further retracted into the housing until it reaches its fully retracted position, thereby exposing the entire length of the needle to be inserted into the user's tissue. This configuration is shown in Figures 8, 8A, 8B.

為了抵達此組構,縮回針保護件20,使得腿部52之自由端55支承於各自的第一肋條143上,並因此依次抵抗觸發器彈簧37之作用而在近側方向中推動觸發器構件35。因此,栓銷135係於針保護件20的完全縮回位置(如圖8、8A、8B上所顯示)中由間隙87脫離,由此釋放此等閂鎖特徵89、103。To reach this configuration, the needle guard 20 is retracted so that the free ends 55 of the legs 52 bear on the respective first ribs 143 and thereby in turn push the trigger member 35 in the proximal direction against the action of the trigger spring 37. Thus, the latch 135 is disengaged from the gap 87 in the fully retracted position of the needle guard 20 (as shown in FIGS. 8, 8A, 8B), thereby releasing the latching features 89, 103.

此組構對應於觸發器構件35之釋放位置,其中彈性支臂85係自由地朝內偏轉,且其中在注射彈簧34的作用之下,突出部89係由邊緣103的止動表面脫離。This configuration corresponds to the released position of the trigger member 35, in which the resilient arms 85 are free to deflect inwardly and in which the projections 89 are disengaged from the stop surfaces of the edge 103 under the action of the injection spring 34.

於所述操作階段期間,由於尖頭105在軸向通道153中之嚙合,觸發器構件35仍然被防止於保持構件33上方旋轉。在觸發器構件35的完全縮回位置中,尖頭105係坐落於凸輪軌道150之打開端151處,至少部分地在軸向通道153內,因此仍防止觸發器構件35相對保持構件33的旋轉。During the operating phase, the trigger member 35 is still prevented from rotating over the retaining member 33 due to the engagement of the tip 105 in the axial channel 153. In the fully retracted position of the trigger member 35, the tip 105 is seated at the open end 151 of the cam track 150, at least partially within the axial channel 153, and thus the trigger member 35 is still prevented from rotating relative to the retaining member 33.

當釋放此等閂鎖特徵時,柱塞桿31可於注射彈簧34之作用下被向前驅動至其遠側位置(如圖9上所顯示),由而在藥物容器中向前推動柱塞9並排出藥物。When these latching features are released, the plunger rod 31 can be driven forward to its distal position (as shown in FIG. 9 ) under the action of the injection spring 34 , thereby pushing the plunger 9 forward in the drug container and expelling the drug.

因此,將理解的是,針保護件20之縮回依序地造成阻擋特徵79、139的釋放,且接著於進一步縮回時,造成觸發器構件35由其阻擋位置軸向移位至其釋放位置。這依序造成閂鎖特徵89、103被釋放並啟動此注射裝置,其中注射彈簧34將柱塞桿31驅動至其遠側位置,藉此注射藥物。It will therefore be appreciated that retraction of the needle guard 20 sequentially causes the release of the blocking features 79, 139 and then, upon further retraction, causes the trigger member 35 to be axially displaced from its blocking position to its released position. This in turn causes the latching features 89, 103 to be released and activate the injection device, wherein the injection spring 34 drives the plunger rod 31 to its distal position, thereby injecting the drug.

觸發器彈簧37之存在確保於釋放阻擋特徵79、139之後,腿部52的自由端55及第一肋條143保持相互嚙合。這確保閂鎖特徵89、103之釋放-及因此裝置的啟動-發生在適當之針插入深度,對應於針保護件20的完全縮回位置。The presence of the trigger spring 37 ensures that the free end 55 of the leg 52 and the first rib 143 remain engaged with each other after the blocking features 79, 139 are released. This ensures that the release of the latching features 89, 103 - and therefore the activation of the device - occurs at the appropriate needle insertion depth, corresponding to the fully retracted position of the needle guard 20.

圖9、9A、9B上所說明之組構對應於一旦注射已完成,使用者就開始釋放此裝置上的壓力。柱塞桿31處於其遠側位置且針保護件20在針保護件彈簧21之作用下返回至一部分延伸位置。The configuration illustrated in Figures 9, 9A, 9B corresponds to the user starting to release the pressure on the device once the injection has been completed. The plunger rod 31 is in its distal position and the needle guard 20 returns to a partially extended position under the action of the needle guard spring 21.

為了抵達此組構,腿部52於斜面141上方朝遠側地滑回,藉此釋放懸臂137,當觸發器構件35係藉由觸發器彈簧37在遠側方向中偏向時,懸臂137可往外地撓曲回至其初始位置。於觸發器彈簧37的作用下,觸發器35係因此軸向地朝前運動,由此運動此軸向通道153,以便收納尖頭105。在此相對動作中,尖頭105係於軸向通道153之端部帶入與終端通道155的橫向表面嚙合(如在圖7B上可見)。To reach this arrangement, the leg 52 slides back distally over the ramp 141, thereby releasing the cantilever 137, which can bend outwardly back to its initial position when the trigger member 35 is biased in the distal direction by the trigger spring 37. Under the action of the trigger spring 37, the trigger 35 is thus moved axially forward, thereby moving the axial channel 153 to receive the tip 105. In this relative movement, the tip 105 is brought into engagement with the transverse surface of the terminal channel 155 at the end of the axial channel 153 (as can be seen in FIG. 7B ).

於觸發器彈簧37之作用下,尖頭105與凸輪軌道150的相互嚙合造成尖頭105被偏向朝終端通道155。然而,當第二肋條145支承在腿部52之軸向邊緣57上時,防止觸發器構件35及保持構件33的相對旋轉。防止此相對旋轉,直至針保護件20返回至其完全延伸位置,而對應於抵達邊緣57之近側端的第二肋條145。Under the action of the trigger spring 37, the mutual engagement of the tip 105 and the cam track 150 causes the tip 105 to be biased toward the terminal passage 155. However, relative rotation of the trigger member 35 and the retaining member 33 is prevented when the second rib 145 bears on the axial edge 57 of the leg 52. This relative rotation is prevented until the needle guard 20 returns to its fully extended position, corresponding to the second rib 145 reaching the proximal end of the edge 57.

在此裝置於注射後之最終狀態中,且一旦使用者將此裝置由注射部位完全撤回並完全釋放此裝置上的壓力,針保護件20就返回至其完全延伸位置,亦對應於圖2之位置,其中它完全覆蓋此針8。In the final state of the device after injection, and once the user has completely withdrawn the device from the injection site and completely released the pressure on the device, the needle guard 20 returns to its fully extended position, also corresponding to the position of FIG. 2 , in which it completely covers the needle 8 .

在圖10、10A、10B上說明此最終組構。This final structure is illustrated in Figures 10, 10A, and 10B.

為了抵達此組構,針保護件20已朝遠側地運動達一段距離,使得軸向邊緣52於第二肋條145上滑動之後抵達一位置,其中凹口56係與第二肋條145對應地定位,由而允許觸發器構件35旋轉。To reach this configuration, the needle guard 20 has been moved distally a distance so that the axial edge 52 reaches a position after sliding on the second rib 145, wherein the notch 56 is positioned corresponding to the second rib 145, thereby allowing the trigger member 35 to rotate.

在觸發器彈簧37的作用及凸輪隨動件(尖頭105)於凸輪軌道150中之相互嚙合下,造成觸發器構件35旋轉,使終端通道155的傾斜後壁被迫在尖頭105上滑動。然後,第二肋條145嚙合藉由凹口56所形成之對應橫向邊緣,藉此將針保護件20閉鎖於其完全延伸位置中。這防止針保護件20再次縮回,且作為一安全措施,防止針暴露用以避免受傷的風險。Under the action of the trigger spring 37 and the mutual engagement of the cam follower (tip 105) in the cam track 150, the trigger member 35 is caused to rotate, so that the inclined rear wall of the terminal channel 155 is forced to slide on the tip 105. The second rib 145 then engages the corresponding transverse edge formed by the notch 56, thereby locking the needle guard 20 in its fully extended position. This prevents the needle guard 20 from being retracted again and acts as a safety measure to prevent the needle from being exposed to avoid the risk of injury.

將理解的是,凸輪系統105、150取決於針保護件20之軸向移位及位置來允許或防止觸發器構件35相對保持構件33的相對移位、無論是軸向或旋轉式。It will be appreciated that the cam systems 105, 150 allow or prevent relative displacement, either axially or rotationally, of the trigger member 35 relative to the retaining member 33, depending on the axial displacement and position of the needle guard 20.

藉由跨騎在軸向通道153內之尖頭105來防止觸發器構件35旋轉。於觸發器構件35的阻擋位置及釋放位置兩者中,此尖頭105嚙合在軸向通道153內,而防止相對旋轉。The trigger member 35 is prevented from rotating by the tip 105 riding in the axial channel 153. In both the blocking position and the release position of the trigger member 35, the tip 105 is engaged in the axial channel 153 to prevent relative rotation.

為了使觸發器構件35能夠於閉鎖期間旋轉,觸發器構件35必需在來自觸發器彈簧37的作用之下朝遠側地運動,直至尖頭105完全脫離此軸向通道153。於圖9B中所顯示的此種狀態可僅只一旦釋放柱塞桿31時被實現。一旦支臂85不再可與觸發器構件35干涉,觸發器構件35將能夠朝遠側地運動超過其初始位置(如圖2上所顯示),且尖頭105最終將離開軸向通道153。這剛好發生在尖頭105與終端通道155形成接觸之前。一旦尖頭105離開軸向通道153並接觸此終端通道155,第二肋條145將與針保護件20的軸向邊緣57形成接觸,而防止觸發器構件35之旋轉,直至針保護件已返回至其完全延伸狀態。In order for the trigger member 35 to be able to rotate during the locking period, the trigger member 35 must move distally under the action of the trigger spring 37 until the tip 105 completely leaves the axial channel 153. This state shown in FIG. 9B can only be achieved once the plunger rod 31 is released. Once the arm 85 can no longer interfere with the trigger member 35, the trigger member 35 will be able to move distally beyond its initial position (as shown in FIG. 2), and the tip 105 will eventually leave the axial channel 153. This occurs just before the tip 105 comes into contact with the terminal channel 155. Once the tip 105 leaves the axial channel 153 and contacts the terminal channel 155, the second rib 145 will come into contact with the axial edge 57 of the needle guard 20, preventing rotation of the trigger member 35 until the needle guard has returned to its fully extended state.

如果使用者於裝置的此狀態中推動在針保護件20上,則針保護件20之橫向邊緣56接觸第二肋條145,且終端通道155的前壁接著推動抵靠著尖頭105,其牢牢地固定至外殼3。定向終端通道155之前壁,使得沒有可藉由終端通道155的前壁軸向地按壓於尖頭105上造成的相對旋轉。在所說明之實施例中,這是藉由垂直於主軸線X的終端通道之前壁來達成。If the user pushes on the needle guard 20 in this state of the device, the transverse edge 56 of the needle guard 20 contacts the second rib 145 and the front wall of the terminal channel 155 is then pushed against the tip 105, which is firmly fixed to the housing 3. The front wall of the terminal channel 155 is oriented so that no relative rotation can be caused by the front wall of the terminal channel 155 pressing axially on the tip 105. In the illustrated embodiment, this is achieved by the front wall of the terminal channel being perpendicular to the main axis X.

在替代實施例(未示出)中,凸輪系統可被倒置,使凸輪隨動件係設於觸發器構件上,且凸輪軌道係設在保持構件上。於所述組構中,凸輪隨動件可為呈由觸發器構件的套筒本體徑向且朝內地突出之尖頭形式。所說明實施例係較佳的,雖然作為部件係更易於用傳統之注射成形方法製造。In an alternative embodiment (not shown), the cam system may be inverted so that the cam follower is provided on the trigger member and the cam track is provided on the retaining member. In such an arrangement, the cam follower may be in the form of a prong protruding radially and inwardly from the sleeve body of the trigger member. The illustrated embodiment is preferred, although it is more easily manufactured as a component by conventional injection molding methods.

在進一步的替代實施例(未示出)中,對應於徑向止動部79及耳片139之鎖定特徵可在不同配置中提供,其中徑向止動件係藉由保持構件中的凹部所形成,且耳片係形成於由觸發器構件之套筒本體徑向地朝內突出的懸臂上。在此等實施例中,針保護件之腿部係可徑向滑動地嚙合於保持構件與觸發器構件之間。在所述案例中,針保護件的縮回造成懸臂之往外偏轉(如與所說明的較佳實施例中之朝內偏轉相反)及鎖定特徵的釋放。而且,於此等實施例中,對應於肋條143、145之第一肋條及第二肋條由觸發器構件的套筒本體徑向朝內地突出。In a further alternative embodiment (not shown), the locking features corresponding to the radial stop 79 and the tab 139 may be provided in a different configuration, wherein the radial stop is formed by a recess in the retaining member and the tab is formed on a cantilever projecting radially inwardly from the sleeve body of the trigger member. In such embodiments, the legs of the needle guard are radially slidably engaged between the retaining member and the trigger member. In the described case, retraction of the needle guard causes an outward deflection of the cantilever (as opposed to the inward deflection in the described preferred embodiment) and release of the locking feature. Moreover, in these embodiments, the first rib and the second rib corresponding to the ribs 143, 145 protrude radially inward from the sleeve body of the trigger component.

將理解的是,根據本發明之裝置包括安全特徵、諸如防止意外啟動,其係藉由相當簡單的手段來達成,而消除對於額外部件及處理步驟之需要。本發明提供高度耐用性及可靠性,這對於與救命藥品結合使用的緊急裝置尤其重要。It will be appreciated that the device according to the present invention includes safety features, such as preventing accidental activation, which are achieved by relatively simple means, eliminating the need for additional parts and processing steps. The present invention provides a high degree of durability and reliability, which is particularly important for emergency devices used in conjunction with life-saving drugs.

1:注射裝置 2a:前外殼 3:細長外殼 3a:前外殼 3b:後外殼 5:藥物容器 6:筒件 7:藥物 8:針 9:柱塞 10:凸緣 11:前肩部 15:鞘套 17:基底部分 20:針保護件 21:針保護件彈簧 22:帽蓋 25:注射驅動機制 31:柱塞桿 33:保持構件 34:注射彈簧 35:觸發器構件 37:觸發器彈簧 41:外壁 42:內壁 43:套筒 44:徑向連接肋條 45:孔口 46:止動表面 47:脊部 48:止動部分 49:肋條螺紋區段 50:鞘套部分 51:前環形邊緣 52:腿部 53:通孔 54:突出部 55:自由端 56:橫向邊緣 57:區段 58:翼片 59:前翼片邊緣 61:圓柱形壁 63:前端環形壁 64:凹部 65:抓握套筒 67:鉗爪 68:主肋條 69:脊狀表面 70:收縮部 71:圓柱形本體 73:徑向封閉壁 75:徑向閂鎖 77:凹部 79:徑向止動部 81:實心本體 83:徑向板塊 85:彈性支臂 87:間隙 89:突出部 101:中空本體 102:中心軸向孔 103:周向邊緣 105:尖頭 107:固定扣合部 108:分支 109:傾斜邊緣 111:支承凸緣 113:導引壁 131:套筒本體 133:封閉壁 135:栓銷 137:懸臂式撓性支臂 139:徑向耳片 141:斜面 143:第一肋條 145:第二肋條 150:凸輪軌道 151:軸向通道 153:軸向通道 155:終端通道 160:軸環 1: injection device 2a: front housing 3: elongated housing 3a: front housing 3b: rear housing 5: drug container 6: barrel 7: drug 8: needle 9: plunger 10: flange 11: front shoulder 15: sheath 17: base 20: needle guard 21: needle guard spring 22: cap 25: injection drive mechanism 31: plunger rod 33: retaining member 34: injection spring 35: trigger member 37: trigger spring 41: outer wall 42: inner wall 43: sleeve 44: radial connecting rib 45: Orifice 46: Stop surface 47: Ridge 48: Stop portion 49: Rib thread section 50: Sheath section 51: Front annular edge 52: Leg 53: Through hole 54: Protrusion 55: Free end 56: Transverse edge 57: Segment 58: Wing 59: Front wing edge 61: Cylindrical wall 63: Front annular wall 64: Recess 65: Gripping sleeve 67: Clamping claw 68: Main rib 69: Ridge surface 70: Constriction 71: Cylindrical body 73: Radial closing wall 75: Radial latch 77: Recess 79: Radial stop 81: Solid body 83: Radial plate 85: Flexible arm 87: Gap 89: Protrusion 101: Hollow body 102: Central axial hole 103: Circumferential edge 105: Point 107: Fixed snap-fitting part 108: Branch 109: Inclined edge 111: Support flange 113: Guide wall 131: Sleeve body 133: Closing wall 135: Latch 137: Cantilevered flexible arm 139: Radial ear 141: Inclined surface 143: First rib 145: Second rib 150: Cam track 151: Axial channel 153: Axial channel 155: Terminal channel 160: Shaft ring

現在將參考以下附圖更詳細地敘述本發明的較佳實施例,其中: [圖1]係根據本發明之較佳實施例的注射裝置之分解立體圖; [圖2]係如於儲存組構中組裝的圖1之裝置在使用前於第一軸向平面中的橫截面圖; [圖2A]係在圖2之組構中的裝置於垂直軸向平面中之橫截面圖; [圖3]係圖1的裝置之單獨前外殼的正視圖; [圖3A及3B]分別係來自圖3之方向3A中之側視圖及軸向平面3B-3B中的橫截面圖; [圖4]係圖1的裝置之單獨針保護件的立體圖; [圖5]係圖1之裝置的單獨保持構件之俯視圖; [圖6]係圖1的裝置之單獨觸發器構件的俯視圖; [圖6A]係來自圖6之軸向平面6A-6A的橫截面圖; [圖7]係圖1之裝置在觸發此裝置的第一步驟中於圖2之平面中的橫截面圖,其中針保護件係部分地縮回,對應於使用者開始將裝置壓抵靠著注射部位; [圖7A及7B]係圖7之組構中的裝置之沒有外殼的局部分解視圖,分別是正視圖及俯視圖; [圖8]係圖1之裝置在觸發此裝置的第二步驟中於圖2之平面中的橫截面視圖,其中針保護件係完全縮回,對應於針在注射部位之完全插入; [圖8A及8B]係圖8的組構中之裝置的沒有外殼之局部分解視圖,分別是正視圖及俯視圖; [圖9]係圖1的裝置於此裝置之第一閉鎖步驟中在圖2的平面中之橫截面圖,其中針保護件係返回至部分延伸位置,對應於使用者開始由注射部位撤回裝置; [圖9A及9B]係圖9的組構中之裝置的沒有外殼之局部分解視圖,分別是正視圖及俯視圖; [圖10]係圖1的裝置在此裝置之最終閉鎖組構中於圖2的平面中之橫截面視圖,其中針保護件係返回至其完全延伸位置,對應於此裝置的最終使用後組構; [圖10A及10B]係圖10之組構中的裝置之沒有外殼的局部分解視圖,分別是正視圖及俯視圖。 The preferred embodiment of the present invention will now be described in more detail with reference to the following figures, wherein: [FIG. 1] is an exploded perspective view of an injection device according to a preferred embodiment of the present invention; [FIG. 2] is a cross-sectional view of the device of FIG. 1 assembled in a storage structure before use in a first axial plane; [FIG. 2A] is a cross-sectional view of the device in the structure of FIG. 2 in a vertical axial plane; [FIG. 3] is a front view of a single front housing of the device of FIG. 1; [FIGS. 3A and 3B] are a side view in direction 3A and a cross-sectional view in axial plane 3B-3B from FIG. 3, respectively; [FIG. 4] is a perspective view of a single needle guard of the device of FIG. 1; [Figure 5] is a top view of a single retaining member of the device of Figure 1; [Figure 6] is a top view of a single trigger member of the device of Figure 1; [Figure 6A] is a cross-sectional view from the axial plane 6A-6A of Figure 6; [Figure 7] is a cross-sectional view of the device of Figure 1 in the plane of Figure 2 in the first step of triggering the device, wherein the needle guard is partially retracted, corresponding to the user starting to press the device against the injection site; [Figures 7A and 7B] are partial exploded views of the device in the assembly of Figure 7 without the outer shell, which are front view and top view respectively; [Figure 8] is a cross-sectional view of the device of Figure 1 in the plane of Figure 2 in the second step of triggering the device, wherein the needle guard is fully retracted, corresponding to the complete insertion of the needle at the injection site; [Figures 8A and 8B] are partial exploded views of the device in the configuration of Figure 8 without the outer shell, which are a front view and a top view respectively; [Figure 9] is a cross-sectional view of the device of Figure 1 in the plane of Figure 2 in the first locking step of the device, wherein the needle guard is returned to a partially extended position, corresponding to the user starting to withdraw the device from the injection site; [Figures 9A and 9B] are partial exploded views of the device in the configuration of Figure 9 without the outer shell, which are a front view and a top view respectively; [Figure 10] is a cross-sectional view of the device of Figure 1 in the plane of Figure 2 in the final locked configuration of the device, wherein the needle guard is returned to its fully extended position, corresponding to the final configuration of the device after use; [Figures 10A and 10B] are partial exploded views of the device in the configuration of Figure 10 without the outer casing, which are front and top views, respectively.

1:注射裝置 1: Injection device

3:細長外殼 3: Slim shell

3a:前外殼 3a: Front shell

3b:後外殼 3b: Rear shell

5:藥物容器 5:Medication container

6:筒件 6: Cylinder parts

10:凸緣 10: flange

15:鞘套 15: Sheath

17:基底部分 17: Base part

20:針保護件 20: Needle protector

21:針保護件彈簧 21: Needle guard spring

22:帽蓋 22: Cap

25:注射驅動機制 25: Injection drive mechanism

31:柱塞桿 31: Plunger rod

33:保持構件 33: Retaining components

34:注射彈簧 34: Injection spring

35:觸發器構件 35: Trigger components

37:觸發器彈簧 37: Trigger spring

41:外壁 41: Outer wall

43:套筒 43: Sleeve

45:孔口 45: Orifice

47:脊部 47: Spine

49:肋條螺紋區段 49: Rib thread section

50:鞘套部分 50: Sheath part

52:腿部 52: Legs

54:突出部 54: protrusion

55:自由端 55: Free end

56:橫向邊緣 56: Horizontal edge

57:區段 57: Section

58:翼片 58: Wings

61:圓柱形壁 61: Cylindrical wall

65:抓握套筒 65: Grip sleeve

67:鉗爪 67: Clamping claws

68:主肋條 68: Main ribs

69:脊狀表面 69: Ridged surface

71:圓柱形本體 71: Cylindrical body

73:徑向封閉壁 73: Radial closed wall

75:徑向閂鎖 75: Radial latch

81:實心本體 81: Solid body

83:徑向板塊 83: Radial plate

85:彈性支臂 85: Elastic arm

87:間隙 87: Gap

89:突出部 89: protrusion

101:中空本體 101: Hollow body

102:中心軸向孔 102: Center axial hole

103:周向邊緣 103: Circumferential edge

105:尖頭 105: Pointed head

111:支承凸緣 111: Support flange

113:導引壁 113:Guide wall

131:套筒本體 131: Sleeve body

133:封閉壁 133: Closed wall

139:徑向耳片 139: Radial ear piece

141:斜面 141: Slope

145:第二肋條 145: Second rib

X:軸線 X: axis

Claims (23)

一種注射裝置,包含: 細長外殼(3),沿著縱向軸線(X)延伸並建構來收納藥物容器(5),該藥物容器設有含有該藥物(7)之筒件(6)、附接至其上的針(8)、及可在該筒件內位移以經過該針排出該藥物之柱塞(9); 針保護件(20),其可伸縮地安裝於該外殼(3)中並可在延伸位置與縮回位置之間軸向地運動,而於該延伸位置中,該針保護件由該外殼朝遠側地突出並圍繞該針(8),且該縮回位置從該延伸位置朝近側地隔開,對應於將該裝置(1)壓抵靠著注射部位用以啟動該注射裝置的條件; 針保護件彈簧(21),使該針保護件(20)在該遠側方向中偏向; 注射驅動機制(25),用於在該筒件(6)內驅動該柱塞(9),並因此排出該藥物,該注射驅動機制包括: 柱塞桿(31),可於該外殼(3)內軸向地運動在近側位置與遠側位置之間,用於在該筒件(6)內驅動該柱塞(9); 注射彈簧(34),配置用於使該柱塞桿(31)偏向至其遠側位置; 保持構件(33),固定在該外殼(3)內,用於在該注射裝置的初始狀態中抵抗該注射彈簧(34)之偏向作用將該柱塞桿(31)保持於其近側位置中,該保持構件(33)及該柱塞桿(31)具有對應的閂鎖特徵(85、89、103),該等閂鎖特徵(85、89、103)包括止動表面(103)及形成有突出部(89)之對應可徑向偏轉的彈性支臂(85),由此該柱塞桿(31)係藉由該突出部(89)與該止動表面(103)之嚙合而保持在其近側位置中;及 觸發器構件(35),包含阻擋特徵(135),並藉由當使該針保護件(20)從其延伸位置運動至其縮回位置時,該阻擋特徵(135)可由阻擋位置軸向地移位至釋放位置,於該阻擋位置中,該阻擋特徵(135)防止該彈性支臂(85)的徑向偏轉,因此防止該突出部(89)由該對應之止動表面(103)脫離,而在該釋放位置中,該彈性支臂係自由徑向地偏轉,由此該突出部(89)係於該注射彈簧(34)的偏向作用之下由該對應之止動表面(103)脫離; 其中該針保護件(20)的縮回造成該觸發器構件(35)朝近側地運動,並因此造成該等閂鎖特徵(85、89、103)之釋放且因此造成該注射裝置(1)的啟動, 該注射裝置(1)更包含閉鎖機制,用於一旦該裝置已被啟動及一旦該針保護件已藉由該針保護件彈簧(21)返回至其延伸位置,則防止該針保護件(20)縮回, 其中該觸發器構件(35)能夠取決於該針保護件(20)之軸向位移及位置相對該保持構件(33)旋轉,且該閉鎖機制包含: 凸輪系統(105、150),設在該觸發器構件(35)及該保持構件(33)上,其防止該觸發器構件於該針保護件(20)縮回時旋轉,並當該針保護件(20)係在啟動該裝置之後返回其延伸位置時造成旋轉進入一阻擋角位置;及 止動特徵(145),配置於該觸發器構件(35)上,使得該止動特徵在用於啟動該裝置的縮回期間處於該針保護件(20)之軸向路徑以外,且在該觸發器構件(35)的阻擋角位置中與該針保護件(20)干涉。 An injection device comprises: an elongated housing (3) extending along a longitudinal axis (X) and constructed to accommodate a drug container (5), the drug container having a barrel (6) containing the drug (7), a needle (8) attached thereto, and a plunger (9) displaceable within the barrel to expel the drug through the needle; a needle guard (20) telescopically mounted in the housing (3) and axially movable between an extended position and a retracted position, wherein in the extended position the needle guard protrudes distally from the housing and surrounds the needle (8), and the retracted position is proximally spaced from the extended position, corresponding to the condition of pressing the device (1) against an injection site for activating the injection device; A needle guard spring (21) biases the needle guard (20) in the distal direction; An injection drive mechanism (25) for driving the plunger (9) in the barrel (6) and thereby expelling the drug, the injection drive mechanism comprising: A plunger rod (31) axially movable between a proximal position and a distal position in the housing (3) for driving the plunger (9) in the barrel (6); An injection spring (34) configured to bias the plunger rod (31) to its distal position; A retaining member (33) is fixed in the housing (3) and is used to hold the plunger rod (31) in its proximal position against the biasing action of the injection spring (34) in the initial state of the injection device. The retaining member (33) and the plunger rod (31) have corresponding latching features (85, 89, 103), and the latching features (85, 89, 103) include a stop surface (103) and a corresponding radially deflectable elastic arm (85) formed with a protrusion (89), whereby the plunger rod (31) is held in its proximal position by the engagement of the protrusion (89) with the stop surface (103); and A trigger member (35) comprising a blocking feature (135) which can be axially displaced from a blocking position to a release position when the needle guard (20) is moved from its extended position to its retracted position, wherein the blocking feature (135) prevents radial deflection of the elastic arm (85) and thereby prevents the protrusion (89) from disengaging from the corresponding stop surface (103), and in the release position, the elastic arm is free to deflect radially, thereby disengaging the protrusion (89) from the corresponding stop surface (103) under the biasing action of the injection spring (34); wherein retraction of the needle guard (20) causes the trigger member (35) to move proximally and thereby causes the release of the latching features (85, 89, 103) and thereby causes activation of the injection device (1), the injection device (1) further comprising a locking mechanism for preventing the needle guard (20) from retracting once the device has been activated and once the needle guard has been returned to its extended position by the needle guard spring (21), wherein the trigger member (35) is capable of rotating relative to the retaining member (33) depending on the axial displacement and position of the needle guard (20), and the locking mechanism comprises: A cam system (105, 150) disposed on the trigger member (35) and the retaining member (33) prevents the trigger member from rotating when the needle guard (20) is retracted and causes the needle guard (20) to rotate into a blocking angle position when the needle guard (20) returns to its extended position after activating the device; and a stop feature (145) disposed on the trigger member (35) such that the stop feature is outside the axial path of the needle guard (20) during the retraction period for activating the device and interferes with the needle guard (20) in the blocking angle position of the trigger member (35). 如請求項1的注射裝置,其中該針保護件(20)具有用於圍繞處於該延伸位置中之針(8)的鞘套部分(50),該鞘套部分(50)具有在該遠側端之通孔(53),用於當該針保護件(20)縮回時使該針(8)通過,及由該鞘套部分(50)軸向地且朝近側地突出的腿部(52),該腿部具有用於當該針保護件(20)縮回時嚙合及移位該觸發器構件(35)之自由端(55)。An injection device as claimed in claim 1, wherein the needle guard (20) has a sheath portion (50) for surrounding the needle (8) in the extended position, the sheath portion (50) having a through hole (53) at the distal end for allowing the needle (8) to pass through when the needle guard (20) is retracted, and a leg (52) protruding axially and proximally from the sheath portion (50), the leg having a free end (55) for engaging and displacing the trigger member (35) when the needle guard (20) is retracted. 如請求項1或2的注射裝置,其中該凸輪系統包括設在該觸發器構件(35)上之凸輪軌道(150)、及設於該保持構件(33)上並界定凸輪隨動件的尖頭(105),該尖頭(105)用於嚙合在該凸輪軌道中。An injection device as claimed in claim 1 or 2, wherein the cam system includes a cam track (150) disposed on the trigger member (35), and a tip (105) disposed on the retaining member (33) and defining a cam follower, the tip (105) being used to engage in the cam track. 如請求項3的注射裝置,其中該保持構件(33)具有實質上圓柱形之中空本體(101),且該觸發器構件(35)具有裝配於該圓柱形中空本體上方之套筒本體(131),使該套筒本體(131)能夠取決於該針保護件(20)的軸向位移及位置而相對於該圓柱形中空本體(101)滑動或旋轉。An injection device as claimed in claim 3, wherein the retaining member (33) has a substantially cylindrical hollow body (101), and the trigger member (35) has a sleeve body (131) mounted on the top of the cylindrical hollow body, so that the sleeve body (131) can slide or rotate relative to the cylindrical hollow body (101) depending on the axial displacement and position of the needle guard (20). 如請求項4的注射裝置,其中該套筒本體(131)係設有第一肋條(143),用於當該針保護件(20)縮回時與該腿部(52)之自由端(55)嚙合,由此造成該觸發器構件(35)朝近側地移位。An injection device as claimed in claim 4, wherein the sleeve body (131) is provided with a first rib (143) for engaging with the free end (55) of the leg (52) when the needle guard (20) is retracted, thereby causing the trigger member (35) to shift proximally. 如請求項4的注射裝置,其中該套筒本體(131)係在其內表面上設有收納該尖頭(105)之凸輪軌道(150),該尖頭(105)由該圓柱形中空本體(101)徑向地及朝內地突出,該凸輪軌道(150)具有與於該近側方向中延伸的軸向通道(153)連接之橫向地定向的終端通道(155),該軸向通道具有一開放之遠側端(151)。An injection device as claimed in claim 4, wherein the sleeve body (131) is provided with a cam track (150) on its inner surface for accommodating the tip (105), the tip (105) protruding radially and inwardly from the cylindrical hollow body (101), the cam track (150) having a transversely oriented terminal channel (155) connected to an axial channel (153) extending in the proximal direction, the axial channel having an open distal end (151). 如請求項4的注射裝置,其中該止動特徵包括由該套筒本體(131)徑向地突出之第二肋條(145),該第二肋條用於與該針保護件(20)選擇性嚙合,用以防止該針保護件朝近側地縮回。An injection device as claimed in claim 4, wherein the stopping feature comprises a second rib (145) radially protruding from the sleeve body (131), the second rib being used to selectively engage with the needle guard (20) to prevent the needle guard from retracting proximally. 如請求項5的注射裝置, 其中該止動特徵包括由該套筒本體(131)徑向地突出之第二肋條(145),該第二肋條用於與該針保護件(20)選擇性嚙合,用以防止該針保護件朝近側地縮回,及 其中該第二肋條(145)係從該第一肋條(143)朝遠側地隔開。 An injection device as claimed in claim 5, wherein the stop feature comprises a second rib (145) radially protruding from the sleeve body (131), the second rib being used to selectively engage with the needle guard (20) to prevent the needle guard from retracting proximally, and wherein the second rib (145) is spaced distally from the first rib (143). 如請求項7的注射裝置,其中該腿部(52)具有由該腿部(52)之自由端(55)朝遠側地隔開並形成一橫向邊緣的凹口(56),該橫向邊緣界定一止動表面,用於在該注射裝置(1)於注射之後的最終狀態中防止該針保護件(20)朝近側地縮回。An injection device as claimed in claim 7, wherein the leg (52) has a recess (56) spaced distally from the free end (55) of the leg (52) and forming a transverse edge, the transverse edge defining a stop surface for preventing the needle guard (20) from retracting proximally in the final state of the injection device (1) after injection. 如請求項3的注射裝置,其中該尖頭(105)被偏向朝該終端通道(155),由此當該針防護件(20)在該針防護彈簧(21)的作用之下移回對應於注射後的該裝置之最終狀態的延伸位置時,造成該觸發器構件(35)旋轉並使該第二肋條(145)嚙合該腿部(52)之橫向邊緣。An injection device as claimed in claim 3, wherein the tip (105) is biased toward the terminal channel (155), whereby when the needle guard (20) moves back to the extended position corresponding to the final state of the device after injection under the action of the needle guard spring (21), the trigger member (35) rotates and causes the second rib (145) to engage the lateral edge of the leg (52). 如請求項10的注射裝置,其中該觸發器構件(35)及該外殼(3)包含處於相互可釋放之嚙合的對應鎖定特徵(79、139),用於將該觸發器構件(35)維持在其阻擋位置中,且其中該等鎖定特徵被設計成當該針保護件(20)由其延伸位置運動至其縮回位置時釋放,由此該針保護件(20)之縮回造成該等鎖定特徵(79、139)的釋放、該等閂鎖特徵(85、89、103)之釋放、及因此該注射裝置的啟動。An injection device as claimed in claim 10, wherein the trigger member (35) and the housing (3) include corresponding locking features (79, 139) in releasable engagement with each other for maintaining the trigger member (35) in its blocking position, and wherein the locking features are designed to be released when the needle guard (20) moves from its extended position to its retracted position, whereby the retraction of the needle guard (20) causes the release of the locking features (79, 139), the release of the latching features (85, 89, 103), and thus the activation of the injection device. 如請求項11的注射裝置,其中該腿部(52)具有一軸向邊緣(57),該軸向邊緣(57)具有一於該鞘套部分(50)與該凹口(56)之間延伸的區段,其界定一在該針保護件(20)之軸向位移期間與該保持構件(33)的對應導引元件(113)滑動地配合的導引元件。An injection device as claimed in claim 11, wherein the leg (52) has an axial edge (57), the axial edge (57) having a section extending between the sheath portion (50) and the recess (56), which defines a guide element that slidably engages with a corresponding guide element (113) of the retaining member (33) during axial displacement of the needle guard (20). 如請求項7的注射裝置,其中該第二肋條(145)係配置於該套筒本體(131)上,用於在該注射裝置(1)注射之後的最終狀態中嚙合該腿部(52)之橫向邊緣,並因此防止該針保護件(20)朝近側地縮回。An injection device as claimed in claim 7, wherein the second rib (145) is arranged on the sleeve body (131) to engage the lateral edge of the leg (52) in the final state of the injection device (1) after injection, thereby preventing the needle guard (20) from retracting proximally. 如請求項1或2的注射裝置,其中該等閂鎖特徵(85、89、103)包括一對形成在該柱塞桿(31)之近側端上的彈性支臂(85),及形成於每一該彈性支臂之自由端的軸向地延伸、各自突出部(89)。An injection device as claimed in claim 1 or 2, wherein the latching features (85, 89, 103) include a pair of elastic arms (85) formed on the proximal end of the plunger rod (31), and axially extending, respective protrusions (89) formed at the free end of each of the elastic arms. 如請求項14的注射裝置,其中該保持構件(33)包含具有軸向孔(102)之徑向壁,該軸向孔具有界定該等閂鎖特徵(85、89、103)的該止動表面之周向邊緣(103)。An injection device as claimed in claim 14, wherein the retaining member (33) comprises a radial wall having an axial hole (102), the axial hole having a circumferential edge (103) of the stop surface defining the latching features (85, 89, 103). 如請求項15的注射裝置,其中該等突出部(89)係由該等各自之彈性支臂(85)徑向地及往外地突出,該等彈性支臂由該徑向壁軸向地突出經過該孔(102),而當該柱塞桿(31)處於其近側位置中時,使該等突出部(89)與該止動表面(103)相互嚙合。An injection device as claimed in claim 15, wherein the protrusions (89) protrude radially and outwardly from the respective elastic arms (85), and the elastic arms protrude axially from the radial wall through the hole (102), so that when the plunger rod (31) is in its proximal position, the protrusions (89) and the stop surface (103) engage with each other. 如請求項16的注射裝置,其中該阻擋特徵包括軸向栓銷(135),該軸向栓銷在該觸發器構件(35)之該阻擋位置中防止該等彈性支臂(85)的朝內偏轉,並因此防止該等突出部(89)由該止動表面(103)脫離。An injection device as claimed in claim 16, wherein the blocking feature includes an axial latch (135) which prevents the elastic arms (85) from deflecting inward in the blocking position of the trigger member (35) and thereby prevents the protrusions (89) from disengaging from the stop surface (103). 如請求項1或2的注射裝置,其中該外殼(3)包含至少一凹部(79),且該觸發器構件(35)包含套筒本體(131),及由該套筒本體往外地突出之至少一懸臂式撓性支臂(137),該懸臂式撓性支臂(137)於其自由端設有用於與該外殼的該凹部(79)可釋放地嚙合之徑向耳片(139),該等鎖定特徵(79、139)包括該耳片(139)及對應的凹部(79)。An injection device as claimed in claim 1 or 2, wherein the housing (3) includes at least one recess (79), and the trigger member (35) includes a sleeve body (131) and at least one cantilevered flexible arm (137) protruding outward from the sleeve body, the cantilevered flexible arm (137) being provided at its free end with a radial ear piece (139) for releasably engaging with the recess (79) of the housing, and the locking features (79, 139) include the ear piece (139) and the corresponding recess (79). 如請求項18的注射裝置,其中該耳片(139)係藉由該懸臂式撓性支臂偏向成嚙合在該凹部(79)內,且該懸臂式撓性支臂(137)係可藉由該針保護件(20)朝內地偏轉,用於由該凹部(79)釋放該耳片(139)。An injection device as claimed in claim 18, wherein the ear piece (139) is biased by the cantilevered flexible support arm to be engaged in the recess (79), and the cantilevered flexible support arm (137) can be deflected inwardly by the needle guard (20) to release the ear piece (139) from the recess (79). 如請求項18的注射裝置,其中該懸臂式撓性支臂(137)包含用於與該針保護件(20)嚙合之斜面(141),當該針保護件(20)在該近側方向中運動時,該斜面的輪廓決定藉由該針保護件(20)之軸向位移所造成的懸臂式撓性支臂(137)之朝內偏轉。An injection device as claimed in claim 18, wherein the cantilevered flexible support arm (137) includes a ramp (141) for engaging with the needle guard (20), and when the needle guard (20) moves in the proximal direction, the profile of the ramp determines the inward deflection of the cantilevered flexible support arm (137) caused by the axial displacement of the needle guard (20). 如請求項18的注射裝置,其中該外殼(3)及該觸發器構件(35)分別具有一對於直徑方向中相對之凹部(79)及對應的懸臂式撓性支臂(137)。An injection device as claimed in claim 18, wherein the housing (3) and the trigger member (35) respectively have a pair of recesses (79) that are opposite in the radial direction and corresponding cantilevered flexible arms (137). 如請求項1或2的注射裝置,更包含配置在該外殼(3)與該觸發器構件(35)之間的觸發器彈簧(37),用於朝遠側地偏向該觸發器構件,由此該觸發器構件(35)在該注射裝置之初始狀態中被偏向至其阻擋位置。The injection device of claim 1 or 2 further comprises a trigger spring (37) disposed between the housing (3) and the trigger member (35) for biasing the trigger member distally, whereby the trigger member (35) is biased to its blocking position in the initial state of the injection device. 如請求項1或2的注射裝置,其中該注射彈簧(34)被設計成於其近側位置中向該柱塞桿(31)賦予一克服與該等閂鎖特徵(85、89,103)相互嚙合之保持力的力量,由此該阻擋特徵(135)之釋放造成該等閂鎖特徵(85、89、103)脫離並造成該注射彈簧(34)將該柱塞桿(31)驅動至其遠側位置。An injection device as claimed in claim 1 or 2, wherein the injection spring (34) is designed to impart a force to the plunger rod (31) in its proximal position to overcome the retaining force of the latching features (85, 89, 103) engaging each other, whereby release of the blocking feature (135) causes the latching features (85, 89, 103) to disengage and causes the injection spring (34) to drive the plunger rod (31) to its distal position.
TW113106099A 2023-02-24 2024-02-21 Injection device with an improved needle guard lockout mechanism TW202434323A (en)

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FR2899482A1 (en) * 2006-04-11 2007-10-12 Becton Dickinson France Soc Pa Automatic medicament/product injection device for patient, has safety shield coupled to housing, and provided in active state at end of needle insertion step before which product/medicament injection step is not started
WO2009114542A1 (en) 2008-03-10 2009-09-17 Antares Pharma, Inc. Injector safety device
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