本揭示係概括有關一用於一藥物傳輸裝置之組件及一包含該組件之各別的藥物傳輸裝置。The present disclosure is directed to a component for a drug delivery device and a respective drug delivery device comprising the component.
藥物傳輸裝置已經變成普及於醫學治療領域，其中係發生未經正式醫學訓練人員之一藥劑的規律注射。例如，這在糖尿病患者中可能日益常見，其中自我治療係使如是患者能夠執行其疾病的有效管理。Drug delivery devices have become popular in the field of medical treatment, in which regular injections of one of the agents without formal medical training personnel occur. For example, this may be increasingly common in diabetic patients, where self-treatment enables a patient to perform effective management of their disease.
具有不同類型的藥物傳輸裝置。另一方面，可以在可重新使用的可重新設定式裝置與可拋棄的不可重新設定式裝置之間作區別。例如，可棄式傳輸裝置係以自我圍堵式裝置供應。該自我圍堵式裝置不具有可移除式預填式卡匣。而是，若不破壞裝置本身則不可從這些裝置移除及更換預填式卡匣。There are different types of drug delivery devices. Alternatively, a distinction can be made between a reusable reconfigurable device and a disposable non-resettable device. For example, disposable transport devices are supplied as self-contained devices. The self-contained device does not have a removable pre-filled cassette. Rather, the prefilled cassettes cannot be removed and replaced from these devices without damaging the device itself.
另一方面，可在僅容許配送一預界定劑量而不可能增加或減少設定劑量的所謂固定式劑量裝置與容許一使用者個別地選擇及配送一數量的使用者可變式劑量之一藥劑的所謂可變式劑量裝置之間作區別。一般來說，所有這些類型的傳輸裝置係可為筆形。Alternatively, a so-called fixed dose device that allows only one predefined dose to be dispensed without increasing or decreasing the set dose can be used to allow a user to individually select and dispense a quantity of one of the user's variable doses. There is a distinction between so-called variable dose devices. In general, all of these types of transmission devices can be pen-shaped.
如上文說明的藥物傳輸裝置一般係包含數個主要元件，例如一卡匣段，其包括一可被圍堵於一殼體或固持件內之卡匣，一針頭組件，其連接至卡匣段的一端，及一額外組件，其可能能夠撥動及/或傳輸一劑量的一藥劑。後者組件可連接至遠離針頭組件之卡匣段的端。一卡匣(常稱為安瓿(ampoule))典型係包括一貯器，其充填有一藥品(例如胰島素)，一可移式塞子或活塞或停止器，其位居卡匣貯器一端，及一頂部，其具有一位居另一常為頸縮狀端之可穿刺密封件或覆套。The drug delivery device as described above generally comprises a plurality of main components, such as a cassette segment, comprising a cassette that can be enclosed in a housing or holder, a needle assembly connected to the cassette portion One end, and an additional component, which may be capable of dialing and/or transmitting a dose of a medicament. The latter component can be attached to the end of the cassette section remote from the needle assembly. One card (often calledAn ampoule typically includes a reservoir filled with a drug (eg, insulin), a removable stopper or piston or stopper, located at one end of the cartridge, and a top having a residence Another piercable seal or cover that is often a necked end.
用於撥動及/或傳輸一劑量的一藥劑之組件係可包含一殼體部份及一活塞桿或導螺桿，其可相對於殼體部份作位移。活塞桿係設計成在一方向將卡匣的塞子或停止器推押至卡匣的一出口，俾使藥品可被驅出裝置外且傳輸至一患者。在一初始狀態，例如裝置的一供應狀態中，當這些部份組裝時，在活塞桿端與卡匣的塞子之間可具有一特定間隙或空隙。例如，所提到的間隙係可為與全部或許多經組裝部份相關聯的公差及/或在裝置的經組裝狀態中不欲預負載卡匣的塞子之結果。後者事實將具有藥品有可能被意外驅出裝置外之結果。An assembly for displacing and/or transmitting a dose of a medicament may comprise a housingAnd a piston rod or lead screw that is displaceable relative to the housing portion. The piston rod is designed to push the stopper or stopper of the cassette to an outlet of the cassette in one direction so that the medicine can be driven out of the apparatus and transmitted to a patient. In an initial state, such as a supply state of the device, when these portions are assembled, there may be a particular gap or gap between the end of the piston rod and the plug of the cassette.For example, the mentioned gaps may be the result of tolerances associated with all or many of the assembled parts and/or plugs that are not intended to be preloaded in the assembled state of the device. The latter fact will have the result that the drug may be accidentally driven out of the device.
活塞桿端與卡匣塞子之間的一間隙係會具有數項缺點。一缺點可能來自於若一使用者首次攝取裝置以供一預定劑量的一藥劑作一所意圖注射之時。實際接收劑量則將等於預定劑量減去活塞桿與塞子之間的初始空氣間隙。例如，此空氣間隙典型係等同於第一劑量的0與0.14ml之間的一損失。對於許多藥物，此懸殊差異係可為顯著且穩穩位於可容許劑量精確度極限之外。因此目前習見使用技術係指示使用者進行一所謂“空氣射擊(air shot)”，意味著使用者必須首次操作裝置而不將藥品注射至其身體內而是空氣中，直到活塞桿與塞子之間的間隙被橫越且流體可開始射出為止。A gap between the rod end and the cassette plug has several disadvantages. OneDisadvantages may arise from a time when a user first ingests a device for a predetermined dose of a medicament for an intended injection. The actual received dose will then be equal to the predetermined dose minus the initial air gap between the piston rod and the plug. For example, this air gap is typically equivalent to a loss between 0 and 0.14 ml of the first dose. For many drugs, this disparity can be significant and stable beyond the limits of allowable dose accuracy. Therefore, it is currently known to use the technique to instruct the user to perform a so-called "air shot", meaning that the user must operate the device for the first time without injecting the drug into his body but in the air until between the piston rod and the plug. The gap is traversed and the fluid can begin to exit.
此行動過程具有的額外缺點係在於在使用者可攝取藥劑的首次注射之前，可能必須拋棄昂貴的藥品。這可能導致藥品及/或藥物傳輸裝置的成本升高。An additional disadvantage of this course of action is that the user can ingest the medicament.Before the first injection, expensive drugs may have to be discarded. This may result in an increase in the cost of the drug and/or drug delivery device.
因此，一目的係在於描述一用於一藥物傳輸裝置之組件暨一具有該組件之藥物傳輸裝置，其設計成俾可在注射一第一劑量的一藥劑之前移除活塞桿與卡匣塞件之間的間隙(從一初始狀態過渡至一起動狀態)。Therefore, a purpose is to describe a component for a drug delivery device.A drug delivery device having the assembly is designed to remove a gap (from an initial state to a co-operating state) between the piston rod and the tamper member prior to injecting a first dose of a medicament.
在第一形態中，藉由根據申請專利範圍第1項之一用於一藥物傳輸裝置之組件解決此目的。該組件包含一殼體部份，一可相對於殼體部份位移之活塞桿，一第一套筒構件及一第二套筒構件，第一及第二套筒構件係耦合至殼體部份。在組件的一初始狀態中，第一套筒構件可相對於第二套筒構件從一初始位置移動至一第二位置，其容許活塞桿從一初始位置軸向地移行至一預定第二位置，俾使組件處於一起動狀態。在組件的起動狀態中，第一套筒構件相對於第二套筒構件位於第二位置中，第一及第二套筒構件係藉由一第一接合特徵被永久性旋轉且軸向地鎖定至彼此，俾使第一及第二套筒構件一起形成一套筒。In the first form, by one of the first item according to the scope of the patent applicationThe components of the drug delivery device address this purpose. The assembly includes a housing portion, a piston rod displaceable relative to the housing portion, a first sleeve member and a second sleeve member, the first and second sleeve members being coupled to the housing portion Share. In an initial state of the assembly, the first sleeve member is movable relative to the second sleeve member from an initial position to a second position that allows the piston rod to move axially from an initial position to a predetermined second position , so that the components are in a state of motion. In the activated state of the assembly, the first sleeve member is in a second position relative to the second sleeve member, the first and second sleeve members being permanently rotated and axially locked by a first engagement feature To each other, the first and second sleeve members together form a sleeve.
組件係提供用於從一可為組件的經傳輸狀態或經傳輸狀況之初始狀態過渡至一其中使組件就緒供一藥物傳輸裝置內之一第一劑量的一藥劑被射出裝置外之起動狀態之特徵。在從初始狀態過渡至起動狀態期間，活塞桿能夠相對於組件的殼體部份從一初始位置軸向地移行至一預定第二位置。其意指在組件的初始狀態中，活塞桿能夠相對於殼體軸向地移行，俾可隨著組件組裝至藥物傳輸裝置中而移除或橫越活塞桿與一藥物傳輸裝置的一卡匣塞子之間的一間隙或空隙。藉由第一套筒構件可從一各別初始位置相對於組件的第二套筒構件移動至一各別第二位置而使得活塞桿能夠從其初始位置軸向移行或運動至其預定第二位置(亦即從初始位置過渡至組件的起動狀態)。這意指第一套筒構件在組件的初始狀態中相對於第二套筒構件之運動係有關於活塞桿從其初始位置至其預定第二位置之軸向運動。在組件的起動狀態中，第一及第二套筒構件係藉由一第一接合特徵而永久性旋轉及軸向地鎖定至彼此，其中第一及第二套筒構件一起形成單一的套筒。在起動狀態中，第一套筒構件相對於第二套筒構件被帶入其第二位置中，這意指當第一套筒構件從其初始位置相對於第二套筒構件運動至其第二位置時，利用使第一及第二套筒構件僅可一起被移動且因此相對於組件的其他部份具有單一體件的功能行為之方式而發生第一及第二套筒構件與組件的其他部份之進一步交互作用。The component is provided for transitioning from an initial state that can be a transmitted state or a transmitted condition of the component to a starting state in which the component is ready for a first dose of a drug within the drug delivery device to be ejected from the device feature. During the transition from the initial state to the starting state, the piston rod is axially movable from an initial position to a predetermined second position relative to the housing portion of the assembly. It means that in the initial state of the assembly, the piston rod can move axially relative to the housing, and the cartridge can be removed or traversed with a click of the piston rod and a drug delivery device as the assembly is assembled into the drug delivery device. a gap or gap between the plugs. The first sleeve member is movable from a respective initial position relative to the second sleeve member of the assembly to a respective second position to enable the piston rod to axially move or move from its initial position to its predetermined second position Position (ie, transition from the initial position to the starting state of the component). This means that the movement of the first sleeve member relative to the second sleeve member in the initial state of the assembly is related to the axial movement of the piston rod from its initial position to its predetermined second position. In the activated state of the assembly, the first and second sleeve members are permanently rotated and axially locked to each other by a first engagement feature, wherein the first and second sleeve members together form a single sleeve . In the activated state, the first sleeve member is brought into its second with respect to the second sleeve memberIn position, this means that when the first sleeve member is moved from its initial position relative to the second sleeve member to its second position, the first and second sleeve members are only movable together and thus relative to Further interaction of the first and second sleeve members with other portions of the assembly occurs in a manner that other portions of the assembly have a single body functional behavior.
由於在組件的啟動狀態中，由於其永久性旋轉及軸向地鎖定交互作用，防止第一套筒構件相對於第二套筒構件的一運動，亦防止從組件的初始狀態過渡至起動狀態期間之活塞桿的進一步運動。這係指唯有在第一套筒構件可相對於第二套筒構件移動，活塞桿才能夠作從初始狀態至啟動狀態之一過渡，亦即用以進行此過渡之活塞桿的一軸向移行。一旦第一套筒構件已經採行其相對於第二套筒構件的第二位置，組件係處於其起動狀態，其中不再可能作出用以進行過渡至起動狀態之活塞桿的進一步軸向移行。Since in the activated state of the assembly, due to its permanent rotation and axial locking interaction, a movement of the first sleeve member relative to the second sleeve member is prevented, and during the transition from the initial state of the assembly to the starting state is prevented Further movement of the piston rod. This means that only when the first sleeve member is movable relative to the second sleeve member, the piston rod can be made to transition from the initial state to the activated state, that is, an axial direction of the piston rod for performing the transition. Move. Once the first sleeve member has taken its second position relative to the second sleeve member, the assembly is in its activated state, wherein further axial travel of the piston rod for transitioning to the activated state is no longer possible.
在本內容中將瞭解“起動狀態”用語作為一其中使組件處於一就緒供使用狀態之組件的狀態；其意指組件當組裝至一藥物傳輸裝置中時可進一步由一使用者操作以供撥動及/或傳輸一預定量的一藥劑。因此，起動狀態提供一其中可進行組件的“正常操作”之狀態。In this context, the term "starting state" will be understood as a state in which the component is placed in a ready-to-use state; it means that the component can be further manipulated by a user for assembly when assembled into a drug delivery device. Moving and/or transmitting a predetermined amount of a medicament. Thus, the starting state provides a state in which "normal operation" of the components can be performed.
第一套筒構件相對於第二套筒構件的一初始運動可設計成使得活塞桿的一軸向移行被限定於一對應於活塞桿端與一其中可使用組件的藥物傳輸裝置之一卡匣塞子之間的一空氣間隙之預定距離。如上文說明的措施具有下列優點，可橫越空氣間隙而不用預期使用者進行“空氣射擊”拋棄藥品以供預備一藥物傳輸裝置供首次注射用。所說明的組件提供容許一使用者以一習見且簡單方式進行一起動作用之特徵，藉以將組件從其初始狀態過渡至其啟動狀態，亦即移除活塞桿端與卡匣塞子之間的一空氣間隙，俾可以一比起習見已知解決方案的實例中更好之方式預備一其中使用該組件的藥物傳輸裝置以供首次使用。An initial movement of the first sleeve member relative to the second sleeve member can be designed such that an axial movement of the piston rod is defined by a cartridge corresponding to one of the drug delivery devices of the piston rod end and a component that can be used therein. a predetermined distance of an air gap between the plugs. The measures as described above have the advantage of traversing the air gap without the intended user performing an "air shot" discarding drug for preparing a drug delivery device for the first injection. The illustrated assembly provides features that allow a user to act together in a conventional and simple manner to transition the assembly from its initial state to its activated state, i.e., remove one between the piston rod end and the cassette stopper. The air gap, 俾 can prepare a drug delivery device in which the assembly is used for first use, in a manner better than the example of the known solution.
根據組件的第一實施例，可設計第一及/或第二套筒構件與活塞桿之間的功能關係俾使第一套筒構件相對於第二套筒構件的一運動僅能夠使活塞桿作一軸向運動。這係指活塞桿的軸向移行並未由第一套筒構件相對於第二套筒構件的一運動所產生，而是受限定且因此某意義來說受控制於第一套筒構件相對於第二套筒構件的運動。在此實例中，僅有在第一套筒構件事實上可相對於第二套筒構件移動，方容許活塞桿的一軸向移行。當第一套筒構件相對於第二套筒構件位於一第二位置時，活塞桿不可能進一步軸向移行以供起動組件。According to a first embodiment of the assembly, the first and/or second sleeve member can be designed withThe functional relationship between the piston rods causes only one movement of the first sleeve member relative to the second sleeve member to cause an axial movement of the piston rod. This means that the axial travel of the piston rod is not produced by a movement of the first sleeve member relative to the second sleeve member, but rather is defined and thus controlled in a sense relative to the first sleeve member relative to Movement of the second sleeve member. In this example, only one axial movement of the piston rod is permitted only when the first sleeve member is actually movable relative to the second sleeve member. When the first sleeve member is in a second position relative to the second sleeve member, the piston rod is unlikely to move further axially for the starting assembly.
在此實施例中，可藉由一使用者在軸向方向相對於組件的殼體部份直接地或經由另一耦合部件間接地推押活塞桿，而產生活塞桿的一軸向運動。In this embodiment, an axial movement of the piston rod can be produced by a user pushing the piston rod indirectly in the axial direction relative to the housing portion of the assembly, either directly or via another coupling member.
根據一替代性第二實施例，第一套筒構件相對於第二套筒構件的運動不只控制或限定活塞桿的一軸向移行，而且亦產生活塞桿的如是一運動。在此實例中，第一及第二套筒構件可作為直接或間接驅動構件以供驅動活塞桿。在此內容中，可想見一使用者操作第一套筒構件並將其相對於第二套筒構件移動，俾使活塞桿(其直接或間接地耦合至第一及/或第二套筒構件)可從其初始位置軸向地移行至其第二位置，亦即進入組件的起動狀態。According to an alternative second embodiment, the movement of the first sleeve member relative to the second sleeve member not only controls or defines an axial movement of the piston rod, but also produces a movement of the piston rod. In this example, the first and second sleeve members can act as direct or indirect drive members for driving the piston rod. In this context, it is contemplated that a user operates the first sleeve member and moves it relative to the second sleeve member, thereby causing the piston rod (which is coupled directly or indirectly to the first and/or second sleeve) The member can be moved axially from its initial position to its second position, ie into the starting state of the assembly.
所提及的全部實施例之一重要事實在於僅在第一套筒構件可相對於第二套筒構件移動下，方可進行用於使組件從其初始狀態進入其起動狀態之活塞桿的一軸向運動。在組件的起動狀態中，第一套筒構件係位於相對於第二套筒構件之其第二位置中並被可旋轉及軸向地鎖定至第二套筒構件且因此無法相對於第二套筒構件作進一步移動。在此狀態中，組件被完全地起動，俾不需要或不容許活塞桿進一步軸向移行藉以進行進入起動狀態之過渡。An important fact of all of the mentioned embodiments is that only one of the piston rods for moving the assembly from its initial state into its starting state can be performed only after the first sleeve member is movable relative to the second sleeve member. Axial movement. In the activated state of the assembly, the first sleeve member is located in its second position relative to the second sleeve member and is rotatably and axially locked to the second sleeve member and thus is incapable of opposing the second sleeve The barrel member is moved further. In this state, the assembly is fully activated, and the transition of the piston rod to the starting state is not required or permitted for further axial travel.
當然，所說明的特徵並未防止活塞桿在進一步使用組件期間作任何的進一步運動。如同使用於一藥物傳輸裝置中之情形，其將牴觸於組件用於撥動及/或傳輸一劑量的一藥劑之意圖。組件的任何進一步操作及與其相關之活塞桿的任何運動係務必藉由組件特徵所造成，其中第一及第二套筒構件一起分別作為一體件或套筒。第一及第二套筒構件之用以使活塞桿能夠如上述般軸向移入一起動狀態中的功能係在組件的進一步操作期間完成。Of course, the features described do not prevent any further movement of the piston rod during further use of the assembly. As in the case of a drug delivery device, it will touchThe component is intended to toggle and/or deliver a dose of a medicament. Any further manipulation of the assembly and any movement of the piston rod associated therewith must be caused by the features of the assembly, wherein the first and second sleeve members together act as a single piece or sleeve, respectively. The function of the first and second sleeve members to enable the piston rod to move axially into the co-operating state as described above is accomplished during further operation of the assembly.
在一實施例中，組件可包含一驅動器，其耦合至活塞桿以供驅動活塞桿。這係指活塞桿的任何運動(或活塞桿的一選定運動)可由驅動器所驅動。因此，驅動器可作為一使用者的操作動作與由其所產生的活塞桿的一運動之間的一耦合構件。在此形態中，驅動器將一操作動作傳遞成為活塞桿的一運動。In an embodiment, the assembly can include a driver coupled to the piston rod for driving the piston rod. This means that any movement of the piston rod (or a selected movement of the piston rod) can be driven by the drive. Thus, the actuator can act as a coupling member between the operational action of a user and a movement of the piston rod produced thereby. In this configuration, the actuator transmits an operational action as a movement of the piston rod.
對於此實施例以添加或取代方式，組件可包含一按鈕，該按鈕可配置於組件的一近端且可耦合至第一套筒構件。在該實例中，組件提供一如上文說明之驅動器，按鈕亦可耦合至驅動器。按鈕可在一潛在的驅動器旁邊提供另一耦合特徵，以供將一使用者的操作動作耦合於第一套筒構件及活塞桿的一者或兩者之運動。In this embodiment, in addition or in the alternative, the assembly can include a button that can be disposed at a proximal end of the assembly and that can be coupled to the first sleeve member. In this example, the component provides a driver as described above, and the button can also be coupled to the driver. The button can provide another coupling feature alongside a potential driver for coupling the motion of a user to the movement of one or both of the first sleeve member and the piston rod.
“近端”用語在此內容中係指比起組件另一端而言，相距一使用該組件的藥物傳輸裝置的一針頭部份而言具有更大距離之組件的一端。這可指對於具有如是一組件之一藥物傳輸裝置，尤其是一筆形裝置，藥物傳輸裝置的一端係形成一卡匣固持件的一針頭組件，且藥物傳輸裝置的另一端由組件的近端形成，如上文說明。簡言之，組件的近端係為當操作一藥物傳輸裝置以供將一藥劑注射至身體內時最遠離一患者的一身體部位之端。The term "proximal" as used herein refers to the end of a component that is at a greater distance from a needle portion of a drug delivery device that uses the assembly than the other end of the assembly. This may mean that for a drug delivery device, such as a one-piece device, such as a component, one end of the drug delivery device forms a needle assembly of one of the cartridge holders, and the other end of the drug delivery device is formed by the proximal end of the assembly. As explained above. Briefly, the proximal end of the assembly is the end of a body part that is farthest from a patient when a drug delivery device is operated for injecting a medicament into the body.
在組件的初始狀態中，按鈕較佳能夠相對於第二套筒構件軸向地移行，按鈕在此軸向移行期間挾帶驅動器俾使驅動器相對於殼體部份被軸向地位移，藉此驅使活塞桿進入其從初始位置至預定第二位置之軸向運動，藉以將組件帶入其起動狀態。在此實施例中，按鈕可耦合至第一套筒構件及驅動器，其中驅動器本身耦合至活塞桿。為此，對應地，藉由第一套筒構件可相對於第二套筒構件移動，而使按鈕能夠相對於第二套筒構件作一軸向運動。In the initial state of the assembly, the button is preferably axially displaceable relative to the second sleeve member, the belt driver axially displaces the driver relative to the housing portion during the axial movement of the button The piston rod is driven into its axial movement from the initial position to the predetermined second position to bring the assembly into its activated state. In this embodiment, the button can be coupled to the firstA sleeve member and a driver, wherein the driver itself is coupled to the piston rod. To this end, correspondingly, the first sleeve member is movable relative to the second sleeve member to enable the button to move axially relative to the second sleeve member.
第一套筒構件可例如相對於第二套筒構件作軸向地移動及/或旋轉。在其軸向移行期間，按鈕係挾帶驅動器，俾使驅動器可相對於殼體部份軸向地位移。驅動器轉而驅使活塞桿進入其從初始位置至起動位置之軸向運動。直到第一套筒構件位於其相對於第二套筒構件之第二位置為止，離散的部份(discrete parts)即按鈕、驅動器、及活塞桿係能夠作此運動。一旦第一套筒構件已經採行後者位置，按鈕不再可能作進一步軸向移行而造成活塞桿從其初始位置進入其起動位置之一過渡。在此實施例中，一使用者可例如受到指示以壓抵配置於組件近端的按鈕，以供起動組件藉以預備一其中使用該組件之藥物傳輸裝置供首次注射用。The first sleeve member can be axially moved and/or rotated, for example, relative to the second sleeve member. During its axial travel, the button is loaded with a drive that axially displaces the drive relative to the housing portion. The drive in turn drives the piston rod into its axial movement from the initial position to the starting position. Until the first sleeve member is in its second position relative to the second sleeve member, discrete portions, ie, buttons, actuators, and piston rods, can perform this movement. Once the first sleeve member has taken the latter position, the button is no longer likely to make further axial travel resulting in a transition of the piston rod from its initial position into its starting position. In this embodiment, a user may, for example, be instructed to press against a button disposed at the proximal end of the assembly for the starting assembly to prepare a drug delivery device in which the assembly is to be used for the first injection.
根據一實施例，第一套筒構件經由一第二接合特徵而接合於第二套筒構件，俾在第一套筒構件的初始位置中使第一及第二套筒構件的各別壁之間的一最大空隙限定於一預定空隙。這係指可經由第二接合特徵限定第一套筒構件相對於第二套筒構件的一運動。因此，第一套筒構件相對於第二套筒構件的運動係受控制及受限定於一預定路徑及/或第一及第二套筒構件的各別壁及/或部份之間的距離。例如，第一套筒構件的一運動僅被准許藉以橫越第一及第二套筒構件之間的一初始空隙，其中第一套筒構件可被移動朝向第二套筒構件，但在一遠離第二套筒構件的方向則否。此特徵可具有下列優點，根據一實施例，其中一使用者可操作一按鈕以供起動，組件僅可將按鈕壓入組件的一殼體中而不可將按鈕拉出組件的殼體外。因此，此特徵提供一易於使用的功能而能夠改良地操控組件，特別是對於有限敏捷度的使用者尤然。According to an embodiment, the first sleeve member is coupled to the second sleeve member via a second engagement feature, the respective walls of the first and second sleeve members being in the initial position of the first sleeve member A maximum gap between the two is limited to a predetermined gap. This refers to a movement of the first sleeve member relative to the second sleeve member via the second engagement feature. Thus, the movement of the first sleeve member relative to the second sleeve member is controlled and limited by a predetermined path and/or the distance between the respective walls and/or portions of the first and second sleeve members. . For example, a movement of the first sleeve member is only permitted to traverse an initial gap between the first and second sleeve members, wherein the first sleeve member can be moved toward the second sleeve member, but in one The direction away from the second sleeve member is no. This feature can have the advantage that, according to one embodiment, a user can operate a button for activation, the assembly can only press the button into a housing of the assembly without pulling the button out of the housing of the assembly. Thus, this feature provides an easy to use function and can be improved to manipulate the components, especially for users with limited agility.
根據一較佳實施例，第一套筒構件相對於第二套筒構件之從其初始位置至其第二位置的運動係為不可逆。一旦第一套筒構件已經相對於一第二套筒構件從其初始位置移動至其第二位置且已經因此採行第二位置，則防止第一套筒構件在從第二位置朝向第一位置的一方向返回之逆向運動。此特徵可如上說明般被第一特徵所支持，據以在第一套筒構件相對於第二套筒構件的第二位置中使第一及第二套筒構件被永久性可旋轉及軸向地鎖定至彼此。如同此內容所說明之不可逆式特徵係具有下列優點，一旦組件已經從其初始狀態橫越至其起動狀態，則組件在組件進一步操作期間被保持在起動狀態中。在起動狀態中係防止用於使第一套筒構件相對於第二套筒構件移動之第一套筒構件的一後續操縱。為此，組件在從初始狀態已經進行過渡至起動狀態之後係採行一保全狀態。不可逆式特徵的另一優點在於可使一使用者能夠容易發現組件是否仍處於其初始狀態或已經處於其起動狀態。According to a preferred embodiment, the movement of the first sleeve member relative to the second sleeve member from its initial position to its second position is irreversible. Once the first sleeve member has been phasedFor a second sleeve member to move from its initial position to its second position and thus the second position has been taken, the reverse movement of the first sleeve member back in a direction from the second position toward the first position is prevented. This feature can be supported by the first feature as explained above, whereby the first and second sleeve members are permanently rotatable and axially in a second position relative to the second sleeve member. Lock to each other. The irreversible feature as described herein has the advantage that once the component has traversed from its initial state to its activated state, the component is maintained in the activated state during further operation of the component. A subsequent manipulation of the first sleeve member for moving the first sleeve member relative to the second sleeve member is prevented in the activated state. To this end, the component assumes a hold state after transitioning from the initial state to the start state. Another advantage of the irreversible feature is that a user can easily find out if the component is still in its initial state or already in its activated state.
根據一實施例，第一套筒構件經由一第三接合特徵而接合於殼體部份，俾在第一套筒構件相對於第二套筒構件的初始位置與第二位置之間防止第一套筒構件相對於殼體部份的旋轉運動。此特徵係在從組件的初始狀態過渡至一起動狀態期間使第一套筒構件的一運動限定至相對於殼體部份的一軸向運動。在一示範性實施例中，第一套筒構件連同一驅動器或一按鈕的任一者或兩者僅可相對於殼體部份被軸向地移動，其中驅動器及/或按鈕亦相對於殼體部份被軸向地移動。According to an embodiment, the first sleeve member is coupled to the housing portion via a third engagement feature that prevents the first portion between the initial position and the second position of the first sleeve member relative to the second sleeve member Rotational movement of the sleeve member relative to the housing portion. This feature limits a movement of the first sleeve member to an axial movement relative to the housing portion during the transition from the initial state of the assembly to the active state. In an exemplary embodiment, either or both of the first sleeve member and the same driver or a button are only axially movable relative to the housing portion, wherein the driver and/or button are also relative to the housing The body portion is moved axially.
因此，組件可設計成使得一使用者在一軸向方向壓抵按鈕，其中第一套筒構件(可能連同驅動器)亦相對於殼體被軸向地移動。為此，活塞桿軸向地移行進入起動狀態，如上文說明。在此運動期間，藉由上文說明的特徵防止按鈕及第一套筒構件的任一者或兩者之旋轉運動。這具有下列優點：例如，只要尚未完全地進行從初始狀態過渡至起動狀況則防止作任何旋轉撥動動作(若組件連同一各別藥物傳輸裝置之設計及用途准許該動作的話)，且當組件已採行其起動狀態而其中活塞桿已經橫越其端點與一經組裝藥物傳輸裝置的一卡匣塞子之間的空氣間隙時則首次能夠具有該作用，如上述內容所說明。因此，由於任何操作運動皆受到組件本身所控制，如是組件提供了安全且改良的操控，特別是對於一具有有限敏捷度的使用者尤然。使用者無法進行任何的錯誤操作運動。Thus, the assembly can be designed such that a user presses against the button in an axial direction, wherein the first sleeve member (possibly together with the driver) is also moved axially relative to the housing. To this end, the piston rod moves axially into the starting state, as explained above. During this movement, the rotational movement of either or both of the button and the first sleeve member is prevented by the features described above. This has the advantage that, for example, any rotational toggle action is prevented as long as the transition from the initial state to the starting condition has not been fully performed (if the component permits the action with the design and use of the same respective drug delivery device), and when the component This effect can be achieved for the first time when the starting state of the piston rod has been traversed between its end point and a cassette plug of an assembled drug delivery device,As explained above. Therefore, since any operational motion is controlled by the component itself, such as the component provides safe and improved handling, especially for a user with limited agility. The user cannot perform any wrong operation movements.
根據一實施例，第二套筒構件包含一接合於殼體部份的一外螺紋之內螺紋，俾使第二套筒構件可相對於殼體部份在一螺旋路徑上移動。此外，第一及第二套筒構件可螺紋式接合於彼此，其中第一套筒構件相對於第二套筒構件之從其初始位置至其第二位置的運動係驅使第二套筒構件進入相對於殼體部份及第一套筒構件之一旋轉運動，俾使第二套筒構件在與第一套筒構件運動方向相反的一方向中相對於殼體部份移動於螺旋路徑上。According to an embodiment, the second sleeve member includes an internal thread that is coupled to the external portion of the housing portion such that the second sleeve member is movable relative to the housing portion in a helical path. Additionally, the first and second sleeve members are threadably engageable with each other, wherein movement of the first sleeve member relative to the second sleeve member from its initial position to its second position urges the second sleeve member into Relative to the rotational movement of the housing portion and one of the first sleeve members, the second sleeve member is moved relative to the housing portion in a helical path in a direction opposite the direction of movement of the first sleeve member.
所說明的特徵係使得第二套筒構件能夠在第一套筒構件相對於第二套筒構件作一運動時起反應，俾使第一套筒構件的運動驅使第二套筒構件進入一各別運動。此耦合係由第一及第二套筒構件的一螺紋式接合所實行。例如，第一套筒構件可相對於組件的殼體部份且相對於第二套筒構件軸向地移行，俾由於兩構件的螺紋式接合而使第二套筒構件被驅使進入相對於殼體部份及第一套筒構件的一旋轉運動。為此，只要第一套筒構件相對於殼體部份及第二套筒構件軸向地移動，第二套筒構件係旋轉。藉由此特徵，可進行組件的額外功能。The illustrated feature is such that the second sleeve member is capable of reacting as the first sleeve member moves relative to the second sleeve member, causing movement of the first sleeve member to urge the second sleeve member into each Don't exercise. This coupling is carried out by a threaded engagement of the first and second sleeve members. For example, the first sleeve member can move axially relative to the housing portion of the assembly and relative to the second sleeve member, the second sleeve member being urged into the shell relative to the shell due to the threaded engagement of the two members a rotational movement of the body portion and the first sleeve member. To this end, the second sleeve member rotates as long as the first sleeve member moves axially relative to the housing portion and the second sleeve member. With this feature, additional functionality of the components can be performed.
在此內容中，可例如以一種在第二套筒構件相對於殼體部份運動(如上文說明由第一套筒構件的一運動所造成)期間使得第二套筒構件所提供的一顯示資訊可被設計成從一初始狀態資訊改變成一起動狀態資訊之方式提供一額外功能。這係指第二套筒構件的運動可指示出組件從初始狀態過渡至起動狀態。因此，第一套筒構件相對於第二套筒構件的運動可實行兩種功能。第一功能係由上述說明提供，其中只要第一套筒構件可相對於第二套筒構件移動，活塞桿能夠從其初始位置至其預定第二位置，亦即起動狀態作一運動。提供第二功能之範圍係在於第一及第二套筒構件作耦合，其中第一套筒構件的一運動造成第二套筒構件的一運動，藉以例如指示出正在進行或已經進行一起動作用。In this context, a display provided by the second sleeve member may be provided, for example, during movement of the second sleeve member relative to the housing portion (as explained above by a movement of the first sleeve member) The information can be designed to provide an additional function from an initial state information to a dynamic state information. This means that the movement of the second sleeve member can indicate the transition of the assembly from the initial state to the activated state. Thus, the movement of the first sleeve member relative to the second sleeve member can perform two functions. The first function is provided by the above description, wherein as long as the first sleeve member is movable relative to the second sleeve member, the piston rod can be moved from its initial position to its predetermined second position, i.e., the activated state. Providing the second function is in the first and second sleeve membersCoupling, wherein a movement of the first sleeve member causes a movement of the second sleeve member, for example, indicating that an action is being made or has been performed together.
較佳地，第二套筒構件係設計成所謂的數字套筒並提供劑量化指標以供設定一藥劑的一預定劑量。藉由劑量化指標指示出一藥劑的劑量，一使用者可經由第二套筒構件的劑量化指標藉由視覺地控制組件中所設定之藥劑量來撥動一劑量。Preferably, the second sleeve member is designed as a so-called number sleeve and provides a dose index for setting a predetermined dose of a medicament. By indicating the dose of a dose by a dose indicator, a user can dial a dose by visually controlling the amount of dose set in the assembly via the dose index of the second sleeve member.
根據另一形態，亦藉由一用於選擇及配送一藥劑之一數量的劑量之藥物傳輸裝置解決上述目的，該裝置係包含一殼體，一含有該藥劑之卡匣，及上文所說明類型之一組件。According to another aspect, the above object is also solved by a drug delivery device for selecting and dispensing a dose of one of the medicaments, the device comprising a housing, a cartridge containing the medicament, and the above One of the types of components.
本文所用的“藥劑”、“藥品”及“藥物”用語暨均等物較佳係指含有至少一藥學主動化合物的藥學配製物，其中在一實施例中，藥學主動化合物具有直到1500 Da的分子量，及/或身為一肽、一蛋白質、一多醣、一疫苗、一DNA、一RNA、一酵素、一抗體或其一片段、一激素或一寡核苷酸、或上述藥學主動化合物的一混合物，其中在另一實施例中，藥學主動化合物係可用來治療及/或預防糖尿病或與糖尿病相關的併發症諸如糖尿病性視網膜病變，血栓失調諸如深部靜脈或肺血栓，急性冠狀動脈症候群(ACS)，心絞痛，心肌梗塞，癌症，黃斑部退化，發炎，花粉熱，動脈硬化及/或類風濕關節炎，其中在另一實施例中，藥學主動化合物係包含至少一肽(peptide)，用以治療及/或預防糖尿病或與糖尿病相關的併發症諸如糖尿病性視網膜病變，其中在另一實施例中，藥學主動化合物係包含至少一人類胰島素或一人類胰島素類似物或衍生物，類昇糖素肽(GLP-1)或其一類似物或衍生物，或促胰島素分泌素-3(exendin-3)或促胰島素分泌素-4(exendin-4)或者促胰島素分泌素-3或促胰島素分泌素-4的一類似物或衍生物。As used herein, the terms "pharmaceutical", "pharmaceutical" and "pharmaceutical" are used preferably to refer to a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da. And/or as a peptide, a protein, a polysaccharide, a vaccine, a DNA, an RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a pharmaceutical active compound Mixture, wherein in another embodiment, the pharmaceutically active compound is useful for treating and/or preventing diabetes or complications associated with diabetes such as diabetic retinopathy, thrombotic disorders such as deep veins or pulmonary thrombosis, acute coronary syndrome (ACS) ), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, arteriosclerosis and/or rheumatoid arthritis, wherein in another embodiment, the pharmaceutically active compound comprises at least one peptide for Treating and/or preventing diabetes or complications associated with diabetes such as diabetic retinopathy, wherein in another embodiment, pharmacy The active compound comprises at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or An analog or derivative of exendin-4 or insulinotropic-3 or insulinotropic-4.
胰島素類似物譬如係為Gly(A21)，Arg(B31)，Arg(B32)人類胰島素；Lys(B3)，Glu(B29)人類胰島素；Lys(B28)，Pro(B29)人類胰島素；Asp(B28)人類胰島素；人類胰島素，其中位置B28中的脯氨酸係由Asp，Lys，Leu，Val或Ala取代且其中在位置B29中Lys可由Pro取代；Ala(B26)人類胰島素；Des(B28-B30)人類胰島素；Des(B27)人類胰島素及Des(B30)人類胰島素。Insulin analogues such as Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp (B28 Human insulin; human insulin, wherein the proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein Lys can be substituted by Pro in position B29; Ala (B26) human insulin; Des (B28-B30) Human insulin; Des (B27) human insulin and Des (B30) human insulin.
胰島素衍生物譬如係為B29-N-蔻醯基-des(B30)人類胰島素(B29-N-myristoyl-des(B30)human insulin)；B29-N-棕櫚醯基-des(B30)人類胰島素(B29-N-palmitoyl-des(B30)human insulin)；B29-N-蔻醯基人類胰島素(B29-N-myristoyl human insulin)；B29-N-棕櫚醯基人類胰島素(B29-N-palmitoyl human insulin)；B28-N-蔻醯基LysB28ProB29人類胰島素(B28-N-myristoyl LysB28ProB29 human insulin)；B28-N-棕櫚醯基-LysB28ProB29人類胰島素(B28-N-palmitoyl-LysB28ProB29 human insulin)；B30-N-蔻醯基-ThrB29LysB30人類胰島素(B30-N-myristoyl-ThrB29LysB30human insulin)；B30-N-棕櫚醯基-ThrB29LysB30人類胰島素(B30-N-palmitoyl-ThrB29LysB30 human insulin)；B29-N-(N-棕櫚醯基-Y-穀氨醯基)-des(B30)人類胰島素(B29-N-(N-palmitoyl-Y-glutamyl)-des(B30)human insulin)；B29-N-(N-石膽基-Y-穀氨醯基)-des(B30)人類胰島素(B29-N-(N-lithocholyl-Y-glutamyl)-des(B30)human insulin)；B29-N-(ω-羧十七醯基)-des(B30)人類胰島素(B29-N-(ω-carboxyheptadecanoyl)-des(B30)human insulin)及B29-N-(ω-羧十七醯基)人類胰島素(B29-N-(ω-carboxyheptadecanoyl)human insulin)。Insulin derivatives such as B29-N-mercapto-des (B30) human insulin (B29-N-myristoyl-des (B30) human insulin); B29-N-palmitino-des (B30) human insulin ( B29-N-palmitoyl-des (B30) human insulin); B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin B28-N-mercapto LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-palmitoyl-LysB28ProB29 human insulin; B30-N- B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palm) --Y-glutamyl)-des(B30) human insulin (B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin); B29-N-(N-stone-based Y-glutamyl)-des(B30) human insulin (B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin); B29-N-(ω-carboxyheptadecanyl) -des(B30)human insulin (B29-N-(ω-carboxyheptade) Canoyl)-des(B30) human insulin) and B29-N-(ω-carboxyheptadecanoyl) human insulin.
促胰島素分泌素-4譬如係指促胰島素分泌素-4-(1-39)，序列H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2的一肽。Insulin-secretin-4 such as insulin-secretin-4-(1-39), sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln -Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro a peptide of -Ser-NH2.
促胰島素分泌素-4衍生物譬如選自化合物的下列清單：H-(Lys)4-des Pro36,des Pro37促胰島素分泌素-4(1-39)-NH2(H-(Lys)4-des Pro36,des Pro37 Exendin-4(1-39)-NH2),H-(Lys)5-des Pro36,des Pro37促胰島素分泌素-4(1-39)-NH2(H-(Lys)5-des Pro36,des Pro37 Exendin-4(1-39)-NH2),des Pro36促胰島素分泌素-4(1-39)(des Pro36 Exendin-4(1-39)),des Pro36[Asp28]促胰島素分泌素-4(1-39)(des Pro36[Asp28]Exendin-4(1-39)),des Pro36[IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[IsoAsp28]Exendin-4(1-39)),des Pro36[Met(O)14,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14,Asp28]Exendin-4(1-39)),des Pro36[Met(O)14,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39)),des Pro36[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)),des Pro36[Trp(O2)25,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39)),des Pro36[Met(O)14 Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39)),des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39))；或des Pro36[Asp28]促胰島素分泌素-4(1-39)(des Pro36[Asp28]Exendin-4(1-39)),des Pro36[IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[IsoAsp28]Exendin-4(1-39)),des Pro36[Met(O)14,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14,Asp28]Exendin-4(1-39)),des Pro36[Met(O)14,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39)),des Pro36[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)),des Pro36[Trp(O2)25,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39)),des Pro36[Met(O)14 Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,Asp28]Exendin-4(1-39)),des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]促胰島素分泌素-4(1-39)(des Pro36[Met(O)14 Trp(O2)25,IsoAsp28]Exendin-4(1-39)),其中基團-Lys6-NH2可被束縛(bound)至促胰島素分泌素-4衍生物的C-終點(terminus)；或下列序列的一促胰島素分泌素-4衍生物：des Pro36促胰島素分泌素-4(1-39)-Lys6-NH2(AVE0010)(des Pro36 Exendin-4(1-39)-Lys6-NH2(AVE0010)),H-(Lys)6-des Pro36[Asp28]促胰島素分泌素-4(1-39)-Lys6-NH2(H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2),des Asp28 Pro36,Pro37,Pro38促胰島素分泌素-4(1-39)-NH2(des Asp28 Pro36,Pro37,Pro38Exendin-4(1-39)-NH2),H-(Lys)6-des Pro36,Pro38[Asp28]促胰島素分泌素-4(1-39)-NH2(H-(Lys)6-des Pro36,Pro38[Asp28]Exendin-4(1-39)-NH2),H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]促胰島素分泌素-4(1-39)-NH2(H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2),des Pro36,Pro37,Pro38[Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-Lys6-NH2(H-(Lys)6-des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2),H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]促胰島素分泌素-4(1-39)-NH2(H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2),des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-Lys6-NH2(H-(Lys)6-des Pro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2),des Met(O)14,Asp28 Pro36,Pro37,Pro38促胰島素分泌素-4(1-39)-NH2(des Met(O)14 Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2),H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-NH2(H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2),des Pro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5 des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-Lys6-NH2(H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2),H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]促胰島素分泌素-4(1-39)-NH2(H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]促胰島素分泌素-4(1-39)-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2),des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]促胰島素分泌素-4(S1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2),H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]促胰島素分泌素-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2)；或上述促胰島素分泌素-4衍生物的任一者之一藥學可接受的鹽或溶劑化物。The insulin secretagogue-4 derivative is, for example, selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 insulin secretagin-4(1-39)-NH2(H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2), H-(Lys)5-des Pro36, des Pro37 insulin secretagogue-4(1-39)-NH2(H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2), des Pro36 insulin secretin-4 (1-39) (des Pro36 Exendin-4 (1-39)), des Pro36 [Asp28] insulin secretion -4 (1-39) (des Pro36 [Asp28] Exendin-4 (1-39)), des Pro36 [IsoAsp28] insulin secretin-4 (1-39) (des Pro36 [IsoAsp28] Exendin-4 ( 1-39)), des Pro36[Met(O)14, Asp28] Insulin Secretin-4 (1-39) (des Pro36[Met(O)14, Asp28] Exendin-4(1-39)), Des Pro36[Met(O)14, IsoAsp28] Insulin Secretin-4 (1-39) (des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39)), des Pro36[Trp(O2) 25, Asp28] insulin secretin-4 (1-39) (des Pro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39)), des Pro36 [Trp (O2) 25, IsoAsp28] Insulin secretin-4 (1-39) (des Pro36[Trp(O2)25, IsoAsp28]Exendin-4(1-39)), des Pro36[Met(O)14 Trp(O2)25, Asp28] insulinotropic Secretin-4 (1-39) (des Pr O36[Met(O)14 Trp(O2)25, Asp28]Exendin-4(1-39)), des Pro36[Met(O)14 Trp(O2)25, IsoAsp28] Insulin Secretin-4 (1- 39) (des Pro36[Met(O)14 Trp(O2)25, IsoAsp28]Exendin-4(1-39)); or des Pro36[Asp28] Insulin Secretin-4 (1-39) (des Pro36[ Asp28]Exendin-4(1-39)), des Pro36[IsoAsp28] Insulin Secretin-4 (1-39) (des Pro36[IsoAsp28]Exendin-4(1-39)), des Pro36[Met(O)14, Asp28] Insulin Secretin-4 (1-39) (des Pro36[Met(O)14, Asp28] Exendin-4 (1-39)), des Pro36[Met(O)14, IsoAsp28] Insulin Secretin-4 (1-39) (des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39)) , des Pro36[Trp(O2)25, Asp28] Insulin secretin-4 (1-39) (des Pro36[Trp(O2)25, Asp28] Exendin-4(1-39)), des Pro36[Trp( O2)25, IsoAsp28] Insulin Secretin-4 (1-39) (des Pro36[Trp(O2)25, IsoAsp28]Exendin-4(1-39)), des Pro36[Met(O)14 Trp(O2) 25, Asp28] Insulin Secretin-4 (1-39) (des Pro36[Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39)), des Pro36[Met(O) 14 Trp(O2)25, IsoAsp28] Insulin secretin-4 (1-39) (des Pro36[Met(O)14 Trp(O2)25, IsoAsp28]Exendin-4(1-39)), wherein the group -Lys6-NH2 can be bound to the C-terminus of the insulin secretagogue-4 derivative; or an insulin secretagogue-4 derivative of the following sequence: des Pro36 insulin secretagogue-4 1-39)-Lys6-NH2 (AVE0010) (des Pro36 Exendin-4(1-39)-Lys6-NH2(AVE0010)), H-(Lys)6-des Pro36[Asp28] Insulin Secretin-4 ( 1-39)-Lys6-NH2(H-(Lys)6 -des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2), des Asp28 Pro36, Pro37, Pro38 Insulin Secretin-4(1-39)-NH2 (des Asp28 Pro36, Pro37, Pro38Exendin-4 (1-39)-NH2), H-(Lys)6-des Pro36, Pro38[Asp28] Insulin Secretin-4(1-39)-NH2(H-(Lys)6-des Pro36, Pro38[Asp28 Exendin-4(1-39)-NH2), H-Asn-(Glu)5des Pro36, Pro37, Pro38[Asp28] Insulin Secretin-4(1-39)-NH2(H-Asn-(Glu) 5des Pro36, Pro37, Pro38[Asp28]Exendin-4(1-39)-NH2), des Pro36, Pro37, Pro38[Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2 (des Pro36, Pro37, Pro38[Asp28]Exendin -4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]insulin secretin-4(1-39)-(Lys)6-NH2 (H-(Lys)6-des Pro36, Pro37, Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[ Asp28] Insulin-secretin-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Asp28]Exendin-4(1-39)-(Lys 6-NH2), H-(Lys)6-des Pro36[Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-Lys6-NH2(H-(Lys)6-des Pro36[ Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2), H-des Asp28 Pro36, Pro37, Pro38[Trp(O2)25] Insulin Secretin-4(1-39)- NH2 (H-des Asp28 Pro36, Pro37, Pro38[Trp(O2)25]Exendin-4(1-39)-NH2), H-(Lys)6-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Insulin secretin-4(1-39)-NH2(H-(Lys)6-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28]Exendin-4(1-39)-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-NH2(H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28]Exend In-4(1-39)-NH2), des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2(des Pro36, Pro37 , Pro38[Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2), H-(Lys)6-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] IsletSecretin-4(1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28]Exendin-4(1-39)-( Lys)6-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2( H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36 [Met(O)14, Asp28] Insulin-secretin-4(1-39)-Lys6-NH2(H-(Lys)6-des Pro36[Met(O)14, Asp28]Exendin-4(1-39 )-Lys6-NH2), des Met(O)14, Asp28 Pro36, Pro37, Pro38 Insulin Secretin-4(1-39)-NH2(des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4( 1-39)-NH2),H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14, Asp28] Insulin Secretin-4(1-39)-NH2(H-(Lys)6- desPro36, Pro37, Pro38[Met(O)14, Asp28] Exendin-4(1-39)-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Asp28] Insulin secretin-4(1-39)-NH2(H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Asp28]Exendin-4(1-39)-NH2), Des Pro36, Pro37, Pro38[Met(O)14, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2 (des Pro36, Pro37, Pro38[Met(O)14, Asp28] Exendin -4(1-39)-(Lys)6-NH2),H-(Lys)6-des Pro36 , Pro37, Pro38[Met(O)14, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36, Pro37, Pro38[Met(O) 14, Asp28] Exendin-4(1-39)-(Lys)6-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Asp28] Insulin Secretin- 4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5 des Pro36, Pro37, Pro38[Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6 -NH2),H-Lys6-des Pro36[Met(O)14, Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-Lys6-NH2(H-Lys6-des Pro36[Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2), H-des Asp28 Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25] Insulin Secretin-4 (1-39)-NH2 (H-des Asp28 Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2), H-(Lys)6-des Pro36, Pro37, Pro38[Met(O)14, Asp28] Insulin Secretin-4(1-39)-NH2(H-(Lys)6-des Pro36, Pro37, Pro38[Met(O)14, Asp28] Exendin-4(1-39)-NH2), H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28] Insulin Secretin-4 (1) -39)-NH2(H-Asn-(Glu)5-des Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2),des Pro36 , Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2 (des Pro36, Pro37, Pro38[Met(O)14 , Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2), H-(Lys)6-des Pro36, Pro37, Pro38[Met(O)14, Trp(O2) 25, Asp28] Insulin-secretin-4 (S1-39)-(Lys)6-NH2(H-(Lys)6-des Pro36, Pro37, Pro38[Met(O)14, Trp(O2)25, Asp28 Exendin-4(S1-39)-(Lys)6-NH2), H-Asn-(Glu)5-des Pro36, Pro37,P Ro38[Met(O)14, Trp(O2)25, Asp28] Insulin Secretin-4(1-39)-(Lys)6-NH2(H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2); or one of the above-mentioned insulinotropic secretin-4 derivatives may be pharmaceutically acceptable Accepted salt or solvate.
激素譬如係為腦下垂體激素或下視丘激素或調節活性肽及其拮抗劑，如Rote Liste，2008版，50章所列，諸如性腺激素(Gonadotropine)(促濾泡素(Follitropin)，促黃體素(Lutropin)，絨毛膜促性腺激素(Choriongonadotropin)，美諾孕(Menotropin))，Somatropine(生長激素(Somatropin))，抗利尿激素(Desmopressin)，血管升壓素衍生物(Terlipressin)，戈那瑞林(Gonadorelin)，曲普瑞林(Triptorelin)，亮丙瑞林(Leuprorelin)，布舍瑞林(Buserelin)，那法瑞林(Nafarelin)，戈舍瑞林(Goserelin)。Hormones such as pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as Rote Liste, 2008 edition, listed in Chapter 50, such as Gonadotropine (Follitropin) Lutropin, chorionic gonadHormone (Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptor Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
多醣譬如係為醣胺多醣，玻尿酸，肝素，低分子量肝素或超低分子量肝素或其衍生物，或上述多醣的硫酸化譬如多硫酸化形式，及/或其藥學可接受的鹽。多硫酸化低分子量肝素之藥學可接受的鹽範例係為依諾肝素鈉。The polysaccharide is, for example, a glycosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or a derivative thereof, or a sulfated hydrazine such as a polysulfated form of the above polysaccharide, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.
抗體係為共用一基本結構之亦稱作免疫球蛋白的球血漿蛋白質(~150 kDa)。由於其具有添加至氨基酸殘留物的醣鏈，其係為醣蛋白。各抗體的基本功能單元係為一免疫球蛋白(Ig)單體(只含一Ig單元)；分泌的抗體亦可為具有兩Ig單元的二合體(dimeric)，如同IgA，具有四Ig單元的四合體(tetrameric)，如同硬骨魚IgM(teleost fish IgM)，或具有五Ig單元的五合體(pentameric)，如同哺乳動物IgM。The anti-system is a ball plasma protein (~150 kDa), also known as immunoglobulin, which shares a basic structure. Since it has a sugar chain added to an amino acid residue, it is a glycoprotein. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); the secreted antibody may also be a dimeric having two Ig units, like IgA, having four Ig units. A tetrameric, like a teleost fish IgM, or a pentameric with five Ig units, like a mammalian IgM.
Ig單體係為一“Y”形分子，其由四個多肽鏈；兩個相同的重鏈及兩個相同的輕鏈所組成，在半胱氨酸殘留物之間被雙硫鍵連接。各重鏈約為440氨基酸長；各輕鏈約為220氨基酸長。重及輕鏈各含有使其摺疊穩定化之鏈內雙硫鍵。各鏈由稱為Ig分域的結構分域(structural domains)構成。這些分域含有約70至110個氨基酸並根據其尺寸及功能分成不同類別(譬如，可變或V，以及固定(constant)或C)。其具有一特徵免疫球蛋白摺疊，其中兩β片係生成“三明治”形狀，被保留半胱氨酸與其他帶電氨基酸之間的交互作用固持在一起。The Ig single system is a "Y" shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains, linked by a disulfide bond between the cysteine residues. Each heavy chain is approximately 440 amino acids long; each light chain is approximately 220 amino acids long. The heavy and light chains each contain an intrachain disulfide bond that stabilizes their folding. Each chain consists of structural domains called Ig domains. These subdomains contain about 70 to 110 amino acids and are classified into different categories depending on their size and function (for example, variable or V, and constant or C). It has a characteristic immunoglobulin fold in which the two beta sheets form a "sandwich" shape that is held together by the interaction between the retained cysteine and other charged amino acids.
具有五類型的哺乳動物Ig重鏈，標示成α、δ、ε、γ及μ。所出現的重鏈類型係界定抗體的同型(isotype)；這些鏈分別出現在IgA、IgD、IgE、IgG及IgM抗體中。There are five types of mammalian Ig heavy chains, designated as α, δ, ε, γ, and μ. The type of heavy chain that is present defines the isotype of the antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
不同的重鏈具有不同的尺寸及組成物；α及γ含有近似450個氨基酸且δ含有近似500個氨基酸，而μ及ε則具有近似550個氨基酸。各重鏈具有兩區，固定區(CH)及可變區(VH)。在一物種中，固定區在相同同型的全部抗體中皆實質地相同，但在不同同型的抗體中則為不同。重鏈γ、α及δ係具有由三個縱列狀Ig分域構成的一固定區(constant region)，及用於添加撓性的一鉸鍊區(hinge region)；重鏈μ及ε具有由四個免疫球蛋白分域構成之一固定區。重鏈的可變區係在不同B細胞產生的抗體中為不同，但對於單一B細胞或B細胞克隆(cell clone)產生的全部抗體則為相同。各重鏈的可變區係為近似110個氨基酸長並由單一Ig分域構成。Different heavy chains have different sizes and compositions; alpha and gamma contain approximately 450 amino acids and δ contains approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, a fixed region (CH ) and a variable region (VH ). In one species, the imprinted regions are substantially identical in all antibodies of the same isotype, but are different in different isotypes of antibodies. The heavy chain γ, α, and δ systems have a constant region composed of three columnar Ig domains, and a hinge region for adding flexibility; the heavy chains μ and ε have The four immunoglobulin domains form one of the fixed regions. The variable regions of the heavy chain differ in the antibodies produced by different B cells, but are identical for all antibodies produced by a single B cell or a B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and consists of a single Ig domain.
在哺乳動物中，有兩類型的免疫球蛋白輕鏈，標示成λ及κ。一輕鏈具有兩個接續的分域：一固定分域(CL)及一可變分域(VL)。一輕鏈的近似長度是211至217個氨基酸。各抗體含有總是相同的兩輕鏈；在哺乳動物中每個抗體中只出現一類型的輕鏈，κ或λ。In mammals, there are two types of immunoglobulin light chains, designated as λ and κ. A light chain has two successive subfields: a fixed domain (CL) and a variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, kappa or lambda, is present in each antibody in a mammal.
雖然所有抗體的一般結構很類似，一給定抗體的獨特性質係取決於可變(V)區，如上文詳述。更確切來說，在輕鏈(VL)及重鏈(VH)上各有三個的可變迴路係負責束縛至抗原，亦即供用於其抗原特異性。這些迴路稱為互補決定區(CDRs)。因為來自VH及VL分域的CDRs係有助於抗原束縛部位(antigen-binding site)，正是由重與輕鏈的組合而非單獨任一者來決定最終的抗原特異性。Although the general structure of all antibodies is very similar, the unique properties of a given antibody depend on the variable (V) region, as detailed above. More specifically, three variable loop systems, each on the light (VL) and heavy (VH) chains, are responsible for binding to the antigen, ie for their antigen specificity. These loops are called complementarity determining regions (CDRs). Because the CDRs from the VH and VL domains contribute to the antigen-binding site, it is the combination of heavy and light chains that does not alone determine the ultimate antigen specificity.
一“抗體片段”係含有如上文界定的至少一抗原束縛片段，並展現與自其衍生該片段的完整抗體實質地相同之功能及特異性。利用木瓜蛋白脢的受限蛋白水解消化(limited proteolytic digestion)將Ig原型劈切成三個片段。各含有一完整L鏈及約一半H鏈之兩個相同的氨基終端片段係為抗原束縛片段(Fab)。具有類似尺寸但包含具有其鏈間雙硫鍵之兩重鏈的羧基終端半部之第三片段係為可結晶化片段(Fc)。Fc含有碳水化合物、互補束縛、及FcR束縛部位。受限胃蛋白脢消化係產生一含有Fab塊件及鉸鍊區之單F(ab’)2片段，包括H-H鏈間雙硫鍵。F(ab’)2對於抗原束縛係為二價。F(ab’)2的雙硫鍵可被劈切以獲得Fab’。並且，重及輕鏈的可變區可被熔合在一起以形成一單鏈可變片段(scFv)。An "antibody fragment" contains at least one antigen-binding fragment as defined above and exhibits substantially the same function and specificity as the intact antibody from which the fragment is derived. The Ig prototype was chopped into three fragments using limited proteolytic digestion of papaya peptone. Two identical amino terminal fragments each containing a complete L chain and about half of the H chain are antigen-binding fragments (Fab). A third fragment of a carboxyl terminal half having a similar size but comprising a double chain having an interchain disulfide bond is a crystallizable fragment (Fc). Fc contains carbohydrates, complementary binding, and FcR binding sites. The restricted peptone digestive system produces a single F(ab')2 fragment containing a Fab block and a hinge region, including an H-H interchain disulfide bond. F(ab')2 is two for antigen bindingprice. The disulfide bond of F(ab')2 can be chopped to obtain Fab'. Also, the variable regions of the heavy and light chains can be fused together to form a single-chain variable fragment (scFv).
藥學可接受的鹽譬如係為酸加成鹽及鹼鹽。酸加成鹽譬如係為HCl或HBr鹽。鹼鹽譬如係為具有選自下列各物的一陽離子之鹽：強鹼或鹼性，譬如Na+，或K+，或Ca2+，或一銨離子N+(R1)(R2)(R3)(R4)，其中R1至R4彼此獨立地代表：氫，一選用性取代的C1-C6-烷基，一選用性取代的C2-C6-烯基，一選用性取代的C6-C10-芳香基，或一選用性取代的C6-C10-雜芳基。藥學可接受的鹽之其他範例係描述於“瑞明敦藥學科學(Remington’s Pharmaceutical Sciences)”17版，金奈若(Alfonso R.Gennaro)(編著)，馬克出版公司(Mark Publishing Company)，美國賓州伊斯頓，1985，及藥學科技百科全書(Encyclopedia of Pharmaceutical Technology)。Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. The acid addition salt is, for example, a HCl or HBr salt. The alkali salt is, for example, a salt having a cation selected from the group consisting of a strong base or a basic such as Na+, or K+, or Ca2+, or a monoammonium ion N+(R1)(R2)(R3)(R4), Wherein R1 to R4 independently of each other represent: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, a selectively substituted C6-C10-aryl group, or an optional one. Sex substituted C6-C10-heteroaryl. Other examples of pharmaceutically acceptable salts are described in Remington's Pharmaceutical Sciences, 17th Edition, Alfonso R. Gennaro (eds.), Mark Publishing Company, Pennsylvania, USA Easton, 1985, and Encyclopedia of Pharmaceutical Technology.
藥學可接受的溶劑化物譬如係為水合物。Pharmaceutically acceptable solvates are, for example, hydrates.
1‧‧‧藥物傳輸裝置1‧‧‧ drug delivery device
2‧‧‧卡匣2‧‧‧Carmen
3‧‧‧外殼體3‧‧‧Outer casing
4‧‧‧按鈕4‧‧‧ button
5‧‧‧顯示資訊5‧‧‧ Display information
6‧‧‧第一套筒構件6‧‧‧First sleeve member
7‧‧‧第二套筒構件7‧‧‧Second sleeve member
8‧‧‧接合特徵8‧‧‧ joint features
9‧‧‧接合特徵9‧‧‧ joint features
10‧‧‧內殼體10‧‧‧ inner casing
11‧‧‧第二套筒構件的內螺紋11‧‧‧ internal thread of the second sleeve member
12‧‧‧內殼體的外螺紋12‧‧‧ External thread of the inner casing
13‧‧‧內殼體的外螺紋13‧‧‧ External thread of the inner casing
14‧‧‧套筒14‧‧‧ sleeve
15‧‧‧接合特徵15‧‧‧ joint features
16‧‧‧驅動器16‧‧‧ drive
17‧‧‧活塞桿17‧‧‧ piston rod
18‧‧‧停止特徵18‧‧‧Stop feature
19‧‧‧塞子19‧‧‧ 塞子
上述類型的一藥物傳輸裝置及一組件的較佳及/或替代性實施例暨進一步特徵係揭露及描述於附屬的申請專利範圍中且亦參照附圖作描述，其中：圖1顯示根據本揭示處於一初始狀態之一藥物傳輸裝置的側視圖；圖2顯示處於一起動狀態之根據圖1的藥物傳輸裝置；圖3顯示根據圖1的藥物傳輸裝置之部份的側視圖；圖4顯示根據圖2的藥物傳輸裝置之部份的側視圖；圖5顯示根據圖1的藥物傳輸裝置之內部份的半透明側視圖；圖6顯示根據圖2的藥物傳輸裝置之內部份的半透明側視圖；圖7顯示處於第三狀態之根據圖1及2的一藥物傳輸裝置之部份的立體圖；及圖8顯示根據圖1及2的一藥物傳輸裝置之部份的立體剖切圖。Preferred and/or alternative embodiments and further features of a drug delivery device and a component of the above type are disclosed and described in the scope of the appended claims and also with reference to the accompanying drawings in which: FIG. a side view of the drug delivery device in an initial state; FIG. 2 shows the drug delivery device according to FIG. 1 in a state of being moved together; FIG. 3 shows a side view of a portion of the drug delivery device according to FIG. 1; 2 is a side view of a portion of the drug delivery device of FIG. 2; FIG. 5 shows a translucent side view of the internal portion of the drug delivery device of FIG. 1; FIG. 6 shows a translucent portion of the internal portion of the drug delivery device according to FIG. a side view; FIG. 7 is a perspective view showing a portion of a drug delivery device according to FIGS. 1 and 2 in a third state;Figure 8 is a perspective cutaway view of a portion of a drug delivery device in accordance with Figures 1 and 2.
圖1顯示一藥物傳輸裝置1處於藥物傳輸裝置1的一初始狀態之側視圖。藥物傳輸裝置1係包含一卡匣(cartridge)2以及一外殼體3，其耦合至卡匣2並容納一用於將藥品撥動及/或配送至卡匣2外以供傳輸至一患者的組件之器件。1 shows a side view of a drug delivery device 1 in an initial state of the drug delivery device 1. The drug delivery device 1 comprises a cartridge 2 and an outer casing 3 coupled to the cassette 2 and containing a device for displacing and/or dispensing the drug outside the cassette 2 for transmission to a patient. Component device.
卡匣2可包含一預定量的一藥品並在其左端提供一螺紋特徵(thread feature)以供安裝一針頭組件(未圖示)藉以將離開卡匣2的藥品注射至一患者的一身體部位中。並且，卡匣2提供一塞子或停止器(未圖示)，其配置於卡匣2內側且可被推押朝向藥物傳輸裝置1的左端，亦即朝向用於卡匣2的針頭組件之螺紋特徵，藉以經由一預定壓力力量將藥品驅出卡匣2外。The cassette 2 may include a predetermined amount of a drug and a thread feature at its left end for mounting a needle assembly (not shown) for injecting a drug leaving the cassette 2 to a body part of a patient in. Further, the cassette 2 is provided with a stopper or stopper (not shown) which is disposed inside the cassette 2 and can be pushed toward the left end of the drug delivery device 1, that is, the thread toward the needle assembly for the cassette 2. The feature is used to drive the drug out of the cassette 2 via a predetermined pressure.
外殼體3除了下文說明的其他部份及器件外係容納一活塞桿(未圖示)，其設計成被一使用者的操作動作所驅動藉以在左方向推押卡匣2的一塞子以供將藥劑驅出裝置1外。特別來說，活塞桿可被如下文說明的器件及構件所驅動。The outer casing 3 houses a piston rod (not shown) in addition to the other parts and components described below, and is designed to be driven by a user's operation to push a plug of the cassette 2 in the left direction for The drug is driven out of the device 1. In particular, the piston rod can be driven by devices and components as described below.
除了一活塞桿外，外殼體3係容納其他部份及器件，顯示出其中的顯示資訊5(經由外殼體3的一半透明窗口)及一按鈕4暨外殼體3之一內器件的一部份。按鈕4配置於藥物傳輸裝置1的一右端。In addition to a piston rod, the outer casing 3 accommodates other parts and components, showing display information 5 therein (through a half transparent window of the outer casing 3) and a portion of the device in one of the buttons 4 and the outer casing 3. . The button 4 is disposed at a right end of the drug delivery device 1.
一般來說，裝置1的左端稱為“遠端”且在藥物傳輸裝置1的所意圖操作期間最為接近一患者的一身體部位以供將藥劑注射至患者身體中。裝置1的右端稱為“近端”且最為遠離一患者的一身體部位。In general, the left end of the device 1 is referred to as the "distal end" and is closest to a body part of a patient during the intended operation of the drug delivery device 1 for injecting the medicament into the patient's body. The right end of the device 1 is referred to as the "proximal end" and is most distant from a body part of a patient.
在根據圖1之裝置1的初始狀態中，描繪裝置1的一經傳輸或供應狀態。這係指如圖1所示的裝置1被供應至一使用者。在此狀態中，在卡匣塞子與活塞桿一端之間具有一空氣間隙(未顯示於圖1，說明於圖8的內容)，其在所意圖操作期間抵靠於卡匣的塞子以供藥物傳輸，如上文所說明。空氣間隙係可為與裝置1的全部經組裝部份的公差相關聯之結果並導因於不欲在經組裝裝置的左方向軸向地預負載卡匣塞子所致，藉以防止藥品意外地注射至裝置1外。In the initial state of the device 1 according to Fig. 1, a transmission or supply state of the device 1 is depicted. This means that the device 1 as shown in Fig. 1 is supplied to a user. In this state, there is an air gap between the click plug and one end of the piston rod (not shown in Figure 1, illustrated inFigure 8)), which is inserted against the stopper of the cassette during the intended operation for drug delivery, as explained above. The air gap can be a result of the tolerance associated with the entire assembled portion of the device 1 and is caused by the undesired preloading of the jam plug in the left direction of the assembled device, thereby preventing accidental injection of the drug. To the outside of the device 1.
可藉由藥物傳輸裝置1從如圖1所描繪的初始狀態至根據圖2的一所謂“起動狀態”之一過渡來橫越活塞桿與塞子之間的空氣間隙，其中在起動狀態中，活塞桿已經被軸向地移動俾使其在卡匣2的塞子處抵靠於一端，活塞桿的一進一步軸向移行係生效使藥劑射出至裝置1外。The air gap between the piston rod and the plug can be traversed by the drug delivery device 1 from one of the initial state as depicted in FIG. 1 to one of the so-called "starting states" according to FIG. 2, wherein in the starting state, the piston The rod has been moved axially so that it abuts against the end of the cartridge 2, and a further axial movement of the piston rod is effective to eject the medicament out of the device 1.
圖2顯示根據圖1的裝置1，但此時處於起動狀態，其中按鈕4在左方向被壓抵至外殼體3中(請見箭頭)。因此，顯示資訊5已經從根據圖1的一起動指標改變成根據圖2的一就緒可操作指標(例如數字“0”以指示出裝置1就緒)。Fig. 2 shows the device 1 according to Fig. 1, but in this case in a starting state, in which the button 4 is pressed into the outer casing 3 in the left direction (see arrow). Therefore, the display information 5 has been changed from the co-movement indicator according to Fig. 1 to a ready-to-operate indicator according to Fig. 2 (e.g., the number "0" to indicate that the device 1 is ready).
根據圖1及2的實施例，按鈕4從根據圖1的初始位置軸向移行至根據圖2的起動位置中係造成裝置1的外殼體3內之活塞桿在左方向作軸向地移行，其中其軸向移行設計成使得在根據圖2的起動位置中，活塞桿係抵靠卡匣2的卡匣塞子，其中裝置1係就緒可供進一步操作。就圖7及8的內容說明裝置1的進一步操作。According to the embodiment of Figures 1 and 2, the axial movement of the button 4 from the initial position according to Figure 1 to the starting position according to Figure 2 causes the piston rod in the outer casing 3 of the device 1 to move axially in the left direction, The axial movement thereof is designed such that in the starting position according to Fig. 2, the piston rod is against the cassette stopper of the cassette 2, wherein the device 1 is ready for further operation. Further operations of the device 1 are illustrated with respect to the contents of Figures 7 and 8.
圖3及4顯示根據圖1及2的藥物傳輸裝置1之內部部份及器件，其至少部份地被裝置1的外殼體3所容納。圖3顯示根據圖1處於初始狀態之裝置的一部份，其中圖4顯示根據圖2處於起動狀態之裝置的一部份。在圖3及4中，外殼體3受隱藏藉以更良好地顯示裝置1內的數個器件之機械交互作用。Figures 3 and 4 show the internal portion and device of the drug delivery device 1 according to Figures 1 and 2, which are at least partially received by the outer casing 3 of the device 1. Figure 3 shows a portion of the apparatus in an initial state according to Figure 1, wherein Figure 4 shows a portion of the apparatus in the activated state according to Figure 2. In Figures 3 and 4, the outer casing 3 is concealed to better display the mechanical interaction of several devices within the device 1.
圖3描繪一內殼體10的一部份，一第一套筒構件6，一第二套筒構件及及一按鈕4(亦請見圖1及2)。第一及第二套筒構件6、7係配置於內殼體10的一外部份周圍。按鈕4耦合至第一套筒構件6，其中第一套筒構件6可相對於第二套筒構件7移動。這係指第一套筒構件6可從其根據圖3之相對於第二套筒構件7的初始位置被移動至根據圖4之相對於第二套筒構件7的一第二位置中。特別來說，藉由在左方向壓抵按鈕4，第一套筒構件6可與按鈕4一起在左方向作軸向移行，俾可進行組件從如圖3所描繪情形至如圖4所描繪情形之一過渡。Figure 3 depicts a portion of an inner casing 10, a first sleeve member 6, a second sleeve member and a button 4 (see also Figures 1 and 2). The first and second sleeve members 6, 7 are disposed around an outer portion of the inner casing 10. The button 4 is coupled to the first sleeve member 6 wherein the first sleeve member 6 is movable relative to the second sleeve member 7. This means that the first sleeve member 6 is detachable from itThe initial position relative to the second sleeve member 7 according to FIG. 3 is moved into a second position relative to the second sleeve member 7 according to FIG. In particular, by pressing the button 4 in the left direction, the first sleeve member 6 can be axially displaced with the button 4 in the left direction, and the assembly can be made from the situation as depicted in FIG. 3 to that depicted in FIG. One of the situations is a transition.
詳言之，由於第一及第二套筒構件6、7螺紋式接合於彼此，按鈕4與第一套筒構件6一起在左方向之一軸向移行係驅使第二套筒構件7進入相對於內殼體10及第一套筒構件6的一旋轉運動。根據圖3及4，一螺紋段(亦即具有一軸向及一圓形部分之段)的各別壁係彼此交互作用，俾令第一套筒構件6在左方向的一軸向運動驅使第二套筒構件7進入一旋轉運動。In detail, since the first and second sleeve members 6, 7 are threadedly engaged with each other, the button 4 and the first sleeve member 6 together in one of the axial directions in the left direction drive the second sleeve member 7 into the opposite direction. A rotational movement of the inner casing 10 and the first sleeve member 6. According to Figures 3 and 4, the respective wall sections of a threaded section (i.e., the section having an axial portion and a circular portion) interact with each other to urge an axial movement of the first sleeve member 6 in the left direction. The second sleeve member 7 enters a rotational movement.
第一套筒構件6提供一與第二套筒構件7交互作用之接合特徵8，藉以將第一及第二套筒構件6、7之間的最大軸向空隙限定至一軸向空隙，如圖3描繪(器件的初始位置)。這係指第一套筒構件6無法在右方向被移動遠離第二套筒構件7。這提供一安全特徵以供防止一使用者以按鈕4將第一套筒構件6在右方向拉出藥物傳輸裝置1外。僅准許與第一套筒構件6一起在按鈕4的左方向之一運動。The first sleeve member 6 provides an engagement feature 8 that interacts with the second sleeve member 7 to define a maximum axial gap between the first and second sleeve members 6, 7 to an axial gap, such as Figure 3 depicts (the initial position of the device). This means that the first sleeve member 6 cannot be moved away from the second sleeve member 7 in the right direction. This provides a security feature for preventing a user from pulling the first sleeve member 6 out of the drug delivery device 1 in the right direction with the button 4. It is only permitted to move together with the first sleeve member 6 in one of the left directions of the button 4.
圖4顯示當按鈕4及第一套筒構件6已經在左方向移行朝向第二套筒構件7時之情形，其中第二套筒構件7已經藉由螺紋式接合於第一套筒構件6造成被旋轉。利用此方式，由於第二套筒構件7的內螺紋11與內殼體10的一外螺紋12之一螺紋式接合，第二套筒構件7已經相對於內殼體10移行(traveled)於一螺旋路徑上。利用此方式，顯示根據圖3的一起動指標(以一有色背景上的一白色P作為象徵)之顯示資訊5係已經改變成一顯示資訊5(以數字“0”作為象徵)，其指示出根據圖4的裝置之一就緒可使用狀態或起動狀態。這係指起動指標已經在順時針方向旋轉，如圖4所描繪的一圓形箭頭作為象徵。Figure 4 shows the situation when the button 4 and the first sleeve member 6 have been moved in the left direction towards the second sleeve member 7, wherein the second sleeve member 7 has been threadedly engaged with the first sleeve member 6 Being rotated. In this manner, since the internal thread 11 of the second sleeve member 7 is threadedly engaged with one of the external threads 12 of the inner casing 10, the second sleeve member 7 has been traveled relative to the inner casing 10 On the spiral path. In this way, the display information 5 showing the moving index according to FIG. 3 (symbolized by a white P on a colored background) has been changed into a display information 5 (symbolized by the number “0”), which indicates One of the devices of Figure 4 is ready for use or starting. This means that the starting indicator has been rotated in a clockwise direction, as symbolized by a circular arrow as depicted in FIG.
在圖4的狀態中，第一及第二套筒構件6、7係鍵式接合(keyed contact)於彼此。其中第一套筒構件6此時除了第一接合特徵8外係經由另一接合特徵9接合於第二套筒構件7，俾使第一及第二套筒構件6、7永久性旋轉及軸向地鎖定至彼此。這係指第一及第二套筒構件6、7一起形成單一的體件或套筒14。唯有第一及第二套筒構件6、7一起以一種一致方式移動方可實行器件的進一步操作。以第二接合特徵9作為輔助，第一及第二套筒構件6、7對於彼此的一相對運動係如同圖3及4之間的過渡般為不可逆，這係指當第一套筒構件6已經抵達根據圖4的其位置時，第一套筒構件6不再可從第二套筒構件7分離。In the state of FIG. 4, the first and second sleeve members 6, 7 are keyed.(keyed contact) on each other. Wherein the first sleeve member 6 is now joined to the second sleeve member 7 via the other engagement feature 9 in addition to the first engagement feature 8, causing the first and second sleeve members 6, 7 to permanently rotate and the shaft Lock to each other to the ground. This means that the first and second sleeve members 6, 7 together form a single body member or sleeve 14. Further operation of the device can be performed only if the first and second sleeve members 6, 7 are moved together in a consistent manner. With the second engagement feature 9 as an aid, a relative movement of the first and second sleeve members 6, 7 to each other is irreversible like the transition between Figures 3 and 4, which refers to when the first sleeve member 6 When the position according to FIG. 4 has been reached, the first sleeve member 6 can no longer be separated from the second sleeve member 7.
根據圖3的第一及第二套筒構件6、7的各別壁之間的軸向空隙係使得第一套筒構件6能夠相對於第二套筒構件7在左方向移動。這轉而使按鈕4能夠與第一套筒構件6一起在左方向移動，如上文說明，俾可進行圖3及4之間的過渡(請見圖4的軸向箭頭)。按鈕4及第一套筒構件6的軸向移行係造成一活塞桿(未顯示於圖3及4)在左方向軸向地移動，俾使活塞桿可從一初始位置橫越至一預定第二位置，其提供一藥物傳輸裝置1的起動狀態，如圖1及2的內容所說明。當按鈕4且特別是第一套筒構件6如圖4描繪位於相對於第二套筒構件7的第二位置時，係防止活塞桿在按鈕4及第一套筒構件6相對於第二套筒構件7的如是一運動期間作進一步軸向移行。這係指圖4的情形顯示藥物傳輸裝置1的一保全狀態(secure state)，其中移除了活塞桿一端與卡匣2的一卡匣塞子之間的一空氣間隙。The axial gap between the respective walls of the first and second sleeve members 6, 7 according to Fig. 3 enables the first sleeve member 6 to move in the left direction relative to the second sleeve member 7. This in turn enables the button 4 to move in the left direction together with the first sleeve member 6, as explained above, the transition between Figures 3 and 4 can be made (see the axial arrows of Figure 4). The axial movement of the button 4 and the first sleeve member 6 causes a piston rod (not shown in Figures 3 and 4) to move axially in the left direction so that the piston rod can be traversed from an initial position to a predetermined number The two positions provide a starting state of a drug delivery device 1, as illustrated in the contents of Figures 1 and 2. When the button 4 and in particular the first sleeve member 6 is depicted in a second position relative to the second sleeve member 7 as depicted in Figure 4, the piston rod and the first sleeve member 6 are prevented from being opposite the second sleeve The tubular member 7 is further axially displaced during a movement. This means that the situation of Fig. 4 shows a secure state of the drug delivery device 1 in which an air gap between one end of the piston rod and a cassette plug of the cassette 2 is removed.
圖5及6代表根據圖3及4之器件的內部份之一半透明視圖。圖5代表根據圖1及3的初始狀態，其中圖6代表根據圖2及4的一起動狀態。Figures 5 and 6 represent a translucent view of the internal portions of the device according to Figures 3 and 4. Fig. 5 represents an initial state according to Figs. 1 and 3, wherein Fig. 6 represents a moving state according to Figs. 2 and 4.
根據圖5，第一套筒構件6位於其相對於第二套筒構件7之外位置中，其中第一套筒構件6提供一第三接合特徵15，其防止第一套筒構件6相對於內殼體10的一旋轉運動。利用此方式，接合特徵15係配置於內殼體10的一外螺紋13之兩螺紋式段(two threaded sections)之間的一切口(cutout)中並阻絕第一套筒構件6相對於殼體10的任何旋轉運動。因此，第一套筒構件6僅可相對於內殼體10朝向一預定停止位置18被軸向地移動，藉以使組件從根據圖1及3的初始位置橫越至根據圖2及4的起動位置中。According to FIG. 5, the first sleeve member 6 is situated in its position relative to the second sleeve member 7, wherein the first sleeve member 6 provides a third engagement feature 15 which prevents the first sleeve member 6 from being opposed to A rotational movement of the inner casing 10. In this manner, the engagement feature 15 is disposed between the two threaded sections of an external thread 13 of the inner casing 10.Any rotational movement of the first sleeve member 6 relative to the housing 10 is blocked in the cutout. Thus, the first sleeve member 6 can only be moved axially relative to the inner casing 10 towards a predetermined stop position 18, whereby the assembly is traversed from the initial position according to FIGS. 1 and 3 to the start according to FIGS. 2 and 4. In the location.
圖6顯示第一套筒構件6位於根據圖4之其相對於第二套筒構件7的第二位置中，其中接合特徵15此時配置於內殼體10的外螺紋13之螺紋式段的一灣部(bay)中。在此位置中，第一套筒構件6能夠相對於內殼體10旋轉，俾使第一套筒構件6可相對於內殼體10移行於外螺紋13中的一螺旋路徑上。在根據圖6的位置中，對應於圖4的位置，第一及第二套筒構件6、7可一起移行於相對於內殼體10之一螺旋路徑上，其中第一套筒構件6移行於外螺紋13中且第二套筒構件7移行於內殼體10的外螺紋12中。並且，經界定的停止特徵(stop feature)18(與圖5比較)係提供第一套筒構件6相對於內殼體10的一經界定位置並限定第一套筒構件6的進一步螺旋運動。根據圖6的停止位置可例如為一初始撥動位置，可自其開始一經預界定量的藥品之任何撥動。為此，在一劑量的一藥劑已經被傳輸至一患者之後，組件可返回至此離散位置(discrete position)，藉以能夠再度自此位置開始作另一劑量的後續撥動。Figure 6 shows the first sleeve member 6 in its second position relative to the second sleeve member 7 according to Figure 4, wherein the engagement feature 15 is now disposed in the threaded section of the external thread 13 of the inner casing 10. In a bay (bay). In this position, the first sleeve member 6 is rotatable relative to the inner casing 10 such that the first sleeve member 6 is movable relative to the inner casing 10 on a helical path in the outer thread 13. In the position according to Fig. 6, corresponding to the position of Fig. 4, the first and second sleeve members 6, 7 can be moved together in a helical path relative to the inner casing 10, wherein the first sleeve member 6 is moved In the external thread 13 and the second sleeve member 7 travels in the external thread 12 of the inner casing 10. Also, a defined stop feature 18 (compared to FIG. 5) provides a defined position of the first sleeve member 6 relative to the inner casing 10 and defines a further helical movement of the first sleeve member 6. The stop position according to Fig. 6 can for example be an initial toggle position from which any toggle of a predefined amount of medicament can be initiated. To this end, after a dose of a medicament has been delivered to a patient, the component can be returned to this discrete position so that subsequent doses of another dose can be resumed from this position again.
根據圖5及6的第三接合特徵15具有下列優點，只要組件尚未安全地橫越進入起動狀態，則防止第一套筒構件6與按鈕4一起的一旋轉運動。這係指一使用者必須進行按鈕4與第一套筒構件6一起的一軸向運動，藉以例如在可進行按鈕4與第一及第二套筒構件6、7一起的一旋轉撥動運動之前分別起動組件或藥物傳輸裝置1。因此，第三接合特徵15係有助於改良裝置的操控並防止裝置的意外或非意願操作，特別是對於有限敏捷度人員尤然。The third engagement feature 15 according to Figures 5 and 6 has the advantage of preventing a rotational movement of the first sleeve member 6 together with the button 4 as long as the assembly has not yet safely traversed into the activated state. This means that a user must perform an axial movement of the button 4 together with the first sleeve member 6, whereby, for example, a rotational movement of the button 4 with the first and second sleeve members 6, 7 can be performed. The component or drug delivery device 1 is activated separately before. Thus, the third engagement feature 15 helps to improve the handling of the device and prevent accidental or unintended operation of the device, particularly for people with limited agility.
圖7顯示根據圖3至6之組件在組件已被起動後之一操作狀態。特別來說，圖7顯示一撥動狀態，其中已經撥動一藥劑之一預定量、亦即一預定劑量。基於此目的，按鈕4及第一套筒構件6與第二套筒構件7已經一起被旋轉，其中第一及第二套筒構件6、7已經相對於內殼體10在右方向遠離內殼體10移行於一螺旋路徑上，俾使按鈕4及第一套筒構件6在右方向突起至外殼體3外。朝向內殼體10，外殼體3具有一切口並受隱藏藉以改良第一及第二套筒構件6、7與內殼體10之間螺紋式接合的更好顯示，而對於組件的機械行為無任何影響。Figure 7 shows an operational state of the assembly according to Figures 3 through 6 after the assembly has been activated. In particular, Figure 7 shows a toggle state in which a predetermined amount of a medicament has been dialed,That is, a predetermined dose. For this purpose, the button 4 and the first sleeve member 6 and the second sleeve member 7 have been rotated together, wherein the first and second sleeve members 6, 7 have been remote from the inner casing relative to the inner casing 10 in the right direction The body 10 travels on a spiral path such that the button 4 and the first sleeve member 6 project out of the outer casing 3 in the right direction. Facing the inner casing 10, the outer casing 3 has a port and is hidden to improve the better display of the threaded engagement between the first and second sleeve members 6, 7 and the inner casing 10, while the mechanical behavior of the assembly is not Any impact.
在撥動動作期間，提供顯示資訊5，其指示出一藥劑的一預定劑量。圖7顯示撥動的一中間階段(例如80單位的47)。During the toggle action, display information 5 is provided indicating a predetermined dose of a medicament. Figure 7 shows an intermediate stage of the toggle (e.g., 47 units of 80 units).
按鈕4與套筒構件67一起可從如圖7描繪的位置在左方向朝向內殼體10軸向地移動，藉以驅使一活塞桿(未圖示)成為相對於內殼體10的軸向運動，俾可對應於根據圖1及2的一裝置使一藥劑的經撥動劑量1被驅出一卡匣出口外。The button 4, together with the sleeve member 67, can be moved axially in the left direction toward the inner casing 10 from the position depicted in FIG. 7, thereby driving a piston rod (not shown) to move axially relative to the inner casing 10.俾 may correspond to a device according to Figures 1 and 2 such that the dialed dose 1 of a medicament is driven out of a cassette outlet.
圖8顯示內殼體10的立體剖切圖，其容納一活塞桿17，一驅動器16及至少部份地容納一按鈕4。按鈕4耦合至驅動器16，俾使按鈕4的一運動傳遞至驅動器16。詳言之，當按鈕4旋轉時，驅動器16亦旋轉(例如以供撥動根據圖7的一劑量)；當按鈕4相對於內殼體10軸向地移動時，驅動器16亦如此。Figure 8 shows a perspective cutaway view of the inner casing 10 housing a piston rod 17, a driver 16 and at least partially receiving a button 4. The button 4 is coupled to the driver 16 to cause a movement of the button 4 to be transmitted to the driver 16. In particular, when the button 4 is rotated, the driver 16 is also rotated (e.g., for a dose according to Figure 7); when the button 4 is moved axially relative to the inner housing 10, the driver 16 is also the same.
此外，驅動器16螺紋式耦合於活塞桿17(請見箭頭)，俾使驅動器16在左下方向的一軸向運動驅使活塞桿17進入一螺旋運動而令活塞桿17亦被驅動成左下方向。活塞桿17可提供任何螺紋特徵以供螺紋式接合於驅動器16。例如，活塞桿16可提供一雙生螺紋配置(twin thread arrangement)。In addition, the driver 16 is threadedly coupled to the piston rod 17 (see arrows) such that an axial movement of the driver 16 in the lower left direction drives the piston rod 17 into a helical motion such that the piston rod 17 is also driven in the lower left direction. The piston rod 17 can provide any threaded feature for threaded engagement with the driver 16. For example, the piston rod 16 can provide a twin thread arrangement.
特別來說，圖8描繪從活塞桿17的一初始位置進入活塞桿17的一起動位置之一過渡(transition)，在該位置中活塞桿17係根據圖1及2抵靠一卡匣2的一塞子。利用此方式，可移除位於其初始位置的活塞桿17與一卡匣2的一塞子19之間的一刻意間隙。可藉由根據圖3及4內容的說明與第一套筒構件6一起移動按鈕4來達成此作用。In particular, Figure 8 depicts a transition from the initial position of the piston rod 17 into the co-operating position of the piston rod 17, in which the piston rod 17 abuts against a cassette 2 according to Figures 1 and 2. A stopper. In this way, a deliberate gap between the piston rod 17 in its initial position and a plug 19 of a cassette 2 can be removed. Can be based on the contents of Figures 3 and 4It is explained that the button 4 is moved together with the first sleeve member 6 to achieve this effect.
當活塞桿17過渡進入其起動位置(請見如圖8描繪之活塞桿17的位置)時，組件可用來撥動及配送預定劑量的藥劑，其中根據圖7內容的說明發生撥動，且其中根據圖8內容的說明發生配送。藉由下列方式發生後者操作：以內殼體10中的塞子19之方向軸向地壓抵按鈕4及驅動器16，俾使活塞桿17亦在軸向方向被驅動並推押塞子19而可根據圖1及2令藥品被驅出裝置1的一卡匣2外。When the piston rod 17 transitions into its starting position (see the position of the piston rod 17 as depicted in Figure 8), the assembly can be used to toggle and dispense a predetermined dose of medicament, wherein a toggle occurs according to the description of Figure 7, and wherein Delivery occurs according to the description of the contents of FIG. The latter operation occurs in the following manner: the button 4 and the driver 16 are axially pressed in the direction of the plug 19 in the inner casing 10, so that the piston rod 17 is also driven in the axial direction and pushes the plug 19 according to the figure. The 1 and 2 drugs are driven out of the cartridge 1 of the device 1.
所描述的實施例僅為示範性實施例而不限制本揭示的基本概念，其中可進行一用於一藥物傳輸裝置的組件之從一初始狀態至一起動狀況的一過渡，其中第一及第二套筒構件6、7可在初始狀態中移動至彼此並在一起動狀態中被永久性旋轉與軸向地鎖定至彼此。這使一活塞桿能夠從一初始位置橫越至一預定的第二位置，其中活塞桿處於一起動狀態。利用此方式，可移除組件的一初始狀態中位於活塞桿與一卡匣塞子之間的一空氣間隙。這有助於更良好地操控及預備一藥物傳輸裝置以供進一步操作，而不需要進行空氣射擊並拋棄昂貴藥品以供起動藥物傳輸裝置。The described embodiments are merely exemplary embodiments and do not limit the basic concepts of the present disclosure, wherein a transition from an initial state to a dynamic condition of a component of a drug delivery device can be performed, wherein the first and the first The two sleeve members 6, 7 are movable to each other in the initial state and are permanently rotated and axially locked to each other in the moving state. This enables a piston rod to traverse from an initial position to a predetermined second position wherein the piston rods are in a co-operating state. In this manner, an air gap between the piston rod and a clicker plug can be removed in an initial state of the assembly. This helps to better manipulate and prepare a drug delivery device for further operation without the need to shoot air and discard expensive drugs for starting the drug delivery device.
4‧‧‧按鈕4‧‧‧ button
5‧‧‧顯示資訊5‧‧‧ Display information
6‧‧‧第一套筒構件6‧‧‧First sleeve member
7‧‧‧第二套筒構件7‧‧‧Second sleeve member
8‧‧‧接合特徵8‧‧‧ joint features
9‧‧‧接合特徵9‧‧‧ joint features
10‧‧‧內殼體10‧‧‧ inner casing
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13015905 | 2013-03-13 |
| Publication Number | Publication Date |
|---|---|
| TW201532639Atrue TW201532639A (en) | 2015-09-01 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW103108585ATW201532639A (en) | 2013-03-13 | 2014-03-12 | Assembly for a drug delivery device and drug delivery device with such an assembly |
| Country | Link |
|---|---|
| TW (1) | TW201532639A (en) |
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