Source: https://patents.google.com/patent/CN103945880B/en
Timestamp: 2020-07-10 17:22:31
Document Index: 210017588

Matched Legal Cases: ['art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 200', 'art 208', 'art 200', 'art 200', 'art 200', 'art 1102', 'art 908', 'art 1508', 'art 1102', 'art 1508', 'art 1600', 'art 1508', 'art 1508', 'art 1508', 'art 1504', 'art 1506', 'art 7', 'art\n202', 'arts\n300', 'arts\n1506']

CN103945880B - There is the automatic injector that independent pin inserts - Google Patents
There is the automatic injector that independent pin inserts Download PDF
CN103945880B
CN103945880B CN201280043854.7A CN201280043854A CN103945880B CN 103945880 B CN103945880 B CN 103945880B CN 201280043854 A CN201280043854 A CN 201280043854A CN 103945880 B CN103945880 B CN 103945880B
CN201280043854.7A
CN103945880A (en
S.贝赫曼
F.马德森
E.W.约翰森
默克专利股份公司
2011-09-09 Priority to US201161532892P priority Critical
2011-09-09 Priority to US61/532892 priority
2012-09-10 Application filed by 默克专利股份公司 filed Critical 默克专利股份公司
2012-09-10 Priority to PCT/IB2012/002247 priority patent/WO2013034984A2/en
2014-07-23 Publication of CN103945880A publication Critical patent/CN103945880A/en
2016-08-17 Publication of CN103945880B publication Critical patent/CN103945880B/en
239000007924 injection Substances 0.000 claims abstract description 590
238000002347 injection Methods 0.000 claims abstract description 589
239000003814 drug Substances 0.000 claims abstract description 117
239000011257 shell materials Substances 0.000 claims description 45
229940079593 drugs Drugs 0.000 abstract description 41
208000003455 Anaphylaxis Diseases 0.000 description 5
230000002052 anaphylactic Effects 0.000 description 1
Disclose a kind of automatic injector with the sequential control that pin inserts and dosage is injected.Having the injection tube (900) of pin to be movably positioned in housing (400) between primary importance and the second position, in primary importance, pin (902) is contained in described housing, and in the second position, pin is projected into outside described housing.Plunger rod tube (100) has at least one locking member being configured to normally lock onto in plunger rod tube by plunger rod (1500).Injection tube actuator (1200) exerts a force to make injection tube move to the second position from primary importance together with plunger rod tube, plunger rod and plunger rod actuator on injection tube.In the second position, locking member is unlocked and discharges plunger rod, thus actuation plunger bar actuator is so that plunger rod advances in injection tube, for carrying at least one drug dose.
There is the automatic injector that independent pin inserts
The present invention relates to automatic injector (e.g., medical automatic injector), and particularly relate to be able to insert individually Enter pin and carry out the automatic injector of injection medicament from the cartridge case containing medicament or the injection tube that is pre-charged with.The present invention especially relates to And pin inserts and the automatic injector that can be performed injected by single drive mechanism by medicament.
Automatic injector is to it is well known in the art that and be generally preferred for oneself by user to use medicament, e.g., is used for The subcutaneous injection of medicament, described medicament e.g. insulin, for treating or alleviate the medicine of multiple sclerosis, flu, lupus etc. Agent；Or the emergency injection for such as epinephrine or adnephrin, such as it is expelled in muscular tissue.
It is generally of different length for subcutaneous injection and the pin for being expelled in muscular tissue.It is commonly used for subcutaneous The pin of injection is of about 12mm(" half inch "), and the pin for being expelled in muscular tissue can have the length of 20mm to 25mm (" one inch "), to guarantee to arrive muscular tissue.
Selected pin hole also can affect the patient's uncomfortable degree during injecting.Aperture is the least, the commonly provided trouble Person's comfortableness is the biggest, and aperture is the biggest, it is allowed to liquid is the fastest via pin conveying and has less power.Therefore, pin is being selected Need during hole to take into account the feature providing acceptable patient comfort and liquid to carry via pin.
Anaphylactic reaction tends to the problem becoming constantly increasing, and for treatment food, insecticide stung wound or bite, medicine For the severe allergic of other anaphylactogen reaction (anaphylaxis) and the inborn or anaphylaxis of exercise induced, generally make With epinephrine or adnephrin.
Epinephrine rapid operation disappears anaphylactoid symptom, and is expelled in the muscle of the superolateral front portion of thigh Epinephrine be generally used for hypersensitive emergency treatment.
Generally, epinephrine automatic injector is that the epinephrine for injecting the single dose measured in advance is for mistake The syringe being intended for single use of the emergency treatment of quick disease.
WO2012/045827 discloses a kind of automatic injector, and it has for plunger rod is connected to injection tube or cloth Put the layout on the retainer in injection tube.But, disclosed automatic injector disadvantageously, single compression spring should For pin insert and injection medicament, this is because the resistance penetrating the pin of skin can tend to by injection tube in injection tube carrier to Rear promotion, thus retainer can contact the plunger rod moved forward and discharge medicament too early, and this may result in wet injection.
US 7,785,292 discloses a kind of automatic injector including housing, and the most single drive mechanism is used for inserting pin And injection medicament.Before allowing piston to be moved forward to injection medicament, injection tube moves to forward facing position.Locking mechanism is at note Shooting cylinder does not makes actuator engage with injection tube when forward facing position, and makes injection tube and housing when injection tube position forwardly Engage.
The document of prior art discloses the single drive mechanism of use, and the joint of single drive mechanism depends on injection tube Position switches.
It is an object of the invention to, in the case of simple automatic injector is provided, it is provided that pin inserts and medicament is injected Reliable separation with the risk of minimum removing dampness injection.
According to the first aspect of the invention, it is provided that there is the automatic injection of the sequential control that pin inserts and dosage is injected Device.Automatic injector can have the housing for accommodating the injection tube with pin, and described injection tube can be positioned at movably In described housing between primary importance and the second position, in described primary importance, described pin is contained in described housing, The described second position, described pin is projected into outside described housing.Additionally, housing receivable plunger rod and plunger rod tube, described post Stopper rod is configured to advance in described injection tube for carrying at least one drug dose.Plunger rod tube can have at least one Locking member, it is configured to interact with plunger rod stop part to be normally locked in plunger rod tube by plunger rod.Injection Cylinder actuator may be configured to exert a force on injection tube, so that injection tube moves to the second position from primary importance, and note Shooting cylinder actuator is also configured to make the plunger rod tube with plunger rod advance to the second position.Plunger rod actuator may be configured to Exert a force on plunger rod so that plunger rod advances to carry at least one drug dose in injection tube.Housing may be configured to Make when injection tube and plunger rod tube advance to the second position locking member unlock and discharge plunger rod from plunger rod tube.Therefore, Plunger rod actuator can be actuated so that plunger rod advances to carry at least one drug dose in injection tube.Therefore, injection Cylinder actuator and plunger rod actuator can be single actuator.
The advantage that injection tube actuator and plunger rod actuator are provided as single drive mechanism is, reduces wet note Penetrate the risk of (that is, liquid preparation spills during pin inserts) from pin.
According to a further aspect in the invention, it is provided that there is the automatic injection of the sequential control that pin inserts and dosage is injected Device.Automatic injector can have the housing for accommodating the injection tube with pin, and injection tube can be positioned at described movably In housing between primary importance and the second position, in described primary importance, described pin is contained in described housing, described The second position, described pin is projected into outside described housing.Additionally, housing receivable plunger rod and plunger rod tube, described plunger rod It is configured to advance in described injection tube for carrying at least one drug dose.Plunger rod tube can have at least one locking Parts, it is configured to interact with plunger rod stop part to be normally locked in plunger rod tube by plunger rod.First spring May be configured to exert a force on injection tube, so that injection tube moves to the second position from primary importance, and the first spring is also May be configured to make the plunger rod tube with plunger rod advance to the second position.Second spring may be configured to exert a force to plunger rod It is upper so that plunger rod advances to carry at least one drug dose in injection tube.Housing may be configured to when injection tube and plunger rod Pipe advances to make locking member unlock during the second position and discharge plunger rod from plunger rod tube.Therefore, the second spring can be actuated So that plunger rod advances for carrying at least one drug dose in injection tube.
Before the first spring being configured to make injection tube advance in the housing being provided and being configured to make plunger rod in injection tube Another advantage of the second spring entered is, can select spring performance according to purpose.Such as, in order to pin is pushed in skin, Typically requiring power the least compared with when from injection tube injection medicament, described power depends on pin hole.Therefore, especially when initially When power is less than the power needed for injection medicament, the design of spring may be the most complicated, and is difficult to be obtained by single spring.
In another aspect of the present invention, the automatic of a kind of sequential control with pin insertion and dosage injection is disclosed Syringe.The injection tube with pin can be positioned at movably in described housing between primary importance and the second position, Described primary importance, described pin is contained in described housing, and in the described second position, described pin is projected into outside described housing.Post Stopper rod pipe can have at least one locking member, and it is configured to normally be locked in plunger rod tube plunger rod.Injection tube drives Moving part exerts a force on injection tube so that injection tube together with plunger rod tube, plunger rod and plunger rod actuator from first Put mobile to the second position.In the second position, locking member can unlock to discharge plunger rod, thus actuation plunger bar actuator with Plunger rod is made to advance in injection tube for carrying at least one drug dose.
Particularly when injecting a medicament in muscular tissue, compared to for hypodermic pin, generally use longer Pin, i.e. be typically about 12mm(" half inch " for hypodermic pin), and can for the pin that is expelled in muscular tissue There is the length (" one inch ") of 20mm to 25mm, to guarantee to arrive muscular tissue.Due to for being injected in muscular tissue The size of longer pin and be easy to inject a medicament into the requirement of the minimum force in muscular tissue, therefore bigger power may must be stored up Deposit in the spring.During the whole shelf life of automatic injector, store high potential energy in the spring also added injection automatically Peripheral part of device is to especially in intensity and therefore requirement in terms of manufacturing cost.
Additionally, when manufacturing the automatic injector with big volume, insert and medicament for pin using single spring Relatively closed tolerance required during both injections may be the most crucial.Therefore, it is a further advantage of the present invention that the fewest part phase For moving each other, thus obtain the system more sane relative to manufacture process.Additionally, it is provided that a spring inserts pin and note Penetrate medicament it is required that spring can prolong in the length bigger compared to the spring diameter being generally arranged in automatic injector Stretch.Additionally, the design of spring performance (as power is distributed) can be simply too much, and therefore reduce the cost of spring.
It can be appreciated that the locking member cooperated with housing or intermediate member (such as reloading handle) can control plunger rod Motion.Therefore, the motion of plunger rod and the injection of thus medicament are controlled by housing or intermediate member.
It is a further advantage of the present invention that for discharge injection tube with allow insert pin mechanism with for discharge for noting The mechanism of the plunger rod penetrating medicament departs from.Therefore, it is being located at the end stop inserted for pin that injection tube locks and is passing through Directly pass is there is not between the release of the plunger rod that the alignment of plunger rod and housing or intermediate member (e.g., reloading handle) provides Connection.Therefore, the inexactness in pin injection process will not be transferred to medicament injection inherently.Therefore, when the release of injection tube When may be configured to discharge plunger rod, the release of injection tube mechanically can depart from plunger rod release.
Locking member can include at least one deflectable member, and housing may be configured to when injection tube and plunger rod tube Advance to during the second position, allow at least one deflectable member to deflect away from plunger rod.
In one or more embodiments, plunger rod tube and injection tube can interconnect, in order to plunger rod tube can not be relative to note Shooting cylinder moves, and vice versa.
Housing can have opening, and such as window or widened section, described opening is configured to advance to the second position in plunger rod tube Time be directed at at least one deflectable member.By making at least one deflectable member be directed at opening, at least one is deflectable Parts may be configured to deflect through or towards opening.When the plunger rod tube with at least one deflectable member is not at second When putting, the inner surface of housing can prevent at least one deflectable locking member from deflecting, and e.g., is deflected outward by, i.e. relative to injection tube And/or the longitudinal axis radial deflection of plunger rod tube.Therefore, plunger rod is lockable in plunger rod tube, and plunger rod actuator (such as the second spring) will remain in compressive state, and plunger rod can not be made to actuate forward in injection tube.Only at plunger rod Pipe and shell nozzle are on time, and at least one deflectable member can deflect, and thus from plunger rod tube release or solution lock Stopper rod.When plunger rod is released from plunger rod tube, plunger rod actuator will be actuated, and before making plunger rod in injection tube Enter, thus delivery of medicaments dosage.
Therefore, when discharging plunger rod, plunger rod actuator can make plunger rod advance in syringe, this is because plunger Bar stop part can be through the locking member of overshoot.Therefore, advance in injection tube in the front end of plunger rod, and plunger rod stop part Can move forward to be administered in plunger rod tube and terminate stop part.Therefore, dosage to be injected can be by being discharged into from plunger rod The distance of administration end stop part is multiplied by the diameter of injection tube and determines.
Plunger rod stop part can have angled surface, and it is naturally pressed against the angled table in deflectable locking member On face.Therefore, when plunger rod is promoted forward by plunger rod actuator, plunger rod forces deflectable locking member towards described opening Deflection.
In one or more embodiments, at least one deflectable locking member can be for the motion of plunger rod Down position be hinged in plunger rod tube.Therefore, at least one deflectable locking member is higher, this is because thrust rather than draw Power is applied at least one deflectable locking member.Deflectable locking member is hinged on another advantage of down position It is, it is ensured that only when the whole length of deflectable locking member is opposed with whole opening, deflectable locking member is the most deflectable. This also implies, and automatic injector is only just guaranteeing what the exact sequence that medicament is injected performed after the pin formed completely inserts Control aspect is more sane.Specifically, for having the acute medicament quickly injected of medicine, i.e. when using big vent needle, It is important that sequential control is sane.
As described above, plunger rod actuator can include spring, e.g., compression spring, and in certain embodiments, plunger rod Spring can at one end be strongly attached in plunger rod tube.
Driving force can be applied directly on plunger rod (e.g., in plunger rod flange) by plunger rod actuator, in order to such as Only drive forwards plunger rod.The advantage being applied directly on plunger rod by driving force is, it may not be necessary to complicated part is come Make the loading between different piece move, and additionally, power can be applied in a controlled manner, the most substantially do not have or significantly subtract Little in how much power will actually be applied on plunger rod and the uncertainty of the therefore aspect how soon medicament is discharged.
Plunger rod actuator (such as the second spring) such as may be provided in plunger rod tube, and injection tube actuator is (such as the first bullet Spring) may be provided in outside plunger rod tube.
Housing also can accommodate the injection bobbin for keeping injection tube, and injection tube can have injection tube flange, then notes Shooting cylinder flange may be locked between injection bobbin and plunger rod tube.Therefore, including injection tube, it is interconnected to for plunger rod and plunger rod The injection tube assembly of the injection bobbin of the plunger rod tube that actuator is positioned in can move integrally as one.By injection tube, The advantage that injection bobbin and plunger rod tube lock together is, part accidental movement relative to each other does not interferes with medicament Conveying.
In one or more embodiments, automatic injector can be the automatic injector that can reload.
In certain embodiments, automatic injector may be configured to carry more than one drug dose, e.g., two medicament agent Amount, e.g., multiple drug dose etc., e.g., two single drug dose etc..In certain embodiments, the second dosage or any its The conveying of his dosage can it will be clear that operator input actuate automatic injector, for other inject.
It is an advantage of the current invention that this automatic injector can be used for depending on the user of automatic injector or the behaviour of patient Make to carry one or more drug dose.Therefore, one or more single dosage can such as from contain medicament cartridge case or The injection tube conveying being pre-charged with.It is an advantage of the current invention that it will be clear that operator or patient/user input to permit Permitted to carry additional dose.Operator's input can include that operation reloads mechanism, and reload mechanism and can include actuating injection automatically Device is injected for another.
Plunger rod tube at least can include allowing conveying the first dosage and/or the first locking member of the second dosage and the second lock Limiting-members, or plunger rod tube can include allowing conveying the first dosage, the second dosage and/or multiple locking members of multiple dosage. Each in first locking member, the second locking member and/or multiple locking member all may be configured to and plunger rod stop part phase Engage with continuing.First locking member, the second locking member and/or multiple locking member can be the first deflectable locking member, Two deflectable locking members and/or multiple deflectable locking member.It is an advantage of the current invention that the release for plunger rod tube Two windows are located on same component, i.e. reloading on handle, therefore manufacturing tolerance can be better controlled.
Housing can include being configured to when injection tube is in the second position respectively with the first locking member, the second locking member And/or the first opening, the second opening and/or multiple opening of multiple locking member alignment.
Can be devised, any intermediary element (e.g., handle) that opening is defined between housing and plunger rod tube In.Therefore, deflectable locking member can the inner side of thus intermediary element limit, and opening can be only defined in intermediary element or any In intermediary element and housing, such as, to allow the deflection completely of locking member.
Can be devised, the principle that proposed allows any amount of injection, and automatic injector can include one group, two Group and/or many group locking members and corresponding opening, wherein each locking member and corresponding opening can be respectively provided at housing and/or appoint At independent position on the periphery of what intermediary element and plunger rod tube.
The advantage of opening is provided in the element (as at housing or in intermediary element) to be, substantially only one element Tolerances dosage conveying in manufacture controls.Therefore, the first dosage carried and other dosage any can with aligned with each other, And from but highly controllable.
In order to carry more than one dosage, automatic injector can be actuated more than once, and therefore plunger rod actuator is also One or many can be actuated.Plunger rod actuator may be configured to make plunger rod move when the first of plunger rod actuator actuates First distance, and move another distance when another of plunger rod actuator is actuated.
After having performed the first medicament injection or the injection of other medicament, engageable second sticking department of plunger rod stop part Part or other locking member.It is therefoie, for example, when having carried the first dosage, it is deflectable that plunger rod stop part will engage second Locking member, and thus be ready to be directed at just conveying second dose with the opening in housing once the second deflectable locking member Amount.
In one or more embodiments, the second of plunger rod actuator actuate can be after the reloading of automatic injector Carry out, and carry out after the repeating motion from primary importance to the second position at injection tube and/or injection tube assembly.
In one or more embodiments of the invention, it is possible to provide a kind of housing having for accommodating injection tube assembly The automatic injector that can reload.Injection tube assembly can include the injection tube with pin, and described injection tube assembly can move Being positioned in described housing between primary importance and the second position, in described primary importance, described pin is contained in institute dynamicly Stating in housing, in the described second position, described pin is projected into outside described housing.Injection tube assembly may also include that plunger rod, described Plunger rod is configured to advance in described injection tube for carrying at least one drug dose；And plunger rod actuator, institute State plunger rod actuator to be configured to exert a force to described plunger rod so that described plunger rod advance in described injection tube with In carrying at least one drug dose.Additionally, injection tube actuator may be housed in housing, and it is configured to exert a force to injection On cartridge module, so that injection tube moves to the second position from primary importance.Housing may also include and reloads handle, described adds again Carry handle construction become reload described automatic injector for inject another drug dose, the wherein said handle that reloads can connect Receive described injection tube assembly so that described in reload the operator of handle or patient's operative configuration becomes to make described injection tube assembly It is withdrawn into described primary importance and reloads described injection tube actuator simultaneously, with so that described automatic injector prepares It is used on another drug dose of conveying.Injection tube assembly may also include injection tube retainer, and it is movably positioned in injection tube In and sealing injection cylinder content, and plunger rod be configured to engage injection tube retainer.
In one or more embodiments, it is possible to provide a kind of injection tube having for accommodating the injection tube including having pin The automatic injector reloaded of the housing of assembly.Described injection tube assembly can be positioned in described housing movably Between primary importance and the second position, in described primary importance, described pin is contained in described housing, at described second Putting, described pin is projected into outside described housing.Injection tube assembly may also include plunger rod actuator, and described plunger rod actuator constructs Become to exert a force to described plunger rod, so that described plunger rod advances for carrying at least one medicament in described injection tube Dosage.Housing also can accommodate injection tube actuator, and described injection tube actuator is configured to exert a force to described injection tube assembly, So that described injection tube moves to the described second position from described primary importance, and automatic injector also includes reloading hands Handle, described in reload handle construction become reload described automatic injector for inject another drug dose.Described reload Handle may be connected to described injection tube assembly so that described in reload the operator of handle or patient's operative configuration becomes to make described note Shooting cylinder assembly is withdrawn into described primary importance and reloads described injection tube actuator simultaneously.
In one or more embodiments, it is possible to provide a kind of housing having for accommodating needle shield and injection tube assembly The automatic injector that can reload.Injection tube assembly can include band pin and the injection tube of plunger rod actuator, and described plunger rod drives Moving part is configured to exert a force to plunger rod, so that described plunger rod advances for carrying at least one in described injection tube Drug dose.Injection tube actuator may be configured to exert a force to described injection tube assembly, so that described injection tube is from described Primary importance moves to the described second position, and reloads handle and may be configured to reload described automatic injector for transmission Another drug dose, the wherein said handle that reloads is connected to described injection tube assembly and described needle shield so that described add again The operator or the patient's operative configuration that carry handle become to make described injection tube assembly be withdrawn into described primary importance and add simultaneously again Carry described injection tube actuator and discharge described needle shield.
In one or more embodiments, it is possible to provide a kind of method reloading automatic injector, wherein can reload Automatic injector has for accommodating needle shield and the housing of injection tube assembly.Injection tube assembly can include having pin and plunger rod The injection tube of actuator, described plunger rod actuator is configured to exert a force to plunger rod, so that described plunger rod is at described note Shooting cylinder is advanced for carrying at least one drug dose.Injection tube actuator may be provided in housing, and is configured to execute power It is added to described injection tube assembly, so that described injection tube moves to the described second position from described primary importance, described Dosage can be transmitted in two positions.Automatic injector may also include and includes reloading handle, described in reload handle construction become reload Described automatic injector is for transmitting another drug dose, and wherein the method includes: reload handle described in operation so that institute State injection tube assembly to be withdrawn into described primary importance, reload described injection tube actuator and discharge described needle shield, thus Described automatic injector is made to be ready for carrying another the second dosage.
In one or more embodiments, it is possible to provide a kind of operation can reload the method for automatic injector.Automatically injection Device can include the housing for accommodating injection tube assembly.Injection tube assembly can include the injection tube with pin, and described injection tube Assembly can be positioned at movably in described housing between primary importance and the second position, in described primary importance, described Pin is contained in described enclosure interior, and in the described second position, described pin is projected into outside described housing.Injection tube assembly also can wrap Including plunger rod actuator, described plunger rod actuator is configured to exert a force to plunger rod, so that described plunger rod is at described note Shooting cylinder is advanced for carrying at least one drug dose, and housing also can accommodate and is configured to exert a force to described injection tube Assembly is so that described injection tube moves the injection tube actuator to the described second position from described primary importance, for actuating State automatic injector skin sensor, for described injection tube assembly is locked in described primary importance injection tube lock, with And reload handle, wherein the method can comprise the following steps that and actuates described skin sensor so that described injection tube lock rotates And discharge described injection tube assembly；Described injection tube assembly is made to move to the described second position from described primary importance；Release institute State plunger rod actuator with delivery of medicaments dosage；Make described skin sensor deexcitation to cover described pin and by described skin Sensor is locked in deexcitation position.Described method may also include by operation described in reload handle reload described automatically Syringe, wherein said reloading comprises the steps that and makes described injection tube assembly move to described primary importance from the described second position； Reload described injection tube actuator；Described injection tube assembly is locked in described primary importance；And unlock described skin biography Sensor, the most described automatic injector is ready for carrying another drug dose.
In the other embodiment of the present invention, it is possible to provide a kind of automatic injection for carrying at least one drug dose Device.Automatic injector can have the housing of the injection tube assembly for accommodating the injection tube including band pin.Described injection tube assembly Can be positioned at movably in described housing between primary importance and the second position, in described primary importance, described Pin is contained in described enclosure interior, and in the described second position, described pin is projected into outside described housing.Automatic injector also can wrap Include the sound generator being configured to send sound when being administered.
The advantage of above-mentioned automatic injector is, this mechanism is completely reversibility.Therefore, the appointing of the form such as skin sensor What sharp object protection device may be locked in centre position, i.e. after conveying the first dosage and reload automatic injector it Before.Therefore, between dosage carries, patient is also protected from acupuncture.Particularly with advantage for the acute treatment of such as allergy Being, after the first dosage conveying or the injection of the first dosage, needle shield can be locked, this is because patient is perhaps without entering The treatment of one step, and therefore throw aside after the first dosage conveying or re-use described automatic injector.Therefore, in order to safely Disposing automatic injector or injection tube assembly, skin sensor can advantageously cover pin after delivered dose, and also may be used Forward facing position it is locked in immediately after dosage carries.
It is a further advantage of the present invention that automatic injector has compact size, this is because injection tube assembly and pin protect It is enclosed within when reloading described device and recalls, thus limit the length of described device.
The present invention can provide a kind of automatic injector, and it is independent at least twice that it allows patient to have from the execution of single injection tube Inject, and operator or patient can apply similar step to perform the first injection, the second injection and other injection any.Operator Or patient may must actuate automatic injector, to allow the second or further medicament injection or conveying.
Run through present disclosure, automatic injector have the forward end being intended to be pressed against on patient skin in its one end or Front end, and towards automatic injector the other end to the back-end or rear end.Therefore, term " forward " or " downwards " are (as transported forward Move or move downward) mean when automatic injector is positioned at it for the expection operating position of injection towards front end or towards patient Skin.Similarly, backward or upwards (such as rearward movement or move upward) mean when automatic injector be positioned at its for Rear end towards automatic injector or the skin away from patient during the expection operating position injected.Additionally, the top of automatic injector End is the rear end of automatic injector, i.e. when automatic injector is positioned at it for the expection operating position of injection farthest away from trouble One end of the skin of person.
Additionally, it is to use same or different injection tubes so that automatic injector is ready to use that term " reloads " meaning Inject in another.Reloading of automatic injector is performed when injection tube is located in automatic injector.When reloading or actuating again During actuator (such as spring), power is returned to actuator.Such as, the reloading or actuate again and include reloading tension force of spring On spring.
In one or more embodiments of the invention, the automatic injector that can reload can when opening described device quilt Actuate.For the emergency injection of medicament, for operator or patient advantageously, open described device it Rear and before actuating automatic injector, need not other step, e.g., by skin sensor backup on the skin of the patient.
In one or more embodiments of the invention, injection tube actuator and plunger rod actuator are individually to drive Part.Therefore, injection tube actuator can separate with plunger rod actuator, and in certain embodiments, injection tube actuator can be bullet Property device, e.g., spring, such as compression spring.Equally, plunger rod actuator can be elastic device, e.g., spring, e.g., compression spring. Injection tube actuator may be configured to act on injection tube assembly, to be driven to second from primary importance by injection tube assembly Put.Injection tube actuator may be provided in housing, and housing is bootable or stable injectable cylinder actuator.Plunger rod actuator can construct Become to act on plunger rod, and may be provided in plunger rod tube.Plunger rod tube may be guided or stability column stopper rod actuator.
In certain embodiments, automatic injector also includes: be configured to be locked in injection tube the injection tube of primary importance Lock；And it is configured to the skin sensor of release injection tube lock when with the skin engagement of patient, wherein by being sensed by skin Device presses against actuates skin sensor on the skin of patient.
Therefore, skin sensor can be at least one of cylindrical form surrounding injection tube assembly, and skin sensing Device may be configured to be connected on skin sensor actuator.Skin sensor actuator can be elastic drive part, e.g., spring.? In one or more embodiments, skin sensor actuator is spring, and described spring may be configured to position at skin sensor It is in slack position when forward facing position.Such as, pass by skin sensor is expressed on the skin of patient to actuate skin Sensor.Therefore, operator's compressible skin sensor actuator, e.g., spring, and make skin sensor be moved back by away from skin Dynamic.Once automatic injector is removed from skin, and the skin sensor actuator (such as spring) compressed just can be released, and by This skin sensor will be promoted forward by skin sensor actuator.
In one or more embodiments, automatic injector may also include security feature, and e.g., pin protection element, e.g., pin protects Set, to protect pin and to prevent from surprisingly contacting with pin.In certain embodiments, skin sensor can cover pin, and accordingly acts as structure Cause the skin sensor of release injection tube actuator as described above, and also serve as the pin protection unit being configured to cover pin Part.However, it is contemplated that going out pin protection element (such as needle shield) can be element separate with skin sensor.Hereinafter, can be right Skin sensor carries out reference, but those skilled in the art is it will be clear that the pin protection feature of correspondence can be answered equally Use the pin protection element separated with skin sensor.
Pin protection element (such as skin sensor) may can be locked in forward facing position, in order to prevents the accident with pin from connecing Touch.Such as, pin protection element can be locked after having injected dosage or between multiple injection.Such as, pin protection element Locking projections can be included, and locking projections may be configured to only lean against when having carried the first dosage on the convex ridge of injection tube lock, Thus pin is protected element be locked in forward facing position and prevent the rearward movement of pin protection element.Can be devised, pin is protected The locking of element it be also possible to use other locking mechanism any and realizes.
Skin sensor can have the forward facing position of locking and the forward facing position of unblock equally, and such as, skin sensor Can be locked after being complete each injection circulation.In the advantage that injection circulation is complete the sensor of locking injection afterwards Being, the accident minimizing or eliminating automatic injector actuates the risk injected for another.By by skin sensor Be locked in the forward facing position of this locking, it will be clear that operator or patient input actuate automatic injector again and make institute State automatic injector and be ready for another injection circulation.Such as, skin sensor includes locking projections, and locking projections can structure Cause on the convex ridge only leaning against injection tube lock when having carried the first dosage, thus skin sensor is locked in forward facing position And prevent the rearward movement of skin sensor.Can be devised, the locking of skin sensor can use other locking machine any Structure realizes.
Reload handle to may be configured to interact further with pin protection element and/or skin sensor, to add again Make pin protection element and/or skin sensor unlock during load, and in one or more embodiments, the rotation reloading handle makes Injection tube lock rotates, so that pin protection element and/or skin sensor unlock.At unlocked position, pin can be allowed to protect element And/or the rearward movement of skin sensor, so that automatic injector is ready for another injection.In one or more realities Executing in example, pin protection element and/or skin sensor are in the unlocked position when opening described device, and in delivery of medicaments It is locked after dosage.
Thering is provided the advantage being just in the automatic injector of resting state from packaging taking-up to be, automatic injector can be answered Inject for emergency medication, e.g., anaphylaxis anaphylaxis etc..Therefore, the most important thing is for patient or user, be not required to Will be at the consideration of the function aspects of automatic injector or user's manual, but described device is by being pushed against skin by automatic injector Can directly injection medicament on skin.
There is provided the advantage to pin protection element and/or the locking of skin sensor to be after delivered dose, be in this Automatic injector in state can be thrown aside or etc. another medicament pending inject.The most advantageously, patient, Anyone contact pin and/or the accident of the automatic injector that user or manipulation are thrown aside actuate automatic injector to perform another agent The most limited presence or absence of risk of amount injection circulation.
Use reload mechanism unlock further security feature (as pin protect element, skin sensor etc.) provide The advantage of the automatic injector with security feature of completely reversibility when reloading device.Therefore, automatic injector can be provided with mark The security feature of quasi-automatic injector, it is located in the automatic injector reloaded of completely reversibility.
When automatic injector is in the position preparing delivered dose, injection tube may be locked in primary importance.Therefore, injection Cylinder initially can all be locked in primary importance (that is, when automatic injector is opened) and after each time reloads action.Injection Cylinder can be locked in primary importance by injection tube.Such as, injection tube lock can be released when actuating skin sensor.
Skin sensor actuate the rearward movement that may be configured to cause skin sensor, the thus angulation of skin sensor Degree surface may be configured to engage with the angled surface of injection tube lock, so that the lateral movement of skin sensor is changed into injection tube The angled motion of lock.Such as, skin sensor can be actuated on the skin of the patient by being pressed against by skin sensor, from And promote skin sensor backward.Injection tube lock can have a cylindrical form, and be configured so to skin sensor and be moved back by Slide in injection tube is locked time dynamic.Therefore, the angled surface of skin sensor can be the projection on the outside of skin sensor, And injection tube lock angled surface can be injection tube lock inside on projection, in order to when skin sensor injection tube lock in cunning Time dynamic, the angled surface of the angled surface of skin sensor and injection tube lock is engageable, thus the angulation of skin sensor Injection tube lock is actuated on degree surface so that it rotates.
Injection tube lock can include only by convex ridge, and injection tube assembly can only lean against stopping in injection tube lock and lean on convex ridge, from And injection tube assembly is locked in primary importance.The angled motion of injection tube lock can discharge note by making syringe lock rotation Shooting cylinder assembly, and thus from only discharging injection tube assembly by convex ridge.
In one or more embodiments, injection tube lock may also include injection tube lock and guides notch, and injection tube assembly can Including injection tube assembly projection；Injection tube assembly projection may be configured to guide in notch at injection tube lock move.Injection tube lock draws Guide groove mouth can include only by convex ridge, and the rotation of injection tube lock can make projection from only moving to release by convex ridge in guiding notch Position, wherein injection tube assembly projection can advance to injection tube along guiding downwards off-position near convex ridge, the notch path Lock end stop, so that injection tube assembly moves to the second position from primary importance.Therefore, stop when injection tube assembly end Block piece injection tube lock guide notch marches to injection tube lock end stop from off-position time, injection tube assembly can be from the One position is moved to the second position.
Guide notch can include inclined lead notch at least partially so that when injection tube assembly moves from primary importance Can further rotate to injection tube lock during the second position.
Therefore, injection tube assembly may be locked in primary importance, in this primary importance, travels forward and is limited by injection tube lock (e.g., by only limiting by convex ridge).When injection tube lock rotates, injection tube assembly can freely move forward, and injection tube actuator Can thus be released so that injection tube assembly moves to the second position from primary importance.Therefore, travel forward and can be injected by joint The injection tube assembly projection of cylinder lock end stop limits.Therefore, along automatic injector longitudinal axis from only by convex ridge to The distance of end stop may indicate that the pin traveling from primary importance to the second position, and therefore end stop can limit pin Insertion depth.
It can be seen that injection tube lock controlled injection cylinder and/or the motion (such as, travel forward) of injection tube assembly, Such as from the motion of primary importance to the second position.Therefore, injection tube lock can control the insertion of pin.
Injection tube assembly can include coaxially around the injection bobbin of injection tube and the plunger rod coaxially around plunger rod Pipe, injection bobbin and plunger rod tube are interconnected by the injection tube tube connector that can engage with plunger rod adapter.
Plunger rod actuator can at one end be strongly attached on the rear end of plunger rod tube, and is configured to engage at the other end Plunger rod.Plunger rod actuator can lock when injection tube assembly moves to the second position from primary importance, and therefore, plunger rod Same position can be maintained at when injection tube assembly moves to the second position from primary importance.Therefore, plunger rod actuator, plunger Bar and plunger rod tube can be moved forward by injection tube actuator.
Plunger rod may be configured to be released when injection tube assembly is in the second position, thus actuation plunger bar actuator with Plunger rod is made to move forward.Therefore, plunger rod engageable injection tube retainer, and thus actuate forward injection tube retainer, and Delivery of medicaments dosage.Plunger rod generally can move forward pre-spacing before plunger rod stop part bond post stopper rod in injection tube From, and prevent the motion further along of plunger rod.Preset distance may indicate that the pharmaceutical quantities depending on injection tube size and carry.
Before engaging the first plunger rod stop part, the second plunger rod stop part and/or other plunger rod stop part any, Plunger rod actuator may be configured to make plunger rod move the first preset distance when the first of plunger rod actuator actuates, at plunger The second of bar actuator when actuating, move the second preset distance, move other pre-spacing when other of plunger rod actuator is actuated From etc..First preset distance, the second preset distance and/or other preset distance can be different distances, to allow at note automatically The first of emitter actuate, second actuate and/or other actuates conveying different agents dosage afterwards.
The second of plunger rod actuator is actuated or other is actuated and after automatic injector reloads, and therefore can inject Cartridge module is after any motion of primary importance to the second position.Therefore, injection tube assembly from primary importance to the second position Motion can include so that plunger rod, plunger rod actuator and plunger rod tube move with injection tube assembly.Therefore, plunger rod Can remain locked on any plunger rod stop part, and the plunger when making injection tube assembly move to primary importance from the second position Bar actuator can not drive forwards plunger rod.After being complete the first injection circulation, plunger rod can be until actuating automatically After syringe, injection tube assembly second time and/or move to the second position from primary importance again is just released.
In one or more embodiments, the user operation reloading handle can include rotary motion, described user Operation be such as easy to actuate automatic injector and so that automatic injector be ready for the second medicament conveying and/or other Medicament carries.
Reload handle and may be configured to rotary motion, and automatic injector may also include intermediate member and (e.g., reverses Ring), the convert rotational motion reloading handle to be become the translational motion of at least injection tube assembly.
The intermediate member that can be interconnected to injection tube assembly can have projection, and described projection is configured to along reloading drawing of handle Guiding element or surface longitudinal ground are mobile, thus make injection tube assembly recall from the second position when the user reloading handle operates To primary importance.In certain embodiments, the guiding piece or the surface that reload handle can be the angled guide member reloading handle Or surface, and projection can move along inclined surface when the operation reloading handle.Therefore, injection tube assembly can be along inclined surface It is actuated, so that injection tube assembly moves to primary importance from the second position, and injection tube assembly can be made to further rotate.Cause This, the guiding piece during injection tube assembly can be locked along injection tube enters primary importance.
Projection on intermediate member can be pushed on inclined surface top and enter by the complete operation reloading handle Two reload handle notch or another reloads in handle notch.Therefore, after making injection tube assembly recall, injection tube group Part further rotates.This rotary motion can allow injection tube assembly to rotate on injection tube lock convex ridge, and is locked by injection tube assembly It is scheduled on primary importance, and so that described device is ready for another conveying.Therefore, second is arrived when middle member protrusions Reloading handle notch or another is when reloading handle notch, injection tube assembly rotates on injection tube lock convex ridge.
Second reloads handle notch and/or any another reloads handle notch and can have inclined surface, with allow from Reloading continuously of dynamic syringe.In one or more embodiments, reload handle and include that two inclinations reload handle groove Mouthful, to allow reloading continuously of automatic injector.
Second to reload handle notch can be the notch almost parallel with the longitudinal axis of automatic injector, and does not tilt Surface crown, therefore second reload handle notch and/or another reloads handle notch and can only allow lengthwise movement, thus Prevent reloading further of automatic injector.Accordingly, because the convert rotational motion of handle can not be become injection by intermediate member The translational motion of cartridge module, therefore reload handle and may not reload automatic injector and make it ready for noting for another Penetrate.
Reload operation and be operable to make the operation of automatic injector on the contrary, and such as can make injection tube actuator, injection Cylinder lock, skin sensor etc. are contrary.
In one or more embodiments, automatic injector housing may also include " preparation " state and " being not ready to " or " complete Become " the instruction of state." preparing " the first position of rotation that state may indicate that injection tube is locked, in this position, injection tube assembly is locked It is scheduled on primary importance.Can rotate relative to housing when injection tube assembly is in injection and move further along relative to housing Time, only injection tube assembly is in the first latched position just display " preparation " state in window.Additionally, when skin sensor is in During released state, " preparation " state can only indicate to operator or patient.Therefore, " prepare " state and may indicate that automatic injector exists Prepare when opening to be used, and instruction automatic injector will prepare to be used reloading of automatic injector afterwards.
Instruction can be arranged to label window, and it can disclose the syringe lock such as provided below housing or other knot any Information in constitutive element part, wherein by recording, indicating " preparation " state by color coding etc..Instruction also can be arranged to inspection Look into window, described inspection hatch can be arranged in case when automatic injector is in SBR the medicine in injection tube or medicament Visible window, and wherein when automatic injector is in any " being not ready to " or " completing " state, the observation quilt of medicine or medicament Block.
Inspection hatch also can provide the observation of medicament before injection medicament at automatic injector, thus provides medicament to use Property, the visual inspection of medicament color, quality etc..
When injection tube assembly is in primary importance, skin sensor and/or needle shield may extend up to the whole length of pin To hide pin from the sight line of patient or user, and skin sensor and/or needle shield are also configured to when carrying After dosage, pin extends up to the whole length of pin when being withdrawn.
In one or more embodiments, automatic injector may be configured to provide sound when delivery of medicaments, in order to is giving Such as sound is produced by sound generator during medicine.Sound can produce during the whole conveying of dosage, or sound can be at dosage At least some of period of conveying produces, e.g., time of delivery more than 50% during, at last 1/3rd of time of delivery Period, during substantially the entirety of time of delivery etc..Therefore, automatic injector may also include and is configured to when being administered send sound Sound generator, and in certain embodiments, sound generator can include ratch mechanism.Ratch mechanism can be any conventional ratchet Mechanism, e.g., including the ratch mechanism of flexible arm, the inclination that flexible arm is positioned to engage on plunger rod relative to injection tube assembly Tooth, such as, in order to only allow travelling forward of plunger rod.
Generally, when by injection tube delivery of medicaments, it is advantageous that by pin in a period of time after injection has occurred and that It is maintained at the appropriate location below skin.Therefore, the absorption of medicament can be significantly improved, and additionally, medicament can be reduced from injection The risk that position spills.But, it is likely difficult to differentiate when injection completes for patient or user, and therefore should be true The fixed time period after injection.
In the embodiment of some prior aries, after having injected dosage, i.e. be complete injection circulation After, produce sound, but this means during injecting, there is three phases for patient or user: first, Silent period during injection dosage；The most sound stage, i.e. be administered end signal；And be the most again silent period, on these rank Pin must be kept under the skin by section, patient or user.For patient or user, the especially use under intense strain (if emergency medication injection, then this is it may be the case that for), this is likely difficult to implement person.
It would thus be advantageous at least some of period generation sound of dosage conveying, thus the sound when injection medicament Sound indicates, i.e. provide sound when being administered, and when sound stops, pin may must be maintained at skin and assign by user A period of time.This causes only two stages, i.e. has injection stage and the silent period of sound, user in silent period Pin may be kept under the skin, and this process is simpler possibly for implementing for user.
In order to produce sound when being administered, sound generator or noisemaker (such as ratch mechanism) can be with automatic injectors It is integrally formed.
Such as, plunger rod can be the linear ratchet with multiple tooth, and described tooth is configured to and combines what plunger rod tube provided Multiple ratchets interact, in order to produce sound when plunger rod extends past ratchet.Ratch mechanism can include flexible arm, and it is fixed Position becomes the inclined teeth being positioned to engage on plunger rod relative to injection tube assembly.
Ratch mechanism allows movement the most in one direction inherently, therefore provides and only allows along forward together with plunger rod The ratch mechanism of the motion in direction, and can prevent plunger rod from returning to its initial position.Therefore, sound generator also acts as anti- Tampered component because ratch mechanism guarantee used automatic injector inseparable and with another injection tube be loaded on with In new patient or user, this is because plunger rod can not be withdrawn into initial position from injection tube.
In one or more embodiments, injection tube assembly may also include tamper-evident component (such as tampered guard member), and anti- Tampered component such as can include ensuring that the protection mechanism being moved rearwards by preventing plunger rod, e.g., ratch mechanism, as only allowed plunger The proal ratch mechanism of bar.
In one or more embodiments, automatic injector can re-use, and therefore, user may be able to be taken apart certainly Dynamic syringe is to replace injection tube.Such as, user possibility can only replace the injection tube with pin, or user possibility can Injection tube assembly is replaced with new injection tube assembly.
Generally, automatic injector may be provided in shell, and shell may be necessary when automatic injector is ready to be used It is removed.
Cartridge case or the injection tube being pre-charged with are typically provided with pin.In order to pin will be protected during transport and realizes sharp object guarantor Protecting, injection tube pin is typically provided with soft protection part and rigid protective part, i.e. rigid needle shield (RNS).So that automatically note Emitter is ready for injection, and generally, soft protection part and rigid protective part need to be removed.But, for security reasons, And owing to protection part can be difficult to by user close, therefore rigid needle shield can be implemented and remove part.Rigid needle shield removes portion Divide and at least partially around rigid protective part, and can such as grasp the spine in rigid protective part, in order to rigid protective portion Point can be removed along with rigid needle shield removes part and remove.
Shell (such as transport housing) can be such as by pulled straight motion, torsion, these combination, or the skill with this area Known to art personnel, any alternate manner removes.In certain embodiments, shell can hold injection tube assembly, but does not hold again Charging handle.Shell can be held in place by being located at the ring snap fastener reloaded between handle and shell.Shell and adding again Carry Handleset and by holding shell and the bonding strips sealing of Handleset can be reloaded.Shell can be by against reloading hands Handle slightly reverses shell and removes from automatic injector, and such as, this uses the taper knob on automatic injector, rotating Power changes into lengthwise movement, and this is partially by rotating and disconnecting adhesive tape partially by axial displacement along the longitudinal direction Part.Further, since length travel, RNS removes part can start to be pulled away from RNS, and wherein remaining dismounting of RNS is held by operator OK.The gear drive realized by rotation on taper knob contributes to operator or user was easier in the longer storage time Overcome the possible high bonding force of RNS afterwards；Moved small distance, then operator can be easily with much smaller RNS is pulled away from remaining distance by power.Reload handle and can produce longitudinal fortune in any known way relative to the torsion of shell Dynamic, such as, by taper knob, revolving force changed into lengthwise movement, or by female thread, wherein predetermined rotate along one Outward winding and will produce being longitudinally separated between handle and shell in direction.
RNS(rigid needle shield) entry needle on injection tube can be covered, and can pacify in advance before assembling automatic injector Dress is on the injector.The step making automatic injector be ready for injection can include removing the step of rigid needle shield, by This entry needle becomes exposing.In certain embodiments, removing of RNS can be the composition portion of automatic injector assembly actuation Point, and therefore come automatization by operator, user or patient.RNS removes part and may be arranged such that the automatic note including RNS Emitter is not tampered during storing, and additionally, RNS can be protected, in order to avoid RNS to show from any of its initial sealing position Work physics misplaces.Such as, the dislocation of this type of physics can be radially or longitudinally displacement, or is caused by oscillating motion etc., and this physics is wrong Automatic injector performance can be had and has a strong impact on by position.The process removing RNS can be sane and reliable, but simultaneously, RNS is carried The sealing of confession should be effectively.Therefore, when device is actuated, automatically removing of RNS can ensure that external force pair during storage cycle RNS not or has minimum Physical interaction.And, when device is actuated, it can be the most sane that RNS removes, because of For otherwise it may make operator be difficult to close to for manually removing.Therefore, the mechanism with RNS handing-over can meet two phases Anti-requirement.Additionally, it can be easy and intuitively that automatic injector and RNS remove the assembling of part.
In certain embodiments, RNS removes part can have a generally cylindrical form, but can have along its sidepiece narrow Groove, to allow the insertion of whole RNS.Additionally, RNS removes part can have U-shaped otch on the end surface of injection tube, with Just allow the existence of injection tube, and the diameter/size of U-shaped otch may be designed to the maximum gauge less than RNS, but be large enough to Not physical contact during storage, i.e. do not touch the upper part of injection tube or RNS.RNS remove part in place in the case of, It is pulled away from the longitudinal force of injection tube and will ensure that now that RNS removes the joint between the larger diameter edge on part and RNS, and thus RNS can be promoted to be pulled away from from injection tube.
RNS removes part can laterally be applied to RNS and injection tube assembly, or RNS removes part and can longitudinally apply, from And be pushed to RNS and injection tube assembly from front.Multiple extension hooks can be grasped in RNS rear, in order to by removing at RNS Apply pulling force in part and be pulled away from RNS.In another embodiment, the multiple deflectable extension finger with arrival RNS rear can It is contemplated that permission is lateral assemble or longitudinally or axially assemble.
In one or more embodiments, RNS removes and partly also can cooperate with skin sensor, in order to the most deflectable portion Divide (such as deflectable finger hook) can be pushed in skin sensor during removing via tight diametric fit.Such as, skin passes Sensor can have internal diameter, such as 12mm, only to allow hook to pass, but passes with skin owing to deflectionable part outer radial extends (diameter) Allowance free space between the internal diameter of sensor, any potential radial deflection that can minimize hook (that is, is being applied by from pulling force Stress time).
Now with reference to the accompanying drawing present invention more fully described below, shown in the drawings of the exemplary reality of the present invention Execute example.But, the present invention is presented as multi-form, and should regard as and be not limited to embodiment as herein described.But, these are real Execute example and be provided for present disclosure by for thoroughly with complete, and will fully convey the scope of the invention to this area Technical staff.Throughout, identical reference represents identical element.Therefore, will not be with reference to the description of each figure Describe identical element in detail.
Fig. 1 shows the decomposition view of automatic injector,
Fig. 2 A-G shows the explanatory view of the automatic injector being in various state in terms of user perspective,
Fig. 3 A-C shows the indicator being in different conditions,
Fig. 4 A-C shows the handle top of automatic injector and corresponding shell,
Fig. 5 A-E shows rigid needle shield removing components,
Fig. 6 A-E shows the sectional view of the automatic injector according to the present invention during the different operating stage,
Fig. 7 A-N shows that be in the various stage reloads handle, plunger rod tube and plunger rod,
Fig. 8 A-C shows the details of skin sensor,
Fig. 9 A-F shows and reloads mechanism according to the present invention,
Figure 10 A-E shows the injection tube lock guide rail being in the various stage,
Figure 11 A-B shows the detail view of inspection hatch,
Figure 12 A-C shows sound generator,
Figure 13 A-B show for single or repetition dosage carry reload handle,
Figure 14 illustrates in greater detail injection tube assembly,
Figure 15 shows another automatic injector according to an embodiment of the invention.
Hereinafter, by more detail and be described with reference to the automatic injection of any of above aspect according to the present invention Device.Provide the automatic injector 10 reloaded of a kind of housing 400 having for accommodating injection tube assembly 20.Injection tube Assembly 20 can include the injection tube 900 with pin 902, and injection tube assembly 20 can move between the first location and the second location Be positioned in housing 400, in primary importance, pin 902 is contained in housing 400, and in the second position, pin 902 is projected into shell Outside body 400.Injection tube assembly 20 may also include that and is movably positioned in injection tube 900 and sealing injection cylinder content 904 Injection tube retainer 908；It is configured to engage the plunger rod 1500 of injection tube retainer 908；And plunger rod actuator 1600, its It is configured to exert a force to so that plunger rod 1500 advances in injection tube 900 on plunger rod 1500, for conveying at least Individual drug dose.Additionally, injection tube actuator 1200 may be housed in housing 400, and it is configured to exert a force to injection tube group So that injection tube 900 moves to the second position from primary importance on part.Housing 400 can farther include to be configured to reload certainly Dynamic syringe 10 reloads handle 1400 for another drug dose of injection, wherein reloads handle 1400 and may be connected to note On shooting cylinder assembly, in order to reload handle 1400 user operative configuration become make injection tube assembly be withdrawn into primary importance and with Time reload injection tube actuator 1200, so that automatic injector is ready for carrying another drug dose.
In FIG, it is provided that the exploded view of injection tube actuator according to an embodiment of the invention.Shell 100 is provided For carrying shell, and it is configured to be removed by user before using at automatic injector 10.Rigid needle shield removes part 200 Preferably cooperate with shell 100 and rigid needle shield 300, in order to rigid needle shield easily can be removed with shell 100.
Automatic injector has the housing 400 being configured to surround other automatic injector part, other automatic injector portion Dividing and include injection tube lock 500 and skin sensor 600, these partial cooperatives are with release and locking pin sheath and injection tube assembly. Skin sensor actuator 700 can be spring.Injection bobbin provides into receiving and has the injection tube 900 of pin 902, and and plunger rod Pipe 1100 interconnects.Sound generator 1000 is positioned between injection tube 900 and plunger rod tube 1100.Injection tube actuator 1200 structure Cause on the injection tube 900 acted in injection bobbin 800.Housing lock ring 1300 makes housing 400 and reloads handle top 1800 interconnection.Handle 1400 interconnects with handle top 1800, and allows to cooperate with injection tube lock 500 and skin sensor 600 Reload described device, as described further below.Plunger rod 1500 includes being configured to relative to sound generator 1000 Multiple teeth 1502 of sound are produced time mobile.Plunger rod actuator 1600 is configured to exert a force on plunger rod 1500.Reverse The convert rotational motion of handle top is become the translational motion of injection tube assembly by ring 1700.Handle top 1800 is positioned at note automatically The end of emitter 10, and be configured to when reloading described device rotate relative to housing 400.
The automatic injector being in various use state when Fig. 2 shows from the point of view of user or patient.At Fig. 2 A In, automatic injector is enclosed in shell 100, and shell 100 adjoins handle top 1800.In fig. 2b, shell 100 is moved Remove, and automatic injector 10 becomes visible.Automatic injector 10 includes that housing 400, housing 400 have inspection hatch 402 and skin Skin sensor 600.Medicament 904 in injection tube 900 is visible via inspection hatch 402, as indicated by the dead color of window, thus indicates User automatic injector is ready for using.Handle top 1800 is configured to and reloads handle 1400 and interact, then adds Carry handle 1400 visible on handle top 1800 section below ground in fig. 2b.Skin sensor 600 be in extension to anteposition Put, and cover pin completely.In fig. 2 c, skin sensor is promoted slightly backward relative to the skin of patient, and pin 902 exists In skin sensor opening 602 visible.Also do not actuate automatic pin to insert.In figure 2d, skin sensor 600 be pushed backwards and It is in withdrawn position, and has actuated the insertion of automatic pin so that pin 902 highlights from skin sensor, and the end of injection tube 900 In skin sensor opening 602 visible.In this position, pin is configured for insertion in the skin of patient.When user is in injection After when skin removes pin 902, skin sensor 600 is pushed forward and covers pin 902.Pin sensor is in the locked position. It can be seen that Fig. 2 C to Fig. 2 E Chinese medicine is all without visible via inspection hatch 402, thus user device is indicated to be not in standard Get the initial position of delivered dose ready.In fig. 2f, by making handle top 1800 reload certainly relative to housing 400 rotation Dynamic syringe 10, skin sensor is in the unlocked position, and the medicament 904 in injection tube 900 is visible via inspection hatch 402.? In Fig. 2 G, after having carried the second dosage, skin sensor is in the locked position, and inspection hatch 402 indicates at this device In getting out position.
In figure 3, it is provided that indicator window 402,404.Illustrate in greater detail inspection hatch 402 He of automatic injector 10 Label window 404.In figure 3 a, automatic injector is in and gets out state, and its middle cover and shell are removed.Inspection hatch is opened, And therefore expose the medicament 904 in injection tube 900, and skin sensor actuator 700 is also visible via described window.Seen Be that skin sensor is positioned at the forward facing position of unblock, and device get out delivered dose, this also by label window 404 with reading " READY " instruction.In figure 3b, during pin 902 has been expelled to the skin 1900 of patient.Skin sensor is recalled completely, and housing 400 only lean against on the skin 1900 of patient.Inspection hatch is closed, and blocks medicament, and the label window tool when dosage has been injected There is reading " DONE ".In fig. 3 c, skin sensor is fully extended, and is in the forward facing position of locking, and skin sensor lock Lug 608 is visible.Inspection hatch is closed, and label window still has reading " DONE ".It is seen that during injection process, pin 902 is invisible for the user actuating automatic injector or operator, and skin sensor also serves as needle shield or pin Guard shield.From Fig. 2 and Fig. 3 it is seen that, the total length of automatic injector carry another dosage time do not dramatically increase, and this Bright advantage there are provided the compact automatic injector that can carry one or more dosage.As described further below, Compact size is obtained due to the reversible feature of automatic injector.
Fig. 4 illustrates in greater detail the mechanism for removing shell 100.As seen in figure 4 a, shell 100 adjoins handle top Portion 1800.Shell can the ring snap fastener of appropriate location by being between handle 1400 and shell 100 be held in place.Outward Shell 100 and handle top 1800 (can not shown by one piece of adhesive tape around shell 100 and handle top 1800 element wound Go out) seal.When actuating, i.e. when user opens automatic injector 10, shell 100 is by making it in handle top 1800 On slightly reverse and remove from automatic injector 10, this employs the cone (e.g., reloaded on handle 1400) on automatic injector Shape knob 1402, to change into the lengthwise movement destroying bonding, as shown in Figure 4 B by revolving force.In figure 4b, its China and foreign countries Shell slightly rotates breakseal and makes ring snap fastener be disengaged.The lengthwise movement caused by taper knob 1402 and by After both pulling action that user causes, shell 100 partially by rotate and partly length travel and be removed.
In Figure 5, RNS(rigid needle shield) 300 cover the stacking entry needle 902 on injection tubes 900, and generally entering It is pre-installed in before device assembly line on injection tube 900.So that automatic injector 10 is ready for injection, rigid needle Sheath needs to be removed to expose pin.Removing of RNS 300 is the ingredient of automatic injector actuation, and therefore for It is automated for user or operator.RNS removes part 200 and may be arranged such that the automatic injector including RNS 300 10 are not tampered during storing.Preferably, RNS 300 can be protected, in order to avoids the initial sealing position from RNS 300 Any significant physics dislocation.The dislocation of this type of physics can be such as radial displacement or length travel, and can be by oscillating motion etc. Cause.The dislocation of these physics can have serious impact, and the most flexible entry needle 902 to automatic injector performance.Remove The process of RNS 300 needs sane and reliable, but simultaneously, RNS 300 sealing provided should be effective.Therefore, automatically Automatically the removing of RNS 300 when actuating or open of syringe 10 can ensure that power extraneous during storage cycle and RNS 300 Not or there is minimum Physical interaction.And, when device is actuated, it can be the most sane that RNS removes, and this is Because otherwise it may make operator be difficult to close to for manually removing.Therefore, the mechanism with RNS 300 handing-over must expire Two contrary requirements of foot.Additionally, the assembling with the automatic injector that RNS removes part 200 should easily and directly perceived.
In fig. 5, show in detail part, and RNS removes part 200 and has generally cylindrical form, and have along it The slit 202 of sidepiece, to allow whole RNS 300 to be inserted into.Have in the end towards injection tube additionally, RNS removes part 200 U-shaped otch 204 on surface is to allow injection tube 900 to exist, and the diameter/size of U-shaped otch 204 is designed to less than RNS The maximum gauge of 300, but it is large enough to during storing not carry out physical contact, i.e. do not touch injection tube 900 or RNS 300 Upper part.RNS remove part 200 in place in the case of, the longitudinal force being pulled away from injection tube will ensure that RNS removes portion now Divide the joint between the larger diameter edge on 200 and RNS 300, and thus RNS 300 can be promoted to be drawn from injection tube 900 From.
In the present embodiment, RNS removes part 200 and laterally can be executed relative to RNS 300 and injection tube assembly 900 With, and Fig. 5 B shows that the RNS being laterally applied on RNS 300 removes part 200.In this embodiment, RNS removes part 200 and do not meet the assembly stacked the most vertically of automatic injector.Fig. 5 C shows that having RNS removes part The injection tube 900 of 200, and skin sensor 600 is arranged on RNS and removes on the circumference of part 200.
Removing part 200 to benefit from described RNS, RNS removes fixing by heat between part 200 and shell 100 Stacking proposes.In figure 5d, shell or lid 100 and RNS remove the cross section at the interface between part 200 in the case of mounted Being illustrated, RNS removes the end 206 of part and is shown as and extends beyond shell 100.In Fig. 5 E, it is seen that be applied with Thermal reactor is folded, and RNS removes end 206 partly and has been deformed into standing part 208.However, it is possible to envision, any other is consolidated Determining means will be possible, such as, and screw or rivet, use ultrasonic bonding etc..
Owing to rigid needle shield removes fixing between part 200 and shell 100, when shell moves, RNS removes part Will be mobile.Accordingly, because be applied to the torsion on shell 100 relative to handle top 1800 and longitudinal position that pulling action causes Moving, RNS removes part 200 and will start to be pulled away from RNS 300, and wherein remaining of RNS 300 is removed and performed by operator or user. The gear drive realized by rotation on taper knob 1402 contributes to operator or user is easier to when longer storage The possible high bonding force of RNS 300 is overcome after between；Once RNS 300 has moved small distance, then operator can be easy RNS 300 is pulled away from remaining distance by ground, fully to discharge pin 902 under much smaller power input.To envision, by The alternate manner rotating generation lengthwise movement can be substituted for taper knob 1402, such as, is realized by female thread, wherein along one Individual preset rotating direction is outwarded winding and is longitudinally separated producing between handle and shell.Use taper knob 1402 to have and be better than inside The advantage hiding feature is, it is helpful during the assembling of automatic injector assembly, is used for so that two this is because exist The spin orientation being clearly visible of individual portion confluence.
Fig. 6 shows the sectional view of the automatic injector being in multiple injection stage.In fig. 6, automatic injector is in Storage stage.In addition to handle top 1800, automatic injector 10 is enclosed in shell 100.RNS 300 and RNS removes part 200 is the most in place to protect pin 902 and to be easy to remove RNS.Plunger rod 1500 is in initial position, and the front end of plunger rod 1500 1510 are positioned to and have with a certain distance from injection tube retainer 908 surface.Therefore, the slightly accidental movement of plunger rod 1500 will not Injection tube retainer 908 can be affected.
In fig. 6b, it is shown that the just automatic injector after injection the first dosage.Pin 902 exposes and inserts patient In the skin of (not shown), and plunger rod 1500 moves forward under the effect of plunger rod actuator (that is, spring) 1600, So that the projection of plunger rod 1508 is only by the first stop part 1102 of plunger rod tube 1100, see other details in Fig. 7.Stop Part 908 has moved forward to discharge the first drug dose, and skin sensor 600 is in withdrawn position.
In figure 6 c, at pin 902 after skin is recalled, skin sensor 600 is by skin sensor actuator 700 Mobile to front latched position.At stage C in figure 6 c, automatic injector can in statu quo be thrown aside, or is reloaded with defeated Send second or another dosage.
Fig. 6 D shows at the automatic injector 10 reloaded after described device: plunger rod 1500 is at plunger rod actuator Move forward under the effect of (that is, spring) 1600, in order to the projection 1508 of plunger rod only leans against the second of plunger rod tube 1100 only On block piece 1104, see other details in Fig. 7.Retainer 908 has moved forward to discharge the first drug dose, and skin Sensor 600 is in withdrawn position.
Skin sensor 600 is the most unlocked and unlocked position forwardly, and injection tube actuator 1200 has reloaded (that is, recalling) is to initial compression position, and injection tube 900, injection bobbin 800, plunger rod tube 1100, plunger rod 1500 and plunger Bar actuator 1600 has been recalled, and does not make the parts mentioned be moved relative to.
In Fig. 6 E, have been carried out the second injection or another injection.Plunger rod 1500 is at plunger rod actuator Move forward under the effect of (that is, spring) 1600, in order to the projection 1508 of plunger rod only leans against the second of plunger rod tube 1100 only On block piece 1104, see other details in Fig. 7.Retainer 908 moved forward to discharge the second drug dose or another Drug dose.Skin sensor 600 is in front latched position and automatic injector can be thrown aside, and can perform an another shot, Or such as by the new injection tube being pre-charged with is refilled up to automatic injector and automatic injector can be re-used.
In figure 6, it is seen that plunger rod actuator 1600 includes plunger rod spring 1600.Plunger rod spring 1600 At one end it is strongly attached to plunger rod tube 1100 at 1602.It is seen that plunger rod actuator 1600 is direct by driving force Be applied on plunger rod 1500, e.g., plunger rod flange 1508(i.e., plunger rod projection 1508) on.In figure 6, seen It is that plunger rod actuator acts on the top of plunger rod flange 1508, and the opposite side of plunger rod flange 1508 is by plunger rod 1500 are normally locked in plunger rod tube 1100 so that plunger rod stop part 1508 is pressed against in locking member 1108 (that is, pressure Lean against on plunger rod tube stop part 1102).
Housing also accommodates the injection bobbin for keeping injection tube, and injection tube has injection tube flange, injection tube flange It is locked between injection bobbin and plunger rod tube.In the present example, injection bobbin and plunger rod tube are provided as two Individually unit is to be easily assembled to, but injection bobbin be can be devised and actuator rod tube can be to maintain injection tube, plunger rod A pipe with plunger rod actuator.
It is seen that plunger rod actuator is arranged in plunger rod tube, and injection tube actuator is arranged on plunger Outside rod tube.
In Fig. 7 A-L, it is shown that reload handle and with the cooperating of plunger rod tube and plunger rod.Such as in figure 1 above The only top section 30 of the automatic injector seen in any accompanying drawing to Fig. 6 or seen in any accompanying drawing is the most visible. Automatic injector can control insertion and the dosage injection of pin according to priority as shown in Figure 7.Show suitable with stage A to L The operation that sequence controls.Fig. 7 A, 7C, 7E, 7G, 7I and 7K show and reload handle 1400, plunger the processing stage of being in various Rod tube 1100 and plunger rod 1500, and Fig. 7 B, 7D, 7F, 7H, 7J and 7L show the automatic note being in stage A, C, E, G, I and K The sectional view of emitter.
Plunger rod 1500 is configured to advance in injection tube (the most not shown) for carrying at least one medicament agent Amount.Plunger rod tube 1100 has at least one locking member 1108, and it is configured to interact with plunger rod stop part 1508, with Plunger rod 1500 is normally locked onto plunger rod tube 1100(and sees Fig. 7 M, 7N) on.Injection tube actuator 1200 does not shows in the figure 7 Go out, but actuating of injection tube actuator illustrated by arrow 42,44, i.e. plunger rod tube 1100 and plunger rod 1500 both to Front movement, i.e. move to the second position from primary importance.Plunger rod actuator 1600 is the most not shown, but plunger rod drives Actuating of moving part 1600 is illustrated by single arrow 42, it illustrates only plunger rod and moves forward, i.e. by plunger rod actuator 1600 The power applied forces plunger rod 1500 to advance in injection tube (not shown) for carrying at least one drug dose.Seen Be housing 400 or intermediary element 1400(in this example i.e., reload handle 1400) include opening or aperture 1420.Housing Or intermediary element 1400 is configured to make locking member at injection tube (not shown) and plunger rod tube 1100 when advancing to the second position 1108 unlock and discharge plunger rod 1500 from plunger rod tube 1100, thus actuation plunger bar actuator (not shown), so that post Stopper rod 1500 advances for carrying at least one drug dose in injection tube.
Locking member 1108 includes at least one deflectable member 1108, and housing 400 and/or intermediate member 1400 construct Become to allow at least one deflectable member 1108 remote when advancing to the second position at injection tube (not shown) and plunger rod tube 1100 Deflect from plunger rod 1500.Therefore, seeing in Fig. 7 A, Fig. 7 B, the plunger rod 1500 in plunger rod tube 1100 is in initial bit Put, i.e. primary importance, to prepare delivery of medicaments dosage.After the moving forward of plunger rod tube 1100 and plunger rod 1500 The second position, plunger rod tube is in the second position.Seeing in Fig. 7 C, Fig. 7 D, plunger rod 1500 is not relative to plunger rod tube 1100 move, and plunger rod tube 1100 and plunger rod 1500 move forward relative to housing or intermediate member 1400.Plunger It is internal that bar actuator generally rear end 1512 circumferentially around plunger rod 1500 is positioned at plunger rod tube 1100, and be configured to by Power is applied in plunger rod projection 1508.Rear end 1512 can have the diameter of reduction, i.e. relative to the other parts of plunger rod The diameter reduced for the diameter of (such as, relative to the front end of plunger rod 1510).
Plunger rod tube 1100 and injection tube (not shown) generally interconnect, in order to plunger rod tube 1100 can not be relative to injection tube 900 move, and vice versa.Plunger rod tube 1100 can interconnect with injection tube 900, or such as via plunger rod tube lug 1110 Interconnect with injection tube 800.
Housing has opening 1420, and opening 1420 is window or aperture, and is configured to advance to second in plunger rod tube It is directed at at least one deflectable member when putting.In fig. 7d, it can thus be seen that the first deflectable locking member 1108 and window or aperture 1420 alignments, thus allow locking member 1108 to deflect and allow plunger rod projection 1508(such as, plunger rod stop part 1508) logical Cross.
In figure 7e it is seen that after release plunger rod 1500, plunger rod actuator 1600 makes plunger rod 1500 Advance in injection tube 900 so that plunger rod stop part 1508 can be through the locking member of overshoot.
Deflectable locking member 1108,1110 is positioned at the both sides of plunger rod as seen in fig. 7b, and therefore opens Mouth 1420,1422 is also provided on both sides.
In Fig. 7 G, handle 1400 rotates as shown in arrow 1401, and has the plunger rod tube of plunger rod 1500 Before 1100 rotate and are withdrawn into identical initial position as shown in Figure 7A, and plunger rod keeps relative to plunger rod tube simultaneously Carry is put, and plunger rod actuator (the most not shown) also keeps the first extended position.The second dosage is performed defeated from this position Send, and Fig. 7 I and Fig. 7 J show as by the plunger rod tube with plunger rod shown in arrow 42,44 repeat travel forward, with Just the second window 1422 is made to be directed at the second deflectable locking member 1110 and allow locking member 1110 to deflect.Therefore, plunger rod Actuator 1600 be released or actuate to promote plunger rod 1500 through the second locking member 1110, for the most single arrow 42 As shown in carry the second dosage, and Fig. 7 K, Fig. 7 L show the plunger rod of the progressive position being in injection tube.Therefore, Plunger rod actuator be configured to make plunger rod 1500 the first of plunger rod actuator 1600 actuate lower movement first apart from and Another distance of lower movement is actuated at another of plunger rod actuator 1600.
It is seen that the second of plunger rod actuator actuates and carry out afterwards reloading of automatic injector, and therefore At injection tube assembly 20(i.e., such as injection tube 900, injection bobbin 800, plunger rod 1500 and plunger rod tube 1100) from first Put and carry out after the repeating motion of the second position.
Therefore, automatic injector can carry at least one or two single drug dose.
Seeing in Fig. 7 M, Fig. 7 N, plunger rod stop part has angled surface 1509, and it is normally pressed against at deflectable lock On the angled surface 1109 of limiting-members 1108.Deflectable locking member 1108,1110 is downward move relative to plunger rod Position is hinged in plunger rod tube 1100.Therefore, deflectable locking member can be only in deflectable locking member 1108,1110 Whole length opposed with whole opening 14 time just deflection.
At least one deflectable member be configured to the opening in housing 400 and/or intermediate member 1400 to punctual partially Turn.
When deflectable locking member 1108,1110 not with window 1420 on time, generally by handle 1400 or housing 400 Inner surface 1424 prevents deflectable locking member 1108,1110 from deflecting, and sees in Fig. 7 N, deflectable locking member 1108,1110 it is not fully located in window 1420,1422, and therefore can not deflect.
Therefore plunger rod tube 1100 can at least include the first locking member being configured to engage with plunger rod stop part 1508 1008 and second locking member 1110.
Fig. 8 illustrates in greater detail the phase interaction of skin sensor 600 and skin sensor 600 and injection tube lock 500 With.In fig. 8 a, skin sensor 600 and injection tube lock 500 are in its initial position, and therefore skin sensor 600 is in Front unlocked position.The projection 604 with angled surface 606 is seen at skin sensor 600.In the fig. 8b, the most logical Cross to be pressed against on the skin of patient skin sensor 600 and actuate skin sensor 600, and skin sensor 600 is towards injection Cylinder lock 500 moves.Therefore, the angled surface 512 that angled surface 606 is locked with injection tube engages, thus works as skin sensor 600 promote injection tube lock 500 rotation when recalling.In Fig. 8 C, skin sensor 600 is depressed (recalling i.e., completely) completely, and Close with injection tube interlocking after rotation.Fig. 8 D shows injection tube lock protruding 604 and the angled surface of injection tube lock 500 The detail view of 504.
In fig .9, illustrate in greater detail and reload mechanism.At Fig. 9 A(in the bottom of accompanying drawing) in, it is seen that there is pin 902 Injection tube 900 highlight from injection bobbin 800 at the first end (e.g., front end) 804.Injection bobbin 800 connects with plunger rod tube 1100 Close, and the lug 1110 on the front end 1101 of plunger rod tube 1100 with injection bobbin 800 engage so that plunger rod tube 1100 and note Shooting cylinder pipe 800 interconnects.Generally, during assembly, insertion is injected bobbin 800 by the injection tube 900 being pre-charged with pin 902 In, and include that the plunger rod tube 1100 of plunger rod 1500 and plunger rod actuator 1600 will be installed to injection tube 900 and injection tube On pipe 800, and the lip 910 of injection tube will lock between injection bobbin 800 and plunger rod tube 1100.In plunger rod tube 1100 Lug 1112 be configured to and injection tube lock 500 interaction (for other details, see Figure 10).Injection bobbin 800 has Injection bobbin inspection hatch 802, it is configured to interact with injection tube lock inspection hatch 502 and housing inspection hatch 402.Injection bobbin Protruding 806 can interact with skin sensor 600 and provide starting force, and when actuating automatic injector, user must pull against This starting force.This is to reduce another security feature of risk that the accident of automatic injector is actuated.
Reload handle 1400 to slide in plunger rod tube 1100, and torsion ring 1700 via torsion ring lug 1702 with again Charging handle 1400 and plunger rod tube 1100 interconnect.
In figure 9 a, delivered the first dosage, just looked at torsion ring lug 1702 and be located at first and reload handle groove In mouthfuls 1404, and torsion ring lug 1702 moves forward along notch side 1406, and is positioned at first and reloads handle notch At the bottom of 1404.
Reload handle 1400 and torsion ring 1700 can be symmetrical, in order to applied power is uniformly distributed, and because of There is the torsion ring lug 1702 that is symmetrically disposed on each side of torsion ring in this, each torsion ring lug 1702 with about reloading Handle notch be symmetrically arranged each first reload handle notch interconnection.
In figures 9 b and 9, reload handle 1400 to rotate as shown in arrow 1401, so that self is non-rotatable Torsion ring is promoted along inclined notch sidepiece 1408 via torsion ring lug 1702.In figures 9 b and 9, it is seen that add again making Carry after handle slightly rotates (such as, about 30 degree), as by reloading seen by the rotation of handle taper knob 1402, torsion Ring lug 1702 slightly moves along inclined notch sidepiece 1704.This will include injection tube 900, injection bobbin 800, plunger rod tube 1100, and plunger rod 1500 and plunger rod actuator 1600(the most not shown) injection tube assembly pull back and Entrance reloads in handle 1400, as shown in arrow 24 as.
In Fig. 9 C, reload handle and further rotate, such as, total corotating 45 degree, and torsion ring lug 1702 is towards The apical margin 1410 of charging handle notch 1404 moves again and again, so that including injection tube 900, injection bobbin 800, plunger rod tube 1100 and plunger rod 1500 and plunger rod actuator 1600(the most not shown) injection tube assembly 20 further to recession Return and travel further into and reload in handle 1400.When making to reload handle 1400 and rotating, plunger rod tube lug 1112 also court Only rotating by convex ridge 506 of injection tube lock 500, this can it is seen from figure 10 that.
As seen in Fig. 9 D, the continuation reloading handle 1400 rotates torsion ring lug 1702 and torsion ring 1700 and note Shooting cylinder assembly 20 raises together and reloads above the apical margin 1410 of handle top 1400 first, and entrance second reloads handle In notch 1414.At injection tube assembly 20(and more specifically, plunger rod tube lug 1112) it is suspended on injection tube locking by convex Before on ridge 506, as arrow 22 indicates, will be to including the torsion ring 1700 of torsion ring lug 1702 and injection tube assembly Front mobile relatively short distance, such as several mm.Automatic injector 10 is then in initial position, and prepares conveying the second injection or another note Penetrate.Due to second, to reload handle notch be the notch only allowing longitudinally to move along the axis of automatic injector, automatically injects Device is locked after conveying the second dosage, and therefore automatic injector is not constructed to carry plural dosage.Therefore, Automatic injector can carry less than two dosage.It addition, envisioned constructive alternative, and this is in fig. 13 by more detail Illustrate.
What Fig. 9 E and Fig. 9 F showed that the system of reloading depends on that the longitudinal direction of injection tube assembly 20 recalls alternative reloads merit Can, and Fig. 9 E shows and reloads handle 1400 and the position of torsion ring lug 1702 after having carried the first injection. In Fig. 9 F, the longitudinal direction of injection tube assembly 20 is recalled and is made automatic injector reload.
Figure 10 shows and makes skin sensor 600 can lock 500 and control the injection tube of drug administration mechanism by rotary injection cylinder The detail view of lock guide rail 504.First, as seen in Figure 10 A, spring-loaded injection tube assembly 20 is convex by plunger rod tube Sheet 1112 only leans against the injection tube locking of injection tube lock 500 by convex ridge 506, thus retrain injection tube assembly 20 to reach Dynamic.Skin sensor 600 is in the forward facing position of unblock.
In fig. 1 ob, skin sensor is pressed against on the skin of the patient, and injection tube lock ground as shown in arrow 24 is like that Rotate.Therefore, injection tube assembly 20 lifts away from injection tube locking by convex ridge 506.
In fig 1 oc, injection tube assembly 20 moves down along injection tube lock guide rail 504, thus by injection tube assembly 20 promote forward, thus cause the injection of pin 902.During the injection of pin, injection tube lock further rotate so that give cartridge with It is administered window alignment thus allows injection medicament.After injection, as seen in Figure 10 D, when pin 902 is recalled from the skin of patient Time, skin sensor 600 is promoted forward by skin sensor actuator 700.At this point, two pinchings of skin sensor lean against On the shelf of injection tube lock, thus by described folder lock into place to protect pin.In Figure 10 E, device is reloaded, and injection tube Assembly 20 is in initial position, and skin sensor 600 is in front unlocked position.
Figure 11 shows the detail view of inspection hatch 402.In Figure 11 A, housing inspection hatch 402, injection bobbin inspection hatch 802 It is directed at injection tube lock inspection hatch 502, and the medicament 904 in injection tube 900 is visible.Additionally, skin sensor actuator 700 warp Inspection hatch 502 is locked from housing inspection hatch 402 and injection tube.In Figure 11 B, it can thus be seen that inspection hatch misalignment, and injection tube The only a part of lock 500 is followed by visible at housing inspection hatch, thus shows that described device is not ready for conveying note Penetrate dosage.
Advantageously, user or patient can see medicament by inspection hatch 402,502 and 802 when medicament is injected, Because this gives any sensation being injected to user.
In fig. 12 it is shown that include the ratch mechanism of the plunger rod 1500 interacted with sound generator 1000.Sound Tone generator 1000 includes flexible arm 1002, and it is located and configured to the inclined teeth of bond post stopper rod relative to injection tube assembly 20 1502.The tooth 1502 that is inclined upwardly on plunger rod can only allow travelling forward of plunger rod.
It is seen that ratch mechanism 1500,1502,1000,1002 is configured to when delivery of medicaments provide sound, in order to Sound is produced when being administered.Inclined teeth is arranged along the length setting of plunger rod and the whole length approximately along plunger rod, in order to Sound is produced during first dosage conveying and during the second dosage and/or other dosage any carry.But, envisioned That inclined teeth can be distributed only in a part for plungers length, and be such as configured to only from injection tube carry the first dosage, Sound is produced, to indicate the medicament in injection tube to terminate during the medicament of two dosage, other dosage any or final dose.
Advantageously at least some of period in dosage conveying produces sound, thus refers to sound when injection medicament Show, i.e. sound is provided when being administered, and when when sound stops, pin may must be maintained at below skin one section by user Between.
Therefore, plunger rod 1500 as shown in Figure 12 is the linear ratchet with multiple inclined teeth 1502, and it is configured to Interact with the multiple flexible arms 1002 arranged with plunger rod tube 1100, in order to advance forwardly past flexibility at plunger rod 1500 Engage with plunger rod 1500 during arm, thus produce sound.
In fig. 12, plunger rod 1500 is illustrated in plunger rod tube and is in initial position, i.e. before administration.At figure In 12B, delivered the medicament of the first dosage, and plunger rod 1500 along forward direction move corresponding with the first dosage away from From.Seen by be to there is sound delay time when plunger rod moves to the second stop part 1504 from the first stop part 1506, this table Bright: only to move forward when retainer 908 and during just in delivery of medicaments, just start that sound occurs.Ratch mechanism shows in C in more detail Go out, be wherein clear that flexible wall 1002 engages with the inclined teeth 1502 of plunger rod 1500.
Owing to ratch mechanism 1500,1502,1000,1002 only allows motion in one direction, therefore prevent plunger rod 1500 return to initial position.Therefore, it is to avoid the automatic injector used is loaded on and is supplied to another injection tube newly User.Therefore, ratch mechanism 1500,1502,1000,1002 also serves as tamper-evident component.
Figure 13 illustrates in greater detail two and different reloads handle.May be configured to it is seen that reload handle Allow one, two, three, the conveying of four or more dosage.In Figure 13 a, it is provided that there are two straight sidepieces of band Reload handle notch 1412 reload handle 1400, in order to reload handle notch and allow only along the axle of automatic injection tube The lengthwise movement of line, and thus do not allow the rotary motion along inclined surface.This means that it is possible for only once injecting, and again Loading function is unavailable.It is seen that, automatic injection tube is in initial position, and wherein torsion ring lug 1702 is positioned at and reloads hands At the top of handle notch 1404.In Figure 13 b, reload handle 1400 and be shown as having and reload handle notch 1414, its There is the straight sidepiece for injection process and angled sides 1416, torsion ring lug 1702 when reloading along inclined side Portion 1416.It is provided with only two symmetrical reloads handle notch 1414 it is seen that reload handle, and therefore due to handle Rotation never lock, therefore an infinite number of reloading is possible.Such as, if automatic injector can re-use and permit Permitted such as to be loaded on new injection tube assembly, then this reloads handle and is probably favourable.As shown in Figure 13 a and Figure 13 b Two any combinations reloading handle the notch design 1414 followed in Figure 13 b can be provided and do not allow to add the most again Any combination reloaded of the predetermined quantity that the locking notch 1412 carried combines.Reload the quantity of notch mainly by automatically The size limitation of syringe.
In fig. 14, injection tube assembly 20 be shown as including injecting bobbin 800, injection tube 900, plunger rod tube 1100, Plunger rod 1500 and plunger rod actuator 1600.Being envisioned, part can use various connector part to assemble, and this Outward, plunger rod tube and injection bobbin can be provided as a part.It is seen that injection tube assembly 200 can be as one Element moves, and by act in injection tube Pipe Flange 806 and/or plunger rod flange 1114 injection tube actuator (1200, Not shown in Figure 14) promote forward or by acting on injection tube assembly 20 (e.g., on injection tube assembly lug 1112) Reload handle action to recall.
In fig. 15 it is shown that another automatic injector according to an embodiment of the invention, comprising: lid or shell 1；Shell Body 2；Skin sensor 3；Injection bobbin or bearing 4；Injection tube 5, it has the rigidity covering pin at storage location (not shown) Needle shield；For acting on the plunger rod 6 on the medicament in injection tube 5；Plunger rod actuator or motor-driven spring 7；Surround plunger Bar actuator 7 and at least one of plunger rod tube 8 of plunger rod 6；And injection tube actuator (such as motor-driven spring) 9, its structure Cause and at least act on injection tube 5 and be preferably applied to include that injection bobbin 4, injection tube 5, plunger rod 6, plunger rod drive On the injection tube assembly of moving part 7 and plunger rod tube 8.Needle shield actuator (such as needle shield spring) 13 is configured to act on pin to be protected On set/skin sensor 3.Automatic injector also includes reloading handle 11 and reloading handle top 12.
Automatic injector 10 prepares when opening to use.Automatically injection tube 10 is applied to injection site, this by needle shield 3 to Several millimeters of pusher.Therefore, plunger rod tube is used for discharging injection tube actuator 9, thus drive plunger rod 6 and plunger rod carrier or pipe 8, thus drive injection tube 5 forward, so that pin is inserted in patient.When inserting pin, plunger rod spring 7 is released, thus Cause using the first dosage.Plunger rod 6 is travel downwardly, until it clashes into stop part, this determines dosage size.It addition, just Before plunger rod 6 only leans on, just provide audible feed signal to operator or patient and " be administered and terminate ".The propelling of injection also may be used Observed by window.After completing the injection, automatic injector is raised from injection site, and needle shield 3 is by using pin to protect Sleeve spring 10 and extend forward and be locked in its external position, wherein opening diameter and the combination from the distance of needle point ensure that point Sharp thing is protected.Automatic injector disables now, and can install with lid and be thrown aside, or automatic injector can be accurate when needed It is ready for the second injection.Therefore, automatic injector is ready to be prepared as the second injection.By turning handle top 12, And thus rotation reloads handle 11, plunger rod carrier or pipe 8 and injection tube carrier or pipe 4 is recalled backward.This is by being bonded on The details reloaded on the plunger rod carrier 8 in the screw thread in handle 11 completes.When handle has been pulled, plunger rod carrier 8 and injection tube carrier 4 self disable.Additionally, when reloading handle and rotating, described in reload handle by needle shield 3 from it Position, portion unlocks, and this makes plunger rod carrier 8 and injection tube carrier 4 move forward when being actuated.
When automatic injector is applied to injection site, needle shield 3 is pushed backwards a few mm, and thus injection tube carrier 4 It is configured to release and inserts spring or injector motor 9, thus drive forwards plunger rod 6 and injection tube carrier 4, so that pin quilt Insertion into a patient.When inserting pin, injection spring (that is, plunger rod actuator) 7 is released, thus cause using first (or the Two or any further) dosage.Plunger rod 6 is travel downwardly, until it clashes into stop part, this determines dosage size.It addition, just Fortunately plunger rod 6 is only by before, just provides audible feed signal to patient and/or user and " is administered and terminates ".Pushing away of injection Enter and observe also by window.After the second injection or any further injection, when pin is pulled from patient and needle shield 3 is locked When being scheduled on its external position, needle shield 3 is promoted forward by needle shield spring 13.In addition, reload handle 11 and also disable, this Mean that whole device is deactivated and can be thrown aside safely.
1 lid or shell
2 lower houses
3 needle shields
4 injection tube bearings
5 injection tubes with pin
6 plunger rods
7 plunger rod motor or actuators
8 plunger rod carriers
9 injection tube motor or actuators
10 automatic injectors that can reload
11 upper shells or reload handle
13 needle shield springs
20 injection tube assemblies
The top section of 30 automatic injectors
22,24,42,44 arrows
200 RNS(rigid needle shield) remove part
202 slits
204 U-shaped otch
206 RNS(rigid needle shield) remove portion distal end
208 standing parts
300 RNS(rigid needle shield)
400 housings
402 inspection hatch
404 label windows
500 injection tube locks
502 injection tube lock inspection hatch
504 injection tube locks guide notch/track
506 injection tube lock convex ridges
508 off-positions
510 injection tube lock end stop
512 injection tube lock angled surface
600 skin sensors
602 skin sensor openings
604 is protruding
700 skin sensor actuators
800 injection bobbins
802 injection bobbin inspection hatch
804 front ends
806 injection bobbins are protruding
808 injection tube Pipe Flanges
810 injection tube tube connectors
900 injection tubes
904 injection tube contents (medicament)
908 injection tube retainers
1000 sound generators
1101 front ends
First stop part of 1102 plunger rod tube-locking member stop part
Second stop part of 1104 plunger rod tube
1106 end stop positions
1108 first locking members
1110 second locking member plunger rod tube lugs
1112 plunger rod tube lugs/injection tube assembly lug
1114 plunger rod tube flanges
1116 plunger rod tube adapters
The rear end of 1118 plunger rod tube
1200 injection tube actuators
1300 housing lock rings
1402 taper knobs
1404 first reload handle notch
1406 notch side
1408 inclined notch sidepieces
1410 first apical margins reloading handle notch
1412 reload handle notch
1414 second reload handle notch
1420 first windows
1422 second windows
1424 inner surfacies
1500 plunger rods
1504 second stop parts
1506 first stop parts
The projection of 1508 plunger rods, plunger rod stop part
The angled surface of 1509 plunger rod stop parts
The front end of 1510 plunger rods
The rear end of 1512 plunger rods
1600 plunger rod actuators
One end of 1602 plunger rod actuators
1702 torsion ring lugs
1900 skin barrier portions.
1. having an automatic injector for the sequential control that pin inserts and dosage is injected, described automatic injector has housing, Described housing is used for accommodating:
Having the injection tube of pin, described injection tube can be positioned at movably in described housing and be positioned at primary importance and the second position Between, in described primary importance, described pin is contained in described housing, and in the described second position, described pin is projected into described shell It is external,
Plunger rod, described plunger rod is configured to advance in described injection tube for carrying at least one drug dose,
Plunger rod tube, described plunger rod tube have be configured to described plunger rod stop part interact with by described plunger rod just Often lock onto at least one locking member in described plunger rod tube,
Injection tube actuator, described injection tube actuator is configured to exert a force to described injection tube, so that described injection tube Moving to the described second position from described primary importance, described injection tube actuator is further configured to make have described plunger rod Described plunger rod tube advance to the described second position,
Plunger rod actuator, described plunger rod actuator is configured to exert a force to described plunger rod, so that described plunger rod exists Described injection tube advance for carrying at least one drug dose,
Wherein said housing is configured to when described injection tube and described plunger rod tube make described lock when proceeding to the described second position Limiting-members unlocks and discharges described plunger rod from described plunger rod tube, thus actuates described plunger rod actuator so that described plunger Bar advances for carrying at least one drug dose in described injection tube；
Wherein, described locking member includes at least one deflectable member, and wherein said housing is configured to when described injection tube Allow at least one deflectable member described inclined away from described plunger rod when advancing to the described second position with described plunger rod tube Turn.
Automatic injector the most according to claim 1, wherein, described plunger rod tube and the interconnection of described injection tube so that institute State plunger rod tube to move along the longitudinal direction relative to described injection tube, and described injection tube can not be relative to described plunger rod Pipe moves along the longitudinal direction；
Wherein, described housing has opening, described opening be configured to when described plunger rod tube advances to the described second position with At least one deflectable member described is directed at.
Automatic injector the most according to claim 2, wherein, at least one deflectable member described is configured to described Opening in housing is to punctual deflection.
4. according to automatic injector in any one of the preceding claims wherein, wherein, described plunger rod actuator includes plunger Bar spring；
Wherein, described plunger rod spring is at one end strongly attached in described plunger rod tube.
Automatic injector the most according to any one of claim 1 to 3, wherein, described plunger rod actuator is by driving force It is applied directly on described plunger rod.
Automatic injector the most according to any one of claim 1 to 3, wherein, described housing also accommodates for keeping State the injection bobbin of injection tube, and wherein, the described injection tube with injection tube flange is locked in described injection bobbin with described Between plunger rod tube.
Automatic injector the most according to any one of claim 1 to 3, wherein, described plunger rod actuator is located at described In plunger rod tube, and wherein said injection tube actuator is located at outside described plunger rod tube.
Automatic injector the most according to any one of claim 1 to 3, wherein, the inner surface of described housing prevents described At least one deflectable locking member deflects；
Wherein, when described plunger rod is released, described plunger rod actuator makes described plunger rod advance in described injection tube, Because described plunger rod stop part can be through described deflectable locking member.
Automatic injector the most according to any one of claim 1 to 3, wherein, plunger rod stop part has normally presses Lean against the angled surface on the angled surface of described deflectable locking member, wherein, at least one deflectable locking described Parts down position for the motion relative to described plunger rod is hinged in described plunger rod tube.
Automatic injector the most according to any one of claim 1 to 3, wherein, described automatic injector is to reload 's.
11. automatic injectors according to any one of claim 1 to 3, wherein, described plunger rod tube include being configured to At least the first locking member that described plunger rod stop part sequentially engages and the second locking member；
Wherein, described housing includes being configured to when described injection tube is in the described second position lock with the most described first respectively Limiting-members and described second locking member alignment the first opening and the second opening.
12. automatic injectors according to claim 10, wherein, described automatic injector is configured to carry two or more Individual single drug dose.
13. automatic injectors according to claim 10, wherein, described plunger rod actuator is configured to make described plunger exist The first of described plunger rod actuator moves the first distance when actuating, and moves when another of described plunger rod actuator is actuated Another distance.
14. automatic injectors according to claim 13, wherein, the second of described plunger rod actuator actuate described from Dynamic reloading of syringe is carried out afterwards, and at described injection tube assembly from described primary importance to the weight of the described second position Carry out after multiple motion.
15. automatic injectors according to claim 10, also include being configured to reload adding again of described automatic injector Carry handle, and the wherein said user operation reloading handle includes rotary motion；
Wherein, described in reload handle construction for rotary motion, described automatic injector also includes intermediate member, described centre The described convert rotational motion reloading handle is become the axially-movable of the most described injection tube assembly by component, wherein, described in Between component have be configured to operation described in reload handle time along described in reload the projection that the inclined surface of handle moves；
Wherein, described projection is pushed on inclined surface top and enters second add by the complete operation reloading handle described in again Carry in handle notch；
Wherein, described second reload handle notch there is the inclined surface allowing to reload described automatic injector continuously；
Wherein, described second reloads handle notch only allows lengthwise movement, thus prevents from reloading described automatic note further Emitter.
16. automatic injectors according to claim 10, wherein, reloading of described automatic injector is configured so that institute The operation stating automatic injector is reverse.
17. automatic injectors according to any one of claim 1 to 3, wherein, also include that injection tube lock and skin sense Device, described injection tube Lock structure becomes described injection tube is locked in described primary importance, described skin sensor be configured to Described injection tube lock is discharged, wherein by described skin sensor being pressed against the skin of user during the skin engagement of user On actuate described skin sensor；
Wherein, actuating of described skin sensor is configured to cause moving upward of described skin sensor, thus skin sensing The angled surface of device is configured to engage with the angled surface of injection tube lock, thus by the lateral movement of described skin sensor Change into the angled motion of described injection tube lock.
18. automatic injectors according to claim 17, wherein, described injection tube assembly only leans against described injection tube lock On convex ridge, so that described injection tube to be locked in described primary importance, and the angled motion of wherein said injection tube lock discharges institute State injection tube assembly.
19. automatic injectors according to any one of claim 1 to 3, wherein, described plunger rod tube includes that plunger rod is convex Sheet, described plunger rod tab configuration one-tenth guides in notch at injection tube lock and moves to injection tube lock from the off-position adjacent to convex ridge End stop；
Wherein, in described injection tube lock guiding notch, described injection is marched to from described off-position when described plunger rod lug During cylinder lock end stop, described injection tube moves to the described second position from described primary importance.
20. automatic injectors according to claim 17, wherein, the described injection tube assembly in the described second position Travel forward and limited by the described plunger rod lug engaging injection tube lock end stop；
Wherein, when described automatic injector is removed from the skin of user, skin sensor actuator is configured to each Promote forward to cover described pin by described skin sensor after injection circulation.
21. automatic injectors according to claim 17, wherein, described injection tube assembly includes coaxially around described note The injection bobbin of shooting cylinder and the plunger rod tube coaxially around described plunger rod, described injection bobbin and described plunger rod tube warp It is interconnected by the injection tube tube connector that can engage with plunger rod tube adapter；
Wherein, described injection tube assembly is configured to when middle member protrusions is located in first handle notch or second handle notch Only lean against on injection tube lock convex ridge；
Wherein, reloading of described automatic injector is configured to make described injection tube actuator, injection tube lock, skin sensor etc. Reversely.
22. automatic injectors according to any one of claim 1 to 3, wherein, described automatic injector housing also includes For indicating the indicator of " preparation " state and " being not ready to " state；
Wherein, described " preparation " state indicates the first position of rotation of described injection tube lock, at described first position of rotation, described Injection tube assembly is locked in described primary importance.
23. automatic injectors according to claim 17, wherein, when described injection tube assembly is in described primary importance Time, described skin sensor extends up to the whole length of described pin, with described pin hiding in terms of the visual angle of user；
Wherein, described skin sensor is configured to when pin described after delivered dose is withdrawn extend up to described pin Whole length；
Wherein, described skin sensor has the forward facing position of locking and the forward facing position of unblock；
Wherein, when operation reloads handle, described skin sensor unlocks at described forward facing position.
24. automatic injectors according to any one of claim 1 to 3, wherein, described automatic injector also includes structure Become the sound generator sending sound when being administered；
Wherein, described sound generator includes ratch mechanism；
Wherein, described ratch mechanism includes flexible arm, and described flexible arm is positioned to for engaging relative to described injection tube assembly Inclined teeth on described plunger rod；
Wherein, described ratch mechanism only allows travelling forward of described plunger rod.
25. automatic injectors according to any one of claim 1 to 3, wherein, described injection tube assembly also includes thief-proof Open component；
Wherein, described tamper-evident component includes the protection mechanism guaranteeing to prevent the rearward movement of described plunger rod.
26. automatic injectors according to any one of claim 1 to 3, wherein, described automatic injector is to re-use 's；
Wherein, described injection tube assembly is interchangeable.
27. 1 kinds of automatic injectors with the sequential control that pin inserts and dosage is injected, described automatic injector has housing, Described housing is used for accommodating:
First spring, described first spring is configured to exert a force on injection tube so that described injection tube is from described first Putting mobile to the described second position, described first spring is also configured to make the described plunger rod tube with described plunger rod advance to The described second position,
Second spring, described second spring is configured to exert a force to described plunger rod, so that described plunger rod is in described injection Advance for carrying at least one drug dose in Tong,
At least one locking member wherein said is configured to when making the described plunger rod tube with described plunger rod advance to described Unlocking during the second position, so that described plunger rod unlocks from described plunger rod tube, and it is described to allow described second spring to make Plunger rod advances in described injection tube.
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