WO2008114035A1 - Improved autoinjector - Google Patents

Improved autoinjector Download PDF

Info

Publication number
WO2008114035A1
WO2008114035A1 PCT/GB2008/001015 GB2008001015W WO2008114035A1 WO 2008114035 A1 WO2008114035 A1 WO 2008114035A1 GB 2008001015 W GB2008001015 W GB 2008001015W WO 2008114035 A1 WO2008114035 A1 WO 2008114035A1
Authority
WO
WIPO (PCT)
Prior art keywords
autoinjector
packaging
chamber
kit
medicament
Prior art date
Application number
PCT/GB2008/001015
Other languages
French (fr)
Inventor
Kevin Stamp
Ian Charles Cleathero
Original Assignee
The Medical House Plc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to GB0705388.7 priority Critical
Priority to GB0705388A priority patent/GB0705388D0/en
Application filed by The Medical House Plc filed Critical The Medical House Plc
Publication of WO2008114035A1 publication Critical patent/WO2008114035A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/2013Having specific accessories triggering of discharging means by contact of injector with patient body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

An autoinjector kit comprising an autoinjector including: a first chamber (40a) for containing a dry component of a medicament, and a second chamber (50) for containing a wet component of a medicament; reconstitution means for mixing said dry and wet components by placing said first and second chambers into fluid communication with one another, packaging (10); wherein said packaging is adapted to automatically actuate said reconstitution means to mix said dry and wet components upon movement of at least a part thereof relative to at least a part of the autoinjector.

Description

IMPROVED AUTOINJECTOR

This invention relates to the field of autoinjectors for the administration of liquid medication.

BACKGROUND

An autoinjector is an automatic injection device designed to facilitate automated delivery of a dose of medicament to a patient through a hypodermic needle, the injection usually being administered by the patient themselves. The injection can be delivered subcutaneously or intra-muscularly, depending upon the properties of the autoinjector. An autoinjector works by delivering an injection automatically upon actuation by the patient, for example pressing a button, moving a lever or part of a housing etc. This is in contrast to a conventional manual syringe where the patient himself needs to directly depress a plunger into a barrel containing medicament in order to effect the injection. The terms "autoinjector" and "injection device" are used interchangeably in the following description.

Some types of medication for delivery by an autoinjector are provided and stored in a two-part form, having a solid component and a liquid component, for example as a powdered medicament and a liquid solvent. The powdered medicament may comprise a ground-down or milled solid medicament or may be a powder prepared by a lyophilisation process for example. The liquid part may be a second medicament, rather than a solvent or diluent. Such two-part formulations are well known and sometimes referred to as "wet-dry" formulations. Immediately before the medicament is delivered by injection into the patient, the wet and dry components of the formulation are mixed together so that a combined medicament is delivered by the autoinjector.

During storage and before use of the autoinjector, it is essential that the wet and dry components of the formulation are kept separate from one another within the autoinjector. When it is desired to deliver an injection, the wet and dry components need to meet together quickly and effectively before being expelled from the injection device. A prior art autoinjector is described in EP0361668 (Medimech Limited) in which an autoinjector has at least two chambers containing different ingredients of a medicament separated by an impermeable membrane. When it is desired to deliver an injection, a lance moves to cut or pierce the membrane allowing the ingredients to mix immediately before a plunger drives a needle out of the body of the injector to discharge the medicament through the needle.

Another autoinjector is described in WO02/49691 (Gillespie) in which a spring-operated plunger forces pressurised liquid from a first chamber causing a releasable seal between the first and a second chamber to disengage so that liquid can flow through the second chamber dissolving any dry medicament therein.

Another autoinjector is described in EP1709984 (Meridian Medical Technologies, Inc) in which the liquid is pressurised upon actuation of the device such that a fluid passageway between first and second chambers is opened in order that the wet and dry components can meet. In an alternative embodiment, a seal between the first and second chambers is punctured by a spike, allowing their respective contents to mix.

In all three of the above prior art devices, mixing of the medicament is effected almost simultaneously with expulsion of the medicament from the device, the wet component being "flushed" through the dry component on its way out of the autoinjector. This has the advantage of reducing the total time between the user actuating the device and delivery of the injection. However, potentially there is a disadvantage in such "flushing" action, for example if mixing of the components is not homogenous, or if some of the dry component is left behind inside the device. Incomplete mixing can also result in a blockage of the injection needle.

Generally, in a wet-dry autoinjector, the dry chamber containing the solid medicament powder also contains a volume of air or other gas which is replaced by the liquid medicament entering therein when the medicament is reconstituted or mixed. Any excess gas has to be "bled" from the chamber before injection takes place, else the device would undesirably inject an unacceptable volume of gas into the patient as well as the reconstituted medicament. In addition, excess gas in the chamber may cause bubbling or foaming during mixing and/or injection (again with the risk of injecting unwanted gas into the patient). Bleeding excess gas from the chamber prior to injecting the medicament increases the total operating time of the device, which may be undesirable in an emergency situation, or where the patient is needle-phobic, and it is advantageous to effect the injection as quickly as possible.

SUMMARY OF THE INVENTION

According to a first aspect of the invention there is provided an autoinjector kit comprising an autoinjector including: a first chamber for containing a dry component of a medicament, and a second chamber for containing a wet component of a medicament; reconstitution means for mixing said dry and wet components by placing said first and second chambers into fluid communication with one another, packaging; wherein said packaging is adapted to automatically actuate said reconstitution means to mix said dry and wet components upon movement of at least a part thereof relative to at least part of the autoinjector.

The packaging of a conventional autoinjector normally has no function other than to protect and possibly seal the autoinjector during storage and transport, and is often simply discarded before using the autoinjector. At least part of the packaging is moved, usually by the user, to activate reconstitution before an injection of medicament can be delivered. If the movement required to actuate the reconstitution means occurs during the opening of the packaging, the components of the medicament can be mixed rapidly and without the need for a separate positive action or intervention by the user who may be in a stressful situation and requiring the autoinjector to be ready for use as quickly as possible. In some situations and depending upon the properties of the medicament concerned, it may be possible to reconstitute the medicament as described above but then to delay delivery of the injection, for example by a few hours. Priming the device by reconstituting the medicament in advance may make the delivery of a medicament injection, when required, even quicker and simpler to perform in an emergency situation.

According to a second aspect of the invention there is provided a method of reconstituting a two-part medicament comprising the steps of: providing an autoinjector kit as described in any of the preceding paragraphs; and moving said at least part of said packaging relative to at least part of the autoinjector so as to actuate said reconstitution means.

According to a further aspect of the invention there is provided an autoinjector including: a first chamber for containing a dry component of a medicament, and a second chamber for containing a wet component of a medicament; an axially-moveable stopper intermediate the first and second chambers ; reconstitution means for mixing said dry and wet components by putting said first and second chambers into fluid communication with one another; wherein said reconstitution means is capable of pressurising said wet component so that, upon entry of the pressurised wet component into said first chamber, hydraulic forces cause said axially-moveable stopper to move so as to increase the volume of said first chamber to accommodate said wet component.

The first chamber containing the dry component is preferably initially provided with little or no gas therein, as the stopper is axially-positioned to abut the dry component which may be packed in place. When the reconstitution means is actuated, the stopper moves axially only enough to increase the volume of the first chamber sufficiently to accommodate the wet component entering therein. Therefore, throughout, the volume of unwanted gas in the chamber is kept to a minimum, reducing the likelihood of bubbling or foaming during mixing, and reducing the volume of gas which may eventually be undesirably injected into the user. Furthermore, the reconstitution stage is effected automatically by the hydraulic forces present in the pressurised wet component, without requiring any intervention or action by the user once it has been initiated.

Further features of the invention are defined in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present invention will now be more particularly described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 is an exploded view of the autoinjector kit components;

Figure 2 is a cross-sectional view of the autoinjector kit, in its storage condition; Figure 3 is a cross-sectional view of the autoinjector kit, with the proximal pin wedge removed and the mixing stage in process;

Figure 4 is a cross-sectional view of the autoinjector, with the medicament fully mixed and the injection ready to be delivered;

Figure 5 is a cross-sectional view of the autoinjector, during delivery of the injection;

Figure 6 is a cross-sectional view of the autoinjector, after delivery of the injection is complete with the needle still exposed;

Figure 7 is a cross-sectional view of the autoinjector, after delivery of the injection and retraction of the needle; In Figures 4-7, the autoinjector's internal springs are not illustrated, to improve clarity.

Figure 8 is a perspective view of a second embodiment of the autoinjector kit in which the packaging need not be removed from the device before delivery of a medicament;

Figure 9A shows the autoinjector kit of Figure 8 part-way through twisting the end cap relative to the main packaging section;

Figure 9B, drawn to a larger scale, shows internal detail of the rear part of the main packaging section and autoinjector therein;

Figure 10A shows the autoinjector kit of Figure 8 further through twisting the end cap relative to the main packaging section;

Figure 10B drawn to a larger scale, shows internal detail of the rear part of the main packaging section and autoinjector therein, with the guide ribs 86 abutting endstops 88;

Figure 11 shows the autoinjector kit of Figure 8 with the end cap 11 removed from the main packaging section;

Figure 12 shows the autoinjector placed against an injection site, ready to administer an injection of medicament; and Figure 13 shows an alternative embodiment of an autoinjector including a double ended "floating needle" disposed between the dry and wet medicament chambers.

DETAILED DESCRIPTION

Throughout this application, the words "comprise" and "contain" and variations of the words, for example "comprising" and "comprises", means "including but not limited to", and is not intended to (and does not) exclude other components, integers or steps.

Throughout this application, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Throughout this application, reference to a "forward" direction means the direction which is towards the patient when the injection device is in use. The "forward" or "distal" end of the injection device is the end nearest the patient's skin when the device is in use. Similarly, reference to a "rearward" direction means the direction which is away from the patient and the "rearward" or "proximal" end of the device is the end furthest from the patient's skin when the injection device is in use.

Throughout this application, reference to a "wet component of the medicament" means any liquid medicament, solvent, diluent, gel or other substantially liquid component. "Wet" does not imply a complete absence of any solid matter.

Throughout this application, reference to a "dry component of the medicament" means any solid, powder or other substantially dry component. "Dry" does not imply a complete absence of liquid, and the dry component may comprise a stiff paste or slurry for example.

Throughout this application, reference to "packaging" means the packaging inside which the autoinjector is normally stored, transported and/or provided to the user and which needs to be opened, manipulated and/or removed before the autoinjector can be used.

The packaging may be separable from the working components of the autoinjector and may be disposable. Alternatively, at least part of the packaging may form part of the working components of the autoinjector. The packaging may also serve to provide a sterile barrier for the autoinjector and the medicament contained therein.

Throughout this application, reference to "opening" of the packaging means manipulating, removing or otherwise acting on said packaging so that the autoinjector is no longer in its storage condition. Once the packaging is opened, it may not be possible to safely re-close the packaging and store the autoinjector for future use, although it is envisaged that, in some embodiments, it may be possible to re-close the packaging after reconstitution has taken place to store the autoinjector for future delivery of medicament.

Throughout this application, references to "reconstitution" include the term "mixing" wherein components of a medicament are mixed together with no solution, reaction or other chemical process necessarily taking place.

Features, integers, characteristics or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.

In general, an autoinjector includes a needle which is located within the housing of the device. Upon activation of a force-generating source, a portion of the needle extends out of the housing and penetrates the outer layer of skin to deliver medicament. An improved autoinjector is described in our international patent application, published under number WO 2005/070481. This device requires that the needle is moved axially so that it can appear beyond the end of the nozzle for the duration of the injection, after which the needle retracts automatically, so that it is never in sight of the user. The device also requires that the plunger is moved axially so that medicament is ejected. The overall complexity of the autoinjector is significantly reduced by both of these requirements being effected by one component, namely an inner housing (having reference numeral 7 in WO 2005/070481).

Referring to Figures 1 and 2 of the present application, selected components of the autoinjector will now be described. The device is stored, transported and provided to the user inside a cylindrical outer packaging tube 10, sealed with an outer tube end cap 11 and O-ring 12. Unusually, the outer packaging tube 10 (which may be referred to as "secondary packaging") includes part of the means for actuating the reconstitution or mixing stage for the dry and wet components of the medicament. The rear end of the outer packaging tube 10 is provided with an inwardly-directed rear pin wedge 13 (shown in Figure 2) whose function will be described later.

Immediately inside the outer packaging tube 10 are the outer housing 20 of the device and its front end cap 21. The outer housing 20 is similar in function to the outer housing described in WO 2005/070481.

Inside the outer housing 20 is the rear housing 30 which has various slots and other guide means therein for controlling the path of other components during delivery of an injection. The rear housing 30 is attached to a front housing 31 which covers and conceals the injection needle 32.

The dry component of the medicament is stored in the front chamber 40a of a dry medicament chamber 40. Dry chamber 40 has two chambers 40a and 40b which are separated and sealed from one another by an axially-moveable stopper 41. The rear chamber 41b initially contains air or other gas. The front chamber 40a is full, with the stopper 41 abutting the dry component. In this way, the initial volume of unwanted gas in the chamber is minimised and is usually limited only to the small volume of gas located between the particles of the dry component.

The wet component of the medicament is stored in a wet medicament chamber 50. The wet chamber has a needle 51 at its front end which is staked into (but not through) the stopper 41 of the dry chamber. The staked needle 51 provides a seal between the wet and dry chambers. The rear of the wet chamber 50 is sealed by an axially-moveable stopper 52.

Reconstitution of the medicament is effected by a reconstitution housing 60, reconstitution ram 61 which abuts the rear wet chamber stopper 52 and a reconstitution spring 62 which biases the ram 61 forwardly. In the storage position illustrated in Figure 2, it can be seen that the ram 61 has rearwardly extending flexible fingers 61A which are wedged apart by pin wedge 13. The wedged-apart flexible fingers 61 A cannot pass the narrowed potion 6OA of the reconstitution housing, despite being forwardly-biased by the spring 62. Expulsion of the medicament from the device is effected by an injection ram 70 which, in use, abuts the dry chamber stopper 41.

For controlling delivery of the injection, an inner housing 80 and compression pad 81 are provided which are comparable to inner housing 7 and syringe holder 100 described in WO 2005/070481 and our co-pending application number PCT/GB2007/000141 respectively. These components form part of the injection delivery means.

The function of these components will now be described with reference to Figures 2-7. In its storage condition (see Figure 2) the internal components of the autoinjector, in particular the reconstitution components, are unable to move axially because of the presence of pin wedge 13 inwardly-directed from the rear of the outer packaging tube 10.

When the user is ready to actuate the device, he pulls off the outer tube cap 11 and tips the device forward and out of the outer packaging tube 10. As soon as he does this, reconstitution of the medicament can begin with the reconstitution ram 61 being tipped off the pin wedge 13 so that, as shown in Figures 3 and 4, the fingers 61 A are now free to flex radially-inwardly so that they can pass narrowed portion 6OA under the force of spring 62. Forward movement of the reconstitution ram 61 pushes the stopper 52 forward onto the incompressible liquid in the wet chamber 50 so that the whole wet chamber 50 moves axially forwards. This causes the needle 51 staked in the dry chamber stopper 41 to be driven right through to puncture the stopper creating a fluid connection between the wet and dry chambers.

Referring now to Figure 4, the wet component of the medicament which is under pressure from the forward moving reconstitution ram 61 is forced through the needle 51 into the dry chamber 40a. Hydraulic forces and turbulence in the incoming wet component contributes to and facilitates its mixing with the dry component. The wet component enters the dry chamber 40a, displacing any gas present between the dry component particles. Note that the injection needle 32 is not in fluid communication with the medicament chamber 40a because its rear end is inside a needle housing 33. As the chamber 40a fills with reconstituted medicament, the stopper 41 starts moving axially-rearwardly, slipping over needle 51 until the full volume of wet component has been transferred from the wet chamber 50 to the chamber 40a. In this way, not only does little or no unwanted gas remain in the chamber 40a, but once the reconstitution stage is complete (as shown in Figure 4), the volume of the chamber 40a has increased only to the minimum volume required to contain the reconstituted medicament, ready for expulsion from the device.

Using this improved autoinjector, the reconstitution of the medicament (which for example might take only 2-3 seconds depending upon the characteristics of the medicament) takes place whilst the user is removing the secondary packaging (10, 11 , 12, 13) and moving the device to the injection site. Thus, a separate mixing stage occurs which is distinct from the medicament delivery stage, (unlike the "flushing"-type action of the prior art devices simultaneous with the injection), but without need for the user to positively actuate and then wait for the mixing to take place. Furthermore, the reconstituted medicament ends up in a chamber of the minimum volume necessary.

Once the medicament is reconstituted, an injection delivery mechanism takes over which has similarities with that described in WO 2005/070481. Figure 4 shows the medicament fully mixed and ready for delivery. When it is desired to deliver an injection, the user removes the front end cap 21 from the device in the direction indicated by the arrow in Figure 4 and places the front housing 31 of the device on the skin at the injection site, grasping the outer housing 20.

Referring to Figure 5, application of forward force F to the outer housing 20, actuates the main energy source of the device (usually a spring, not illustrated in Figure 5), causing the inner housing 80 (comparable to inner housing 7 in WO 2005/070481) to drive the needle forwardly out of the device (through an aperture or septum) in the front housing and into the injection site. This comprises the "first position" of the inner housing described in WO 2005/070481. At or around the same time, the rear end of the injection needle 32 punctures a septum or the like between the rear of the needle housing 33 and the chamber 40a, bringing the needle 32 into fluid communication with the medicament chamber 40a.

Next, referring to Figure 6, the injection ram 70 is driven forward by the inner housing 80, pushing the stopper 41 into the reconstituted medicament in the chamber 40a so as to drive the medicament out of the device through needle 32. This comprises the "second position" of the inner housing described in WO 2005/070481. Referring to Figure 7, once the medicament has been delivered, the inner housing 80 causes the needle 32 to retract back into the front housing 31 so that it is completely concealed from the user. This comprises the "third position" of the inner housing described in WO 2005/070481.

Figures 8-12 show an alternative embodiment in which it is not necessary to fully remove the outer packaging in order to reconstitute the medicament. The reconstitution process is nevertheless similar to that described above, (i.e. removal of pin wedge 13 from flexible fingers 61a) and is activated upon opening the packaging.

Figure 8 shows an autoinjector stored within an outer packaging tube 10' having an outer tube end cap 11'. A guide pin 84 will be described below. When it is desired to open the packaging, the end cap 11' can be twisted with respect to the packaging tube 10', in the direction indicated by the arrow in Figure 8.

Referring now to Figure 9A, the tube end cap 11' comprises a main section 11a' and a spigot 11 b'. The spigot section 11b' has a smaller diameter than the main section and normally fits inside the packaging tube 10'. The spigot 11b' has at least one guide channel 82 therein which may be an aperture or a groove or the like. The guide channel 82 is preferably helical and is illustrated more clearly in Figure 11 where it can be seen that the channel 82 has an open end 82a and a closed end 82b.

Turning back to Figure 9A, the guide channel 82 is adapted to receive at least one guide pin 84 projecting radially inwardly from an inner surface of the packaging tube 10'. When the device is in a stored condition, the packaging tube 10' fits over the spigot section 11b' and the guide pin 84 is disposed in the guide channel 82 and axial movement of the packaging tube 10' relative to the end cap 11" is prevented.

It is possible to twist the packaging tube 10' relative to the end cap 11', but only in one direction as the guide pin 84 is initially disposed adjacent the closed end 82b of the guide channel 28. When the packaging tube 10' is twisted relative to the end cap 11 ', the guide pin 84 travels along the guide channel 82 so that the packaging tube 10' moves axially relative to the end cap 11'. The autoinjector 90 contained within the packaging tube remains stationary relative to the end cap 11'. Consequently, there is relative axial movement between the autoinjector 90 and the packaging tube 10'. The effect of this relative axial movement is illustrated with reference to Figures 9B and 1OB. The rear end of the autoinjector 90 comprises rearwardly-projecting ramps 88 which are preferably helical and have the same pitch as the guide channel 82 on the end cap 11'. The rear end 10a' of the packaging tube 10' has inwardly-projecting guide ribs 86 that project towards the front of the autoinjector. A pin wedge 13, similar to that described above in relation to the first embodiment, is located centrally of the guide ribs 86, projecting towards the front of the autoinjector and holding apart flexible fingers 61a. When the autoinjector is in its storage condition (as in Figure 8) wherein the packaging tube 10' is securely fastened to the end cap 11', the forwardmost extremities of the guide ribs 86 are at the bottoms of the ramps 88 so that the distance between rear end of the autoinjector 90 and the inner surface of the rear end 10a' of the packaging tube 10' is substantially equal to the length of the guide ribs 86. Relative axial movement of the autoinjector and the outer packaging tube is not possible as there is no axial space in which such movement could occur.

When the packaging tube 10' is twisted and moves axially relative to the end cap 11' and autoinjector (as shown in Figure 9A), the guide ribs 86 are guided up the ramps 88 causing the pin wedge 13 to withdraw from within the flexible fingers 61a (Figure 9B). Further twisting of the packaging tube 10' relative to the end cap 11' causes the guide ribs 86 to reach the top of the ramps 88 and abut endstops 88a as shown in Figure 10A. At this point the pin wedge 13 is removed clear of the flexible fingers 61a so that the flexible fingers 61a are free to flex radially-inwards allowing reconstitution to begin. The process of reconstitution then occurs as described above. It should be noted that the present embodiment allows reconstitution to be initiated before complete removal of end cap 11'. By the time the user has removed the end cap 11' completely from the autoinjector, the reconstitution has occurred. This is important for applications where it might be undesirable for the patient if an injection is administered before reconstitution is complete.

In order for the user to administer an injection of medicament, the end cap 11' must be fully removed from the packaging tube 10'. The end cap 11' is freed from the packaging tube 10' when the guide pin 84 passes through the open end 82a of the channel 82 (Figure 11). Removal of the end cap 11' preferably also removes the end cap and/or needle sheath from the needle so that, with the end cap 11 ' removed, the front end of the autoinjector 90 is revealed and ready for actuation. Alternatively, the end cap and needle sheath of the autoinjector (not illustrated) could be removed by the user in a separate stage.

In one embodiment, the packaging tube 10' may also be removed from the autoinjector 90 at this stage, the autoinjector being actuated to deliver medicament by the user directly acting on the outer housing of the autoinjector (as described above). However, in the illustrated embodiment, it is not necessary to remove the packaging tube 10' and the autoinjector can be actuated to deliver medicament to an injection site 92 by application of a forward force F (Figure 12) to the packaging tube 10'. In this instance, the packaging tube 10' itself forms part of the injection delivery means of the autoinjector. The force F is transmitted to the autoinjector through the guide ribs 86. Actuation then occurs according to the process described above with reference to Figures 5-7.

The improved autoinjector described herein is quick and easy to operate by the user and is particularly, but not exclusively, suitable for use in emergency applications. The reconstitution of the medicament has the advantage of comprising effective mixing of the wet and dry components (rather than simply flushing one through the other upon exiting the device) but does not unduly prolong the overall operating time of the device because the mixing is initiated automatically upon opening the outer packaging tube and can take place whilst the user is moving the device to the desired injection site. In addition, the user may wish to reconstitute the medicament but then re-seal the packaging (replace the cap, for example) so that the packaging can be reopened and the already reconstituted medicament delivered quickly as required in an emergency situation. This would only be possible for certain medicaments having suitable storage properties.

Alternative types of packaging which are capable of initiating the reconstitution of the medicament are envisaged. For example, instead of the outer packaging tube 10 and pin wedge 13, the autoinjector could be wrapped in a sealed flexible plastics material, the opening of which initiates reconstitution of the medicament, perhaps upon release of a vacuum seal, or by releasing a previously-constrained component.

Alternative seals between the wet and dry chambers are possible instead of the needle

51 staked in the dry chamber stopper 41. For example, both the rear of the dry chamber and the front of the wet chamber may be sealed with stoppers, septums or the like, and a double-ended needle could be provided therebetween. The double-ended needle could be staked at both ends into the respective stoppers, both being punctured by the needle during the reconstitution stage. Alternatively, the double-ended needle could initially be in contact with neither of the stoppers (a "floating needle") and only contact and then puncture them during the reconstitution stage. One such example of a "floating needle" 51' is shown in Figure 13 prior to reconstitution. The needle 51' has a rear end 51a' proximate the wet chamber 50 and a front end 51b' proximate the dry chamber 40a and is located in a needle hub, 98. Upon removal of the pin wedge 13, the force of the forward moving reconstitution ram 61 causes forward axial movement of the needle hub 98 and the needle 51' so that the front end 51 b' penetrates the dry chamber stopper 41. Once the front end 51b' of the needle 51' has entered the dry chamber 40a, the wet chamber 50 continues to move axially forward over the needle 51'. The rear end 51a' of the needle then penetrates a septum 96 in the wet chamber 50 thereby establishing fluid communication between the wet 50 and dry 40a chambers. Reconstitution of the wet and dry components of the medicament can then take place as described above with reference to Figure 4. Other alternatives regarding seals, stoppers and needles will be envisaged by the skilled reader.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. An autoinjector kit comprising an autoinjector including: a first chamber for containing a dry component of a medicament, and a second chamber for containing a wet component of a medicament; reconstitution means for mixing said dry and wet components by placing said first and second chambers into fluid communication with one another, packaging; wherein said packaging is adapted to automatically actuate said reconstitution means to mix said dry and wet components upon movement of at least a part thereof relative to at least a part of the autoinjector.
2. The autoinjector kit of claim 1 wherein at least a part of said packaging comprises a part of an injection delivery means of said autoinjector.
3. The autoinjector kit of claim 1 or claim 2 wherein said opening involves the removal of said autoinjector from said packaging.
4. The autoinjector kit of any of claims 1-3 wherein said packaging includes an inwardly-directed pin or protrusion which is capable of interacting with a component of said autoinjector.
5. The autoinjector of claim 4 wherein said pin or protrusion is integrally -formed with said packaging.
6. The autoinjector kit of any of the preceding claims wherein said packaging includes a main packaging section and a removable front end cap.
7. The autoinjector kit of any of the preceding claims wherein said main packaging section comprises a generally cylindrical tube.
8. The autoinjector kit of claim 6, or claim 7 when dependent on claim 6, wherein said end cap includes a guide means capable of cooperating with guide means on said main packaging section to guide relative movement therebetween along a defined path.
9. The autoinjector kit of claim 8 wherein said end cap guide means comprises a generally helical channel and said main packaging guide means comprises an inwardly-directed pin or protrusion.
10. The autoinjector kit of any of claims 6-9 wherein said autoinjector is axially fixed with respect to said front end cap.
11. The autoinjector kit of any of claims 6-10 wherein said autoinjector is axially moveable with respect to said main packaging section.
12. The autoinjector kit of any of claims 6-11 wherein said main packaging section includes a guide means capable of cooperating with guide means on said autoinjector to guide relative movement therebetween along a defined path.
13. The autoinjector kit of claim 12 wherein said main packaging guide means comprises at least one inwardly directed rib or protrusion.
14. The autoinjector kit of claim 12 or claim 13 wherein said autoinjector guide means comprises at least one generally helical ramp.
15. The autoinjector kit of any of claims 1 to 5 wherein said packaging includes a sealed flexible wrapping.
16. The autoinjector kit of any of the preceding claims wherein said autoinjector is as claimed in any of claims 20-26.
17. An autoinjector kit substantially as described herein with reference to and as illustrated by any appropriate combination of the accompanying drawings.
18. A method of reconstituting a two-part medicament comprising the steps of: providing an autoinjector kit as claimed in any of claims 1 to 17; and opening said packaging so as to actuate said reconstitution means.
19. A method of reconstituting a two-part medicament comprising the steps of: providing an autoinjector kit as claimed in any of claims 8 to 14; moving at least part of said packaging relative to at least a part of said autoinjector so as to actuate said reconstitution means; and, preferably, removing said end cap;.
20. An autoinjector including: a first chamber for containing a dry component of a medicament, and a second chamber for containing a wet component of a medicament; an axially-moveable stopper intermediate the first and second chambers ; reconstitution means for mixing said dry and wet components by putting said first and second chambers into fluid communication with one another; wherein said reconstitution means is capable of pressurising said wet component so that, upon entry of the pressurised wet component into said first chamber, hydraulic forces cause said axially-moveable stopper to move so as to increase the volume of said first chamber to accommodate said wet component.
21. The autoinjector of claim 20 further comprising injection delivery means which is separately actuable to said reconstitution means.
22. The autoinjector of claim 20 or claim 21 wherein said stopper abuts said dry component in said first chamber.
23. The autoinjector of any of claims 20-22 wherein said stopper provides a seal between said first and second chambers.
24. The autoinjector of any of claims 20-23 wherein said reconstitution means includes a needle in fluid communication with said second chamber, moveable between a first position in which the needle is staked into said stopper and sealed from said first chamber, and a second position in which the needle punctures said stopper so that said first and second chambers are in fluid communication with one another.
25. The autoinjector of any of claims 20-23 wherein the rear of said first chamber and the front of said second chamber are sealed with a stopper, septum or other seal and wherein said reconstitution means includes a needle moveable between a first position in which the needle is floating between said first and second chamber seals, and a second position in which the needle punctures said first and second chamber seals so that said first and second chambers are in fluid communication with one another.
26. An autoinjector substantially as described herein with reference to and as illustrated by any appropriate combination of the accompanying drawings.
PCT/GB2008/001015 2007-03-21 2008-03-20 Improved autoinjector WO2008114035A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
GB0705388.7 2007-03-21
GB0705388A GB0705388D0 (en) 2007-03-21 2007-03-21 Improved autoinjector

Publications (1)

Publication Number Publication Date
WO2008114035A1 true WO2008114035A1 (en) 2008-09-25

Family

ID=38008803

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2008/001015 WO2008114035A1 (en) 2007-03-21 2008-03-20 Improved autoinjector

Country Status (2)

Country Link
GB (2) GB0705388D0 (en)
WO (1) WO2008114035A1 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009265915B2 (en) * 2008-07-04 2012-04-19 Shl Group Ab Medicament delivery device with mixing mechanism
CN102844065A (en) * 2010-02-05 2012-12-26 赛诺菲-安万特德国有限公司 Medicated module with lockable needle guard
CN102940920A (en) * 2012-10-30 2013-02-27 无锡耐思生物科技有限公司 Mixing pre-filled and sealed injector
CN103596610A (en) * 2011-06-10 2014-02-19 杜杰克特医疗系统有限公司 The injection device
AU2010255758B2 (en) * 2009-06-02 2014-12-18 Sanofi-Aventis Deutschland Gmbh Medicated module with bypass and needle guard
WO2016028820A3 (en) * 2014-08-18 2016-04-14 Windgap Medical, Inc Portable drug mixing and delivery device and associated methods
US9907910B2 (en) 2013-03-15 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10195361B2 (en) 2013-03-15 2019-02-05 Windgap Medical, Inc. Portable drug mixing and delivery system and method
US10220147B2 (en) 2015-08-13 2019-03-05 Windgap Medical, Inc. Mixing and injection device with sterility features

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2462811B (en) * 2008-08-18 2012-08-15 Medical House Ltd Improved autoinjector
NL2002379C2 (en) * 2008-12-29 2010-06-30 D O R C Dutch Ophthalmic Res Ct International B V An ophthalmic device and an intravitreal method.
GB0901801D0 (en) * 2009-02-05 2009-03-11 Medical House Plc The Improved autoinjector
CA2686433A1 (en) * 2009-11-20 2011-05-20 Duoject Medical Systems Inc. Double push injection device
US9017292B2 (en) 2010-12-31 2015-04-28 Novo Nordisk A/S Medical injection device
CN103415314B (en) * 2011-01-04 2015-11-25 赛诺菲-安万特德国有限公司 Safety device for an injection device and pre-filled syringes
CH705692A2 (en) 2011-11-03 2013-05-15 Tecpharma Licensing Ag Delivery device for mixing an active substance with a solution liquid.
GB201212190D0 (en) * 2012-07-09 2012-08-22 Oval Medical Technologies Ltd Injector device with mechanism for preventing accidental activation
WO2014060563A2 (en) * 2012-10-17 2014-04-24 Oval Medical Technologies Limited Automatic drug delivery devices
CN104968381B (en) * 2012-12-21 2017-07-04 卡贝欧洲有限公司 The medication delivery device
TWI577409B (en) 2013-10-10 2017-04-11 Carebay Europe Ltd Medicament delivery device
TWI569841B (en) * 2013-10-10 2017-02-11 Carebay Europe Ltd Medicament delivery device

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2604363A1 (en) * 1986-09-30 1988-04-01 Merieux Inst An injection of substances, in particular DRUG
US4755169A (en) * 1985-05-20 1988-07-05 Survival Technology, Inc. Automatic medicament ingredient mixing and injecting apparatus
WO1994009839A1 (en) * 1992-11-05 1994-05-11 Sti International Limited Automatic two-chamber injector
FR2741810A1 (en) * 1995-11-30 1997-06-06 Soc Et Et D Applic Tech Sedat Syringe for injecting extemporaneous mixture of two liquids
US5665071A (en) * 1993-05-27 1997-09-09 Washington Biotech Corp. Reloadable automatic or manual emergency injection system
WO2005070481A1 (en) * 2004-01-23 2005-08-04 The Medical House Plc Injection device
WO2006062997A1 (en) * 2004-12-06 2006-06-15 Washington Biotech Corporation Method and apparatus for delivering epinephrine
GB2426931A (en) * 2005-06-10 2006-12-13 Pa Knowledge Ltd Injection device
WO2007131013A1 (en) * 2006-05-03 2007-11-15 Antares Pharma, Inc. Two-stage reconstituting injector

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9611562D0 (en) * 1996-06-03 1996-08-07 Applied Research Systems Device
US7731678B2 (en) * 2004-10-13 2010-06-08 Hyprotek, Inc. Syringe devices and methods for mixing and administering medication

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4755169A (en) * 1985-05-20 1988-07-05 Survival Technology, Inc. Automatic medicament ingredient mixing and injecting apparatus
FR2604363A1 (en) * 1986-09-30 1988-04-01 Merieux Inst An injection of substances, in particular DRUG
WO1994009839A1 (en) * 1992-11-05 1994-05-11 Sti International Limited Automatic two-chamber injector
US5665071A (en) * 1993-05-27 1997-09-09 Washington Biotech Corp. Reloadable automatic or manual emergency injection system
FR2741810A1 (en) * 1995-11-30 1997-06-06 Soc Et Et D Applic Tech Sedat Syringe for injecting extemporaneous mixture of two liquids
WO2005070481A1 (en) * 2004-01-23 2005-08-04 The Medical House Plc Injection device
WO2006062997A1 (en) * 2004-12-06 2006-06-15 Washington Biotech Corporation Method and apparatus for delivering epinephrine
GB2426931A (en) * 2005-06-10 2006-12-13 Pa Knowledge Ltd Injection device
WO2007131013A1 (en) * 2006-05-03 2007-11-15 Antares Pharma, Inc. Two-stage reconstituting injector

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009265915B2 (en) * 2008-07-04 2012-04-19 Shl Group Ab Medicament delivery device with mixing mechanism
AU2010255758B2 (en) * 2009-06-02 2014-12-18 Sanofi-Aventis Deutschland Gmbh Medicated module with bypass and needle guard
US9238107B2 (en) 2009-06-02 2016-01-19 Sanofi-Aventis Deutschland Gmbh Medicated module with bypass and needle guard
CN102844065A (en) * 2010-02-05 2012-12-26 赛诺菲-安万特德国有限公司 Medicated module with lockable needle guard
US9033933B2 (en) 2010-02-05 2015-05-19 Sanofi-Aventis Deutschland Gmbh Medicated module with lockable needle guard
CN103596610A (en) * 2011-06-10 2014-02-19 杜杰克特医疗系统有限公司 The injection device
CN102940920A (en) * 2012-10-30 2013-02-27 无锡耐思生物科技有限公司 Mixing pre-filled and sealed injector
US10195361B2 (en) 2013-03-15 2019-02-05 Windgap Medical, Inc. Portable drug mixing and delivery system and method
US9907910B2 (en) 2013-03-15 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
JP2017525470A (en) * 2014-08-18 2017-09-07 ウィンドギャップ メディカル, インコーポレイテッド Portable drug mixing and delivery device and related method
CN106794305A (en) * 2014-08-18 2017-05-31 温德加普医疗股份有限公司 Portable drug mixing and delivery device and associated methods
CN106573111A (en) * 2014-08-18 2017-04-19 温德加普医疗股份有限公司 Portable drug mixing and delivery device and associated methods
US9907911B2 (en) 2014-08-18 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US9925335B2 (en) 2014-08-18 2018-03-27 Windgap Medical, Inc Portable drug mixing and delivery device and associated methods
US9950115B2 (en) 2014-08-18 2018-04-24 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
EP3183016A4 (en) * 2014-08-18 2018-05-02 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
AU2015305641B2 (en) * 2014-08-18 2018-11-08 Windgap Medical, Inc Portable drug mixing and delivery device and associated methods
WO2016028820A3 (en) * 2014-08-18 2016-04-14 Windgap Medical, Inc Portable drug mixing and delivery device and associated methods
US10300198B2 (en) 2014-08-18 2019-05-28 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10300199B2 (en) 2014-08-18 2019-05-28 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10220147B2 (en) 2015-08-13 2019-03-05 Windgap Medical, Inc. Mixing and injection device with sterility features

Also Published As

Publication number Publication date
GB2447787A (en) 2008-09-24
GB0705388D0 (en) 2007-04-25
GB0805269D0 (en) 2008-04-30

Similar Documents

Publication Publication Date Title
JP4326704B2 (en) Pen injector with an automatic material compound functions
US5167641A (en) Auto-retracting needle injector system
US9833579B2 (en) Medical injection device
RU2179864C2 (en) Needleless injector
CN102361660B (en) Injection device
DK2131898T3 (en) autoinjector
JP4660190B2 (en) Drug delivery system
DK2758102T3 (en) An automatic injection device
JP5721598B2 (en) Intradermal syringe
JP4236843B2 (en) A locking mechanism for the jet injection device
US9233206B2 (en) Continuous feed hypodermic syringe with self contained cartridge dispenser
CN1255192C (en) Medical arrangement
US7361160B2 (en) Injection apparatus comprising a needle-protecting device
EP1161961B1 (en) Jet injector
EP0361668A1 (en) Automatic injectors
EP1932558B1 (en) Auto-Injector
US9352088B2 (en) Auto-injector
RU2559019C2 (en) Surgical suturing instrument with medication dispenser
CN101420995B (en) Improved autoinjector supporting the syringe at the front
JP4578484B2 (en) Injection device
EP2146762B1 (en) Improved autoinjector
US4394863A (en) Automatic injector with cartridge having separate sequentially injectable medicaments
EP1843808B1 (en) Device for delivering medicament
CN102427841B (en) Injection devices
US20070021716A1 (en) Nozzle device with skin stretching means

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08718852

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase in:

Ref country code: DE

122 Ep: pct app. not ent. europ. phase

Ref document number: 08718852

Country of ref document: EP

Kind code of ref document: A1