Patent Application
20160074586
The invention relates to a container for a safe injection device. The container comprises at least one first closed chamber for containing an active substance and optionally a second closed chamber for containing a liquid substance comprising an active substance or a solvent. The two chambers are separated by a separation wall which can be broken by exertion of an external pressure on the external wall of the second chamber, resulting in mixing of the substances contained in the two chambers. The container can be connected to a needle for injecting a liquid composition. The injection device comprising said container is ready to use and cannot be reused.
Injections are the most common health care procedure worldwide. In developing and transitional countries alone, some 16 thousand million injections are administered each year. More than 90% injections are given for therapeutic purposes while 5 to 10% are given for preventive services, including immunization and family planning.
Unsafe injections place patients at risk of disability and death. Reuse of injection devices without sterilization is of particular concern according to the World Health Organization as it may transmit hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV), accounting for 32%, 40% and 5% of new infections in 2000, respectively. In addition, inappropriate and unhygienic use of multi-dose vials may transmit bloodborne pathogens. Moreover, an estimated 4.4% of HIV infections and 39% of HBV and HCV infections are attributed to occupational injury. Among the factors which can cause risks in giving injections or collecting blood are the reuse of injection equipment and the use of non-sterile or reprocessed syringes and needles. (World Health Organization: WHO best practices for injections and related procedures toolkit, 2010).
Accordingly, there is a need for safe injection devices. As the WHO states, “syringes with a reuse prevention feature offer the highest level of safety for injection recipients.” The WHO also recommends using a single-dose vial for each patient, in order to reduce cross-contamination between patients.
A preferred injection device would thus be one that contains a single bolus, is ready to use in order to avoid contamination upon bolus preparation in environments where sterility can be hard to achieve, and cannot be reused. At the same time, shelf-life of the medication to be administered should be as high as possible. Several disposable, ready-to-use injection devices have been disclosed. However, none of these devices have solved the problem.
The present invention is directed to a container for an injection device, which overcomes the problems recited above.
It is an object of the present invention to provide a ready-to-use, disposable container comprising:
It is a further object of the present invention to provide a ready-to-use, disposable container comprising:
It is another object of the present invention to provide an injection device comprising such a container connected to a needle, for injection of a liquid composition.
The present injection device can be activated without a plunger. The container of the present invention is particularly well suited for mixing two substances with only limited action required from the user, who only needs to exert a transient pressure on the side of the second chamber in order to allow mixing of the substances contained in the two chambers. The present container allows mixing in such a manner that formation of air bubbles upon mixing and prior to injection is greatly reduced in preferred embodiments. Such a container can prolong storage times by allowing individual storage of compounds which may have a longer shelf-life than the liquid composition to be achieved.
The invention further relates to a disposable injector comprising:
In the present context, the term ‘feeding unit’ is synonymous with ‘injection displacement means’.
Definitions
Active Substance
As understood herein, an active substance is any substance or compound, such as a molecule, a macromolecule, a protein, an antibody, a vaccine, a nucleic acid molecule, an antigen, a lipid, or any compound which has an activity on the body, its metabolism, or its immune response.
Breakable Upon Exertion of an External Force
The term “breakable upon exertion of an external force” as used herein in reference to the wall separating the two chambers of the container is to be understood as follows. Said separation wall is such that it can be deformable, but not breakable when the container is in an inactive state, that is when no external force is exerted on any of the external walls of any of the chambers. At the same time, said separation wall is breakable: exerting an external force on the external wall of the second chamber results in an increased pressure in the second chamber, which in turn results in increased forces being exerted on the separation wall, so that said separation wall is broken, ruptured, torn or punctured. Rupturing or breaking of the separation wall allows fluid communication between the two chambers of the container. The separation wall is not restorable once broken, i.e. breaking or rupturing of the separation wall is not reversible.
Chamber
A chamber as understood herein is a compartment which is closed and can contain a liquid or solid substance.
Deformable
The term “deformable” as used herein refers to the ability of a wall to change shape without breaking. The external wall of the first chamber will be hereinafter referred to as the first outer wall; the external wall of the second chamber will be hereinafter referred to as the second outer wall. The separation wall may be deformable so that its shape can be altered by the internal pressures of the chambers on each side of the wall, but the wall only breaks if an external force is applied to the second outer wall, which normally results in an increased internal pressure within the second chamber. The first and second outer walls may be deformable so that their shape can be altered by an external force, such as an external lateral force, but the walls do not break upon application of the said external force.
Distal
The term distal refers herein to the physical location of a part of the injector. A part of the injector is located distally when it is in the half of the injector opposite to the skin contacting surface.
Elongation at Break
Elongation at break, also known as fracture strain, is the ratio between length after breakage and initial length. It expresses the capability of a material to resist changes of shape without crack formation. The elongation at break is determined by tensile testing. Elongation at break is expressed as a percentage.
Impermeable/Water-Tight
The separation wall of the container described herein is impermeable or water-tight, i.e. it does not allow communication or exchange of the substances contained in the two chambers surrounding said separation wall, unless it is broken.
Needle
A needle as understood herein refers to a needle for injecting a liquid composition, such as a pharmaceutical composition. Such a needle may have zero, one or two sharp ends In the case of needles with two sharp ends, the sharp distal end can be used to rupture a breakable seal such as a membrane which is comprised in the means for attaching a needle, for example on the wall of the second chamber, so that the composition contained in the container can flow within the needle. The needle can be capped at the proximal end, to avoid accidental sticking or spillage of the liquid composition of the container. The means for attaching a needle comprise conventional means known in the art: the needle may be glued to the container, encased in the container, or the means for attaching a needle is such as a luer lock.
Pressure
Pressure is the effect of a force applied to a surface. Pressure is the amount of force acting per unit area. The symbol of pressure is p. The internal pressures herein referred to relate to the pressures within the chambers of the container. The chambers may be filled and/or sealed under conditions where the pressure is lower than the atmospheric pressure, so that their internal pressure is inferior to 1 atm (or 1.0197×10−5 Pa).
Proximal
The term proximal refers herein to the physical location of a part of the injector. A part of the injector is located distally when it is in the same half of the injector as the skin contacting surface.
Retraction
The term retraction is herein used in reference to a movement of the plunger from a proximal position where it is located within the housing of the injector to a distal position, where it is located outside the housing of the injector. The plunger is retracted when the user exerts a pulling force on it.
Separation Wall
The separation wall is the wall that is in contact with the two chambers of the container and prevents the substances contained therein to flow together. The separation wall of the present container is impermeable and breakable upon exertion of an external force, and normally also deformable in that it can resist the internal pressures of the chambers surrounding it. Thus, when the container is in an inactive state, the separation wall prevents any exchange between the substances of the two chambers.
It is an object of the present invention to provide a ready-to-use, disposable container comprising:
It is a further object of the present invention to provide a ready-to-use, disposable container comprising:
The active substance contained in the at least one first chamber can be a pharmaceutically active substance, such as a vaccine or a medical formulation. When the container does not comprise a second chamber, the active substance contained in the first chamber is preferably in a liquid form.
In some embodiments, the container comprises only one first chamber containing an active substance. The active substance is then preferably in a liquid form. In such embodiments, the dimensions of the second outer wall in relation to the dimensions of the first outer wall are such that the second outer wall can be pressed towards the first outer wall. In other words, the second outer wall is such that when a force is exerted upon it, it is pressed towards the first outer wall, thereby reducing the volume of the first chamber so that it is emptied and the active substance is dispensed.
In some embodiments the container optionally comprises a second chamber, the liquid substance contained in the second chamber can be a solvent or an active compound, such as an adjuvant in solution, so that a liquid composition generated by mixing the substances contained in the first and second chambers is an active solution, such as a pharmaceutically active solution, such as a vaccine. The container disclosed herein thus may allow separate storage of two active substances or compounds, and may thereby increase shelf-life of the container as compared to a container containing a solution consisting of a mixture of the same two substances.
Also provided is a container in which the first chamber contains an active substance in a solid form. In one embodiment the active substance contained in the first chamber is lyophilised; the active substance can be introduced in the first chamber before being lyophilised. In another embodiment the active substance contained in the first chamber is a solution.
The first and second chambers are defined partly by a first and second outer wall, respectively, and separated by a separation wall, which further defines the first and second chambers. Thus in such embodiments the first chamber is fully defined by the first outer wall and the separation wall. The second chamber is fully defined by the second outer wall and the separation wall. The first and second outer walls and the separation walls are impermeable or water-tight so that the substances contained in the first and second chambers are confined in their respective chamber prior to use (in the “inactive” state) and cannot flow from one chamber to the other. In one embodiment, the separation wall is manufactured from a polymer, such as cyclic olefin copolymer or cyclic olefin polymer. The separation wall can be rendered impermeable or liquid-tight by treatment with paraffin or petroleum jelly, or any treatment used in the art to render polymers liquid-tight. The separation wall is preferably breakable, i.e. exertion of an external force in the form of a lateral pressure exerted by the user on the external wall of the second chamber or pushing a needle against the separation wall preferably results in breaking, tearing, puncturing (or a combination thereof) of the separation wall. The container with an intact separation wall is in the “inactive” state, while the container with a ruptured separation wall, in which mixing of the substances contained in the first and second chambers is possible, is in an “active” state. As can be appreciated, the lateral force that the user needs to exert on the external wall of the second chamber preferably only requires the use of one hand.
The first chamber forms a cavity. The dimensions and/or shape of the second chamber may be such that the second chamber can be pushed towards the first chamber, e.g. when the user exerts a lateral force on one or both of the first and the second outer walls with his fingers. When present, the second chamber is of such shape and/or dimensions relative to the first chamber that the second chamber can be at least partly contained within the cavity formed by the first chamber. The second outer wall is adapted to be pressed towards the first outer wall for dispensing the contents of the first chamber. Thus the volume defined by the middle plane and the second outer wall is preferably smaller than the volume defined by the middle plane and the first outer wall.
The first and the second outer walls may be deformable or non deformable upon exertion of a pressure such as a lateral pressure. Preferably at least one of the first and second outer walls is deformable upon pressure. In some embodiments the first outer wall is rigid and not deformable when an external force is exerted upon it; for example, a force resulting from a user applying his fingers on the container when using the container does not result in substantial deformation of the first outer wall. In some embodiments the second outer wall is deformable. Thus in some embodiments application of pressure on the container results in deformation of the second outer wall but not in deformation of the first outer wall.
It will be appreciated that the deformability of the outer walls may be related to the nature of the materials from which said walls are manufactured. Thus in some embodiments, the first outer wall is manufactured from a rigid material such as metal or glass. A non-limiting example of a suitable metal is steel. In such embodiments the first outer wall is not deformable. In other embodiments, the first outer wall is manufactured from a polymer. Examples of suitable polymers include, but are not limited to, cyclic olefin polymer and cyclic olefin copolymer. In particular embodiments, the first outer wall is manufactured from a material which will allow the first outer wall to change shape without breaking when an external force is exerted upon it, such as when a user applies pressure on the walls with his fingers.
In some embodiments, the second outer wall is manufactured from a polymer. Suitable polymers are cyclic olefin copolymer and cyclic olefin polymer. Thus in some embodiments the second outer wall is deformable and is manufactured from a material which will allow the first outer wall to change shape without breaking when an external force is exerted upon it, such as when a user applies pressure on the wall with his fingers.
Thus the first outer wall may be manufactured from metal and the second outer wall from a polymer. In another embodiment, the first outer wall may be manufactured from glass and the second outer wall from a polymer. In yet another embodiment, the first outer wall and the second outer wall may be manufactured from the same polymer or from different polymers.
The deformability of the outer walls may be dependent on the thickness of the walls. Thus a force exerted by the fingers of a user on the first and second outer walls may result in deformation of thinner polymer walls, while thicker polymer walls will not be deformed. Likewise, it will be appreciated that outer walls manufactured from glass may break upon exertion of such a force if they are too thin.
In some embodiments, the second outer wall is more deformable than the first outer wall. The first and second outer walls may also be deformable to the same extent. In some containers of the invention the first and second outer walls are manufactured from the same material but have different thicknesses. The second outer wall may be thinner than the first outer wall, whereby the second outer wall may be more deformable or flexible than the first outer wall. The first and second outer walls may also be manufactured from different materials and have identical or different thicknesses. The first and second outer walls may be equally deformable.
The first outer wall may be manufactured from glass and have a thickness of 1 mm or more, such as 1.1 mm or more, such as 1.2 mm or more, such as 1.5 mm or more, such as 2 mm or more. The first outer wall may be manufactured from metal, such as steel, and have a thickness of 0.5 mm or more, such as 0.75 mm or more, such as 1 mm or more, such as 1.25 mm or more, such as 1.5 mm or more. The first outer wall may be manufactured from a polymer and have a thickness of 1 mm or more, such as 1.1 mm or more, such as 1.2 mm or more, such as 1.5 mm or more, such as 2 mm or more. The second outer wall may be manufactured from a polymer and have a thickness of 0.1 mm or more, such as 0.2 mm or more, such as 0.3 mm or more, such as 0.5 mm or more, such as 0.75 mm or more, such as 1 mm or more, such as 1.25 mm or more, such as 1.5 mm or more, such as 2 mm or more.
In some embodiments the ratio between the thickness of the second outer wall and the thickness of the second outer wall is between 1/5 and 1/20, such as between 1/7 and 1/15, such as between 1/8 and 1/12, such as between 1/9 and 1/11. Preferably the ratio is 1/10.
In some embodiments the first and the second outer walls are directly connected. In some embodiments, the first and the second outer wall may be manufactured from a single piece of manufacturing material. This may be advantageous in the embodiments where the first and second outer walls are manufactured from the same material. In other embodiments, the first and second outer walls may be directly connected so as to define a single entity. The first and second outer walls may thus be welded or glued together, so that the volume they define is impermeable and liquid-tight.
Disclosed herein are embodiments in which the thickness of the separation wall is comprised between 10 and 250 μm, such as between 20 and 200 μm, such as between 30 and 150 μm, such as between 40 and 100 μm, such as between 40 and 90 μm, such as between 40 and 80 μm, such as between 40 and 70 μm, such as between 40 and 60 μm, such as 50 μm. In a preferred embodiment, the separation wall is 50 μm thick.
Preferred embodiments are those in which the elongation at break of the separation wall is equal to or less than 15%, such as equal to or less than 14%, such as equal to or less than 13%, such as equal to or less than 12%, such as equal to or less than 11%, such as equal to or less than 10%, such as equal to or less than 9%, such as equal to or less than 8%, such as equal to or less than 7%, such as equal to or less than 6%, such as equal to or less than 5%, such as equal to or less than 4%, such as equal to or less than 3%, such as equal to or less than 2%.
Also envisioned herein are containers in which the volumes of the first and second chambers are such that the sum of these volumes is comprised between 0.1 and 20.0 mL. For example, the sum of the volumes of the first and second chambers is comprised between 0.2 and 18 mL, such as between 0.3 and 16 mL, such as between 0.4 and 14 mL, such as between 0.4 and 12 mL, such as between 0.4 and 10 mL, such as between 0.4 and 8 mL, such as between 0.5 and 6 mL, such as between 0.6 and 4 mL, such as between 0.5 and 2 mL, such as between 0.6 and 1 mL, such as between 0.7 and 0.9 mL, such as 0.8 mL. In a preferred embodiment the sum of the volumes is equal to 0.8 mL.
In preferred embodiments, the elongation at break of the separation wall is at least equal to the greatest of the elongations at break of the first and second outer walls. In embodiments where the elongation at break of the separation wall is equal to the greatest of the elongations at break of the first and second outer walls, the breaking, tearing, puncturing (or a combination thereof) of the separation wall can be facilitated by protuberances present on the internal side of at least one of the outer walls. Upon exertion of an external force on at least one outer wall, said protuberances are contacted with the separation wall and exert a supplementary tension facilitating its breaking, tearing, puncturing (or a combination thereof). The protuberances of these embodiments can be of any kind that will help facilitate the breaking, tearing, puncturing (or a combination thereof) of the separation wall, as will be evident to the skilled person.
In some preferred embodiments, the internal sides of the external walls of the first and/or second chamber carry at least one protuberance in at least one location along different axes, so that when a mechanical force is exerted on the external wall of the second chamber, said at least one protuberance is contacted with the separation wall, facilitating breaking of the separation wall and resulting in the substances of the two chambers being mixed.
In another preferred embodiment, the internal side of the external wall of the second chamber carries at least one protuberance in at least one location, while the internal side of the external wall of the first chamber is devoid of protuberance. In another embodiment, the internal side of the external wall of the second chamber carries one protuberance in one location along an axis Al and the internal side of the external wall of the second chamber carries two protuberances in two locations along axes A2 and A3; A1, A2 and A3 are not identical and can be parallel. In a particular embodiment, A1 is located between A2 and A3.
The container also comprises means for attaching a needle, or any injection system suitable for injecting a sterile composition, such as a Luer Lock system. The needle of some embodiments can be covered with a cap at its proximal end. At least the proximal end of the needle is sharp. In some embodiments, the distal end of the needle is sharp and can be used to perforate the external wall of the chamber to which the means for attaching a needle are attached, to allow communication between the container and the needle so that the liquid composition can be injected. For example, the user can exert an external force, such as push the needle inside the container. In this embodiment, the axis of the needle and the axis of the separation wall are parallel but not identical. In a preferred embodiment, the needle is connected to the first chamber. In other embodiments, a breakable seal such as a membrane separates the distal end of the needle from the chambers, and the membrane is broken prior to injection.
Fluid communication between the container and the needle may be prevented by e.g. the presence of a breakable seal. The breakable seal can be broken upon exertion of a lateral force on at least one of the first and second outer walls. Breaking of the seal may be facilitated by the at least one protuberance present on the second outer wall. In such embodiments the at least one protuberance is located such that upon exertion of a lateral pressure, the protuberance will come in contact and apply pressure on the seal, whereby breakage is attained.
The breakable seal between the needle and the container may be manufactured essentially as described above for the separation wall. Breaking of the seal results in fluid communication between the container and the needle, thereby allowing the composition or solution contained in the container to flow through the needle. Thus exertion of a lateral force on at least one of the first and second outer walls allows emptying of the container.
Disclosed herein is a container in which the substance in the first chamber is in a solid form and the substance in the second chamber is in a liquid form. In a preferred embodiment enhanced mixing of the substances can be achieved if the pressure within the first chamber is lower than the pressure within the second chamber, so that when the separation wall is broken, the differences in pressure facilitates mixing of the two substances. Such a difference in pressure can be achieved by sealing the first chamber containing the substance in a solid form in conditions where the pressure is lower than the atmospheric pressure, while the second chamber containing the liquid substance is sealed under normal atmospheric conditions. In such embodiments the difference in pressure should be such that it does not cause breaking of the separation wall in the inactive state, but that it can break upon activation, i.e. upon exertion of an external force such as piercing by a needle or application of a lateral mechanical force on the second outer wall. In a preferred embodiment, the external force is a lateral mechanical force exerted by the user with his fingers on the second outer wall. In embodiments where the external force is a mechanical force exerted by the user with his fingers on the second outer wall, the first and second external walls are such that the mechanical pressure does not result in breaking of said external walls. The second outer wall is deformable, i.e. it is possible to increase the internal pressure within the second chamber by exerting a mechanical force on said second outer wall as discussed above, so that the mechanical force results in breaking of the separation wall but not in breaking of the first or of the second outer wall. Because of the difference in pressure between the two chambers, mixing of the substances contained in the two chambers of such a container is enhanced and occurs with minimal formation of air bubbles.
A container as described herein may be housed in a housing. The housing is preferably such that it is possible to exert a mechanical force on said housing, allowing for breaking of the separation wall. The housing may comprise a lid, preferably an internal lid, which can help facilitating breaking of the separation wall. Such an embodiment is described in
Also disclosed herein is a container supplied with a lid; examples of such embodiments are shown in
Also within the scope of this application is an injection device comprising a container as described for injecting a liquid composition resulting in the mixing of the substances contained in the first and second chambers of said container. In some embodiments the liquid composition is a vaccine composition. In other embodiments, the liquid composition consists of a bolus of a pharmaceutically active composition. The injection device is in an inactive state as long as the separation wall between the first and second chambers is intact, while it goes into an active state upon exertion of an external force resulting in breaking of the separation wall and mixing of the substances of the first and second chambers of the container, yielding an active liquid composition. After the device has reached the active state, it cannot be brought back to an inactive state, because the separation wall cannot be reformed. Thus the device described herein is auto-destructible and cannot be reused.
The single-use, auto-destructible device described herein is as such particularly well-suited for injection of vaccine compositions in humans in developing countries, minimising contamination risks dues to recycling of injection devices. The container described herein is easy to operate and is ready to use, thus minimising manipulation times and as a result minimising occupational injuries or risks of contamination for the staff performing vaccination programmes.
It is a further object of the invention to provide a disposable injector comprising:
In the present context, the term ‘feeding unit’ is synonymous with ‘injection displacement means’.
The sequence through which said plunger body, said medicine chamber and said needle are displaced may be performed automatically through the action of the displacement means.
In some embodiments the injector further comprises a needle guide body provided with a passage for receiving and guiding said injection needle.
In a preferred embodiment the needle guide body has an abutment surface facing in a distal direction towards said pressing surface and arranged for axial displacement between a second distal position, a second intermediate position and a second proximal position.
In a further preferred embodiment said injection displacement means, preferably biasing means, is adapted to displace said plunger body from said first distal position to said first proximal position such that said plunger body, said medicine chamber, said guide body and said needle are displaced in the following sequence:
The sequence through which said plunger body, said medicine chamber, said guide body and said needle are displaced may be performed automatically through the action of the displacement means.
It is preferred that the medicine chamber:
In some embodiments, the injection liquid is a pharmaceutically active liquid.
Having a separate container inside the medicine chamber allows separate manufacturing of the container and of the remaining parts of the injector, thus conveniently allowing containers with various contents to be used with the same injector. As a result a variety of injectors may be produced containing different injection liquids.
The invention further relates to a disposable automatic injector for injecting an injection liquid and comprising:
In some embodiments, the needle guide body is immobile within the housing. In other embodiments, the needle guide body is arranged so that movement of the needle guide body, for example by application of a pressure on its distal abutment surface, results in movement of the needle in the same direction. For example the needle guide body may be connected to the needle.
The medicine chamber may comprise a top and a bottom surface (4a and 4c, respectively,
The top and bottom surfaces of the medicine chamber may be planar or curved. Preferably, said surfaces are not parallel and their axes intersect at the proximal end of the injector. The top and bottom surfaces should be so arranged relative to each other that they may at least partly overlap, i.e. they should be so arranged that exertion of a pressure on the walls of the housing enables compression of the medicine chamber by the top and bottom surfaces.
In some embodiments, a spring is positioned between the injection needle and the displacement means. When the plunger is retracted, for example when the user pulls the plunger, the spring is tensioned for being released so that the displacement means is moved forward by the spring force. In some embodiments, said spring is made of rubber. In other embodiments, the displacements means comprises a rubber band.
Also disclosed are embodiments in which the container is made of a plastic film. Preferably, the region of the container which is to be penetrated by the sharp distal end of the needle is provided with a sealing film. Upon penetration of the container by the distal end of the needle, the sealing film seals against the side surface of the needle, thus ensuring that no injection liquid is spilled on the sides of the needle. Such sealing film may for example be made of rubber or of polymers as is known in the art.
In some embodiments, the injection liquid is a pharmaceutically active liquid, such as a vaccine.
It is another object of the invention to provide a disposable injector wherein said container for containing an injection liquid consists of:
In preferred embodiments, the first and second chambers are impermeable, so that the dry matter and the liquid they contain may not spill in the medicine chamber in which the container is placed. The peel section is preferably also impermeable, thus contact between the liquid and the dry matter is prevented as long as the plunger is not being retracted. The peel section is breakable, so that upon retraction of the plunger, breakage of the peel section allows contacting of the dry matter of the first chamber with the liquid of the second chamber, resulting in a liquid composition or injection liquid.
In some embodiments, the dry matter comprises an active substance, such as a pharmaceutically active substance, such as a vaccine. The liquid contained in the second chamber may comprise an active substance or a solvent. In some embodiments, the liquid is a solvent, such that it results in an active solution upon mixing with the active substance of the first chamber.
In some embodiments, complete retraction of the plunger results in mixing of the dry matter and the liquid. For example, the plunger may be provided with protuberances or teeth, so that upon retraction the protuberances get in contact with the top of the medicine chamber, thus resulting in vibrations facilitating mixing of the dry matter and the liquid.
Pharmaceutically active substances have a longer storage life when in a dry form. Active substances in dry form also often display higher stability when confronted to uncontrolled environmental conditions such as high or low temperature, temperature variations or pressure variations. Thus embodiments with two separate chambers may be particularly relevant when the injection liquid is a pharmaceutically active substance, as it may extend the shelf life of the injector.
In some embodiments, the proximal skin contact wall of the housing is provided with an antiseptic means intended for being applied to the injection site. Such antiseptic means may be any means known in the art such as commercial antiseptics, for example trichlorophenylmethyliodosalicyl. In embodiments where the antiseptic means is volatile, the skin contact wall may be covered by an air-tight membrane or peel section to prevent its evaporation.
The invention also relates to an injector, wherein a cross-section of the housing is of rectangular shape. The cross-section of the housing may thus be square, rectangular, and have sharp or round edges. Such embodiments present several advantages compared to injectors where a cross-section of the housing is rectangular. The dead volume of the injector, i.e. the volume which is not essential for its proper functioning, is reduced, thus reducing the total volume of the injector as compared to a circular injector containing the same volume of medicine, and thus allowing storage in a lesser space. The rectangular shape allows the user to get a better grip on the housing as it provides flat, lateral surfaces. The housing may also be equipped with grips on its lateral faces in order to further facilitate manipulation.
In some embodiments, the housing is provided with a window, which may allow visualisation of the medicine chamber, in order to allow the user to check for integrity of the medicine bag, or for correct mixing of the contents of the medicine chamber.
The invention will in the following be described in greater detail with reference to the accompanying drawings:
Housing 31
Housing lock 31a
Housing hole 31b
Curved path in housing 31c
Needle stop inside housing 31d
Housing feeding stop 31e
Plunger 32
Spring attachments 32a
Plunger hook 32b
Plunger teeth 32c
Plunger trigger 32d
Displacement means 33
Displacement means hooks 33a
Displacement means recess 33b
Medicine chamber 34
Medicine chamber pal 34a
Medicine chamber bottom 34c
Medicine chamber top 34e
Medicine chamber intermediate section 34g
Medicine chamber connecting rod 34i
Needle 35
Needle plastic part 35a
Needle rear end 35b
Spring or rubber band 36
Medicine bag 37
Medicine bag liquid chamber 37a
Medicine bag dry chamber 37b
Medicine bag peel section 37c
Referring to
From there, the spring or rubber band 36 is passed around hooks 32b (only one is visible in
a-c show the syringe with the plunger fully retracted.
a show the syringe from the outside in perspective.
Upon retraction the plunger teeth 32c hits the top of the medicine chamber 34e in points 34k, whereby the medicine chamber top 34e is pressed down towards the medicine bag 37 so that the peel section 37c (see
a-c show the syringe with the plunger 32 pushed so that the feeding device recess 33b is almost released from the housing lock 31 by the plunger 32 triggering 32d squeezed in between them.
a-c shows the syringe with the needle released into the skin.
a shows the syringe from the outside in perspective.
a-c show the syringe with the medicine chamber completely released and ready to inject the medicine.
The displacement means 33 continuously pushes forward on the connecting rod 34i of the medicine chamber due to the spring force of the spring or rubber band 36 that acts between the feed device hooks 33a and the spring attachments 32a. Thereby the medicine chamber 34 continues forward and when the medicine chamber pal 34a no longer pushes the needle 35 onwards, the medicine bag frame 37 is punctured by the needle rear end 35b. The needle continues until stopped by the needle stop 31d inside the housing, while the medicine chamber continues until it hits the needle plastic part 35a.
a-c show the syringe when the medicine bag 37 has been emptied and the connecting rod 34i of the medicine chamber has passed.
Since the displacement means 33 continuously exerts a forward directed force from the bearing 34j on the medicine chamber connecting rod 34i, the connecting rod transforms this force to both a forward and downward force on the medicine chamber top 34e via the intermediate section 34g and the hinges 34f and 34h. As the medicine chamber 34 is prevented by the needle 35 from moving further forward the chamber top 34e is pressed down towards the medicine bag 37. The length of the medicine chamber connecting rod is adapted in such a way that when the medicine chamber connecting rod reaches the vertical position, the medicine bag 37 fully compressed, and thus emptied.
a-c show the syringe in its end position.
a shows the syringe from the outside in perspective.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2013 70247 | May 2013 | DK | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/DK2014/050120 | 5/2/2014 | WO | 00 |
