Patent Application
20230072178
The present invention generally relates to an auto-injector, which is an automatic or semi-automatic drug delivery device adapted to receive a drug filled cartridge and expel a dose therefrom.
In the disclosure of the present invention reference is mostly made to the treatment of Human Growth Hormone, HGH, however, this is only an exemplary use of the auto-injector.
The most common type of auto-injection devices adapted to receive a drug filled cartridge (also termed reservoir or container) and expel a dose therefrom are generally elongated e.g. pen-formed for being hold in a user's one hand and utilizes a so-called cartridge holder adapted to receive and mount a cartridge in the device. Correspondingly, most pen-formed drug delivery devices comprises a generally cylindrical cartridge holder for receiving and holding a generally cylindrical drug-filled cartridge in a mounted position, the cartridge comprising a proximally facing and axially displaceable piston, and a main body with a housing in which a drug expelling mechanism is arranged, the mechanism comprising an axially displaceable piston rod adapted to engage the piston of a mounted cartridge to thereby expel a dose of drug from the cartridge. Between the cartridge holder and the main body coupling means is provided allowing a user to remove the cartridge holder from the main body and reattach it when a used cartridge has been exchanged with a new cartridge. The cartridge is inserted in the cartridge holder by axial movement through a proximal opening. Conventionally, the coupling means are in the form of a threaded connection or a bayonet coupling.
It is conventionally only insufficiently addressed that there is a need for devices that are easier and more intuitive to use.
US 2014/358093 discloses a drug delivery system comprising a cartridge and a front-loaded cartridge holder adapted to axially receive and hold a cartridge in a loaded position. The cartridge comprises first coupling means arranged at the distal portion, and the cartridge holder comprises second coupling means arranged at the distal portion, wherein the first and second coupling means are configured to engage each other to thereby axially secure a cartridge mounted in the cartridge holder.
However, this front-loaded drug delivery system is cumbersome to use since it requires that a user uses two hands for the operation of loading the drug delivery system with a cartridge since one hand is needed to hold the device and another is needed to insert and rotate the cartridge. For at least some groups of users this may prevent own use or make own use very cumbersome.
WO 2008/062025 discloses a medical delivery system comprising a container which is adapted to be fastened to a dosing assembly. One of the container and the dosing assembly comprises a rotatable element adapted to cooperate with the other one of the container and the dosing assembly, so as to lock/fasten the container to the dosing assembly.
There is provided an auto injector for administering injection of a medicament from a cartridge containing the medicament, the auto injector comprising:
Thereby the ejector rest portion and the ejector lock support member in combination may form a stop that is disengaged at the first angle and engaged at the second angle.
Thus, it is appreciated that, at the second angle, the ejector lock by its turning effectively introduces a stop, by its support member receiving the rest portion. The stop prevents further movement of the rest portion beyond the support member in the receiving direction, if the rest portion is not otherwise prevented from landing on the support member. Thus, the stop contributes to prevent the cartridge from movement beyond a stop position, relative to the housing, in the receiving direction.
At least when the needle of the cartridge assembly penetrates a being's skin a force is transferred from the needle to the cartridge and works to push the cartridge backwards in the receiving direction against the stop when it is engaged. The stop at least contributes to maintaining the position of the cartridge since otherwise precise dose administering may be obstructed.
When the ejector, by means of the stop, sits at the stop position, its ejector support face supports that an end portion of the cartridge or cartridge assembly rests thereon to prevent unintended movement in the receiving direction.
The auto injector enables convenient front-loading of a cartridge accommodated in a cartridge assembly. Since the needle on the cartridge assembly may be protected by a needle cover reliably attached to the cartridge assembly, there is no increased risk of being injured by the needle while loading the auto injector with a cartridge accommodated in a cartridge assembly.
The auto injector enables convenient front-loading by: overcoming the spring-loaded bias when the cartridge meets the support face of the ejector, guiding the cartridge retention members from the passage to a position where the cartridge is prevented from moving out of the cartridge receiver, and turning the ejector lock to prevent movement beyond the stop in the receiving direction such that the cartridge maintains its position in the housing when a pressure on the needle in the receiving direction is at least partially transferred to the cartridge. It is important that the cartridge maintains its position since otherwise precise dose administering is obstructed.
It is appreciated that various distances should be dimensioned such that the support face of the ejector lock abuts the rest portion of the ejector when the cartridge sits in the retention position. Thereby the cartridge is locked or is in a locked position being prevented both from a forward movement and a backward movement, wherein the backward movement is the same as the receiving direction. The cartridge is locked when the stop is engaged i.e. when the ejector lock is at the second angle, whereas the cartridge is unlocked when the stop is disengaged i.e. when the ejector lock is at the first angle.
In some aspects the ejector lock support member extends axially from a wall of the ejector lock, e.g. in the form of a pin, to support the ejector at a transversely extending ejector rest portion. In some aspects the ejector lock support member extends transversely along a rim or edge of the ejector lock to support the ejector at transversely extending ejector rest portion or at an axially extending rest portion.
In some aspects one or more of the ejector lock support portion, the ejector rest portion and the ejector slot are recessed into the ejector lock or the ejector.
It is appreciated that the ejector lock is supported e.g. in a bearing that allows the lock to turn or be turned, at least a fraction of a revolution, while preventing a longitudinal movement.
In some embodiments, the ejector comprises an ejector rod with an ejector support face; wherein the ejector rod has an ejector rod bore to form a longitudinal passage, and wherein the ejector support face is arranged at one end of the ejector rod and has a disc shape or an annular shape.
Thereby the disc shape or annular shape may form the support for the cartridge to rest thereon all around its end portion periphery. An aperture of the bore is located in a centre portion of the ejector abutment face. The bore gives room for a plunger that at least over some displacements thereof may move, independently of the ejector, to move a first stopper of the cartridge to expel at least a portion of the medicament from the cartridge.
In some embodiments, the ejector rod comprises an ejector collar arranged about the ejector support face. The ejector collar may have an inner diameter which is larger than an outer diameter of an end portion of the cartridge or cartridge assembly such that when the end portion of the cartridge or cartridge assembly abuts the ejector support face, the collar accommodates the end portion of the cartridge or cartridge assembly in a centralised position relative to the ejector rod.
Thereby the cartridge or cartridge assembly can be guided to abut robustly on the ejector support face. In some aspects the ejector collar has an inner chamfer face which improves guiding of the cartridge or cartridge assembly towards the ejector support face.
In some embodiments, the ejector comprises an ejector rod configured with one or more ejector cut-outs to form one or more ejector cogs between the ejector cut-outs; and wherein the ejector lock is configured with one or more ejector lock cogs between one or more ejector lock cut-outs, respectively.
Thereby the one or more ejector cogs may abut with the one or more ejector lock cogs to form the stop when engaged. The stop is engaged by aligning the cogs of the ejector and the ejector lock. Turning of the ejector lock at least a portion of a revolution about the longitudinal axis may disengage the stop whereby the ejector cogs can be accumulated in the ejector lock cut-outs. In this way the cogs and the cut-outs form complementary cogs and cut-outs.
The one or more cogs of the ejector rod and the one or more complementary cut-outs of the ejector lock are arranged at angular ranges about the longitudinal axis such that a cog can be accommodated in its entirety or partially by a complementary cut-out. A cog may extend over e.g. 45 degrees and a complementary cut-out may extend over 45 degrees plus an angular range to allow a clearance when the ejector rod and thus the cog moves in the longitudinal direction in or out of the cut-out of the ejector lock.
The angles at which cut-outs, cogs and complementary cogs and cut-outs are located implicitly define the first angular position where the ejector lock and ejector rod mutually are angularly positioned to allow movement of the cartridge assembly in the receiving direction, and the second angular position where the ejector lock and ejector rod mutually are angularly positioned to restrict movement of the cartridge assembly in the receiving direction at least restricted from moving beyond a predefined longitudinal position.
In the second angular positon, at least one cog of the ejector rod abuts end-to-end at least one cog of the ejector lock; whereas in the first angular position, the at least one cog of the ejector rod is accommodated in a complementary cut-out.
The ejector cogs have end portions denoted an ejector rest portion and the ejector lock cogs have end portions denoted an ejector lock support portion. The ejector lock support portion supports the ejector rest portion when the stop is engaged.
Thus the cogs have respective end portions which abut one another when the stop is engaged. Cut-outs of the ejector rod and cut-outs of the ejector lock have respective bottom portions. The bottom portions may extend between side portions separating cogs and cut-outs.
At a longitudinal position of the ejector rod where the cogs abut one another, the ejector defines by its length relative to the ejector lock at which position the cartridge or cartridge assembly is restricted from further movement by means of the stop in the receiving direction. The ejector may be suspended by a resilient member to move in the opposite direction of the receiving direction, in which case the cogs of the ejector rod travels away from the cogs of the ejector lock.
As mentioned above the cartridge or cartridge assembly may be supported at a disc shape or annular shape, which in some embodiments is configured with a surrounding collar.
In some aspects the ejector rod has four cogs and four cut-outs and the ejector lock has four complementary cogs and four complementary cut-outs. This gives a good trade-off between the amount of rotation needed to turn the ejector rod and the ejector lock relative to each other from a securely locked position to an open position and mechanical robustness of the cogs.
In some aspects the cogs and cut-outs have an even angular size, e.g. 45 degrees or 60 degrees—in both cases minus an angular range to allow a clearance between a cog and a cut-out.
In some embodiments one or more of the cut-outs and the cogs have a substantially rectangular shape.
Thus, the one or more cut-outs, such as ejector cut-outs and/or ejector lock cut-outs have edges orthogonal to the longitudinal axis and edges along the longitudinal axis. Due to the edges along the longitudinal axis a good engagement for retaining a relative angular position between the ejector rod and the lock is obtainable at least when the stop is engaged.
In some aspects thereof the ejector cut-outs accommodate ejector lock cogs and ejector lock cut-outs accommodate ejector cogs in a complementary manner such that spaces are substantially filled out between cogs to resemble a cylindrical object. However, an angular clearance is typically needed between cogs to allow sufficiently low friction of a longitudinal movement and to allow for variations occurring during manufacture of the ejector and ejector lock.
In some aspects the cut-outs and the cogs comprise a triangular portion, an arc of a circle or another polygon or curve.
In some embodiments the one or more cut-outs and the one or more cogs comprise a portion that is inclined relative to the longitudinal axis and relative to an axis orthogonal to the longitudinal axis.
The portion that is inclined relative to the longitudinal axis may be one or more of an end portion of one or more cogs, a bottom portion of one or more cut-outs, and a side portion of one or more cogs or cut-outs.
As an aspect of securing smooth longitudinal movement any angle between a side portion and a bottom portion should be 90 degrees or greater and any angle between a side portion and an end portion should be 90 degrees or greater. Thereby it should be prevented that a nose or overhang is formed, behind which cogs could be stuck in unfortunate positons.
In some of the aspects, wherein a portion is inclined, the ejector cut-outs may accommodate ejector lock cogs and ejector lock cut-outs may accommodate ejector cogs in a complementary manner such that spaces are substantially filled out between cogs to resemble a cylindrical object. However, an angular clearance is typically needed between cogs to allow sufficient low friction of a longitudinal movement.
In some embodiments, ejector cogs and lock cogs comprise an end portion that is inclined relative to the longitudinal axis at an angle of less than 40 degrees or less than 30 degrees or less than 20 degrees relative to the orthogonal of the longitudinal axis.
The inclined end portions may contribute such that when the stop is engaged by turning of the lock, further turning of the lock causes a longitudinally tightening force acting on the ejector and transmitted though the ejector to the cartridge and/or cartridge assembly. In this way it may be possible to at least substantially remove clearances that occur due to manufacture variations.
The end portions of lock cogs and end portions of ejector cogs are inclined substantially at the same angle such that the end portions are mutually parallel. In some aspects the bottom portions of the cut-outs may be inclined by substantially the same angle. Thereby the cogs fit into the cut-outs.
Thus the cogs have respective end portions which abut one another when the stop is engaged. Due to the inclined end portions and possibly manufacture variations, a desired tightening force or clearance reduction may occur at an angular position of the lock where the ejector cogs and the lock cogs do not align centre-to-centre, but somewhat offset therefrom.
Thereby it may be possible to tighten up the cartridge in a more precise longitudinal position as well as ensuring that cartridge length dimension tolerances do not result in or at least risk expelling fluid from the cartridge when pressing the needle towards the skin. Thus the risk of unintended rearward travel of the cartridge due to short cartridge length in combination with a too retracted lock position is reduced. Had the cartridge not been prevented from such unintended rearward travel, a plunger rod in contact with the stopper could possibly press out medicament too soon before the needle is properly inserted in the skin of the patient and thus the full dose would not be administered to the patient.
In some embodiments, the ejector comprises an ejector rod configured with a substantially cylindrical portion with one or more chamfers about the longitudinal axis to form a rotational asymmetric end portion; and wherein the ejector lock is configured with one or more complementary chamfer cuts to form a complementary rotational asymmetric end portion.
In some aspects the chamfer is positioned such that the end portion extends over a portion that is substantially orthogonal to the longitudinal axis. The end portion that extends over a portion that is substantially orthogonal to the longitudinal axis may extend over less than 180 degrees e.g. over less than 120 degrees or less than 90 degrees.
In some embodiments, the auto injector comprises a plunger rod; wherein the ejector comprises an ejector rod which is spring-loaded by a spring ejector member; wherein the plunger rod and the bore are configured for longitudinal relative movement.
Thereby the ejector and the plunger rod can be closely integrated. Also, the plunger rod may be moved along the longitudinal axis, at least over some distance, without bringing the ejector rod along and vice versa.
The ejector rod may comprise a cylindrical object through which the bore extends; wherein the above-mentioned cut-outs and cogs are located at one end of the cylindrical object and wherein the above-mentioned disc shape or annular shape is arranged at the other end.
In some aspects, the bore through the ejector rod and an exterior face of the plunger rod are configured with coupling means and complementary coupling means, respectively, that retains a relative angular position and allows a relative longitudinal movement. There may be formed a track extending along a straight line along the longitudinal axis on the wall of the bore that engages with a groove in the plunger rod, and/or vice versa. Thereby longitudinal movement is allowed while angular retention is provided.
In some embodiments, the plunger rod comprises an inner plunger rod part and an outer plunger rod part; wherein the inner plunger rod part and the outer plunger rod part are coupled by a thread; wherein the inner plunger part is retained in a bearing allowing rotation of the inner plunger part while preventing a longitudinal movement; and wherein the outer plunger rod part is retained in an angular position relative to the housing.
Thereby the outer plunger part may be actuated to move in the longitudinal direction by rotation of the inner plunger rod part. The outer plunger part may be configured to move a first stopper of the cartridge to expel at least a portion of the medicament from the cartridge.
In some aspects the inner plunger rod part is rotational driven by a drive module, which may comprise a motor and one or more of transmission and gearing to couple the motor to the inner plunger rod. The inner plunger rod part may comprise a spindle portion that engages with an inner thread in the outer plunger rod part.
In some aspects the outer plunger rod part is retained in the angular position relative to the housing in that there is formed a longitudinally extending plunger rod groove in the wall of the outer plunger rod; wherein the plunger rod groove engages with a longitudinally extending bead or track on the inner wall of the ejector rod bore. This configuration allows displacement, at least over some distances, of the outer plunger rod relative to the ejector rod and vice versa while retaining a relative angular position between them.
In some embodiments, the auto injector comprises an angle retaining slot and an angle retaining guide configured to engage with each other and arranged on or in the cartridge receiver or a member rigidly coupled to the cartridge receiver and at the ejector rod.
Thereby the ejector rod is suspended for angular retention with the cartridge receiver and for longitudinal displacement at least over some distances.
In some aspects the angle retaining slot is configured in a member that accommodates the ejector rod and plunger rod when in a retracted position;
the angle retaining slot may sit next to the ejector rod when it is retracted. The member, which may accommodate a motor coupled to drive the inner plunger rod, may comprise a collar providing a curb or seat for a spring inflicting the spring-load on the ejector. The angle retaining guide is then arranged on the ejector rod.
In some embodiments the ejector lock comprises an ejector lock guide pin configured to engage with a plunger rod track provided in the plunger rod, such that longitudinal movement of the plunger rod, at least over a predefined range, inflicts a turning of the ejector lock about the longitudinal axis.
Thereby it is possible to drive the auto injector with a single motor which at some displacements of the plunger rod inflicts turning of the lock and at other displacements of the plunger rod inflicts expel of a dose of medicament from the cartridge. At least the plunger rod track may be configured such that the plunger rod turns the ejector lock and disengages the stop at retracted positions where the plunger rod is at a position at a distance from the cartridge. The plunger rod track may be configured such that stop is engaged at advanced positions of the plunger rod, when at least it abuts or presses on a stopper of the cartridge.
In some embodiments movement of the plunger rod in the receiving direction, at least over a range of longitudinal positions, inflicts a turning of the ejector lock to the first angular position. Thereby the stop is disengaged at retracted positions of the plunger rod.
In some embodiments, the ejector lock is configured with an ejector lock bore to accept at least an end portion of the outer plunger rod and an ejector lock guide pin that extends inwardly from a wall of the ejector lock bore; wherein the outer plunger rod is configured with a plunger rod track that engages with the ejector lock guide pin and extends from a plunger rod distal rim towards the cartridge assembly opening; wherein the plunger rod track has at least one track portion that leads the ejector lock guide pin from a first angle to a second angle that are angularly spaced apart to turn the ejector lock from the first angular position to the second angular position.
Thereby rotation of the inner plunger rod part may bring about a longitudinal movement of the outer plunger rod part to at least engage with the cartridge at least at some longitudinal positions of the outer plunger rod part and to inflict a rotation of the ejector lock at other longitudinal positions of the outer plunger rod part to either lock or unlock the ejector member rod.
In some aspects the track is configured such that it rotates the ejector lock via the guide pin to a position that unlocks the ejector rod when the outer plunger rod is at an extreme longitudinal position away from the cartridge receiver opening. The track may rotate the ejector lock via the guide pin to another position that locks the ejector rod when the outer plunger rod is at a less extreme longitudinal position away from the cartridge receiver opening. Thus, as the outer plunger rod member is moved from an extreme position in the direction opposite of insertion, the ejector lock moves from a position where the ejector is unlocked to a position where the ejector is locked.
It is appreciated that the angular position of the guide pin relative to the cogs and cut-outs and the angular position of the outer plunger rod relative to the ejector rod are synchronized such that the rotation inflicted to the ejector lock by the track via the guide pin is angularly positioned to allow the cogs to abut end-to-end in second angular position, and the cogs to be accommodated in the cut-outs in the first angular position. It is appreciated that in the first angular position, the ejector is unlocked by the ejector lock and in the second angular position the ejector is locked by the ejector lock.
In some aspects the length of the ejector member and ejector lock when adjoining each other such that the cogs are accommodated by the complementary cut-outs.
The ejector lock is arranged e.g. in a bearing that allows the lock to turn or be turned, at least a fraction of a revolution, while preventing a longitudinal movement.
In some aspects the at least one track portion that leads the guide pin from the first angle to the second angle is inclined about 40-50 degrees relative to the longitudinal axis.
In some aspects the at least one track portion that leads the guide pin from the first angle to the second angle is an intermediate portion that continues from a first longitudinally extending track portion and continues to second longitudinally extending track portion. In some aspects thereof the first track portion is wider than the second track portion. In some aspects, wherein the first track portion is wider than the second track portion, the first track portion may comprise an inclined guide face or chicane that guides the guide pin into the intermediate track portion. The first track portion may extend from the first angle to the second angle. The inclined guide face may be inclined about 40-50 degrees relative to the longitudinal axis. The track is generally configured with track portions that extends longitudinally or at steep inclination angles; such that in the latter case, a turn is smoothly inflicted the guide pin typically by inclination angles not closer to the orthogonal of the longitudinal direction than about 30 degrees. Thereby, at least for that reason, the guide pin will not be stuck in the track.
In some aspects the track has a width at least at a portion of the track which is equal to a dimension of the guide pin plus a clearance, wherein the dimension of the guide pin may be its diameter or diameter or a circumferential circle or a width of the pin. The clearance may be smaller than 50% or smaller than 20% or smaller than 10% the dimension of the guide pin.
The first, entry, portion of the plunger rod track may be wider than the intermediate and second portion of the plunger rod track. Thereby the ejector lock guide pin may be received and guided into the track at wider angles. This may prevent the ejector lock guide pin from unintentionally obstructing movement of the plunger rod.
In some embodiments, the plunger rod track is configured as a recess that extends from the plunger rod distal rim of the outer plunger rod. The depth of the recess matches a length of the guide pin such that they engage sufficiently for turning the ejector lock.
In some embodiments the ejector lock is coupled to a resilient member that biases the ejector lock towards the second angular position. Thereby more retracted positions of the plunger rod are required to disengage the ejector lock. This is particularly useful when an entry portion of the plunger rod track accepts the ejector lock guide pin at wider angles.
In some embodiments the auto injector comprises a drive module with a motor and one or more of transmission and gearing to couple the motor to the inner plunger rod. The drive module may be power suppled from one or more of a battery and a power supply. The drive module may be controlled via a microprocessor programmed to control the plunger rod via the drive module in response to user activated controls such as push-buttons.
A more detailed description follows below with reference to the drawing, in which:
Various embodiments are described hereinafter with reference to the figures. Like reference numerals refer to like elements throughout. Like elements will, thus, not be described in detail with respect to the description of each figure. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the claimed invention or as a limitation on the scope of the claimed invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
The term ‘user’ refers to a human being using the auto injector for self-administering a medicament. In this respect the user may also be designated a ‘patient’. Thus, one use case of the auto injector is self-administration of a medicament. The auto injector is described with this use case in mind. However, in another use case an assistant, e.g. a nurse or home carer, may operate the auto injector to administer the medicament into the patient. The latter use case is also enabled by the present disclosure of the auto injector.
The user may use the auto injector in connection with his or hers daily activities.
The auto injector 4 comprises a housing 6. The auto injector 4 comprises a cartridge receiver 300. The cartridge receiver is configured to receive a cartridge and/or a cartridge assembly comprising a cartridge. The cartridge may contain the medicament.
The cartridge receiver 300 has a cartridge receiver opening 301. The cartridge receiver 300 is configured to receive the cartridge and/or the cartridge assembly through the cartridge receiver opening 301 in a cartridge receiving direction 304 along a longitudinal axis, L.
The auto injector 4 may comprise a user interface 1100, as illustrated. The auto injector 4 comprises a trigger member, such as the contact member 1102. The contact member 1102 may be configured to be pressed against an injection site on a patient's skin. The contact member 1102 may be movable in the cartridge receiving direction 304, relative to the housing, if pressed against the injection site. The contact member 1102 may be part of the user interface 1100.
The user interface 1100 comprises a first input member 1108, e.g. a button. The first input member 1108 may provide for a user input from a user. For example, the first input member 1108 may be used for receiving a push from a user to proceed to a next step.
The user interface 1100 comprises a first output member 1110 as illustrated, e.g. a plurality of LEDs. The first output member 1110 may provide for a user output to a user. The user interface 1100 may comprise a second output member (not shown), e.g. a speaker. The second output member may be configured to provide audible output to the user. For example, the first output member 1110 and/or the second output member may be used to indicate a step in the procedure to the user and/or to indicate an error message.
The auto injector 4 may comprise a cover (not shown) to protect the auto injector from dirt and filth when not in use.
By front loading is understood that at least the cartridge 700 is received with its needle end pointing out of the cartridge receiver opening 301. When the cartridge is being inserted and especially when it is fully inserted or almost fully inserted, the cartridge or cartridge assembly may be substantially covered by the housing or the contact member 1102. Especially in this situation the needle cover 908 serves as a protective means that makes it possible for a user at least to press on the needle cover 908 or a tip thereof to fully insert the cartridge without being injured by the needle. When the cartridge is fully inserted and sits in a retention position it is possible to detach the needle cover such that the auto injector is ready for use to inject the medicament or a portion thereof contained in the cartridge. After use, i.e. when a dose of medicament has been injected, the needle cover is attached such that the needle cover again serves as a protective means that makes it possible for a user at least to press on the needle cover 908 or a tip thereof to remove the cartridge without being injured by the needle.
The cartridge 700 comprises a cartridge compartment 702. The cartridge compartment 702 may be configured for containing a medicament. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 comprises a cartridge outlet 714 at the first cartridge end 718. The cartridge may be configured to expel medicament through the cartridge outlet 714. The cartridge outlet 714 may be sealed by a needle penetrable sealing. The sealing may be made from rubber and optionally comprise a piercing which enables the needle to penetrate the sealing, while sealing the medicament when the needle is not penetrating the sealing.
The cartridge comprises a first stopper 708 movable inside the cartridge compartment, e.g. in a first stopper direction 722, e.g. towards the first cartridge end. For example, the medicament may be expelled through the cartridge outlet 714 upon movement of the first stopper 708 in the first stopper direction. The cartridge comprises a cartridge back face 716 at the second cartridge end. The cartridge back face 716 comprises a cartridge back end opening for providing access to the first stopper 708 for a plunger rod.
As illustrated, the cartridge 700 may be a dual chamber cartridge. The cartridge comprises a second stopper 710 movable inside the cartridge compartment 702, e.g. in the first stopper direction 722, e.g. towards the first cartridge end. The cartridge compartment 702 comprises a first cartridge sub-compartment 704 and a second cartridge sub-compartment 706. The first cartridge sub-compartment 704 is between the first stopper 708 and the second stopper 710. The second cartridge sub-compartment 706 is between the second stopper 710 and the cartridge outlet 714. The cartridge comprises a bypass section 712 for providing fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment. The bypass section 712 provides fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment when the second stopper 710 is positioned in the bypass section 712.
The first cartridge sub-compartment 704 contains a first medicament component 792 of the medicament 790. The first medicament component 792 may be a liquid as illustrated. The second cartridge sub-compartment 706 contains a second medicament component 794 of the medicament 790. The second medicament component 794 may be a powder composition. By positioning of the second stopper 710 within the bypass section 712, the first medicament component 792 may be transmitted into the second cartridge sub-compartment 706 via the bypass section 712, thereby mixing the first medicament component 792 and the second medicament component 794 to achieve the combined medicament 790.
The cartridge 700 may generally have a cylindrical form. However, the bypass section 712 may form a protrusion from the generally cylindrical form.
As shown, the cartridge holder 800 accommodates the first cartridge end 718 of the cartridge. The cartridge holder 800 has a cartridge holder slot 814 which accommodates the bypass section 712 which is shown in
The needle assembly coupling portion 812 makes it possible to couple the cartridge 700, via the cartridge holder 800, to a needle assembly as will be described in greater detail below.
The needle assembly 900 is coupled to the cartridge holder by a respective needle assembly coupling portion 812 and cartridge holder coupling portion 906 of the needle assembly and the cartridge holder. The coupling portions 812 and 906 may be in the form of threading.
The needle assembly 900 comprises a needle hub 904 that holds a needle 902. The needle hub 904 may have a bore at its one end into which the needle extends and on sidewalls of which the needle assembly coupling portion 812 is arranged. The needle assembly 900 also comprises a needle cover 908 that may be coupled by frictional coupling to the needle hub.
The cartridge receiver compartment 302 has an additional second section 330, with an annular shape, at a second distance, more remote than the first distance, from the cartridge receiver opening 301. The second section 330 has second guide members 322. The second guide members 322 are arranged with inclined faces and at angular positions about the longitudinal axis such that a cartridge retention member 808 having passed the passage 316 next to a first guide member 312 in the receiving direction is guided behind the first guide member 312 by an angular turning about the longitudinal axis, L.
The second guide members 322 form a second bore also accepting the cartridge assembly 600. The diameter of the second bore is substantially the same as the first bore, i.e. slightly larger than an outer diameter of the cartridge assembly 600 excluding the cartridge retention members 808, but smaller than the diameter of a circle circumscribing the cross section of the cartridge assembly 600 and the cartridge retention members 808. The cartridge retention members 808 can thereby not pass a second guide member 322. So when a cartridge retention member 808 lands on the second guide members 322, a turning of the cartridge assembly is inflicted.
The cartridge receiver 300 comprises flanges and coupling means such as opening 352 for coupling to other components of the auto injector (not shown). The cartridge receiver 300 also comprises a base 354 comprising a bore 356 for a spring (not shown) providing a spring-bias to the contact member 1102, which may be guided by a guide rod (not shown) accommodated in a bore 350.
The first section 310 comprises first guide members 312 and the second section 330 comprises second guide members 322.
The first guide members 312 extends over first guide member angles 314 and are spaced apart to form passages 316 at passage angles 318 between the first guide members 312.
The second guide members 322 have first faces 324 and second faces 326 (cf.
The first guide members 312 have a first guide face that faces the cartridge receiver opening, i.e. to the right hand side in this depiction, and forms a convex pointing shape with an apex directed towards the cartridge receiver opening.
The first guide members 312 also have a face that faces away from the cartridge receiver opening, i.e. to the left hand side in this depiction, and forms a concave shape with a slope portion 334, at slope angles 336, leading towards a retention portion 328 at or about a bottom portion of the concave shape at a retention angle 332. The slope portion 334 is inclined relative to the longitudinal axis and relative to the orthogonal thereto such that a turning of the cartridge is inflicted when a cartridge retention member 808 is pushed towards the slope portion 334 by a spring-loaded ejector 200. The turning brings the cartridge retention member 808 to the retention portion 328. To limit further turning of the cartridge assembly, a retention face 348 is provided substantially along the longitudinal axis.
Further, the first guide members 312 also have an eject face 338 with a slope that is inclined relative to the longitudinal axis and relative to the orthogonal thereto such that a turning of the cartridge is inflicted when a cartridge retention member 808 is pushed towards the slope portion 338 by a spring-loaded ejector 200.
Dashed lines indicate a so-called inbound journey of the cartridge retention member 808 and dashed-dotted lines indicate a so-called outbound journey. To avoid cluttering the figure, not all reference numerals are inserted, however the reference numerals used in
When a cartridge assembly 600 with a cartridge retention member 808 is inserted, starting out in the receiving direction, the cartridge retention member 808 follows an inbound journey. As examples the inbound journey may start at position 1 or position 2 or position 3 at different angles. At position 2 the cartridge retention member 808 may pass straight into the passage 316 to position 6, whereas at position 1 the first guide member 312 inflicts a turning of the cartridge retention member, starting at position 4, where the cartridge retention member lands on the first guide member and continuing by the inflicted turning and longitudinal movement such that it is guided into the passage 316. Also at position 3 on the other side of the passage 316, a first guide member 312 inflicts a turning of the cartridge retention member, starting at position 5, where the cartridge retention member lands on the first guide member and continuing by the inflicted turning and longitudinal movement such that it is guided into the passage 316. Thus, substantially irrespective of the angle at which the cartridge retention member is received, it is guided into the passage 316.
Continuing its journey from a position, such as position 6, in the passage, in the receiving direction, the cartridge retention member lands on a second guide member 322 of the second section 330 and in particular on a first section 344 thereof. Due to the inclined face of the first section 344, a turning of the cartridge retention member 808 is inflicted, such that the cartridge retention member 808 turns from position 7 to position 8, where it meets one of the first riser portions 340 which prevents further rotation. At this position, a user inserting the cartridge assembly will feel that the cartridge assembly stops moving, and will therefore intuitively release the force used for insertion. At this position 8, a release of the force will make the spring-loaded ejector push the cartridge assembly and the cartridge retention member 808 outwards, opposite the receiving direction, to position 9. At position 9 the cartridge retention member 808 lands on the slope portion 334 of a first guide member 312 leading towards the retention portion 328 at or about a bottom portion of the concave shape at a retention angle 332. Due to the spring-loaded ejector working to push the cartridge retention member 808 outwards, the cartridge retention member 808 and hence the cartridge stays in a retention position, position 10.
It should be noted that as the cartridge retention member travels out over the second riser portion 342, it passes a point of no return and the inbound journey is generally not reversible. So, should the user ease the force used for insertion before position 8, but after the point of no return, the cartridge still ends up in the retention position.
While in the retention position the cartridge and the cartridge assembly may be prevented from moving in the receiving direction by a lock that introduces a stop. Thereby the cartridge stays in its retention position even if a force overcoming the spring-load on the cartridge or cartridge assembly is overcome e.g. while the needle penetrates the skin. When the lock is released again to remove the stop, an outbound journey can start.
An outbound journey starts out from position 10 and is initiated when the spring-loaded force is overcome in the receiving direction, e.g. by a user pressing on a needle cover of the cartridge assembly. The cartridge retention member then lands on the second face 326 (cf.
It is noted that the direction of rotation, DR, is defined by the direction of the slopes of the first face and second face since they define in which direction turning is inflicted.
With respect to the length of an ejector rod 202 and the length of ejector cogs 226 thereof, to be explained in greater detail further below, it is noted that the cartridge retention member 808 should be allowed to travel between a first and a second extreme positions, L1 and L2, spaced apart at a longitudinal distance L12. At the position L2, the cartridge retention member 808 is at its retention position, i.e. an advanced position towards the cartridge receiver opening. At the position L1, the cartridge retention member 808 is at a ‘deepest’ position, in the receiving direction, given by the second face 326 or section 346 thereof. Thus, the ejector should be able to travel the distance L12. In some embodiments the position L3 may be located at a ‘deeper’ position than L1, in which case the ejector should allow the cartridge assembly retention member 808 to travel between L3 and L2.
The arrow designated by capital ‘R’ indicates a radial axis orthogonal to the longitudinal axis.
Each of one of the first sections 344 and each of one of the second sections 346 may extend over section angles. Section angles may by e.g. about 15 degrees.
The second guide members 322 of the second section 330 comprises a first face 324 that extends at least partly over passage angles 318 and first guide member angles 314. A second face 326 extends between first faces, alternately. The first riser portions 340 separate the first faces 324 and the second faces 326.
The outer plunger rod 404 is configured with a plunger rod track 406. The track 406 may extend from the rim of the outer plunger rod at the other end than the plunger rod front end 410. The plunger rod track 406 has at least a first track portion 428 that leads an ejector lock guide pin 216 (cf.
A second track portion 432 extends from a plunger rod distal rim 424 along the longitudinal axis, L, towards and to connect with the first track portion 428 which is inclined with respect to the longitudinal axis e.g. at an angle of about 45°, e.g. about 30-45°, with respect to the longitudinal axis, L. Thereby the second track portion 432 accommodates the ejector lock guide pin 216 when the outer plunger rod 404 is in a forward position, towards the cartridge receiver opening 301, to expel a medicament by moving the first stopper 708 in the first stopper direction as mentioned above. When the second track portion 432 accommodates the ejector lock guide pin 216, the ejector lock 212 is angularly positioned to prevent the ejector rod 202 from moving backwards. A third track portion 430 connects with the first track portion 428 and continues along the longitudinal axis towards the plunger rod front end 410. Thereby the third track portion 430 accommodates the ejector lock guide pin 216 when the outer plunger rod 404 is in a backward position, opposite the cartridge receiver opening 301, whereat the outer plunger rod 404 is moved backwards, away from the first stopper 708. Thus, the longitudinal position of the outer plunger rod 404 has the dual function of:
This is explained in greater detail below.
Thus, the outer plunger rod part 404 is configured with a plunger rod track 406 that engages with the ejector lock guide pin 216 and extends from a plunger rod distal rim 424 towards plunger rod front end 410 and thus the cartridge receiver opening 301.
The ejector rod 202 has an ejector collar 224 arranged about an ejector support face 204, which supports the cartridge at a cartridge back face 716, which may have the form of a rim. The ejector rod 202 has an ejector rod bore 222 to form a longitudinal passage all through the ejector rod 202. The ejector rod bore 222 allows the outer plunger rod 404 to move along the longitudinal axis.
The ejector rod 202 is configured with one or more ejector cut-outs 228 to form one or more ejector cogs 226 between the ejector cut-outs 228. Complementary therewith, the ejector lock 212 is configured with one or more ejector lock cogs 232 between one or more ejector lock cut-outs 230, respectively. The ejector lock 212 is supported e.g. in a bearing that allows the lock to turn or be turned, at least a fraction of a revolution, while preventing a longitudinal movement. The ejector lock 212 may have a flange or a recess that engages with a complementary recess or protrusion, respectively, to maintain the ejector lock 212 in a fixed longitudinal position while allowing it to be turned at least a fraction of a revolution. The ejector cut-outs 228 are also denoted ejector slots 228.
As shown, the ejector lock 212 has an angular position such that the ejector lock cogs 232 align with the ejector cut-outs 228. The ejector rod 202 can thus move in the receiving direction until an end portion 206 of the ejector cogs abuts a bottom portion 214, of the ejector lock cut-outs 230, since the ejector lock cogs 232 and the ejector cogs 226 have substantially the same length. Thus, a bottom portion 214 of the ejector lock cut-outs 230 abuts the end portion 206 of the ejector cogs 226. The end portion 206 of the ejector rod 202 is also denoted an ejector rest portion 206.
When the ejector lock 212 is turned such that ejector cogs 226 align with ejector lock cogs 232, a stop is introduced and the ejector rod 202 is prevented from moving in the receiving direction. The stop is introduced because, in that angular position of the ejector lock 212, the end portion 206 of the ejector rod 202 abuts the ejector lock support portion 234 of the ejector lock 212. The ejector lock support portion 234 of the ejector lock 212 is also denoted an ejector lock support portion 234.
The ejector rod 202 may be prevented from turning, by means of an angle retaining guide 207 when it engages with an angle retaining slot 238 (cf.
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Thus, at least both of the length of the ejector rod 202 and the length of the cogs and the cut-outs should be dimensioned to allow the cartridge assembly retention member 808 to travel between position L1 and L2 and L3 and L2.
Thus, the elongated ejector 200 is suspended to move along the longitudinal axis, L, and is enabled to move beyond a stop position 250 (cf.
The cartridge assembly 600 comprises a cartridge holder 800. The cartridge holder 800 is configured for retention of the cartridge 700 in the cartridge receiver 300 of the auto injector 4. The cartridge holder 800 comprises a cartridge retention member 808. The cartridge retention member 808 engages with the cartridge receiver 300 for reception and retention of the cartridge 700 and the cartridge assembly 600 in the cartridge receiver 300.
The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700, e.g. by the needle hub 904 having a cartridge holder coupling portion 906, e.g. a threaded coupling portion, being in engagement with a needle assembly coupling portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be blocked by a resilient sealing being penetrated by the needle 902, when the needle assembly 900 is attached to the cartridge 700.
The auto injector 4 comprises a code sensor 24 configured to read the cartridge code feature 1000. When the cartridge assembly 600 is inserted, as shown, the cartridge code feature 1000 is lined up with the code sensor 24.
The auto injector 4 comprises a plunger rod 400. The plunger rod 400 is configured to advance a first stopper of the cartridge 700. The plunger rod 400 comprises an outer plunger rod 404 with an inner thread, and an inner plunger rod 402 with an outer thread. The thread of the inner plunger rod 402 is in engagement with the thread of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the auto injector. The movement of the plunger rod 400 comprises rotation of the inner plunger rod 402. The rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404, due to the outer plunger rod 404 being rotationally restricted. The outer plunger rod 404, when moved translationally in the first stopper direction 722, is configured to abut the first stopper of the cartridge 700, and to move the first stopper in the first stopper direction 722.
The drive module 500 is coupled to actuate the plunger rod 400. The drive module 500 is electrically connected to a battery for receiving electrical power. The drive module 500 comprises a motor 502, such as an electro-mechanical motor, such as a DC motor. The drive module 500 comprises a transmission 504 for coupling the motor 502 to the inner plunger rod 402 of the plunger rod 400.
The auto injector 4 comprises an ejection sensor 26, such as a plunger rod position sensor. The ejection sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the ejection sensor 26 comprises a tachometer configured to count/detect the revolutions of the motor 502. Thus, the position of the plunger rod 400 may be determined based on the count of revolutions of the motor 502. The ejection sensor 26 may, based on the detection of the position of the plunger rod 400, detect the expelling of medicament and/or air in the cartridge compartment. The position of the plunger rod 400 may be indicative of the position of the first stopper of the cartridge 700, e.g. the most advanced position of the plunger rod 400 during reception of the cartridge 700 may be indicative of the position of the first stopper of the cartridge 700.
The contact member comprises a needle cover engagement member 1114. The needle cover engagement member 1114 is configured to abut a needle cover abutment face, e.g. of a needle cover positioned on the cartridge inserted into the cartridge receiver 300.
The auto injector 4 comprises a contact member sensor 1104 configured to detect a position of the contact member 1102. The contact member sensor 1104 comprises a first contact member sensor 1130 and a second contact member sensor 1132. The first contact member sensor 1130 and the second contact member sensor 1132 may be optical sensors. The contact member sensor 1104 detects the position of the contact member 1102 by the contact member protruding part 1112 covering the first contact member sensor 1130 when the contact member 1102 is in a first contact member position, and the contact member protruding part 1112 covering the second contact member sensor 1110 when the contact member 1102 is in a second contact member position.
The first contact member position may be detected by the first contact member sensor 1130 being covered and the second contact member sensor 1132 being covered. The second contact member position may be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 being covered. The extended contact member position may be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 not being covered.
The first contact member position may be the retracted contact member position, or close to the retracted contact member position. The contact member 1102 may have been moved to the first contact member position by the contact member 1102 being pressed against an injection site, thereby inserting the needle 902 into the injection site. The contact member protruding part 1112 has moved with the contact member 1102. The contact member protruding part 1112 covers the first contact member sensor 1130. The contact member protruding part 1112 covers the second contact member sensor 1132.
In
According to a first item there is provided an auto injector (4) for dministering injection of a medicament from a cartridge containing the medicament, the auto injector (4) comprising: a housing (6); a cartridge receiver (300) with a cartridge receiver compartment (302) configured to receive a cartridge assembly (600), with at least one cartridge retention member (808), when inserted through a cartridge receiver opening (301) along a longitudinal axis (L) in a receiving direction; wherein the cartridge receiver (300) has a passage (316) through which the at least one cartridge retention member (808) travels at least in the receiving direction, and a member (312) preventing movement beyond a retention position in a direction opposite of the cartridge receiving direction (304); an elongated ejector (200) that is configured with: an ejector support face (204) for supporting the cartridge or cartridge assembly (600) and an ejector rod (202) configured with one or more ejector cut-outs (228) to form one or more ejector cogs (226) between the ejector cut-outs (228); and an ejector lock (212) supported for turning at least a fraction of a revolution and maintained in a longitudinal position relative to the housing (6); wherein the ejector lock (212) is configured with one or more ejector lock cogs (232) between one or more ejector lock cut-outs (230); wherein the elongated ejector (200) is suspended to move along the longitudinal axis (L) and is enabled to move beyond a stop position (250) at a first angular position of ejector lock (212) and is prevented from moving beyond the stop position (250) by the ejector cogs (226) abutting the ejector lock cogs (232) at a second angular position of the ejector lock (212).
At the first angular position of ejector lock, the elongated ejector is enabled to move beyond the stop position since the ejector cogs enter the ejector lock cut-outs. In some aspects the ejector rod is a substantially cylindrical rod coaxially arranged with the ejector lock, which comprises a substantially cylindrical portion.
The ejector lock may be coupled directly or indirectly to drive means comprising a motor to rotate to and from the first angular position and the second angular position. In some aspects the ejector lock is rotated by manual operation.
In some aspects the ejector rod 202 has an ejector rod bore 222, forming a longitudinal passage through the ejector rod 202, wherein a plunger rod 400 is arranged to move longitudinally. The Plunger rod may comprise an outer plunger rod with an inner, longitudinal thread, and an inner plunger rod, such as a threaded rod, coupled such that rotation of the inner plunger rod causes the outer plunger rod to move longitudinally. The outer plunger rod may be prevented from rotating, while the inner plunger rod is supported to rotate and kept in a fixed longitudinal position. The inner plunger rod may be driven by a motor.
In some aspects the ejector lock is operated to rotate to and from the first angular position and the second angular position by being coupled to the plunger rod, whereby a longitudinal displacement of the plunger rod rotates the ejector lock.
Other aspects of the first item are set out in the claims and in the present specification.
| Number | Date | Country | Kind |
|---|---|---|---|
| 15203132.4 | Dec 2015 | EP | regional |
| 15203137.3 | Dec 2015 | EP | regional |
This application is a continuation of U.S. application Ser. No. 16/060,627, filed Jun. 8, 2018, which is a U.S. National Phase Application of PCT International Application Number PCT/EP2016/082855, filed on Dec. 29, 2016, designating the United States of America and published in the English language, which is an International Application of and claims the benefit of priority to European Patent Application No. 15203137.3, filed on Dec. 30, 2015, and European Patent Application No. 15203132.4, filed Dec. 30, 2015. The disclosures of the above-referenced applications are hereby expressly incorporated by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16060627 | Jun 2018 | US |
| Child | 17985438 | US |
