AUTOINJECTION DEVICE WITH RECONFIGURATION CAPABILITY FOR MULTIPLE CHAMBER DRUG CARTRIDGES - Patent application

Abstract

A handheld motor-driven drug reconstitution and automatic injection device (1) having a proximal drive system (2) including an elongated body (3) housing a controllable drive motor (6) and an axially drivable piston rod (7), and a distal drug cartridge holder assembly (11) housing a multi-chamber (30, 31) drug cartridge (25), wherein the cartridge holder assembly (11) is releasably attached to a distal zone (23) of the drive system (2), and the drive system (2) and the cartridge holder assembly (11) are configured to impart movement to the drug cartridge holder assembly (11) such that the drug cartridge holder assembly (11) moves from a first, substantially extended, distal configuration along a central longitudinal axis to a second, substantially collapsed, proximal configuration along the central longitudinal axis, the relative movement of the drug cartridge holder assembly (11) resulting in the reconstitution of an injectable product from the substances contained in each chamber (30, 31).

Description

[Technical field]

[0001] The present invention relates generally to the field of motor-driven automatic injector drug delivery devices, and in particular to motor-driven automatic pen-type drug injectors. Such devices are generally well known in the art and provide a useful alternative to other drug delivery devices, such as manually operated pen-type injectors, particularly where a user of the manual device has difficulty in preparing and / or using the device to effect an injection of an injectable product, such as a drug. [Background technology]

[0002] A motor-driven auto-injector known in the art is described in PCT application published as WO 03099357. This document discloses a drug injection device having a motor drive member which, when advanced, is inserted into a fluid container to expel fluid from the fluid container. The drive member includes an internal hollow portion which fits over at least a portion of a motor drive driver assembly when the drive member is retracted to enable a compact device to be provided.

[0003] An automatic injector adapted to receive a cartridge including a barrel, a needle and a plunger assembly is known from WO2014008393, the automatic injector comprising a housing, a cartridge carrier for receiving a part of the cartridge, a plunger carrier, at least one transfer device coupling the cartridge carrier to the plunger carrier, an elongated drive enabling movement of the plunger carrier, the plunger carrier and / or the cartridge carrier comprising an opening for receiving the at least one transfer device, a motor and a gearbox assembly coupling the motor to the elongated drive. In the automatic injection device described herein, the barrel, needle, plunger assembly and drug cartridge are insertable into and removable from a housing that completely encloses and surrounds the barrel, needle and plunger assembly. The housing is shown as being composed of two parts, an upper part and a lower part, with a hinge along one side of the housing, the upper part and the lower part being movably attached one relative to the other, thereby allowing the housing to be opened and closed. The housing is designed with a sufficient hollowed out portion to allow for the introduction of the cartridge, needle and plunger assembly and removal during use. A removable battery powered motor drives a threaded screw supporting a movable carriage, the movable carriage meshing with the threads of the threaded screw and indexing to the threads to move forward or backward in a forward or backward direction in response to actuation of the motor. The indexed movable carriage, upon actuation of the motor, engages the plunger assembly to drive the threaded screw forward, driving the plunger assembly forward and expelling the drug contained in the drug cartridge from the cartridge and into the needle where it forms the user of the automatic injector.

[0004] A further motor-driven auto-injector is known from PCT application published as WO2015044102. This document shows an injection pen used to inject an active ingredient into a patient's body, the device comprising an electric motor, a cartridge for storing the active ingredient, a piston adapted to slide in the cartridge, a mechanism for pushing the piston in the cartridge driven by the motor during injection, a display screen and means for controlling the amount of active ingredient injected. The motor, the pushing mechanism and the cartridge are all aligned along a common longitudinal axis.

[0005] As can be seen from the above prior art examples, handheld motor-driven automatic injection devices, such as motor-driven pen injectors, are known per se and generally include: a drive system including a hollow elongated body having a substantially central longitudinal axis along the elongated body and defining a bore extending along the longitudinal axis located within the hollow elongated body, the elongated hollow body of the drive system further housing a user controllable drive motor and an axially drivable piston rod coupled to the motor and located within the bore; a drug cartridge holder assembly attached to or forming an integral part of the drive system, the cartridge holder housing a cartridge having an injectable substance, such as a drug; may be considered to include one or more of:

[0006] The documents exemplified above generally relate to either single-chamber drug cartridges or single-syringe configurations that contain pre-prepared formulations to be injected. Unfortunately, not all drugs or drug combinations can be prepared and / or formulated for pre-prepared formulations. Some drugs are relatively unstable or have a relatively short storage life, and once diluted, dissolved, and otherwise composed into an injectable product formulation, some therapeutic treatments further require simultaneous administration of separate or similar drugs, which are not compatible when stored together under conditions used for normal storage and dispensing of injectable drugs. For this reason, multiple simultaneous or sequential drug injection systems have been developed.

[0007] Alternatively, motor-driven drug injection systems have been developed, such as autoinjector pens, which allow the use of multi-chamber cartridges to compose or reconstitute an injectable drug product prior to administration. Such a system is known from PCT application published as WO2019002534. This document discloses an automatic injector for administering a medicament, the automatic injector including: a housing; a cartridge receiver configured to receive a cartridge including a first stopper and a cartridge compartment accommodating a medicament, the cartridge compartment having a first cartridge subcompartment accommodating a first medicament component of the medicament and a second cartridge subcompartment accommodating a second medicament component of the medicament; a drive module coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position, the plunger rod configured to move the first stopper; and a processing unit coupled to the drive module, the processing unit configured to control the drive module to move the plunger rod from the first plunger rod position to a mix plunger rod position at a mix plunger rod speed, the mix plunger rod position being selected to position the first stopper at a position where the first medicament component is mixed with the second medicament component and to provide a start signal after a number of complete reversals of the automatic injector have been performed.

[0008] One problem with multi-chamber drug cartridges is that they can be problematic to properly and safely mount on the drive system, as they are often only held in the drive system by a limb, usually the proximal end, or must be fully contained in the drive system body to maintain sufficient axial stability during actuation of the piston rod. Since the bodies of such motor-driven systems are already quite long in any case, mounting a multi-chamber drug cartridge on the proximal end of the drive system body tends to add significant length to the overall length of the auto-injector. This extra length is often a cause of increased difficulty in use for the average user of such systems, as the user finds it difficult to easily operate and operate the device one-handed, which can lead to reduced patient compliance with the associated treatment regimen. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 03099357 Brochure [Patent Document 2] International Publication No. 2014008393 Brochure [Patent Document 3] International Publication No. 2015044102 Brochure [Patent Document 4] International Publication No. 2019002534 Brochure Summary of the Invention

[0010] It is therefore an object of the present invention to provide a motor-driven automatic injection device of reduced length which also includes an automatic reconstitution feature in at least the dual-chamber cartridge prior to injection, and wherein the automatic injection device is a longitudinally axially configured automatic injection device, such as a pen-type drug injection device.

[0011] For the purposes of the present invention, a longitudinally axially configured auto-injector refers to a motor-driven auto-injection device in which all of the relative functional components are substantially aligned along a common single longitudinal axis of the device and the piston acts along said common longitudinal or longitudinal axis. In this regard, the auto-injector envisaged by the present invention does not relate to box-type auto-injectors or auto-injectors that include a motor-driven piston that is indirectly driven, for example, by a set of gears, drive mechanisms or motors that are orthogonally arranged or angularly displaced compared to the longitudinal axis of movement along which the piston is driven.

[0012] Other objects will become apparent from the following description of various embodiments of the present invention.

[0013] Accordingly, one object of the present invention is a handheld, motor-driven drug reconstitution and automatic injection device comprising: a proximal drive system, the proximal drive system comprising: an elongated body having a substantially central longitudinal axis along the elongated body and a bore extending within the body along the longitudinal axis, the elongated body housing a controllable drive motor and an axially drivable piston rod coupled to the motor disposed within the bore; and a distal drug cartridge holder assembly, the distal drug cartridge holder assembly comprising: configured to receive within said assembly a multi-chamber drug cartridge including at least a first substance stored in a first chamber and at least a second substance stored in a respective second chamber, the first and second chambers being disposed in a nose-to-tail arrangement in substantial axial alignment with the central longitudinal axis; the distal drug cartridge holder assembly having a proximal end releasably attached to a distal zone of the proximal drive system and a distal end configured to receive an injection needle; the proximal drive system and the distal drug cartridge holder assembly are configured to impart movement to the drug cartridge holder assembly, the drug cartridge holder assembly moving from a first substantially extended, distal configuration along the central longitudinal axis to a second substantially folded, proximal configuration along the central longitudinal axis; Relative movement of the drug cartridge holder assembly as it is moved by the drive system along the longitudinal central axis from a first substantially extended distal configuration to a second substantially folded proximal configuration results in reconstitution of an injectable product including at least the first and second substances located in only one of the at least the first or second chambers after said reconstitution.

[0014] As used herein, the terms "proximal" and "distal" are spatial references used to define the relative spatial location of various components of the automatic injection device with respect to normal use of the device when held in the hand of a user. In this context, "proximal" refers to the location of an object, or the movement or direction of movement of a component of the automatic injection device, toward or near the hand of a user that holds the device in the manner in which the device is normally handled and operated. In this case, "proximal" refers to the end of the device gripped by the user, opposite the other end of the device where the drug is expelled or injected into the user. As a result, the term "distal" refers to the location of an object, or the movement or direction of movement of a component of the automatic injection device, toward or near the ejection or injection end of the device.

[0015] The proximal drive system is therefore located at the end of the automatic injection device that is typically held or gripped in the user's hand, which is similar to motor-driven automatic injectors already known in the art, as shown in the general introduction.

[0016] The proximal drive system includes an elongate body having a substantially central longitudinal axis extending along said elongate body, and a bore extending into said body along said longitudinal axis. The elongate body and bore may be integrally formed of the same material or may consist of several assembled components, e.g., two complementary halves of at least partially hollowed-out body material, which fit together and are held together by suitable attachment means, such as clips, or by welding or gluing, e.g., ultrasonically welding the complementary halves together. The complementary at least partially hollowed-out body halves together define a longitudinal bore. The elongate body also houses a controllable drive motor, typically located and housed within the bore of the elongate body, and located substantially at or adjacent the proximal end of the elongate body of the drive system. The drive motor is controllable via a suitably equipped controller, e.g., a programmable microcontroller located on a printed circuit board, and is advantageously located on the elongate body of the drive system or housed within the bore of said elongate body. A user interface, e.g., an LCD display, can be provided to allow a user to input commands that control the automatic injection device and thus the drive motor. The user interface can provide access to a dose setting system, including, for example, dose increase / decrease buttons, dose cancel and / or reset buttons. At the proximal end of the automatic injection device, the bore can be suitably closed by an actuation button, which can be directly or indirectly connected to a drive motor that is controllable, for example, via an electrical or electronic switch component, and via a controller.

[0017] The axially drivable piston rod is coupled to the motor and is also disposed within the bore of the elongated body of the drive system. The axially drivable piston rod is connected to the motor directly or via an axle and / or a suitable gear set to control the speed and torque applied to the drivable piston rod when the motor is actuated. The drivable piston rod is configured to provide an axial movement of the piston from a proximal position towards a distal position under the control of the drive motor. Such piston rods are generally known per se for automatic injectors and typically include threaded rods with threads provided on the outer surface of the road. Advantageously, the drivable piston rod further comprises a piston nut disposed around the piston rod and having an internal threaded surface that complementarily engages with the external threaded surface of the piston rod. When the motor is actuated to operate in a forward drive configuration, the piston rod is rotated by the drive motor and the threads of the piston rod engage with the threads of the piston nut to move the nut distally along the piston rod. Similarly, when the motor is actuated to operate in a reverse or reverse drive configuration, the drive motor rotates the piston road in the opposite direction to the forward drive, thereby moving the piston nut proximally. The nut is provided with a proximal surface configured to contact a proximal stopper of the drug cartridge, thereby forcing said stopper along the inside of the drug cartridge. Such general arrangements for threaded piston rods, threaded nuts and drug cartridge stopper engagement are known per se in the art.

[0018] The automatic injection device of the present invention further includes a distal drug cartridge holder assembly configured to accommodate within said assembly a multi-chamber drug cartridge including at least a first substance stored in a first chamber and at least a second substance stored in a respective second chamber, the first and second chambers being arranged in a nose-tail configuration in substantial axial alignment with the central longitudinal axis.

[0019] Drug cartridges are generally known in the art as such. As mentioned above, for the purposes of this specification, a drug cartridge includes at least a first substance stored in a first chamber and at least a second substance stored in a respective second chamber, the first and second chambers being arranged in a nose-tail arrangement in substantial axial alignment with a central longitudinal axis. Thus, the drug cartridge is preferably a dual-chamber cartridge of a type known in the art. The first chamber is generally defined as the volume between a first stopper generally located at the proximal end of the drug cartridge and a second stopper generally located at a position between the proximal end of the drug cartridge and the distal end of the drug cartridge. The second chamber is generally defined by the volume between the second stopper and the distal end of the drug cartridge, or optionally a third stopper. The first chamber contains a first substance, e.g., a first component, of an injectable product that requires reconstitution prior to injection. The second chamber contains a second substance, e.g., a component generally different from the first component, which is necessary to constitute or reconstitute the appropriate injectable product prior to injection. The first substance and / or the second substance can be a powder, a fluid, a liquid, a gel, a gas, and / or any combination thereof. One of the first or second substances can be a solute, e.g., a powder composition. The other of the first or second substance can then be a fluid, e.g., a liquid, a solvent suitable for that solute. For example, the second substance can be a powder composition and the first substance can be a fluid composition, e.g., water, ethanol, saline, buffer or preservative solution, etc., as are commonly known. The relative function and definition of the first and second substances is only limited by the requirement that, when reconstituted, they together constitute an injectable product that can act as a drug with the appropriate pharmaceutical effect. The drug can be, for example, any number of chemical or biological entities with pharmaceutical activity, e.g., vaccines, RNA, DNA, proteins, polypeptides, hormones, any manner of pharmacologic active chemical or biological molecules, or their metabolites, etc.

[0020] Multiple chamber, including dual chamber, cartridges of the kind envisaged for use in the present invention are generally provided with a bypass providing fluid communication between a first chamber and at least a second chamber. The cartridge may alternatively have multiple bypass sections providing fluid communication between adjacent chambers. One or more bypasses are generally closed in an initial manufacturing configuration via the positioning of stoppers separating and defining the chambers. As these stoppers are moved via distal translational movement of the drive piston and / or nut in contact with the first stopper, each of the stoppers eventually translates distally, either by pressure in the upstream chamber exerted on the downstream stopper, or by direct contact of the upstream or proximal stopper before on the downstream or distally located stopper, thereby moving the stopper onto the bypass to allow fluid communication between one chamber and its next adjacent chamber, or another appropriately connected chamber. Fluidic material in one chamber then enters the bypass connected chamber via the bypass and mixes with the material in the other chamber to reconstitute the injectable product.

[0021] The device according to the invention is further defined by the distal drug cartridge holder assembly having a proximal end releasably attached to the distal zone of the proximal drive system and a distal end configured to receive an injection needle. Again, generally, means for attaching the needle to the distal end of the cartridge holder are well known in the art, for example, via a luer lock system, an externally threaded distal tip of the cartridge holder assembly that engages with a corresponding internal thread on the cone of the needle holder, etc. Furthermore, various means of releasably attaching the proximal end to the distal zone of the drive system can be envisaged, such as clips, protrusions and corresponding recesses, for example, a bayonet mount, threads on the external surface of the proximal end of the cartridge holder assembly, and complementary threads on an internal surface at or adjacent to the distal end of the drive system elongate body, etc. For the purposes of this specification, screw-removable attachment systems are particularly preferred, as they tend to provide both a fixed, precisely axially aligned, and easily removable attachment by unscrewing of the cartridge holder assembly about the central longitudinal axis of the automatic injection device drive system.

[0022] Additionally, the device according to the present invention is further defined in that the proximal drive system and the distal drug cartridge holder assembly are configured to impart movement to the drug cartridge holder assembly, said drug cartridge holder assembly moving from a first substantially extended, distal configuration along the central longitudinal axis to a second substantially folded, proximal configuration along the central longitudinal axis, In other words, the cartridge holder assembly is moved relative to the drive system body to cause the cartridge holder assembly to fold or retract from an initial extended configuration at a distal position to a final substantially folded position at a proximal position.

[0023] The relative movement of the drug cartridge holder assembly from a first substantially extended distal configuration to a second substantially folded proximal configuration when moved along the longitudinal central axis by the drive system serves to effect a reconstitution of the injectable product comprising at least a first and a second substance. By moving the cartridge holder assembly in a proximal direction, the piston rod contacts and further crushes a first proximal stopper of the multi-chamber cartridge, and the proximal movement of the cartridge holder assembly driven by the drive system continues to push the proximal stopper in a distal direction, which acts on a second intermediate stopper under the influence of the relative pressure in the chambers, pushing the second intermediate stopper in a distal direction to expose a bypass, allowing the first substance, e.g. a fluid such as a solvent, to be forced from the first chamber through the bypass into the second chamber to dissolve the second substance, e.g. a drug, in powdered solute form. Once the folded configuration of the cartridge holder assembly is reached and the injectable product is reconstituted, the injectable product is placed in only one of the chambers, and in the case of a dual chamber cartridge, preferably the second chamber, thereby positioning said injectable product for injection, as typically found in single chamber cartridges containing a pre-prepared or pre-compounded injectable product.

[0024] As described above, the cartridge holder assembly engages in a relative movement from an extended distal configuration to a folded proximal configuration. Various relative movements of the cartridge holder assembly can be envisaged for the auto-injector and reconstitution device of the present invention. The cartridge holder assembly is further configured to be operated by the proximal drive system in a reverse relative movement compared to the reconstitution movement to move the components of the cartridge holder assembly from the proximal folded configuration to the distal extended configuration for the purpose of enabling removal of the cartridge holder assembly and replacement of the cartridge with a replacement multi-chamber cartridge requiring reconstitution of the substance contained therein.

[0025] Therefore, according to another object of the present invention, the relative movement of the drug cartridge holder assembly from the extended configuration to the folded configuration comprises a telescopic movement. In other words, the cartridge assembly is configured and designed to allow relative telescopic movement of its components from the extended configuration to the folded configuration under the influence of and controlled by the drive system. The telescopic movement of the cartridge holder assembly may be any suitable movement that causes the components of the cartridge holder assembly to telescope relative to each other when transitioning from the extended configuration to the folded configuration.

[0026] Therefore, according to a further object of the present invention, the relative movement of the drug cartridge holder assembly from the extended configuration to the folded configuration includes both rotational and translational telescopic movements. Such a combination of rotational and translational telescopic movements in the cartridge holder assembly has been found to be particularly advantageous. In particular, such a combination allows a significant reduction in the overall length of the autoinjector and reconstitution device, thereby improving the user experience and patient acceptance of the device.

[0027] In a still further object of the present invention, the drug cartridge holder assembly comprises a plurality of interconnected elongated hollow bodies arranged in concentric axial alignment about a central longitudinal axis. The elongated concentrically arranged hollow bodies envisaged hereby are ideally suited to move from an extended distal configuration to a folded proximal configuration. The number of concentrically arranged hollow bodies for the cartridge holder assembly may potentially be virtually unlimited within the limits of being able to accommodate and hold a corresponding multi-chamber drug cartridge, but preferably the number of interconnected hollow bodies constituting the cartridge holder assembly is preferably between 3 and 5 interconnected elongated hollow bodies, depending on the degree and precision of relative movement desired, as well as the maximum allowable length that would be useful to a user or patient using the device, and most preferably and advantageously consists of three interconnected elongated hollow bodies arranged in concentric axial alignment about a central longitudinal axis.

[0028] Therefore, in accordance with yet another object of the present invention, a medication cartridge holder assembly comprising: a first elongate body including a bore axially aligned with a longitudinal axis; a second elongate body including a bore axially aligned with the longitudinal axis; a third elongate body including a bore axially aligned with the longitudinal axis; Including, The three elongate bodies are interconnected and configured in concentric axial alignment about a central longitudinal axis.

[0029] In the above configuration, the first elongated body of the drug cartridge holder assembly and the third elongated body of the drug cartridge holder assembly are advantageously connected to each other via a contact surface comprising an inner surface of the first elongated body and an outer surface of the third elongated body, respectively. Such contact surfaces can be formed, for example, by corresponding interacting threads provided on each surface. Particularly useful and advantageous features have been determined by arranging such threads on the outer surface of the third elongated body at or adjacent to the proximal end of the third elongated body of the drug cartridge holder assembly. Similarly, in a corresponding manner, particularly useful and advantageous features have been found by arranging the inner surface threads substantially along the inner bore-facing surface of the first elongated body of the drug cartridge holder assembly. As a result of such a configuration, when driven by the drive system, the configured permitted movement of the third elongated body relative to the first elongated body of the drug cartridge holder assembly is a rotational movement about the longitudinal axis and along the contact surface in the proximal direction.

[0030] In the above configuration, the second elongate body of the drug cartridge holder assembly is concentrically disposed therearound and extends distally from a proximal end beyond the first elongate body to a distal end. In such a configuration, the second elongate body of the drug cartridge holder assembly completely covers and surrounds, or substantially covers and surrounds, the entire length of the first elongate body of the cartridge holder assembly.

[0031] The first elongated body of the drug cartridge holder assembly and the second elongated body of the drug cartridge holder assembly are respectively connected to each other via a contact surface including cooperating interlocking means provided on the second elongated body and the first elongated body, respectively. The respective cooperating interlocking means are configured to allow relative rotational movement of the first elongated body within the bore of the second elongated body. When driven by the drive system, the respective interlocking means cooperate to rotate the first elongated body about the longitudinal axis within the bore of the second elongated body. In this configuration, the first elongated body of the cartridge holder assembly is coaxially mounted and physically attached inside the second elongated body of the cartridge holder assembly to maintain a suitable coaxial separation from said second elongated body. The physical, rotatably acceptable interlocking attachment of the first elongated body of the cartridge holder assembly to the second elongated body of the cartridge holder assembly can be achieved in various ways, for example, via a radially oriented protrusion or a radially oriented annular shoulder extending outwardly from the outer surface of the first elongated body and located at or adjacent to the proximal end of the first elongated body. The second elongated body can include one or more corresponding recesses for receiving and locating the protrusion or shoulder of the first elongated body or a corresponding annular recess or groove provided at a suitable proximal location of said second elongated body. In this way, the first elongated body is not only free to rotate within the second elongated body about its longitudinal axis when driven by the drive system, but also rotates within the second elongated body under the impetus of the drive system. Alternatively, the above-described configuration can be reversed, with the second elongate body having an inwardly directed protrusion or an annular shoulder directly on the inside and a corresponding groove or recess provided in the first elongate body, such that the first elongate body is free to rotate about the longitudinal axis when driven by the drive system.

[0032] Furthermore, the distal end of the second elongated body of the drug cartridge holder assembly is concentrically disposed around and extends over at least the proximal end of the third elongated body of the drug cartridge holder assembly. The second elongated body is shaped and dimensioned to interact with the third elongated body to prevent distal movement of said third body beyond a predetermined point. Such a configuration may, for example, include an annular protrusion located at the distal end of the second elongated body that extends inwardly into the bore of the second elongated body, the annular protrusion abutting an outward abutment protrusion extending from the outer surface of the third elongated body at the most distal position permitted by the third elongated body. The abutment protrusion of the third elongated body is disposed at a substantially proximal position on the outer surface of the third elongated body. The interaction of the annular inward projection of the second elongated body and the outward abutting projection of the third elongated body constitutes and defines the permissible movement of the third elongated body relative to the second elongated body of the drug cartridge holder assembly, defining said movement as translational movement along the longitudinal axis in a proximal direction inside the bore of the second elongated body when driven by the drive system.

[0033] According to yet another object of the present invention, the auto-injector and reconstitution device further includes a coupling member configured to couple a proximal end of the drug cartridge holder assembly to an axially drivable piston rod of the drive system. Thus, the coupling member includes an elongated coupling member body having a bore axially aligned with the longitudinal axis and housed within the elongated body of the drive system. The coupling member is configured to rotate freely about the longitudinal axis within the bore of the elongated body of the drive system until reconstitution is complete. Specifically, the coupling member can rotate about the longitudinal axis under the impetus of the actuated drivable piston rod until the third elongated body of the cartridge holder assembly reaches its maximum travel distance in the proximal direction, at which point the coupling member is locked in rotation about the longitudinal axis relative to the cartridge holder assembly, thereby preventing further rotation.

[0034] The coupling member and the drivable piston rod are connected to each other via corresponding piston drive engagement means provided on the elongate body of the coupling member and the drivable piston rod, respectively. Any suitable engagement means are suitable for such connection, but typically, by way of example, each such engagement means may comprise one or more longitudinal slots provided on the coupling member body extending parallel or substantially parallel to the longitudinal axis, and one or more outwardly protruding wings provided on the piston rod, whereby the wings engage with the slots, which allow translational movement of the wings, whereby the piston rod translates along the longitudinal axis. Optionally and advantageously, the protruding wings are automatically biased in the proximal direction by a biasing member, such as a spring, disposed in or on the coupling member after injection or after removal of the cartridge holder assembly after reconstitution, whereas the wings of the drivable piston are supported when moved in the distal direction upon drive by the motor to perform reconstitution and injection. Once an injection has been performed, the cartridge holder assembly is removed and decoupling of the cartridge holder assembly from the coupling member causes the biasing spring to push back against the wing portions, driving the piston rod proximally and returning the piston rod to its initial position.

[0035] The coupling member further comprises a distal engagement means configured to engage with the proximal end of the first elongated body of the cartridge body holder assembly. When driven by the drive system, the distal engagement means of the coupling member are configured to transmit rotation of the elongated body of the coupling member about the longitudinal axis to the first elongated body of the cartridge holder assembly. Such distal engagement means can be any suitable engagement means, such as a simple frictional engagement between a distal surface of the coupling member body and, for example, a proximally located, inwardly projecting annular shoulder extending from an inner surface of the bore of the first elongated body of the cartridge holder assembly. However, preferably and advantageously, the distal engagement means of the coupling member comprises at least one or more splines or tongues extending parallel to the longitudinal axis at the distal end of the coupling member and arranged around the longitudinal axis. These splines or tongues are inserted into corresponding engagement means, such as grooves provided on the inner surface, of the proximal end of the first elongated body of the cartridge holder when the cartridge holder assembly is mounted on the drive system. In the given example, the splines are dimensioned and configured to interact with the grooves to lock the coupling member and the first elongated body of the cartridge holder assembly together, so that rotation of one causes rotation of the other to the same extent. It should be understood that the tongues and grooves can be configured in an opposite arrangement, for example with a tongue on the first elongated body of the cartridge holder assembly and a groove on the coupling member, respectively. In any of these configurations, rotation of the coupling member caused by the actuation of the drivable piston by the drive system directly rotates the first elongated body of the cartridge assembly holder together with the coupling member. This rotation causes the third elongated body to counter-rotate and retract into the bore of the first elongated body until the proximal end of the third elongated body abuts against a proximally located annular shoulder provided in the bore of the first elongated body.

[0036] As mentioned above, the axially drivable piston rod comprises an externally threaded piston rod connected to a drive motor. The drivable piston rod further comprises an internally threaded nut, whereby actuation of the drive motor drives the threaded rod to engage the internally threaded nut and moves said nut from a proximal position to a distal position along said longitudinal axis due to interaction between the external thread of the threaded rod and the internal thread of the threaded nut. The internally threaded nut is provided with piston drive engagement means located on the outer surface of the nut, said piston drive engagement means being configured to engage with respective corresponding engagement means located in or on the coupling member. For this purpose, for example, as mentioned above, the threaded nut is advantageously provided with outwardly projecting wings that interact with slots provided in the coupling member body. In this way, the threaded nut rod advances in the distal direction when the motor is actuated to drive the piston rod, and the nut translates along the longitudinal axis due to engagement of the wings in the slots, while at the same time stabilizing the threaded nut along the longitudinal axis through interaction between said slots and said wings.

[0037] During the reconfiguration step, the motor is actuated to drive the drivable piston. The respective elongated bodies of the coupling member and the first elongated body of the cartridge holder assembly are rotationally locked via respective corresponding tongues / splines and grooves, for example as described above. Wings of the threaded nut, pushed forward by the threaded drive piston, engage with slots in the coupling member body, causing the coupling member to rotate and engage with the first elongated body of the cartridge holder assembly, which is also rotated. Rotation of the first elongated body of the cartridge holder assembly counter-rotates the third elongated body of the cartridge holder assembly via threaded interacting contact surfaces provided between the first and third elongated bodies of the cartridge holder assembly, thereby retracting the third elongated body into the bores of both the second and first elongated bodies of the cartridge holder assembly. This withdrawal corresponds to a proximal movement of the third elongate body, which continues until the proximal end of the third elongate body abuts the inwardly projecting annular shoulder of the first elongate body of the cartridge holder assembly. At this point, the first elongate body of the cartridge holder assembly is prevented from further rotation as it is held between the coupling member and the third elongate body of the cartridge holder assembly. The nut stops rotating and is instead pushed distally by interaction with the threaded piston under control of the drive motor until it contacts the first stopper of the multi-chamber cartridge, at which point further actuation of the threaded piston and nut pushes the stopper distally to mix the first and second substances and reconstitute them as described above with respect to the general function of the multi-chamber drug cartridge.

[0038] Once reconstitution is complete, an injection can be performed, for example, by connecting a suitable needle to the distal end of the cartridge holder assembly and operating the autoinjector in the normal manner to perform the injection. To allow replacement of the now empty cartridge after the injection, the threaded nut can be withdrawn, i.e. moved in the proximal direction by reversing the direction of the drive motor, causing the threaded piston to interact with the threaded nut via the respective thread, and the nut to move in the proximal direction again. This reverse movement rotates the first elongated body of the cartridge holder assembly in a direction opposite to its previous rotation direction for reconstitution, thereby pushing the third elongated body back in the distal direction until the outward projections on its surface come into abutting contact with the inwardly projecting annular shoulder of the second elongated body of the cartridge holder assembly. As a result, the cartridge holder assembly returns from the folded configuration to the extended configuration before reconstitution was initiated. The cartridge holder assembly can now be disconnected from the drive system and a new cartridge can be inserted into the assembly for a new reconstitution operation and / or injection.

[0039] Additionally, if desired, the drivable piston can be fully reset manually at this juncture by pressing on the distal end of the nut as needed, such manual intervention defeating the threaded contact engagement between the threaded piston and the nut, and the biasing spring presses against wings of the nut to force the nut proximally back to its initial position.

[0040] According to yet a further embodiment, there is provided a process for reconstitution of an injectable product contained in a multi-chamber drug cartridge of an automatic injection device, the multi-chamber drug cartridge of the automatic injection device including at least one first substance stored in a first chamber and at least one second substance stored in a respective second chamber, the first and second chambers being disposed in a nose-tail arrangement in substantial axial alignment with a central longitudinal axis of the automatic injection device; Providing a handheld motor-driven drug reconstitution and auto-injection device as described herein; activating a function of the automatic injection device including at least a reconstitution step prior to injection; Including, The reconstitution step includes driving a drive motor of the device to cause relative movement of the drug cartridge holder assembly from a first substantially extended distal configuration to a second substantially folded proximal configuration along a central longitudinal axis of the device, thereby effecting reconstitution of the injectable product in only one of the at least first or second chambers.

[0041] The various objects of the present invention set forth above, as well as other such objects, will become apparent from the following detailed description of one example of an apparatus according to the invention, taken in conjunction with the accompanying drawings, which are provided for purposes of illustration and in which: [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 is a schematic exploded perspective view of a motor-driven auto-injector and reconstitution device according to the present invention. [Diagram 2] FIG. 2 is a first schematic cross-sectional view of the device of FIG. 1 prior to reconfiguration. [Diagram 3] FIG. 2 is a first schematic cross-sectional view of the device of FIG. 1 after reconfiguration. [Figure 4] FIG. 2 is another schematic cross-sectional view of the device of FIG. 1 prior to reconfiguration. [Diagram 5] FIG. 2 is another schematic cross-sectional view of the device of FIG. 1 after reconfiguration. EXAMPLES

[0043] Figures 1 to 5 represent different schematic views of the device according to the invention. Figures 4 and 5 differ from Figures 2 and 3 mainly in the fact that the cross-sections shown represent a 90° rotation of the device along its longitudinal axis. All other elements remain the same as in Figures 2 and 3 and are numbered accordingly.

[0044] Referring now to Figure 1, a handheld motor-driven drug reconstitution and autoinjection device (1) according to the present invention is represented diagrammatically in an exploded perspective view. The device (1) comprises a drive system (2) including an elongated body (3', 3'') made up of a proximal portion (3') and a distal portion (3'') that mate and interlock together to form the elongated body (3', 3'') having a substantially central longitudinal axis (4) along said elongated body (3', 3''). A bore (5) extends within said body (3', 3'') along said longitudinal axis (4), the elongated body (3', 3'') being advantageously surrounded by two further complementary covers (3A, 3B) that can be secured to one another, for example by gluing, ultrasonic welding, clipping, or by force-fitting the two halves (3A, 3B) together. Preferably, the elongated body (3', 3'') is integrally molded, for example by injection molding. The elongated body (3', 3'') houses a controllable drive motor (6) and an axially drivable piston rod (7) coupled to said motor (6) disposed in said bore (5). The controllable drive motor is usefully arranged on a printed circuit board (9) and is controlled by a controller (8) suitably housed in one of the complementary covers (3A, 3B). The controller (8) is a programmable controller such as an EEPROM or other suitable programmable controller of a type commonly known in the art, for example a microcontroller.The controller (8) may be integrated with or connected to other electrical or electronic components, e.g., a power source, such as an optionally rechargeable battery or a lithium-ion type battery, one or more communication circuits, e.g., a near field communication circuit, an RFID circuit, and / or a Bluetooth® communication circuit, such as a Bluetooth® LE circuit for low energy consumption, one or more memory storage components for storing data, e.g., including volatile and / or non-volatile memory storage, one or more sensors connected to the controller for capturing data from the automatic injection device or the drive system, one or more display components configured to display a signal, such as a value or a visual signal, representative of data or a functional state of the device, such as an LCD display, one or more user input components configured to allow user input into the device, e.g., to set a dose to be administered, as well as other components in the device, e.g., one or more switches for activating or deactivating a proximal button (10) located and seated at a proximal end of the elongated body of the drive system connected to the controller (8) and configured to operate the motor (6) to drive the piston rod (7). The communication circuitry is configured to transmit information from, for example, the autoinjector and reconstitution device (1) via a correspondingly programmed application to a remote data collection and processing device, such as a remote or distributed computing system, or for example a smartphone, or usefully configured to receive information from such a remote data collection and processing device, stored in or transmitted by any other type of mobile communication device. As can be seen in FIG. 1, the bore (5) of the elongated body (3', 3'') houses a motor (6) and a threaded piston rod (7) axially aligned within the bore (5), along with other components described herein. The bore (5) is closed by a proximal button (10) that seats and covers the proximal end of the bore (5).

[0045] The device (1) further includes a drug cartridge holder assembly (11). A distal cap (12) is provided to cover the cartridge holder assembly (11) when the cartridge holder assembly () is attached to the drive system (2). The cartridge holder assembly includes three elongate bodies (13, 14, 15) each including a bore (13A, 14A, 15A) extending along the longitudinal axis (4). The first elongate body (13) having a proximal end (16) and a distal end (17) is connected at its proximal end (16) to a distal zone of the drive system (2) as described herein. The first elongate body (13) has a threaded contact surface (18) on an inner surface of the bore (13A) that extends substantially entirely along the bore (13A) from the distal end (17) to the proximal end (16). A second elongated body (15) having a proximal end (19) and a distal end (20) has a bore (15A) of a larger diameter than either the first elongated body (13) or the third elongated body. In FIG. 1, the second elongated body (15) is shown distal to both the first and third elongated bodies (13, 14) in an exploded view, but it should be understood that both the first and third elongated bodies (13, 14) are coaxially and concentrically disposed within the bore (15A) of the second elongated body (15) of the cartridge holder assembly (11), and the second elongated body (15) extends essentially the entire length of the first elongated body (13). Located adjacent the proximal end (19) of the second elongated body (15), the outer surface (21) of the body (15) has threads (22). The threads (22) of the second elongated body (15) are configured and dimensioned to allow the second elongated body (15) to engage with a distal region or zone (23) of the distal portion of the body (3''), in particular with threads (24) provided on the inner surface of the body (3'') facing inwardly into the bore (5). The threads (24) and the threads (22) interact and complement each other to form an engagement interface that allows the cartridge holder assembly (11) to be removably attached to the drive system (2) by threading the cartridge holder assembly into the distal zone of the drive system (2).Furthermore, optional corresponding abutment protrusions are advantageously provided on the inner and / or corresponding outer surfaces of the elongate bodies (13, 14) to facilitate and / or effect longitudinal and axial alignment, and / or respective superimposed alignment, of observation windows optionally provided in each of the first and third elongate bodies (13, 14, 15).

[0046] Prior to mounting the cartridge holder assembly (11) on the distal zone (23) of the drive system (2), in particular on the distal zone of the body (3''), a multi-chamber drug cartridge (25), e.g. a dual-chamber drug cartridge containing at least a first and a second substance to be reconstituted into an injectable product, is axially inserted into the cartridge holder assembly (11) through the bore (13A) of the first elongated body (13). As shown in FIG. 1, the dual-chamber drug cartridge (25), e.g. made of glass, has a proximal end (26) and a distal end (27), defining a bore in a known manner with a first proximal stopper (28) located at or substantially adjacent the proximal end (26) and a second stopper (29) located distal to the first stopper (28) along the bore, thereby forming a first chamber (30). The first chamber (30) contains a first substance or component of the drug to be reconstituted, e.g. a solvent. The second stopper (29) is distal to the second stopper (29) and further defines a second chamber (31) within a volume between the second stopper (29) and the distal end (27) of the cartridge (25). The second chamber (31) contains a second substance or component to be reconstituted when the component is reconstituted, for example a solute powder soluble in a solvent. The first chamber (30) and the second chamber (31) are interconnected by a bypass (32) formed as a narrow conduit or passage between the two chambers, and in the initial position of the stoppers, before reconstitution is actuated, the bypass (32) is closed by the second stopper (29), thereby preventing the first and second substances from contacting each other.

[0047] The third elongate body (14) is coaxially and concentrically seated within the bore (13A) of the first elongate body (13). The third elongate body (14) has a proximal end (33) and a distal end (34). When the drug cartridge is inserted into the holder assembly (11), the distal end (27) of the drug cartridge (25) rests and is engaged by a neck (35) on the distal end (34) of the third elongate body (14). The proximal end (33) of the third elongate body (14) is provided with threads (36) on the exterior surface (37) of the elongate body (14). The threads (36) extend in the opposite direction to the threads (18) on the inner surface of the first elongated body (13), and when the two threads (18, 36) engage with each other, for example by rotation of the first elongated body caused by the driving of a motor and a threaded piston, the third elongated body is drawn into the bore (13A) of the first elongated body (13) and moves proximally relative thereto. At the same time, the third elongated body (14) translates along the bore (15A) of the second elongated body. The third elongated body (15) is provided with an inwardly facing annular shoulder or protrusion (38) located at its distal end (20) which at least partially overlaps the third elongated body (14) in the initial extended configuration of the cartridge holder assembly (11). Undesired distal movement of the third elongate body (14) is prevented by engagement of a protruding annular shoulder (38) on the second elongate body (15) with an outwardly protruding abutment (39) on the outer surface of the third elongate body.

[0048] The auto-injector and reconstitution device (1) further includes a coupling member (40) configured and dimensioned to rotatably couple the cartridge holder assembly (11) to the drivable drive piston (7). The coupling member includes an elongated body (41) having a bore (42), a proximal end (43), and a distal end (44). The elongated body (41) has a narrower diameter portion (41A) extending from the proximal end at least partially along the length of the body (41), for example approximately halfway along the length of the body (41). The narrower diameter portion (41A) provides a space for accommodating a biasing member (45), such as a coil spring, disposed coaxially around an outer surface of said narrower diameter portion (41A) and seated against a distal end of the narrower diameter portion forming a radially projecting shoulder (47) (see FIG. 4). The narrower diameter portion (41A) also includes at least one longitudinal slot (46), and preferably two such slots, diametrically opposed, extending parallel along the longitudinal axis (4) from the proximal end (43) of the narrower diameter portion (41A) to the distal end and shoulder (47). The distal end (44) of the coupling member (40) is provided with a plurality of tangs or splines extending parallel along the longitudinal axis (4) and radially distributed about said axis. The splines or tangs (48) are configured and dimensioned to engage and interlock with correspondingly sized and configured grooves (49) located at the proximal end (16) of the first elongated body (13) of the cartridge holder assembly (11) and with an inner surface (50) of said body (13) facing inwardly into its bore (13A). Upon attachment of the cartridge holder assembly to the drive system, such as by threading the second elongated body (15) into the distal zone (23) of the drive system, the interlocking of the splines or tongues (48) of the coupling member (40) with the grooves (49) of the first elongated body (14) rotatably locks the coupling member (40) and the first elongated body (13), meaning that any rotation imparted to the coupling member will be transmitted to the first elongated body of the cartridge holder assembly, as long as said body (13) is physically capable of rotating in the direction of rotation applied by the motor via the piston rod (7).

[0049] Returning now to the cartridge holder assembly, the first elongated body (13) is mounted and held within the bore (15A) of the second elongated body (15). The first elongated body (13) is provided with interlocking engagement means that interlock with the third elongated body (15) to prevent relative distal or proximal movement between the two bodies (13, 15). Such interlocking means is also configured to allow the first elongated body (13) to rotate about its longitudinal axis. An example of a suitable interlocking engagement means may be an annular protruding shoulder (51) extending from or adjacent the proximal end (16) of the first elongated body of the cartridge holder assembly, which engages with a correspondingly sized and configured annular groove (52) provided on or adjacent the proximal end (19) of the third elongated body of the cartridge holder assembly. In this manner, the first elongate body (14) of the cartridge holder assembly (11) is free to rotate within the bore (15A) but is prevented from moving distally and proximally along the longitudinal axis (4).

[0050] The threaded piston (7) has threads (53) on an exterior surface of the piston (7). The piston (7) further includes a nut (54) having internal threads (55) extending opposite the threads of the piston (7). A proximal end (56) of the nut (54) abuts a distal end (57) of a motor (6) within the device (1) prior to use. When the threaded piston (7) is rotated, the engagement of the internal threads (55) of the nut (54) with the external threads (53) of the piston (7) causes the nut (54) to move distally, away from the distal end (57) of the motor (6). To prevent the threaded nut from simply extending the threaded piston to the end of the threads when the motor is actuated, for example by pressing the button switch (10) after setting the dose via the controller (8), the threaded nut is also provided with a number of radially outwardly projecting wings (58) located at the proximal end (56) of the nut (54). The wings (58) are configured and dimensioned to engage with parallel radially distributed or opposing slots (46) provided in the coupling device. The nut (54) is rotationally constrained by the interaction of the wings (58) with the slots (46), which in turn exerts a rotational force about the longitudinal axis on the coupling member (40). The coupling member (40) then also rotates as it is attached to the first elongated body (13) of the cartridge holder assembly (11). Further rotation of the threaded piston via the drive motor moves the nut (54) distally with the wings (58) in the slots (46) relative to the biasing member (45). Rotation of the coupling member (40) transmitted to the first elongated body (13) of the cartridge holder assembly causes the internal threads of the body (13) to contact the external threads of the third elongated body (14), thereby drawing said third body (14) into the bore (13A) of the first elongated body (13). This proximal movement of the third body (14) progresses until the proximal end (33) of the third body (14) comes into abutting contact with an inwardly projecting annular shoulder (59) provided within the bore (13A) of the first body (13) and extending from an inner surface of said body (13) into the bore.When the third elongate body (14) of the cartridge holder assembly reaches the maximum allowable proximal travel, it can no longer rotate. Similarly, the body (13) can no longer rotate, nor can the coupling member (40) rotate. The cartridge holder assembly is now in a fully collapsed configuration (see Figures 3 and 5).

[0051] The threaded piston then continues to drive the nut (54) in a distal direction until the distal end (60) of the nut (54) contacts the first stopper (28). The distal end (60) of the nut (54) may advantageously be provided with a cap or insert (61) made of a rubber, elastomer, or similarly suitable plastic material, forming a bearing surface for the distal end (60) of the nut (54) against the first stopper (28).

[0052] Continued operation of the drive motor advances the nut (54) and end (60) distally, pushing the first stopper (28) and contents of the first chamber (30) distally. The pressure increase caused by compression of the contents in the first chamber (30) as the first stopper is moved distally by the nut (54) causes the second stopper (29) to also move distally until it moves beyond the proximal inlet (62) of the bypass (32). With the proximal inlet (62) of the bypass (32) exposed to the substance in the first chamber, and under the continued distal movement of the first stopper caused by the continued distal movement of the nut (54), the substance in the first chamber, e.g., solvent liquid, is pushed through the first bypass inlet through the bypass (32) and into the second chamber, allowing reconstitution of the two substances to proceed. The first stopper (28) is continually pushed distally into the drug cartridge via the motor (6) and nut (54) until all of the first substance has been forced through the bypass (32) into the second chamber (31) and reconstitution has occurred. An injection needle can now be attached to the distal end (34) of the third elongated body (14) of the cartridge holder assembly and the injection can proceed according to the normal commands and controls of such an automatic injection device.

[0053] Once the injection is completed and the cartridge is accordingly emptied of the injectable product contained therein, the direction of rotation of the motor can be reversed, for example, via the controller and the actuation button. Reversal of the motor direction causes the nut to move again in a proximal direction towards the distal end (57) of the motor. In addition, the biasing member (45) pushes the wings (58) of the nut (54) to facilitate moving the nut (54) back in a proximal direction. As the proximal movement proceeds, the nut (54) reaches a position where the coupling member (40) and the first elongated body (13) of the cartridge holder assembly (11) are again free to rotate, under the influence of the wings, in a direction opposite to that required for reconfiguration, thereby causing the third elongated body (14) to move again in a distal direction to move the cartridge holder assembly (11) from the collapsed state to the extended state. Distal movement of the third elongate body (14) is eventually halted by abutting contact of the protruding annular shoulder (38) of the second elongate body (15) with an outwardly protruding abutment (39) on the exterior surface of the third elongate body (14). At this point, the nut (54) has returned to its initial starting position and the cartridge holder assembly (11) has reached its initial extended configuration. The cartridge holder assembly (11) can then be removed and the used cartridge replaced with a new one to resume the reconstitution and injection sequence.

Claims

1. A handheld motor-driven drug reconstitution and automatic injection device (1), comprising: a proximal drive system (2) and a distal drug cartridge holder assembly (11); The proximal drive system (2) comprises: The invention comprises an elongated body (3) having a substantially central longitudinal axis (4) along the elongated body (3) and a bore (5) extending within the body (3) along the longitudinal axis (4), the elongated body (3) housing a controllable drive motor (6) and an axially drivable piston rod (7) coupled to the motor (6) disposed within the bore (5); The distal drug cartridge holder assembly (11) comprises: a multi-chamber drug cartridge (25) configured to be received in said assembly (11) including at least a first substance stored in a first chamber (30) and at least a second substance stored in a second chamber (31), said first and second chambers (30, 31) being arranged in a nose-to-tail arrangement in substantial axial alignment with said central longitudinal axis (4), said first chamber (30) being provided proximally with a first stopper (28) and said first chamber (30) being provided between said first chamber (30) and said second chamber (31) being provided with a bypass (32) formed as a passageway; the distal drug cartridge holder assembly (11) having a proximal end (16, 19) releasably attached to a distal zone (23) of the proximal drive system (2) and a distal end (34) configured to receive an injection needle; the proximal drive system (2) and the distal drug cartridge holder assembly (11) are configured to impart movement to the drug cartridge holder assembly (11) such that the drug cartridge holder assembly (11) transitions from a first substantially extended, distal configuration along the central longitudinal axis to a second substantially folded, proximal configuration along the central longitudinal axis; In the distal configuration, the bypass (32) is closed by the second stopper (29) to prevent the first substance in the first chamber (30) and the second substance in the second chamber (31) from contacting each other; when the drug cartridge holder assembly (11) is transitioned by the drive system (2) along the central longitudinal axis (4) from the first substantially extended distal configuration to the second substantially folded proximal configuration, the first stopper (28) moves distally until it contacts the second stopper (29), thereby opening the bypass (32) and bringing the first substance and the second substance into contact to reconstitute an injectable product, the injectable product being located in only one of the at least first or second chambers (30, 31) after the reconstitution; The drug cartridge holder assembly (11) a first elongated body (13) including a bore (13A) axially aligned with said longitudinal axis; a second elongated body (15) including a bore (15A) axially aligned with said longitudinal axis; a third elongated body (14) including a bore (14A) axially aligned with said longitudinal axis; Including, the first elongate body (13), the second elongate body (15), and the third elongate body (14) are interconnected and concentrically axially aligned about the central longitudinal axis (4); the second elongated body (15) is concentrically disposed around the first elongated body (13) and the third elongated body (14); the first elongated body (13) and the third elongated body (14) are connected to each other via contact surfaces including an inner surface of the first elongated body and an outer surface of the third elongated body (14), respectively, and the second elongated body (15) is concentrically disposed around the first elongated body (13) and the third elongated body (14); the first elongated body (13) of the drug cartridge holder assembly and the third elongated body (14) of the drug cartridge holder assembly are connected to each other via contact surfaces including an inner surface (18) of the first elongated body (13) and an outer surface (36) of the third elongated body (14), respectively; When driven by the drive system (2), movement of the third elongate body (14) relative to the first elongate body (13) of the drug cartridge holder assembly (11) is configured to be permitted to rotate about the longitudinal axis (4) and in a proximal direction along the contact surfaces (18, 36). A handheld motor-driven drug reconstitution and auto-injection device (1).

2. 2. The handheld motor-driven drug reconstitution and automatic injection device (1) of claim 1, further configured to be operated by the proximal drive system (2) with an inverse relative motion compared to the reconstitution motion to transition the components of the cartridge holder assembly (11) from a proximal folded configuration to a distal extended configuration.

3. The handheld, motor-driven drug reconstitution and automatic injection device (1) according to claim 1, wherein the transition of the drug cartridge holder assembly (11) from the extended configuration to the folded configuration comprises an extension and retraction movement.

4. 2. The handheld, motor-driven drug reconstitution and automatic injection device (1) according to claim 1, wherein the transition of the drug cartridge holder assembly (11) from the extended configuration to the folded configuration comprises both rotational and translational telescopic movements.

5. 2. The handheld, motor-driven drug reconstitution and automatic injection device (1) of claim 1, wherein the drug cartridge holder assembly (11) comprises a plurality of interconnected elongated hollow bodies (13, 14, 15) concentrically and axially aligned about the longitudinal central axis (4).

6. the second elongate body (15) of the drug cartridge holder assembly (11) is concentrically disposed around the first elongate body (13) and extends distally from a proximal end (19) to a distal end (20); the distal end (20) of the second elongate body (15) of the drug cartridge holder assembly (11) is concentrically disposed around and extends over at least a proximal end (33) of the third elongate body (14) of the drug cartridge holder assembly (11); when driven by the drive system (2), the configured permitted movement of the third elongate body (14) relative to the second elongate body (15) of the drug cartridge holder assembly is a translational movement along the longitudinal axis (4) in a proximal direction inside the bore (15A) of the second elongate body (15); A handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 1.

7. said first elongate body (13) of said drug cartridge holder assembly (11) and said second elongate body (15) of said drug cartridge holder assembly (11) are connected to each other via a contact surface including cooperating interlocking means (51, 52) provided on said second elongate body (15) and said first elongate body (13), respectively; each cooperating interlocking means (51, 52) configured to permit relative rotational movement of the first elongate body (13) within the bore (15A) of the second elongate body (15); when driven by the drive system (2), the respective interlocking means (51, 52) cooperate to rotate the first elongated body (13) about the longitudinal axis (4) within the bore (15A) of the second elongated body (15); A handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 1.

8. 2. The handheld motor-driven drug reconstitution and automatic injection device (1) of claim 1, further comprising a coupling member (40) configured to couple a proximal end (16) of the drug cartridge holder assembly (11) to the axially drivable piston rod (7) of the drive system (2).

9. the coupling member (40) includes an elongate body (41) having a bore (42) axially aligned with the longitudinal axis (4) and received within the elongate body (3', 3'') of the drive system (2); said coupling member (40) and said drivable piston rod (7) are connected to each other via corresponding piston drive engagement means (46, 53, 54, 55, 58) provided in or on said elongated body (41) of said coupling member (40) and said drivable piston rod (7), respectively; when driven by the drive system (2), the respective piston drive engagement means (46, 53, 54, 55, 58) cooperate to allow the coupling member (40) to rotate freely within the elongate body (3', 3'') of the drive system (2); A handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 8.

10. 10. The handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 9, wherein the piston drive engagement means (53, 54, 55, 58) arranged on the drivable piston rod (7) is configured to be automatically biased in a proximal direction after injection or removal of the cartridge holder assembly after reconstitution by a biasing member (45) arranged in or on the coupling member (40).

11. the coupling member (40) further comprises a distal engagement means (48) configured to engage with a proximal end (16) of the first elongate body (13) of the cartridge body holder assembly (11); The handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 9 or claim 10, wherein the distal engagement means (48) of the coupling member (40) is configured to transmit a rotation of the elongated body (40) of the coupling member about the longitudinal axis (4) to the first elongated body (13) of the cartridge holder assembly (11) when driven by the drive system (2).

12. an axially drivable piston rod (7) including an externally threaded (53) piston rod (7) connected to said drive motor (6) and an internally threaded (55) nut (54), whereby actuation of the drive motor (6) drives said threaded rod (7) into engagement with said internally threaded nut (54), thereby moving said nut (54) from a proximal position to a distal position along said longitudinal axis (4); A handheld motor-driven drug reconstitution and automatic injection device (1) according to claim 9.

13. 2. The handheld motor-driven drug reconstitution and automatic injection device (1) of claim 1, wherein the drug cartridge holder assembly (1) is releasably attached to a distal zone (23) of the drive system (2) via respective cooperating surfaces (22, 24) provided on the main body of the drive system (2) and the second elongated body (15) of the cartridge holder assembly (11).

14. 1. A process for the reconstitution of an injectable product contained in a multi-chamber drug cartridge (25) of an automatic injection device (1), comprising at least a first substance stored in a first chamber (30) and at least a second substance stored in a respective second chamber (31), the first and second chambers (30, 31) being disposed in a nose-to-tail arrangement in substantial axial alignment with a central longitudinal axis (4) of the automatic injection device (1), comprising: Providing a handheld motor-driven drug reconstitution and automatic injection device (1) according to any one of claims 1 to 13; activating a function of the automatic injection device (1) including at least a reconstitution step prior to an injection; Including, A process wherein the reconstitution step includes driving a drive motor (6) of the device to cause relative movement of a drug cartridge holder assembly (11) from a first substantially extended distal configuration to a second substantially folded proximal configuration along the central longitudinal axis (4) of the device (1), thereby effecting reconstitution of the injectable product in only one of the at least first or second chambers (30, 31).

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