Automatic injector device with reconstitution function for multi-chamber cartridges

Abstract

A handheld motor-driven drug reconstitution and automatic injector device (1) has a proximal drive system (2), the proximal drive system (2) comprising an elongated body (3) accommodating a controllable drive motor (6) and an axially drivable piston rod (7), and a distal cartridge holder assembly (11) accommodating a multi-chamber (30, 31) cartridge (25), the cartridge holder assembly (11) being releasably attached to the drive system (2), the drive system (2) and the cartridge holder assembly (11) being configured to impart movement to the cartridge holder assembly (11), wherein the cartridge holder assembly (11) moves from a first substantially extended distal configuration along a central longitudinal axis to a second substantially contracted proximal configuration along the central longitudinal axis, the relative movement of the cartridge holder assembly (11) causing the substance contained in each chamber (30, (31) to be reconstituted to form an injectable product.

Description

Technical Field

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

[0002] A motor-driven automatic injector known in the art is described in the PCT application published in WO03099357. The document discloses a drug injection device having a motor-driven drive member that is inserted into a fluid container when the drive member is advanced to force the fluid out of the container. The drive member includes an internal hollow portion that cooperates with at least a portion of the electric drive assembly when the drive member is retracted to allow a compact device to be provided.

[0003] From WO2014008393A1, a kind of automatic syringe is known, and this automatic syringe is suitable for receiving a barrel including a tube, a needle, and a plunger assembly, and this automatic syringe comprises a housing, a barrel bracket for receiving a part of the barrel, a plunger bracket, at least one transmission device for coupling the barrel bracket to the plunger bracket, an elongated drive device that enables the plunger bracket to move, an opening for receiving at least one transmission device included in the plunger bracket and / or the barrel bracket, a motor, and a transmission assembly for coupling the motor to the elongated drive device. In the automatic syringe device described in this document, the tube, the needle, the plunger assembly, and the cartridge can be inserted into the housing and can be removed from the housing, and the housing completely encapsulates and closes the tube, the needle, and the plunger assembly. The housing is shown as consisting of two parts, an upper part and a lower part, wherein a hinge along one side of the housing enables the upper part and the lower part to be movably attached relative to each other, and thus allows the opening and closing of the housing. The housing is designed to have a sufficiently hollow part to allow the introduction and removal of the cartridge, the needle, and the plunger assembly when used up. A motor powered by a removable battery drives a threaded screw which supports a movable carriage which engages and indexes with the threads of the threaded screw and moves forward or backward in response to activation of the motor for movement in a forward or reverse direction.

[0004] When the motor is activated to drive the threaded screw forward, the indexed movable carriage engages the plunger assembly to drive the plunger assembly forward and expel the medicament contained in the cartridge from the cartridge into the needle and there into the user of the autoinjector.

[0005] Another motor-driven automatic injector is known from PCT application publication number WO2015044102A1. The document describes an injection pen for injecting an active ingredient into a patient, the device comprising a 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 a device for controlling the amount of active ingredient to be injected. The motor, the pushing mechanism, and the cartridge are all aligned along a common longitudinal axis.

[0006] As can be seen from the examples of prior art given above, hand-held motor-driven auto-injector devices, such as motor-driven pen injectors, are known per se and can generally be considered to include one or more of the following:

[0007] a drive system comprising a hollow elongated body having a substantially central longitudinal axis along said elongated body and defining a bore within said hollow elongated body extending along said longitudinal axis, wherein the elongated hollow body of the drive system further houses a drive motor controllable by a user, and an axially drivable piston rod coupled to the motor and positioned within the bore; and

[0008] A cartridge holder assembly, which is attached to or forms an integral part of the drive system, the cartridge holder housing a cartridge having an injectable substance, such as a drug.

[0009] The above-mentioned document generally relates to a single chamber cartridge or a single syringe structure, comprising a pre-prepared drug preparation to be injected. Unfortunately, not all medicines or drug combinations can be prepared and / or formulated to be suitable for pre-prepared preparations. Once some medicines are diluted, dissolved or otherwise formulated into injectable product preparations, they are relatively unstable or have a relatively short shelf life. In addition, some therapeutic treatments require separate or co-administration of similar drugs, and when stored together under the conditions of normal storage and distribution for injectable drugs, these drugs are incompatible. For this reason, multiple simultaneous or successive drug injection systems have been developed.

[0010] Alternatively, motor-driven drug injection systems such as autoinjector pens have been developed that allow the use of a multi-chamber cartridge in which the injectable drug product is made or reconstituted prior to administration. Such a system is known from PCT application publication number WO2019002534A1. The document discloses an automatic injector for administering a drug, the automatic injector comprising a housing; a barrel holder configured to receive a barrel, the barrel comprising a first stopper and a barrel separation chamber containing a medicament, the barrel separation chamber having a first barrel separation chamber containing a first medicament component of the medicament and a second barrel separation chamber containing a second medicament component of the medicament; a drive module connected to move a plunger rod between a retracted plunger rod position and an extended plunger rod position, the plunger rod being configured to move the first stopper; a processing unit connected to the drive module, wherein the processing unit is configured to control the drive module to move the plunger rod from the first plunger rod position to a mixing plunger rod position at a mixing plunger rod speed, wherein the mixing plunger rod position is 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 multiple complete inversions of the automatic injector have been performed.

[0011] One of the problems with multi-chamber cartridges is that they can be problematic to correctly and safely mount to a drive system, as they are typically held on the drive system only by a tip (usually a proximal tip), or they need to be fully enclosed in the drive system body in order to maintain adequate axial stability during driving of the piston rod. The body of such a motor-driven system is already quite long, so attaching the multi-chamber cartridge to the proximal tip of the drive system body tends to significantly increase the overall length of the auto-injector. This additional length is often a source of increased difficulty for ordinary users of such systems, as they find it difficult to easily manipulate and operate the device with one hand, which can lead to reduced patient compliance with the associated treatment regimen.

[0012] It is therefore an object of the present invention to provide a motor-driven autoinjector device of reduced length, which also includes an automatic reconstitution function in at least a dual chamber cartridge prior to injection, and wherein the autoinjector device is a longitudinally axially configured autoinjector, such as a pen-type drug injector. Summary of the invention

[0013] For the purposes of the present invention, a longitudinally axially configured autoinjector refers to a motor-rotating autoinjector device in which all relevant functional components are substantially aligned along a common single longitudinal axis of the device and in which the piston acts along said common longitudinal or longitudinal axis. In this regard, the autoinjectors contemplated by the present invention do not relate to cartridge autoinjectors, or autoinjectors that include a motor-driven piston that is indirectly driven, for example by a set of orthogonally positioned or angularly displaced gears, drive mechanisms or motors as compared to driving the piston to move along the longitudinal axis.

[0014] Other objects will become apparent from the following description of various embodiments of the invention.

[0015] Therefore, one object of the present invention is a handheld motor-driven drug reconstitution and auto-injector device comprising:

[0016] Proximal drive system, comprising:

[0017] an elongated body having a substantially central longitudinal axis along the elongated body and a bore extending along the longitudinal axis and within the body, the elongated body housing a controllable drive motor and an axially drivable piston rod coupled to the motor within the bore; and

[0018] A distal cartridge holder assembly configured to

[0019] housing within the assembly a multi-chamber 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 positioned in an end-to-end arrangement substantially axially aligned with the central longitudinal axis;

[0020] wherein the distal cartridge holder assembly has a proximal end and a distal end, the proximal end being releasably attached to a distal region of the proximal drive system, the distal end being configured to receive an injection needle;

[0021] The proximal drive system and the distal cartridge holder assembly are configured to impart movement to the cartridge holder assembly, wherein the cartridge holder assembly moves from a first substantially extended distal configuration along a central longitudinal axis to a second substantially retracted proximal configuration along the central longitudinal axis; and

[0022] Wherein, when the drive system moves along the longitudinal center axis, the relative movement of the cartridge holder assembly from the first basically extended distal structure to the second basically contracted proximal structure causes the injectable product to be reconstructed, and the injectable product includes at least a first substance and a second substance, and the at least first substance and the second substance are located in only one of at least the first chamber or the second chamber after reconstruction.

[0023] In this specification, the terms "proximal" and "distal" are spatial references used to define the relative spatial positions of various components of the device relative to normal use of the auto-injector device when held by a user. In this regard, "proximal" means the position of an object, or the direction of movement or travel of a component of the auto-injector device, that is, toward or near the hand of a user holding the device in the manner in which the device is normally manipulated and operated. In this case, "proximal" means the end of the device that is grasped by the user is opposite to the other end of the device from which the drug is ejected or injected into the user. Therefore, the term "distal" refers to the position of an object, or the direction of movement or travel of a component of the auto-injector device, that is, toward or near the ejection or injection end of the device.

[0024] The proximal drive system is located at the end of the auto-injector device which will typically be held or gripped in the user's hand. This is similar to motor-driven auto-injectors as known in the art as indicated in the general introduction.

[0025] The proximal drive system comprises an elongated body having a substantially central longitudinal axis extending along the elongated body, and a hole extending along the longitudinal axis and in the body. The elongated body and the hole can be formed as a whole of the same material, or formed by several assembled parts, for example, two complementary halves of at least partially hollow body material, matched and held together by suitable connecting devices such as clips, or by welding or adhesives, for example, ultrasonic welding of complementary halves to each other. The complementary, at least partially hollow body halves jointly define the longitudinal hole. The elongated body also accommodates a controllable drive motor, which is usually located and accommodated in the hole of the elongated body and is substantially located at or near the proximal end of the elongated body of the drive system. The drive motor can be controlled by a properly equipped control device, for example, a programmable microcontroller located on a printed circuit board, which is also advantageously located on the elongated body of the drive system, or accommodated in the hole of the elongated body. A user interface can be provided to allow a user to enter a command, such as an LCD display, which will control the automatic injector device and thus control the drive motor. The user interface may provide, for example, access to a dose setting system including dose increase and decrease buttons, a dose cancel and / or reset button. At the proximal end of the autoinjector device, the aperture may be suitably closed by an actuation button which may be directly or indirectly connected to the controllable drive motor, for example, via an electrical or electronic switch component and to the controllable drive motor via the control device.

[0026] Axially drivable piston rod is connected to the motor and is also located in the hole of the elongated body of the drive system. Axially drivable piston rod is directly or connected to the motor via a shaft and / or a suitable gear set to control the speed and torque applied to the drivable piston rod when the motor is started. The drivable piston rod is configured to provide the axial movement of the piston from the proximal position towards the distal position under the control of the drive motor. This piston rod itself is normally used for known automatic syringes, and usually at least comprises a threaded rod, which has a thread arranged on the outer surface of the passage. Advantageously, the drivable piston rod also comprises a piston nut, which is located around the piston rod and has an inner threaded surface, which engages with the outer threaded surface of the piston rod in a complementary manner. When the motor is started to operate in the forward drive configuration, the piston rod is rotated by the drive motor, and the thread of the piston rod engages with the thread of the piston nut so that the nut moves toward the distal direction along the piston rod. Similarly, if the motor is activated to operate in a reverse or backward drive configuration, the drive motor rotates the piston channel in the opposite direction to the forward drive and thereby moves the piston nut in a proximal direction. The nut is provided with a proximal surface configured to contact a proximal stop of the cartridge and thereby push the stop along the interior of the cartridge. This general configuration of the threaded piston rod of the cartridge, the threaded nut and the stop engaging is known per se in the art.

[0027] The automatic injector device of the present invention also includes a distal cartridge holder assembly configured to accommodate a multi-chamber cartridge therein, the multi-chamber cartridge including at least a first substance stored in a first chamber and at least a second substance stored in a corresponding second chamber, the first chamber and the second chamber being positioned in an end-to-end arrangement substantially axially aligned with the central longitudinal axis.

[0028] The cartridge itself is also generally known in the art. As described above, for the purpose of this specification, the cartridge includes at least a first substance stored in a first chamber and at least a second substance stored in a corresponding second chamber, the first chamber and the second chamber being positioned in an end-to-end arrangement substantially axially aligned with the central longitudinal axis. Therefore, the 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 and a second stopper, the first stopper being generally located at the proximal end of the cartridge, and the second stopper being generally located at a position between the proximal end of the cartridge and the distal end of the cartridge. The second chamber is generally defined by the volume between the second stopper and the distal end of the cartridge or an optional third stopper. The first chamber includes a first substance, such as a first component, of an injectable product that needs to be reconstructed before injection. The second chamber includes a second substance, such as a component that is generally different from the first component, which is necessary for preparing or re-preparing a suitable injectable product before 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 substance or the second substance can be, for example, a solute, such as a powder composition. The other of the first substance or the second substance can then be a suitable solvent for the solute, such as a fluid, such as a liquid. For example, the second substance can be a powder composition, and the first substance can be a fluid composition, such as commonly known, such as water, ethanol, saline solution, buffer solution or preservative solution. The relevant functions and definitions of the first substance and the second substance are limited to satisfying the requirements of constituting an injectable product when reconstructed together, and the injectable product can serve as a drug with a suitable pharmaceutical effect. The drug can be, for example, any number of pharmaceutically active chemical or biological entities, such as vaccines, RNA, DNA, proteins, polypeptides, hormones, any form of pharmaceutically active chemical or biological molecules, or their metabolites, etc.

[0029] It is envisioned that the multi-chamber cartridge including a dual chamber for use in the present invention is usually provided with a bypass that provides fluid communication between a first chamber and at least a second chamber. The barrel may alternatively have a plurality of bypass portions that provide fluid communication between adjacent chambers. One or more bypasses are usually closed by the position of the stoppers that separate and define the chambers during the initial manufacturing configuration. When these stoppers are moved by the distal translational movement of the drive piston and / or nut that contacts the first stopper, each stopper will eventually translate in the distal direction by applying pressure in the upstream chamber on the downstream stopper, or by directly contacting the previously upstream or proximal stopper or the distally positioned stopper on the downstream stopper, so that the stopper moves across the bypass to allow fluid communication between a chamber and the next adjacent chamber of the chamber or another suitably connected chamber. Then, the fluid material in one of the chambers enters the chamber connected to the bypass via the bypass and mixes with the material in the other chamber to reconstruct the injectable product.

[0030] The device according to the present invention is further defined as a distal cartridge holder assembly having a proximal end releasably attached to a distal region of a proximal drive system, and a distal end configured to receive an injection needle. Here, the device for mounting the needle on the distal end of the cartridge holder is generally known in the art, for example, by a Luer lock system, a root tip distal to the outer surface thread of the cartridge holder assembly, etc., which is engaged with a corresponding internal thread disposed on the cone of the needle holder. In addition, it is conceivable that various devices that releasably attach the proximal end to the distal region of the drive system, such as a clip, a protrusion and a corresponding groove (e.g., a bayonet mount), a thread disposed on the outer surface of the proximal end of the cartridge holder assembly, and a complementary thread disposed on an inner surface at or near the distal end of the elongated body of the drive system, etc. For the purpose of this specification, a threaded releasable attachment system is particularly preferred because these systems tend to provide a secure, correctly axially aligned, and easily releasable attachment by unscrewing the cartridge holder assembly around the central longitudinal axis of the automatic syringe device drive system.

[0031] In addition, the device according to the present invention is further defined as that the proximal drive system and the distal cartridge holder assembly are configured to impart a motion to the cartridge holder assembly, wherein the cartridge holder assembly moves from a first substantially extended distal configuration along the central longitudinal axis to a second substantially retracted proximal configuration along the central longitudinal axis. In other words, the cartridge holder assembly moves relative to the drive system body to achieve a retraction or retraction of the cartridge holder assembly from an initial extended configuration in the distal position to a final substantially retracted position in the proximal position.

[0032] When the cartridge holder assembly is moved by the drive system along the longitudinal center axis from a first substantially extended distal configuration to a second substantially retracted proximal configuration, the relative movement of the cartridge holder assembly is responsible for achieving reconstitution of the injectable product comprising at least a first substance and a second substance. By moving the cartridge holder assembly in the proximal direction, the piston rod contacts a first proximal stop of the multi-chamber cartridge, and the cartridge holder assembly is driven by the drive system to further retract, the proximal movement continues to push the proximal stop in the distal direction, the proximal stop acts on the second intermediate stop due to the relative pressure in the chamber, and pushes the second intermediate stop in the distal direction so as to expose the bypass and enable the first substance (e.g., a fluid such as a solvent) to be pressed from the first chamber through the bypass into the second chamber and dissolve the second substance (e.g., a drug in the form of a powdered solute). When the cartridge holder assembly has reached the collapsed configuration and the injectable product is reconstituted, the injectable product is located in only one of the chambers, and in the case of a dual chamber barrel, the injectable product is preferably located in the second chamber, thereby positioning the injectable product for injection as is typically found in a single chamber barrel including a pre-prepared or pre-formulated injectable product.

[0033] As described above, the cartridge holder assembly is engaged in a relative motion from an extended distal configuration to a retracted proximal configuration. Various relative motions of the cartridge holder assembly are contemplated for the present autoinjector and reconstitution device. The cartridge holder assembly is also configured to be operated by a proximal drive system in a relative motion that is reversed compared to the reconstitution motion to move components of the cartridge holder assembly from a proximal retracted configuration to a distal extended configuration, in order to allow removal of the cartridge holder assembly and replacement of a cartridge of a multi-chamber cartridge that requires reconstitution of the substance contained therein.

[0034] Therefore, according to another object of the present invention, the relative movement of the cartridge holder assembly from the extended configuration to the contracted configuration includes telescopic movement. In other words, the barrel assembly is configured and designed to allow the components of the barrel assembly to undergo relative telescopic movement under the influence and control of the drive system, thereby moving from the extended configuration to the contracted configuration. The telescopic movement of the cartridge holder assembly can 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 contracted configuration.

[0035] Therefore, according to another object of the present invention, the relative movement of the cartridge holder assembly from the extended configuration to the retracted configuration includes a rotational telescopic movement and a translational telescopic movement. It has been found that this combination of rotational and translational telescopic movement in the cartridge holder assembly is particularly advantageous. In particular, this combination allows a significant reduction in the overall length of the autoinjector and the reconstitution device, thereby improving the user experience of the device and the patient's acceptance of the device.

[0036] In another object of the present invention, a cartridge holder assembly comprises a plurality of interconnected elongated hollow bodies that are axially aligned concentrically about a longitudinal center axis. The elongated concentrically arranged hollow bodies contemplated by the present specification are ideally adapted to move from an extended distal configuration to a retracted proximal configuration. The number of concentrically arranged hollow bodies for a cartridge holder assembly, within the limits of being able to encapsulate and retain a corresponding multi-chamber drug cartridge, may be virtually unlimited, 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 desired degree and accuracy of relative movement, and the maximum acceptable length useful to a user or patient using the device, and most preferably and advantageously consists of three interconnected elongated hollow bodies arranged concentrically axially aligned about a longitudinal center axis.

[0037] Therefore, according to another object of the present invention, the cartridge holder assembly comprises:

[0038] a first elongated body including a bore axially aligned with said longitudinal axis;

[0039] a second elongated body including a bore axially aligned with the longitudinal axis; and

[0040] a third elongated body including a bore axially aligned with said longitudinal axis,

[0041] The three elongated bodies are interconnected and organized in concentric axial alignment about a longitudinal center axis.

[0042] In the above arrangement, the first elongated body of the cartridge holder assembly and the third elongated body of the cartridge holder assembly are advantageously connected to each other via contact surfaces, respectively, which contact surface includes the inner surface of the first elongated body and the outer surface of the third elongated body. Such contact surfaces can be formed, for example, by corresponding and interacting threads arranged on each surface. By positioning such threads on the outer surface of the third elongated body, located at or adjacent to the proximal end of the third elongated body of the cartridge holder assembly, particularly useful and advantageous functions have been determined. Similarly, and in a corresponding manner, by positioning the threads of the inner surface to be substantially always along the inner surface of the first elongated body of the cartridge holder assembly facing the inner hole, particularly useful and advantageous functions have been found. The result of this arrangement is that, when driven by the drive system, the third elongated body is allowed to rotate relative to the first elongated body of the cartridge holder assembly around the longitudinal axis and along the contact surface in the proximal direction.

[0043] In the above structure, the second elongated body of the cartridge holder assembly is concentrically positioned and extends from the proximal end to the distal end on the first elongated body in the distal direction. In this arrangement, the second elongated body of the cartridge holder assembly completely covers and surrounds, or substantially covers and surrounds the entire length of the first elongated body of the cartridge holder assembly.

[0044] The first elongated body of the cartridge holder assembly and the second elongated body of the cartridge holder assembly are connected to each other via contact surfaces, respectively, and the contact surfaces include cooperative interlocking devices respectively arranged on the second elongated body and the first elongated body. The corresponding cooperative interlocking devices are configured to allow relative rotational movement of the first elongated body in the second elongated body hole. When driven by the drive system, the corresponding interlocking devices cooperate to rotate the first elongated body around the longitudinal axis in the hole of the second elongated body. In this arrangement, the first elongated body of the cartridge holder assembly is coaxially mounted inside the second elongated body of the cartridge holder assembly and physically attached to the second elongated body of the cartridge holder assembly so as to maintain appropriate coaxial separation with the second elongated body. The physical, rotation-allowing 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 a variety of ways, for example, via a protrusion or radial annular shoulder radially oriented at or near the proximal end of the first elongated body extending outward from the outer surface of the first elongated body. The second elongated body may include one or more corresponding grooves to accommodate and position the protrusion or shoulder of the first elongated body, or alternatively, include corresponding annular grooves or grooves provided at appropriate proximal positions of the second elongated body. In this way, when driven by the drive system, the first elongated body is not only free to rotate around the longitudinal axis within the second elongated body, but also rotates within the second elongated body under the impetus of the drive system. Alternatively, the above construction can be reversed, the second elongated body has an inwardly directed protrusion or an inwardly directed annular shoulder, and a corresponding groove or recess is provided on the first elongated body, resulting in the first elongated body being free to rotate around the longitudinal axis when driven by the drive system.

[0045] In addition, the distal end of the second elongated body of the cartridge holder assembly is concentrically positioned around at least the proximal end of the third elongated body of the cartridge holder assembly and extends thereon. The shape and size of the second elongated body are designed to interact with the third elongated body to prevent the third body from moving distally beyond a predetermined point. This configuration may include, for example, an annular protrusion located at the distal end of the second elongated body, which extends inwardly into the hole of the second elongated body, and at the farthest position allowed by the third elongated body, the annular protrusion abuts against an outward abutting protrusion extending from the outer surface of the third elongated body. The abutting protrusion of the third elongated body is located on the outer surface of the third elongated body at a substantially proximal position on the third elongated body. The interaction configuration of the annular inward protrusion of the second elongated body and the outward abutting protrusion of the third elongated body allows the third elongated body to move relative to the second elongated body of the cartridge holder assembly, and defines the movement as a translational movement in the proximal direction along the longitudinal axis inside the hole of the second elongated body when driven by the drive system.

[0046] According to another object of the present invention, the automatic syringe and the reconstitution device also include a coupling member, which is configured to couple the proximal end of the cartridge holder assembly to the axially drivable piston rod of the drive system. Therefore, the coupling member includes a slender coupling member body, which has a hole axially aligned with the longitudinal axis and accommodated in the slender body of the drive system. The coupling member is configured to rotate freely around the longitudinal axis in the hole of the slender body of the drive system until the reconstruction is completed. Specifically, the coupling member can rotate around the longitudinal axis under the impetus of the activated drivable piston rod until the third slender body of the cartridge holder assembly has reached its maximum travel distance in the proximal direction, at which time the coupling member is prevented from rotating further because it is locked against the cartridge holder assembly and cannot rotate around the longitudinal axis.

[0047] The coupling member and the drivable piston rod are connected to each other via corresponding piston drive engagement means provided on the elongated body of the coupling member and the drivable piston rod, respectively. Any suitable engagement means are suitable for such connection, but in general, and by way of example, such corresponding engagement means may comprise one or more longitudinal slots extending parallel or substantially parallel to the longitudinal axis provided in the coupling member body, and one or more outwardly projecting wings provided on the piston rod, whereby the wings engage in the slots, which slots allow the wings and thereby the piston rod to move in translation along the longitudinal axis. Optionally and advantageously, after injection, or after removal of the cartridge holder assembly after reconstitution, the projecting wings are automatically biased in the proximal direction by a biasing member located in or on the coupling member, such as a spring, against which the wings of the drivable piston abut when the wings of the drivable piston are moved in the distal direction by the motor, to enable reconstitution and injection. Once injection has occurred, the cartridge holder assembly is removed and disengagement of the cartridge holder assembly from the coupling member subsequently causes the biasing spring to push back against the wing, driving the piston rod in a proximal direction and returning it to its initial position.

[0048] The coupling member further comprises a distal engagement device configured to engage with the proximal end of the first elongated body of the cartridge holder assembly. When driven by the drive system, the distal engagement device of the coupling member is configured to cause the rotation of the elongated body of the coupling member about the longitudinal axis to be transmitted to the first elongated body of the cartridge holder assembly. Such distal engagement device may be any suitable engagement device, such as a simple friction engagement between the distal surface of the coupling member body and a proximally protruding annular shoulder extending, for example, from the inner surface of the hole of the first elongated body of the cartridge holder assembly. However, preferably and advantageously, the distal engagement device of the coupling member comprises at least one or more splines or tongues extending parallel to the longitudinal axis and positioned around the longitudinal axis at the distal end of the coupling member. When the cartridge holder assembly is mounted to the drive system, these splines or tongues are inserted into corresponding engagement devices, such as grooves, which are arranged at the proximal end of the first elongated body of the cartridge holder, for example on the inner surface. In the examples given, the size and configuration of the splines are designed 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 spline will cause the other spline to rotate by the same angle. It should be understood that the tongue and the groove can be configured in an opposite arrangement, for example, the tongues are respectively arranged on the first elongated body of the cartridge holder assembly, and the grooves are respectively arranged on the coupling member. In any of these arrangements, the rotation of the coupling member caused by the drive system driving the drivable piston will directly cause the first elongated body of the cartridge assembly holder to rotate synchronously with the coupling member. This rotation causes the third elongated body to rotate in the opposite direction and be pulled into the hole of the first elongated body until the proximal end of the third elongated body abuts against a proximal annular shoulder arranged in the hole of the first elongated body.

[0049] As described above, the axially drivable piston rod comprises an externally threaded piston rod connected to a drive motor. The drivable piston rod also comprises an internally threaded nut, whereby activation of the drive motor drives the screw to engage the internally threaded nut, the interaction of the external threads of the screw and the internal threads of the threaded nut causing the nut to move from a proximal position to a distal position along the longitudinal axis. The internally threaded nut is provided with a piston drive engagement device located on the outer surface of the nut, the piston drive engagement device being configured to engage with respective corresponding engagement devices located in or on the coupling member. To this end, for example, as described above, the nut is advantageously provided with an outwardly protruding wing that interacts with a groove provided in the coupling body. Thus, when the motor is activated and the piston rod is driven, the nut screw advances in a distal direction, the nut translates along the longitudinal axis due to the engagement of the wing in the groove, and at the same time the nut is stabilized along the longitudinal axis by the interaction between the groove and the wing.

[0050] During the reconstruction step, the motor is started to drive the drivable piston. The corresponding elongated body of the coupling member and the first elongated body of the cartridge holder assembly are locked and cannot rotate, for example, via the corresponding corresponding tongue / spline and groove as described above. The wing of the nut pushed forward by the threaded drive piston engages with the groove of the coupling body, so that the coupling member rotates and combines with the first elongated body of the cartridge holder assembly, which also causes rotation. The rotation of the first elongated body of the cartridge holder assembly causes the third elongated body of the cartridge holder assembly to rotate in the opposite direction via the threaded interaction contact surface provided between the first elongated body and the third elongated body of the cartridge holder assembly, thereby retracting the third elongated body into the holes of both the second elongated body and the first elongated body of the cartridge holder assembly. This withdrawal corresponding to the proximal movement of the third elongated body will continue until the proximal end of the third elongated body abuts against the inwardly protruding annular shoulder of the first elongated body of the cartridge holder assembly. At this point, the first elongated body of the cartridge holder assembly is prevented from further rotation because it is retained between the coupling member and the third elongated body of the cartridge holder assembly. The nut stops rotating and is instead pushed in the distal direction by interacting with the threaded piston under control of the drive motor until it contacts the first stop of the multi-chamber cartridge, at which point further driving of the threaded piston and nut pushes the stop in the distal direction to cause the first and second substances to mix and reconstitute, as described above with respect to the general function of the multi-chamber cartridge.

[0051] Once reconstruction is completed, injection can be subsequently performed, for example by connecting an appropriate needle to the distal end of the cartridge holder assembly and operating the automatic injector in the usual manner to achieve injection. After the injection, in order to allow the now empty cartridge to be replaced, the nut can be withdrawn, i.e., moved in the proximal direction by reversing the direction of the drive motor, thereby causing the threaded piston to interact with the threaded nut via the corresponding thread and causing the nut to move in the proximal direction again. This reverse movement will cause the first elongated body of the cartridge holder assembly to rotate in the direction opposite to its previous rotation direction for reconstruction, and thereby cause the third elongated body to be pushed back in the distal direction until the outward protrusion on its surface abuts against the inward protruding annular shoulder of the second elongated body of the cartridge holder assembly. As a result, before reconstruction begins, the cartridge holder assembly moves back from the contracted configuration to the extended configuration. Now, the cartridge holder assembly can be disengaged from the drive system, and a new barrel can be inserted into the assembly for a new reconstruction operation and / or injection.

[0052] Additionally, if desired, the drivable piston can be fully reset manually at this engagement, if desired, by depressing the distal end of the nut. Such manual intervention will overcome the threaded contact engagement between the threaded piston and the nut, and the biasing spring will push against the wings of the nut to force it rearwardly, in the proximal direction, to its initial position.

[0053] According to another embodiment, a method is provided for reconstituting an injectable product contained within a multi-chamber drug cartridge of an autoinjector device, the injectable product comprising at least a first substance stored within a first chamber and at least a second substance stored within a respective second chamber, the first chamber and the second chamber being positioned in an end-to-end arrangement substantially axially aligned with a central longitudinal axis of the autoinjector device, the method comprising:

[0054] providing a handheld motor-driven drug reconstitution and auto-injector device as described herein;

[0055] activating a function of the autoinjector device prior to injection, the function involving at least a reconstitution step;

[0056] The reconfiguration step includes driving a drive motor of the device to cause a cartridge holder assembly to move relative to a first basically extended distal configuration along a longitudinal center axis of the device to a second basically contracted proximal configuration, thereby achieving reconfiguration of the injectable product in only one of the at least first chamber or the second chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The various objects of the present invention as stated above and other such objects will become apparent from the following detailed description of examples of the apparatus according to the present invention taken in conjunction with the accompanying drawings, which are provided for the purpose of illustration and in which:

[0058] Figure 1 a schematic exploded perspective view showing a motor-driven automatic injector and a reconstitution device according to the present invention;

[0059] Figure 2 express Figure 1 a first schematic cross-sectional view of a device prior to reconstruction;

[0060] Figure 3 express Figure 1 a first schematic cross-sectional view of the device after reconstruction;

[0061] Figure 4 express Figure 1 An alternative schematic cross-sectional view of the device prior to reconstruction;

[0062] Figure 5 express Figure 1 Another schematic cross-sectional view of the device after reconstruction. DETAILED DESCRIPTION

[0063] Figures 1 to 5 Different schematic diagrams showing the device according to the invention. Figure 4 and Figure 5 and Figure 2 and Figure 3 The main difference is that the cross section shown shows the device rotated 90° about its longitudinal axis. Apart from this, all elements remain the same. Figure 2 and Figure 3 are the same as in the examples and are numbered accordingly.

[0064] Now go to Figure 1 , a hand-held motor-driven drug reconstitution and auto-injector device 1 according to the present invention is schematically shown in an exploded perspective view. The device 1 comprises a drive system 2, which comprises an elongated body 3', 3", which is composed of a proximal part 3' and a distal part 3", which fit and interlock together to form the elongated body 3', 3", and has a substantially central longitudinal axis 4 along the elongated body 3', 3". A hole 5 extends along the longitudinal axis 4 and is located in the body 3', 3", and the elongated body 3', 3" is advantageously closed, for example by two further complementary shells 3A, 3B, which can be fixed together, for example, by press-fitting or gluing, ultrasonic welding, clamping of the two halves 3A, 3B. Preferably, the elongated body 3', 3" is integrally formed, for example by injection molding. The elongated body 3', 3" houses a controllable drive motor 6 and an axially drivable piston rod 7, which is coupled to said motor 6 located in the bore 5. The controllable drive motor is controlled by a controller 8, which is effectively located on a printed circuit board 9 and appropriately housed in one of the complementary housings 3A, 3B. The controller 8 is a programmable controller, such as an EEPROM or other suitable programmable controller, such as a microcontroller of the type known in the art. The controller 8 may be integrated or connected to other electrical or electronic components, such as: a power source such as a battery, optionally rechargeable, or a lithium-ion type battery; one or more communication circuits, such as a near field communication circuit, a radio frequency identification circuit (RFID) and / or a Bluetooth communication circuit, such as for low energy consumption; LE( LE) circuitry; one or more memory storage components for storing data, including, for example, volatile and / or non-volatile memory storage; one or more sensors connected to the controller for capturing data from the autoinjector device or drive system; one or more display components (such as an LCD display) configured to display a value or signal (such as a visual signal) representing data or functional status of the device; one or more user input components configured to enable user input to the device, such as for setting a dose to be administered; and one or more switches for activating or deactivating other components within the device, such as a proximal button 10 located and arranged at the proximal side of the elongated body of the drive system, which is connected to the controller 8 and configured to activate the motor 6 to drive the piston rod 7. The communication circuitry is configured, for example, for transmitting information from the autoinjector and reconstitution device 1 to a remote data collection and processing device, such as a remote or distributed computing system, such as a smartphone via a correspondingly programmed application, or stored on or transmitted by any other kind of mobile telecommunication device, but is also usefully configured to receive information from such a remote data collection and processing device. Figure 1 As shown, the bore 5 of the elongated body 3 ′, 3 ″ accommodates the other components described herein, the motor 6 and the threaded piston rod 7 are axially aligned within the bore 5 . The bore 5 is closed by a proximal button 10 which is located at and covers the proximal end of the bore 5 .

[0065] The device 1 also includes a cartridge holder assembly 11. A distal cap 12 is provided to cover the cartridge holder assembly 11 when the cartridge holder assembly 11 is mounted to the drive system 2. The cartridge holder assembly includes three slender bodies 13, 14, 15, each of which includes a hole 13A, 14A, 15A extending along the longitudinal axis 4. The first slender body 13 has a proximal end 16 and a distal end 17, and the proximal end 16 of the first slender body 13 is connected to the distal region of the drive system 2 as will be described herein. The first slender body 13 has a threaded contact surface 18 on the inner surface of the hole 13A, and the threaded contact surface extends substantially all the way along the hole 13A from the distal end 17 to the proximal end 16. The second slender body 15 has a proximal end 19 and a distal end 20, and the second slender body 15 has a hole 15A, which has a larger diameter than the first slender body 13 or the third slender body. In Figure 1In the exploded view of FIG. 1 , the second elongated body 15 is shown distal to the first and third elongated bodies 13, 14, however, it should be understood that the first and third elongated bodies 13, 14 are both coaxially and concentrically arranged within the bore 15A of the second elongated body 15 of the cartridge holder assembly 11, and the second elongated body 15 extends substantially over the entire length of the first elongated body 13. The threads 22 are located near the proximal end 19 of the second elongated body 15 and on an outer surface 21 of the body 15. The dimensions of the threads 22 of the second elongated body 15 are configured so that the second elongated body 15 can engage with a distal region 23 of a distal portion of the body 3", and in particular with threads 24 provided on an inner surface of the body 3", which inner surface faces inwardly toward the bore 5. The threads 24 and 22 interact and complement each other to form an engaging contact surface that enables the cartridge holder assembly 11 to be removably mounted to the drive system 2 by screwing the cartridge holder assembly into the distal region of the drive system 2. In addition, optional correspondingly abutting protrusions are advantageously provided on the inner surface and / or the respective outer surface of the elongated bodies 13, 14, 15 to facilitate and / or achieve longitudinal and axial alignment of the (optional) viewing windows in the first and third elongated bodies 13, 14, and / or respectively superimposed alignment.

[0066] Before mounting the cartridge holder assembly 11 on the distal region 23 of the drive system 2, and in particular on the distal region of the body 3″, a multi-chamber cartridge 25, for example a dual-chamber cartridge containing at least a first substance and a second substance for reconstituting an injectable product, is axially inserted into the cartridge holder assembly 11 through the aperture 13A of the first elongated body 13. Figure 1 As shown, a dual chamber cartridge 25, for example made of glass, has a proximal end 26 and a distal end 27, and defines a hole in a known manner, wherein a first proximal stopper 28 is located at or substantially adjacent to the proximal end 26, and a second stopper 29 is located along the hole distal to the first stopper 28, thereby forming a first chamber 30. The first chamber 30 includes a first substance or component of the drug to be reconstituted, such as a solvent. The second stopper 29 also defines a second chamber 31 in the volume, which is located distal to the second stopper 29 and 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, such as a solute powder that is soluble in the solvent when the component is reconstituted. The first chamber 30 and the second chamber 31 are connected to each other by a bypass 32 formed as a narrow conduit or channel between the two chambers, and before the reconstitution operation, in the initial position of the stopper, the second stopper 29 closes the bypass 32, thereby preventing the first substance and the second substance from contacting each other.

[0067] The third elongated body 14 is coaxially and concentrically disposed within the bore 13A of the first elongated body 13. The third elongated body 14 has a proximal end 33 and a distal end 34. When the cartridge is inserted into the holder assembly 11, the distal end 27 of the cartridge 25 stops and engages with a neck 35 provided at the distal end 34 of the third elongated body 14. The proximal end 33 of the third elongated body 14 is provided with a thread 36 on an outer surface 37 of the elongated body 14. The thread 36 extends oppositely to the thread 18 provided on the inner surface of the first elongated body 13, so that when the two threads 18, 36 engage with each other, for example, by rotation of the first elongated body caused by the drive of the motor and the threaded piston, the third elongated body retracts into the bore 13A of the first elongated body 13, thereby moving relative thereto in the proximal direction. At the same time, the third elongated body 14 translates along the bore 15A of the second elongated body. The third elongated body 15 has an inwardly facing annular shoulder or protrusion 38 at its distal end 20 which at least partially overlaps the third elongated body 14 in the initial expanded configuration of the cartridge holder assembly 11. The third elongated body 14 is prevented from unwanted distal movement by the engagement of the protruding annular shoulder 38 of the second elongated body 15 with an outwardly protruding abutment 39 provided on the outer surface of the third elongated body.

[0068] The autoinjector and reconstitution device 1 also include a coupling member 40 sized and configured to rotationally 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, such as along about half the length of the body 41. The narrower diameter portion 41A provides space for accommodating a biasing member 45, such as a coil spring, which is coaxially disposed around the outer surface of the small diameter portion 41A and abuts against the distal end of the narrower diameter portion, which forms a radially protruding shoulder 47, such as Figure 4The narrower diameter portion 41A further comprises at least one longitudinal groove 46, and preferably two such grooves, preferably diametrically opposed, extending in parallel along the longitudinal axis 4 from the proximal end 43 to the distal end of the narrower diameter portion 41A and a shoulder 47. At the distal end 44 of the coupling member 40, a plurality of tongues or splines are provided, extending in parallel along the longitudinal axis 4 and radially distributed around the axis. The splines or tongues 48 are sized and configured to engage and interlock with a correspondingly sized and configured groove 49 on the inner surface 50 of the inwardly facing body aperture 13A of the body 13, which is located at the proximal end 16 of the first elongated body 13 of the cartridge holder assembly 11. When the cartridge holder assembly is mounted to the drive system, for example by screwing the second slender body 15 into the distal region 23 of the drive system, the interlocking of the spline or tongue 48 of the connecting member 40 with the groove 49 of the first slender body 14 causes the connecting member 40 and the first slender body 13 to be rotationally locked, which means that as long as the body 13 can be physically rotated in the rotational direction imposed by the motor through the piston rod 7, any rotation imparted to the connecting member will be transmitted to the first slender body of the cartridge holder assembly.

[0069] Returning now to the cartridge holder assembly, the first elongated body 13 is mounted and retained within the bore 15A of the second elongated body 15. The first elongated body 13 is provided with an interlocking engagement means which interlocks with the third elongated body 15 to prevent relative distal or proximal movement between the two bodies 13, 15. Such an interlocking means is also configured to allow the first elongated body 13 to rotate about the longitudinal axis. An example of a suitable interlocking engagement means may be an annular protruding shoulder 51 extending from or adjacent to the proximal end 16 of the first elongated body of the cartridge holder assembly and engaging in an annular groove 52 of corresponding size and configuration provided at or adjacent to the proximal end 19 of the third elongated body of the cartridge holder assembly. In this way, the first elongated body 14 of the cartridge holder assembly 11 is free to rotate within the bore 15A and is also prevented from moving in the distal and proximal directions along the longitudinal axis 4.

[0070] The threaded piston 7 has a thread 53, which is provided on the outer surface of the piston 7. The piston 7 also includes a nut 54, which is provided with an internal thread 55, which extends opposite to the thread of the piston 7. Before use, the proximal end 56 of the nut 54 rests on the distal end 57 of the motor 6 in the device 1. Due to the engagement of the internal thread 55 of the nut 54 with the external thread 53 of the piston 7, rotating the threaded piston 7 causes the nut 54 to move in the distal direction away from the distal end 57 of the motor 6. In order to prevent the nut from simply extending the threaded piston to the end of the thread when the motor is activated, for example by pressing the button switch 10 for reconstitution and automatic injection after the dose has been set via the controller 8 for reconstitution and automatic injection, the threaded nut is also provided with a plurality of radially outwardly protruding wings 58, which are located at the proximal end 56 of the nut 54. The wings 58 are configured and dimensioned to engage with parallel and radially distributed or opposite grooves 46 provided on the coupling device. Since the nut 54 is rotationally constrained by the interaction of the wings 58 with the slots 46, this causes a rotational force about the longitudinal axis to be applied to the coupling member 40. In turn, since the coupling member 40 is attached to the first elongated body 13 of the cartridge holder assembly 11, it also begins to rotate. Further rotation of the threaded piston by the drive motor causes the nut 54 to move distally in the slot 46 together with the wings 58 against the biasing member 45. The rotation of the coupling member 40 is transmitted to the first elongated body 13 of the cartridge holder assembly, causing the internal threads of the body 13 to contact the external threads of the third elongated body 14 and thereby withdrawing the third body 14 into the bore 13A of the first elongated body 13. This movement of the third body 14 in the proximal direction continues until the proximal end 33 of the third body 14 is in abutment contact with the inwardly protruding annular shoulder 59, which is disposed within the bore 13A of the first body 13 and extends from the inner surface of the body 13 into the bore. Once the third elongated body 14 of the cartridge holder assembly has reached the maximum allowed proximal travel distance, it can no longer rotate. Similarly, the body 13 can no longer rotate, and the coupling member 40 can no longer rotate. The cartridge holder assembly is now fully in the collapsed configuration (see Figure 3 and Figure 5 ).

[0071] Subsequently, the threaded piston continues to drive the nut 54 in the distal direction, causing the distal tip 60 of the nut 54 to contact the first stop 28. The distal tip 60 of the nut 54 may advantageously be provided with a cap or insert 61 made of rubber, elastomer or similar suitable plastic material to form a bearing surface against the first stop 28 at the distal tip 60 of the nut 54.

[0072] Continued actuation of the drive motor causes the nut 54 and the tip 60 to advance in the distal direction, thereby pushing the first stopper 28 and the contents of the first chamber 30 in the distal direction. As the first stopper is moved distally by the nut 54, the pressure generated by the compression of the contents in the first chamber 30 also causes the second stopper 29 to move distally until it also moves beyond the proximal inlet 62 of the bypass 32. Once the proximal inlet 62 of the bypass 32 has been exposed to the substance in the first chamber, and under the action of the continued distal movement of the nut 54, causing the first stopper to continue to move distally, the substance in the first chamber, such as a solvent liquid, is pushed through the bypass 32 into the second chamber via the first bypass inlet, and allows the reconstitution of the two substances to continue. The first stopper 28 is continuously pushed in the distal direction within the cartridge by the motor 6 and the nut 54 until all of the first substance has been pressed into the second chamber 31 through the bypass 32 and reconstitution has been achieved. An injection needle may now be mounted to the distal end 34 of the third elongate body 14 of the cartridge holder assembly and the injection allowed to proceed in accordance with the usual commands and controls of such an autoinjector device.

[0073] Once the injection is complete and the cartridge is now emptied of any injectable product therein, the direction of rotation of the motor can be reversed, for example, by means of a controller and an actuation button. The reversal of the direction of the motor causes the nut to move back again in the proximal direction towards the distal end 57 of the motor. In addition, the biasing member 45 pushes the wing 58 of the nut 54 to facilitate the movement of the nut 54 back in the proximal direction. As the movement in the proximal direction proceeds, the nut 54 will reach a position where the connector 40 and the first elongated body 13 of the cartridge holder assembly 11 will again be free to rotate under the influence of the wing in a direction opposite to the direction required for reconstitution, and in this case, the third elongated body 14 will again move in the distal direction, thereby changing the cartridge holder assembly 11 from a retracted state to an extended state. The distal movement of the third elongated body 14 will eventually be stopped by the protruding annular shoulder 38 of the second elongated body 15 abutting against the outwardly protruding abutment 39 provided on the outer surface of the third elongated body 14. At this point, the nut 54 will return to its initial starting position, and the cartridge holder assembly 11 will reach its initial extended configuration. The cartridge holder assembly 11 can then be removed and the failed cartridge replaced with a new cartridge to restart the sequence of reconstitution and injection.

Claims

1. A handheld motor-driven drug reconstitution and automatic injector device (1), comprising: The proximal drive system (2) comprises: An elongated body (3) having a central longitudinal axis (4) along the elongated body, and a hole (5) extending along the central longitudinal axis (4) and in the elongated body (3), the elongated body (3) accommodating a controllable drive motor (6) and an axially drivable piston rod (7) located in the hole (5) and connected to the motor (6); and A distal cartridge holder assembly (11) configured as follows: a multi-chamber cartridge (25) housed within the cartridge holder assembly (11), the multi-chamber cartridge 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 positioned in an end-to-end arrangement axially aligned with the central longitudinal axis (4); wherein the distal cartridge holder assembly (11) has a proximal end (16, 19) and a distal end (34), the proximal end being releasably attached to a distal region (23) of the proximal drive system (2), the distal end being configured to receive an injection needle; The proximal drive system (2) and the distal cartridge holder assembly (11) are configured to be capable of imparting movement to the cartridge holder assembly (11), wherein the cartridge holder assembly (11) moves from a first extended distal configuration along the central longitudinal axis to a second retracted proximal configuration along the central longitudinal axis; and wherein, when the cartridge holder assembly (11) is driven by the drive system (2) to move along the central longitudinal axis (4), the relative movement of the cartridge holder assembly (11) from the first extended distal configuration to the second retracted proximal configuration affects the reconstitution of an injectable product, the injectable product comprising at least a first substance and a second substance, the at least first substance and the second substance being located within only one of the at least first chamber or the second chamber (30, 31) after the reconstitution; and The cartridge holder assembly (11) further comprises: a first elongated body (13) comprising a bore (13A) axially aligned with said central longitudinal axis; A second elongated body (15) comprising a bore (15A) axially aligned with said central longitudinal axis; and a third elongated body (14) comprising a bore (14A) axially aligned with said central longitudinal axis, The three elongated bodies (13, 14, 15) are interconnected and organized in concentric axial alignment around the central longitudinal axis (4).

2. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The cartridge holder assembly (11) is further configured to be operated by the proximal drive system (2) in a relative movement opposite to the reconfiguration movement to move components of the cartridge holder assembly (11) from a proximally retracted configuration to a distally extended configuration.

3. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 2, wherein: The movement of the cartridge holder assembly (11) from the extended configuration to the retracted configuration comprises a telescopic movement.

4. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 2, wherein: The movement of the cartridge holder assembly (11) from the extended configuration to the retracted configuration includes rotational telescopic movement and translational telescopic movement.

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

6. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The first elongated body (13) of the cartridge holder assembly and the third elongated body (14) of the cartridge holder assembly are respectively connected to each other via contact surfaces, the contact surfaces comprising an inner surface (18) of the first elongated body (13) and an outer surface (36) of the third elongated body (14); When driven by the drive system (2), the third elongated body (14) is configured to allow rotational movement of the cartridge holder assembly (11) relative to the first elongated body (13) about the central longitudinal axis (4) and in a proximal direction along the contact surfaces (18, 36).

7. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The second elongated body (15) of the cartridge holder assembly (11) concentrically surrounds the first elongated body (13) and extends in the distal direction from the proximal end (19) to the distal end (20); The distal end (20) of the second elongated body (15) of the cartridge holder assembly (11) concentrically surrounds and extends around at least the proximal end (33) of the third elongated body (14) of the cartridge holder assembly (11); as well as The movement of the third elongated body (14) relative to the second elongated body (15) when driven by the drive system (2) is configured to allow translational movement in a proximal direction along the central longitudinal axis (4) within the bore (15A) of the second elongated body (15).

8. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The first elongated body (13) of the cartridge holder assembly (11) and the second elongated body (15) of the cartridge holder assembly (11) are connected to each other via contact surfaces, the contact surfaces comprising cooperating interlocking means (51, 52) respectively provided on the second elongated body (15) and the first elongated body (13); The corresponding cooperating interlocking means (51, 52) are configured to allow the first elongated body (13) to make relative rotational movement within the hole (15A) of the second elongated body (15); as well as When driven by the drive system (2), the respective interlocking means (51, 52) cooperate to rotate the first elongated body (13) about the central longitudinal axis (4) within the bore (15A) of the second elongated body (15).

9. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: Also included is a coupling member (40) configured to couple a proximal end (16) of the cartridge holder assembly (11) to an axially drivable piston rod (7) of the drive system (2).

10. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 9, wherein: The coupling member (40) comprises an elongated body (41), the elongated body (41) of the coupling member (40) having a hole (42) axially aligned with the central longitudinal axis (4) and received within the elongated body (3', 3") of the drive system (2); The coupling member (40) and the drivable piston rod (7) are connected to each other via corresponding piston drive engagement means (46, 53, 54, 55, 58), the piston drive engagement means being respectively arranged in or on the elongated body (41) of the coupling member (40) and the drivable piston rod (7); When driven by the drive system (2), respective piston drive engagement means (46, 53, 54, 55, 58) cooperate to allow the coupling member (40) to rotate freely within the elongated body (3', 3") of the drive system (2).

11. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 10, wherein: The piston drive engagement means (53, 54, 55, 58) on the drivable piston rod (7) is configured to be automatically biased in the proximal direction after injection or after reconstitution by a biasing member (45) located in or on the coupling member (40).

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

13. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The axially drivable piston rod (7) comprises an externally threaded (53) piston rod (7) connected to the drive motor (6) and an internally threaded (55) nut (54), whereby activation of the drive motor (6) drives the threaded rod to engage the internally threaded nut (54), thereby moving the nut (54) from a proximal position to a distal position along the longitudinal axis (4).

14. The handheld motor-driven drug reconstitution and auto-injector device (1) according to claim 1, wherein: The cartridge holder assembly (11) is releasably attached to a distal region (23) of the drive system (2) via corresponding mating surfaces (22, 24) provided on the body of the drive system (2) and the second elongated body (15) of the cartridge holder assembly (11).

15. A method for reconstituting an injectable product contained in a multi-chamber cartridge (25) of an autoinjector 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 chamber (30) and the second chamber (31) being positioned in an end-to-end arrangement axially aligned with a central longitudinal axis (4) of the autoinjector device (1), the method comprising: There is provided a handheld motor driven drug reconstitution and auto-injector device (1) according to any one of claims 1 to 14; activating a function of the automatic injector device (1), the function involving at least a reconstitution step prior to injection; The reconstitution step comprises driving a drive motor (6) of the automatic injector device to cause the cartridge holder assembly (11) to relatively move along a central longitudinal axis (4) of the automatic injector device (1) from a first extended distal configuration to a second retracted proximal configuration, thereby achieving reconstitution of the injectable product in at least only one of the first chamber (30) or the second chamber (31).

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