DRUG PREPARATION AND DELIVERY DEVICE
20230321352 · 2023-10-12
Assignee
Inventors
- Vincent DELOBELLE (Montbonnot-Saint-Martin, FR)
- Adrien BOUILLET (Montbonnot-Saint-Martin, FR)
- Mahutin Akle (Montbonnot-Saint-Martin, FR)
Cpc classification
A61M5/204
HUMAN NECESSITIES
A61M2005/3128
HUMAN NECESSITIES
A61M5/19
HUMAN NECESSITIES
A61J1/2089
HUMAN NECESSITIES
A61M5/1413
HUMAN NECESSITIES
A61M5/31596
HUMAN NECESSITIES
International classification
A61M5/19
HUMAN NECESSITIES
A61M5/315
HUMAN NECESSITIES
Abstract
The present invention relates to a drug preparation and drug delivery device comprising: a drug preparation unit comprising at least two receptacles capable of containing constituents to be mixed, at least one of the receptacles being movable inside the drug preparation unit, a drug administration means, such as an injection or spray means, a fluid circuit capable of fluidically connecting the at least two receptacles and the administration means, the connecting of the fluid circuit with the at least two receptacles being made using at least two piercing means when said at least two receptacles move from an initial position to a contact position with said at least two corresponding piercing means, an electromechanical assembly for fluidically driving the constituents within the fluid circuit, characterised in that said drug preparation unit comprises a release mechanism comprising a compressed drive spring which, when it is released, is capable of generating a movement along an axis A1 of at least one of the movable receptacles towards at least one of said piercing means in order to create the fluid connection with the fluid circuit.
Claims
1. Device (2) for drug preparation and drug delivery comprising: -a drug preparation unit (200) comprising at least two containers (600, 600′) capable of containing constituents to be mixed, at least one of the containers (600, 600′) being mobile in said drug preparation unit (200), -a means of administration (721) of the drug, such as an injection or spray means, -a fluidic circuit (700,700′) able to put in fluidic connection the at least two containers (600, 600′) and the administration means (721), the connection of the fluidic circuit (700, 700′) with the at least two containers (600, 600′) being made through at least two piercing means (701) when said at least two containers (600, 600′) move from an initial position to a contact position with said at least two corresponding drilling means (701), -an electromechanical assembly (900) for the fluidic drive of the constituents within the fluidic circuit (700, 700′), the electromechanical assembly (900) being able to activate the fluidic circuit (700, 700′), by means of′ a motorized pump (710), characterized in that said drug preparation unit (200) comprises a release mechanism (4) comprising a compressed driving spring (500) which, upon its release, is able to generate a displacement along an axis (A1) of at least one of the mobile containers (600, 600′) towards at least one of said drilling means (701) to create the fluidic connection with the fluidic circuit (700, 700′).
2. Device (2) for drug preparation and drug delivery according to claim 1 further comprising: -a motorized pump (710) connected to said fluidic circuit (700, 700′) to circulate at least one of the constituents in said fluidic circuit (700, 700′) once the fluidic connection has been created.
3. Device (2) for drug preparation and drug delivery according to claim 1 wherein the drug preparation unit (200) comprises: -a cradle (300) comprising a first flat wall (302) perpendicular to an axis A1 parallel to the movement of said containers (600, 600′) and, -a cart (400) movably mounted in said drug preparation unit and abutting against at least one of the containers (600, 600′), said cart (400) comprising a second flat wall (403) parallel to the first flat wall (302) of the cradle (300), -said drive spring (500) being compressed between said first flat wall (302) of the cradle (300) and said second flat wall (403) of the carriage (400) so that the release of the compressed drive spring moves the at least one container (600, 600′) through the carriage (400) to at least one of said piercing means (701).
4. Device (2) for drug preparation and drug delivery according to claim 1 wherein the release mechanism (4) comprises: -a container support (450) extending in the direction Al coaxially with the compressed drive spring (500), said support (450) comprising at least two elastic fixing means (452) of said containers (600), -an intermediate piece (460) removably securing the container support (450) to the compressed drive spring (500), -said joining being done using an elastic clamp (461) belonging to the container support (450) and resiliently retaining a first push rod (451) belonging to said intermediate part (460), so that the force exerted by the spring required to separate the intermediate piece (460) and the container support (450) is greater than or equal to the force required to move at least one of the mobile containers (600, 600′).
5. Device (2) for drug preparation and drug distribution according to claim 4 wherein: -at least one of the two containers (600, 600′) is closed by a shutter (620) capable of moving under the effect. an external thrust in order to expel its constituent, and in which, -said intermediate piece (460) comprises a second push rod (462) extending parallel to the axis (Al) of pushing the containers along said axis (Al) of the shutter (620) in order to exert a force on said shutter (620) after separation between the intermediate part (460) and the container support (450).
6. Device (2) for preparing medicament and dispensing medicament according to claim 1 comprising an activation unit (1) capable of occupying an inactive position in which the compressed driving spring (500). is maintained and an active position in which the compressed drive spring (500) is released.
7. Device (2) for drug preparation and drug delivery according to claim 6 wherein the activation unit (1) comprises a retaining element (401,401′) capable of being driven by said activation unit (1) from a position of holding the spring (500) in its compressed state to a position of release of the spring (500), said release position of the spring (500) being obtainable by a rotation or a translation of said unit of activation (1) by a user.
8. Device (2) for drug preparation and drug distribution according to claim 6 wherein the activation unit (1) comprises an electronic card provided with an electronic switch of optical, magnetic, or contact type, able to wake up the electromechanical assembly for the motorized drive of the pump (710).
9. Device (2) for drug preparation and drug delivery according to claim 1 wherein the fluidic circuit (700) comprises a network of fluidic channels (733,733′) extending in a plane (734) and in connection with the at least two containers (600, 600′) and the administration means (721) via channels to reduce the bulk in the device (2).
10. Device (2) for drug preparation and drug delivery according to claim 1 wherein the fluidic circuit (700′) comprises a network of fluidic channels (733”) extending at the periphery of a central part (750) to reduce bulk and reduce dead volumes in the fluid path.
11. Device (2) for drug preparation and drug distribution according to claim 1 such as a first assembly comprising the fluid circuit (700,700′), the at least two containers (600, 6000′) and the administration means is disposable while a second assembly comprising the release mechanism (4), motorized pump (710) and the electromechanical assembly (900) for its training is reusable.
12. Device (2) for drug preparation and drug delivery according to claim 1 comprising a fluid selector (720) capable of selectively connecting the at least two containers (600, 600′) and the means of administration (721).
13. A method of automated preparation and distribution of a medicament using a device according to claim 1 and comprising the following steps: -providing a medicament preparation unit (200) comprising at least two containers (600, 600′), one comprising a drug in hydrated or dehydrated form and the other a solvent, -providing a means of administration (721) of the medicament, such as an injection or spray means, -provide a fluidic circuit (700,700′) able to put in fluidic connection the at least two containers (600, 600′) and the administration means (721), the connection of the fluidic circuit (700, 700′) with the at least two containers (600) being made through at least two piercing means (701) when said at least two containers (600, 600′) move from an initial position to a position of contact with said at least two corresponding drilling means (701), -providing an electromechanical assembly (900) for the fluidic entrainment of the constituents within the fluidic circuit (700, 700′), characterized in that the automated preparation and dispensing of the drug comprises the release of a release mechanism (4 ) comprising a compressed drive spring (500) which, when released, generates a displacement along an axis (Al) of at least one of the mobile containers (600, 600′) towards at least one of said piercing means (701) to create the fluidic connection with the fluidic circuit (700, 700′).
14. A method of automated preparation and dispensing of a medicament according to claim 13, in which electronic activation causes the fluidic entrainment of the constituents within the fluidic circuit and the administration of the medicament.
15. The method of automated preparation and dispensing of a medicament according to claim 14, in which the electronic activation takes place during the movement of at least one of the mobile containers (600, 600′) by means of a switch on. the path of movement of said containers.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0045] The invention will be better understood, and other aims, details, features and advantages thereof will appear more clearly upon reading the following detailed explanatory description of embodiments of the invention provided as purely illustrative and non-limiting examples, with reference to the appended schematic drawings.
[0046] In these drawings:
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
DETAILED DESCRIPTION
[0061] The present invention relates to a device for delivering a liquid product and it will be better understood upon reading the following figures, which are a non-limiting illustration of the invention.
[0062] In
[0063] The assembly 900 contains at least one motor intended to activate the motor pump 710 and all of the electronic elements including the activation means as described hereinabove. More particularly, the electronic assembly 900 may comprise in particular an optical, magnetic or contact type electronic switch, able to wake up the electromechanical assembly 900 for the motorized drive of the pump 710.
[0064] At least one of the primary receptacles 600, 600′ is preloaded. In the case of two drug constituents to be mixed, the two primary receptacles 600, 600′ are preloaded. Thus, they already include the drugs or drug elements intended to be administered. This allows getting rid of the different steps of connection of receptacles which may conventionally require forces greater than 30N (sometimes up to 60N). For some pathologies or some conditions and/or situations (for example a very alienating momentary condition such as a migraine attack, or a stress situation, or medical emergency), or age categories, this stress may become a real brake on the proper progress of the activation of an auto-injector. Therefore, the activation mode and the device 2 according to the present invention aims to make the starting action of the device 2 more reliable.
[0065] The entire device is contained in a shell C composed of two complementary portions (cf.
[0066] The electromechanical assembly 900 and the motor pump 710 are fastened directly or via a support part in the shell C. The fluid circuit 700 may be assembled with the electromechanical assembly 900 or coupled to the shell C. The assembly of the fluid circuit 700 may be permanent or removable in order to be able to discard it if it is soiled and is not intended to be reused. As illustrated in the exploded view of
[0067] The device according to the invention may include a first disposable assembly including the fluid circuit 700, the motor pump 710 and the receptacles 600, 600′ and a second reusable assembly including the electromechanical assembly 900 able to drive the pump 710 and the fluid circuit 700, the first disposable assembly and the second reusable assembly being arranged so as to be connectable and detachable respectively from one another.
[0068] For example, in the case where the device uses two receptacles, the first receptacle may, for example, contain a fluid solvent and the second receptacle may contain a solid powder or a lyophilized product.
[0069] In such a case, the advantage of the electromechanical assembly 900 is the ability to parameterize a mixing sequence defined, inter alia, by: [0070] a number of back-and-forth movements between the two primary receptacles 600, 600′, and [0071] the rotational speed of the motor pump 710 to stir the fluidic solvent within the fluid circuit 700.
[0072] In the case where only one of the two primary receptacles 600, 600′ includes a drug, this possibly enables the suction of a body fluid before being mixed with the preloaded drug then administered again by the device 2.
[0073] The electromechanical unit 900 also allows, by means of the motor pump 710, controlling an accurate dose to be injected, this dose possibly being smaller than the volume of fluid contained in the primary receptacles 600, 600′. Thus, this allows adapting to a wide variety of patients. This confers a certain advantage over devices intended to administer the entire content of their receptacle, for example until the pressure within the receptacle becomes insufficient to expel the content.
[0074] The motor pump 710 also allows circulating fluid in the fluid circuit while avoiding any sudden actuation, such as a spring or piston activation, requiring a given force that some patients cannot impart.
[0075]
[0076]
[0077] The drug preparation unit 200 also comprises, within it, a carriage 400 in the form of a planar part extending in a plane parallel to that of the first planar wall 302 of the cradle 300.
[0078] A drive spring 500 is compressed between the first planar wall 302 of the cradle 300 and the carriage 400. The drive spring 500 has an axis coincident with the axis A1 of longitudinal extension of the drug preparation unit 200. The accurate operation of the spring is described later on.
[0079] On the face opposite to that in contact with the drive spring 500, the carriage 400 bears against the planar base of the first primary receptacle 600, which herein has a cylindrical shape with the axis A1. It should be noted that the first primary receptacle 600 is associated with the carriage 400. Thus, the first primary receptacle 600 is movable within the cradle 300, and therefore within the drug preparation unit 200.
[0080] A second primary receptacle 600′ is comprised in the drug preparation unit 200. The two primary receptacles referenced 600, 600′ are in
[0081] At its distal end with respect to that in contact with the carriage 400, each primary receptacle 600, 600′ comprises a corresponding septum 601, 601 allowing hermetically closing said primary receptacle 600, 600′. This also allows permanently preserving the preloaded content of each primary receptacle 600, 600′.
ARRANGEMENT
First Embodiment
[0082] In this first embodiment, the two primary receptacles 600, 600′ are movable. Only the second primary receptacle 600′ comprises a removable bottom, enabling the compression of the fluid.
[0083] In
[0084] The fluid circuit 700 facing the primary receptacles 600, 600′ is replicated in
[0085] In the embodiment illustrated in
[0086] As already mentioned above, the fluid(s) can circulate in both directions in the fluid circuit 700, allowing for an efficient mixing by several back-and-forth movements.
[0087] The release mechanism 4 removably coupled to the compressed drive spring 500 comprises a hooked end 401 at its distal end, with respect to the carriage 400, of a foldable blade 402. The hooked end 401 is in abutting contact with the cradle 300 so as to limit its movement 4 of releasing the compressed drive spring 500 during translation thereof.
Second Embodiment
[0088] In this embodiment, the two primary receptacles 600, 600′ are movable. The bottom of each primary receptacle 600, 600′ is static.
[0089] Referring now to
[0090] In
[0091] In this embodiment, the stud 301 is retained by a hook 401′ able to rotate about an axis of rotation A2 to release it and enable the compressed drive spring 500 to move the second primary receptacle 600′, which is secured thereto, towards the needles 701, 701′. The first primary receptacle 600 is not represented. The stud 301 has a groove with a shape complementary to the opening of the hook 401′ enabling said hook 401′, when it is engaged, to block its movement of releasing the compressed drive spring 500. A release is obtained during the clockwise rotation of the hook 401′. The reconstituted mixture can be dispensed using an injection needle 721 after having circulated through the fluid circuit 700′.
[0092] The release of the compressed drive spring 500 is easier to understand with
[0093] It is entirely possible to consider, according to the invention, an embodiment where the release is done by translation of the retaining element 401, 401′ (hooked end or stud) rather than a rotation.
[0094] Furthermore, in an embodiment where there would be only one receptacle able to be moved, this would imply that the second receptacle is pre-connected, i.e. fluidly connected beforehand with the fluid circuit. This embodiment is not discarded.
[0095] Reference is now made to
[0096] The intermediate part 460 is disposed between the receptacle support 450 and the compressed drive spring 500. The intermediate part 460 removably secures the receptacle support 450 to the compressed drive spring 500.
[0097] This fastening is done, in
[0098] The axis of elongation of the push rod 451, the axis of the compressed drive spring 500, and the axis of elongation of the receptacle support 450 are coincident so that the force exerted by the spring is exerted at the elastic clamp. When the latter exceeds a given threshold F0, there is detachment between the intermediate part 460 and the receptacle support 450. It should be noted that the force needed to detach the intermediate part 460 and the receptacle support 450 is greater than or equal to the force needed to move at least one of the movable receptacles 600.
[0099] Thus, there is first a movement of the receptacle support 450, then contact with the support stop 453. Afterwards, there is detachment between the intermediate part 460 and the receptacle support 450 then, a distance d is able to be covered by the first push rod 451 which pushes against the receptacle support 450 to drive the latter and the receptacles 600 (not represented) that it would bring towards the needles 701 for fluid connection with the fluid circuit 700.
[0100] In a preferred embodiment of the release mechanism 4 according to the invention as illustrated in
[0101] The length L of the second push rod 462 is larger than the distance h separating the free end of the first push rod 451 and the stop surface on which said first push rod 451 bears to move the receptacle support 450. This also depends on the positioning height of the shutter 620 of the second receptacle 600′.
[0102] We will now describe a first embodiment of the fluid circuit 700 using
[0103]
[0104] In
[0105] The fluid channels 733, 733′ are visible at the main surface of the central part 750. Hence, the fluid channels 733, 733′ are mostly in a plane 734. These channels are closed by one or more sealing plate(s) assembled by welding or heading to the central part 750. The fluid channels 733, 733′, are connected to the pump barrel 731 and to the dispenser barrel 732 via connection channels 735 to the plane 734 containing the fluid channels 733, 733′. The fluidic cassette 730 may also be made by plastic injection.
[0106]
[0107] A second embodiment of the fluid circuit 700′ is illustrated using
[0108] In this second embodiment of the fluid circuit, the elements common to the devices illustrated in
[0109] In
[0110] Sealing between the central part 750 and the peripheral parts 753 is achieved by compressed elastomeric seals 754. This embodiment allows having a three-dimensional fluid circuit which has the advantage of reducing bulk and the dead volumes in the fluidic path.
[0111] In general, and not related to a particular embodiment according to the invention, at least one needle 701, metallic or plastic, can be connected to the fluid channels 733, 733′, 733″ of the fluidic cassette 730. The needles 701, 701′ allow drawing the constituents contained in the primary receptacles 600, 600′.
[0112] The pump 710 may be a rotary pump, an oscillating-rotary pump, or a linear piston pump. The pump 710 may be mono-directional or bi-directional. The latter is actuated in order to move the fluid between two primary receptacles 600, 600′ and/or to move the fluid between a primary receptacle 600, 600′ and the delivery means 721 which may be a needle but also a sprayer for example. This has a significant advantage, as indicated hereinabove.
[0113] The fluid selector 720 is necessary for devices according to the invention allowing carrying out drug preparation and drug distribution or for devices according to the invention allowing carrying out reconstitution between primary receptacles 600, 600′ whose number is greater than or equal to two.
[0114] The fluid selector 720 is actuated in order to distribute the fluid between the different fluid channels 733, 733′, 733″. The fluid selector 720 may be rotary or linear. It includes at least two inlets and one outlet. The two inlets and the outlet are connected to a primary receptacle 600, 600′. An outlet may also be connected directly to an injection needle 721 or with a hose between the fluid selector 720 and the injection needle 721. In the case where the injection needle 721 is connected to the fluid selector 720 by a hose, it is possible to motorize the movement of the injection needle 721.
Other Embodiments
[0115] The electromechanical assembly 900 (cf.
[0116] In an alternative embodiment, the motors of the pump and of the fluid selector may be associated with a reduction gear. It is also possible to consider a pump docking system and a fluid selector docking system on the output axes of the pump and fluid selector motors. The pump and fluid selector docking systems may be plates, clips, suction cups, magnets, or bayonets. A single pump motor can be used if the movements of the pump and of the fluid selector are synchronized.
[0117] We will now describe in detail, thanks to
[0118]
OPERATION
First Embodiment
[0119] In this first embodiment, it is necessary to perform an action on the removable bottom of the second primary receptacle 600′ to facilitate the suction by the motor pump 710 of the second primary receptacle 600′ regardless of the position of the device 2. The device 2 according to the first embodiment has the advantage of not requiring complete push on the second primary receptacle 600′ but only “breaking” the sticking forces between the walls of the second primary receptacle 600′ and its removable bottom. These sticking forces may be greater with ageing of the device 2.
Second Embodiment
[0120] Thanks to the electromechanical assembly 900, the device 2 according to the present invention enables a decorrelation between the drug reconstitution and the injection. There is sequencing of the operations, which allows eliminating any risk of administration without being assured of the optimal reconstitution of the drug.
[0121] The operating kinematics of the second embodiment (that of
[0122] When the activation button 100 is activated by a user by a rotation or a translation, it moves the foldable blade 402, thereby releasing the retaining element 401, 401′.
[0123] As illustrated in
[0124] This action will release the compressed drive spring 500 thus generating a translational movement of the carriage 400 with the primary receptacles 600, 600′ in the cradle 300 towards the needles 701, 701′ (cf.
[0125] In a preferred embodiment, the drug delivery process is activated once the receptacle(s) is or are connected to the fluid circuit 700.
[0126] In order to trigger this delivery process, during the movement of the carriage 400 or at the end of its movement, the carriage 400 can wake up the electronics of the device according to the invention by actuating an electronic switch. The electronic switch may be a contact switch or an optical switch or possibly a magnetic switch.
[0127] Of course, the device comprises a battery, when the electronic switch is actuated, the battery can be connected to the electronics. Depending on the selected electronic switch, the battery may be: either partially connected to the electronics, which means that a slight electric current will be consumed by the electronics, or completely disconnected from the electronics, which means that there will be no power consumption, thereby lengthening the service life of the battery. In the case of a reusable device, it will be preferable to use a rechargeable battery.
[0128] It is essential to note that the two embodiments disclosed regarding the release mechanism 4 and the two embodiments regarding the planar and three-dimensional fluid circuits are mechanically independent and can therefore be combined to obtain configurations of the device according to the invention.
[0129] The device according to the invention intends the combination of the preparation and the administration by injection of drug products. If the subcutaneous pathways of a patient have been primarily explored, it is possible to consider to the least the intravenous and intramuscular pathways as other pathways.
[0130] The device according to the invention enables mixing between a constituent A and a constituent B. If the constituent A is the solvent and the constituent B the pharmaceutical active substance, it is possible to consider, as already mentioned, filling the first receptacle 600 with a body fluid: blood, lymph, or other non-circulating biological liquids (synovial, cerebrospinal, pleural...), for extra-corporeal homogenization of the active substance in a target liquid, for re-administrations via the appropriate injection mode according to the invention.
[0131] It is also possible to use the device according to the invention for mixing two liquids: in this case we will talk about a co-injection device. The field of application preferably remains healthcare and the medical sector.
REFERENCE NUMERALS
[0132] 1: Activation unit [0133] 2: Device according to the invention [0134] 200: Drug preparation [0135] 300: Cradle [0136] 301: Hook [0137] 302: First planar wall of the cradle [0138] 4: Release mechanism [0139] 400: Carriage [0140] 401, 401′: Retaining element [0141] 402: Foldable Blade [0142] 403: Second planar wall of the carriage [0143] 450: Receptacle support [0144] 451: First push rod [0145] 452: Receptacle fastening elastic means [0146] 453: Support stop [0147] 460: Intermediate part [0148] 461: Elastic clamp [0149] 462: Second push rod [0150] 500: Drive spring [0151] 600, 600′: Receptacle [0152] 601, 601′: Septum [0153] 620: Shutter [0154] 700, 700′: Fluid circuit (planar or three-dimensional) [0155] 701, 701′: Piercing means [0156] 710: Motor pump [0157] 720: Fluid selector [0158] 721: Administration means [0159] 730: Fluidic cassette [0160] 731: Pump barrel [0161] 732: Barrel of the fluid selector [0162] 733, 733′, 733″: Fluid channels [0163] 734: Plane of the fluidic cassette [0164] 735: Link channel [0165] 750: Central part of the fluid circuit [0166] 753: Peripheral parts [0167] 754: Compressed elastomeric seals [0168] 800: Electronic tray [0169] A1: Main axis of the device (axis of the receptacles, of the spring, of the needles) [0170] C: Shell [0171] d: Distance between the first push rod and the receptacle support before fluid connection with the fluid circuit. [0172] L: Length of the second push rod