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Title:
MOBILE CARRIAGE UNIT
Document Type and Number:
WIPO Patent Application WO/2024/003329
Kind Code:
A1
Abstract:
The present invention relates to a carriage unit (10) configured to secure two elongated containers (101, 102) paired together to create a fluidic junction, the carriage unit (10) comprising first (12) and second (14) securing members comprising respective first (S12) and second (S14) restraining surfaces, the first and second securing members (12, 14) being mobile between: - an active configuration in which the first and second securing members (12, 14) enable the fluidic junction to be secured by the first and second restraining surfaces (S12, S14) in direct contact with the outer surface of the fluidic junction, to apply a restraining force regularly spread over an outer surface of the fluidic junction, and - an inactive configuration in which the first and second securing members (12, 14) enable the elongated containers (101, 102) to be added or removed from the carriage unit (10).

Inventors:
BOUILLET ADRIEN (FR)
JOLY MATHIE (FR)
LE LOC’H CYRIL (FR)
OUVRARD FLORIAN (FR)
Application Number:
PCT/EP2023/067951
Publication Date:
January 04, 2024
Filing Date:
June 30, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
EVEON (FR)
International Classes:
A61M39/00; A61J1/20; B01F31/00; B01F35/00
Foreign References:
US20020101785A12002-08-01
US20200206703A12020-07-02
US10773222B12020-09-15
US20170136151A12017-05-18
Attorney, Agent or Firm:
ICOSA (FR)
Download PDF:
Claims:
CLAIMS Carriage unit (10) configured to secure two elongated containers (101, 102) paired together by a fluidic conduct (16) configured to put the two elongated containers (101, 102) in tight fluidic connection, this tight fluidic connection creating a fluidic junction (J), each of the elongated containers (101, 102) and the fluidic conduct (16) presenting an outer surface (Sioi, S102, Sie), and the fluidic junction (J) presenting an outer surface (Sj) comprising the outer surface (Sie) of the fluidic conduct (16) and a distal portion of the outer surface (S101, S102) of each elongated container (101, 102), the carriage unit (10) comprising: a first securing member forming a basis (12) comprising a first restraining surface (S12), a second securing member forming a cover (14) comprising a second restraining surface (S14), the first and second securing members (12, 14) being mobile with regards to each other, between: o an inactive configuration in which the first and second securing members (12, 14) are spaced apart from another and enable the elongated containers (101, 102) to be added or removed from the carriage unit (10), o an active configuration in which the first and second securing members (12, 14) are close to one another and enable the fluidic junction (J) to be secured by the first and second restraining surfaces (S12, S14) in direct contact with the outer surface (Sj) of the fluidic junction (J) and wherein the first and second securing members (12, 14) are configured to, when the carriage unit (10) is in the active configuration, locally apply a restraining force at the fluidic junction (J) by means of the first and second securing surfaces (S12, S14), wherein the restraining force is regularly spread over the outer surface of the fluidic junction (J). Carriage unit (10) according to the preceding claim, wherein the fluidic conduct (16) is a connecting element separate from the first and second securing members (12, 14). Carriage unit (10) according to claim 1, wherein the fluidic conduct (16) is comprised within the first or second securing member (12, 14). Carriage unit (10) according to any one of the preceding claims, wherein it comprises a tightening device (18) configured to urge the first and second securing members (12, 14) towards active configuration. Carriage unit (10) according to any one of the preceding claims, wherein the first securing member (12) forms a basis and comprises at least one elongated container positioning element (20) configured to maintain each elongated container (101, 102) in a specific predetermined place on the first securing member (12). Carriage unit (10) according to the preceding claim, wherein the at least one elongated container positioning element (20) is an elongated groove, the first restriction surface (S12) being comprised within said elongated groove, the first securing member (12) comprising first (20a) and second (20b) elongated grooves each extending along a securing axis (Ai, A2). Carriage unit (10) according to the preceding claim, wherein the securing axis (Ai) of the first elongated groove (20a) and the securing axis (A2) of the second elongated groove (20b) are aligned, such that the two elongated containers are paired along the same securing axis, each of the two elongated containers (101, 102) further presenting an axial opening, the fluidic junction (16) being aligned with the securing axis. Mixing system (100) configured to mix the content of two elongated containers (101, 102) comprising a mobile end configured to be mobile in translation inside each elongated container (101, 102) so as to define, within each elongated container (101, 102), a variable volume chamber, said elongated containers (101, 102) being further configured to cooperate with an associated elongated element (111, 112) to translate the mobile end inside each elongated container (101, 102) to vary the volume of the chamber, each associated elongated element (111, 112) comprising a cooperating end (111b, 112b) cooperating with the mobile end of the elongated container (101, 102), and an opposite free end (I l la, 112a), the mixing system (100) comprising: a carriage unit (10) according to the any one of the preceding claims, said carriage unit forming a mobile carriage unit (10), a static unit (22) extending along a circulation axis parallel to at least one of securing axes (Ai, A2) of the mobile carriage unit (10), the static unit (22) comprising: o a circulation track (24) extending along the circulation axis and on which the mobile carriage unit (10) is mounted so as to be movable in translation along the circulation axis, o at least one external flange (26) situated at one of the extremities of the circulation track (24), the external flange (26) being configured to receive the free end (I l la, 112a) of one of the associated elongated elements (111, 112).

9. Mixing system (100) according to the preceding claim, wherein a position of the at least one external flange (26) can be adapted, along the circulation axis, to a length of the elongated container (101, 102) and the associated elongated element (111, 112).

10. Mixing system (100) according to any one of claims 8 and 9, comprising two external flanges (26), each flange (26) cooperating with the associated elongated element (111, 112) of one of the two paired elongated containers (101, 102).

11. Mixing system (100) according to any one of claims 8 to 10, further comprising an actuation unit (28) configured to move the mobile carriage unit (10) once activated.

12. Mixing system (100) according to claim 8 to 11, comprising a control unit configured to set at least one movement parameter chosen at least between speed and position of a movement in translation of the mobile carriage unit (10) along the circulation track (24) of the static unit (22), and to control the actuation unit (28). Mixing system (100) according to claim 12, wherein the control unit is configured to vary the movement parameter. Mixing kit comprising: a mixing system (100) according to claim 13, two elongated containers (101, 102) comprising a mobile end configured to be mobile in translation inside each elongated container (101, 102) so as to define, within each elongated container (101, 102), a variable volume chamber, said elongated containers (101, 102) being further configured to cooperate with an associated elongated element (111, 112) to translate the mobile end inside each elongated container (101, 102) to vary the volume of the chamber, and a fluidic conduct (16) configured to put the two elongated containers (101, 102) in tight fluidic connection in order to create a fluidic junction (J), the elongated containers (101, 102) and the fluidic conduct (16) each presenting an outer surface (Sioi, S102, Sie), the fluidic junction (J) presenting an outer surface comprising a distal portion of the outer surface (S101, S102) of each elongated container (101, 102) and the outer surface (Sie) of the fluidic conduct (16). Mixing method carried out by means of a mixing system (100) according to claim 13, wherein the method comprises following steps: securing a first elongated container (101) to a first extremity of the fluidic conduct (16), securing a second elongated container (102) to a second extremity of the fluidic conduct (16), adjusting the elongated containers (101, 102) on the first securing member (12), putting the carriage unit (10) in the active configuration, connecting at least one flange (26) to one of the elongated containers (101, 102) by means of the associated elongated element (111, 112), moving the carriage unit (10) with respect to the static unit (22) in translation along the circulation axis.

Description:
MOBILE CARRIAGE UNIT

FIELD OF INVENTION

[0001] The present invention relates to a device for securing two containers which contents are to be mixed.

BACKGROUND OF INVENTION

[0002] Nowadays, a considerable number of medical preparations are extemporaneous preparation. Extemporaneous preparations are classically known as preparations comprising at least one very (re)active, instable and/or very sensitive compound which therefore need to be prepared right before being administrated to the patient. Depending on the product, it can be prepared by healthcare workers or by the patients themselves.

[0003] More specifically, the interest for the preparation of vaccines in oil emulsions increased over the past decade. Water-in-oil emulsions enable the formation of a depot, which then enables slow passive antigen release and thus decelerated degradation. This formulation is particularly advantageous for antigens which need an increased clinical response rate. This type of formulation is classically prepared by a user manipulating two syringes (syringe A and syringe B) end-to-end connected by an intermediary connector. A specific process needs to be put into practice by the user and can be summarized as follows: forcing a small amount of adjuvant from syringe B to syringe A by pressing the syringe B plunger, slowly pushing back the same volume of the mix from syringe A back to syringe B.

[0004] The two previous steps can be repeated until the mixed portion has become cloudy, for example milky white. Then, the user needs to increase the volume by small amounts and each time do the same mixing until final completion. Such manual preparation requires intense training and nerve wrecking attention in order to guarantee an equal peptide distribution in the emulsion while being highly repeatable and reproducible. The preparation quality shall not be influenced by the user nor by the change of material. Considering that the easiest preparation requires several minutes and over 20 back and forth movements, a technical solution is needed to save preparation time and improve the repeatability of the preparation.

[0005] Similar issues exist for the production of suspension type formulations (including nanosuspensions). This type of formulations is highly advantageous as nanoparticles enable higher drug loadings than other possible approaches. It is also highly advantageous to administer insoluble or poorly soluble drugs as suspensions rather than in their liquid formulation counterpart, as suspension usually leads to higher drug stability. Thus, suspension type formulations are highly advantageous for long-acting injectable medicines. Even though advance was made in the field of particle processing technologies to generate nanoparticle suspensions, it is highly difficult to obtain satisfying formulation with sufficient stability during the period between manufacture and use. For the Formulator, one of the main concerns is to permit easy re-suspensibility of settled particulate matter but also to decrease the sedimentation rate. If the solid particles, which gradually settle, cake too fast inside the syringe, this can cause difficulties or inefficient administration. To overcome this challenge, suspensions may require a reconstitution step just prior use. Thus, there may be chances of non-uniformity of dose at the time of administration if the reconstitution is not properly achieved by healthcare workers or the patient himself.

[0006] Besides, during the past decades, significant progress was made in the field of cell-based therapy. However few improvements were brought in the field of tools and protocol standardization to use for administration even if those steps are highly critical to improve cells survival rates.

[0007] For the most difficult cases, depending on the molecule to emulsify, it can be difficult to obtain a manual preparation stable through time with highly repeatable processes. Due to physicochemical property such as molecule size, salts, polarity, it can be necessary to apply much higher speed and force than what is manually possible in order to obtain stable emulsions with high repeatable and reproducible processes. SUMMARY

[0008] In order to fulfill those objectives, the present invention relates to a carriage unit configured to secure two elongated containers paired together by a fluidic conduct configured to put the two elongated containers in tight fluidic connection, this tight fluidic connection creating a fluidic junction, each of the elongated containers and the fluidic conduct presenting an outer surface, and the fluidic junction presenting an outer surface comprising the outer surface of the fluidic conduct and a distal portion of the outer surface of each elongated container, the carriage unit comprising: a first securing member forming a basis comprising a first restraining surface, a second securing member forming a cover comprising a second restraining surface, the first and second securing members being mobile with regards to each other, between: an inactive configuration in which the first and second securing members are spaced apart from one another and enable the elongated containers to be added or removed from the carriage unit, an active configuration in which the first and second securing members are close to one another and enable the fluidic junction to be secured by the first and second restraining surfaces in direct contact with the outer surface of the fluidic junction and wherein the first and second securing members are further configured to, when the carriage unit is in the active configuration, locally apply a restraining force at the fluidic junction by means of the first and second securing surfaces, the restraining force being regularly spread over the outer surface of the fluidic junction.

[0009] The present invention ensures a strong maintenance of the fluidic junction, enabling fluidic conduct of any kind to be implemented, whatever its thickness, its flexibility or other is. This brings a solution to improve stability and efficiency for mixing sensitive preparations, thus leading to a standardization of extemporaneous preparation involving two containers end-to-end connected. The present invention enables standardized preparation (repeatable and reproducible results) but also time saving and energy (mental and physical) sparing for the healthcare workers and the patients. The present invention thus enables to consider a wider range of possible formulations for the drug as the device enables standardization even if settings, such as speed and time, can hardly be performed manually with appropriate repeatability and reproducibility.

[0010] The carriage unit according to the invention may include one or more of the following characteristics, taken separately from one another or in combination with one another.

[0011] The fluidic conduct may be a connecting element separate from the first and second securing members.

[0012] The fluidic conduct may be comprised within the first or second securing member.

[0013] The carriage unit may comprise a tightening device configured to urge the first and second securing members towards active configuration.

[0014] The first securing member may form a basis and comprises at least one elongated container positioning element configured to maintain each elongated container in a specific predetermined place on the first securing member.

[0015] The at least one elongated container positioning element may be an elongated groove, the first restriction surface being comprised within said elongated groove, the first securing member comprising first and second elongated grooves each extending along a securing axis.

[0016] The securing axis of the first elongated groove and the securing axis of the second elongated groove may be aligned, such that the two elongated containers are paired along the same securing axis, each of the two elongated containers further presenting an axial opening, the fluidic junction being aligned with the securing axis.

[0017] The first and second elongated grooves may extend in the same plane.

[0018] Each elongated groove may be a layered groove configured to accommodate elongated containers having different diameters. [0019] The first and second securing members may be connected to each other by means of a pivot connection.

[0020] The carriage unit may comprise a temperature monitoring and control system configured to monitor and control the temperature of the elongated containers.

[0021] The carriage unit may comprise a leakage recuperation unit.

[0022] A further object of the present invention regards a mixing system configured to mix the content of two elongated containers comprising a mobile end configured to be mobile in translation inside each elongated container so as to define, within each elongated container, a variable volume chamber, said elongated containers being further configured to cooperate with an associated elongated element to translate the mobile end inside each elongated container to vary the volume of the chamber, each associated elongated element comprising a cooperating end cooperating with the mobile end of the elongated container, and an opposite free end, the mixing system comprising: a carriage unit as defined previously, said carriage unit forming a mobile carriage unit, a static unit extending along a circulation axis parallel to at least one of securing axes of the mobile carriage unit, the static unit comprising: a circulation track extending along the circulation axis and on which the mobile carriage unit is mounted so as to be movable in translation along the circulation axis, at least one external flange situated at one of the extremities of the circulation track, the external flange being configured to receive the free end of one of the associated elongated elements.

[0023] The mixing system according to the invention may include one or more of the following characteristics, taken separately from one another or in combination with one another.

[0024] A position of the at least one external flange can be adapted, along the circulation axis, to a length of the elongated container and the associated elongated element. [0025] The mixing system may comprise two external flanges, each flange cooperating with the associated elongated element of one of the two paired elongated containers.

[0026] The mobile carriage unit may be secured in a removable manner to the circulation track.

[0027] The mixing system may be configured to mix the content of the two elongated containers, wherein each flange comprises a pinching system configured to secure the free end of each associated elongated element.

[0028] The mixing system may be configured to mix the content of two elongated containers, wherein each flange comprises an imprint configured to accommodate the free end of each associated elongated element.

[0029] At least one of the free ends of the associated elongated elements may be part of the external flange.

[0030] The mixing system may further comprise an actuation unit configured to move the mobile carriage unit once activated.

[0031] The mixing system may comprise a control unit configured to set at least one movement parameter chosen at least between speed and position of a movement in translation of the mobile carriage unit along the circulation track of the static unit, and to control the actuation unit.

[0032] The control unit may be configured to vary the movement parameter.

[0033] The control unit may comprise at least one sensor configured to measure the movement parameter, the control unit being configured to control the actuation unit based on the measured movement parameter.

[0034] The control unit may comprise at least one sensor configured to measure a fluidic resistance inside the elongated containers.

[0035] The present invention thus proposes a solution to healthcare workers in order to automatize this preparation. [0036] According to another aspect, the invention proposes a mixing kit comprising: a mixing system as defined previously, two elongated containers comprising a mobile end configured to be mobile in translation inside each elongated container so as to define, within each elongated container, a variable volume chamber, said elongated containers being further configured to cooperate with an associated elongated element to translate the mobile end inside each elongated container to vary the volume of the chamber, and a fluidic conduct configured to put the two elongated containers in tight fluidic connection in order to create a fluidic junction, the elongated containers and the fluidic conduct each presenting an outer surface, the fluidic junction presenting an outer surface comprising a distal portion of the outer surface of each elongated container and the outer surface of the fluidic conduct.

[0037] According to another aspect, the invention proposes a mixing method carried out by means of a mixing system as defined previously, wherein the method comprises following steps: securing a first elongated container to a first extremity of the fluidic conduct, securing a second elongated container to a second extremity of the fluidic conduct, adjusting the elongated containers on the first securing member, putting the carriage unit in the active configuration, connecting at least one flange to one of the elongated containers by means of the associated elongated element, moving the carriage unit with respect to the static unit in translation along the circulation axis.

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The invention will be better understood, and other aims, details, characteristics and advantages thereof will emerge more clearly on reading the detailed explanatory description which follows, of embodiments of the invention given by way of illustration, purely illustrative and non-limiting examples, with reference to the accompanying drawings, in which: figure 1 is a perspective view of an assembly two elongated containers, configured as syringes, having axial openings facing each other and connected to one another by a fluidic conduct of a connecting element, figure 2 is a perspective view of one of the syringes of the assembly of figure 1, figure 3 is a perspective view of the connecting element of the assembly of figure 1, figure 4 is a perspective view of a first securing member of a carriage unit according to an embodiment of the invention, the first securing member having a first restraining surface arranged within elongated grooves configured to receive the assembly of figure 1, figure 5 is a perspective view of the carriage unit comprising a second securing member movably mounted of the first securing member of figure 4, the second securing member having a second restraining surface, the carriage unit being in an inactive configuration in which the first and second securing members are spaced apart from each other so as to enable the assembly of figure 1 to be added or removed from the carriage unit, figure 6 is a perspective view of the carriage unit of figure 5 in an active configuration in which the first and second securing members are tightened to enable a fluidic junction including the connecting element and distal portions of the elongated containers to be secured by the first and second restraining surfaces in direct contact with an outer surface of the fluidic junction to apply a restraining force regularly spread over the outer surface of the fluidic junction, figure 7 is a partial view in perspective of a mixing system including a static unit having a circulation track on which the carriage unit of figure 6 is movable in translation, the mixing unit having an actuation unit configured to move the carriage unit, the actuation unit including a pinion and rack arrangement, figure 8 is a perspective view of the mixing system of figure 7 further comprising external flanges arranged to actuate the syringes when the carriage unit reciprocates along the circulation track so as to mix contents of the elongated containers, the mixing system further comprising a control unit for controlling the actuation unit, figure 9 is a variant of the mixing unit in which the actuation unit includes a screw endless screw and nut arrangement.

DETAILED DESCRIPTION

[0039] This invention relates to a carriage unit 10 configured to secure two elongated containers 101, 102.

[0040] The two elongated containers 101, 102, shown in figures 1 and 2, each extend along a central axis and present an axial opening. Each of the two elongated containers 101, 102 comprises a hollow body and a mobile end mounted within the body so as to be mobile in translation along the central axis. Each mobile end thus defines, within each elongated container 101, 102, a variable volume chamber. Each of the elongated containers 101, 102 is further configured to cooperate with an associated elongated element 111, 112 to translate the mobile end inside the body and thus vary the volume of the chamber. A typical elongated element 111, 112 is for example, a piston. Each elongated element 111, 112 thus comprises a free end I l la, 112a and a cooperating end 111b, 112b. The cooperating end 111b, 112b is configured to cooperate with the mobile end of the corresponding elongated container 101, 102. The free ends I l la, 112a are configured to enable actuation of the elongate element 111, 112 in any suitable manner. The elongated containers 101, 102 might be a syringe or a cartridge.

[0041] The carriage unit 10 comprises: a first securing member 12, forming a basis, comprising a first restraining surface S12, a second securing member 14, forming a cover, comprising a second restraining surface S14, a fluidic conduct 16 configured to put the two elongated containers 101, 102 in tight fluidic connection in order to create a fluidic junction J.

[0042] Once secured to the carriage unit 10 (by means of the first and second securing members 12, 14), the two elongated containers 101, 102 are paired together by the fluidic conduct 16. The fluidic junction J thus comprises the fluidic conduct 16 and a distal portion 101D, 102D of each of the two elongated containers 101, 102. The elongated containers 101, 102 each present an outer surface Sioi, S102. The fluidic conduct also present an outer surface S16. As the elongated containers 101, 102 and the fluidic conduct 16 each present an outer surface S101, S102, Si6, the fluidic junction J thus also presents an outer surface Sj. The outer surface Sj of the fluidic function J thus comprises a distal portion of the outer surface S101, S102, of each elongated container 101, 102 and the outer surface Si6 of the fluidic conduct 16.

[0043] The first and second securing members 12, 14 are mobile with regards to each other. They are mobile between two configurations defining relative positions of the first and second securing members 12, 14 regarding each other: o an active configuration in which the relative positions of the first and second securing members 12, 14, close to one another, enable the fluidic junction J to be secured by the first and second restraining surfaces S12, S14 in direct contact with the outer surface Sj of the fluidic junction J and o an inactive configuration in which the relative positions of the first and second securing members 12, 14, spaced apart from one another, enable the elongated containers 101, 102 to be added to or removed from the carriage unit 10.

[0044] When the carriage unit 10 is in its active configuration, the first and second securing members 12, 14 are put, at least partially, in contact with each other and form a housing configured to accommodate the fluidic junction J. In particular regarding the embodiment of figure 5, the cooperation of the first and second restraining surfaces S12, S14 form a housing configured to accommodate an receive at least the fluidic conduct 16. The housing may present a general O shape, or a general U shape presenting dimensions similar to the dimensions of the fluidic junction J. The bottom of the housing is formed in or by the first securing member 12. The top of the housing is formed in or by the second securing member 14. Thus, when the carriage unit 10 is in its active configuration, the first and second securing members 12, 14 locally apply a restraining force at the fluidic junction J by means of the first and second restraining surfaces S12, S14. More precisely, the first and second restraining surfaces S12, S14 cooperate to apply said restraining force at the fluidic junction J. The restraining forces are regularly spread over the outer surface Sj of the fluidic junction J. In particular, the restraining surfaces S12, S14 may be complementary to the outer surface Sj of the fluidic junction J. This way, the restraining surfaces S12, S14 cooperate by friction with the outer surface Sj, the first restraining surface S12 cooperating with a first part of the outer surface Sj of the fluidic junction J and the second restraining surface S14 cooperating with a first part of the outer surface Sj of the fluidic junction J. Considering the embodiment illustrated on figure 5, the first and second restraining surfaces S12, S14 cooperate each with a part of the outer surface Si6 of the fluidic conduct 16 and a part of the outer surfaces S101, S102 of the elongated containers 101, 102.

[0045] The fact that the force is applied around the fluidic junction J and not any other part of the elongated containers 101, 102 has at least two advantages: first, no force is exerted on parts of the body of the elongated containers 101, 102 through which the elongated elements 111, 112 and the mobile end slide, avoiding thus any deformation that would lead to an impediment of the displacement elongated element 111, 112 and the mobile end inside the elongated containers 101, 102, second, the fluidic junction J includes the most resistant part, namely the distal part, of many types of elongated containers 101, 102 like a syringe or a cartridge.

[0046] The active configuration of the carriage unit 10 therefore does not trigger any significant elongated container 101, 102 deformations.

[0047] On the other hand, when the carriage unit 10 is in its inactive configuration, the first and second securing members 12, 14 do not cooperate with each other. In this configuration, the housing is open and can easily be filled with the fluidic junction J.

[0048] As can be seen on figure 3, the fluidic conduct 16 can be a connecting element, like for example a cartridge adapter. This connecting element is external to the securing members 12, 14 and can be, in some embodiments, removably secured to the securing members 12, 14. A connecting element is preferably quite small and flexible, in order to avoid any risk for it to break. It might comprise an external duct which could be removably secured to the securing members 12, 14 or even not secured at all to the securing members 12, 14. In the latter case, the fluidic conduct 16 is secured to the elongated containers 101, 102. For example, the fluidic conduct 16 can be interlocked on the elongated containers 101, 102 in order to form the fluidic junction J. In this case, the fluidic conduct 16 indirectly secured to the carriage unit 10 through its securing to the elongated containers 101, 102. In the represented embodiment, the fluidic conduct 16 is straight and connects the axial openings of the elongated containers 101, 102 thereby providing a straight fluidic junction J. In other embodiments, the fluidic junction J could have any other suitable configuration, the fluidic conduct 16 being conformed accordingly.

[0049] In some embodiments, the fluidic junction 16 can be based on “I-connector technology” developed by companies by Green Peptide, Smiths Medical or Promepla, or the connector DIDRACDLLFT® from Didanorm. In some other embodiments, the fluidic junction 16 can be based on a male/f emale “opening lock opening lock” between the two containers 101, 102 if those comprise a needle.

[0050] In some alternative embodiment, the fluidic conduct 16 is integrated within the first or second securing member 12, 14 and the elongated containers 101, 102 are directly connected to each other through the fluidic conduct rigidly fixed to the first or second securing member 12, 14 in any suitable manner. The fluidic conduct 16 can comprise a needle (or any other piercing means e.g a spike) to pierce a septum, for example. In those embodiments, the first and second restraining surfaces S12, S14 directly cooperate with the outer surfaces S101, S102 of the elongated containers 101, 102. In the active configuration, the housing formed by the first and second securing members 12, 14 is formed around the fluidic conduct 16 is order to still accommodate the fluidic junction J and display the same properties as listed here-above.

[0051] In some particular embodiment (see figure 4), the first securing member 12 forms a basis laying horizontally and configured to contain the elongated containers 101, 102. In this case, the second securing member 14 might form a cover connected to the first securing member 14 by means of a pivot connection along two respective edges facing each other of the first and second securing members 12, 14. Such configuration enables a proper closure on elongated containers 101, 102 which might contain toxic content.

[0052] In order to facilitate the securing of the elongated containers 101, 102 inside the carriage unit 10, the carriage unit may comprise an tightening device 18 configured to urge the first and second securing members 12, 14 towards the active configuration. In the represented embodiment, the tightening device 18 comprises a threaded member mounted on one of the first and second securing members 12, 14 cooperating with a tapped bore arranged in the other of the first and second securing members 12, 14 so that a tightening of the threaded member in the tapped bore imparts the restraining force. In other embodiments, the tightening device could be configured in any other suitable manner, especially implementing an elastically deformable member, such as a spring.

[0053] In some embodiments, the first securing member 12 may comprise at least one, preferably two, elongated container positioning element(s) 20 configured to maintain each elongated container 101, 102 in a specific predetermined place on the first securing member 16. The advantage brought by such a positioning element 20 is to have a total control (with high level of precision) on the position of the elongated containers 101, 102 on the securing elements 12, 14. Such a control leads to a better control of the displacement of the elongated elements 111, 112 inside the elongated containers 101, 102 as will be explained further below.

[0054] In some embodiments, said positioning element 20 might be a gripper or a clamp. As can be seen on figure 4, the elongated container positioning element 20 can, for example, also be an elongated groove, preferably two elongated grooves. More precisely, the first securing member 16 comprises a first and a second elongated grooves 20a, 20b, each extending along a securing axis Ai, A2. In those cases, the first restraining surface Si6 is comprised within said elongated groove(s).

[0055] In some embodiments, each elongated groove 20a, 20b is a layered groove in order to accommodate several elongated containers 101, 102 diameters. In particular, the layered groove has coaxial inner surfaces of different diameters corresponding to different diameters of the body of elongated containers 101, 102. Elongated containers 101, 102 with smaller diameters can be maintained between inner surfaces of smaller diameter of the elongated grooves 20a, 20b, and elongated containers 101, 102 with larger diameter can be maintained between inner surfaces of larger diameter of the elongated grooves. This way, one single groove can accommodate a huge variety of elongated containers 101, 102 regardless of their diameters.

[0056] In some embodiment, each of the first and a second elongated grooves 20a, 20b may have a remaining portion apart from the restraining surface. The remaining portion may have a diameter greater than that of the body of the elongated container 101, 102. Then, the elongated container 101, 102 can be accommodated between the elongated grooves, at a distance from the inner surfaces of the remaining portions, thanks to its distal portion held by the first and second restraining surfaces, directly or through the fluidic conduct.

[0057] In the example illustrated on figures 4 to 6, the securing axis Ai, A2 extend in the same plane and are axially aligned, such that the two elongated containers 101, 102 are paired in the same plane, along the same securing axis. As each of the two elongated containers 101, 102 presents an axial opening, the fluidic junction J is thus aligned with the securing axis Ai, A2. However, in an alternative embodiment, the two elongated containers 101, 102 and the fluidic conduct 16 could be arranged in any other suitable manner.

[0058] Some reactants can deteriorate if heated too much. Therefore, in some embodiments, the carriage unit 10 comprises a temperature monitoring and control system configured to monitor and control the temperature of the elongated containers 101,

102. This way, an operator can act accordingly if a risk of over-heating appears.

[0059] The carriage unit 10 may comprise a leakage recuperation unit. This comes particularly handy in case the manipulate elongated containers 101, 102 contain toxic products which might hurt the operator or damage some material in case some accidental leakage was to come in contact with human skin or sensitive material. Such a leakage recuperation unit prevents this and improves the safety of the manipulation of the carriage unit 10. The leakage recuperation unit may comprise the elongated grooves 20a 20b. For example, in one embodiment, the bottom of each elongated groove 20a, 20b may be made, at least partially, of a porous material which enables leaking liquid to be absorbed by the carriage unit 10. In another embodiment, each elongated groove 20a, 20b, may comprise small grooves which may be able to collect and keep any leaking fluid. In those embodiments, the leakage recuperation unit may further comprise an internal conduct forming a leakage trapping zone. Said leakage trapping zone being connected to the elongated grooves 20a, 20b and thus enabling to safely centrally collect and keep any leaking liquid.

[0060] Once the two elongated containers 101, 102 are paired and secured to the carriage unit 10, the operator can activate each elongated element 111, 112, for example with their thumbs, in a safe and handy way as the elongated containers 101, 102 are maintained in fluidic communication and maintained axially in a stable way. By moving the elongated elements 111, 112 back and forth, the operator is able to mix the contents of both the elongated containers 101, 102.

[0061] However, according to the present invention, the carriage unit 10 is part of a mixing system 100 which can be actuated by an operator in order to mix the content of the two elongated containers 101, 102. The mixing system 100 is therefore configured to mix the content of the two elongated containers 101, 102 secured on the carriage unit 10.

[0062] The mixing system 100 together with the elongated containers 101, 102 form a mixing kit which is ready to be manipulated by the operator.

[0063] Therefore, the mixing system 100 comprises: the carriage 10 unit forming, in this context, a mobile carriage unit, a static unit 22 extending along a circulation axis X parallel to at least one of the securing axes Ai, A2 of the mobile carriage unit 10,

[0064] As represented in figures 7 and 8, The static unit 22 comprises: o a circulation track 24 extending along the circulation axis X, o at least one external flange 26 situated at one of the extremities of the circulation track 24, [0065] The circulation track 24 is configured to receive the mobile carriage unit 10 in order to enable it to circulate in both directions along the circulation axis X with regards to at least one external flange 26. In the embodiments displaying two external flanges 26 (see figure 8), each one at an extremity of the circulation track 24, the mobile carriage unit 10 is configured to circulate between those two external flanges 26.

[0066] In some embodiments, the mobile carriage unit 10 is secured in a removable manner to the circulation track 24. This eases any cleaning process or enables to discard the mobile carriage unit 10 without discarding the whole mixing system 100. This might be important in case the products to be mixed are toxic and safety reasons impose a unique use of said the carriage unit 10.

[0067] In some embodiments, the free ends I l la, 112a, of the associated elongated elements 111, 112 cooperating with the elongated containers 101, 102 to be paired is part of at least one external flange 26. The elongated element 111, 112 can be additionally secured to the external flange or can be directly comprises by the external flange 26. This is a particularly relevant embodiment when considering the mixing of the content of at least one cartridge, for example.

[0068] When the content to be mixed comes from elongated containers 101, 102 having their own elongated element 111, 112, each external flange 26 is configured to receive the free end I l la, 112a of the elongated element 111, 112 associated with one the elongated containers 101, 102. In some embodiments, each external flange 26 thus comprises a pinching system configured to secure the free I l la, 112a end of each associated elongated element 111, 112. In another embodiment, each external flange 26 comprises an imprint configured to accommodate the free end I l la, 112a of each associated elongated element 111, 112. The position of each external flange 26 can moreover be adapted, along the circulation track 24, to the length of each elongated container 101, 102 and the associated elongated element 111, 112. This way, any type of elongated container 101, 102 and their associated elongated elements 111, 112 can be safely secured to the mixing system 100. Preferably, the mixing system 100 comprises two external flanges 26, each flange 26 cooperating with the associated elongated element 111, 112 of one of the two paired elongated containers 101, 102. [0069] Thus, each free end of the elongated containers 101, 102 is secured to its corresponding external flange 26 and the fluidic junction J is secured to the mobile carriage unit 10. When the mobile carriage unit 10 is put into motion along the circulation track 24, the two elongated containers 101, 102 move along while the elongated elements 111, 112 remain static thus leading the elongated elements 111, 112 to slide inside the bodies of the elongated containers 101, 102, modifying the volumes of the internal chambers and thus chasing the content of the first elongated container 101 inside the second elongated container 102 and vice versa, in accordance with the back and forth movement of the mobile carriage unit 10.

[0070] In some embodiments, the mixing system 100 further comprises an actuation unit 28 configured to put the mobile carriage unit 10 into motion once activated. This enables to move the mobile carriage unit 10 at a very quick pace. This is particularly advantageous for emulsion, suspension or preparation of pasty product or jelly/viscous products, as those necessitate either a huge amount of very fast back and for the movements or a great strength for translating the elongated elements 111, 112 inside the elongated containers 101, 102.

[0071] The actuation unit 28 comprises a driving system that might, as depicted on figure 7, include a pinion and rack arrangement 29 or, in a variant shown in figure 9, involves an endless screw and nut arrangement 29’. In the latter case, the endless screw forms the circulation track 4 on which the carriage unit 10 is mounted through the nut. The mobile carriage unit 10 is set in motion thanks to its fastening (screw nut) to the driving system. In this configuration, the connection between the fastening and the mobile carriage unit 10 is preferably reversible.

[0072] The presence of an actuation unit 28 brings solutions to better prepare a cell suspension able to maintain a homogeneous distribution and viability to ensure effective clinical translation, by controlling speed and force when cells are homogenized within the vehicle. It is also an objective of this invention to enable high quality extemporaneous preparation of injectable suspensions. [0073] Regarding the presence of an actuation unit 28 that can achieve a very high speed, it is very important to rely on a securing / fastening system of the elongated containers 101, 102 inside the carriage unit 10 which avoid any mechanical stress on any sensitive part of the elongated cylinders 101, 102: at high speed, any deformation on the elongated cylinders 101, 102 may trigger flexion of the whole mixing system 100, generate resilient forces and leading to damages to the carriage unit 10 and the mixing system 100 and potential harmful situations.

[0074] In order to allow the operator to set a predetermined number of cycles or a predetermined speed, the actuation unit 28 may be connected to a control unit. The control unit may be configured to set at least one movement parameter chosen at least between speed and position of the movement in translation of the mobile carriage unit along the circulation track of the static unit, and to control the actuation unit accordingly. The control unit may comprise at least one sensor configured to measure the speed and/or position of the mobile carriage unit 10. Regarding that some content might be (or become) very viscous, the mixing system 100 may also comprise at least one sensor configured to measure the fluidic resistance inside the elongated containers 101, 102. This enables the mixing system 100 to stop the mixing when the resistance exceeds a threshold number and put, for example, the elongated containers 101, 102 at risk of fissuring or breaking.

[0075] The presence of speed and/or position sensors enables performing advanced and optimized preparations in which strokes of the elongated element within the elongated containers can be modulated, especially in terms of length and speed, whatever the size of elongated containers is. In addition, speed and position sensors enable speed of the carriage unit to be known at any position of the stroke and hence to adapt the movement of the carriage unit accordingly. Product clogging at the beginning of the preparation may also be avoided, for example by detecting a speed decrease. Product clogging can also be detected by an unexpected raise in resistance of the fluid to compression sensed by the sensor measuring the fluidic resistance.

[0076] The mixing system 100 may further comprise limit switches placed either under the static unit 22 or under the mobile carriage unit 10. The present of limit switches implies that only a full displacement up to the limit switch of the mobile carriage unit 10 can allow the mobile carriage unit 10 to reverse its movement along the circulation track 24. This solution can be replaced or added with a motor blockage detection via an encoder, which allows the mobile carriage unit 10 to reverse its motion along the circulation track 24 if a blockage is detected due to potential product clogging. This solution is particularly advantageous in order to control at low or medium speed. In an alternative or complementary manner, a motor blockage detection may be implemented by a software based solution part of the control unit. This allows to set an electric current threshold before stopping the actuation unit 28, (thus to detect at least one of syringe bottom and excessive pushing force). This solution is particularly effective at medium and high speed.

[0077] More precisely, the mixing kit as detailed here-above, enables the operator to carry out a mixing method comprising following steps: securing a first elongated container 101 to a first extremity of the fluidic conduct 16, securing a second elongated container 102 to a second extremity of the fluidic conduct 16, adjusting the elongated containers 101, 102 on the first securing member 12, putting the carriage unit 10 in the active configuration, connecting the at least one external flange 26 to one of the elongated containers 101, 102 by means of the associated elongated element 111, 112, moving manually or automatically the carriage with respect to the static unit in translation along the circulation axis to mix the contents of the first and second elongated containers.

[0078] The activation of the mixing system 100 might comprises at least the following steps: setting a predetermined number of back-and-forth cycles, setting a predetermined speed, and possibly, setting a temperature or fluidic resistance threshold. [0079] The number of back-and-forth cycles as well as the speed can be registered at once, possibly by a qualified operator, and executed automatically by the control unit performing the whole mixing method. Alternatively, these movement parameters could be set separately at one or several stages of the mixing method. In any of the above alternatives, the movement parameters can be varied along the mixing method to have for example a first number of first stages performed at a low speed, and once mixing has been initiated without clogging, a second number of second stages performed at a higher speed.

[0080] Additional step could comprise size selection of the elongated containers, for example among syringes or cartridges of 1 mL, 3 mL and 5 mL, and adjustment of the restraining surfaces of the carriage unit.

[0081] The present invention enables the standardization of complex fluid preparation prior to use. By complex fluid the present specification means, liquid-solid preparation (suspensions), or liquid-liquid preparation (emulsion) or viscous fluid such as gel or hydrogel. The use of the term standardization implies that this invention allows a perfect control of product preparation regarding at least time, product handling and speed in order to obtain highly repeatable results compare to manual preparation made by healthcare workers, patients, trained laboratory workers as example.