Improved mixing device, mixing system and mixing method

Abstract

The mixing device of FIG. 1B comprises a multi-element spring system in which an eccentric load connected to the rotor of the motor is located towards a first end of a first beam that realizes the backbone of the mixing device. One or more connections interconnect the backbone to one or more other beams, respectively, to create the multi-element spring system. A load, such as a vial or other container in which the diluent is located, is located away from the motor. In this way, the spring system supports two independent but complementary eccentric load generating subsystems resulting respectively from the controlled rotation of the rotor [and its eccentric load] and then the pivoting of the diluent in the vial / container in response to the rotation of the connected eccentric load on the rotor. Both of these eccentric loads contribute to the complex multi-directional bending of the multi-element spring system [relative to a fixed anchor point].

Description

[Technical field]

[0001] The present invention generally relates to a mixing device and a mixing method. More specifically, but not exclusively, the present invention relates to a mixer for mixing or reconstituting solids and liquids, particularly in the context of preparing pharmaceutical formulations in which a diluent is introduced into a vial containing a sterile compound, such as a crystal or powder, sometimes requiring homogeneous mixing for just-in-time "water-free" dissolution. However, the present invention has a broader application, particularly for mixing (including dissolving, diluting or suspending) relatively small amounts, and regardless of whether the base component is in liquid or otherwise, and finds application in home mixers for cosmetics such as nail varnish, tattoo ink, food mixing (such as that required for preparing nutritional drinks or liquid-mixable supplements), and even in veterinary medicine for the preparation of pharmaceutical products. [Background technology]

[0002] As is known, drugs are often stored in powder form (lyophilized) since they may degrade quickly when mixed into a solution and, as a result, lose their effectiveness. Powdered drugs are typically used for parenteral administration. These powdered drugs or medicines are often labeled as "powders for infusion" and "powders for injection". Moreover, drugs administered orally are often liquid / solid suspensions, with components settling or separating over time during storage.

[0003] The powdered drugs must be mixed, or reconstituted, in a container (usually a vial) with a liquid, commonly referred to as a "diluent." The liquid suspensions often require manual mixing to homogenize or dissolve the drug prior to administration.

[0004] Once the diluent is added to the powdered drug, the liquid-powder mixture must be stirred in the container until the drug powder is dissolved, i.e., the reconstitution process is complete. For example, the United States Pharmacopeia "USP"

[2006] defines completeness of reconstitution as the complete dissolution of solids leaving no visible residue of undissolved matter, or the reconstituted solution is significantly less clear than an equal volume of diluent or purified water present in a similar container and tested under similar conditions.

[0005] For drugs in suspension, the instruction "shake well before use" is common, but there is no means to test for completeness of mixing or for the specific movements required to achieve an acceptable mix. For drugs and agents delivered by spray, the instructions often contain a similar general "shake well before use" instruction, but the instruction is itself subjective and may be interpreted differently by different people or may otherwise be ignored.

[0006] Currently available solutions to the problem of effective mixing, whether for drug reconstitution [used as a specific example throughout this specification] or other products requiring mixing industrially or at home, focus on either automated systems that aim to optimize the mixing step to achieve the best dissolution and / or mixing for drug reconstitution in the shortest amount of time, or are otherwise manual in nature.

[0007] Commercially available automated / mechanical systems achieve mixing using the following motions: rotating the vessel about its longitudinal axis; rotating the vessel about the central axis of a rotating disk, the vessel having a longitudinal axis parallel or inclined or perpendicular to such axis of rotation; shaking the vessel at variable frequency or amplitude; inducing a vortex in the diluent by a mixing tool immersed in the diluent.

[0008] Manual mixing methods such as shaking and swirling are often performed by technicians such as nurses or pharmacists. The time to achieve effective mixing can take anywhere from a few seconds to a few minutes. It would be impossible for a human to manually repeat complex movements for such a long period of time and achieve consistent results in an easily reproducible manner. In fact, even for expert healthcare personnel, the subjective nature of mixing can result in insufficient dispersion of the active pharmaceutical ingredient prior to administration to the patient.

[0009] Indeed, current practices for the preparation of pharmaceutical products, particularly in the case of just-in-time pharmaceutical products, are unreliable and / or labor intensive, and indeed have several specific problems associated with producing effectively mixed preparations.

[0010] For example, the sterility of the pharmaceutical ingredients must be maintained whether liquid, solid or mixed, i.e. the vial is permanently sealed and the diluent is preferably introduced through seal penetration rather than opening to avoid air exposure. Magnetic or physical mixing techniques, such as introducing a magnetic stirrer or rod, respectively, into the vial, are further frowned upon because the stirrer / rod, respectively, are foreign objects and added cost items, and both may compromise sterility depending on how the foreign object was previously handled or introduced.

[0011] In some instances, due to the lack of effective mixers on the market, mixing of certain medications is frequently, if not entirely, performed manually. Such manual mixing is a specialized skill that requires (a) proficiency in producing the necessary swirling technique for the vial contents, (b) physical strength, and (c) effort. In an example situation, the drug Tazocin® is notoriously difficult to mix, taking more than 10 minutes to mix to a "water-free" state with no visually identifiable particulates. Such manual processing can lead to (a) repetitive strain injuries, and / or (b) suboptimal mixing and, therefore, (c) suboptimal dosing resulting from a lack of objectivity in manufacturing. At least some of these mixing problems lead to questions regarding the efficacy of the reconstituted medication and, therefore, patient outcomes.

[0012] The time-consuming nature of manual medication reconstitution is exacerbated by staff shortages, while the costs associated with ineffective and / or inefficient manual mixing are substantial. None of these issues are conducive to value-based care.

[0013] The need for "just-in-time" drug reconstitution dictates local, time-sensitive drug reconstitution, which requires the presence of trained medical personnel, which is not always possible due to the time of day or location where reconstitution is required.

[0014] There is a need for an efficient mixing apparatus and associated methods for effectively making up or reconstituting pharmaceuticals, or more generally, a mixing apparatus that provides effective mixing of other commercial products such as household paints, varnishes, food products, etc. in a consistent and reproducible manner. Summary of the Invention

[0015] According to a first aspect of the invention, there is provided a method for producing a mixing device comprising: a rotary actuator applying an eccentric load; a controller providing parameter control defining the operation of the rotary actuator and an instantaneous amount of energy provided to the mixing device at least in part through the controlled rotation of the eccentric load; a mount configured to rigidly hold the rotary actuator; a clamp configured to hold a mixing container representing a mass, the mixing container containing at least one liquid as part of a collection container's contents; and a multi-element spring including a plurality of coupling beams each providing at least one degree of motion, the multi-element spring including: a primary beam having a proximal end and a distal end, the primary beam separating the proximal end from the distal end, the actuator mount and the rotary actuator being rigidly connected substantially at the proximal end, and a lateral side plate configured to provide a bending motion associated with the controlled rotation of the eccentric load. a multi-element spring that is subjected to a bending moment; a second beam secured to a distal end of the main beam via a first substantially rigid hinge, the second beam extending outwardly relative to the main beam, the first substantially rigid hinge allowing bending movement of the second beam relative to the main beam, the second beam further securely holding the clamp and, in use, the mixing container; a third beam secured to a portion of the main beam via a second substantially rigid hinge, the third beam extending outwardly relative to the main beam and in a different orientation relative to an orientation of the first substantially rigid hinge: the outward extension of the third beam increases from the second substantially rigid hinge over a width of the third beam; and the third beam positioned to allow differing amounts of bending movement along the second substantially rigid hinge when further connected to a stable brace structure in use.

[0016] In an embodiment of the invention the control device is arranged to operate in at least two stages distinguished between a primary stage transitioning to a kick stage, in which the energy profile delivered by parameter control of the rotary actuator changes significantly with respect to that of the primary stage.

[0017] The primary stage induces motion in the contents of the collection vessel in the attached mixing vessel, and the kick stage is arranged to generate a high speed swirling motion in the contents of the collection vessel, which may resemble a vortex. The swirling motion may also be generated gradually.

[0018] In an embodiment, the controller may be arranged to vary the rotational speed of the rotary actuator and the eccentric load to create various rotational speeds. Control of additional selected actuator parameters may include control of at least one of a duty cycle in a pulse width modulated signal that controls the rotation of the rotary actuator and the eccentric load, and a voltage supply to the motor of the rotary actuator to affect a change in current through the motor. As described herein, the controller may control operation of the rotary actuator to control the supply of energy to the system until complete mixing or dissolution of the contents in the mixing vessel is achieved.

[0019] In the described embodiment, the control device is arranged to instantiate a primary stage of inducing a chaotic movement by shaking the contents of the collection vessel in the attached mixing vessel, and then at least a secondary stage of inducing a swirling movement in the contents of the collection vessel.

[0020] In various described embodiments, the controller is arranged to operate to control the supply of energy to the mixing device supplied by operation of a rotary actuator, the rotary actuator having functionality including at least one of a linear variation in the energy supplied, an exponential variation in the energy supplied, and a non-linear variation in the energy supplied.

[0021] In accordance with the present invention, the movement of the contents of the collection vessel represents a secondary eccentric load that induces further bending motion by generating dynamic bending forces in the multi-element spring resulting from time-varying loads acting at the proximal and distal ends of the primary beam.

[0022] Preferably, the multi-element spring is of unitary construction, such as molded as a single piece of plastic material.

[0023] In another aspect of the invention, a multi-element spring is provided that includes: a rotational actuator supporting a first eccentric load, the rotational actuator responsive to a control program that defines how energy is imparted to the mixing device through time-varying rotational control of the first eccentric load; and a multi-element spring including a plurality of coupling beams each providing at least one degree of motion in a different plane of motion for each of the plurality of coupling beams, at least one pair of the plurality of coupling beams being connected to one another by a substantially rigid hinge, one of the plurality of beams being a backbone having a first end to which the rotational actuator and the first eccentric load are rigidly secured. There is provided a mixing apparatus comprising: a base; a second end remote from the first end, the second end having a clamp for securing the mixing vessel during use, the clamp proximate the second end and spaced apart from the first end; wherein the multi-element spring is arranged to flex with multiple degrees of freedom in response to a combination of action and reaction forces induced by rotation of a first eccentric load at the first end and a secondary eccentric load held proximate the clamp, the second eccentric load being induced substantially by rotation of the first eccentric load, the second eccentric load generating a reaction force at least in part via the base.

[0024] A second link beam of the plurality of beams has an effective variable stiffness longitudinally along the length of a substantially rigid hinge connecting the second link beam to the backbone.

[0025] In a further aspect of the invention, a mixing system is provided in combination with a sealed vial realizing a mixing vessel, the sealed vial being internally sterile and containing a sterile compound dissolved, diluted or suspended in or by a sterile diluent introduced into the vial by seal permeation.

[0026] In another aspect of the invention, a method is provided for dissolving or intimately mixing a sterile compound or solid into a diluent or liquid introduced into a sterile vial initially containing (a) a sterile compound or solid and (b) a gas, the method comprising generating a plurality of time-varying dynamic multi-directional bendings in individual elements of a multi-element spring of a mixer to induce a swirling motion of the diluent within the vial, the initial motion of the diluent being generated by bending the individual elements of the multi-element spring of the mixer while the vial is held firmly at or near a remote second end of the first element. the time-varying dynamic multi-directional bending in the elements of the multi-element spring is produced by selectable motor-driven rotation of a mixer first eccentric load at a proximate first end of the first element, relative to a substantially kinematically stable brace point to which one element of the multi-element spring is rigidly fixed; and controllably causing a change in energy imparted to the multi-element spring by varying operating parameters of the motor driving the rotation of the first eccentric load to create at least a swirl in the diluent of the sterile vial.

[0027] In this manner, the swirling occurs before a vortex is formed within the contents of the sterile vial. Additionally, the movement of the contents within the vial represents a secondary eccentric load that induces a compound bending by generating dynamic bending forces within the elements of the multi-element spring, the compound bending occurring from at least different positions relative to a time-varying load applied to the separated proximal and distal ends of the first element.

[0028] In a preferred method of dissolution or homogenization, mixing is promoted by causing a change in the rotational speed of the contents in the vial by the rotational speed of the first eccentric load. The change in rotational speed is caused by at least one of a change in the duty cycle of a pulse width modulated signal controlling the rotation of the first eccentric load, a change in frequency modulation rate, and a change in voltage supplied to a motor controlling the rotation of the first eccentric load to affect a change in current in the motor. Preferably, the method provides for a controlled supply of energy to the mixer until mixing or dissolution of the contents in the mixing vessel is achieved.

[0029] In yet another aspect of the present invention, there is provided a method of dissolving or diluting or suspending a compound with a diluent introduced into a mixing vessel tightly held by a mixer, the method comprising:

[0030] combining a diluent and a compound in a mixing vessel to form a mixture;

[0031] initially shaking or pivoting the mixture by dynamically bending a plurality of elements of a multi-element spring in different planes of motion, the bending being initially induced by rotation of a first eccentric load by a rotational actuator at a first end of a primary structural element of the multi-element spring, the shaking or pivoting of the mixture resulting from multi-planar bending of the primary structural element connected by at least a first connection to a reference structural element; the reference structural element also bending relative to a stable brace structure;

[0032] a microprocessor-based controller providing parameter controls defining an instantaneous amount of energy provided to the mixing device through operation of the rotary actuator and controlled rotation of the first eccentric load; and

[0033] inducing a complementary secondary bending in the multi-element spring by pivoting or shaking the mixture under said rotational action, the complementary secondary bending producing a spatially separated second eccentric load, the spatially separated second eccentric load being generated in the mixing vessel, the mixing vessel being securely held by a clamp, the clamp being securely fastened to or adjacent the second end of the main structural element;

[0034] and controllably varying or maintaining motion of the first eccentric load at the first end to supply energy to the mixer.

[0035] The mixing vessel may be one of: an open-top vessel; a sealable vessel having a replaceable top or cap; a pre-sealed vessel that contains the contents and allows the pre-sealed vessel to be pierced to introduce a diluent.

[0036] In another aspect of the invention, there is provided a mixing device comprising: a multi-element spring including a plurality of coupling beams each supporting a plurality of planes of motion, at least one pair of the plurality of coupling beams being connected to one another by a substantially rigid hinge, the at least one pair including: a base beam having a first end arranged to securely hold a rotational actuator supporting a first eccentric load, and a second end remote from the first end, the second end including a clamp for securing a mixing vessel in use; and a reference beam coupled to the base beam along the substantially rigid hinge, the reference beam extending outwardly relative to the base beam, the reference beam having an effective variable stiffness in a longitudinal direction relative to an orientation of the base beam, the multi-element spring being arranged to flex with a plurality of degrees of freedom in response to a combination of complementary forces resulting from rotation of the first eccentric load and a secondary eccentric load held in the clamp, the secondary eccentric load being substantially induced in response to rotation of the first eccentric load.

[0037] The reference beam may be inclined at an angle ranging from about 5 degrees to about 90 degrees with respect to the backbone beam. The angle depends on the variable stiffness of the reference beam. In a preferred arrangement, the relative motion of the reference beam with respect to the backbone beam is differential. In one or more embodiments described herein, the reference beam is comprised of multiple discrete elements having different stiffnesses.

[0038] Optionally, at least one of the plurality of bond beams may include one or more material reliefs defining various shapes within or on the surface of the beam, the material relief being at least one of an end notch, a hole, a channel, a variable length, and a variable thickness.

[0039] According to a first aspect of the invention, there is provided a mixing device comprising: a rotary actuator applying an eccentric load; a controller for parameter control of the rotary actuator to at least partially control energy supplied to the mixing device through controlled rotation of the eccentric load; a mount configured to hold the rotary actuator; a clamp configured to hold a mixing vessel representing a mass, the mixing vessel containing at least one liquid as part of a collection vessel's contents; and a multi-element spring including a plurality of coupling beams each providing at least one degree of motion, the coupling beam having: a primary beam having a proximal end, a distal end, and a bottom edge, the mount and the rotary actuator being substantially parallel to the primary beam. A blended device is provided that includes a multi-element spring including a primary beam rigidly connected at a proximal end; a second beam secured to a distal end of the primary beam via a first substantially rigid hinge, the second beam extending outwardly relative to the primary beam, the first substantially rigid hinge allowing bending movement of the second beam relative to the primary beam, the second beam further retaining a clamp; and a third beam secured to a portion of a lower edge of the primary beam via a second substantially rigid hinge, the third beam extending outwardly relative to the primary beam and positioned to allow differing amounts of bending movement along the second substantially rigid hinge when further connected to a stable brace structure in use.

[0040] Also disclosed herein is a mixing system comprising a mixing apparatus of various aspects (and a number of preferred embodiments), wherein the second bonding beam is fixedly secured to a stable reference structure, and wherein the second bonding beam is arranged to flex relative to the stable reference structure in use.

[0041] Also disclosed is a multi-element spring in which at least one combination connection is substituted for a substantially rigid hinge connected to a beam, which allows for the realization of a functionally equivalent combination connection in the form of a curved beam.

[0042] The present invention further includes a rotary actuator that applies the eccentric load, a controller that performs parametric control defining the operation of the rotary actuator and an instantaneous amount of energy that is at least partially provided to the mixing device through the controlled rotation of the eccentric load, a mount configured to securely hold the rotary actuator, and a clamp configured to hold a mixing container, the mixing container including at least one liquid as part of the contents of the collection container, and a multi-element spring including a plurality of structural elements connected to each other by at least one connection, the at least one connection supporting relative dynamic changes in orientation between the connected structural elements under dynamic load, the multi-element spring having a proximal end and a distal end. A mixing device is disclosed that includes a main structural element having a multi-element spring, the mount and rotational actuator being securely coupled substantially at or toward a proximal end and at or toward a distal end, the clamp being secured to securely hold a mixing container within the mixing device in use, and a reference structural element connected to a portion of the main structural element through a first connection, the reference beam extending relatively outwardly from the main structural element and in different orientations relative to an orientation of the main structural element, the reference structural element having a shape designed to allow different amounts of bending movement relative to a stable brace structure when further connected to the stable brace structure in use.

[0043] Also disclosed is the mixing device of the previous paragraph, wherein a support structural element is interposed between the distal end of the main structural element and the clamp, the support element extending relatively outwardly from the main structural element and in a different orientation relative to the orientation of the main structural element, and the clamp is secured to the support structural element.

[0044] Also disclosed is a mixing device in which at least two of the main structural element, the reference structural element, the support structural element, the clamp, and the mount are formed as a continuum.

[0045] For clarity, it will be readily understood that a structural element may be an interlocking connection, a beam, a cantilever, or an arrangement of interlocking elements arranged to act as a beam(s) or system of beams, or a functional equivalent such as, for example, a lattice structure.

[0046] Broadly, one aspect of the invention relates to a system for mixing or dissolving one or more ingredients or compounds with a liquid, the system comprising: a container for holding the one or more ingredients or compounds and the liquid; (a) a mixer having a plurality of beams, each beam interconnected by a substantially rigid hinge, wherein the beam-to-hinge combination or combination connection is configured such that, under an applied motor-induced force, at least: a portion of the plurality of beams and / or combination connection bends or curves in one or more planes of motion, and a portion of the plurality of beams and / or combination connection bends or curves in one or more planes of motion. (b) a mixer, in which a beam forms a multi-element spring that undergoes relative angular or linear displacement in different planes of motion with respect to the beam; and (b) two eccentric loads located apart from each other but attached to the multi-element spring, wherein: the first eccentric load is an eccentric mass on the rotor of a controllable motor; and the second eccentric load is generated by agitation of one or more ingredients or compounds and the liquid, the agitation following bending and displacement of the multi-element spring due to motor-induced forces introduced into the multi-element spring by controlled operation of the motor.

[0047] The present invention, in its various aspects and embodiments, provides a mixer that can achieve faster and generally better dissolution / homogenous mixing for pharmaceutical formulations and other small volume emulsions or solutions, however, the concepts of the present invention may be extended for larger volume mixing.

[0048] The present invention thus provides a new and improved mixer. Generally speaking, the mixer includes a combination of connected spring beams or cantilevers connected via a substantially rigid hinge or functional equivalent, the structure preferably being manufactured as a single piece. The mixer is driven by a motor having an eccentric load, which when rotated induces a torsional or bending force throughout the multi-element spring. However, some of the spring system may be adapted to a brace. The beams create multiple planes / degrees of motion within the multi-element spring, which in use are transferred to the contents of, for example, a vial that is rigidly but removably attached to the mixer. Thus, in use, the contents of the vial undergo mixing, the nature and direction of the mixing being governed by the multiple planes / degrees of freedom of motion.

[0049] Once a swirling motion is induced in the contents (from the sum of the bending forces induced by the programmable operation of the motor and the movement of the eccentric load), the moving contents act as a complementary (reinforcing or destructive) secondary eccentric load. The system is thus subjected to complex and complementary torsional forces emanating from the vial, further complicating the movements within the multi-element spring. A second triggering event, controlled by the operation of the motor, is employed to, at the limit, cause the contents of the vial to form a vortex. The overall arrangement has been proven to establish effective mixing.

[0050] Depending on the combination of forces generated by the rotation of the motor shaft and associated eccentric mass on the rotor, the forces caused by the movement of the contents within the vial / container, and the forces generated by the spring beam arrangement, many generally discernible fluid motions can be achieved within the vial, including at least shaking, vibrating, swirling, and vortexing. [Brief description of the drawings]

[0051] Exemplary embodiments of the invention are described below with reference to the accompanying drawings.

[0052] In Figure 1: [Figure 1A]1 shows a perspective view of a mixing device according to a preferred embodiment of the present invention. [Figure 1B] 1 shows different perspective views of a mixing device according to a preferred embodiment of the present invention;

[0053] [Diagram 2] 1A and 1B show an embodiment of the mixing device. [Diagram 3] 1A and 1B show dimensions of an embodiment of the mixing device.

[0054] [Figure 4] FIG. 2 shows a perspective view of a mixing device according to a first alternative construction arrangement. [Diagram 5] 1 shows different perspective views of a mixing device according to a first alternative construction arrangement.

[0055] In [Figure 6]; [Figure 6A] FIG. 2 shows a perspective view of a mixing device according to a second alternative construction arrangement. [Figure 6B] 1 shows a different perspective view of a mixing device according to a second alternative construction arrangement. [Figure 6C] 1 shows a partial assembly view of a mixing device according to a second alternative construction arrangement.

[0056] In [Figure 7]; [Figure 7A] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 7B] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 7C] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 8A]The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 8B] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 8C] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 9A] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 9B] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown. [Figure 9C] The FEA approximation of the relative motion of components, beams, and hinges over time and with applied direction of force for the mixer system and multi-element spring [Figure 2] is shown.

[0057] In [Figure 10]; [Figure 10A] 3 shows photographic images taken with a high speed digital camera of in-cycle operation of a mixing device fabricated according to the design of FIG. 2. [Figure 10B] 3 shows photographic images taken with a high speed digital camera of in-cycle operation of a mixing device fabricated according to the design of FIG. 2. [Figure 10C] 3 shows photographic images taken with a high speed digital camera of in-cycle operation of a mixing device fabricated according to the design of FIG. 2. [Figure 10D] 3 shows photographic images taken with a high speed digital camera of in-cycle operation of a mixing device fabricated according to the design of FIG. 2. [Figure 10E]3 shows photographic images taken with a high speed digital camera of in-cycle operation of a mixing device fabricated according to the design of FIG. 2.

[0058] In [Figure 11]; [Figure 11A] 1 shows images of the evolution of orbital motion relative to identified features of a mixing device manufactured according to the design in [Figure 2], mapped by tracking software. [Figure 11B] 1 shows images of the evolution of orbital motion relative to identified features of a mixing device manufactured according to the design in [Figure 2], mapped by tracking software. [Figure 11C] 1 shows images of the evolution of orbital motion relative to identified features of a mixing device manufactured according to the design in [Figure 2], mapped by tracking software. [Figure 11D] 1 shows images of the evolution of orbital motion relative to identified features of a mixing device manufactured according to the design in [Figure 2], mapped by tracking software. [Figure 11E] 1 shows images of the evolution of orbital motion relative to identified features of a mixing device manufactured according to the design in [Figure 2], mapped by tracking software.

[0059] In [Figure 12]; [Figure 12A] A basic diagram of a mixing device with an alternative structural arrangement that is functionally equivalent to the two-beam configuration in [Figure 6] is shown. [Figure 12B]

[0033] Figure 6 shows a basic diagram of a mixer with an alternative structural arrangement that is functionally equivalent to the two-beam configuration of Figure 6, as well as the three-beam mixer arrangement of Figures 1A and 1B.

[0060] In [Figure 13]; [Figure 13A] 1 shows an alternative, functionally equivalent hinge and beam construction that produces the substantially rigid hinge and associated connecting beam of FIG. 1 and other figures. [Figure 13B]1 shows an alternative, functionally equivalent hinge and beam construction that produces the substantially rigid hinge and associated connecting beam of FIG. 1 and other figures. [Figure 13C] 1 shows an alternative, functionally equivalent hinge and beam construction that produces the substantially rigid hinge and associated connecting beam of FIG. 1 and other figures.

[0061] In [Figure 14] [Figure 14A] 13A-13C show diagrams of alternative functionally equivalent arrangements of a three-beam mixer incorporating one or more substantially rigid hinges to provide further alternative structural arrangements for the multi-element spring of the present invention. [Figure 14B] 13A-13C show different views of alternative functionally equivalent arrangements of a three-beam mixer incorporating one or more substantially rigid hinges to provide further alternative structural arrangements of the multi-element spring of the present invention. [Figure 14C] 13A-13C show different views of alternative functionally equivalent arrangements of a three-beam mixer incorporating one or more substantially rigid hinges to provide further alternative structural arrangements of the multi-element spring of the present invention.

[0062] In [Figure 15]; [Figure 15A] 13A-13C show diagrams of yet another alternative functionally equivalent arrangement of a two-beam mixer incorporating at least one substantially rigid hinge and connecting beam, realizing another alternative structural arrangement of the multi-element spring of the present invention. [Figure 15B] 13A-13C show different views of yet another alternative functionally equivalent arrangement of a two-beam mixer incorporating at least one substantially rigid hinge and connecting beam, realizing another alternative structural arrangement of the multi-element spring of the present invention.

[0063] In [Figure 16]; [Figure 16A] 17B shows an FEA approximation of time and applied directional force describing the relative motion of various components of the multi-element spring mixer embodiment of FIG. 17A. [Figure 16B]17B shows an FEA approximation of time and applied directional force describing the relative motion of various components of the multi-element spring mixer embodiment of FIG. 17A.

[0064] In [Figure 17]; [Figure 17A] 6 illustrates another configuration of a mixing device incorporating the multi-element spring and multi-eccentric load principles of the present invention, and an alternative embodiment of the combination connection directly replaces the hinge shown in FIG. [Figure 17B] FIG. 1 shows an illustration of a generated multi-element spring and beam arrangement generated by an artificial intelligence (AI)-enabled generative design module of a computer-aided design (CAD) package. [Figure 17C] 1 shows different views of a generated arrangement of multi-element springs and beams generated by an artificial intelligence (AI)-powered generative design module of a computer-aided design (CAD) package. [Figure 17D] 1 shows different views of a generated arrangement of multi-element springs and beams generated by an artificial intelligence (AI)-powered generative design module of a computer-aided design (CAD) package. [Figure 17E] 1 shows different views of a generated arrangement of multi-element springs and beams generated by an artificial intelligence (AI)-powered generative design module of a computer-aided design (CAD) package.

[0065] [Figure 18] 17B to 17E are renderings of the AI ​​CAD tool generated models. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] Reference is now made to Figures 1A and 1B, which show different perspective views of a mixing device 100 according to a preferred embodiment of the present invention, and to Figures 2 and 3, which show and reflect general but approximate dimensions of the various components (and therefore general dimensional ratios) for an established example of a mixing device embodying the concepts of the present invention.

[0067] The mixing device 100 is based on bending interactions of multiple (at least two, typically three) beams 102-104 and beams 102-106, respectively, in different planes of motion relative to a fixed anchor point 108, such as a heavy stable block or other bracing structure. Such bending, which results in relative displacement between the beams as well as in-plane torsional strain of one or more beams, is initially caused by the controlled rotation of a rotor 110 of a motor 112, which is rigidly fixed at or towards a first end 116 of a first beam 102 (also called the "backbone 102" or "main beam 102"), such as via a clamp 114. The rotor 110 supports, i.e., bears, an eccentric load 118. The interconnected beams 102-106 thus realize a multi-element spring.

[0068] The backbone 102 may be considered to have a shape such as generally rectangular, however, it may include generally radially shaped edge notches 122-124 along the periphery of the backbone 102, and optionally weight reducing and / or strength reducing notches 120 in that region. However, the shape is a design option, and the shape may be generally symmetrical or may have asymmetrical features. The edge notches 122-124 define connection points of the backbone 102 to other bending beams: (1) at least laterally extending lateral beams (or reference beams) 104 that project outwardly from or near the lower or bottom edge of the backbone, and (2) an optional but generally preferably present support beam 106 that also extends generally outwardly and away from the backbone 102, extending from a second end 134 of the backbone 102 and having a different orientation (i.e., inclined if not tangential) than the lateral beams 104. Thus, the first and second ends of the backbone define the length of the backbone 102 between its proximal and distal ends.

[0069] The connection points between the backbone 102 and each of the lateral beams 104 and support beams 106 are via respective substantially rigid hinges 126-128. For clarity, "substantially rigid" means that the hinges are generally stable, although bending or twisting may be induced within or along the length of the hinge when sufficient force is applied to the elements that make up the multi-element spring. Each substantially rigid hinge 126-128 allows bending movement of the respective beam relative to the backbone 102.

[0070] The support beam 106 can securely attach a container, such as a vial 130, to the support beam 106 via a suitable clamp 132. The attachment is generally centered along the support beam 106, but the exact location is a design option. The support beam is optional because, in one embodiment, the vial 130 can simply be secured to the second end 134 via a suitable clamp or end loop, although such securing reduces the overall movement of the vial 130 and does not provide physical support for the vial 132, but reduces the overall mass and complexity of the mixing device 100. The support beam 106 is shown in the exemplary embodiment of FIGS. 1A and 1B and 2 as being generally square in shape, but other shapes are possible, including, for example, those having corner notches that may define hinge connections to portions of the backbone 102.

[0071] The transverse beams 104 may extend substantially tangentially from the plane of the backbone 102, but alternatively, the transverse beams may be angularly inclined (not solely or superficially perpendicular to the backbone 102). To introduce flexure and movement to the backbone 102 and the transverse beams 104, the transverse beams 104 may be realized as variable length beams with varying bending forces across the width of the beam. Thus, the transverse beams 104 may be realized as generally rectangular plates fixedly attached, such as by means of diagonally offset screws or functional equivalents, to underlying triangular anchor points 108 or other suitably shaped stable anchors, as best shown in FIG. 1B. For example, the contact area between the brace structure and the transverse beams 104 may be triangular, with the two sides of the triangle being the two sides of the transverse beams, and the hypotenuse of the triangle bisecting the transverse beam from one angle to another. This is illustrated by the arrows L, L' to L" of the various lengths of the transverse beams 104 in [Figure 2]. Thus, the amount of bending movement of the transverse beams 104 increases across the width of the beam as a result of the shape and interconnections with the anchor points 107. In this manner, the transverse beams [or any functionally equivalent structure such as arcs] are arranged to allow different amounts of bending movement along the substantially rigid hinges connecting the transverse beams 104 to the backbone 102 when further connected to a stable bracing structure in use. The bracing structure supporting the anchor points may be the stand or base of the mixing device. Bending of the transverse beams can be achieved by making the contact area between the bracing structures smaller than the third beam. The contact area can be shaped to change the degree and direction of bending.

[0072] 1A, 1B and 2 are thus variable length beams that support the movement of the multi-element spring / composite in different planes of motion relative to other structural features of the multi-element spring (such as support beams) under various applied directional forces. Also, all bending forces within the multi-element spring are relative to the motion stability of the bracing structure / anchor points 108.

[0073] As alluded to above (FIGS. 1A and 1B), but not shown, in a sterile system, the diluent may be loaded into a syringe and then introduced into the interior of the [glass] vial 130 by the syringe needle piercing a self-sealing butyl membrane 150 set within a foil cap 152 (in FIG. 1B).

[0074] For example, the transverse beams of the embodiments of Figures 1A, 1B and 2 may be realized by alternative structures such as simple springs 500 or torsion spring configurations 600-604, as shown in the alternative mixer embodiments of Figures 4 and 5 (simple springs) and Figures 6A, 6B and 6C (torsion springs), respectively. Functionally, however, these alternative embodiments function in the same manner as Figures 1A and 1B, as both the backbone 102 and the support beams 106 still undergo bending and / or planar or angular displacement under applied directional forces. In fact, as will be described below, particularly with reference to (but not limited to) Figures 12A and 12B, the simple springs 500 may be considered "combined connections". However, the physical shape of the stable anchors or brace points 108 may be altered to take into account the obvious connection requirements of each simple or torsion spring arrangement. Thus, the simple or torsion springs, respectively, provide additional motion to the mixer's multi-element spring, and these motion capacities are harnessed by the placement and operation of the eccentric loads from (i) the action force arising from the eccentric load of the motor and (ii) the reinforcing reaction force component resulting from the resulting stirring and swirling of the liquid and / or solid compounds / ingredients in the vial.

[0075] This is subject to control by the motor controller 160 (see FIG. 1A) with respect to the operation of the motor. For a typical pharmaceutical mixer, the typical mass of the eccentric load is in the region of about 30 grams (g) to 40 g. The motor typically has a body height of about 30 millimeters (mm) and a diameter of 25 mm. The rotation speed is, and preferably is, varied during the course of mixing in order to give the system a kick that encourages the formation of a vortex in the contents of the vial, but in FIGS. 1A and 1B (for the exemplary preparation of Tazocin®) the rotation speed is selected to be in the exemplary but typical range of 1 revolution per second (1 r / s) to about 14 r / s. Without wishing to be bound by theory, this rotation speed depends on the desired fluid movement and, for other preparations, also on the load, size and overall configuration of the multi-element spring of the mixer.

[0076] Typical vial masses are in the region of about 90g to 100g, including 20ml of water and 4.5g of powdered drug capacity. The vial has a nominal diameter of 46mm and a height of 73mm (for a 50ml Type II glass vial with a butyl rubber stopper and an aluminum / plastic seal). Thus, vial mixing volumes of drug are in the typical range of a few milliliters to tens of milliliters. As will be appreciated by those skilled in the art, scaling to larger volumes requires sufficient strengthening of the planar intersection to handle the increased forces resulting from the increased mass in the components being mixed.

[0077] The multi-element spring of the mixer 100 is preferably one-piece in construction, such as a molded body. Suitable materials for the multi-element spring include rigid plastics. A suitable plastic is polyoxymethylene "POM" (acetal), although other rigid plastics may be used. Acetal is a common engineering plastic best known for its strength, stiffness, and ability to withstand a variety of harsh conditions. Other suitable materials include metals, metal alloys, carbon fiber and fiberglass composites, or hybrid material constructions that exhibit "spring" properties, as will be appreciated. These include beryllium copper alloys, titanium alloys, spring steel, and titanium.

[0078] The materials and geometry of the multi-element spring, including the substantially rigid hinges, thus provide a sufficiently robust, rigid and flexible structure that resists deformation and is capable of repeated bending in multiple planes when placed under forces in various directions. As will be readily understood, stiffness relates to how a component bends under a load versus returning to its original shape when the load is removed. Thus, an applied force can bend, induce strain, and stretch to some degree each component of the multi-element spring of the mixer of the present invention.

[0079] Schematically, one or more substantially rigid hinges interconnect the backbone 102 to one or more other beams, respectively, to create a multi-element spring system. A load, such as a vial or other container containing a mixture of diluent and compound, is located away from the motor. In this way, the multi-element spring system supports two independent yet complementary eccentric load generating subsystems, each resulting from the controlled rotation of the rotor (and its eccentric load) and then the swirling of the diluent in the vial / container in response to the rotation of the connected eccentric load on the rotor. The effect of the eccentric load on the motor can be varied by changing at least one of the position and mass of the eccentric mass relative to the motor. Both of these eccentric loads contribute to a complex multi-directional bending of the multi-element spring system [relative to the fixed anchor point 108], which acts to induce a vortex in the contents of the vial, a desired fluid motion that promotes mixing. The nature of the mixing is very complex and does not result in a simple vortex as would be seen, for example, with a vortex mixer. In fact, the relative motion of the interconnected beams 102-106 via the substantially rigid hinges 126-128 is quite complex.

[0080] It will be appreciated that the positioning of the attached motor (including the driving eccentric mass) and vial (with enclosed contents) results in a small biased preload on the multi-element spring arrangement. More specifically, once the mixer is loaded with a vial, equilibrium conditions bias the complex spring system such that the center of gravity of the system induces some slight twisting of the backbone 102 along the two substantially rigid hinges 126-128. As a result, under stable conditions, the motor and vial may be slightly bowed forward and tilted to the side, i.e., there is a small angular tilt in both the backbone 102 and the outwardly extending lateral beams 104 relative to a vertical reference [defined relative to the backbone] and a horizontal reference [defined relative to the outward extension of the lateral beams 104], respectively. The effect is that during motor operation and mixing activity, as the tilt angles of the various spring beams are bent backwards and upwards relative to the vertical and horizontal references, a random scouring motion is initially created within the vial contents as they overcome the additional force of gravity. Eventually, operation of the system will bring it to a state of resonance where the motion of each of the system's multiple spring beams is no longer extreme, but at this point mixing has progressed sufficiently that a vortex of the contents has formed or is forming.

[0081] With regard to the functional operation of the mixing device of the present invention, the eccentric load 118 on the rotor 110 of the motor 112 is controllably rotated (usually clockwise) to induce a force on the rigidly constrained (with respect to the brace point 108) multi-element spring. This results in the movement of the vial and its contents. When the speed of the eccentric load is programmatically changed (usually increased), the sum of the action and reaction forces (from the moving masses of the motor assembly and the vial assembly, respectively) and the energy storage in the spring results in an elliptical movement of the vial [it should be noted that other patterns may occur, but are rarely circular in nature]. The elliptical movement is usually not symmetrical about the elliptical axis, and in fact the movement at various points in the multi-element spring is different (as shown in some of the accompanying drawings). As a result, the diluent / solids in the vial are caused to move, e.g., rotate, swirl, vibrate and shake, and / or undergo a generally chaotic washing movement. As the contents within the vial begin to move and swirl, a secondary eccentric load is generated that changes the magnitude of flex within the multi-element spring of the mixing device 100. In a preferred secondary stage, the rotational speed of the rotor is altered to cause the vial contents to reach a resonant condition and induce a vortex or high speed swirling of the vial contents, thereby adapting the controllable input force to produce an enhanced differential flex or different flex cycle within the multi-element spring.

[0082] The control device (reference number 180 in FIG. 1A) is preferably arranged to operate according to a program having at least two differentiated stages, namely (i) a primary stage followed by a transition to a so-called "kick stage" where the energy profile provided by the parameter control of the rotary actuator changes significantly compared to that of the primary stage. The primary stage thus induces a swirling motion in the collection vessel contents in the ancillary mixing vessel, while the kick stage generally generates a vortex in the collection vessel contents. The control device 180 is thus arranged to vary and control the rotational speed of the rotary actuator, i.e. the rotor and the eccentric load, to produce different swirling speeds. Furthermore, the control device 180 is arranged to instantiate a primary stage inducing a motion by shaking the contents of the collection vessel in the ancillary mixing vessel / vial 130, and then at least a secondary stage inducing a swirling motion in the contents of the collection vessel as the system approaches and achieves resonance. The movement of the collective contents within the vial 130 represents a secondary eccentric load that induces further bending motion by generating dynamic bending forces within the multi-element spring resulting from time-varying loads acting at the proximal and distal ends of the backbone (or main) beam 102.

[0083] Control of selected parameters of motor operation may relate to at least one of: control of the duty cycle in a pulse width modulated signal that controls rotation of rotor 110 and associated eccentric load 118; and voltage supplied to motor 112 to affect variation in current through the motor.

[0084] The motion of the top of the vial following the kick phase generally follows an elliptical path. The generation of the vortex is caused by the controller establishing a relative predicted motion state as the system (consisting of the mixing vessel, multi-element spring, and rotary actuator) collectively approaches the system resonance.

[0085] The controller is preferably arranged to operate to control the energy supply including at least one of: a linear variation in the energy supplied; a variation in the energy supplied; and a non-linear variation in the energy supplied. The controlled supply of energy to the system is maintained until complete mixing or dissolution of the contents within the vial 130 or other mixing vessel is achieved.

[0086] A practical outcome of the new mixer design of the various embodiments is that, in a completely exemplary case of preparation of an eye clear state for the drug Tazocin®, reconstitution is achieved in approximately 90 seconds, as opposed to the current standard manual mixing practice which requires approximately 12 minutes. Of course, other drugs and mixtures, including but not limited to bodybuilding beverage supplements and varnishes, can also be more effectively reconstituted or made using the new mixer.

[0087] Referring to Figures 7A-7C, 8A-8C, and 9A-9C, these figures show approximations of the motion of the beams and hinges with various components of the mixer system and the multi-element spring, respectively. Images are shown using finite element analysis "FEA" for the "lock location" at the interface of the transverse beam 104 and the brace point(s) of the support structure. Although modeled solely from the perspective of the ninety degree (90°) rotation of the eccentric mass 118 on the motor (and not from the additional perspective of the secondary eccentric load from the vial), the FEA shows a sequence of superimposed relative displacements of the beams 102-106, hinges 126-128, and vial 130 (particularly notable with respect to portions "B" and "C" of Figures 7-9). The superimposed line images as well as the variations in shading and intensity levels all reflect the displacements. However, it should be noted that the FEA representation is only indicative of the possible motions and bendings within the system of the present invention. Thus, since the FEA representations depend on the parameters used, Figures 7 to 9 are neither qualitative nor quantitative and, in this case, should be treated as a basic first approximation of the motion, at least as it will be appreciated, FEA modeling for multiple individual eccentric loading conditions is very complex.

[0088] However, the FEA of Figures 7A-9C reinforces the nature of motion in the mixer of the present invention, and Figures 10A-10E show a series of photographic images taken with a high speed camera at 500 frames per second of the in-cycle operation of the mixer. In Figures 10A-10E, a central white circular dot is introduced to indicate both the rotor position and the center of the eccentric load 118 on the rotor 110. Both the rotor position and the center of the eccentric mass are shown to vary in the cycle from the point of rotational motion of the eccentric mass under load at approximately the 12 o'clock position through subsequent positions of approximately the 1 o'clock, 5 o'clock, 7 o'clock, and 11 o'clock positions. Additionally, the circular markers at the remote tips of the support beams 106 and above the substantially rigid hinges connecting the backbone 102 to the support beams 106, as well as the line markers at the upper and lower edges of the backbone 102 and support beams 106, exhibit distortion in the plane of these beams as a result of relative motion between these line markers, as well as twisting and general displacement of the components of the multi-element spring in multiple planes of motion.

[0089] 11A-11E show a series of photographed images mapped by tracking software of the evolution of an orbital motion tracking feature of a mixing device manufactured according to the design of [FIG. 2]. The time-lapse images in the cycle establish complex bending and movement of references within the entire mixer, including: i) the central rotor 110; ii) the midpoint of the eccentric mass 118 on the rotor; iii) a top point above the substantially rigid hinge connecting the backbone 102 to the support beam 106; iv) the remote tip of the support beam 106; v) the midpoint of the clamping member that holds the vial 130 firmly to the support beam; and vi) the edge region of the clamping member radially offset from said midpoint of the vial clamping member.

[0090] The information obtained from the series of tracking trajectories in Figures 11A to 11E is as follows:

[0091] i) there is variation in both the relative displacement of each point and the orbital motion; some orbits are roughly elliptical, some somewhat circular, some somewhat rectilinear, and most successive orbits are spatially offset over time. In the latter respect, the relative strength of the tracks reflects the orbital evolution;

[0092] ii) there is a relative change in relative position between different mark points;

[0093] iii) the evolution of the trajectories of adjacent points may be in different senses, i.e. a first trajectory relative to the center of the rotor may be counterclockwise, whereas the trajectory relative to a central point on the eccentric mass 118 may evolve clockwise;

[0094] iv) The continuous trajectories may differ in that they have one or more crossover points, and the system is not exactly in tune with the operation.

[0095] Thus, Figures 11A to 11E confirm that the complex bending nature between interacting aspects of the multi-element spring of the mixing device of the present invention reflects the differentially directional forces of different magnitudes that arise within the mixer to result in effective mixing (of pharmaceuticals, varnishes, paints, soluble food preparations, or whatever).

[0096] 12A and 12B show basic diagrams of a mixer with two alternative structural arrangements that are functionally equivalent to the two-beam arrangement of [FIG. 6] and the three-beam mixer arrangement of FIGS. 1A and 1B, respectively.

[0097] FIG. 12A shows a primary beam 102 having a distal end 134 and a proximal end 116, connected to a functionally equivalent first combination connection 140, which is further connected to a stable anchor or brace point 108. The first combination connection 140, which replaces (for example) the reference beam 104 and substantially rigid hinge 128 of FIG. 1A, is attached to the primary beam 102 and has an integrally formed curved element that extends downward and out of the plane of the primary beam. Although the curved element is shown to be centrally located, its exact location along the length of the primary beam is design dependent and determined by stiffness, spring, and / or total load requirements. The first combination connection 140 is positioned to allow for a change in the relative orientation between the beam 102 and the stable anchor or brace point 108 in use that is roughly equivalent to that allowed by a substantially rigid hinge, and is also positioned to allow for a change in stiffness or flexibility relative to the hinge axis of the combination connection 140 in use.

[0098] FIG. 12B shows the multi-element spring of FIG. 12A with the addition of a second combination connection 143 joined to the distal end 134 of the beam 102 and extending at an angle (between obtuse and acute) to the plane of the primary beam 102. The second combination connection 143 replaces, for example, the substantially rigid hinge 126 and beam 106 of FIG. 1A. The second combination connection 143 is arranged to allow a change in relative orientation and / or position, in use, between at least the distal end 134 of the beam 102 and the distal end of the second combination connection 143, generally equivalent to the change allowed by the substantially rigid hinge 128, and is also arranged to allow a change in stiffness or flexibility of the combination connection 143 relative to the hinge axis, in use. The second combination connection 143 can again be implemented to include a curve.

[0099] [Incidentally, as will be readily understood by those skilled in the art, and for purposes of clarity only, a hinge axis is a line about which a body or geometric object rotates or may be thought of as rotating.]

[0100] In response to variations in loads and resulting torsional forces experienced by mating connections 142 and 143 shown in Figures 12A and 12B (for example), non-uniform bending moments about the hinge axes, as well as variations in thickness and / or shape of mating connections 142 and 143, cause changes in the relative positions and orientations of the respective hinge axes during use.

[0101] FIGS. 16A and 16B and the FEA of FIGS. 13A-15B generally show how such a combination connection 140 having variable thickness 141, 142 allows relative motion under time-varying loads that is approximately comparable to at least the combination of the reference beam 104 and substantially rigid hinge 128 of FIGS. 1 and 2 and 7A-9C.

[0102] Unless particular arrangements are mutually exclusive, the various embodiments described herein may be combined to generate complementary functions or systems that enhance system functionality and / or support effective discrimination of user-perceivable similarities and dissimilarities. Such combinations will be readily understood by those skilled in the art in view of the entirety of the foregoing description. Similarly, aspects of the preferred embodiments may be implemented in stand-alone arrangements where a more restrictive functional arrangement is appropriate. Indeed, unless features of certain preferred embodiments are expressly identified as incompatible with one another or the surrounding context implies that they are mutually exclusive and cannot be readily combined in a complementary and / or supportive sense, it will be understood that the entirety of this disclosure contemplates and contemplates that specific features of those complementary embodiments may be selectively combined to provide one or more comprehensive but slightly different technical solutions, each of which achieves cyclonic mixing with a mixing vessel (whether the mixing vessel is sealed or not). With respect to any proposed process flows relating to the operation of the designs shown in the accompanying exemplary drawings, these may be varied with respect to the exact execution points of steps within the process, so long as the overall effect or permutation achieves the same objective result or a significant intermediate result that enables progression to the next logical step. Thus, the flow process is logical rather than absolute.

[0103] Aspects supporting various embodiments of the present invention may be provided in downloadable form or on a computer readable medium, such as a CD-ROM, that includes program code that, when instantiated, performs the linked embedded functions, such as on a web server. For example, a particular mixing control algorithm for a particular compound may be selected from a local library or downloaded. Such a control algorithm may define discrete timing transitions between mixing stages, including changes that affect the rotational speed of the eccentric weight, thus affecting the energy profile of the energy delivered to the system.

[0104] It will be understood that the above description is given by way of example only and may be modified in detail within the scope of the invention. For example, the shape of the connecting structure between the abutting mixing surfaces may include edge notches with a curved profile that reduces the physical size of the material through which the force passes from one component to the next. Additionally, notches may be included in the various beams to reduce overall weight. Dimensions such as the overall length of the beams, the length of the substantially rigid hinges, the nature of the material in terms of composition (plastics such as polypropylene or metal), and the uniformity of the various thicknesses may be adjusted to tailor the resulting system to a particular application. In fact, as will be appreciated, compensatory changes between interacting components of a multi-element spring may alter, i.e., offset, the dimensions of one component at the expense of the dimensions of another component while still achieving the same mixing effect. In other words, the ratio of the dimensions of the components may be changed and thus the relative angular displacement may be affected, while the resulting multi-element spring may still achieve the desired vortex generation.

[0105] Adjustment of the system may be achieved, for example, by controlled energy supply by a motor and / or by changing the mass or the position of the eccentric mass on the rotor and / or the position of the mixing vessel, in other words the eccentric load of the rotary actuator may be a variable eccentric load.

[0106] However, refinement of the tuning of the physical parameters that affect the specific bending of the various beams and hinges [that realize the multi-element spring of the mixer] to optimize the mixer for a specific application can result in a mixer that is detuned for different applications, e.g., different pharmaceutical products. In this regard, the mixing performance can be tuned based on the general physical structure and then honed for a specific application through the selection of (i) active control of the rotational speed of the motor, and / or (ii) selected mass of the eccentric mass on the motor, and / or (iii) mass and / or position of the vial / container, and / or (iv) selected position of the eccentric weight fixed to the shaft of the motor. As will be appreciated, the energy generated by the rotational speed and the rotational force can be used to affect the bending of the various spring beams.

[0107] Thus, the dimensions of the main dimensions of the various beams and associated hinges (as well as the eccentric load(s) and the positioning of the vial / container) are exemplary. The dimensions shown in the table of FIG. 3 represent a conditioning system particularly suited for the preparation and mixing of Tazocin® (a composition known to be difficult to mix into a water-free state). Thus, variations in dimensions such as the length and thickness of the backbone 102, the radius of the notch 124, and the weight and position of the eccentric load 118 are not limited, so long as the principles of dual loading of a multi-element, multi-spring system with an eccentric generator as described herein are observed. In fact, the thickness of the various features and materials selected for the manufacture of the various components of the mixing device will depend to some extent on the load and physical size of the mixing device. Thus, one skilled in the art will understand this description and will recognize that the dimensions in the table of FIG. 3 may vary and, in fact, the flexibility, and therefore the relative movement, of one component may be purposely counterbalanced with the flexibility of another interacting component.

[0108] An important aspect remains consistent: regardless of the multiple degrees of freedom of motion that can be induced in the mixer's preloaded, multi-element spring system, the spring system supports two independent, yet complementary, eccentric load generating subsystems: the eccentric load motor and the relatively remotely located contents within the vial / container.

[0109] In the latter respect, without wishing to be bound by theory, it is understood that any eccentricity induced by the vial / container and its load is introduced into the system by (i) a relative change in the center of gravity of the vial / container and its contents with respect to the overall multi-element spring mixer, and / or (ii) the force required to overcome the action of gravity resisting rearward motion of the contents relative to the stationary steady-state position of the contents.

[0110] Furthermore, while the above description has focused on exemplary mixing of pharmaceuticals in sterile vials, specifically (but not exclusively) on mixing solutions for Tazocin®, the construction concepts of the multiple spring element mixer can be applied to the mixing or production of creams or emulsions. In mixing emulsions, the viscosity of the emulsion is the limiting factor. The present invention can mix virtually any combination of liquids and solids, dissimilar liquids, and multiple solid / liquid combinations.

[0111] Rather than being generally planar in nature, the beam or beams may themselves be formed from or include curved surfaces [hence bow-shaped] that may be continuous with radii [corresponding to the aforementioned substantially rigid hinges], the curved surfaces providing significant changes in orientation of and between any active beam elements (whether each of the active beam elements is generally flat or curved). The radii may be constant or variable. Without wishing to be bound by theory, the use of curved surfaces may reduce local stresses at the points of orientation change while maintaining multi-dimensional movement and multiple axes of motion within the mixing device. The formation of this alternative but functionally equivalent structure may be achieved by injection molding processes, 3D printing, or by appropriately bending formed metal or composite plates. The radius elements may also be optionally selectively thickened / thinned or reinforced over the connection length of complementary active elements within the structure, although such thickening / thinning / reinforcement comes at the expense of flexibility / flexing characteristics and resulting movement within and between the active elements of the mixing device.

[0112] As described herein and understood from FEA analysis, the purpose of a "substantially rigid hinge" is to support a flexure connection between two structural elements (e.g., the beams discussed above) and allow movement of at least those two structural elements about an axis of the hinge. It will thus be understood that a substantially rigid hinge can be realized in many alternative forms, including, but not limited to, (a) a simple curve (in the form of a radius curve or variable radius curve) (as shown in Figures 1A and 1B) along which a hinge axis or axes are realized, (b) the curved beam arrangements of Figures 4 and 5, (c) the alternative spring and pin hinge of [Figure 6], and (d) the combination connections of Figures 13B through 17A.

[0113] Although some preferred embodiments are described as using two or three beams that are substantially perpendicular to one another, each beam joined by a "substantially rigid hinge," the invention is not so limited. Any equivalent functional arrangement provided by a curved shape, where at least one of the substantially rigid hinges is a radius (as shown in Figures 13A-13C), can be readily substituted.

[0114] The FEA results shown in Figures 16A and 16B demonstrate that the structures in the various mixer configurations of different embodiments of the present invention have functionally similar responses to time-varying forces. Note that in Figures 15 and 17, the eccentric forces introduced by the separation load are shown only as indicator blocks (145 and 146).

[0115] Although several alternative and complementary arrangements are described herein for realizing the multi-element spring of the mixer 100, at least the functional equivalence of the beam 102 connected to the beam 104 by a substantially rigid hinge 128 and the stable anchor point 108 is required. The dimensions and arrangement of the functionally equivalent components depend at least on the nature of the two eccentric loads, their locations relative to each other and to the beam 102, and the location and behavior of the connecting substantially rigid hinge 128 or equivalent mating connection (FIGS. 15A-17A).

[0116] It will be appreciated that with the use of advanced structural and material property modeling design tools, a functional equivalent of the interconnected bending elements in an interconnected lattice structure can be realized as a single part or a limited number of connectable parts. Such a lattice is functionally equivalent to the main beam 102, the reference beam 104, and the second substantially rigid hinge 128, as shown in Figures 17B to 17D. In fact, by analyzing the example of the movement trajectory illustrated in the present specification (Figures 7A to 11E), a function equivalent to the multi-element spring of the disclosed mixer 100 can be realized with the help of the aforementioned advanced structural and material property modeling design tools. The intermediate lattices in Figures 17B to 17D show merely exemplary inverted design forms generated by a generative design tool programmed with the requirements specification based on Figure 17A. These are merely manufacturing issues for the preferred approach in physically realizing the mixer of the present invention.

[0117] The placement of the beams and hinges of the mixer may be accomplished through traditional manufacturing and assembly processes or may be accomplished, at least in part, through additive manufacturing processes. The options for combining the structural elements and necessary hinges are numerous, and various alternative layouts can be created using artificial intelligence-powered design aids such as generative design, many of which are enabled using 3D printing processes such as selective laser sintering, melt deposition modeling, and electron beam melting of a selection of metals and plastic polymers, including, but not limited to, metals, metal alloys, polymers, and fiber-reinforced polymer material blends.

[0118] Such 3D printable arrangements and associated additive fabrication methodologies potentially allow for the separation of a single structural element (or beam) or hinge into two or more complementary portions or complex lattice structures or structures arranged to be functionally equivalent to the beam or hinge, or any combination thereof, respectively, and further allow for the assembly, if desired, of the beam or beams and the hinge or hinges into a single structure or a fewer number of connected individual structures arranged to be functionally equivalent to the joined or connected individual elements or features, as shown in Figures 17B through 17E and further in example 148 of [Figure 18].

[0119] Therefore, the functional design of the described embodiments is not limiting as long as the principles of decoupled eccentric double loading of a multi-element, multi-spring system bending in multiple geometric planes are respected.

[0120] While the principles of the blender have been described in detail above, the overall blending system may include complementary monitoring and / or identification technology, such as a camera subsystem. The camera subsystem may be arranged to interpret container label details from a code or label, text or graphic reading. This may be used as a safety cross-check to audit or program the blender to follow a particular energy delivery sequence.

[0121] The camera subsystem can also capture the time position of the moving mechanisms of the mixing device to identify potential wear of the device components, thereby enabling modification of operating parameters to ensure consistent mixing results and / or create service / maintenance actions.

[0122] Additionally, the mixing device of any of the embodiments may optionally be enabled with position, proximity, and single or multi-axis motion sensors to capture the position of the moving mechanism of the mixing device in time. The sensors may complement or replace any optical camera-based subsystem.

[0123] The mixing device may also be connected to a remote computer or computer network, such as a cloud-based service, and operate as a connected device, i.e., an Internet of Things (IoT) device, configured to communicate bidirectionally with remote resources, thereby enabling monitoring of operating parameters of the mixing device and, if desired, some degree of supervisory control.

[0124] The mixing device or its functional components may be incorporated into a complex robotic system that may robotically add diluent to the mixing container and / or robotically insert the mixture container into the clamp. There is no preferred order to the above-mentioned robotic steps of adding diluent or inserting the mixture container into the clamp. As an example, a microprocessor-controlled robotic system having multiple mixing devices or functional components thereof may be aimed at mixing multiple mixtures with a lesser degree of manual manipulation required to achieve the desired result of multiple mixed chemicals or mixtures.

[0125] Terms The following clauses, which represent equivalent structural alternatives and / or operational functional modifications of the mixing apparatus according to various embodiments of the present invention, are consistent with and are included within the overall description above.

[0126] Clause I. A mixing apparatus comprising: a multi-element spring including a plurality of coupling beams each supporting a plurality of planes of motion, at least one pair of the plurality of coupling beams being coupled together by a substantially rigid hinge, the at least one pair comprising: a base beam having a first end arranged to securely hold a rotary actuator supporting a first eccentric load, and a second end remote from the first end, the second end including a clamp for securing a mixing vessel, in use; and a reference beam coupled to the base beam along the substantially rigid hinge, the reference beam extending outwardly relative to the base beam, the reference beam being oriented in a direction substantially parallel to the axis of the base beam. a reference beam having an effective variable stiffness in the longitudinal direction relative to the reference beam, and an electromechanical actuator arranged to controllably cause rotation of the first eccentric load; and a microprocessor-based controller for parameter control defining operation of the electromechanical actuator and an instantaneous amount of energy supplied to the mixing device, wherein the multi-element spring is arranged to flex in multiple degrees of freedom in response to a combination of complementary forces resulting from rotation of the first eccentric load and a secondary eccentric load held in a clamp, the secondary eccentric load being substantially induced in response to rotation of the first eccentric load.

[0127] Clause II. The mixing apparatus of clause I, wherein the reference beam is inclined at an angle ranging from about 5 degrees to 90 degrees relative to the backbone beam.

[0128] Clause III. The mixing device of any one of clauses I and II, wherein the angle depends on a variable stiffness of the reference beam.

[0129] Clause IV. A mixing device comprising: a rotary actuator applying an eccentric load; a microprocessor-based controller providing parameter control of the rotary actuator to at least partially control energy provided to the mixing device through controlled rotation of the eccentric load; a mount configured to hold the rotary actuator; a clamp configured to hold a mixing vessel representing a mass, the mixing vessel containing at least one liquid as part of a collection vessel's contents; and a multi-element spring including a plurality of coupling beams each providing at least one degree of motion: a primary beam having a proximal end, a distal end, and a bottom edge, the mount and the rotary actuator being rigidly coupled substantially at the proximal end of the primary beam. a second beam secured to a distal end of the primary beam via a first substantially rigid hinge, the second beam extending outwardly relative to the primary beam, the first substantially rigid hinge allowing flexural movement of the second beam relative to the primary beam, the second beam further retaining a clamp; and a third beam secured to a portion of a lower edge of the primary beam via a second substantially rigid hinge, the third beam extending outwardly relative to the primary beam, the outward extension of the third beam increasing from the second substantially rigid hinge across a width of the third beam, the third beam being positioned to allow differing amounts of flexural movement along the second substantially rigid hinge when further connected to a stable brace structure in use.

[0130] Clause V. The mixing device of any one of clauses I to IV, wherein the mixing performance is adjusted based on at least one of active control of the rotational speed of the rotary actuator, a selected mass of an eccentric load on the rotary actuator, a mass of the clamp, a position of the clamp, a mass of the mount, a position of the mount, a mass of the mixing vessel, a position of the mixing vessel, a mass of a compound contained in the mixing vessel, a mass of a liquid contained in the mixing vessel, a position of the rotary actuator, and a mass of the rotary actuator.

[0131] Clause VI. The mixing device of any one of clauses I to V, wherein the mixing performance is adjusted based on at least one of: active control of the rotational speed of the rotary actuator; a selected mass of an eccentric load on the rotary actuator; a mass of the clamp; a position of the clamp; a mass of the mount; a position of the mount; a mass of the mixing vessel; a position of the mixing vessel; a mass of a compound contained in the mixing vessel; a mass of a liquid contained in the mixing vessel; a position of the rotary actuator, a mass of the rotary actuator.

[0132] Clause VII. The mixing device of any one of clauses I to VI, wherein the controller is arranged to cause a change in the rotational speed of the contents of the collection vessel through control of a selected parameter, said selected parameter control by the controller affecting the rotational speed of the eccentric load about the rotational actuator.

[0133] Clause VIII. The mixing apparatus of any one of clauses I to VII, wherein the eccentric load of the rotary actuator is a variable eccentric load having at least one of a selectable weight, a selectable shape of the eccentric load, a selectable position of the eccentric load relative to the shaft of the motor, a selectable shape of the eccentric load, a selectable material density of the eccentric load, and a selectable mass distribution within the eccentric load.

[0134] Clause IX. The mixing device of any one of clauses I to VIII, wherein the bending force in the multi-element spring is relative to the motion stability of the brace structure.

[0135] Clause X. The mixing device of any one of clauses I to IX, wherein resultant forces within the mixing device resulting from the controlled operation cause the mixing vessel to move in a generally predictable periodic orbit.

[0136] Clause XI. A mixing device according to any one of clauses I to X, wherein in use, resultant forces within the mixing device resulting from its controlled operation cause the mixing vessel to move in a chaotic trajectory.

[0137] Clause XII. The mixing device of any one of clauses I to XI, wherein the material relief of various shapes is at least one of edge notches, holes, channels, variable length, various geometric shapes, and variable thickness.

[0138] Clause XIII. A mixing device according to any one of clauses I to XII, wherein the control device is arranged to instantiate a primary stage of inducing a chaotic movement by shaking the contents of the collection vessel in the attached mixing vessel, and then at least a secondary stage of inducing a swirling movement in the contents of the collection vessel.

[0139] Clause XIV. A mixing device according to any one of clauses I to XIII, wherein the approximate generation of the vortex is caused by the control device establishing a relative expected movement state as the system consisting of the mixing vessel, the multi-element spring and the rotary actuator collectively approaches a system resonance.

[0140] Clause XV. The mixing device of any one of clauses I to XIV, wherein the mixing performance is adjusted based on at least one of active control of the rotational speed of the rotary actuator, a selected mass of an eccentric load on the rotary actuator, a position of the eccentric load on the rotary actuator, a mass of the mixing vessel, a position of the mixing vessel, a mass of the compound contained in the mixing vessel, a mass of the liquid contained in the mixing vessel, and a position of the rotary actuator.

[0141] Clause XVI. A method of dissolving or intimately mixing a sterile compound or solid into a diluent or liquid introduced into a sterile container initially containing (a) a sterile compound or solid and (b) a gas, the method comprising: generating a plurality of time-varying, dynamic, multi-directional bendings in individual elements of a mixer multi-element spring to induce a swirling motion of the diluent within the container, the initial motion of the diluent being generated by selectable motor-driven rotation of a mixer first eccentric load at a proximate first end of a first element of the mixer multi-element spring while the container is rigidly secured at or near a remote second end of the first element, the time-varying, dynamic, multi-directional bendings in the elements of the multi-element spring being relative to a substantially kinematically stable brace point to which one element of the multi-element spring is rigidly secured; and controllably causing a change in energy imparted to the multi-element spring by varying operating parameters of the motor driving said rotation of the first eccentric load to create at least a swirl within the diluent in the sterile container.

[0142] Clause XVII. The method of dissolving or intimate mixing as described in clause XVI, wherein the movement of the contents within the container represents a secondary eccentric load that induces a compound bending by generating dynamic bending forces within elements of the multi-element spring, the compound bending arising from different locations relative to a time-varying load applied to the separated proximal and distal ends of the first element.

[0143] Clause XVIII. The method of dissolving or intimately mixing of clause XVI or clause XVII, further comprising causing a change in the rotational speed of the contents within the container via the rotational speed of the first eccentric load.

[0144] Clause XIX. The method according to clauses IV to VII, wherein the one or more damping mechanisms are connected to the multi-element spring, providing for the preparation of at least one of the multi-element spring or the mixing device. Patent Literature

[0145] WO 05 / 077511 essentially relates to a "rocking table" supported by four spring legs.

[0146] DE 2941421 relates to a paint mixer in which the paint can is held in place on a vibrating plate by magnets. The up and down motion produced by this device does not suggest or show that a mixing vortex can be created.

[0147] US Patent No. 3,637,190 relates to an open, non-sterile system for deburring / polishing workpieces in a drum. This follows, for example, from col. 2, lines 18 to 24, i.e. "Chamber 35... is adapted to receive a medium M of... ceramic chips or other abrasive material and a suspended batch of parts P to be surface-finished by deburring, polishing, descaling, or the like." The fact that the system uses a coil spring and a spring beam to achieve a resonant frequency of vibration with changing load. US Patent No. 3,623,706 relates to US Patent No. 3,637,190.

[0148] US Patent No. 3,643,384 also relates to US Patent No. 3,637,190. The subject matter of US Patent No. 3,643,384 describes a large trough for deburring large objects such as aircraft wings (see first stage, lines 4 to 8). The trough is arranged to be shaken / vibrated by a spring bias. GB Patent No. 992002 is another deburring machine in the form of a trough type oscillator, as can be seen in [Figure 6] of the same document.

[0149] DE 1913374 relates to a system for polishing and potentially cleaning rather than mixing. Figures 4 to 8 of DE 1913374 establish that this system is not a sealed via, but a lid clamping system on a rotary table driven by a motor with an eccentric load (elements 7 and 9).

[0150] US Patent Application Publication No. 2006 / 093529, issued as US Pat. No. 8,017,094, is a biological sample analyzer that operates on the premise of shaking.

[0151] Chinese Patent No. 112354438 relates to sieving wheat flour, as shown in Figures 4 and 5 of the document.

[0152] Chinese Utility Model No. 215877456 states that the utility model discloses a drug dispensing device for hospital pharmacies, which includes a drug mixing drive mechanism, a drug bottle positioning auxiliary mechanism, a device base, a left support vertical plate, a right support vertical plate, an auxiliary spring, a drug mixing operation groove, an auxiliary drug bottle frame, a small drug bottle, and a drug mixing auxiliary plate.

[0153] The problem to be solved in JP-A-09-52039 is solved by providing a vibration device having only one motor and one vibrator by arranging the vibrator, eccentric weight, and motor in series and aligning the center of gravity with the center of vibration force of the eccentric weight. In the solution, the vibrator 1, eccentric weight 5, and drive motor 8 are arranged in series. The axis of the vibrator 1, which passes through the center of gravity of the vibrator 1 and is parallel to the annular vibration axis of the vibrator 1, the rotating shaft of the eccentric weight 5, and the rotating shaft of the motor 8 are arranged in a straight line, and the whole is placed on a common frame 10 and supported on a base 12 by a spring 11. The weights of the vibrator 1 and the motor 8 and the distance to the eccentric weight 5 are adjusted so that the whole center of gravity coincides with the center of vibration force of the eccentric weight 5.

[0154] In the specification of Chinese Patent No. 106732096, it is stated that the present invention discloses a test tube shaking device, which belongs to the field of experimental equipment. The upper end central part of the base is fixedly connected to the vertical plate; the vertical plate is arranged with an output shaft fixing hole; the motor output shaft of the motor is sleeved into the output shaft fixing hole; the rear end of the motor output shaft is fixedly connected to one end of the crank; the other end of the crank is fixedly connected to one end of the connecting rod, and the other end of the connecting rod is connected to the connecting block on the test tube clamp through a connecting bolt; the test tube is clamped in the center of the test tube clamp; the open end of the test tube is plugged by a test tube plug; the transverse track and the longitudinal track are arranged on the vertical plate; the fixed magnets are arranged at the four corners of the joint between the transverse track and the longitudinal track; the reversing plate is arranged on each fixed magnet; and the control box is arranged on the vertical plate. The transverse or longitudinal shaking function of the test tube is achieved through the transverse track, the longitudinal track and the sliding column, and the diversity of the experiment is achieved.

[0155] In the specification of Chinese Patent No. 106732096, it is described that the test tube shaking device belongs to the field of laboratory equipment, the upper end center of the base is fixedly connected to a vertical plate, the vertical plate is provided with an output shaft fixing hole, the motor output shaft of the motor is sleeved into the output shaft fixing hole, the end of the output shaft of the motor is fixedly connected to one end of the crank, the other end of the crank is fixedly connected to one end of the connecting rod, the other end of the connecting rod is connected to the connecting block on the test tube fixture through a connecting bolt, the test tube of test tube A is clamped in the center of the clamp, and the open end of the test tube is blocked by a test tube stopper. The vertical plate has horizontal and longitudinal paths, and fixed magnets are arranged at the four corners where the horizontal and longitudinal paths intersect. An inversion plate is arranged on the fixed magnet, and a control box is arranged on the vertical plate, which realizes the function of shaking the test tube horizontally or vertically through horizontal, vertical rails and sliding columns, thereby realizing the diversity of experiments.

[0156] WO 2008 / 103004 states that the present disclosure is a drug mixing device that vibrates and rotates a drug bottle containing two or more different types of drugs to mix the drugs. The drug mixing device includes a drug bottle receiving unit, a device body, an eccentric motor attached to the device body, and a power supply source. When the eccentric motor is energized by power supplied from the power supply source to generate vibrations, the generated vibrations cause the drug bottle attached to the drug bottle receiving unit to vibrate and rotate.

[0157] US 2007 / 0145067 describes a system and method for dispensing a viscous fluid that includes a container mounted on a vibrating support. The container is typically a blender container in which smoothies are prepared. A motor drives an unbalanced weight, causing the container support to vibrate. This causes the viscous fluid in the container to fluidize. The container and container support rotate.

[0158] GB 1057877 describes a laboratory mixer in which a work holder 1 having clamps 3, 4 for a flask 5 to be stirred is rigidly connected to the stator 13 of an electric motor 14 and means such as an eccentric weight 16 are provided, one at each end of the motor shaft 15, to cause the rotor of the motor to rotate off balance. Elastic support means such as rubber or artificial rubber blocks 11, 17 are provided between the upper part 9 of the housing 10 and the flange 7 of the holder 1, and between the lower part of the housing and its support surface 18, respectively.

[0159] In the specification of the Chinese Patent Publication No. 114558488, it is stated that the present invention provides a blending device, a blending method and a sample analysis device, the blending device includes a limiting block, a gripper sliding block, a gripper assembly and a rotating shaft, the gripper sliding block is clearance-fitted with the limiting block, the rotating shaft is clearance-sleeved connected with the gripper sliding block, and the auxiliary axis of the auxiliary shaft part of the rotating shaft is eccentrically arranged with respect to the main axis of the main shaft part of the rotating shaft. The limiting groove is clearance-fitted with the gripper sliding block, and the auxiliary axis of the auxiliary shaft part of the rotating shaft and the main axis of the main shaft part of the rotating shaft are eccentrically arranged, and the gripper sliding block can be driven to rotate in the limiting piece according to a preset moving path when the rotating shaft rotates, so that the peripheral blood test tube or the venous blood test tube is connected to perform a uniform mixing action.

[0160] In the specification of Chinese Patent Publication No. 106139985, it is stated that the present invention relates to a high-efficiency sample vibration and uniform mixing device and a method of use. The high-efficiency sample vibration and uniform mixing device comprises a base, four brackets, a sample frame, and an eccentric motor vibration system; the upper part of the base is connected to the sample frame through four brackets; the eccentric motor vibration system is located in the center of the base and arranged vertically; the eccentric motor vibration system is composed of a center-of-gravity deflection semi-cylindrical block, a bearing, a motor, and a control system; the center-of-gravity deflection semi-cylindrical block is connected to the motor through a bearing, and the motor is electrically connected to the control system.

Claims

1. A mixing device (100) comprising: A rotary actuator (110, 112) that applies an eccentric load (118); a controller (180) for controlling parameters defining the motion of the rotary actuator and the instantaneous amount of energy provided to the mixing device (100) through the controlled rotation of the eccentric load (118); a mount (114) configured to securely hold the rotary actuator; a clamp (132) configured to hold a mixing vessel (131) or multiple mixing vessels, said mixing vessel containing at least one liquid as part of the contents of a collection vessel; A multi-element spring (102, 104) including a plurality of structural elements connected to one another by at least one connection, the at least one connection supporting relative dynamic change in azimuth angle between the connected structural elements under dynamic loads, the spring comprising: the multi-element spring including a main structural element (102) having a proximal end and a distal end, the mount and rotational actuator being substantially rigidly connected at or towards the proximal end, the main structural element (102) undergoing a bending movement due to controlled rotation of the eccentric load, and the clamp (132), which in use rigidly secures the mixing vessel to the mixing device, being substantially rigidly connected at the distal end; a reference structural element (104) connected to a portion of the main structural element via a second substantially rigid (128) connection, the reference structural element extending relatively away from the main structural element and being oriented differently relative to an orientation of the main structural element, the reference structural element being positioned such that when further connected to a stable brace structure in use, the reference structural element allows different amounts of bending movement relative to the stable brace structure; A mixing device (100) comprising:

2. 2. The mixing device of claim 1, wherein a support structural element (106) is secured to the distal end of the main beam (102) via a first substantially rigid connection (126), the support structural element (106) extending relatively away from the main beam, the first substantially rigid connection allowing bending movement of the support structural element relative to the main structural element, and the support structural element supports the clamp (132) that securely fastens the mixing container to the mixing device in use.

3. said main structural element; the reference structural element; The clamp; the mount; and the mixing vessel; 3. The mixing device of claim 1 or 2, wherein at least two of said components are formed of a unitary structure.

4. The controller is arranged to operate to control the supply of energy to the mixing device provided by operation of the rotary actuator, the rotary actuator comprising: A constant supply of energy; Linearly varying supply of energy; Exponentially varying supply of energy; and Nonlinear fluctuations in energy supply, The mixing device according to any one of claims 1 to 3, having at least one of the following functions:

5. The mixing device according to any one of claims 1 to 4, wherein at least one of the plurality of structural elements comprises one or more material reliefs of various shapes.

6. The mixing device according to any one of claims 1 to 5, wherein the movement of the contents of the collection receptacle represents a secondary eccentric load that induces further bending movements by generating dynamic bending forces in the multi-element spring (102, 104) or (102, 104, 106) resulting from time-varying loads acting on the proximal and distal ends of the main structural element.

7. A sealed container realizing the mixing device and said mixing vessel according to any one of claims 1 to 5, said sealed container being internally sterile and containing a sterile compound dissolved, diluted or suspended in or by a sterile diluent introduced into said vessel by seal permeation.

8. 8. The mixing apparatus of claim 1, wherein resultant forces within the mixing apparatus resulting from controlled operation of the mixing apparatus cause the mixing vessel to move in a generally predictable periodic orbit.

9. 9. A mixing device according to any one of claims 1 to 8, wherein the control device is controllably arranged to establish the generation of a vortex-like effect within the contents of the vessel, the vortex-like effect arising from mechanical interactions between components within the mixing device approaching conditions approximating system resonance.

10. The mixing device according to any one of claims 1 to 7, wherein the control device is arranged to instantiate at least one stage of inducing chaotic motion by shaking the contents of the collection vessel in the auxiliary mixing vessel.

11. 1. A method for dissolving, diluting or suspending a compound with a diluent introduced into a mixing vessel held securely by a clamp (132) of a mixing device (100), the method comprising: fastening said mixing vessel (131) to said clamp, said mixing vessel containing a combination of a diluent and a compound or a combination of a liquid and another liquid to produce a mixture; initially shaking or pivoting the mixture by dynamically bending a plurality of elements of a multi-element spring (102, 104, 106) in different planes of motion, the bending being initially caused by rotation of a first eccentric load by a rotational actuator rigidly secured within a mount (114) at a first end of a primary structural element (102) of the multi-element spring, the shaking or pivoting of the mixture resulting from multi-planar bending of the primary structural element being connected by at least a second connection (128) to a reference structural element (104), the reference structural element being further arranged to bend relative to a stable brace structure; controlling operation of said rotary actuators (110, 112) using a microprocessor-based controller (180), thereby providing an instantaneous amount of energy to said mixing device through controlled rotation of said first eccentric load (118); inducing a complementary secondary bending in the multi-element spring through an induced swirling or shaking of the mixture by action of the rotation of the first eccentric load, the complementary secondary bending creating a spatially separated second eccentric load in the mixing vessel, the bending and eccentric forces acting together to produce a mixing effect in the mixture; A method comprising:

12. 12. The method of claim 11, wherein the support structural element is not included between the distal end of the main structural element and the clamp, the primary beam is positioned to attach a clamp at or near the distal end of the primary beam, and the spatially separated second eccentric load in the mixing vessel is induced by the controlled rotation of the first eccentric load (118) and the bending force of the multi-element spring (102, 104) to collectively produce a mixing effect within the mixture.

13. 1. A processor-controlled mixing system for mixing or dissolving one or more ingredients or compounds with a liquid, comprising: A motor (112) having a rotor (118); a processor arranged to control the supply of energy to the system by controlled operation of the motor; A container (130) for holding said one or more ingredients or compounds and said liquid; and a plurality of beams (102, 104, 106) or (102, 104), each interconnected by at least one substantially rigid connection, the combination of the beams and connections forming a multi-element spring in which, under an applied motor-induced force, at least some of the beams bend or curve in one or more planes of motion, and some of the beams undergo relative angular or relative linear displacement in different planes of motion of the beams; and first and second eccentric loads spaced apart from one another but attached to the multi-element spring, the first and second eccentric loads comprising: the first eccentric load is an eccentric mass on the rotor of the motor; the second eccentric load is generated by agitation of the one or more ingredients or compounds and the liquid in the container, the agitation following bending and displacement of the plurality of beams in response to a motor-induced force introduced into the multi-element spring by controlled operation of the motor by the processor; and A system comprising:

14. 14. The system of claim 13, wherein the plurality of beams includes the reference beam and at least the primary beam, the primary beam positioned to mount a clamp on the container and further positioned to mount the clamp away from the first eccentric load.

15. The system of claim 14 , wherein the plurality of beams further includes a support beam, the support beam being a third beam coupled to an end of the primary beam and positioned to mount the clamp.

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