Cavitation induced mixing

Abstract

The present invention relates to a mixing or suspension autoinjector device comprising a housing having a plurality of separate and distinct chambers disposed therein, where one or more medicaments and / or liquids are present in one or more chambers; and one or more displacement mechanisms corresponding to each of the chambers disposed within the housing. A cavitation needle bearing a plurality of protrusions situated on the outer surface of the cavitation needle is housed in a chamber adjacent to the chamber configured to mix or suspend particulates into an injection liquid or combine dissimilar liquids; the cavitation needle is configured to enter the chamber to induce the formation of cavitation cavities or bubbles, thereby improving the mixing, dispersion, and / or suspension of particulates into an injection liquid or dissimilar liquids, before the combination is administered through the needle.

Description

TITLE OF THE INVENTION: Cavitation Induced MixingINVENTOR: Girum Yemane-TekesteCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 714,251 filed October 31, 2024, which is hereby incorporated by reference in its entirety for all that it contains (including all references therein) for all purposes as if restated and set forth fully herein to the maximum extent allowable by law.FIELD OF THE PRESENT PATENT APPLICATION

[0002] The present invention relates to medical devices, methods, and systems to generate cavitating bubbles within an injection chamber to facilitate the mixing and / or suspension of particles into an injection liquid, or the mixing and / or suspension of dissimilar liquids, at the point of administration of the mixture or suspension to a human or other animal. The liquid and / or particulate medicaments may be contained in one or more cartridges, reservoirs, containers, or packages located within the body of the injector, with each unit storing one or more medicaments or drug agents, that are combined at the point of administration within a single chamber and dispensed through a single needle. Following combination and / or reconstitution with the aid of cavitation, the mixture or suspension may be administered through a single injection site for an intramuscular (IM) or subcutaneous (SC or SQ) injection.BACKGROUND OF THE INVENTION

[0003] Cavitation in injector systems may occur upon abrupt and uncontrolled acceleration and deceleration of liquid within a medicament chamber. Cavitation involves the rapid formation and growth of vapor-filled cavities within a liquid when the static pressure falls below the liquid’s vapor pressure. The sudden change in fluid pressure causes the formation and collapse of vapor-1142018934filled bubbles within a liquid. When the cavitation cavities or bubbles collapse, an intense shock wave may be generated within the liquid impacting nearby surfaces. In certain injector systems, abrupt acceleration of a syringe or plunger may induce undesired severe cavitation events, imposing extraneous stresses upon the device, that may lead to device failure. Upon collapse, the vapor-filled cavities generate an intense shock wave that may lead to protein aggregation and damage to the device container. Thus, cavitation is generally deemed to be an undesirable phenomenon and injectors are designed to avoid cavitation in the injection chamber.

[0004] It has been a surprising and unexpected discovery of the present invention that the generation of cavitating bubbles within the liquid in a medicament chamber may improve the dispersion, dissolution, and solubilization of particles in the liquid, or the dispersion, dissolution, and solubilization of dissimilar liquids, which improves the administration of the mixture, solution, or suspension to the human or animal, with reduced wastage, improved homogeneity of the mixture or suspension, and improved accuracy of dose delivery. Such a system is of particular use where the dry medicament may be in particulate form and is stored separately from a liquid such as a diluent and must be rapidly and efficiently mixed into a single homogenous liquid formulation at the point of administration. Alternatively, the system may be useful where the medicament is in a particulate form that sediments or precipitates during storage or transport and must be resuspended or re-mixed into the injection medium at the point of administration. The system may also be useful in combining medicaments where one or more medicaments are in liquid form that are preferably stored separately until the point of administration or where the two liquids are immiscible during storage because of dissimilar chemical properties and therefore must be mixed or suspended at the point of administration.2142018934

[0005] In some instances, it may be preferable to transport one or more dry medicaments and one or more liquids separately, as the combination may have a shorter shelf life or be difficult to transport. However, manual combination of medicaments and / or suspension fluids at the point of administration may result in errors or may take too long, especially where the combination must occur in an emergency setting, for example during an anaphylactic shock or asthmatic attack, where prompt and rapid administration is essential to preserve the patient’s life and optimize therapeutic outcomes. Accordingly, the present invention allows reliable preservation of the particles and fluids or dissimilar fluids, optionally in separate chambers, within the same device without premature mixing or other compromise, while preserving ease of administration via a single activation of the system wherein the generation of cavitating bubbles facilitates the dispersion, dissolution, or solubilization of particles in a liquid, or mixing of dissimilar fluids, at the time of administration. Devices, methods, and systems described in the prior art lack optimization of dispersion, dissolution, or solubilization through cavitation and fail at one or more of these aspects, among other problems addressed by the present invention.

[0006] The present invention may be discussed with reference to medications and / or healthcare, but it will be understood that the present invention and its features may apply beyond medications and / or healthcare. Further, the present invention may be discussed with reference to injection, but it will be understood that embodiments of the present inventions and features thereof may include and / or apply to other administration routes, such as aerosolized, nebulized, spray applications, or any other administration route that may be known to persons having ordinary skill in the art.

[0007] Other features of the present invention will be apparent to persons having ordinary skill in the art in light of this disclosure and description.3142018934BRIEF SUMMARY OF THE INVENTION

[0008] It shall be understood the invention described herein comprises systems, which may include apparatuses, assemblies, devices, and / or kits, and may also include methods pertaining to the same.

[0009] In exemplary embodiments of the present invention, the injector system may comprise a housing or barrel with a forward end or administration end and a rear end away from the administration end. In certain embodiments, the injector further includes an activable power assembly, a first recessed plunger with an inner surface with a curved or conical recess on the surface apposed to a chamber comprising medication, a first chamber comprising medicament in the form of one or more fluids and / or particulates, a second recessed plunger with an inner surface with a curved or conical recess on the surface apposed to a chamber comprising medication, and a needle housing chamber located sequentially to the first chamber, comprising a cavitation needle and an injection needle.

[0010] The barrel may have an inner surface along a length with an administration end. The first and second recessed plungers may be in the barrel in frictional contact with the inner surface of the barrel. The cavitation needle may have a length, a forward end and a rear end. The cavitation needle may be hollow comprising an outer body at a first end and an inner body at a second end. The cavitation assembly may comprise protrusions along the length of the outer body situated in the needle housing chamber.

[0011] In a first state, the fluid and / or particles, or two or more dissimilar fluids, may be in a chamber between the first and second recessed plungers with a gas disposed within the chamber. In a second state, applying a force to the first recessed plunger moves the first and second recessed plungers and chamber forwardly through the needle housing chamber towards the injection end,4142018934moving the chamber over a length of the cavitation needle with protrusions. The acceleration of a liquid passing over a cavitation needle length with protrusions, optionally in conjunction with the gas bubble, causing the formation of cavitation cavities within the chamber mixing and / or suspending the particles in the liquid or causing the mixing of dissimilar liquids.

[0012] In exemplary embodiments, the cavitation assembly may comprise protrusion ridges that cause vibrations and multiple accelerations causing the formation of cavitation cavities or bubbles within the chamber.

[0013] In exemplary embodiments, applying the force may move the second plunger until it meets and is punctured by the cavitation needle.

[0014] In exemplary embodiments, applying the force may move the second plunger until it meets and is punctured by the injection needle.

[0015] In exemplary embodiments, applying the force may move the first plunger until it meets at least one barrier blocking further movement.

[0016] In exemplary embodiments, the liquid in the chamber with the mixed or suspended particles, or the emulsion of dissimilar liquids, may be injected into the administration site.

[0017] In exemplary embodiments, after applying a force the first plunger may meet and be punctured by a needle at the administration end, and the liquid with mixed and / or suspended particles, and / or the mixture or suspension of dissimilar liquids present in the chamber, may be injected through the needle.

[0018] In exemplary embodiments, after applying the force the first plunger may meet at least one barrier, which may block further translation of the first plunger.5142018934

[0019] In another embodiment, an injector system may comprise multiple sequential chambers, separated by separation assembly, and a bypass within the barrel or housing permitting liquid from one chamber to flow to another chamber for mixing.

[0020] In an exemplary embodiment, the first chamber may be configured to retain and / or may retain a powder positioned therein, and the second chamber may be configured to retain and / or may retain a liquid positioned therein. The separator between the first chamber and the second chamber may include a flow channel or conduit providing fluid communication between the first chamber and the second chamber. A portion of the conduit may comprise the cavitation needle comprising protrusions on the outer surface of the conduit. The auto-injector may also include a stopper positioned within the second chamber to obstruct the conduit so that the first chamber and the second chamber are not in fluid communication in a first configuration or position of the stopper. The configuration of the chambers and / or stopper may permit the separation of the drug and its diluent for long term storage. The configuration of the chambers and / or stopper and / or flow channel are configured to permit the reconstitution of the drug and the diluent upon activation of the system which triggers the passage of the cavitation needle through the first chamber. The acceleration and deceleration of the liquid flowing over the cavitation needle as the first chamber moves towards the injection end of the barrel generates cavitation cavities which creates a turbulence within the liquid, assisting in the mixing and / or suspension of a powder in the liquid or in the mixing or suspension of two dissimilar liquids.

[0021] The second chamber may be situated within a housing having a forward end and a rear end. In exemplary embodiments, the second chamber may be rearwardly contained by a rear plunger and is operatively linked to a power assembly. The second chamber may be configured to store one or more liquids. On the activation of the power assembly, the rear plunger may move forwardly6142018934through the housing, pushing contents of the second chamber out into the conduit in fluid communication with the first chamber. The transmission of liquid through the conduit may further be agitated by the cavitation needle situated in the intervening needle housing chamber, and aid in generating cavitation bubbles in the first chamber. Exemplary embodiments may also use the liquid and / or a gas to assist in the reconstitution of the drug by mixing the powder and the liquid.

[0022] In exemplary embodiments, activating the power source situated rearwardly to the third chamber may push the liquid through the conduit into the first chamber and may compress the first power source.

[0023] In exemplary embodiments, the liquid entering the first chamber may mix or suspend the particles into the liquid without requiring manual mixing by a user.

[0024] In exemplary embodiments, pushing the contents of the first chamber may mix or suspend the particles into the liquid without requiring manual mixing by a user.

[0025] In exemplary embodiments, activating the first power source may move the first chamber forwardly within the housing until the injection needle enters the first chamber through the second plunger. The first chamber contents may then enter the needle at its base and flow to its tip and be dispensed.

[0026] In exemplary embodiments, the first plunger may meet and be blocked by at least one barrier at the injection end.

[0027] In exemplary embodiments, the first plunger may meet and be blocked by at least one barrier at the needle base.

[0028] In exemplary embodiments of the present invention, an injector system may comprise a length with an injection end having an injection needle with a base and a tip; a moveable first chamber, having an inner surface, configured to store a plurality of particles and liquid and7142018934comprising (i) a first recessed plunger in the chamber in frictional contact with the inner surface with a recess oriented towards the needle end, (ii) a power source configured to move the first chamber relative to inner length , (iii) a second recessed plunger having a recessed surface oriented towards the first plunger, disposed in frictional contact with the inner surface and within the chamber between the power source and the injection needle, its recessed surface oriented towards the injection needle.

[0029] In an exemplary embodiment a second chamber may be located parallel to the first chamber, separated by a separator between the first and third chamber. The separator between the first chamber and second chamber may include a flow channel or conduit providing fluid communication between the first and third chamber, wherein a portion of the flow channel or conduit traverses an intervening needle housing chamber. The flow channel or conduit providing fluid communication between the first and second chamber, may comprise an inner body at the first end, and an outer body at the second end. The portion of conduit traversing the needle housing chamber may comprise one or more protrusions on the outer body of that portion of the conduit traversing the needle housing chamber. The second chamber may further include a stopper positioned within the second chamber to obstruct the flow channel so that the first chamber and the second chamber are not in fluid communication in the first configuration or position of the stopper. The configuration or position of the stopper and or chambers may permit the separation of a drug and its diluent, or the separation of two drugs, for long term storage. The configuration of the chambers and / or stopper and / or flow channel and / or the cavitation needle are configured to permit the mixing of the liquid and particulate drug substance, or the mixing of two dissimilar liquid drug products, with the aid of cavitating cavities or bubbles formed within the first chamber during the reconstitution stage.8142018934

[0030] In certain embodiments, activating the second power source pushes the liquid through the conduit into the first chamber and activates the first power source.

[0031] In exemplary embodiments, activating the first power source advances the first and second recessed plungers over the conduit and toward the injection needle thereby accelerating the liquid within the first chamber such that the liquid cavitates as it passes over the protrusions on the surface of the portion of the conduit comprising the cavitation needle.

[0032] In exemplary embodiments, the cavitation assists in the mixing or suspension of particles in a liquid or in the mixing or suspension of two dissimilar liquids.

[0033] In exemplary embodiments, the acceleration of the liquid and the particles over a portion of the conduit with a plurality of protrusions assists in mixing or suspension of particles in a liquid or in the mixing or suspension of two dissimilar liquids.

[0034] In certain embodiments, the second recessed plunger stops advancing upon reaching the base of housing thereby decelerating the liquid within the first chamber such that the gas is displaced out of the liquid as the first plunger continues pushing the liquid in the first chamber through the injection needle. The displacement of gas may cause the formation of cavitation cavities or bubbles which assists in mixing or suspension of particles in a liquid or in the mixing or suspension of two dissimilar liquids.

[0035] In certain embodiments, the first recessed plunger stops advancing upon reaching the second recessed plunger, wherein the liquid and the particles are expelled through the injection needle and the gas remains between the first and second recessed surfaces in a final state.

[0036] In certain embodiments of the present invention, a cavitation-induced mixing or suspension method may comprise activating a second power source, wherein: the second power source, upon activation, pushes a liquid from a second chamber through a conduit to a first chamber having a9142018934plurality of particles and gas between a first recessed plunger nearer a first power source and a second recessed plunger nearer an injection needle, the liquid entering the first chamber thereby activating the first power source; and the first power source, upon activation, accelerates the liquid within the first chamber such that the liquid cavitates and pushes the contents of the first chamber toward the injection needle; further wherein (i) the liquid decelerates upon the second recessed plunger reaching the injection needle such that the gas is displaced out of the liquid and (ii) the liquid and the particles are expelled through the injection needle with the gas remaining between the first and second recessed plungers within the first chamber.

[0037] In an exemplary embodiment, a cavitation induced mixing or suspension injector system may comprise a first and second chamber located sequentially in a barrel separated by a separation assembly between the chambers, and a bypass flow channel apposed on a length of the barrel. The injector system includes an activateable power assembly that is linked operatively to a rear plunger that rearwardly is in frictional contact with the first chamber, a separation assembly forwardly confining the first chamber and rearwardly confining a second chamber, and a plunger forwardly confining the second chamber. The first and second chambers are not in fluid communication in the initial position. The barrel length further comprises a bypass flow channel that allows fluid communication when the separation assembly is apposed to the length of the bypass flow channel. The configuration of the chambers, plungers, separation assembly, and bypass flow channel and / or the cavitation needle are configured to permit the mixing of the liquid and particulate drug substance, or the mixing of two dissimilar liquid drug products, with the aid of cavitating cavities or bubbles formed within the second chamber during the reconstitution stage.

[0038] In certain embodiments the first chamber may comprise a liquid diluent.10142018934

[0039] In certain embodiments the second chamber may comprise a drug substance in the form of particles or a liquid composition.

[0040] In certain embodiments the second chamber may comprise a volume of gas.

[0041] Throughout embodiments disclosed herein, the cavitation needle may be hollow.

[0042] Throughout embodiments disclosed herein, the cavitation needle may be solid.

[0043] Throughout embodiments disclosed herein, the tip of the cavitation needle may be situated fully within a needle housing assembly in a resting state.

[0044] Throughout embodiments disclosed herein, the tip of the cavitation needle may be situated within a chamber in a resting state.

[0045] Throughout embodiments disclosed herein, suspension of particles in fluid may not require manual mixing, and / or might be automatic. Throughout embodiments disclosed herein, administration of particles may be via injection, and / or might be automatic.BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG. 1A depicts a single-chamber administration system according to the present invention;

[0047] FIG. IB depict a single-chamber administration system according to the present invention;

[0048] FIG. 2A depicts a method for administration according to the present invention;

[0049] FIG. 2B depicts a method for administration according to the present invention;

[0050] FIG. 2C depicts a method for administration according to the present invention;

[0051] FIG. 2D depicts a method for administration according to the present invention;

[0052] FIG. 2E depicts a method for administration according to the present invention;

[0053] FIG. 3 depicts an administration system according to the present invention;11142018934

[0054] FIG. 4 depicts an alternative embodiment of a single-chamber administration system according to the present invention;

[0055] FIG. 5A depicts an exemplary method for administration according to the present invention;

[0056] FIG. 5B depicts an exemplary method for administration according to the present invention;

[0057] FIG. 5C depicts an exemplary method for administration according to the present invention;

[0058] FIG. 5D depicts an exemplary method for administration according to the present invention;

[0059] FIG. 5E depicts an exemplary method for administration according to the present invention;

[0060] FIG. 6A depicts a double-barreled administration system and method for particle administration according to the present invention;

[0061] FIG. 6B depict a double-barreled administration system and method for particle administration according to the present invention;

[0062] FIG. 7A depicts a sequentially chambered administration system and method for particle administration according to the present invention;

[0063] FIG. 7B depicts a sequentially chambered administration system and method for particle administration according to the present invention;

[0064] FIG. 7B depicts a sequentially chambered administration system and method for particle administration according to the present invention;12142018934

[0065] FIG. 7C depicts a sequentially chambered administration system and method for particle administration according to the present invention;

[0066] FIG. 7D depicts a sequentially chambered administration system and method for particle administration according to the present invention;

[0067] FIG. 7E depicts a sequentially chambered administration system and method for particle administration according to the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0068] In the disclosure herein, details are set forth for purpose of description. However, a person having ordinary skill in the art will realize the invention may be practiced without all the specifics herein. The embodiments and explanations are intended, therefore, to be illustrative only, and not limiting. Similarly, where examples are used, they are not intended to be limiting unless the context clearly indicates otherwise. Accordingly, “for example” or “e.g.” should be read as “for example, and without limitation,” unless the context clearly indicates limitation is intended.

[0069] As used herein, a fluid, and / or the contents of a first chamber, may comprise at least one substance. The meaning of “substance” includes: active pharmaceutical ingredient, amalgam, analgesic, anesthetic, antibiotic, antidote, antifungal, antimicrobial, antiseptic, antitoxin, antiviral, biologic, drug, elixir, matter, medicament, medication, medicine, mixture, ingredient, inoculation, pharmaceutical, prescription, reconstitution, serum, solute, solution, solvent, suspension, tincture, vaccination, and vaccine. It shall be understood that substance includes the foregoing across various modes of administration (e.g. intra-articular, intradural, intraluminal, intramuscular, intrathecal, parenchymal, subcutaneous, sublingual), purposes for use (e.g. analgesia, anesthesia, chemotherapy, sedation, sterilization), and recipients (e.g. a human of any age or any other mammal, animal, or creature), including regarding any specialty or discipline within healthcare or13142018934any similar field or art, and whether for diagnosis, inquiry, investigation, prevention, research, therapy, treatment, or any combination thereof. It shall also be understood that a substance may be the result of adding, combining, dissolving, mixing, reconstituting, suspending, and / or any other manner of uniting two or more component substances. It shall further be understood that a substance should be fluid but may comprise different states of matter.

[0070] Referencing herein to a ‘first’ and / or ‘second’ and or third is intended to identify one component (e.g., a plunger, chamber, power source, etc.) from another, and is not intended to specify a specific number of elements or in defining an order. Therefore, for example, the first chamber may be the second chamber or third chamber or vice versa when describing different exemplary embodiments of the invention. For all embodiments throughout the present disclosure, the terms first, second, and third are used to differentiate components but not to dictate, limit, mandate, or necessitate any arrangement, configuration, order, or sequence.

[0071] The meaning of other terms may be defined herein explicitly or otherwise and / or will be apparent to persons having ordinary skill in the art.

[0072] The systems and methods herein may be used in, for, and / or across various settings and / or types of facilities and / or levels of care. In certain embodiments, the present invention may pertain particularly to outpatient settings. For instance, systems and methods herein could make easier and simplify the self-administration of injections. For example, medications might be designed for long-term use and / or administration, such as once monthly injections to be absorbed by the body slowly in between interval doses. In other examples, administration might be more or less frequent. In certain embodiments, administration (e.g., injection) might be directed, executed, and / or accomplished by a person who is also the intended recipient. Substances to be administered, however, might comprise particles that settle within a fluid, especially in commercial or other14142018934preparations designed to withstand extensive and / or varied transportation, temperature, storage, and / or pressure conditions. In these and other scenarios, it can be desirable and / or advantageous to achieve particle suspension without the need for manual mixing by a user. This could avoid and / or prevent user error, such as inadequate or forgotten mixing, which could compromise the effective dose administered.

[0073] In certain embodiments of systems and methods herein, a force may be applied in the direction of gravity. A force may also be applied in one or more other directions, which may be with or not with the direction of gravity. In certain embodiments of systems and methods herein, the application of a force may be binary (e.g., cannot be applied partially). In certain embodiments of systems and methods herein, entering a second state may be irreversible (e.g., cannot return to the corresponding first state). In certain embodiments of systems and methods herein, a force and / or power source may comprise spring(s), compressed gas, and / or other actuator(s) and / or mechanism(s). A force may be applied, and / or a power source may be activated, as the result of input from a human or otherwise. A force (including a force from a power source) over a period of time may be constant or variable in intensity, and may include one or more predetermined or other patterns.

[0074] In exemplary embodiments of systems and methods herein, the force(s) and / or power source(s) cause the particles to be suspended in the fluid in a sufficiently homogeneous manner (e.g., with minimal to no sediment). Further, in exemplary embodiments, methods and systems herein are configured wherein the sufficiently homogenous nature of the suspension can be maintained throughout administration (e.g., throughout the time the suspension begins to be injected through the needle until the suspension ceases to be injected through the needle). The flow15142018934of fluid (and / or first chamber components) at different points in the embodiments herein may be turbulent.

[0075] FIGS. 1A-B schematizes an exemplary embodiment of a single barrel injector system that mixes and / or suspends particles into a liquid or mixes dissimilar liquids through cavitation where particles and / or liquids are stored within a single chamber. FIG. 1A shows an external view of an injector 100 with a barrel 102, a rearward end 104 to the barrel, a forward end 106 to the barrel, a crimp assembly 108 connected to the barrel 102, and an injection needle 110 with distal end 126. The barrel is preferably made of glass, but it could also be formed from other material such as plastic. Disposed within the barrel 102 is a first power source 113 linked operatively to a first recessed plunger 114. The first recessed plunger 114 rearwardly confines a mixing chamber 116; the mixing chamber is forwardly confined by the second recessed plunger 118. A needle chamber 120 housing the cavitation needle 122 and the proximal end of an injection needle 124 is disposed in the forward end of the barrel 102 and is housed forwardly to the mixing chamber 116 in the barrel 102. The needle chamber 120 is rearwardly confined by the second recessed plunger 118, which separates the needle chamber 120 from the mixing chamber 116, and forwardly by a crimping assembly 108. FIG. IB shows an exemplary view of the single barrel cavitation injector 100 with a needle cap 112 protecting the distal end of needle 126 in the resting state.

[0076] FIGS. 2A-E are cross-sectional views of exemplary embodiments of resting and activated states of a single barreled cavitation injector. Fig. 2A is a cross-sectional view of a single barrel injector 100 in the resting state, wherein the upper seal plunger 114 is disposed in frictional contact with the mixing chamber 116. In the resting state of Fig. 2 A, the upper seal plunger rearwardly 114 confines the mixing chamber 116; the first recessed plunger 114 further comprises a first recess or cavity 128 on the surface oriented toward the mixing chamber and needle housing16142018934chamber. A second recessed plunger 118 is disposed in frictional contact with mixing chamber 116 between first recessed plunger 114 and needle housing chamber 120 and has a second recess or cavity 136 oriented towards first recessed plunger 114. Contained within the mixing chamber 116 is a volume of gas 130. The volume of gas 130 present in the mixing chamber 116 may be in the range of 0.25-100 ml. If the single barreled injector 100 is held with the injection needle 110 downward relative to gravity, the gas 130 present in the mixing chamber 116 is collected in the recess or cavity 128 of the first recessed plunger 114.

[0077] The injector 100 further includes a needle housing chamber 120 comprising a cavitation needle 122, the rearward end 124 of the injection needle 110 oriented towards the mixing chamber 116, and a volume of air 150. The cavitation needle 122 further comprising protrusions 148 on the external surface of the cavitation needle 112 facing the needle housing chamber. The protrusions 148 may comprise any combination of one or more ridges, bosses, or other equivalents or variations readily apparent to those of ordinary skill in the art. The protrusions 148 may be in the range of 0.05in - 0.2 in. The cavitation needle 122 is immovably situated along the length of the barrel 102, with the forward end of the cavitation 154 needle in frictional contact with the crimp assembly 108 at the forward end of the barrel 106. In the resting state, the tip or rearward end 152 of the cavitation needle 122 is positioned rearwardly to the mixing 116. In some embodiments, the tip 152 of the cavitation needle 122 may be situated within the body of the second recessed plunger 118. In some embodiments, the cavitation needle may be hollow 122.

[0078] In an exemplary embodiment, the crimp assembly 108 may comprise a crimp seal 138 that maintains an airtight seal between the barrel 102 and the crimp assembly 108. The crimp assembly 108 further comprises an exhaust seal 140 (see, e.g. FIG. 3) with or more exhaust ports 142a-b. The crimp assembly 108 further comprises an injection needle base 146 that is affixed to the crimp17142018934assembly 108 by a metal crimp 144. The injection needle 110 traverses the injection needle base 146 such that the rearward end of the injection needle 124 is positioned immovably within the needle housing chamber 120 and the forward end of the injection needle 126, which comprises the administration end, extends out of the forward end of the barrel 106.

[0079] FIGS. 2B-E are a series of cross-sectional views of the single barrel injector 100 in a progression of the activated state. In exemplary embodiments, upon activation, the power assembly 113 (see, e.g., FIG. 2A) advances the first recessed plunger 114 and moves the first recessed plunger 114 and the mixing chamber 116 towards the forward end of the barrel 106. The movement of the first recessed plunger 114 and the mixing chamber 116 towards the forward end of the barrel 106 moves the second recessed plunger 118 towards to the forward end of the barrel 106 causing the cavitation needle 112 to pierce the surface of the second recessed plunger 118 apposed to the contents to the mixing or medicament chamber 116 and entering the chamber 116. The traversing of a length of the cavitation needle 112 where the length comprises protrusions 148 into the mixing chamber 116 volumetrically displaces the contents 130, 132, 134 of the mixing chamber 116. The reverberations of the protrusions 148 during the traverse of the cavitation needle 122 through the mixing chamber 116 further agitates the contents 130, 132, 134. In an exemplary embodiment, the liquid 132 accelerates inside mixing chamber 116 in response to the movement of the chamber 116 over the cavitation needle 122, including movement over the protrusions 148. Acceleration of the liquid 132 in the mixing chamber 116 causes its static pressure to become lower than the vapor pressure, creating a vacuum within the liquid 132 and / or causing the gas 130 to expand within mixing or medicament chamber 116. In exemplary embodiments when the barrel 100 is held with the forward end of the injection needle 126 downward relative to gravity, the gas 130 present in the mixing and medicament chamber is pushed into the first recess 128 of the first recessed plunger18142018934114. The acceleration of the liquid 132 over the length of the cavitation needle 122 with protrusions 148 creates a turbulence that the static pressure of the liquid 132 to become lower than the vapor pressure of the liquid 132, thereby creating a vacuum within the liquid 132, which in turn causes the gas 130 in the first recessed chamber 128 to expand into the volume of the liquid 132 in the mixing chamber 116. This expansion of gas 130 within the accelerating liquid 132, in conjunction with the displacement of the liquid 132 volume in the mixing or medicament chamber 116 results in the generation of cavitating bubbles within the liquid 132, thereby creating a turbulence mixing and / or suspending particles 134 and / or dissimilar liquids 134 present in the mixing chamber 116 into the liquid 132 contained in the mixing chamber 116.

[0080] As the first recessed plunger 114, mixing chamber 116, and second recessed plunger 118, descend forwardly through the needle housing chamber 120, the gas 150 present in the needle housing chamber is displaced and exhausted from the barrel 102 through one or more crimp exhaust ports 142 a-b, located on the crimp exhaust seal 140 (see, e.g., FIG. 3A) within the crimp assembly 108.

[0081] As shown in Fig. 2D-E, the second plunger 118 moves downward through the needle housing chamber 120 until it is punctured by the rearward end of the injection needle 124, with the rearward end of the injection needle 124 entering the mixing chamber 116 and moving towards the first recessed plunger 114. As the first recessed plunger 114 moves forwardly through the needle housing chamber 120, it may be punctured by the rearward end of the cavitation needle 152 within the needle housing chamber 120. Further movement of the second recessed plunger 118 stops on reaching the base of the barrel 102. In exemplary embodiments, the resulting deceleration of liquid 132 within the mixing chamber 116 causes the gas 130 in the mixing chamber 116 to be displaced out of liquid 132 because the static pressure of liquid 132 increases to be above the vapor19142018934pressure. When injector 100 is oriented with injection needle 110 downward relative to gravity, the gas in the mixing chamber 130 at this stage is preferentially displaced toward the recess or cavity of the first plunger 128. On displacement of the gas 130 from the liquid 132, the cavitating bubbles collapse, further agitating the contents of the mixing chamber 116 and improving the mixing or suspension of particulates or dissimilar liquids into the liquid. The mixture or suspension then flows into the rearward end of the injection needle 124 and through the length of the injection needle to be dispensed or administered through the forward end of the injection needle 126.

[0082] In exemplary embodiment as shown in Fig. 2E, the second recessed plunger 118 is punctured by rearward end of the injection needle 124, allowing the contents of mixing chamber 116 (e.g., at this stage the mixture, agitation, and / or suspension of particles or dissimilar liquids 134 within the liquid 132) to be in fluid communication with the injection needle 110 and to flow through the length of the injection needle to be dispensed or administered through a tip or forward end of the injection needle 126.

[0083] As shown in FIG. 2E, the first recessed plunger 114 stops advancing upon reaching second recessed plunger 116. In exemplary embodiments, the mixture or suspension of liquid 132 and particles or dissimilar liquid 134 is expelled through the forward end of the injection needle 126 and the gas 130 present in the mixing chamber is retained in the space between first recessed cavity 128 and / or the second recessed cavity 136, between the first 114 and second 118 recessed plungers. As such, only the intended suspension and / or mixture is injected to a target site, without injection of the gas 130 into the site of administration.

[0084] FIG. 3 represents a cross-sectional view of the position of the needle cap 112 relative to the crimp exhaust ports 142a-b located on the crimp exhaust seal 140. When the forward end of the injection needle 126 which extends beyond the barrel 102 is capped, the injection needle cap20142018934112 blocks the release of the gas 150 present in the needle housing chamber 120 through the crimp exhaust ports 142a-b. In an exemplary embodiment, the needle cap 112, when positioned over forward end if the injection needle 126 and the crimp assembly 108, may prevent the premature activation of the injector as the trapped gas 150 within the needle housing chamber 122 cannot escape through the crimp exhaust ports 142 a-b. and the pressure of the trapped gas 150 prevents forward movement of the first and second recessed plungers 114, 116 and mixing chamber 116 towards the injection needle 110.

[0085] FIG. 4 schematizes an alternative embodiment of a single barrel injector where the power assembly 113 comprising an expansion place spring 156, expansion space seal 158, and expansion space plug 160, where the power assembly 113 is operatively connected to the first recessed plunger 114.

[0086] FIGS. 5 A-E illustrates steps of an exemplary embodiment of a particle administration method according to the present invention in connection with a system such as the injector of FIGS 1-2. In FIG. 5A, activation of a power assembly 113 or a power source pushes the first recessed plunger 114, a mixing chamber 116, and a second recessed plunger 118 forwardly along the needle housing chamber 120 toward the rearward end of a cavitation needle 152. At this stage, a gas 130 occupies the first recessed cavity 128 of the first recessed plunger 114 and the particles or dissimilar liquid 134 rests within second recessed cavity 136 of the second recessed plunger 118. A liquid 132 occupies the space between the gas 130 and the particles or dissimilar liquid 134 in the mixing chamber 116.

[0087] In FIGS. 5B-C, the first recessed plunger 114, the mixing chamber 116, and second recessed plunger 118 move forwardly through the needle housing chamber 120 with the rearward end of a cavitation needle 152 puncturing the second recessed plunger 118 to enter the mixing21142018934chamber 116. Acceleration of the liquid 132 flowing over the protrusions 148 on the length of the cavitation needle 122 causes the static pressure of the liquid 132 to decrease relative to the vapor pressure, causing the gas 130 situated in the recess 128 of the first recessed plunger 114 to expand into the liquid 132 causing the generation of cavitation bubbles within the of liquid 132. This agitates, displaces, mixes, and / or suspends particles or dissimilar liquid within the liquid 132 of the mixing chamber 116.

[0088] In FIG. 5C, the second recessed plunger 118 stops advancing upon reaching the base of the barrel 102 or needle housing chamber 120, resulting in deceleration of liquid 132. The change in acceleration of the liquid causes its static pressure to increase relative to the vapor pressure, displacing gas 150 out of liquid 132 and back toward and / or into first recessed cavity 128 of the first recessed plunger.

[0089] In FIG. 5D, the first recessed plunger 114 forwardly moves along the needle housing chamber 120 towards the rearward end of an injection needle 124; in some embodiments, the first recessed plunger may be punctured by the rearward end of the cavitation needle 152 as it forwardly moves towards the injection needle 110. The movement of the first recessed plunger 114 towards the second recessed plunger 118 pushes the contents of the mixing chamber 116 (i.e., the suspension and / or mixture with liquid 132 and / or particles or dissimilar liquid 134) through the rearward end of the injecting needle 124, and injecting the mixture or suspension present in the mixing chamber 116 to a desired target site.

[0090] In FIG. 5E, the first recessed plunger 114 stops advancing upon meeting second recessed plunger 118. In exemplary embodiments, at this stage, the mixture or suspension liquid 132 and particles or dissimilar liquid 134 originally present in the mixing chamber 116 have been injected; and the gas 130 remains within first recessed cavity 128 of the first recessed plunger 114 and / or22142018934second recessed cavity 136 of the second recessed plunger 118 without being advanced out forward end 124 of the injection needle 110. There may be some degree of residual liquid 132 and / or particles or dissimilar liquid 134 remaining within the mixing chamber 116 and / or needle 110.

[0091] FIG. 6A-B schematizes an exemplary embodiment of a particle administration system that agitates and suspends particles into a liquid via cavitation.

[0092] FIG. 6A shows an external view of an injector 600 with a forward end 604 and a rearward end 602, a first barrel 606, a second barrel 608, a conduit 610 between the first and second barrel, and an injection needle 612 situated on the forward end of the first barrel. The first barrel 606 and second barrel 608 are preferably made of glass, but it could also be formed from other material such as plastic. Disposed within the first barrel 606 is a first power source 614 linked operatively to a first recessed plunger 616. The first recessed plunger 616 rearwardly confines a mixing chamber 618; the mixing chamber 618 is forwardly confined by a second recessed plunger 620. A needle housing chamber 622 is housed forwardly to the mixing chamber 618 in a first barrel 606, and housing a portion of the conduit 610 that is the cavitation needle 624 and the rearward end of an injection needle 626 in the first barrel 606. The conduit 610 is hollow with an inner end facing the flow liquid and an outer end facing away from the flow of liquid. A portion of the conduit 610 situated in the needle housing chamber 622 in the first barrel 606 comprises the cavitation needle 624 and has a plurality of protrusions 632 on the outer end. Protrusions 632 may comprise any combination of one or more ridges, bosses, or other equivalents or variations readily apparent to those of ordinary skill in the art. The needle housing chamber 622 is rearwardly confined by the second recessed plunger 620, which separates the needle housing chamber 622 from the mixing chamber 618, and forwardly by a crimping assembly 630. A second barrel 608 comprises a second23142018934power source 634 operatively linked to a plunger 636 which is disposed in frictional contact with a storage chamber 638 housed within the body of the second barrel 608. The mixing chamber 618 of the first barrel and the storage chamber 638 of the second channel are in fluid communication through a hollow conduit 610.

[0093] FIG. 6B is a cross-sectional view of an exemplary embodiments of a double-barreled injector 600 in the resting state. In the resting state exemplified in Fig. 6B, the first recessed plunger 616 rearwardly confines the mixing chamber 618; the first recessed plunger 616 further comprises a first recess or cavity 640 on the surface of the first recessed plunger 616 that is oriented toward the mixing chamber 618 and needle housing chamber 622. A second recessed plunger 620 is disposed in frictional contact with the mixing chamber 618 and is situated between the mixing chamber 618 and needle housing chamber 622. The second recessed plunger 620 has a second recess or cavity 642 oriented towards first recessed plunger 616. Contained with the mixing chamber 618 is a volume of gas 644. The volume of gas 644 present in the mixing chamber 618 may be in the range of 0.25-100 ml. The mixing chamber 618 may further comprise particles 646. In exemplary embodiments the particles 646 comprising the mixing chamber 618 may be lyophilized medicaments or particulate medicaments that must be mixed or suspended into a diluent, which may be a liquid 650 flowing in from the storage chamber 638 at the point of administration. In alternative embodiments, both the mixing 618 and the storage chambers 638 comprise liquid medicaments.

[0094] As seen in FIG. 6B, the first power source 614 may comprise an expansion space 652. The expansion space may comprise a spring 654, which may be a solid (e.g., a spring) or a fluid (e.g., a liquid or a gas) or any other spring mechanism or construct known to persons having ordinary24142018934skill in the art that can provide force to the first plunger 614. The expansion space may further comprise an expansion spacer plug 656, and an expansion space seal 658.

[0095] In an exemplary embodiment, the storage chamber 638 is configured to store a liquid 650. The liquid 650 is disposed between the plunger 636 and seal or plug 668 prevents the flow of liquid 650 from the storage chamber through the conduit when the injector 600 is in its resting state.

[0096] The second power source 634 is configured to, upon activation, to release the seal 668 and push liquid 650 out of storage chamber 638 and through conduit 610 into mixing chamber 618. In exemplary embodiments, liquid 650 entering the mixing chamber 618 expands the volume of mixing chamber 618 and / or activates first power source 614. Activation may occur through various means such as via compression of expansion space 652 and / or activation of the first power source 614.

[0097] In exemplary embodiments, first power source 614, upon activation, advances the first recessed plunger 616, the mixing chamber 618, and second recessed plunger 620 over the portion of the conduit 610 that is the cavitation needle 624 with a length comprising protrusions 632. In a manner similar to that described in conjunction with FIGS. 2A-E and 5A-E, the components of the mixing chamber 618 flowing over the protrusions 632 of the cavitation needle 624 as it traverses through the mixing chamber 618, are accelerated with an associated drop in static pressure, expansion of gas in the mixing chamber, and the formation of cavitation bubbles which, on collapsing, generate a shock wave that agitates the liquid in the mixing chamber 618, thereby mixing or suspending the particles in the liquid or mixing two dissimilar liquids.

[0098] In a manner similar to that described in conjunction with FIGS. 2D-E and 5D-E, In exemplary embodiments, second recessed plunger 620 is punctured at the base by the rearward end of the injection needle 626, allowing the contents of mixing chamber 618 (e.g., at this stage25142018934the mixture or suspension of particles or dissimilar liquid 646 within the liquid 650 from the storage chamber) to enter rearward end of injection needle 626 and proceed to be injected out through a tip 630. As described in conjunction with FIGS. 2E and 5E, the first recessed plunger 616 stops advancing upon coming into contact with the second recessed plunger 620, trapping the gas 644 between first 640 and second recessed cavities 642 between the first 616 and second recessed plungers 620 while the mixture or suspension of liquids and particles in the mixing chamber 618 are dispensed through the forward end or tip of the injection needle 630.

[0099] FIG. 7A schematizes an exemplary embodiment of an injection system where the mixing chamber 716 and storage chamber 774 are situated sequentially in the same barrel 702, where the system is configured to agitate and suspend particles and / or dissimilar liquids into a liquid in the mixing chamber 716 via cavitation at the point of administration. In an exemplary embodiment, the barrel 702 has a forward end 706 and a rear end 704. In certain embodiments, the injector 700 further includes an activatable power assembly 713 that is linked operatively to a rear plunger 770, a first or storage chamber 774 comprising a liquid 732, a separation assembly 768, a second or mixing chamber 716, a needle housing chamber 720 comprising a cavitation needle 722 and the rearward end of an injection needle 724, and a bypass flow insert 766. The injector further comprises a crimp assembly 708 positioned at the forward end of the barrel 706, where the crimp assembly 708 is similar in structure to the crimp assembly 108 described in connection with FIGS. 2A-E. The injector further comprises an injection needle 710 where the rearward end 724 is housed in the needle housing chamber 720, and the forward end of the injection needle 726 extends outwards from the crimp assembly 708. A needle cap or sheath 712 covers the forward end of the injection needle (not shown) and the crimp assembly 708 in the resting state. As described in connection with the injector of FIGS. 2A-E, in an exemplary embodiment, the needle cap or sheath26142018934protects 712 the forward end of the injection needle and prevents premature activation of the autoinjector by obstructing the exhaust of gas 750 present in the needle housing chamber 720 through the crimp exhaust ports (not shown) present in crimp exhaust seal (not shown). Obstructing the exhaust of the gas present in the needle housing chamber prevents the forwardly movement of plungers and chambers which are then unable to displace the gas present within the needle housing chamber.

[0100] FIG. 7B is a schematic cross-sectional representation of the sequentially chambered injector. The storage chamber 774 is rearwardly confined by an upper plunger 770, and forwardly by a separation assembly 768. The separation assembly 768 has a rearward end apposed to the storage chamber 774 and a forward end apposed to the mixing chamber 716. The forward end of separation assembly 768 apposed to the mixing chamber 716 further comprises a recess or cavity 772 oriented towards the lower plunger 776 and needle housing chamber 720. The mixing chamber 716 is confined rearwardly by the forward end of the separation assembly 768, and forwardly a lower plunger 776. The lower plunger 776 has a rearward end apposed to the mixing chamber 716 and a forward end apposed to the needle housing chamber 720. The rearward end of the lower plunger 776 comprises a recess or cavity oriented towards the separation assembly 768. In a resting state, the mixing chamber 716 may further comprise a gas 730 and particles or dissimilar liquids 734.

[0101] In a resting state, the bypass flow channel 766 may be situated forwardly to the lower plunger 776. In certain embodiments, the bypass flow channel 766 may be in fluid communication with the needle housing chamber 720. In an alternative embodiment, the bypass flow channel 766 may be apposed, wholly or in part, to the lower plunger seal 776. In a resting state, the bypass flow channel 766 is not in fluid communication with the storage 774 or mixing chamber 716.27142018934

[0102] In exemplary embodiments, the barrel 702 has an inner diameter along the portions of barrel 702 not comprising a bypass flow channel. The barrel length 702 comprising the bypass flow channel 766 may have a greater inner diameter compared with the inner diameter of a barrel length without the bypass flow channel.

[0103] In a resting state of FIG. 7B, there is circumferential sealing between the storage chamber 774 and the upper plunger 770 and separation assembly 768. The circumferential sealing means that a liquid 732 in storage chamber 774 and the gas 730 and particulates and / or dissimilar liquids 734 in the mixing chamber 108 cannot combine in the resting state because the liquid 732 in the storage chamber 774 and cannot pass the edge of the separation assembly and be in fluid communication with the mixing chamber 716.

[0104] As exemplified in FIGS. 7 C-D, on activation of the power assembly 713 or application of force, the upper plunger 770, separation assembly 768, and lower plunger 776, which are in frictional contact (with circumferential sealing) with the barrel 702, moves forwardly along the length of the barrel 702. When the separation assembly768 is moved into a position abutting the bypass flow channel 766, the storage 774 and mixing chambers 716 are in fluid communication through the bypass flow channel 766, and the liquid 732 from the storage chamber 774 flows into the mixing chamber 716 via the bypass flow channel 766. When liquid 732 from the storage chamber 774 enters the mixing chamber 716, the mixing chamber’s 716 volume increases to accommodate the inflow while that of the storage chamber 774 diminishes. In certain embodiments, the separation assembly 768 moves rearward towards the upper or rear plunger 770 as liquid 732 enters the mixing chamber 716, further forcing out the remaining liquid 732 from the storage chamber 774 into the mixing chamber 716 through the bypass channel 766. The total volume of liquid 732 from the storage chamber 774 is lower than the final expanded volume of28142018934the mixing chamber 716 and at least a portion of the volume of the mixing chamber 716 comprises a gas 730, and a volume of the mixing chamber 716 comprises particles and / or dissimilar liquids 734.

[0105] On further application of force, for example through the power assembly 713, the upper seal plunger 770, the empty (or nearly empty) storage chamber 774, the separation assembly 768, mixing chamber 716, and lower plunger 776 continue to move downwardly the length of the needle housing chamber 729 causing the cavitation needle 722 to pierce the surface of the lower plunger 776 and enter the mixing chamber 716.

[0106] As described in the context of FIGS. 2B-E, and FIGS. 5B-E, the acceleration of the liquid 732 flowing over the cavitation needle 722 and its protrusions 748 as the mixing chamber 716 moves forwardly towards the rearward end of the injection needle 724, causes a sharp drop in the static pressure of the liquid 732, triggering the formation of cavitation bubbles and cavities and causing the gas 730 in the mixing chamber 716 to expand. When the liquid 732 decelerates as the lower plunger 776 comes to a rest at the bottom of the barrel 702, the cavitation bubbles and cavities collapse, agitating the liquid 732 and facilitating the mixing and / or suspension of particles and / or dissimilar liquids into the greater volume of liquid 732 present in the mixing chamber 716. The mixture or suspension then flows through the rearward portion of the injection needle 724 that pierces the lower plunger 776 to enter the mixing chamber 716 as it moves downwardly in the needle housing chamber 720. In a manner similar to that described in the context of FIG. 5E, the separation plunger 768 stops advancing upon meeting the lower plunger 776. In exemplary embodiments, the mixture or suspension liquid 732 and particles or dissimilar liquid 734 originally present in the mixing 716 and the storage chambers 774 have been injected; and the gas 73029142018934remains trapped within recessed cavity 772 of the separation assembly 768 and / or the recessed cavity 776 of the lower plunger 778 without being advanced out of the forward end 12

[0107] Embodiments of the invention can be configured for the administration (e.g., injection) of suspensions (e.g., having particles sized greater than one micron in diameter) or colloids (e.g., having particles sized less than one micron in diameter) or combinations thereof.

[0108] Exemplary embodiments described herein include two separate power sources operating in an automatic and conjoined manner for automatic sequential activation, enabling reconstitution without the need for a user’s intervention (for example, fracturing membranes, vigorous shaking, etc.).

[0109] The power sources for exemplary embodiments described herein may be shown and described as spring loaded. However, other power sources are also contemplated herein. For example, the power sources may be any combination of compressed gas or springs or other actuation mechanism.

[0110] Systems and methods of the invention can be configured for specific use with one or more medicaments.

[0111] In certain embodiments, a drug and / or powder may comprise at least one item selected from the group consisting of: acyclovir, albuterol, amoxicillin, amphotericin B, ampicillin, anidulafungin, artesunate. atropine, azithromycin, benzylpenicillin, brincidofovir, buprenorphine, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, cephalexin, cilastatin, clavulanate, clindamycin, clobazam, clonazepam, cloxacillin, cortisone, dantrolene, dexamethasone, diazepam, epinephrine, ertapenem, erythromycin, flumazenil, ganciclovir, hydrocortisone, imipenem, ketoconazole, lamotrigine, levetiracetam, meropenem, methylprednisolone, micafungin, midazolam, morphine, naloxone, naltrexone,30142018934norepinephrine, penicillin, pentamidine, perampanel, piperacillin, pralidoxime, prednisolone, prednisone, rufinamide, sulbactam, sulfamethoxazole, sumatriptan, tazobactam, topiramate, trimethoprim, valacyclovir, valproate, valproic acid, vancomycin, voriconazole, and zonisamide.

[0112] For example, medicaments according to embodiments of the present invention may include glucagon like peptide 1 (GLP-1) agonists and / or sodium glucose cotransporter 2 (SGLT-2) inhibitors. SGLT-2 inhibitors may include canagliflozin, ertugliflozin, dapagliflozin, and / or empagliflozin. GLP-1 agonists may include dulaglutide, exenatide, exenatide extended release, semaglutide, liraglutide, tirzepatide, and / or lixisenatide. Medicaments may further include inactive ingredients and / or additives, such as, e.g., sodium phosphate, propylene glycol, phenol, and / or water.

[0113] In certain embodiments, a diluent may comprise at least one item selected from the group consisting of: dextrose, lactated Ringer’s, Ringer’s solution, saline, and water. Concentrations may vary and will be readily apparent to persons having ordinary skill in the art. For example, a dextrose solution may comprise 5% dextrose in water (D5), 10% dextrose in water (DIO), etc. Further, a saline solution may be hypotonic, such as 0.45% sodium chloride or half normal saline (1 / 2NS); roughly isotonic, such as 0.9% sodium chloride or normal saline (NS); or hypertonic, such as 3% sodium chloride; etc. In addition, a diluent may comprise a combination, such as D5 with NS, D5 with 1 / 2NS, etc. Other concentrations and / or combinations will be apparent to persons having skill in the art. It shall be understood diluents

[0114] may further comprise preservatives and / or additives, which will be apparent to persons having skill in the art. A diluent may comprise one or more emollients and / or oils.31142018934

[0115] Embodiments of the present invention may comprise certain medicaments, particles, liquids, and / or fluids, or combinations thereof, with examples provided herein. It shall be known that these examples are non-limiting, and extend to agents in identical or similar classes and / or with identical or similar mechanisms of action, and shall include equivalents with generic or other naming, all of which will be readily apparent to persons having ordinary skill in the art. Those of ordinary skill in the art will appreciate that the scope of the present invention encompasses and is directed to agents spanning various categories, including, for example, antibiotics, anticonvulsants, antidotes, antifungals, antihistamines, anti-inflammatories, antimicrobials, antivirals, immunizations, vaccinations, and sympathetic and parasympathetic agonists and antagonists.

[0116] In exemplary embodiments, a powder may comprise the antiviral brincidofovir, offering particular utility in treating viral infection in remote settings, such as. for example, infection with a member of the Ebolavirus genus.

[0117] In exemplary embodiments, a powder may comprise a vaccination, such as those against influenza (flu), tuberculosis (TB), poxviridae, variola viral infection (e.g., smallpox), and varicella-zoster viral infection (e.g., chicken pox and / or shingles). In particular embodiments, a powder may comprise a polysaccharide conjugate vaccine. One example may comprise the Haemophilus influenzae type B (HIB) vaccine (which may be reconstituted, e.g., in 0.4% saline).

[0118] In exemplary embodiments, a powder may comprise antidotes for nerve gas or pesticide poisoning. In particular embodiments, a powder may comprise atropine, its diluent may comprise pralidoxime, and their second liquid may comprise scopolamine. In other embodiments, a powder may comprise 2-pyridine aldoxime methyl chloride (2PAM) and its diluent may32142018934comprise atropine. In other embodiments, a powder may comprise atropine, its diluent may comprise sterile water or saline, and their second liquid may comprise pralidoximeln exemplary embodiments, a powder may comprise epinephrine, such as lyophilized epinephrine. In further embodiments, its diluent may comprise saline, such as NS (0.9% sodium chloride). Epinephrine in solution may be sensitive to container material, imposing restrictions on storage, transportation, and shelf-life. The possibility of epinephrine in powder form, with the advent of the inventive features of the present invention, allows for a more forgiving and durable product, with improved shelf life and drug stability, including across a wider range of container materials (e.g., plastic).

[0119] Regarding the present invention, unless context clearly requires otherwise, persons having ordinary skill in the art will readily see that the method embodiments, and / or apparatus, assembly, device, and / or kit embodiments, include all the same and corresponding features and / or variations described in greater detail with system embodiments discussed herein, and vice versa, including any and all combinations or permutations among or across embodiments or embodiment types.

[0120] Components of the present invention can comprise commonly used materials in the art, such as plastic, rubber, glass, polymeric materials, metals, and / or alloys. In some embodiments, a barrel, barrier, needle, and / or any component or combination thereof may comprise one or more items selected from the group consisting of: medical grade plastic, glass, stainless steel, and aluminum. In some embodiments, plungers may comprise industry standard medical plungers and / or pistons. In some embodiments, a plunger, conduit, and / or any component or combination thereof may comprise one or more items selected from the group consisting of: polytetrafluoroethylene, polyethylene, polypropylene, and polyisoprene.33142018934

[0121] The foregoing pertains to certain embodiments only. Persons having ordinary skill in the art will readily detect improvements or variations that may apply to other embodiments within the scope of this invention in light of this disclosure. The disclosure herein provides description of the present invention and elements thereof. It will be understood that such specifics are for illustrative and exemplary purposes only and are not intended to be limiting. The invention described herein is not intended to be limited to the embodiments discussed in the detailed description or shown in the figures. The figures are only meant to be generally representative and are not necessarily drawn to scale. The figures are not meant to be inherently limiting as to relative proportions.34142018934

Claims

CLAIMSWhat is claimed is:

1. An injector system comprising: a barrel, a first plunger housed within the barrel, a second plunger housed within the barrel, a cavitation needle housed within the barrel, a mixing chamber housed within the barrel, an injection needle, and a power source.

2. The injector system of claim 1 wherein the first plunger comprises a first recess and the second plunger comprises a second recess.

3. The injector system of claim 1 wherein the cavitation needle comprises protrusions.

4. The injector system of claim 1 wherein the injector system consists of a single barrel.

5. The injector system of claim 1 further comprises exhaust ports.

6. The injector system of claim 1 wherein the mixing chamber comprises a gas, a liquid, and a plurality of solid particles.

7. The injector system of claim 1 wherein the mixing chamber comprises a gas. a first liquid, and a second liquid.

8. The injector system of claim 1 wherein the barrel, the first plunger, the second plunger, the cavitation needle, the mixing chamber, and the power source are configured to accelerate a liquid in the mixing chamber to cavitate.

9. The injector system of claim 6 wherein the gas in the mixing chamber comprises air.3514201893410. The injector system of claim 6 wherein the liquid comprises one or more of atropine, pralidoxime, propylene glycol, glycol, phenol, or water.

11. The injector system of claim 6 wherein the plurality of solid particles comprises one of dulaglutide, exenatide, exenatide extended release, semaglutide, liraglutide, tizepatide, lixisenatide, canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, sodium phosphate, and phenol.

12. The injector system of claim 6 wherein the plurality of solid particles comprises one of atropine, 2-pyridine aldoxime methyl chloride (2PAM), and lyophilized epinephrine.

13. An injector system comprising: a first barrel, a second barrel, a first plunger housed within the first barrel. a second plunger housed within the first barrel, a third plunger housed within the second barrel, a cavitation needle, a conduit, an injection needle, and, a power source.

14. The injector system of claim 13 wherein the first barrel and second barrel partially house the conduit.

15. The injector system of claim 13 wherein the first barrel comprises a mixing chamber.

16. The injector system of claim 13 wherein the first barrel comprises a spring.

17. The injector system of claim 13 wherein the conduit comprises the cavitation needle.3614201893418. The injector system of claim 13 wherein the first barrel comprises a gas, and plurality of particles.

19. The injector system of claim 13 wherein the second barrel comprises a second liquid.

20. The injector system of claim 13 wherein the liquid comprises one or more of atropine, pralidoxime, propylene glycol, glycol, phenol, or water.

21. The injector system of claim 13 wherein the plurality of solid particles comprises one of dulaglutide, exenatide, exenatide extended release, semaglutide, liraglutide, tizepatide, lixisenatide, canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, sodium phosphate, and phenol.

22. The injector system of claim 13 wherein the plurality of solid particles comprises one of atropine, 2-pyridine aldoxime methyl chloride (2PAM), and lyophilized epinephrine.

23. An injector system comprising: a barrel, a first plunger, a storage chamber, a separation assembly, a mixing chamber, a second plunger, a bypass flow channel, a cavitation needle, an injection needle, and a power source.3714201893424. The injector system of claim 23 wherein the separation assembly comprises a first recess and the second plunger comprises a second recess.

25. The injector system of claim 23 wherein the cavitation needle comprises protrusions.

26. The injector system of claim 23 wherein the injector system comprises of a single barrel.

27. The injector system of claim 26 further comprises a bypass flow channel.

28. The injector system of claim 23 wherein the mixing chamber comprises a gas and a plurality of solid particles.

29. The injector system of claim 23 wherein the storage chamber comprises a liquid.

30. The injector system of claim 23 wherein the barrel, the first plunger, the separation assembly, second plunger, the cavitation needle, the storage chamber, the mixing chamber, the bypass assembly, and the power source are configured to accelerate a liquid in the mixing chamber to cavitate.

31. The injector system of claim 23 wherein the gas in the mixing chamber comprises air.

32. The injector system of claim 23 wherein the liquid comprises one or more of atropine, pralidoxime, propylene glycol, glycol, phenol, or water.

33. The injector system of claim 23 wherein the plurality of solid particles comprises one of dulaglutide, exenatide, exenatide extended release, semaglutide, liraglutide, tizepatide, lixisenatide, canagliflozin, ertugliflozin, dapagliflozin, empagliflozin, sodium phosphate, and phenol.

34. The injector system of claim 23 wherein the plurality of solid particles comprises one of atropine, 2-pyridine aldoxime methyl chloride (2PAM), and lyophilized epinephrine.

35. A method of administration comprising:38142018934activating a power source housed in a barrel to induce cavitation of a liquid housed in a mixing chamber wherein the mixing chamber comprises a cavitation needle, the liquid and a gas; and administering a composition comprising the liquid via an injection needle wherein the injection needle is partially housed in the barrel.

36. The method of administration of claim 35 wherein the composition further comprises a plurality of solid particles.39142018934

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