WO2025226593A1

WO2025226593A1 - Particle suspension auto-injector

Info

Publication number: WO2025226593A1
Application number: PCT/US2025/025602
Authority: WO
Inventors: Girum Yemane-Tekeste
Original assignee: Kindeva Drug Delivery LP
Current assignee: Kindeva Drug Delivery LP
Priority date: 2024-04-24
Filing date: 2025-04-21
Publication date: 2025-10-30
Anticipated expiration: 2026-10-24

Abstract

Disclosed and described herein are methods and systems for particle administration. Certain embodiments of the present invention comprise one or more chambers, with a plurality of particles and a fluid between two plungers, configured wherein applying a force disperses the fluid and particles such that the particles are suspended into the fluid.

Description

TITLE OF THE INVENTION: Particle Suspension Auto-Injector

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63/638,227, filed April 24, 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.

BACKGROUND OF THE INVENTION

[0002] The present invention relates to methods and systems for suspension of particles in fluid and administration of the suspended mixture, such as in the example of intramuscular (IM) or subcutaneous (SC or SQ) medication injection into a human or other animal. The present invention allows reliable preservation of the particles and fluid, optionally in separate chambers, within the same system without unwanted mixing or other compromise, in a manner capable of withstanding distant transportation and long shelf-life durability, while preserving ease of administration by the user at time of administration via a single activation of the system. Methodologies and systems described in the prior art lack such optimization and fail at one or more of these aspects, among other problems addressed by the present invention. 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, and/or topical administration(s), or any other administration route that may be known to persons having ordinary skill in the art. [0003] Other features of the present invention will be apparent to persons having ordinary skill in the art in light of this disclosure and description.

BRIEF SUMMARY OF THE INVENTION

[0004] 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.

[0005] In certain embodiments of the present invention, a particle administration system may comprise a barrel, first and second plungers, a fluid, and a plurality of particles. The barrel may have an inner surface along a length with an administration end. The first and second plungers may be in the barrel in frictional contact with the inner surface. In a first state, the fluid and particles may be between the first and second plungers, with the first plunger at a distance from the administration end and the second plunger further from the administration end. In a second state, applying a force to the second plunger may move the first and second plungers and the fluid and particles toward the administration end.

[0006] In certain embodiments, applying the force may suspend the particles in the fluid.

[0007] In certain embodiments, applying the force may move the first plunger until it meets and is punctured by a needle.

[0008] In certain embodiments, applying the force may move the first plunger until it meets at least one barrier blocking further movement.

[0009] In certain embodiments of the present invention, a particle administration method may comprise applying a force translating a fluid and a plurality of particles toward an administration site wherein the particles may be suspended in the fluid. [0010] In certain embodiments, the force may be applied to a second plunger in a barrel. The barrel may comprise a length having two ends, wherein one may be an administration end configured to appose the administration site. The barrel may also comprise an inner surface along the length. The second plunger may be in frictional contact with the inner surface. In a first state prior to applying the force, the fluid and particles may be between the second and first plungers in the barrel. The first plunger may be in frictional with the inner surface. The first plunger may be disposed along the length of the barrel so that the first plunger is between the second plunger and administration end yet at a distance from the administration end. In a second state, subsequent to applying the force, the fluid and particles may be translated toward the administration site, and the particles may be suspended in the fluid.

[0011] In certain embodiments, the fluid with the suspended particles may be injected into the administration site.

[0012] In certain embodiments, after applying the force, the first plunger may meet and be punctured by a needle at the administration end, and the fluid with the suspended particles may be injected through the needle.

[0013] In certain embodiments, after applying the force the first plunger may meet at least one barrier, which may block further translation of the first plunger.

[0014] In certain embodiments of the present invention, a particle administration system may comprise an injector having a length with an injection end. The injection end may have a needle with a base and a tip. The injector may comprise a first chamber with a first inner surface and a second chamber with a second inner surface. The first chamber may be configured to store a plurality of particles. The first chamber may have a first plunger and a first power source. The first plunger may be in frictional contact with the first inner surface. The first power source may be configured to, upon being compressed, push contents of the first chamber out of the first chamber and through the needle. The second chamber may be configured to store a fluid. The second chamber may have a second plunger and a second power source. The second plunger may be in frictional contact with the second inner surface. The second power source may be configured to, upon activation, push the fluid out of the second chamber and through a conduit between the second and first chambers.

[0015] In certain embodiments, activating the second power source may push the fluid through the conduit into the first chamber and may compress the first power source.

[0016] In certain embodiments, fluid entering the first chamber may suspend the particles into the fluid without requiring manual mixing by a user.

[0017] In certain embodiments, pushing the contents of the first chamber may suspend the particles into the fluid without requiring manual mixing by a user.

[0018] In certain embodiments, pushing the first chamber contents may push the first plunger until it meets and is punctured by the base of the needle. The first chamber contents may enter the needle at its base and flow to its tip.

[0019] In certain embodiments, the first plunger may meet and be blocked by at least one barrier at the injection end.

[0020] In certain embodiments of the present invention, a particle administration method may comprise activating a second power source to push a fluid from a second chamber through a conduit to a first chamber and suspend a plurality of particles from the first chamber into the fluid. Pushing the fluid into the first chamber may also compress a first power source to push the contents of the first chamber toward an administration site and may further suspend the particles into the fluid. [0021] In certain embodiments, pushing the first chamber contents may push a first plunger until it meets and is punctured by a base of a needle. The first chamber contents may enter the needle at its base and flow to a tip.

[0022] In certain embodiments, the first plunger may meet and be blocked by at least one barrier at the needle base.

[0023] Embodiments of the present invention may comprise certain drugs, powders, diluents, and/or second liquids, 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.

[0024] 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, norepinephrine, penicillin, pentamidine, perampanel, piperacillin, pralidoxime, prednisolone, prednisone, rufmamide, sulbactam, sulfamethoxazole, sumatriptan, tazobactam, topiramate, trimethoprim, valacyclovir, valproate, valproic acid, vancomycin, voriconazole, and zonisamide. [0025] 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 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.

[0026] In exemplary embodiments, a powder may comprise the antiviral brincidofovir, offering utility in treating viral infection in geographical areas that may not be readily accessible, such as, for example, infection with a member of the Ebolavirus genus.

[0027] 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). [0028] 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 may comprise atropine. In other embodiments, a powder may comprise atropine, its diluent may comprise sterile water or saline, and their second liquid may comprise pralidoxime.

[0029] In 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).

[0030] Throughout embodiments disclosed herein, suspension of particles in fluid might not require manual mixing, and/or might be automatic. Throughout embodiments disclosed herein, administration of particles might be via injection, and/or might be automatic.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] For purpose of explanation, aspects of several embodiments are depicted in the following illustrative figures, wherein:

[0032] FIG. 1 depicts a single-chamber particle administration system according to the present invention;

[0033] FIGS. 2A-E depict a method for particle administration according to the present invention; [0034] FIGS. 3A-C depict a dual-chamber particle administration system according to the present invention;

[0035] FIGS. 4A-L depict an exemplary method for particle administration according to the present invention; and

[0036] FIGS. 5A-B depict an exemplary system for particle administration according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0037] In the disclosure herein, details are set forth for the 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.

[0038] 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 or any 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.

[0039] Referencing herein to a ‘first’ and/or ‘second’ 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 vice versa when describing different exemplary embodiments of the invention. For all embodiments throughout the present disclosure, the terms first and second are used to differentiate components but not to dictate, limit, mandate, or necessitate any arrangement, configuration, order, or sequence.

[0040] 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.

[0041] 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 other preparations 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.

[0042] FIG. 1 depicts a particle suspension auto-injector 100 comprising a barrel 101 with an administration end having a needle 102. Injector 100 further comprises first plunger 103 and second plunger 104. In FIG. 1, injector 100 is illustrated in a first state with a plurality of particles 105 and a fluid 106 between the plungers 103, 104, first plunger 103 at a distance from the administration end, and second plunger 104 at a further distance from the administration end than first plunger 103. Injector 100 is configured for dispersion of fluid 106 and particles 105 upon the application of a force in a second state (not illustrated) such that particles 105 are suspended within fluid 106. Particularly, a force moving fluid 106 and particles 105 toward the administration end (such as, e.g., a force on second plunger 104) may suspend particles 105 in fluid 106 when the force and/or injector 100 are configured with respect to, for example: the dimensions, flexibility, malleability, and/or pliability, or lack thereof, of barrel 101; the volume, viscosity, and/or density of fluid 106; the buoyancy, dimensions, density, and/or mass of particles 105; the material characteristics, dimensions, and/or flow rate within needle 102; the force applied and associated energy, power, work, jerk, acceleration, and/or velocity; and/or temperature conditions; and the fluid dynamics resulting therefrom. In certain embodiments, fluid 106 is of a low viscosity, such as saline or water. A low viscosity fluid may reduce the need for cold storage or cold chain transportation. Variations within the scope of the present invention will be apparent to persons having ordinary skill in the art. [0043] In certain embodiments, barrel 101 may comprise a syringe or other container. Barrel 101 may be cylindrical or comprise one or more other shapes. In injector 100, plungers 103, 104 are configured to be in frictional contact with an inner surface of barrel 101 and translatable along the length of barrel 101. The cross section of the inner surface of barrel 101 can be in other orthogonal or other non-parallel relation to its length.

[0044] In certain embodiments, the force applied pushes second plunger 104 and first plunger 103 toward the administration end until first plunger 103 meets and is punctured by (not illustrated) a base of needle 102. The fluid 106 and particles 105 suspended therein may enter needle 102 at its base and be injected out a tip of needle 102. In certain embodiments, injector 100 may comprise at least one barrier (not illustrated) at its administration end wherein first plunger 103 upon reaching the barrier(s) is blocked from further translation or movement (e.g., in that direction).

[0045] 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. [0046] 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 flow of fluid (and/or first chamber components) at different points in the embodiments herein may be turbulent, including in part.

[0047] Turning to FIGS. 2A-E, a method of particle suspension and administration is shown using a system of the present invention — specifically, an embodiment of injector 100 with barrel 101 comprising annular barrier 107 at the administration end.

[0048] FIG. 2A illustrates a first state prior to the application of force. Particularly, FIG. 2A shows injector 100 in a vertical configuration with respect to gravity, particles 105 and fluid 106 between the first and second plungers, and particles 105 settled down onto the first plunger and fluid 106 generally above particles 105.

[0049] In FIG. 2B, application of a force 108 triggers a dynamic second state, which is illustrated across FIGS. 2B-E. In the illustrated embodiment, force 108 is a constant downward force applied to the second plunger 104 As force 108 pushes the second plunger downward, the second plunger pushes fluid 106 downward (also pushing the first plunger 103 downward), but fluid 106 moves faster/further than particles 105, resulting in suspension as illustrated in FIG. 2C. Continued application of force 108 in FIG. 2D takes the suspended mixture down to the administration end, where the base of needle 102 punctures the first plunger. Shortly after the first plunger is punctured, the first plunger reaches barrier 107, blocking further downward movement of the first plunger. However, continued application of force 108 as seen in FTG. 2E keeps pushing the second plunger downward, which effectively compresses the suspended mixture to enter the base of needle 102 and be subsequently injected out of its tip. The injected mixture comprises dispersed particles 105 in fluid 106. Variations within the scope of the present invention will be apparent to persons having ordinary skill in the art.

[0050] Referring now to FIG. 3A, depicted is an external view of a dual-chamber particle suspension auto-injector 300 comprising an outer body 312 and safety cap 313. As seen in an internal planar view in FIG. 3B, injector 300 comprises a first chamber 301 and a second chamber 302. Injector 300 has a length axis with an injection end having needle 310 configured with its tip 317 away from and its base 316 toward first chamber 301. First chamber 301 is configured to store a plurality of particles 305, and also houses a first plunger 303. Injector 300 is configured for a first power source 308 to, upon being compressed, push the contents of first chamber 301 (out of first chamber 301, through needle 310) and also first plunger 303. Second chamber 302 is configured to store a fluid 306, and also houses a second plunger 304. Injector 300 is configured for a second power source 309 to, upon being activated, push fluid 306 out of second chamber 302, through a conduit 311 in fluid communication between second chamber 302 and first chamber 301

[0051] In exemplary embodiments, injector 300 may further comprise: safety lock 314, which may be configured to cover needle 310 following injection; activator 315, which may be configured to activate second power source 309 upon the injection end of injector 300 being pressed against an injection site; and/or actuator 318, which may be configured to compress (and/or actuate) first power source 308 upon fluid 306 entering first chamber 301. In certain embodiments, first plunger 303 may serve as a lower seal for first chamber 301 and second plunger 304 may serve as an upper seal for second chamber 302, and injector 300 may further comprise a second chamber lower seal 319 and a first chamber upper seal 320. In some embodiments, injector 300 may comprise a variable expansion space 321 between first chamber 301 and first power source 308, and expansion space 321 may be bordered by first chamber upper seal 320 and expansion space seal 322. FIG. 3C depicts external oblique views of injector 300 in a first configuration 300a with, and a second configuration 300b without, safety cap 313.

[0052] As illustrated in FIG. 3B, when auto-injector 300 is in a first state (before activation of second power source 309), particles 305 and fluid 306 are stored in physically separated chambers and do not intermix. It is not until shortly prior to administration, when a second state (not illustrated in FIG. 3B) is triggered (e.g., upon the activation of second power source 309), that an ensuing series of events (outlined below) allow suspension of particles 305 into fluid 306 and subsequent injection (e.g., immediately) of the resultant mixture.

[0053] In certain embodiments, activation of second power source 309 pushes second plunger 304, which pushes fluid 306 into conduit 311. The interface/border between second chamber 302 and conduit 311 may be maintained with a valve, bladder, and/or other construct known in the art. E.g., entry of fluid 306 to conduit 311 may be controlled with the advent of an additional needle and plunger (neither illustrated in FIG. 3B) between fluid 306 into conduit 311, wherein a force from activated second power source 309 pushes such plunger until it is punctured by such needle, creating an opening into second chamber 302 with fluid communication into conduit 311. In certain embodiments, conduit 311, and/or the interface between conduit 311 and second chamber 302, may only permit one-way flow (such as only permitting flow of fluid 306 out of and away from second chamber 302). [0054] In certain embodiments, after fluid 306 is pushed into conduit 311, fluid 306 is transmitted to first chamber 301. In FIG. 3B, conduit 311 has roughly a ‘U-shaped’ configuration and/or results in net inversion (or a 180-degree reversal) of the vector of flow of fluid 306 as it courses from second chamber 302 to first chamber 301; however, conduit 311 may comprise different configurations, dimensions, sizes, directions, and/or courses. In certain embodiments, conduit 311 causes the flow of fluid 306 to be turbulent. The interface/border between first chamber 301 and conduit 311 may be maintained with a valve, bladder, and/or other construct known in the art, etc. Such interface between conduit 311 and first chamber 301 may only permit one-way flow (e.g., only permitting flow of fluid 306 into first chamber 301 and out of conduit 311).

[0055] In certain embodiments, fluid 306 entering first chamber 301 may suspend particles 305 from within first chamber 301 into fluid 306. In certain such embodiments, the fluid 306 entering first chamber 301 may comprise turbulent flow to further agitate and/or suspend particles 305 into a mixture with fluid 306.

[0056] In certain embodiments, fluid 306 entering first chamber 301 may compress, and/or result in the compression of, first power source 308 (e.g., via pushing on a border, edge, or other component of, and/or expanding, first chamber 301). Compression of first power source 308 may be configured to, upon being compressed, exert force to push what first chamber 301 contains at that time (e.g., a combination of particles 305 with fluid 306, with or without full or partial suspension of particles 305 into fluid 306 in a mixture). Said pushing of the first chamber 301 contents may itself suspend (or further suspend) particles 305 into fluid 306 (e.g., via the dynamics described in embodiments regarding FIGS. 1 and 2A-E).

[0057] In injector 300, first plunger 303 is situated between the contents of first chamber 301 and needle 310. As such, the pushing of first chamber 301 contents also pushes first plunger 303 toward and into needle 310 until needle 310 punctures first plunger 303. This thus creates an opening with fluid communication between first chamber 301 and needle 310. Shortly after first plunger 303 is punctured, first plunger 303 reaches barrier 307, blocking further movement of first plunger 303. Continued pressure from first power source 308 effectively compresses the suspended mixture to enter the base of needle 310 and be subsequently injected out of its tip.

[0058] 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.

[0059] The present invention also includes particle administration methods using systems such as injector 300. For example, a method may comprise activating the second power source, triggering the second state and its series of events described above.

[0060] FIGS. 4A-L show an exemplary embodiment of a particle administration method according to the present invention in connection with a system such as injector 300. In FIG. 4A, injector 300 still has its safety cap 313 in place. In FIG. 4B, safety cap 313 has been removed, revealing activator 315, which is not obscured by the outer body of injector at the injection end. In FIG. 4C, the injector has been positioned with the injection end in apposition to an injection site 335. In FIG. 4D, the injector has been pressed against injection site 335, causing relative retraction of the activator with respect to needle 310, which emerges and punctures injection site 335. In FIG. 4E, said relative retraction of the activator into the outer body of the injector activates second power source 309. This marks the transition of the injector from its first state to its second state.

[0061] In FIG. 4F, second power source 309 pushes second plunger 304 downward. Movement in FIGS. 4A-L may be referred to with terms such as ‘down’ and ‘up’ only for purposes of explanation of the figures as illustrated. Similarly, components in FIGS. 3A-5B may be described with terminology such as ‘upper’ or ‘lower’ also solely for explanatory purposes. It shall be understood these terms are not limiting as to any element’s possible directions of movement, and/or relative orientations or other configurations, across embodiments of the present invention. Returning to FIG. 4F, the translation of second plunger 304 downward has also resulted in downward translation of second chamber lower seal 319. In certain embodiments, such as FIG. 4F, second chamber lower seal 319 comprises a plunger and conduit 311 comprises a needle oriented toward the second chamber 302, such that downward translation of second chamber lower seal 319 causes it to meet and be punctured by conduit 311. As seen in FIG. 4F, the fluid starts to flow from the second chamber through conduit 311 to first chamber 301.

[0062] In FIG. 4G, continued force from second power source 309 results in second plunger 304 apposing second chamber lower seal 319 with complete compression/evacuation of the second chamber. The fluid having entered first chamber 301 resulted in expansion of first chamber 301, pushing first chamber upper seal 320 upward, which compressed the expansion space with first chamber upper seal 320 meeting and pushing upon expansion seal 322. The upward motion of first chamber upper seal 320 and expansion seal 322 also pushes actuator 318 upward, compressing and/or actuating first power source 308. The fluid entering first chamber 301 may be turbulent. In exemplary embodiments, the injector is configured wherein the fluid entering first chamber 301 suspends the particles into the fluid.

[0063] In FIG. 4H, the actuated first power source 308 exerts a downward force on expansion seal 322, serially also pushing first chamber upper seal 320, the contents of the first chamber, and first plunger 303. First plunger 303 meets and is punctured by the base of the needle. In exemplary embodiments, the particles are further suspended into the fluid during the transit of the contents of the first chamber resulting from first power source 308. [0064] In FIG. 41, continued force from first power source 308 results in first chamber upper seal 320 compressing the first chamber’s contents through needle 310, beginning injection of particles 305 (suspended in the fluid) into the injection site.

[0065] In FIG. 4J, continued force from first power source 308 results in first chamber upper seal 320 apposing first plunger 303 with complete compression/evacuation of the first chamber, completing the administration of particles 305 into the injection site.

[0066] In FIG. 4K, the injector is removed, disengaging needle 310 from the injection site.

[0067] In FIG. 4L, safety lock 315 deploys to cover the exposed needle. In exemplary embodiments, safety lock 315 deploys and/or operates automatically, immediately, and/or irreversibly. Different mechanisms and variations will be readily apparent to persons having ordinary skill in the art.

[0068] FIGS. 5A-B schematize an exemplary embodiment of a particle administration system according to the present invention. FIG. 5A shows an external view of an injector 500 with a first barrel 533, a second barrel 534, and a needle 510.

[0069] FIG. 5B shows an internal planar view of injector 500. The first barrel comprises first chamber 501, bordered by first plunger 503 and first chamber upper seal 520. The second barrel comprises second chamber 502, bordered by second plunger 504 and second chamber bottom seal 519. The first and second barrels (and first chamber 501 and second chamber 502) are bridged by conduit 511. Injector 500 may further comprise at least one crimp and glass seal 528, at least one crimp exhaust seal 529, at least one crimp exhaust channel 530, and/or at least one crimp 531.

[0070] As seen in FIG. 5B, the first barrel may further comprise an expansion space 521 between first chamber 501 and a first power source (not illustrated). Expansion space 521 may house, and/or be defined by, a spacer 524, which could comprise a solid (e.g., a spring) or a fluid (e.g., a liquid or a gas) or any other spacing mechanism or construct known to persons having ordinary skill in the art. The first barrel may also comprise a particles bucket 525 between first chamber 501 and the needle. Particles bucket 525 may be capped with a particles bucket seal 526. The second barrel may also comprise a fluid bucket 527 between second chamber 502 and conduit 511. Fluid bucket 527 may be capped with a fluid bucket seal 528. In certain embodiments, fluid bucket 527 may comprise one or more steps, ridges, springs, protuberances, and/or other designs to agitate fluid as it flows from second chamber 502 before entering conduit 511 (e.g., to create turbulent flow). In certain embodiments, particle bucket 525 may comprise one or more steps, ridges, springs, protuberances, and/or other designs to agitate the contents of first chamber 501 (e.g., particles and a fluid) as they flow from first chamber 501 before entering the needle (e.g., to suspend and/or further suspend the particles into the fluid).

[0071] Systems and methods of the invention can be configured for specific use with one or more medicaments.

[0072] 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.

[0073] 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.

[0074] 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.

Claims

CLAIMS What is claimed is:

1. A particle administration system, comprising a barrel with an inner surface along a length, a first plunger disposed in the barrel in frictional contact with the inner surface, a second plunger disposed in the barrel in frictional contact with the inner surface, a fluid, and a plurality of particles, wherein, in a first state, the first plunger is disposed at a distance from an administration end of the length, the second plunger is disposed further from the administration end than the distance between the administration end and the first plunger, and the fluid and the particles are disposed between the first and second plungers, and in a second state, application of an administration force on the second plunger results in translation of the second plunger, the first plunger, the fluid, and the particles toward the administration end.

2. The system of claim 1, configured wherein the application of the administration force suspends the particles in the fluid.

3. The system of claim 2, wherein the suspension of the particles in the fluid does not require manual mixing.

4. The system of claim 3, wherein the suspension is automatic.

5. The system of claim 2, comprising a needle at the administration end, wherein the application of the administration force results in translation of the first plunger until the first plunger meets and is punctured by the needle.

6. The system of claim 5, comprising at least one barrier at the administration end, configured to block further translation of the first plunger upon the first plunger reaching the barrier.

7. The system of claim 5, configured wherein particle administration comprises injection of the fluid and the particles through the needle.

8. The system of claim 7, configured wherein the particle administration is automatic.

9. A particle administration method, comprising applying an administration force translating a fluid and a plurality of particles toward an administration site wherein the particles are suspended in the fluid.

10. The method of claim 9, wherein the suspension of the particles in the fluid does not require manual mixing.

11. The method of claim 10, wherein the suspension is automatic.

12. The method of claim 9, comprising administering the particles to the administration site.

13. The method of claim 12, wherein the administration is automatic.

14. The method of claim 9, comprising applying the administration force to a second plunger disposed in a barrel, the barrel comprising a length having two ends, one end being an administration end configured to appose the administration site, and an inner surface along the length, the second plunger disposed in frictional contact with the inner surface, wherein in a first state, before applying the administration force, the particles and fluid are disposed between the second plunger and a first plunger, the first plunger disposed in the barrel, in frictional contact with the inner surface, along the length, between the second plunger and the administration end, at a distance from the administration end, and in a second state, after applying the administration force, the particles and fluid are translated toward the administration site, the particles being suspended in the fluid.

15. The method of claim 14, comprising injecting the fluid with the suspended particles into the administration site.

16. The method of claim 15, wherein the injection of the fluid and the suspended particles into the administration site is automatic.

17. The method of claim 15, wherein after applying the administration force the first plunger meets and is punctured by a needle at the administration end and the fluid with the suspended particles are injected through the needle.

18. The method of claim 17, wherein after applying the administration force the first plunger meets and is blocked from further translation by at least one barrier at the administration end.

19. A particle administration system, comprising: a length with an injection end having an injection needle with a base and a tip; a first chamber, having a first inner surface, configured to store a plurality of particles and comprising: a first plunger in the first chamber in frictional contact with the first inner surface; and a first power source configured to, upon being compressed, push contents of the first chamber out of the first chamber and through the injection needle; a second chamber, having a second inner surface, configured to store a fluid and comprising: a second plunger in the second chamber in frictional contact with the second inner surface; and a second power source configured to, upon activation, push the fluid out of the second chamber and through a conduit between the second and first chambers.

20. The system of claim 19, wherein activating the second power source pushes the fluid through the conduit into the first chamber and compresses the first power source.

21. The system of claim 19, configured wherein the fluid entering the first chamber suspends the particles in the fluid without requiring manual mixing by a user.

22. The system of claim 21, wherein the suspension of the particles in the fluid does not require manual mixing.

23. The system of claim 22, wherein the suspension is automatic.

24. The system of claim 19, configured wherein pushing the contents of the first chamber out of the first chamber suspends the particles in the fluid without requiring manual mixing by a user.

25. The system of claim 24, wherein the suspension of the particles in the fluid does not require manual mixing.

26. The system of claim 25, wherein the suspension is automatic.

27. The system of claim 19, wherein the first power source pushing the contents of the first chamber also pushes the first plunger until the first plunger meets and is punctured by the base of the injection needle from where the contents of the first chamber enter the injection needle and flow to the tip of the injection needle.

28. The system of claim 19, comprising at least one barrier at the injection end, configured to block further translation of the first plunger upon the first plunger reaching the barrier.

29. The system of claim 19, configured wherein particle administration comprises injection of the fluid and the particles through the needle.

30. The system of claim 29, configured wherein the particle administration is automatic.

31. A particle administration method, comprising activating a second power source, wherein the second power source, upon activation, pushes a fluid from a second chamber through a conduit to a first chamber, thereby suspending a plurality of particles from the first chamber into the fluid, and compressing a first power source, and the first power source, upon being compressed, pushes the contents of the first chamber toward an administration site

32. The method of claim 31, wherein the suspension of the particles in the fluid does not require manual mixing.

33. The method of claim 32, wherein the suspension is automatic.

34. The method of claim 31, wherein the first power source pushing the contents of the first chamber further suspends the particles into the fluid.

35. The method of claim 34, wherein the further suspension of the particles in the fluid does not require manual mixing.

36. The method of claim 35, wherein the further suspension is automatic.

37. The method of claim 31, comprising administering the particles to the administration site.

38. The method of claim 37, wherein the administration is automatic.

39. The method of claim 31, comprising injecting the fluid with the suspended particles into the administration site.

40. The method of claim 39, wherein the injection of the fluid and the suspended particles into the administration site is automatic.

41. The method of claim 31, wherein the first power source pushing the contents of the first chamber also pushes a first plunger until the first plunger meets and is punctured by a base of a needle from where the contents of the first chamber enter the needle and flow to a tip of the needle.

42. The method of claim 41, wherein after being pushed the first plunger meets and is blocked from further translation by at least one barrier at the base of the needle.

43. The reconstitution auto-inj ector of claim 3, wherein the powder comprises epinephrine and the liquid comprises saline.

44. The reconstitution auto-injector of claim 3, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

45. The reconstitution auto-injector of claim 3 wherein the powder comprises atropine, the liquid comprises pralidoxime, and the second liquid comprises scopolamine.

46. The reconstitution auto-injector of claim 3, wherein the powder comprises 2-pyridine aldoxime methyl chloride and the diluent comprises atropine.

47. The reconstitution auto-injector of claim 3, wherein the powder comprises atropine, the diluent comprises sterile water, and the second liquid comprises pralidoxime.

48. The reconstitution auto-injector of claim 3, wherein the powder comprises atropine, the diluent comprises saline, and the second liquid comprises pralidoxime.

49. The reconstitution auto-injector of claim 11, wherein the powder comprises epinephrine and the liquid comprises saline.

50. The reconstitution auto-injector of claim 11, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

51. The reconstitution auto-injector of claim 11, wherein the powder comprises atropine, the liquid comprises pralidoxime, and the second liquid comprises scopolamine.

52. The reconstitution auto-injector of claim 11, wherein the powder comprises 2-pyridine aldoxime methyl chloride and the diluent comprises atropine.

53. The reconstitution auto-injector of claim 11, wherein the powder comprises atropine, the diluent comprises sterile water, and the second liquid comprises pralidoxime.

54. The reconstitution auto-injector of claim 11, wherein the powder comprises atropine, the diluent comprises saline, and the second liquid comprises pralidoxime.

55. The reconstitution auto-injector of claim 21, wherein the powder comprises epinephrine and the liquid comprises saline.

56. The reconstitution auto-injector of claim 21, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

57. The reconstitution auto-injector of claim 21, wherein the powder comprises atropine, the liquid comprises pralidoxime, and the second liquid comprises scopolamine.

58. The reconstitution auto-injector of claim 21, wherein the powder comprises 2-pyridine aldoxime methyl chloride and the diluent comprises atropine.

59. The reconstitution auto-injector of claim 21, wherein the powder comprises atropine, the diluent comprises sterile water, and the second liquid comprises pralidoxime.

60. The reconstitution auto-injector of claim 23, wherein the powder comprises epinephrine and the liquid comprises saline.

61. The reconstitution auto-injector of claim 23, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

62. The reconstitution auto-injector of claim 23, wherein the powder comprises atropine, the liquid comprises pralidoxime, and the second liquid comprises scopolamine.

63. The reconstitution auto-injector of claim 23, wherein the powder comprises 2-pyridine aldoxime methyl chloride and the diluent comprises atropine.

64. The reconstitution auto-injector of claim 23, wherein the powder comprises atropine, the diluent comprises sterile water, and the second liquid comprises pralidoxime.

65. The reconstitution auto-injector of claim 23, wherein the powder comprises atropine, the diluent comprises saline, and the second liquid comprises pralidoxime.

66. The method of claim 23, wherein the powder comprises atropine, the diluent comprises saline, and the second liquid comprises pralidoxime.