Claims for Patent: 11,497,753

Summary for Patent: 11,497,753

Title:	Hazardous agent injection system
Abstract:	Injection systems comprising a powered injector and one or more hazardous agents are disclosed.
Inventor(s):	Paul K. WOTTON, Peter L. Sadowski, John W. Hayes
Assignee:	Antares Pharma Inc
Application Number:	US16/715,781
Patent Claims:	1. An injection device comprising: a container containing a hazardous agent; an injection outlet member associated with the container for injecting the hazardous agent; a firing mechanism configured to expel the hazardous agent from the fluid chamber through the outlet member for injecting the hazardous agent; an energy source associated with the firing mechanism to power the firing mechanism for causing the injection; a trigger mechanism associated with the firing mechanism configured to move radially outward to activate the firing mechanism; a latching portion coupling the trigger mechanism to the firing mechanism, the latching portion configured to prevent activation of the firing mechanism; and a safety member coupled to a housing, the safety member configured to prevent the trigger mechanism from moving radially outward and configured to prevent movement of the latching portion to prevent the firing mechanism from expelling a therapeutically effective amount of the hazardous agent contained in the container. 2. The injection device of claim 1, wherein the hazardous agent is selected from botulinum toxin, injectable gold, 6-mercaptopurine, 6-thioinosinic acid, azathioprine, chlorambucil, cyclophosphamide, cytophosphane, cytarabine, fluorouracil, melphalan, methotrexate, uramustine, anti-cytokine biologicals, cell receptor antagonists, cell receptor analogues, dexamethasone, progesterone, somatostatin, analogues of dexamethasone, analogues of progesterone, analogues of somatostatin, teriparatide, scopolamine, antihypertensives, blood pressure down regulators, fentanyl, fentanyl citrate, morphine, meperidine, other opioids, adalimumab (anti-tissue necrosis factor monoclonal antibody or anti-TNF), anakinra, daclizumab, basiliximab, azathioprine, cyclosporine, tacrolimus, testosterone, estrogen, growth hormone, insulin, thyroid hormone, follicle stimulating hormone (FSH), epinephrine/adrenaline, gamma-linolenic acid, docosahexanoic acid, arachidonic acid, eicosapentaenoic acid, amobarbital, pentobarbital, secobarbital, phenobarbitol, clonazepam, diazepam, estazolam, flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam, chlordiazepoxide, alprazolam, ashwagandha, Duboisia hopwoodii, prosanthera striatiflora, kava (Piper methysticum), mandrake, valerian, marijuana, eszopiclone, zaleplon, zolpidem, zopiclone, diphenhydramine, dimenhydrinate, doxylamine, promethazine, chloral hydrate, dicyclomine, atropine, ipratropium bromide, oxitropium bromide, tiotropium, levodopa, dopamine, carbidopa, benserazide, co-ceraldopa, co-beneldopa, tolcapone, entacapone, bromocriptine, pergolide, pramipexole, ropinirole, piribedil, cabergoline, apomorphine, lisuride, human growth hormone, erythropoeitin, haloperidol, droperidol, chlorpromazine, fluphenazine, perphenazine, prochlorperazine, thioridazine, trifluoperazine, mesoridazine, periciazine, promazine, triflupromazine, levomepromazine, promethazine, pimozide, chlorprothixene, clopenthixol, flupenthixol, thiothixene, zuclopenthixol, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, amisulpride, asenapine, paliperidone, iloperidone, zotepine, sertindole, aripiprazole, bifeprunox, etanercept, derivatives of any of the foregoing, and combinations of any of the foregoing. 3. The injection device of claim 1, wherein the hazardous agent is methotrexate. 4. The injection device of claim 3, wherein: the injector is a prefilled, single-shot injector; the firing mechanism and energy source are associated and configured for injecting only a single shot of the methotrexate; and the injector comprises a disabling mechanism to disable the injector from making further injections after the single-shot is injected. 5. The injection device of claim 1, wherein the powered injector is configured to inject the therapeutically effective amount of the hazardous agent in less than about 4 seconds. 6. The injection device of claim 1, wherein the powered injector is configured to inject the therapeutically effective amount of the hazardous agent in about 1 second. 7. The injection device of claim 1, wherein the powered injector is a jet injector configured to jet inject the hazardous agent at a rate of at least about 0.5 mL per second. 8. The injection device of claim 7, wherein the energy source is configured for generating a pressure of at least about 300 p.s.i. in the container. 9. The injection device of claim 7, wherein the jet injector is a needle-assisted jet injector, wherein the injection outlet member includes an injection-assisting needle configured for piercing the outer layer of skin of a patient and delivering the hazardous agent as a jet into a tissue of the patient. 10. The injection device of claim 7, wherein the jet injector is a needle-free jet injector, wherein the injection outlet member includes a needle-free nozzle, and the energy source is sufficiently powerful for causing the jet-injected hazardous agent to pierce the outer layer of the skin of a patient to an injection depth. 11. The injection device of claim 1, wherein the hazardous agent is at a concentration of about 7.5 mg to about 150 mg per milliliter. 12. The injection device of claim 1, wherein the safety member is removably coupled to the housing. 13. An injection device comprising: a container containing a hazardous agent; an injection outlet member associated with the container for injecting the hazardous agent; a firing mechanism configured to expel the hazardous agent from the fluid chamber through the outlet member for injecting the hazardous agent; an energy source associated with the firing mechanism to power the firing mechanism jet injecting the hazardous agent from the injection outlet; a trigger mechanism associated with the firing mechanism configured to move radially outward to activate the firing mechanism; a latching portion coupling the trigger mechanism to the firing mechanism, the latching portion configured to prevent activation of the firing mechanism; and a safety member coupled to a housing, the safety member configured to prevent the trigger mechanism from moving radially outward and configured to prevent movement of the latching portion to prevent the firing mechanism from expelling a therapeutically effective amount of the hazardous agent contained in the container; wherein the jet injector is configured to inject the therapeutically effective amount of the hazardous agent at a rate of at least about 0.5 mL per second. 14. The injection device of claim 13, wherein the jet injector is configured to inject the therapeutically effective amount of the hazardous agent in less than about 4 seconds. 15. The injection device of claim 13, wherein the jet injector is configured to inject the therapeutically effective amount of the hazardous agent in about 1 second. 16. The injection device of claim 13, wherein the jet injector is a needle-assisted jet injector, wherein the injection outlet member includes an injection-assisting needle configured for piercing the outer layer of skin of a patient and delivering the hazardous agent as a jet into a tissue of the patient. 17. The injection device of claim 13, wherein the jet injector is a needle-free jet injector, wherein the injection outlet member includes a needle-free nozzle, and the energy source is sufficiently powerful for causing the jet-injected hazardous agent to pierce the outer layer of the skin of a patient to an injection depth. 18. The injection device of claim 13, wherein the hazardous agent is methotrexate. 19. The injection device of claim 13, wherein the safety member is removably coupled to the housing. 20. An injection device for the treatment of inflammatory diseases, comprising: a container containing a hazardous agent; an injection outlet member associated with the container; a firing mechanism; an energy source associated with the firing mechanism; a trigger mechanism associated with the firing mechanism; a latching portion coupling the trigger mechanism to the firing mechanism; and a safety member coupled to a housing, the safety member configured to prevent the trigger mechanism from moving radially outward and configured to prevent movement of the latching portion to prevent the firing mechanism from expelling a therapeutically effective amount of the hazardous agent contained in the container. 21. The injection device of claim 20, wherein the hazardous agent comprises methotrexate and the therapeutically effective amount of methotrexate is sufficient to treat an inflammatory disease, and wherein the inflammatory disease is rheumatoid arthritis. 22. The injection device of claim 20, wherein the jet injector is configured to inject the therapeutically effective amount of the methotrexate agent in less than about 4 seconds. 23. The injection device of claim 20, wherein the safety member is removably coupled to the housing.