Claims for Patent: 12,357,642

Summary for Patent: 12,357,642

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:	US17/938,161
Patent Claims:	1. An injector comprising: a housing; a container disposed within the housing containing a hazardous agent and having an injection outlet member fluidly coupled thereto for injecting the hazardous agent; a firing mechanism configured to move relative to the container to expel the hazardous agent from the container through the injection outlet member; an energy source associated with the firing mechanism to move the firing mechanism relative to the container; a trigger mechanism associated with the firing mechanism; a latching mechanism disposed at least partially within the housing and moveable relative to the housing between a blocking position where the firing mechanism is prevented from moving relative to the container and an unblocking position where the firing mechanism is allowed to move relative to the container; and a safety member removably coupled to the housing and configured to prevent the latching mechanism from moving from the blocking position to the unblocking position when the safety member is coupled to the housing. 2. The injection system 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 system of claim 1, wherein the hazardous agent is methotrexate. 4. The injection system 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 system of claim 1, wherein the injector is configured to inject a therapeutically effective amount of the hazardous agent in less than about 4 seconds. 6. The injection system of claim 1, wherein the injector is configured to inject a therapeutically effective amount of the hazardous agent in about 1 second. 7. The injection system of claim 1, wherein the 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 system of claim 7, wherein the energy source is configured for generating a pressure of at least about 300 psi in the container. 9. The injection system 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 system 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 system 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 system of claim 1, wherein the trigger mechanism is moveable between an engaged position where the trigger mechanism engages the firing mechanism to prevent the energy source from moving the firing mechanism relative to the container and a disengaged position where the trigger mechanism disengages the firing mechanism to allow the energy source to move the firing mechanism relative to the container. 13. The injection system of claim 12, wherein the latching mechanism prevents the trigger mechanism from moving from the engaged position to the disengaged position when the latching mechanism is in the blocking position. 14. The injection system of claim 12, wherein the latching mechanism allows the trigger mechanism to move from the engaged position to the disengaged position when the latching mechanism is in the unblocking position. 15. The injection system of claim 1, wherein the safety member allows the latching mechanism to move from the blocking position to the unblocking position when the safety member is decoupled from the housing. 16. The injection system of claim 1, wherein the latching mechanism comprises a needle guard extending at least partially from the housing and a latch disposed within the housing, where the needle guard is coupled to the latch. 17. An injector comprising: a housing; a container disposed within the housing containing a hazardous agent and having an injection outlet member fluidly coupled thereto for injecting the hazardous agent; a firing mechanism configured to move relative to the container to expel the hazardous agent from the container through the injection outlet member; an energy source associated with the firing mechanism to move the firing mechanism relative to the container jet injecting the hazardous agent from the injection outlet; a trigger mechanism associated with the firing mechanism; a latching mechanism disposed at least partially within the housing and moveable relative to the housing between a blocking position where the firing mechanism is prevented from moving relative to the container and an unblocking position where the firing mechanism is allowed to move relative to the container; a safety member removably coupled to the housing and configured to prevent the latching mechanism from moving from the blocking position to the unblocking position when the safety member is coupled to the housing; and a therapeutically effective amount of the hazardous agent contained in the container, wherein the 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. 18. The injection system of claim 17, wherein the injector is configured to inject the therapeutically effective amount of the hazardous agent in less than about 4 seconds. 19. The injection system of claim 17, wherein the injector is configured to inject the therapeutically effective amount of the hazardous agent in about 1 second. 20. The injection system of claim 17, wherein the 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. 21. The injection system of claim 17, wherein the 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. 22. The injection system of claim 17, wherein the hazardous agent is methotrexate. 23. An injector for the treatment of inflammatory diseases, comprising: a housing; a container disposed within the housing containing a hazardous agent and having an injection outlet member fluidly coupled thereto for injecting the hazardous agent; a firing mechanism; an energy source associated with the firing mechanism; a trigger mechanism associated with the firing mechanism; a latching mechanism disposed at least partially within the housing and moveable relative to the housing between a blocking position where the firing mechanism is prevented from moving relative to the container and an unblocking position where the firing mechanism is allowed to move relative to the container; and a safety member removably coupled to the housing and configured to prevent the latching mechanism from moving from the blocking position to the unblocking position when the safety member is coupled to the housing. 24. The injection system of claim 23, wherein the inflammatory disease is rheumatoid arthritis. 25. The injection system of claim 23, wherein the injector is configured to inject a therapeutically effective amount of the methotrexate agent in less than about 4 seconds.