# US 9,750,881 B2 · Hazardous agent injection system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,881 B2 - Document ID: US9750881B2 - Status: Granted - Kind: B2 - Application number: 15/243,244 - Filed: 2016-08-22 - Published: 2017-02-16 - Granted: 2017-09-05 - Earliest claimed: 2009-03-20 - Assignees: Antares Pharma, Inc. - Applicants: Antares Pharma, Inc. - Inventors: Paul K. Wotton; Peter L. Sadowski; John W. Hayes - Web page: https://patentgrep.com/patent/US9750881B2 ## CPC - A61K 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone - A61K 9/0087: {Galenical forms not covered by A61K9/02 - A61K9/7023} - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61M 5/178: Syringes - A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)} - A61M 5/30: Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)} - A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user} - A61M 2005/2013: {triggering of discharging means by contact of injector with patient body} - A61M 2005/2073: {preventing premature release, e.g. by making use of a safety lock} - A61M 2005/3247: {Means to impede repositioning of protection sleeve from needle covering to needle uncovering position} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Injection systems comprising a powered injector and one or more hazardous agents are disclosed. ## Claims ### Claim 1 A hazardous agent injection system comprising: methotrexate in an amount of about 0.02 ml to about 4.0 ml and at a concentration of about 7.5 mg/ml to about 150 mg/ml; a powered injector comprising: a container containing the methotrexate; an injection outlet member fluidly coupled with the container and configured to deliver the methotrexate to a patient subcutaneously; a firing mechanism coupled to the container and configured to expel the methotrexate from the container through the injection outlet member for injecting the methotrexate; an energy source coupled to the firing mechanism and configured to power the firing mechanism; and a trigger mechanism coupled to the firing mechanism and configured to activate the firing mechanism, wherein the powered injector is configured to eject the methotrexate from the injection outlet member such that one or more of confidence intervals of (a) the maximum concentration of methotrexate in blood plasma of the patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system, (b) the time to reach the maximum concentration of methotrexate in blood plasma of the patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system and (c) area under a curve of a concentration of methotrexate in blood plasma of the patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system falls between about 80% and about 125% of a measured confidence interval of an equivalent dose of methotrexate delivered by a hand-powered syringe, and wherein the powered injector is configured to subcutaneously inject the methotrexate at a pressure of at least about 80 psi. ### Claim 2 (depends on 1) The hazardous agent injection system of claim 1, wherein the powered injector is a jet injector. ### Claim 3 (depends on 2) The hazardous agent injection system of claim 2, wherein the injection outlet member includes an injection-assisting needle, a gauge of the injection-assisting needle being selected from 26 gauge and a higher gauge number. ### Claim 4 (depends on 1) The hazardous agent injection system of claim 1, wherein the powered injector is configured to inject the methotrexate such that the methotrexate is injected at a flow rate of at least about 0.5 ml/sec. ### Claim 5 (depends on 1) The hazardous agent injection system of claim 1, wherein the energy source comprises a spring. ### Claim 6 (depends on 1) The hazardous agent injection system of claim 1, wherein the energy source is configured to eject the methotrexate from the injection outlet member in less than about 5 seconds. ### Claim 7 (depends on 1) The hazardous agent injection system of claim 1, wherein the powered injector further comprises an outer housing member. ### Claim 8 (depends on 7) The hazardous agent injection system of claim 7, wherein the powered injector further comprises a safety member located at a proximal end of the outer housing member. ### Claim 9 (depends on 8) The hazardous agent injection system of claim 8, wherein the safety member is removably affixed to the proximal end of the outer housing member. ### Claim 10 (depends on 9) The hazardous agent injection system of claim 9, wherein the safety member is removably affixed to the proximal end of the outer housing by a plurality of tabs that extend through matching openings formed in the outer housing to form a press-fit between the safety member and the outer housing member. ### Claim 11 (depends on 1) The hazardous agent injection system of claim 1, wherein the container and the injection outlet member coupled to the container comprise a syringe. ### Claim 12 (depends on 11) The hazardous agent injection system of claim 11, wherein the powered injector further comprises a syringe sleeve, the syringe sleeve having a bore portion configured to abut an outside of a syringe wall so as to minimize movement of the syringe caused by activation of the firing mechanism. ### Claim 13 (depends on 1) A method of treating a patient having an autoimmune disease, the method comprising injecting the patient using the hazardous agent injection system of claim 1. ### Claim 14 (depends on 13) The method of claim 13, wherein the autoimmune disease is selected from the group consisting of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, steroid-resistant polymyositis or dermatomyositis, Wegener's granulomatosis, polyarteritis nodosa, and vasculitis.