Hazardous agent injection system

• US 10,555,954 B2
• Filed: 09/01/2017
• Issued: 02/11/2020
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: Wotton, Paul K., Sadowski, Peter L., Hayes, John W.
• Primary Examiner(s): Farrar, Lauren P
• Application Number:
  US15/693,876
• Publication Number:
  US 20170361021A1
• Time in Patent Office: 893 Days
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/0087 Galenical forms not covered by A61K9/02 - A61K9/7023
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Claims

1. A hazardous agent injection system comprising:

a hazardous agent; and

a powered injector comprising;

a housing;

a container containing the hazardous agent disposed within the housing;

an injection outlet member fluidly coupled with the container and configured to deliver the hazardous agent to a patient subcutaneously;

a firing mechanism operatively coupled to the container and configured to expel the hazardous agent from the container through the injection outlet member for injecting the hazardous agent;

an energy source coupled to the firing mechanism and configured to power the firing mechanism;

a trigger mechanism coupled to the firing mechanism and configured to move radially outwardly 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 removably coupled to the 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 the hazardous agent from the container.

2. The hazardous injection system of claim 1, wherein the hazardous agent is methotrexate.

3. The hazardous injection system of claim 2, wherein the methotrexate is 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.

4. The hazardous injection system of claim 1, wherein the housing has a proximal end and a distal end, and the safety member is removably affixed to the proximal end of the housing.

5. The hazardous injection system of claim 1, wherein the safety member includes at least one leg extending from the safety member.

6. The hazardous injection system of claim 5, wherein the at least one leg is flexible.

7. The hazardous injection system of claim 5, wherein the at least one leg is configured to extend into at least one corresponding slot located on the housing.

8. The hazardous injection system of claim 7, wherein the at least one leg of the safety member is pressure fitted into the at least one corresponding slot.

9. The hazardous injection system of claim 7, wherein the at least one leg is configured to engage the latching portion to prevent activation of the firing mechanism.

10. The hazardous injection system of claim 5, wherein the at least one leg is biased outwardly.

11. The hazardous agent injection system of claim 5, wherein the at least one leg extends perpendicular to a surface of the latching portion and abuts the surface of the latching portion to prevent axial movement of the latching portion.

12. The hazardous agent injection system of claim 1, wherein the powered injector is a jet injector.

13. The hazardous agent injection system of claim 1, 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.

14. The hazardous agent injection system of claim 1, wherein the powered injector is configured to inject the hazardous agent such that the hazardous agent is injected at a flow rate of at least about 0.5 ml/sec.

15. The hazardous agent injection system of claim 1, wherein the energy source comprises a spring.

16. The hazardous agent injection system of claim 1, wherein the energy source is configured to eject the hazardous agent from the injection outlet member in less than about 5 seconds.

17. The hazardous agent injection system of claim 1, wherein the safety member is removably affixed to a proximal end of the housing by a plurality of tabs that extend through matching openings formed in the housing to form a press-fit between the safety member and the housing.

18. The hazardous agent injection system of claim 1, wherein the container and the injection outlet member coupled to the container comprise a syringe.

19. The hazardous agent injection system of claim 18, 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.

20. 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.

21. The method of claim 20, 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.

22. The hazardous agent injection system of claim 1, wherein the latching portion is axially moveable from a first position to a second position and the safety member prevents axial movement of the latching portion.

23. The hazardous agent injection system of claim 22, wherein the latching portion in the first position prevents radially outward movement of the trigger mechanism, and

wherein the trigger mechanism is moveable radially outwardly when the latching portion is in the second position.

24. The hazardous agent injection system of claim 1, wherein the trigger mechanism includes protrusions that are biased radially outward.