Needle assisted jet injection device having reduced trigger force

• US 9,744,302 B2
• Filed: 02/11/2014
• Issued: 08/29/2017
• Est. Priority Date: 02/11/2013
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: Travanty, Michael
• Primary Examiner(s): Berdichevsky, Aarti B
• Application Number:
  US14/178,199
• Publication Number:
  US 20140303556A1
• Time in Patent Office: 1,295 Days
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• 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 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• 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 2205/584 having a color code
• 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/3245 Constructional features thereof, e.g. to improve manipulation or functioning
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• 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: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: A61P 1/14 Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 15/10 : for impotence
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 : for osteoporosis
• CPC Class Codes: A61P 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/20 : Hypnotics; Sedatives
• CPC Class Codes: A61P 5/24 : of the sex hormones
• CPC Class Codes: A61P 5/26 : Androgens
• CPC Class Codes: A61P 7/06 : Antianaemics

Abstract

An injector includes a trigger mechanism including: a trigger member disposed about an axis having an aperture and a protrusion, and a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom, the ram assembly further having a trigger engagement member configured to engage the aperture of the trigger member when the trigger member is in a pre-firing condition; an energy source associated with the ram for powering the ram to expel the medicament; and a user-operable firing-initiation member having an aperture engaged with the protrusion of the trigger member and operable for causing an axial translation of the trigger member in a proximal direction from the pre-firing condition to a firing condition in which the trigger engagement member is released from the retaining portion to allow the energy source to fire the ram.

Claims

1. An injector, comprising:

a medicament container containing medicament, the medicament being at least one of testosterone or a derivative thereof;

a trigger mechanism including;

a trigger member disposed about an axis, the trigger member having a trigger member opening and a trigger member protrusion, and

a ram assembly having a ram configured to pressurize the medicament container for expelling the medicament therefrom, the ram assembly further having a trigger engagement member configured to engage the trigger member opening when the trigger member is in a pre-firing condition;

an energy source associated with the ram and configured to powering the ram to expel the medicament; and

a user-operable guard including a firing-initiation member having a guard aperture engaged with the trigger member protrusion, the firing-initiation member operable for causing an axial translation of the trigger member in a proximal direction from the pre-firing condition to a firing condition in which the trigger engagement member is disengaged from the trigger member opening to allow the energy source to fire the ram.

2. The injector of claim 1, wherein the testosterone or a derivative thereof includes an ester of testosterone.

3. The injector of claim 1, wherein the testosterone or derivative thereof includes testosterone cypionate.

4. The injector of claim 1, wherein the testosterone or derivative thereof includes testosterone enanthate.

5. The injector of claim 1, wherein the guard aperture is slidingly engaged with the trigger member protrusion.

6. The injector of claim 1, wherein the ram assembly is of unitary construction.

7. The injector of claim 1, wherein the injector is configured to inject at least 0.5 ml of the testosterone or derivative thereof in about 14 seconds or less.

8. The injector of claim 1, wherein the injector is configured to inject at least 0.5 ml of the testosterone or derivative thereof in about 5 seconds to about 15 seconds.

9. The injector of claim 1, wherein the energy source expels the testosterone or derivative thereof at a stream velocity of at least about 100 centimeters per second.

10. The injector of claim 1, further comprising a container support that is configured for holding the medicament container during injection, and wherein the ram assembly is configured to engage the container support to lock-out the injector after an injection.

11. The injector of claim 10, wherein proximal movement of the user-operable guard is blocked by the ram assembly when the injector is locked-out.

12. The injector of claim 1, wherein a pre-firing color gamut is visible from an exterior of the injector in the pre-firing condition, the injector further comprising:

a housing including a window; and

an indicator having an indicator color that is absent from the pre-firing color gamut, the indicator color being hidden from view within the housing in the pre-firing condition, wherein in the firing condition, the indicator color is visible through the window from an exterior of the injector for indicating the firing condition.

13. The injector of claim 12, wherein the ram assembly includes the indicator.

14. The injector of claim 13, wherein the ram assembly entirely occludes the window in the firing condition.

15. The injector of claim 1, further comprising an end cap, said end cap comprising a ram holding member that axially retains the ram assembly in a proximal position against action of the energy source in the pre-firing condition.

16. The injector of claim 15, wherein the ram holding member engages the trigger engagement member to axially retain the ram assembly in the proximal position against action of the energy source in the pre-firing condition.

17. The injector of claim 16, wherein in the firing condition, the ram assembly is disengaged from the trigger member opening, and the energy source overcomes the engagement between the trigger engagement member and the ram holding member.

18. The injector of claim 16, wherein the ram holding member includes a projection that includes a bulge and a groove that are configured to engaged the trigger engagement member, and the trigger member opening retains the engagement of the trigger engagement member with the bulge and groove in the pre-firing condition.

19. The injector of claim 16, further comprising, a latch retention angle defined by the axis and a contact surface of the ram holding member and the trigger engagement member.

20. The injector of claim 19, wherein the latch retention angle is between about 35°

and about 45°

.

21. The injector of claim 19, wherein the latch retention angle is between about 75°

and about 85°

.

22. The injector of claim 1, further comprising:

an injector housing,

wherein the firing-initiation member includes a skin-contacting member disposed at a distal end of the injector, the skin-contacting member being movable proximally with respect to the housing when a force is applied to the skin-contacting member at the distal end of the injector, the firing-initiation member being associated with the trigger member and configured to cause the axial translation of the trigger member in a proximal direction from the pre-firing condition to the firing condition upon a proximal movement of the skin-contacting member with respect to housing.

23. The injector of claim 22, wherein the skin-contacting member is coupled to the guard, the guard being configured to expose a needle connected to the medicament container upon the proximal movement of the skin-contacting member.

24. The injector of claim 23, wherein the needle is in fluid communication with the medicament container for injecting the medicament expelled therefrom when the ram is fired.

25. The injector of claim 23, wherein the energy source and the needle are configured for jet injecting the medicament through the needle.

26. The injector of claim 25, wherein the energy source is configured to pressurize the medicament from about 90 p.s.i. to and about 600 p.s.i.

27. The injector of claim 25, wherein the energy source and needle are configured for injecting the medicament at an average velocity of at least about 1,000 cm/sec within the needle.