Prefilled syringe jet injector

• US 8,021,335 B2
• Filed: 07/23/2007
• Issued: 09/20/2011
• Est. Priority Date: 01/24/2005
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: Lesch, Paul R. Jr.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Patel; Pritesh
• Application Number:
  US11/781,832
• Publication Number:
  US 20080154200A1
• Time in Patent Office: 1,520 Days
• Field of Search: 604/135, 604/111
• US Class Current: 604/135
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• 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 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• 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 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61M 5/484 Regulating injection pressure

Abstract

A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

Claims

1. A jet injector, comprising:

a prefilled syringe comprising;

a glass container portion defining a fluid chamber containing a medicament,

an injection-assisting needle disposed at the distal end of the chamber, having an injection tip configured for piercing an insertion location, and defining a fluid pathway in fluid communication with the chamber for injecting the fluid from the chamber into an injection site,

wherein the injection-assisting needle is adhered to the glass container portion,

a syringe body that includes a flange, a wall and hub of unitary construction, and where the syringe body of the prefilled syringe is made of glass, and

a plunger movable within the fluid chamber,

a housing that houses the prefilled syringe and is configured for allowing insertion of the needle at the injection location to an insertion point that is at a penetration depth below the surface at the insertion location;

a syringe support supportively mounting the prefilled syringe to the housing;

a syringe cushion associated with the syringe support and prefilled syringe and made of an elastomeric material to compensate for shape irregularities of the pre-filled syringe, and

an energy source configured for biasing the plunger with a force selected to produce an injecting pressure in the medicament in the fluid chamber that substantially remains between about 80 p.s.i. and 1000 p.s.i. during the injection of the medicament to jet inject the medicament from the fluid chamber through the needle to the injection site.

2. The jet injector of claim 1, wherein the energy source and prefilled syringe are configured such that the injecting pressure remains below about 500 p.s.i. and above about 90 p.s.i. during the injection of the medicament.

3. The jet injector of claim 1, wherein the energy source is configured to produce the injecting pressure that remains at least at about 100 p.s.i. during the injection of the medicament.

4. The jet injector of claim 3, wherein the energy source and prefilled syringe are configured such that the injecting pressure remains up to about 350 p.s.i. during the injection of the medicament.

5. The jet injector of claim 1, wherein the housing is configured for allowing insertion of the needle to penetration depth, which is between about 0.5 mm and 5 mm below the surface at the insertion location.

6. The jet injector of claim 1, wherein the housing is configured for allowing insertion of the needle to the penetration depth, which is between about 11 mm and 13 mm below the surface at the insertion location.

7. The jet injector of claim 1, wherein the energy source comprises a spring.

8. The jet injector of claim 7, further comprising a ram that is biased by the spring against the plunger to produce the injection pressure, wherein the ram comprises a bell portion on which the spring is seated, and the bell portion defines a hollow interior configured for receiving the prefilled syringe when the device is fired, such that the spring surrounds the prefilled syringe.

9. The jet injector of claim 1, wherein:

the prefilled syringe has a distal portion in which the injection-assisting needle is located, and a proximal portion opposite the distal portion; and

the syringe support axially supports the proximal portion of the pre-filled syringe during the jet injection of the medicament, such that the distal portion of the prefilled syringe is substantially unsupported in an axially direction.

10. the jet injector of claim 1, wherein the chamber contains about between 0.02 mL and 4 mL of the medicament.

11. The jet injector of claim 1, wherein the housing comprises a retractable guard that is movable between:

a protecting position in which the needle is disposed within the guard; and

an injecting position in which the tip of the needle is exposed for insertion to the insertion point.

12. The jet injector of claim 11, further comprising a trigger mechanism operable associated with the energy source for activating the energy source to jet inject the medicament, wherein the trigger mechanism is configured for activating the energy source after the retractable guard is retracted from the protecting position.

13. The jet injector of claim 12, wherein the retractable guard is operable associated with the trigger mechanism to cause the trigger mechanism to activate the energy source when the guard is retracted to the injecting position.

14. The jet injector of claim 1, wherein the penetration depth and injecting pressure are sufficient to substantially prevent backflow of the injected medicament.

20. The jet injector of claim 1, wherein the prefilled syringe is associated with the housing in a fixed position before and during activation of the energy source for firing of the jet injector.

21. The jet injector of claim 1, wherein the syringe cushion comprises a resilient sleeve portion configured to provide shock absorption during firing of the injector.

22. The jet injector of claim 1, wherein the syringe cushion supports the flange.

15. A jet injector, comprising:

a prefilled syringe comprising;

a glass container portion defining a fluid chamber containing a medicament,

an injection-assisting needle disposed at the distal end of the chamber,

an injecting tip configured for piercing an insertion location and defining a fluid pathway in fluid communication with the chamber for injecting the fluid from the chamber into an injection site,

wherein the infection-assisting needle is adhered to the glass container portion,

a syringe body that includes a flange, a wall and hub of unitary construction, and where the syringe body of the prefilled syringe is made of glass, and

a plunger movable within the fluid chamber,

a housing that houses the prefilled syringe and is configured for allowing insertion of the needle at the injection location to an insertion point that is at a penetration depth of up to 5 mm below the surface at the insertion location;

a syringe support supportively mounting the prefilled syringe to the housing;

a syringe cushion associated with the syringe support and prefilled syringe and made of an elastomeric material to compensate for shape irregularities of the pre-filled syringe, and

an energy source configured for biasing the plunger with a force selected to produce an injecting pressure in the medicament in the fluid chamber that substantially remains between about 80 p.s.i, and 1000 p.s.i, during injection of the medicament to jet inject the medicament from the fluid chamber through the needle to an injection site remote from the injecting tip.

16. The jet injector of claim 15, wherein the penetration depth is between about 1 mm and 4 mm.

17. The jet injector of claim 15, wherein the penetration depth is up to about 3 mm below the surface of at the insertion location.

18. The jet injector of claim 15, wherein the injecting pressure and penetration depth are sufficient such that the injection sire is subcutaneous.

19. The jet injector of claim 15, wherein the energy source and prefilled syringe are configured such that the injecting pressure remains below about 500 p.s.i. and above about 90 p.s.i. during the injection of the medicament.

23. A jet injector, comprising:

a prefilled syringe comprising;

a glass container portion defining a fluid chamber containing a medicament,

an injection-assisting needle disposed at the distal end of the chamber, having an injection tip configured for piercing an insertion location, and defining a fluid pathway in fluid communication with the chamber for injecting the fluid from the chamber into an injection site,

wherein the injection-assisting needle is adhered to the glass container portion,

a syringe body that includes a flange, a wall and hub of unitary construction, and where the syringe body of the prefilled syringe is made of glass, and

a plunger movable within the fluid chamber;

a housing that houses the prefilled syringe and is configured for allowing insertion of the needle at the injection location to an insertion point that is at a penetration depth below the surface at the insertion location;

an energy source configured for biasing the plunger with a force selected to produce an injecting pressure in the medicament in the fluid chamber that substantially remains between 80 p.s.i, to 1000 p.s.i, during injection of the medicament; and

an elastomeric cushion configured to compensate for shape irregularities of the prefilled syringe and absorb energy when the energy source is activated;

wherein the prefilled syringe is associated with the housing in a fixed position before and during activation of the energy source for firing of the jet injector.