Needle assisted jet injector

• US 20050080377A1
• Filed: 12/03/2004
• Published: 04/14/2005
• Est. Priority Date: 08/11/1998
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: Lesch, Paul R. Jr., Holland, Margaret L., Berman, Claude L., Sadowski, Peter L., Deboer, David M.
• Granted Patent: US 7,776,015 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• 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 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• 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 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/349 using adhesive bond or glues

Abstract

A jet injection device with a fluid chamber in a housing member for holding about 0.02 ml to about 3 ml of a medicament. An injection-assisting needle has an injection end that extends from the housing for inserting into a patient to a depth of up to about 5 mm. A force-generating source is configured to apply a pressure reaching about 100-1000 psi to the medicament in the chamber to expel the medicament through the injecting end of the needle.

Claims

1. A jet injection device, comprising:

a housing member having distal and proximal ends;

a fluid chamber within the housing member for holding about between 0.02 ml and 3 ml of a medicament;

an injection-assisting needle disposed at the distal end of the housing member, having an injecting end, and having an association with the fluid chamber to provide a fluid pathway from the fluid chamber through the needle;

a plunger movable within the fluid chamber; and

a force generating source capable of providing sufficient force on the plunger to eject an amount of the medicament from the fluid chamber through the needle;

wherein the injecting end of the needle has a position extending from the housing member by a length selected for inserting into a patient to a needle insertion point at a depth of up to about 5 mm; and

wherein the force generating source is configured such that activation of the force generating source moves the plunger to apply a pressure to the medicament in the fluid chamber reaching about between 100 and 1000 p.s.i. to expel medicament from the fluid chamber and eject the amount of the medicament through the injecting end.

2. The jet injection device of claim 1, wherein the injection site is subcutaneous.

3. The jet injection device of claim 1, wherein the needle insertion point is at a depth of between about 1 mm and 5 mm.

4. The jet injection device of claim 1, wherein the needle insertion point is at a depth of up to about 3 mm.

5. The jet injection device of claim 1, wherein the force generating source and needle are configured such that the medicament is injected at a rate of at least 0.40 ml/sec upon activation of the force generating source.

6. The jet injection device of claim 1, wherein the force generating source and needle are configured to inject the medicament is injected to the injection site in less than about 2.75 seconds.

7. The jet injection device of claim 1, wherein the force generating source and needle are configured to inject the medicament is injected at a rate so that about 1 ml of the medicament is ejected in about 2 seconds.

8. The jet injection device of claim 1, wherein the force generating source and needle are configured to apply to the medicament a pressure that reaches up to about 500 p.s.i.

9. The jet injection device of claim 8, wherein the force generating source and needle are configured to apply to the medicament a pressure that reaches between about 150 and 375 p.s.i.

10. The jet injection device of claim 1, wherein the needle injecting end has a discharge orifice through which the medicament is ejected, the orifice having a diameter of about between 0.004 to 0.012 inches and the needle has a length of between about 1 mm and 5 mm.

11. The jet injection device of claim 1, wherein the needle has a gauge of 26 or 27.

12. The jet injection device of claim 1, wherein the needle comprises:

a injecting end portion that is insertable into the patient to the needle insertion point; and

a proximal portion that has common axial cross-sectional dimensions as the injecting end portion and extends proximally into an injection device housing member in which the fluid chamber is disposed during the ejection of the medicament, the proximal portion being longer than the injecting end portion.

13. The jet injection device of claim 12, wherein the proximal and injecting end portions have substantially common and continuous inner and outer diameters.

14. The jet injection device of claim 1, wherein the fluid chamber is made of glass.

15. The jet injection device of claim 1, wherein the housing member has a concealing association with the needle, wherein the device is configured such that the needle injecting end is extendable from the housing member to allow the insertion to the needle insertion point.

16. The jet injection device of claim 15, wherein the housing member comprises a needle shield located at the distal end of the housing member for concealing the needle, the needle shield being moveable between:

a protecting position, in which the needle is disposed within the guard prior to activation, and

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

17. The jet injection device of claim 16, further comprising an activation element operatively associated with the shield such that the activation element activates the force generating source upon retraction of the shield from the protecting position to the injection position.

18. The jet injection device of claim 1, further comprising a retraction element configured for retracting the needle into the housing member after the medicament is ejected.

19. The jet injection device of claim 1, wherein the housing member and needle are cooperatively associated to allow the insertion of the needle to the insertion point.

20. The jet injection device of claim 1, wherein the force generating source and needle are configured to expel medicament from the fluid chamber and eject the amount of the medicament through the injecting end and past the insertion point to an injection site that is deeper than the needle insertion point.

21. A jet injection device, comprising:

a housing member having distal and proximal ends;

a fluid chamber within the housing member for holding at least about 0.02 ml to 3 ml of a medicament;

an injection-assisting needle disposed at the distal end of the housing member, having an injecting end, and having an association with the fluid chamber to provide a fluid pathway from the fluid chamber through the needle;

a plunger movable within the fluid chamber; and

a force generating source capable of providing sufficient force on the plunger to eject an amount of the medicament from the fluid chamber through the needle;

wherein the injecting end of the needle has a position extending from the housing member by a length selected for inserting into a patient to a needle insertion point at a depth of up to about 5 mm; and

wherein the force generating source is configured such that activation of the force generating source moves the plunger to apply a pressure to the medicament in the fluid chamber to expel medicament from the fluid chamber and eject the amount of the medicament by a through the injecting end and past the insertion point to an injection site the pressure being about between 100 and 1000 p.s.i. while the medicament is being ejected.