Claims for Patent: RE44846

Summary for Patent: RE44846

Title:	Needle assisted jet injector
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.
Inventor(s):	Sadowski; Peter L. (Woodbury, MN), Deboer; David M. (Grand Rapids, MI), Berman; Claude L. (Effingham, NH), Lesch, Jr.; Paul R. (Lino Lakes, MN), Holland; Margaret L. (New Haven, CT)
Assignee:	Antares Pharma, Inc. (Ewing, NJ)
Application Number:	13/531,023
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE44846
Patent Claims:	1. A jet injection device, comprising: a housing member having distal and proximal ends; a fluid chamber within the housing member holding about between 0.02 ml and 3 ml of a medicament comprising fluid; 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, the injecting end of the injection-assisting needle having an axial opening for ejection of the medicament; a plunger movable within the fluid chamber; and a force generating mechanical member within the housing member that is elastically-deformed so as to provide sufficient force to eject the medicament from the fluid chamber through the needle by jet injection in a high-speed jet that exits the injecting end of the needle through the axial opening thereof at a fluid pressure of about between 100 and 1000 p.s.i. to penetrate patient tissue to a distance through and axially beyond the insertion point to an injection site; wherein the injecting end of the needle has a position extending from the housing member by a length selected for inserting into a patient such that the injecting end reaches a needle insertion point at a depth of up to about 5 mm below the surface of the patient's skin; and wherein the device is further configured such that activation of the force generating mechanical member applies the generated force to the plunger to expel the medicament from the fluid chamber. 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 amount of the medicament 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 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 axial opening of the needle injecting end has a diameter of about between 0.004 to 0.012 inches and the needle has a length sufficient for penetrating the skin to a depth of between about 1 mm and 5 mm. 11. The jet injection device of claim 1, wherein the needle is a 26 to 27 gage needle. 12. The jet injection device of claim 1, wherein the needle further comprises a proximal portion that has common axial cross-sectional dimensions with the injecting end 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. 13. The jet injection device of claim 12, wherein the proximal portion and injecting end 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. 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, the injecting end of the injection-assisting needle having an axial opening for ejection of the medicament; a plunger movable within the fluid chamber; and a force generating source comprising a spring pre-compressed to provide sufficient force to eject the medicament from the fluid chamber through the needle by jet injection in a high-speed jet that exits the injecting end of the needle through the axial opening thereof at a pressure of about between 100 and 1000 p.s.i. so as to penetrate patient tissue to a distance through and axially beyond the insertion point to an injection site wherein the needle insertion point is located more superficially than the injection site; wherein the injecting end of the needle has a position extending from the housing member by a length selected for inserting into a patient such that the injecting end reaches a needle insertion point at a depth of no more than about 5 mm below the surface of the patient's skin; and wherein the force generating source is further configured such that activation of the force generating source applies the force of the pre-compressed spring to the plunger to expel the medicament from the fluid chamber. 21. The jet injection device of claim 1 wherein the fluid chamber comprises a frangible material and the force generating member comprises a pre-compressed spring. 22. The jet injection device of claim 1 wherein the fluid chamber comprises glass and the force generating member comprises a pre-compressed elastomer. .Iadd.23. An injection device comprising: an outer housing member having distal and proximal ends; an inner housing member located within the outer housing member; a cartridge assembly disposed within the inner housing member, the cartridge assembly comprising a medicament; a plunger movable within the cartridge assembly; a needle assembly comprising an injecting needle; a needle guard, at least a portion of which is located within the distal end of the outer housing member, the needle guard having an orifice through which the injecting needle passes, and wherein the needle guard has an extended sliding position, a retracted position when the medicament is expelled from the cartridge assembly and an extended locked position to cover the needle after the medicament is expelled from the cartridge assembly; a latch within the proximal end of the outer housing member; and a spring within the proximal end of the outer housing member and in communication with the latch and in force communication with a ram which is in force communication with the plunger to expel medicament from the cartridge assembly through the injecting needle, wherein before the needle guard moves from the extended sliding position toward the retracted position, the spring is under a compression sufficient to provide a force to expel the medicament from the cartridge assembly and the latch retains the spring under the compression until the needle guard reaches the retracted position. .Iaddend. .Iadd.24. An injection device according to claim 23, wherein the injecting needle passes through the orifice before the medicament is expelled from the cartridge assembly. .Iaddend. .Iadd.25. An injection device according to claim 23, wherein the injection needle has an axial opening for ejection of the medicament. .Iaddend. .Iadd.26. An injection device according to claim 23, wherein the cartridge assembly is in fluid communication with the needle assembly. .Iaddend. .Iadd.27. An injection device according to claim 23, wherein at least a portion of the outer housing member comprises transparent material. .Iaddend. .Iadd.28. An injection device according to claim 23, further comprising a second spring located within the needle guard, wherein the second spring applies a force to urge the needle guard towards the distal end of the injector device to conceal the injecting needle before and after the medicament is expelled from the cartridge assembly. .Iaddend. .Iadd.29. An injection device according to claim 23, further comprising a locking mechanism to maintain the needle guard in the extended locked position. .Iaddend. .Iadd.30. An injection device according to claim 23, further comprising a removable safety cap located at the distal end of the housing and covers the needle guard. .Iaddend. .Iadd.31. An injection device comprising: an outer housing member having distal and proximal ends; an inner housing member located within the outer housing member; a cartridge assembly disposed within the housing member, the cartridge assembly comprising a medicament; a plunger movable within the cartridge assembly; a needle assembly in fluid communication with the cartridge assembly and comprising an injecting needle; a spring within the proximal end of the outer housing member in force communication with a ram which is in force communication with the plunger to expel medicament from the cartridge assembly through the injecting needle; a latch within the proximal end of the outer housing member and in releasing communication with the spring; a pushbutton located at the proximal end of the outer housing member and in activating communication with the latch; a needle guard in communication with the pushbutton, at least a portion of the needle guard is located within the distal end of the outer housing member, the needle guard having an orifice through which the injecting needle passes, and wherein the needle guard has an extended sliding position, a retracted position when the medicament is expelled from the cartridge assembly and an extended locked position after the medicament is expelled from the cartridge assembly; and wherein movement of the needle guard communicates with and unlocks the pushbutton to permit a user to manually fire the injection device by depressing the pushbutton to activate the latch and release the spring; and wherein before the needle guard moves from the extended sliding position toward the retracted position, the spring is under a compression sufficient to provide a force to expel the medicament from the cartridge assembly. .Iaddend. .Iadd.32. An injection device according to claim 31, wherein the injecting needle passes through the orifice before the medicament is expelled from the cartridge assembly. .Iaddend. .Iadd.33. An injection device according to claim 31, wherein the injection needle has an axial opening for ejection of the medicament. .Iaddend. .Iadd.34. An injection device according to claim 31, wherein at least a portion of the outer housing member comprises transparent material. .Iaddend. .Iadd.35. An injection device according to claim 31, further comprising a spring located within the needle guard, said spring applies a force to urge the needle guard towards the distal end of the injector device to conceal the injecting needle before and after the medicament is expelled from the cartridge assembly. .Iaddend. .Iadd.36. An injection device according to claim 31, further comprising a locking mechanism to maintain the needle guard in the extended locked position. .Iaddend. .Iadd.37. An injection device according to claim 31, further comprising a removable safety cap located at the distal end of the housing and covers the needle guard. .Iaddend.