Injection devices

• US 6,960,184 B2
• Filed: 06/18/2002
• Issued: 11/01/2005
• Est. Priority Date: 12/18/1998
• Status: Expired due to Term

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Biovail Laboratories Incorporated (Bausch Health Cos., Inc.)
• Inventors: Gonnelli, Robert, Willis, John, Minior, Thaddeus
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/175,541
• Publication Number:
  US 20040249339A1
• Time in Patent Office: 1,232 Days
• Field of Search: 604140-145, 604/82, 604 89- 92, 604/90, 604/91, 604 68- 72, 604 87- 88, 604/93.01, 604125-126, 604131-133, 604/181, 604/187, 604/191, 604/200, 604/218, 604/244
• US Class Current: 604/68
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

Injection devices, such as needleless injection devices, and methods of making the using the same are disclosed.

Claims

1. An injection device comprising:

a housing having a proximate and a distal end;

a first piston disposed in said housing near the proximate end and a second piston intermediate between said distal end and said first piston, said first and second piston independently moveable within the housing, said housing, second piston and first piston defining first and second chambers;

an orifice suitable for needleless injection disposed on said distal end and in fluid communication with said first chamber;

an actuator moveably attached to the said proximate end for moving at least said first piston toward said distal end so to open a fluid passageway between said first and second chambers; and

a propellant disposed in said actuator and causing at least said first piston to expel a substance contained in at least said first chamber through said orifice.

2. The injection device of claim 1, wherein said actuator is activated manually.

3. The injection device of claim 2, wherein said actuator is capable of incremental movement relative to the housing.

4. The injection device of claim 1, wherein said actuator is attached to the housing by a threaded connection.

5. The injection device of claim 1, wherein said housing includes two subparts.

6. The injection device of claim 5, wherein said housing comprises:

a first module comprising a first module housing, said first piston, a first module seal, and said first chamber defined by the first module housing, said first piston, and said first module seal; and

a second module comprising a second module housing, said second piston, a second module seal, and said second chamber defined by said second module housing, said second piston, and said second module seal.

7. The injection device of claim 6, wherein engagement of said first module with said second module enables fluid communication between said first chamber and said second chamber.

8. The injection device of claim 6, wherein one or both modules comprises a piercing member for piercing one or both of the first module and second module seals.

9. The injection device of claim 6, wherein one or both of said module seals are disposed such that upon engagement of said first and second module, one or both of said seals are pierced.

10. A kit comprising one or more of one or both of the modules described in claim 6 wherein at least one of the modules contains a substance to be administered to a subject;

and instructions for use.

11. The kit of claim 10, further comprising one or more one or more other elements of the injection device described in claim 1.

12. A method of making an injection device having disposed therein a substance, comprising:

providing the injection device of claim 1;

and depositing a drug in at least one of said first and second chamber.

13. The method of claim 12, wherein, a drug is lyophilized or sterilized in situ in said at least one chamber.

14. The method of claim 12, wherein, said at least one chamber is provided as part of a second module, and an operation is performed with the rest of the elements of the injection device described in claim 1 present.

15. The method of claim 12, wherein after an operation one or more moisture resistant seals are applied to the at least one chamber.

16. Method of providing a subject with a mixture of a first substance and a second substance comprising:

providing the first substance in the first chamber and the second substance in the second chamber of the device described in claim 1;

moving the actuator to mix the first substance with the second substance and

administer the mixture to the subject.

17. The method of claim 16, wherein said first substance is a liquid and said second substance is a dry substance.

18. The method of claim 16 wherein said second substance is a protein.

19. The injection device of claim 1, wherein the actuator further comprises a plunger or a separate member that transfers movement to said first piston.

20. The injection device of claim 1, wherein the propellant is a pressurized gas.

21. The injection device of claim 1, wherein the propellant is produced by a chemical reaction.