Injection devices

• US 6,406,455 B1
• Filed: 12/17/1999
• Issued: 06/18/2002
• 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): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/465,573
• Time in Patent Office: 914 Days
• Field of Search: 604/68-69, 604/70-72, 604/82, 604/87-88, 604/89-92, 604/93.01, 604/122, 604/124, 604/125, 604/126, 604/181, 604/187, 604/191, 604/199, 604/200, 604/206, 604/218, 604/223, 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 and using the same are disclosed.

Claims

1. An injection device comprising:

a first housing having a gas chamber containing a source of gas, a port in fluid communication with the source of gas, and a displacement mechanism;

a movable plunger in the first housing, the plunger being in fluid communication with the port and the source of gas; and

a second housing defining an orifice configured for needless injection, the second housing including a first piston and a second piston slidably positioned in the second housing, the first and second pistons being movable by the displacement mechanism independently of the motive power of the source of gas,

the second housing, the first piston, and the second piston defining a first chamber capable of storing a fluid,

the second housing and the second piston defining a second chamber capable of storing and mixing a drug, the second chamber being in fluid communication with the orifice,

the plunger being configured to move the first piston toward the second piston, and to move the second piston to a position providing fluid communication between the first chamber and the second chamber, the first chamber capable of decreasing in volume and the fluid in the first chamber capable of transferring to the second chamber, and

the plunger configured to move the second piston upon release of gas from the source of gas, to decrease the volume of the second chamber, and to expel the fluid from the second chamber and through the orifice.

2. The injection device of claim 1, wherein the displacement mechanism is activated manually.

3. The injection device of claim 1, wherein the displacement mechanism is capable of incremental movement of at least one of the pistons.

4. The injection device of claim 1, wherein the displacement mechanism includes contact between the first and second housings and friction between the first and second housings provides incremental movement of at least one of the pistons.

5. The injection device of claim 1, wherein the displacement mechanism includes a threaded contact between the first and second housings and rotation between the housings provides incremental movement of one of the pistons.

6. The injection device of claim 1, wherein the second housing includes a bypass, which when engaged by the second piston, allow communication between the first chamber and the second chamber.

7. The injection device of claim 1, wherein the second housing includes a first module and a second module.

8. The injection device of claim 7, wherein

the first module comprises a first module housing, the first piston, and a first module seal, the first chamber being defined by the first housing, the first piston, and the first module seal; and

the second module comprises a second module housing, the second piston, and a second module seal, the second chamber being defined by the second module housing, the second piston, and the second module seal.

9. The injection device of claim 7, wherein engagement of the first module with the second module enables communication between the first chamber and the second chamber.

10. The injection device of claim 8, wherein one of the modules comprises a piercing member for piercing the module seal on the other module.

11. The injection device of claim 8, wherein one of the seal is pierced when the first and second modules are engaged.

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

providing injection device of claim 1; and

depositing the drug in the second chamber of the injection device.

13. The method of claim 12, wherein the drug is lyophilized or sterilized in situ in the second chamber.

14. The method of claim 12, wherein the second chamber is a part of a first second module.

15. The method of claim 12, wherein the first chamber is a part of a first module.

16. The method of claim 12, comprising applying a moisture resistant seal to the second chamber.

17. A method of providing a subject with a mixture of a first substance and a second substance, the method comprising:

providing the injection device of claim 1;

providing the first substance in the first chamber and the second substance in the second chamber;

activating the device to mix the first substance with the second substance; and

administering the to the subject.

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

19. The method of claim 17 wherein the second substance is a protein.