Single dose delivery device

• US 6,932,791 B2
• Filed: 05/12/2003
• Issued: 08/23/2005
• Est. Priority Date: 02/16/1999
• Status: Expired due to Fees

• Current Assignee: Prismedical Corporation
• Original Assignee: Prismedical Corporation
• Inventors: Taylor, Michael A.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/437,412
• Publication Number:
  US 20040015128A1
• Time in Patent Office: 834 Days
• Field of Search: 604/89, 604 82- 88, 604 90- 92, 604/93.01, 604/148, 604/139, 604/890.1, 604200-205, 604/226, 604411-416, 604/905, 604221-222, 604231-232, 604/235, 604244-246, 604/187, 604/199
• US Class Current: 604/82
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• CPC Class Codes: A61M 5/31531 Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• CPC Class Codes: A61M 5/3294 comprising means for injection of two or more media, e.g. by mixing

Abstract

A microinjection system comprises a device for housing dried forms of medical reagents, such as vaccines, hormones, etc. in single doses. Within a single chamber, a dry reagent bed is provided adjacent a compression component that keeps the bed compacted. In operation, diluent flows through the chamber to carry the reagent out of the chamber in fluid form. In the illustrated embodiments, the fluid carrying reagent is directly delivered from the chamber via a needle. Integral or connectable diluent delivery devices are disclosed for providing an appropriate volume of diluent to the reagent chamber. Unstable formulations of drugs, for example, can be safely stored in dry form. When injection is needed, the drug can be delivered almost instantly in fluid form simply by releasing diluent through the chamber, where the reagent bed is dissolved or suspended while the remaining reagent is continually compacted. The resultant fluid contains a single dose of the reagent and is delivered directly to a patient, desirably without measurement of the fluid form.

Claims

1. A system for delivering single dose units of medical reagents in fluid form, comprising:

a diluent chamber having a connector, the diluent chamber comprising a fixed volume of diluent;

a diluent delivery mechanism within the connector downstream of the diluent chamber;

a reagent chamber including a dry reagent bed, wherein the reagent chamber is integrally connected with the connector and the diluent delivery mechanism;

a compression component in the reagent chamber positioned for exerting pressure upon the reagent bed; and

a reagent delivery mechanism integrally connected with and downstream of the reagent chamber for delivering the reagent in a liquid.

2. The system of claim 1, wherein the diluent delivery mechanism is a needle.

3. The system of claim 1, wherein the reagent bed has a mass between about 10 μ

g and 1.0 g.

4. The system of claim 1, wherein the diluent chamber has a maximum volume of about 10 mL.

5. The system of claim 1, wherein the diluent chamber comprises a bioactive ingredient.

6. The system of claim 1, further comprising a seal between the reagent chamber and the diluent chamber.

7. The system of claim 6, wherein the mechanism for selectively opening the seal comprises an internal needle selectively communicating fluid between the diluent chamber and the reagent chamber.

8. A reagent delivery system, comprising:

a diluent delivery device comprising a diluent chamber having a maximum volume of about 10 mL;

a reagent delivery device, comprising a reagent chamber, a reagent bed, a compression component in the reagent chamber positioned for exerting pressure on the reagent bed;

a diluent delivery mechanism upstream of the reagent delivery device, the diluent delivery mechanism having a proximate end and a distal end; and

a reagent delivery mechanism integrally connected and downstream of the reagent chamber for delivering the reagent in a liquid outside the system.

9. The reagent delivery system of claim 8, wherein the diluent delivery device further comprises a chamber seal between the diluent chamber and the diluent delivery mechanism and the reagent delivery device further comprises a reagent chamber cap upstream of the reagent chamber.

10. The reagent delivery system of claim 9, wherein the diluent delivery mechanism comprises a needle.

11. The reagent delivery system of claim 8, wherein the diluent delivery device further comprises a collar extending from the diluent chamber, wherein the collar is integrally connected with the reagent delivery device.

12. The reagent delivery system of claim 11, wherein the proximate end of the diluent delivery mechanism perforates the chamber seal and the distal end of the diluent delivery mechanism perforates the reagent chamber cap.

13. The reagent delivery system of claim 8, wherein the compression component is porous.

14. The reagent delivery device of claim 8, wherein diluent delivery device comprises a fixed volume of diluent.

15. A method of delivering a defined drug dose in fluid form, comprising:

integrally connecting a diluent chamber with a reagent delivery device comprising a reagent chamber and a reagent delivery mechanism downstream of the reagent chamber, wherein the diluent chamber has a maximum volume of about 10 mL;

converting a dry reagent within the reagent chamber into a fluid form by flowing a diluent along a path from the diluent chamber to the reagent chamber;

compressing the dry reagent with a compacting mechanism while flowing the diluent through the dry reagent; and

delivering the fluid form from the reagent chamber through the reagent delivery mechanism to a drug recipient in fluid communication with the reagent delivery mechanism.

16. The method of claim 15, wherein the reagent delivery mechanism comprises an injection needle.

17. The method of claim 15, connecting the diluent chamber with the reagent delivery device further comprises piercing a seal between the diluent chamber and the reagent chamber, wherein the reagent chamber is downstream of the diluent chamber.

18. The method of claim 15, wherein converting comprises dissolving.

19. The method of claim 15, wherein converting comprises suspending.