Single dose delivery device

• US 6,562,002 B1
• Filed: 02/15/2000
• Issued: 05/13/2003
• 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): Casler, Brian L.
• Assistant Examiner(s): Lam, Ann Y.
• Application Number:
  US09/504,179
• Time in Patent Office: 1,183 Days
• Field of Search: 604/82-92, 604/187, 604/199, 604/235, 604/200
• 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 chamber including a dry reagent bed having a mass of no more than about 1.0 g;

a compression component in the chamber for exerting pressure upon the reagent bed, wherein the compression component comprises an open cell foam; and

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

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

3. The system of claim 1, wherein the reagent is a drug that has activity in a patient.

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

g and 500 mg.

5. The system of claim 1, wherein the reagent bed has a mass between about 1 mg to 25 mg.

6. The system of claim 1, further comprising a diluent delivery device configured to connect upstream of the chamber.

7. The system of claim 6, wherein the diluent delivery device comprises a fixed volume of diluent.

8. The system of claim 7, wherein the fixed volume comprises between about 0.1 mL and 10 mL.

9. The system of claim 8, wherein the fixed volume comprises between about 0.1 mL and 1 mL.

10. The system of claim 6, wherein the diluent delivery device is integrally connected to the chamber.

11. The system of claim 6, wherein the diluent delivery device comprises a bioactive ingredient.

12. The system of claim 6, comprising a seal between the chamber and diluent delivery device when connected.

13. The system of claim 12, further comprising a mechanism for selectively opening said seal.

14. The system of claim 13, wherein said mechanism for selectively opening said seal comprises an internal needle selectively communicating fluid between the diluent delivery device and the chamber.

15. A device for delivering small quantities of drugs, comprising:

a chamber defined between a sealed inlet at an upstream end and a outlet at a downstream end;

a dry reagent bed including at least one bioactive ingredient housed within the chamber;

a spring element biased to compact the dry reagent bed housed within the chamber, wherein the spring element comprises an open cell foam; and

an injection needle integral with the chamber and in fluid communication with the outlet.

16. The device of claim 15, further comprising a hydrophobic plug between the needle and the reagent bed.

17. The device of claim 16, wherein the spring element is interposed between the dry reagent bed and the sealed inlet.

18. The device of claim 15, wherein the dry reagent bed has a mass between about 1 mg and 100 mg.

19. The device of claim 15, wherein the dry reagent bed has a mass between about 1 mg and 25 mg.

20. A reagent delivery system, comprising:

a first compartment comprising a diluent;

a second compartment providing a dry reagent therein;

a compacting mechanism in the second compartment for exerting pressure upon the dry reagent, wherein the compacting mechanism comprises an open cell foam;

a barrier separating the first compartment from the second compartment;

a first mechanism for selectively delivering the diluent from the first compartment to the second compartment to form a fluid carrying the reagent; and

a second mechanism for delivering the fluid carrying the reagent outside the system.

21. The system of claim 20, wherein the diluent has a volume of less than about 100 mL.

22. The system of claim 20, wherein the first mechanism and the second mechanism comprise needles.

23. The system of claim 20, further comprising an adaptor connecting the first compartment to the second compartment.

24. A method of preparing and delivering a defined drug dose, comprising:

converting a dry reagent into a fluid form by flowing a diluent along a laminar flow path through a chamber that houses the dry reagent;

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

delivering the fluid from the chamber directly into a delivery mechanism in fluid communication with a drug recipient.

25. The method of claim 24, wherein the delivery mechanism comprises an injection-needle.

26. The method of claim 24, wherein the delivery mechanism comprises an IV drip line.

27. The method of claim 24, further comprising piercing a seal between an upstream diluent delivery device and the chamber.

28. The method of claim 24, further comprising placing a diluent source housing a fixed fluid volume of less than about 100 mL in fluid communication with the chamber.

29. The method of claim 24, wherein converting comprises dissolving.

30. The method of claim 24, wherein converting comprises suspending.

31. A method of delivering a desired dose of reagent in fluid form, comprising:

providing the desired dose of reagent in dry form;

producing the fluid form by flowing diluent through the reagent in dry form;

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

delivering the desired dose to a patient without measuring the fluid form.