Two-chamber mixing syringe

• US 3,946,732 A
• Filed: 07/18/1974
• Issued: 03/30/1976
• Est. Priority Date: 08/08/1973
• Status: Expired due to Term

• Current Assignee: Ampoules Incorporated
• Original Assignee: Ampoules Incorporated
• Inventors: Hurscham, Alfred A.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US05/489,746
• Time in Patent Office: 621 Days
• Field of Search: 128/218 M, 128/218 D, 128/218 DA, 128/218 PA, 128/218 C, 128/220, 128/234, 128/272, 128/215, 128/216, 128/DIG. 28, 128/235, 128/237
• US Class Current: 604/88
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/31505 Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001

Abstract

Two-chamber syringes for mixing a powdered medicament with a diluent and then injecting the mixed ingredients into a patient are disclosed, together with a technique for assembling those syringes. According to one aspect of the invention, the syringe includes a vial formed with a single glass cylinder closed at one end by a plunger and at its other end by a pierceable diaphragm. An intermediate pierceable diaphragm divides the cylinder into upper and lower chambers, and is locked against axial movement relative to the cylinder. A powdered medicament is provided in the upper chamber and a diluent is provided in the lower chamber. The ingredients are mixed by inserting the vial into a cup-shaped holder having a hollow, pointed needle extending from the base of the holder. Axial pressure on the vial causes the pointed end of the needle to sequentially pierce the end intermediate diaphragms, and to cause the diluent to flow into an opening in the sidewall of the needle, through the needle, and then into the upper chamber from the pointed needle end. The thus-mixed ingredients are dispensed by applying axial pressure to the plunger, or by drawing metered amounts into the medicament pressurizing chamber of a needleless, hypojet injector.

Claims

1. A two-chamber mixing syringe comprising:

a. vial means;

b. a plunger slidable within and closing one end of the vial means;

c. an end diaphragm closing the other end of the vial means;

d. a stationary intermediate diaphragm within said vial means separating the interior of the vial means into first and second chambers respectively defined by said plunger and intermediate diaphragm and by said intermediate diaphragm and said end diaphragm;

said vial means and intermediate diaphragm having coacting parts that comprise means for locking the intermediate diaphragm against axial movement towards said plunger during a mixing operation and during a dispensing operation;

said coacting parts comprising radially extending interengaging and interfering surfaces on said vial means and said intermediate diaphragm;

e. a cup-shaped holder having a cylindrical bore closed at one end and receiving said other end of said vial means with said other end of said vial means spaced from said closed end of said bore; and

f. hollow needle means having a pointed end within the space between said other end of said vial means and said closed end of said bore, whereby an ingredient in said first chamber may be mixed with an ingredient in said second chamber by applying axial pressure to said vial means so that said needle sequentially pierces said end diaphragm and said intermediate diaphragm and whereby said ingredients may be dispersed by advancing said plunger toward said intermediate diaphragm.

2. A two-chamber mixing syringe according to claim 1 wherein said coacting parts lock the intermediate diaphragm against movement in both directions.

3. A two-chamber mixing syringe according to claim 2 wherein said needle means includes another pointed end projecting from said holder in axial alignment with the pointed end within said space and in fluid communication therewith.

4. A two-chamber mixing syringe according to claim 2 wherein said needle means has an opening therein spaced from said pointed end.

5. A two-chamber mixing syringe according to claim 4 wherein said intermediate diaphragm and said end diaphragm have axially aligned pierceable portions.

6. A two-chamber mixing syringe according to claim 5 wherein the axial longitudinal extent of said needle opening exceeds the thickness of the pierceable portion of said intermediate diaphragm.

7. A two-chamber mixing syringe according to claim 6 wherein the needle means within said space projects from end abutment means extending from the closed end of said bore.

8. A two-chamber mixing syringe according to claim 7 wherein the abutment means is adapted to be received within said other end of said vial means.

9. A two-chamber mixing syringe according to claim 7 wherein the distance between the abutment means and the opening in the needle does not substantially exceed the thickness of said end diaphragm.

10. A two-chamber mixing syringe according to claim 7 wherein the distance between said abutment means and the pointed end of the needle exceeds the combined axial extents of the thickness of said end diaphragm, the second chamber and the pierceable portion of said intermediate diaphragm.

11. A two-chamber mixing syringe according to claim 2 wherein portions of the intermediate and end diaphragms defining said second chamber are complementary surfaces for mating engagement.

12. A two-chamber mixing syringe according to claim 2 wherein portions of said plunger and said intermediate diaphragm defining said first chamber are complementary surfaces for mating engagement.

13. A two-chamber mixing syringe according to claim 4 wherein said opening is covered by a flexible sleeve which surrounds said needle.

14. A two-chamber mixing syringe according to claim 2 wherein said coacting parts include an inwardly extending circumferential rib in the vial means which cooperate with a circumferential recess in said intermediate diaphragm.

15. A two-chamber mixing syringe according to claim 14 wherein a circumferential groove in the exterior sidewall of the vial means provides said inwardly extending circumferential rib and wherein a wire clip having prongs directed toward said one end encircles said groove.

16. A two-chamber mixing syringe according to claim 2 wherein energy storing means is provided between said end diaphragm and the closed end of said bore and is adapted to apply increasing amounts of pressure to said end diaphragm as said axial pressure is applied, whereby said energy storing means drives said end diaphragm toward said intermediate diaphragm when said needle pierces said intermediate diaphragm.

17. A two-chamber mixing syringe according to claim 16 wherein said energy storing means comprises a spring.

18. A two-chamber mixing syringe according to claim 16 wherein said needle has a beveled edge, the axial entent of which exceeds the axial extent of a pierceable portion of said intermediate diaphragm.

19. A two-chamber mixing syringe according to claim 3 wherein filter means is provided between the pointed ends of said needle means.

20. A two-chamber mixing syringe according to claim 1 wherein there is provided means between said vial and said cup-shaped holder to prevent withdrawal of said vial from said holder prior to and during axial movement of said vial and cup-shaped holder relative to each other.

21. A two-chamber mixing syringe according to claim 20 wherein said means for preventing said axial movement is located in a circumferential groove in the exterior sidewall of the vial means.

22. A two-chamber mixing syringe according to claim 9 wherein the needle has a beveled edge which constitutes said window opening.

23. A two-chamber mixing syringe comprising:

a. a glass cylinder;

b. a plunger slidable within and closing one end of the cylinder;

c. an end diaphragm closing the other end of the cylinder;

d. a stationary intermediate diaphragm within said cylinder separating the interior of the cylinder into first and second chambers respectively defined by said plunger and intermediate diaphragm and by said intermediate diaphragm and end diaphragm;

said cylinder and intermediate diaphragm having coacting parts that comprise means for locking the intermediate diaphragm against axial movement toward said plunger during a mixing and during a dispensing operation;

said coacting parts comprising radially extending interengaging and interfering surfaces on said vial means and said intermediate diaphragm;

e. a cup-shaped holder having a cylindrical bore closed at one end and receiving said other end of said cylinder with said other end of said cylinder spaced from said closed end of said bore; and

f. a hollow pointed needle within the space between said other end of said cylinder and said closed end of said bore, whereby an ingredient in said first chamber may be mixed with an ingredient in said second chamber by applying axial pressure to said vial means so that said needle sequentially pierces said end diaphragm and said intermediate diaphragm and whereby said ingredients may be dispersed by advancing said plunger toward said intermediate diaphragm.

24. A two-chamber mixing syringe according to claim 23 wherein said coacting parts lock said intermediate diaphragm against axial movement toward said plunger and intermediate diaphragm.

25. A two-chamber mixing syringe according to claim 24 wherein said coacting parts comprise an inwardly extending circumferential rib in the cylinder which cooperates with a circumferential recess in said intermediate diaphragm.