Drug storage and delivery system

• US 5,171,214 A
• Filed: 12/26/1990
• Issued: 12/15/1992
• Est. Priority Date: 12/26/1990
• Status: Expired due to Term

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Ziegler, John S., Larkin, Mark E., Karas, Peter J., Bryant, Peter L., Kolber, Chris M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Polutta, Mark O.
• Application Number:
  US07/634,275
• Time in Patent Office: 720 Days
• Field of Search: 604/82, 604/86, 604/87, 604/88, 604/92, 604/411, 604/412, 604/416, 604/415, 604/905, 604/200-203, 141/27, 222/82, 222/83, 222/83.5, 222/135, 222/136, 222/129, 206/222, 215/DIG. 8, 215/355, 215/247
• US Class Current: 604/82
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 5/2429 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A drug storage and delivery system that includes a drug containing vial assembly, a syringe assembly, and an adapter assembly for attaching the vial assembly to the adapter assembly. The vial assembly includes a vial that is provided with a pierceable stopper and a skirt member that circumscribes the outside of the vial. The syringe assembly includes a cannula extending longitudinally therethrough. The adapter assembly attaches the vial assembly to the syringe assembly in a manner that permits communication between the interior of the vial and the cannula extending through the syringe. The system also permits attachment of the syringe assembly to a container filled with a diluent and means for delivering the diluent into the vial assembly and subsequently directing the mixed solution back into the container.

Claims

1. A storage and delivery system for a flowable substance, comprising:

(a) a vial having a threaded opening, a wall portion and an end portion constructed and arranged to contain a flowable substance;

(b) a pierceable stopper in sealing engagement with said opening in said vial whereby the flowable substance may be extracted from said vial through a needle inserted into said vial through said stopper;

(c) a syringe assembly having a generally cylindrical housing and a cannula supported in said housing and extending longitudinally therethrough along an axis thereof;

(d) an adapter assembly including an adapter member for attaching said vial to said syringe assembly so as to permit communication between the interior of said vial and said cannula extending through said syringe;

(e) a skirt member frictionally engaging said wall portion of said vial, said skirt member having ratchet means associated therewith that cooperates with complementary ratchet means associated with said adapter member upon attachment of said adapter assembly to said vial so as to thereafter prevent disengagement of said vial from said adapter assembly;

(f) a lock member for attaching said adapter member to said syringe assembly wherein said adapter member releasably engages said lock member;

(g) a needle hub member associated with said adapter member and supporting said needle that pierces said stopper as said adapter member is attached to said vial, said vial opening being threaded with said needle hub member threadedly receiving said threaded opening as said adapter member is attached to said vial; and

(h) a fitting portion that cooperates with said lock member to provide fluid communication between said needle and said cannula as said adapter member is attached to said lock member.

2. The invention as defined in claim 1 wherein said needle hub member includes a detent portion for retaining said stopper in place within said opening as said adapter member is attached to said vial.

3. The invention as defined in claim 1 wherein said needle hub member is rigidly secured to said adapter member by ultrasonic welding.

4. The invention as defined in claim 1 wherein said adapter member has elongated recess portions that cooperate with complementary splines associated with said needle hub member to prevent rotation of said needle hub member with respect to said adapter member.

5. The invention as defined in claim 1 wherein said fitting portion of said needle hub member is a female portion of a luer connector in fluid communication with said needle and said lock member includes a complementary male portion of a luer connector in fluid communication with said cannula, such that said male portion is received by said female portion as said adapter member engages said lock member.

6. The invention as defined in claim 5 wherein said lock member is formed with an annular portion that is received within said adapter member as said adapter member engages said lock member.

7. The invention as defined in claim 1 wherein said lock member is formed integrally with said syringe assembly.

8. A system for separately storing and subsequently mixing the contents of at least two containers in one of the containers, said system comprising:

(a) a first container having an opening, a wall portion and an end portion constructed and arranged to contain a first substance, said first container having a pierceable stopper in sealing engagement with said opening whereby the contents of said first container may be extracted therefrom through a needle inserted thereinto through said stopper;

(b) a second container having an opening, a wall portion and an end portion constructed and arranged to contain a flowable second substance, said second container having a pierceable plug in sealing engagement with said opening whereby the contents of said second container may be extracted therefrom through a cannula inserted thereinto through said plug;

(c) a syringe assemby having a generally cylindrical housing and a cannula supported in said housing and extending longitudinally therethrough along an axis thereof, said syringe assembly having a first end portion attachable to said second container so as to permit communication between the interior of said second container and a first end of said cannula as said end extends through said plug; and

(d) an adapter assembly means including an adapter member with complementary ratchet means for attaching said first container to said syringe assembly so as to permit communication between a second end of said cannula and the interior of said first container through a needle inserted through said stopper; and

(e) a skirt member frictionally engaging said wall portion of said first container, said skirt member having ratchet means associated therewith that cooperates with complementary ratchet means associated with said adapter member upon attachment of said adapter assembly to said first container so as to thereafter prevent disengagement of said first container from said adapter assembly.

9. The invention as defined in claim 8 wherein said adapter assembly means includes an adapter member attachable to said vial and a lock member for attaching to said adapter member to said syringe assembly.

10. The invention as defined in claim 9 wherein said adapter member releasably engages said lock member.

11. The invention as defined in claim 10 wherein said adapter member has a needle hub member associated therewith, said needle hub member supporting said needle that pierces said stopper as said adapter member is attached to said vial, and a fitting portion that cooperates with said lock member to provide fluid communication between said needle and the second end of said cannula as said adapter member is attached to said lock member.

12. The invention as defined in claim 11 wherein said opening of said first container is threaded and said needle hub member threadedly receives said threaded opening as said adapter member is attached to said vial.

13. The invention as defined in claim 12 wherein said needle hub member includes a detent portion for retaining said stopper in place within said opening as said adapter member is attached to said vial.

14. The invention as defined in claim 9 wherein said first container has a skirt member in frictional engagement with said wall portion, said skirt member having ratchet means associated therewith that cooperates with complementary ratchet means associated with said adapter member upon attachment of said adapter assembly to said first container so as to thereafter prevent disengagement of said first container from said adapter assembly.

15. The invention as defined in claim 11 wherein said needle hub member is rigidly secured to said adapter member by ultrasonic welding.

16. The invention as defined in claim 11 wherein said adapter member has elongated recess portions that cooperate with complementary splines associated with said needle hub member to prevent rotation of said needle hub member with respect to said adapter member.

17. The invention as defined in claim 11 wherein said fitting portion of said needle hub member is a female portion of a luer connector in fluid communication with said needle and said lock member includes a complementary male portion of a luer connector in fluid communication with said second end of said cannula, such that said male portion is received by said female portion as said adapter member engages said lock member.

18. The invention as defined in claim 17 wherein said lock member is formed with an annular portion that is received within said adapter member as said adapter member engages said lock member.

19. The invention as defined in claim 8 wherein said plug has a threaded portion that is received by a cooperating threaded portion formed in said first end portion of said syringe member.

20. The invention as defined in claim 19 wherein said first end of said cannula pierces said plug as said plug is threadedly received by said syringe member.

21. The invention as defined in claim 10 wherein said second container is cylindrical and said plug is slidably received within said second container such that as said plug moves towards the end portion of said second container the second substance container therein is directed through said cannula and said needle into said first container.

22. The invention as defined in claim 21 wherein said second container is received in said syringe assembly as said plug moves towards said end of said second container.

23. The invention as defined in claim 9 wherein said lock member is formed integrally with said syringe assembly.