Vial access adapter

• US 6,139,534 A
• Filed: 01/24/2000
• Issued: 10/31/2000
• Est. Priority Date: 01/24/2000
• Status: Expired due to Term

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Inventors: Niedospial, John J. Jr., Gabbard, Mark E., Gabbard, Timothy J.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US09/489,619
• Time in Patent Office: 281 Days
• Field of Search: 604/126, 604/403, 604/405, 604/406, 604/411, 604/414, 604/415, 604/905, 215/247, 215/249, 215/270, 215/274, 215/320, 215/355, 215/DIG. 3
• US Class Current: 604/411
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2044 having slits
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

A vial access adapter for withdrawal of a medical fluid contained in a vial which includes a vial access adapter body having a circular top wall with a plurality of vent holes, a circular second wall spaced from the top wall, and a cylindrical side wall which walls define a chamber for holding an anti-bacterial filter. A first spike centrally located in the vial access adapter body extends through the top wall, chamber, and bottom wall, with one end extending above the top wall terminating in a threaded luer connector, while the other end terminates in a sharp point. A flow channel extends through the first spike designed for withdrawal of the medical fluid from the vial. A second spike positioned parallel to the first spike extends from the second wall, one end of which extends into the chamber, and the other end terminates in a sharp point. A flow channel extends through the second spike designed for air flow from the chamber into the vial. An elastomeric membrane positioned within the threaded luer connector seals the opening in the vial access adapter. Preferably the elastomeric membrane is of M-shaped configuration capable of flexing under pressure and of re-sealing itself after being pierced by a luer connector or a syringe equipped with a luer connector.

Claims

1. A vial access adapter-vial assembly comprising:

a) a vial having a medical fluid therein; and

b) a vial access adapter body, wherein said vial comprises a fluid port closed by an elastomeric stopper for hermetically sealing the medical fluid contained therein, said elastomeric stopper having a top surface and a bottom surface;

said vial access adapter body comprising;

a horizontal top wall having a plurality of vent holes therein;

a horizontal second wall spaced parallel from said horizontal top wall;

a cylindrical side wall enclosing a chamber between said horizontal top wall and said horizontal second wall and extending downward from said horizontal second wall forming a skirt and terminating in a bottom rim, wherein said chamber contains an anti-bacterial filter therein;

a first spike centrally located in said vial access adapter body having;

a top portion extending above said horizontal top wall and terminating in an externally threaded luer connector, and a bottom portion extending downward and terminating in a sharp point;

a fluid flow channel in said first spike designed for carrying said medical liquid from said vial;

a second spike positioned parallel to said first spike extending downward from said horizontal second wall and terminating in a sharp point;

an air flow channel in said second spike designed for air flow from said chamber into said vial during withdrawal of said medical liquid from said vial; and

an elastomeric membrane within said externally threaded luer connector for sealing the fluid flow channel;

wherein said first spike and said second spike are pierced through said elastomeric stopper to establish fluid communication with said medical fluid contained in said vial and air flow communication from said chamber into said vial.

2. The vial access adapter of claim 1 wherein said elastomeric membrane is of M-shaped configuration capable of flexing under pressure and re-sealing itself after being pierced by an external access means.

3. The vial access adapter of claim 1 wherein said elastomeric membrane has a thickness of from about 5 mm to about 20 mm, and a durometer of from about 25 to about 80 Shore A.

4. The vial access adapter of claim 1 wherein said elastomeric membrane is of an elastomeric material selected from the group consisting of natural rubber;

acrylate-butadiene rubber;

cis-polybutadiene;

chlorobutyl rubber;

chlorinated polyethylene elastomers;

polyalkylene oxide polymers;

ethylene vinyl acetate;

fluorosilicone rubbers;

hexafluoropropylene-vinylidene;

tetrafluoroethylene terpolymers;

butyl rubbers;

polyisobutene;

synthetic polyisoprene rubber;

silicone rubbers;

styrene-butadiene rubbers;

tetrafluoroethylene propylene copolymers; and

thermoplastic-copolyesters.

5. The vial access adapter of claim 2 wherein said M-shaped elastomeric membrane comprises a leg portion and a cup-shaped portion.

6. The vial access adapter of claim 5 wherein said cup-shaped portion comprises a horizontal bottom portion having a top surface and a bottom surface and a slit therein extending from the top surface thereof towards the bottom surface thereof without penetrating said bottom surface.

7. The vial access adapter of claim 1 wherein said cup-shaped portion, which is unpenetrated has a thickness of from about 0.001 to about 2.0 mm.

8. The vial access adapter-vial assembly of claim 1 wherein said sharp point of said first spike piercing said elastomeric stopper is essentially at the bottom surface of said elastomeric stopper.

9. The vial access adapter-vial assembly of claim 1 wherein said anti-bacterial filter is a circular mat of randomly oriented fibers bound together with a polymeric material selected from the group consisting of polyester elastomers, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, polyethylene and polypropylene treated with an anti-bacterial agent.

10. The vial access adapter-vial assembly of claim 1 wherein said randomly oriented fibers are selected from the group consisting of nylon, cellulose rayon and polyester.